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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" xmlns:media="http://search.yahoo.com/mrss/" > <channel> <title>International Biopharmaceutical Industry</title> <atom:link href="https://international-biopharma.com/feed/" rel="self" type="application/rss+xml" /> <link>https://international-biopharma.com</link> <description>Supporting Modern Science Through Communication</description> <lastBuildDate>Tue, 16 Apr 2024 12:44:44 +0000</lastBuildDate> <language>en-GB</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.5.2</generator> <image> <url>https://international-biopharma.com/wp-content/uploads/2021/03/IBI-150x150.jpg</url> <title>International Biopharmaceutical Industry</title> <link>https://international-biopharma.com</link> <width>32</width> <height>32</height></image> <item> <title>Biotech Sector Survey: From Investment Confidence to Strategic Collaborations</title> <link>https://international-biopharma.com/biotech-sector-survey-from-investment-confidence-to-strategic-collaborations/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 12:44:43 +0000</pubDate> <category><![CDATA[Current Features]]></category> <category><![CDATA[Volume 7 Issue 1]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15867</guid> <description><![CDATA[In the rapidly evolving landscape, ICON’s recently published biotech sector survey provides a roadmap through the intricacies of investment confidence, funding dynamics, and the pivotal role of strategic collaborations. The survey, conducted on ICON’s behalf by Citeline, included 133 respondents, predominantly located in Europe and North America, from small pharmaceutical and biotech companies, mid-size pharmaceutical […]]]></description> <content:encoded><![CDATA[<p>In the rapidly evolving landscape, ICON’s recently published biotech sector survey provides a roadmap through the intricacies of investment confidence, funding dynamics, and the pivotal role of strategic collaborations. The survey, conducted on ICON’s behalf by Citeline, included 133 respondents, predominantly located in Europe and North America, from small pharmaceutical and biotech companies, mid-size pharmaceutical and biotech companies, to large biotech or venture capital organisations.</p> <p>A compelling narrative unfolds as we dissect the survey results, revealing the industry’s resilience and determination despite funding challenges. We explore the imperative of partnerships, delving into their role in funding strategies, and the increasing trend of pharma collaborations, even at the preclinical stage.</p> <p><strong>Key Survey Findings: Stats and Implications</strong></p> <p><strong>R&D Spending Expectations</strong></p> <p>The heartbeat of the biotech innovation lies in its Research and Development (R&D) endeavours, and the survey paints a vivid picture of the sector’s commitment to pushing the boundaries despite financial headwinds. 60% of survey respondents expect to increase their R&D spending over the next one to two years, a testament to the resilience that permeates the industry. This statistic is a powerful indicator of the industry’s faith in the transformative potential of its research initiatives and the impact these endeavours can have on shaping the future of healthcare.</p> <p>Despite the funding challenges that have become an intrinsic part of the biotech landscape, the overwhelming majority expressing an intent to boost R&D spending sends a powerful signal. It signifies a collective determination to forge ahead with novel research, undeterred by financial uncertainties. This optimistic outlook not only underscores the resilience of biotech professionals but also speaks to a broader narrative of belief in the value and impact of biotech innovation on global health.</p> <p>These statistics symbolise a commitment to progress and a belief in the industry’s ability to overcome obstacles. The biotech sector is not merely weathering the storm; it is actively charting a course toward a future where innovative solutions can address some of the most pressing challenges in healthcare. As the industry braces for an uptick in R&D spending, it positions itself as ready and able to unlock new frontiers in science and medicine.</p> <p><strong>Challenges in the Funding Landscape</strong></p> <p>In the complex interplay between innovation and financial viability, the survey unearths critical insights into the challenges embedded within the biotech funding landscape. A significant 47% of respondents identify the rising cost of capital as a substantial influencer. This finding underscores the industry’s acute awareness of its financial pressures, with the cost of capital emerging as a pivotal factor shaping future operations. As biotechs navigate this upward trajectory in capital costs, strategic financial planning becomes paramount to sustaining momentum in drug development.</p>]]></content:encoded> </item> <item> <title>Extractables and Leachables for Inhaled Medicines</title> <link>https://international-biopharma.com/extractables-and-leachables-for-inhaled-medicines/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 12:38:19 +0000</pubDate> <category><![CDATA[Current Features]]></category> <category><![CDATA[Volume 7 Issue 1]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15864</guid> <description><![CDATA[How risk assessments can improve E&L strategies Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are encouraging a more structured approach to product development, such as using Quality by Design (QbD) principles. The structured approaches encouraged by the FDA, EMA, and other regulatory bodies require additional upfront […]]]></description> <content:encoded><![CDATA[<p><em>How risk assessments can improve E&L strategies</em></p> <p>Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are encouraging a more structured approach to product development, such as using Quality by Design (QbD) principles.</p> <p>The structured approaches encouraged by the FDA, EMA, and other regulatory bodies require additional upfront resources compared to a more traditional approach. Performing an initial assessment of materials used in the product and developing a more thorough understanding of products earlier in their development allows more appropriate experiments on the higher-risk aspects rather than generic approaches covering all materials.</p> <p><strong>Benefits of Performing a Risk Assessment</strong></p> <p>Extractables and leachables (E&L) risk assessments are valuable processes that can identify and highlight the risks of potential leachables from both the container closure system and the manufacturing processes. The risk assessments also include the level of risk that leachables might present to user safety and product quality.</p> <p>By performing a risk assessment, manufacturers can better understand the product, whether a medical device or the container closure system, and the manufacturing processes. Identifying risks and scoring them based on that understanding allows for subsequent E&L studies to be more focused. Therefore, decisions around the E&L aspects of the project can be more appropriate.</p> <p><strong>Risk Assessment Lifecycle</strