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Source: https://international-pharma.com/feed/

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<title>PCI Pharma Services Begins Installation</title>
<link>https://international-pharma.com/pci-pharma-services-begins-installation/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 02 May 2024 15:11:45 +0000</pubDate>
<category><![CDATA[News]]></category>
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<description><![CDATA[of Sterile Fill-Finish and Lyophilization Line as Part of $100 Million New Facility Expansion  Construction and validation activities at leading CDMO’s Bedford, NH campus will conclude later this year, with GMP production commencing early 2025. PCI Pharma Services, (“PCI”) a world leading global contract development and manufacturing organization (CDMO), has begun installation of key equipment […]]]></description>
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of Sterile Fill-Finish and Lyophilization Line as Part of $100 Million New Facility Expansion 
Construction and validation activities at leading CDMO’s Bedford, NH campus will conclude later this year, with GMP production commencing early 2025. 
PCI Pharma Services, (“PCI”) a world leading global contract development and manufacturing organization (CDMO), has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus. Twin lyophilizers and a state-of-the-art large-scale isolator filling line are currently being installed at the forthcoming 50,000-square-foot plant, as foundational components of a previously announced, multi-year $100 million capital investment project. Additional equipment will be incorporated in the coming weeks.
The site constitutes the third high-throughput, isolator-based commercial sterile fill-finish facility that PCI has built in the last three years, aligning with the CDMO’s goals of substantially increasing its sterile fill-finish capacity and production capabilities. Since the plant’s 2022 groundbreaking, PCI has methodically developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilization solutions.
The facility will provide increased capacity using Annex 1-compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin 430-square-foot lyophilizers featuring automatic loading and unloading systems. The integrated filler will be capable of manufacturing batch sizes of up to 300,000 vials at a rate of up to 400 vials per minute, providing large-scale capacity for the filling of life changing, late phase clinical and commercial small molecules and biologics – including high-value drug products such as mAbs, oligonucleotides, fusion proteins and peptides.
Engineering and validation runs at the new facility are scheduled to occur in late fall, with the line ready for GMP production in Q1 2025. Starting this summer, PCI will be inviting current and potential clients to visit the plant, providing the opportunity to reserve valuable production capacity.
PCI has over 25 years of experience in lyophilization and sterile fill-finish manufacturing, offering deep technical expertise in the end-to-end processing of innovative and complex products. The new high-volume lyophilization and liquid filling facility will add to PCI’s ability to provide full product lifecycle management – from formulation and lyo cycle development through clinical stages and large commercial-scale sterile manufacturing.
“PCI’s expert technical, engineering and project management teams – working closely with our long-term contractor partners – are among the industry’s most experienced when it comes to delivering complex, time-sensitive capital projects,” said John Ross, Senior Vice President Drug Development and Manufacturing for PCI Pharma Services. “Our soon-to-open and newest sterile fill-finish and lyophilization facility at our expansive Bedford campus will continue to showcase these strengths, and serve to significantly expand our offering in bringing novel medicines to patients.”
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About PCI Pharma Services
PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain), and over 6,000 employees working to bring life-changing therapies to patients. Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients’ lives. For more information, visit <a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpci.com%2F&esheet=53636356&newsitemid=20231019397849&lan=en-US&anchor=pci.com&index=6&md5=ac18861715fc4f6ce941d12b928bd44a" target="_blank" rel="noreferrer noopener">pci.com</a>
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<title>CPHI North America experts ‘mid-sized domestic CDMOs need to invest in operational efficiencies to drive “real” reshoring’</title>
<link>https://international-pharma.com/cphi-north-america-experts-mid-sized-domestic-cdmos-need-to-invest-in-operational-efficiencies-to-drive-real-reshoring/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 30 Apr 2024 13:50:02 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39063</guid>
<description><![CDATA[Supply chain resilience and new partner sourcing to benefit from a boom in outsourcing in 2025 Ahead of CPHI North America held at the Pennsylvania Convention Centre (May 7-9th) experts forewarn that US based domestic CDMOs, particularly those in the mid to small size range, need to invest throughout 2024 if they are to maximise the benefits from the […]]]></description>
<content:encoded><![CDATA[
Supply chain resilience and new partner sourcing to benefit from a boom in outsourcing in 2025
Ahead of <a href="https://www.cphi.com/northamerica/en/home.html" target="_blank" rel="noreferrer noopener">CPHI North America</a> held at the Pennsylvania Convention Centre (May 7-9th) experts forewarn that US based domestic CDMOs, particularly those in the mid to small size range, need to invest throughout 2024 if they are to maximise the benefits from the significant uptick in contract services funding predicted for 2025. Improving supply chain resilience, exploring pilot scale manufacturing of new technologies, and ‘friend shoring’ were also identified as key trends in 2024.
“I see 2024 as still a holding pattern year, where funding is gradually returning to biotech, and this is beginning to filter through again to the outsourcing community. However, it’s not just a case of waiting for the market to return… if US-based smaller and medium sized CROs and CDMOs are to benefit from the likely resurgence in 2025, they need to be focusing now on operational efficiencies and commercial effectiveness. This means investing in manufacturing process improvements, like continuous and titer reductions, as well as other areas of the business that could bring overall efficiencies, from enhancing quality management to areas like AI to enhance/accelerate process development and quality trend analysis. Any area that drives more efficiency in CDMO operations, even streamlining and enhancing effectiveness in new business development using AI enabled tools. So this will be a year of seeking productivity excellence and cost containment to prepare for a potentially bigger resurgence in outsourcing in 2025”, commented CPHI expert, Brian Scanlan, Operating Partner – Life Science Edgewater Capital Partners.
One potential application that will be discussed during the event is using generative AI to analyze requirements for pharmaceutical drug manufacturers and distributors to comply with the impending Drug Supply Chain Security Act, which will come into effect this November (2024).
The advice comes at a timely moment as rumours swirl that the larger Indian CRO/CDMOs appear to be the most immediate beneficiaries of geopolitical outsourcing – i.e. a move away from China – rather than domestic and near shored options.
Bikash Chatterjee, President and Chief Science Officer at Pharmatech Associates – A USP Company who will be chairing a session at the event on “<a href="https://www.cphi.com/northamerica/en/attend/attend/why-attend.html" target="_blank" rel="noreferrer noopener">reshoring opportunities versus realties</a>“, added: “What you are seeing in the USA – and in some ways it’s not a new trend – is a much more considered approach to sourcing. Companies are looking to ensure they have alternative supply and potentially also in different geographic locations from their primary options…. What’s driving this? Well, we have seen a <a href="https://aspe.hhs.gov/reports/preventing-shortages-supply-chain-vulnerabilities" target="_blank" rel="noreferrer noopener">whitepaper come out from HHS</a> earlier this month on preventing drug shortages and in the next few years we could see companies even scored on their supply chain resilience. So we might be entering a period when companies are willing to pay more for extra resilience in their networks.”
Chatterjee suggests that the next six months will see many companies looking to prepare for 2025, with much more detailed planning for supply side resilience and potentially a greater short-term focus on ‘near’ or ‘friend shoring’ options – as opposed to domestic US sites – as these countries are better set, at present, to pick up resources and build ingredients and starting materials networks.
This trend’s impact is evident at CPHI North America, where an anticipated convergence of 4000 attendees and 300 companies will experience a profound shift. North American manufacturers are increasingly diversifying their sourcing of ingredients, seeking options not only in India as alternatives to Chinese suppliers, but also exploring opportunities across the globe, including within Europe and even South America.
This year’s event is focused on empowering the North American ecosystem with the new insight and next-generation manufacturing approaches it will need to ‘retool’ ahead of the anticipated increased in outsourcing in 2025. Both Chatterjee and Scanlan advise that as well working on today’s immediate priorities, forward looking CDMOs should be investing [time as well as traditional capital] in all types of operational efficiencies, from pilot schemes of continuous to using AI to improve workflows in marketing and regulatory documentation.
In total, the event will see some 58 sessions with other notable keynotes on ‘Sustainability: Accelerating the Path to Net Zero’ and ‘the Importance of Excipient Grade in Pharmaceutical Drug Development’.
In total, the event will see some 58 sessions with other notable keynotes on ‘Sustainability: Accelerating the Path to Net Zero’ and ‘the Importance of Excipient Grade in Pharmaceutical Drug Development’.
Sarah Griffin, Event Manager, Pharma Brand US at Informa Markets, stresses the importance of using the event to plan activity in 2025. She added “CPHI North America is at the heart of pharma in the US. s. It’s not just about staying informed and connecting with existing contacts; it’s about actively engaging in the collaborative ecosystem that sustains success in the pharmaceutical industry.  Participating companies can access invaluable resources, forge vital strategic partnerships, and, most importantly, establish the networks and technologies needed to maximize revenue potential in 2025 and beyond.”
To find out more about this year’s networking, the new personalized options and <a href="https://www.cphi.com/northamerica/en/attend/attend/badges.html" target="_blank" rel="noreferrer noopener">registration badges, please visit  CPHI North America</a>.
]]></content:encoded>
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<item>
<title>New NIHR HRC launched for cardiovascular and respiratory medicine</title>
<link>https://international-pharma.com/new-nihr-hrc-launched-for-cardiovascular-and-respiratory-medicine/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:36:30 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39041</guid>
<description><![CDATA[The launch is part of the NIHRs £42m funding to establish 14 new HRCs across England. Guy’s and St Thomas’ and King’s College London (KCL) have launched a new HealthTech Research Centre (HRC) for cardiovascular and respiratory medicine. The new centre is one of 14 new HRCs across England that received a total of £42m […]]]></description>
<content:encoded><![CDATA[
The launch is part of the NIHRs £42m funding to establish 14 new HRCs across England.
Guy’s and St Thomas’ and King’s College London (KCL) have launched a new HealthTech Research Centre (HRC) for cardiovascular and respiratory medicine.
The new centre is one of 14 new HRCs across England that received a total of £42m from the National Institute of Health and Care Research (NIHR).
Based within St Thomas’ hospital campus, the HRC will work with industry and academic partners to develop new technologies, medical devices and digital solutions for cardiovascular and respiratory medicine.
Designed as a ‘one stop shop’, the newly-launched HRC will specifically focus on four themes: cardiovascular disease in adults, technologies for children with congenital heart disease, cardiovascular interventions and respiratory medicine.
In addition, the HRC will develop technologies to support and promote the use of health- technology at home, as well as develop training for the next generation of health-technology innovators and researchers.
Rachel Clough, consultant vascular surgeon and clinical senior lecturer, surgical and interventional engineering, KCL and HRC co-director, commented: “Building on the extensive expertise in the management of cardiovascular diseases, respiratory conditions, biomedical and clinical engineering,…[the] centre…will foster and accelerate the translation to bedside of new promising technologies for the benefit of patients, the NHS and the British economy.”
In November 2023, the NIHR announced funding for new NIHR HRCs to work with businesses to support the development of medical devices, diagnostics and digital technologies to enable people to better monitor their health, diagnose ill health sooner, and improve the management of conditions including cancer, dementia, cardiovascular and respiratory disease.
In February, Cambridge University Hospitals NHS Foundation Trust announced that an innovative brain and spinal injury health technology research centre is set to open this April at Addenbrooke’s Hospital.
With £3m of the total NIHR funding, the Cambridge HRC will bring together NHS partners, businesses and patients from across the UK to develop technologies that improve care while patients are in hospital.
]]></content:encoded>
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<title>New clinical trial aims to investigate skin patches to spot lung transplant rejection</title>
<link>https://international-pharma.com/new-clinical-trial-aims-to-investigate-skin-patches-to-spot-lung-transplant-rejection/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:11:14 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39039</guid>
<description><![CDATA[Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%. A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning […]]]></description>
<content:encoded><![CDATA[
Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%.
A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning system to detect lung transplant rejection.
The SENTINEL trial is being funded by £2m in partnership with the Medical Research Council and the National Institute for Health and Care Research.
Lung transplant rejection is commonly monitored through lung function tests, blood tests, X-rays and lung biopsies. However, until it is advanced, lung transplant rejection can be challenging to identify.
The new trial aims to investigate the new early warning system to identify early signs of rejection to be rolled out to all lung transplant recipients, cutting rejection by up to 50%.
Set to be carried out by the lung transplant teams at specialist cardiothoracic centres across England, for the next three years, the trial will recruit 152 patients who are waiting for a lung transplant.
Patients will receive a 10x3cm skin patch from the forearm of the organ donor to be transplanted onto the undersurface of their own forearm at the same time as the lung transplant.
Often, before the body has started to reject the lungs, the skin tends to reject earlier than other organs and may be identified as a rash on the donated skin patch. If identifiable, a tiny biopsy from the skin will be taken to confirm the presence of rejection for doctors to treat much earlier and try to prevent the lung from rejecting.
“Early detection of organ rejection means a healthier transplant, giving people greater control of their care and speeding up access to treatment,” said Health Minister, Andrea Leadsom.
Andrew Fisher, professor of respiratory transplant medicine, Newcastle University Translational and Clinical Research Unit, said: “The trial has the potential to revolutionise the way lung transplants are performed in the future and reduce the fear associated with detecting and treating rejection early.”
]]></content:encoded>
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<title>CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines</title>
<link>https://international-pharma.com/curevac-and-md-anderson-cancer-center-partner-to-develop-new-cancer-vaccines/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:09:52 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39037</guid>
<description><![CDATA[Both will develop cancer vaccine candidates in selected haematological and solid tumour indications. CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological […]]]></description>
<content:encoded><![CDATA[
Both will develop cancer vaccine candidates in selected haematological and solid tumour indications.
CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines.
The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs.
Solid tumour cancer, such as sarcoma, carcinoma and lymphoma, is characterised by an abnormal mass of tissue that usually does not contain cysts or liquid areas.
Haematologic cancer, otherwise known as blood cancer, including leukaemia, lymphoma and multiple myeloma, begins in blood-forming tissues such as the bone marrow or in the cells of the immune system.
Under the terms of the agreement, MD Anderson will be responsible for conducting phase 1/2 studies of the selected promising validated cancer vaccine candidates and the completion of investigational new drug approvals in certain clinical indications, while also being eligible for certain downstream payments based on potential future commercialisation.
CureVac will gain worldwide exclusive rights to late-stage development, commercialisation or partnering of the cancer vaccine candidates.
The agreement will utilise CureVac’s end-to-end cancer antigen discovery capabilities, mRNA design and manufacturing, and MD Anderson’s expertise in cancer antigen discovery and validation, translational drug development and clinical research, including its Evolution of Cancer, Leukaemia and Immunity Post Stem cEll transplant (ECLIPSE) platform, to contribute to the identification of differentiated cancer antigens based on whole genome sequencing, along with long- and short-read RNA sequencing, and bioinformatics.
Dr Alexander Zehnder, chief executive officer, CureVac, commented: “In combining our respective expertise, we believe we can go further and faster to develop novel, off-the-shelf, mRNA-based cancer vaccines that have the potential to significantly improve patient outcomes.”
Jeffrey Molldrem, chair, haematopoietic biology and malignancy, MD Anderson, said: “Together with CureVac, we hope to embrace this exciting area of drug discovery and development in pursuit of mRNA vaccines that will address significant unmet medical needs.”
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<title>Researchers introduce new AI tool to help clinicians capture uncertainty in medical images</title>
<link>https://international-pharma.com/researchers-introduce-new-ai-tool-to-help-clinicians-capture-uncertainty-in-medical-images/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:07:38 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39035</guid>
<description><![CDATA[The Tyche model could help clinicians and researchers capture crucial information in images. Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image. Funded by the National Institute of Health, […]]]></description>
<content:encoded><![CDATA[
The Tyche model could help clinicians and researchers capture crucial information in images.
Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image.
Funded by the National Institute of Health, the Eric and Wendy Schmidt Center and Quanta Computer, the Tyche machine-learning model could help clinicians and researchers capture crucial information.
In biomedicine, AI models help clinicians by highlighting pixels that show signs of a certain disease or anomaly. However, these types of models usually only provide one answer.
“Having options can help in decision-making” and “so it is important to take this uncertainty into account,” said MIT computer science PhD candidate, Marianne Rakic.
Researchers developed Tyche after modifying a straightforward neural network architecture. After feeding the tool a few examples of segmentation tasks, such as images of lesions in a heart MRI segmented by different human experts, the model learned the tasks and found that 16 example images were enough for the model to make good predictions without retraining.
The team modified the network to output several predictions based on one medical image input and context set, adjusting the network’s layer so candidate segmentations produced could interact with each other and the examples in the context set.
Furthermore, researchers modified the training process to maximise the quality of its best prediction, allowing Tyche to ensure that candidate segmentations are slightly different while still solving the task.
The team also saw that the tool was able to outperform more complex models trained using a large, specialised dataset and performed faster compared to most models.
Researchers believe that Tyche could benefit clinicians and biomedical researchers more than other methods due to its lack of need for retraining, speed and ability to be applied to a variety of tasks.
The team plans to use a more flexible context set on Tyche and aim to explore methods to improve its worst predictions and enhance the system to recommend the best segmentation candidates.
]]></content:encoded>
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<item>
<title>Study reveals how specific nasal cells protect against COVID-19 in paediatric patients</title>
<link>https://international-pharma.com/study-reveals-how-specific-nasal-cells-protect-against-covid-19-in-paediatric-patients/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:05:43 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39033</guid>
<description><![CDATA[The findings suggest why children tend to experience milder symptoms compared to older adults. Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond […]]]></description>
<content:encoded><![CDATA[
The findings suggest why children tend to experience milder symptoms compared to older adults.
Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19.
Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond Street Hospital, University College London Hospital and the Royal Free Hospital.
Researchers focused on the early effects of the SARS-CoV-2 infections using the human nasal epithelial cells (NECs) gathered from children aged up to 11 years, adults aged 30 to 50 years, as well as elderly people aged over 70 years.
After using specialised techniques to regrow these cells into the different types usually found in the nose, researchers used single-cell RNA sequencing to identify the genetic networks and functions of thousands of individual cells to identify 24 epithelial cell types.
The cell cultures from each age group were then either mock-infected or infected with SARS-CoV-2.
After three days, the NECs of children responded rapidly to the virus by increasing interferon, the anti-viral defence in the body, which restricted viral replication.
As the age of people increased, researchers observed that this early anti-viral effect became less apparent – not only did NECs from elderly individuals produce more infectious virus particles, they also increased cell shedding and damage, potentially linking to the greater severity of disease typically observed in older adults.
The team suggests that the strong antiviral response in the NECs of children could explain why younger people tend to experience milder symptoms, while underscoring the importance of age in research and the treatment of infectious diseases.
Dr Claire Smith, associate professor at UCL and Great Ormond Street Institute of Child Health, said: “Our research… could be crucial in developing effective anti-viral treatments tailored to different age groups.”
She added: “We now hope to investigate the long-term implications of these cellular changes and test therapeutic interventions using our unique cell culture model” to research how ageing can impact the body’s response to other viral infections.
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<title>Rapid increase in purchasing teams expected at CPHI North America</title>
<link>https://international-pharma.com/rapid-increase-in-purchasing-teams-expected-at-cphi-north-america/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 16 Apr 2024 09:19:20 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38983</guid>
<description><![CDATA[Macro-uncertainty and large CDMO acquisitions attributed to have driven a surge in R&D, purchasing and QC/QA attendees at the event CPHI North America (7-9 May, 2024) will open at Pennsylvania Convention Center in Philadelphia as the event sees a doubling of attendees* across ‘purchasing and procurement’, ‘R&D’ and ‘Manufacturing’, and ‘QC and QA’. The rapid […]]]></description>
<content:encoded><![CDATA[
Macro-uncertainty and large CDMO acquisitions attributed to have driven a surge in R&D, purchasing and QC/QA attendees at the event
CPHI North America (7-9 May, 2024) will open at Pennsylvania Convention Center in Philadelphia as the event sees a doubling of attendees* across ‘purchasing and procurement’, ‘R&D’ and ‘Manufacturing’, and ‘QC and QA’. The rapid increase is attributed to both a concerted effect by Informa to attract larger buying audiences but is also seen as a response by the USA industry to macro trends – with alternative supply chain options actively being sought by both pharma and biotech companies.
“We have spent a good deal of time researching and investing resources to target these audiences in the last 12 months – in response to exhibitor feedback – but it also shows the strong desire we see among US-based companies to seek out alternative supply options and new partners. Our role is to actively help facilitate these discussions and build an ecosystem of much larger networking opportunities at the event. Companies across the industry have taken note of developments that might affect supply – particularly among the largest CDMOs – and we are here to help them navigate their options and find new suppliers,” commented Sarah Griffin, Manager, Pharma Brand US at Informa Markets.
The 2024 event will be the most innovative ever, with over 350 exhibitors contracted and the addition of three new engagement zones – covering sustainability, innovation, and growth & development [designed to help promote job opportunities and encourage career development conversations] – alongside the first ever Start-Up Market in North America. A dedicated space where smaller innovators and enterprises from the industry can exhibit their exciting new products and solutions.
‘CPHI remains at the heart of pharma in North America, and we love that we’re attracting an increasing number of industry leaders. We are seeing rising numbers of new attendees, particularly this year as we see senior executives from R&D, QC and manufacturing audiences specifically looking to reevaluate both supply and development options,’ said Adam Andersen, Informa’s Executive Vice President, Pharma. He added ‘the great thing about CPHI North America is that we’re still the only show bringing the entire US Pharma supply chain together under one roof – in person, and thanks to our online event platforms our attendees and exhibitors are already making new connections ahead of the event and actively taking forward discussion to forge crucial supply chain partnerships.’
This year’s conference features 4 tracks – spanning ‘Sustainable Futures’, ‘Revolutionizing Drug Manufacturing’, ‘Supply Chain Economy’, and ‘Exploring Excipients’ – as well as a breakfast session on manufacturing excellence and the eagerly anticipated <a href="https://www.cphi.com/northamerica/en/agenda/programme/cdmo-roundtable.html" target="_blank" rel="noopener">CDMO roundtable</a>. The latter is particularly timely, with US-based Manufacturers in high demand in 2024. In total CPHI North American features 50+ experts spanning dozens of sessions that encompass the entire pharmaceutical development and supply chain, with seminars covering themes as varied as ‘marketing’, ‘diversity’ and ‘well-being’.
Additionally, in a further sign of pharma’s increased social responsibility, the new sustainability zone will also host a ‘commitments communication area’: where companies go to publicly pledge their goals and targets for environmental, sustainability or governance over the next few years.
To find out more about this year’s networking, the new personalized options and <a href="https://www.cphi.com/northamerica/en/attend/attend/badges.html" target="_blank" rel="noopener">registration badges, please visit  CPHI North America</a>.
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<title>Woolcool Introduces FreightGuardian: Revolutionary Pallet Cover Ensuring Temperature Integrity for Whole Shipments</title>
<link>https://international-pharma.com/woolcool-introduces-freightguardian-revolutionary-pallet-cover-ensuring-temperature-integrity-for-whole-shipments/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 16 Apr 2024 09:12:00 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38980</guid>
<description><![CDATA[Woolcool, the pioneers of sustainable packaging solutions, proudly announces the launch of FreightGuardian, a cutting-edge pallet cover designed to safeguard whole pallet shipments from temperature fluctuations during transit. Engineered to maintain 2-8°C, Frozen, and CRT temperature ranges, FreightGuardian offers a game-changing innovation in the world of cold-chain freight. Harnessing the power of Woolcool’s thermal technology, […]]]></description>
<content:encoded><![CDATA[<div class="wp-block-image">
<figure class="aligncenter size-large"><img decoding="async" width="1024" height="684" src="https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading-1024x684.jpg" alt="" class="wp-image-38981" srcset="https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading-1024x684.jpg 1024w, https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading-300x200.jpg 300w, https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading-768x513.jpg 768w, https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading-1536x1026.jpg 1536w, https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading-336x224.jpg 336w, https://international-pharma.com/wp-content/uploads/2024/04/Woolcool_freightguardian-loading.jpg 1920w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></div>

Woolcool, the pioneers of sustainable packaging solutions, proudly announces the launch of FreightGuardian, a cutting-edge pallet cover designed to safeguard whole pallet shipments from temperature fluctuations during transit. Engineered to maintain 2-8°C, Frozen, and CRT temperature ranges, FreightGuardian offers a game-changing innovation in the world of cold-chain freight.
Harnessing the power of Woolcool’s thermal technology, FreightGuardian is the World’s first pallet cover made using natural materials, including pure 100% Wool and Cotton as the principal materials. This innovative solution ensures that sensitive products such as pharmaceuticals, food items, and biologics reach their destination in optimal condition, safeguarding their efficacy and quality.
“We are thrilled to unveil FreightGuardian at this year’s LogiPharma show. It is the latest addition to our range of sustainable packaging solutions,” said Josie Morris, Managing Director at Woolcool. “With FreightGuardian, we are empowering businesses to transport temperature-sensitive goods with confidence, knowing that their products are shielded from the adverse effects of temperature fluctuations throughout the supply chain.”
What sets FreightGuardian apart is its robust and reusable design, which helps to optimise costs and provide a sustainable alternative to traditional pallet cover solutions, whilst of course being able withstand the challenges and harsh environments experienced by freight shipments. By utilizing Woolcool’s natural, renewable materials, FreightGuardian not only ensures superior insulation but also minimizes the environmental impact associated with single-use packaging.
“Recognising the importance of sustainability in today’s logistical landscape has become paramount in recent years,” Josie Morris added. “FreightGuardian embodies our commitment to providing high-performing, environmentally conscious solutions that align with our customers’ sustainability goals.”
For more information about FreightGuardian and Woolcool’s range of sustainable packaging solutions, visit <a href="https://www.woolcool.com/freightguardian/" target="_blank" rel="noopener">https://www.woolcool.com/freightguardian/</a> or contact <a href="mailto:sales@woolcool.com">sales@woolcool.com</a> .
About Woolcool:
Woolcool is a leading provider of sustainable packaging solutions, specializing in temperature-controlled packaging for a wide range of industries. With a commitment to innovation and sustainability, Woolcool’s products are designed to protect sensitive goods while minimizing environmental impact. For more information, visit [website].
Contact:
Rosie Murgatroyd
Marketing Manager
Woolcool
<a href="mailto:rosie@woolcool.com">rosie@woolcool.com</a> / 01785 262030
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<title>Harnessing The Power of Solid Form and Particle Engineering to Overcome Solubility and Bioavailability Challenges</title>
<link>https://international-pharma.com/harnessing-the-power-of-solid-form-and-particle-engineering-to-overcome-solubility-and-bioavailability-challenges/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 14:26:04 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[Bioavailability]]></category>
<category><![CDATA[companies]]></category>
<category><![CDATA[development]]></category>
<category><![CDATA[drug]]></category>
<category><![CDATA[Form]]></category>
<category><![CDATA[Harnessing]]></category>
<category><![CDATA[Particle]]></category>
<category><![CDATA[pharmaceutical]]></category>
<category><![CDATA[pipeline]]></category>
<category><![CDATA[poor]]></category>
<category><![CDATA[Solid]]></category>
<category><![CDATA[Solubility]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38969</guid>
<description><![CDATA[An Interview with Veranova’s Craig Grant Persistent challenges in poor solubility and low bioavailability have long impeded the pharmaceutical development pipeline, presenting ongoing hurdles for drug companies. As the industry grapples with increasingly complex new chemical entities, the need for innovative solutions to overcome these challenges becomes more urgent. To delve into this issue, explore […]]]></description>
<content:encoded><![CDATA[
An Interview with Veranova’s Craig Grant
Persistent challenges in poor solubility and low bioavailability have long impeded the pharmaceutical development pipeline, presenting ongoing hurdles for drug companies. As the industry grapples with increasingly complex new chemical entities, the need for innovative solutions to overcome these challenges becomes more urgent.
To delve into this issue, explore current strategies for advancing poorly soluble drugs through the clinical pipeline, and uncover best practices for formulating drugs with solubility issues, IPI Journal spoke with Veranova’s Craig Grant, VP and General Manager, Cambridge. With over two decades of solid form expertise, Craig is a founding figure behind Pharmorphix®, Veranova’s dedicated brand for solid form and particle engineering.
Q: It’s estimated that up to 40% of marketed drugs, and between 70 and 90% of drug candidates in the development stage, exhibit poor solubility.1 Could you explain why solubility and bioavailability continue to be such big issues in bio/pharmaceutical drug formulation?
A: In the pharma and biotech industries, the need for effective therapeutics is continually driving the discovery and development of novel active pharmaceutical ingredients (APIs) and new chemical entities (NCEs). This has resulted in the development of increasingly complex drug scaffolds, often with one or more chiral centres and which routinely possess high molecular weight. Though these drugs offer improved stereoselectivity, target specificity and activity, their complexity often causes them to be poorly soluble, which can cause a wide variety of knock-on issues, most notably poor bioavailability with low drug absorption in the body, resulting in such molecules being assigned to BCS Class II (high permeability, low solubility).2
Moreover, at the candidate selection stage, developers are more likely to focus on potency or efficacy, meaning the downstream developability of NCEs is often overlooked during early-stage development. This can lead to significant challenges further down the development pipeline, leading to costly delays and resource wastages.
Q: As increasingly complex drug molecules enter the development pipeline, how do you see solubility challenges evolving in the future? 
A: With small molecules becoming increasingly more complex, solubility challenges are here to stay. This is even more relevant when considering current pharmaceutical trends, with increased prevalence in existing modalities such as peptides, which, depending on size and/ or complexity, straddle the boundary between small and large molecules. The emergence of new “small molecule” modalities such as PROTACs (PROteolysis TArgeting Chimeras) also brings substantial solubility and developability challenges. PROTACs are a subset of TPD (targeted protein degraders), an emerging therapeutic modality used to treat previously difficult or undruggable targets. Unlike traditional protein inhibition methods, PROTACs are two-pronged molecular entities designed to seek out and degrade disease-causing proteins within the cell. However, due to their size and flexibility, PROTACs typically pose crystallisation and solubility challenges during solid-form studies. PROTACs are just one example of how molecular complexity is likely to continue to present difficulties going forward.
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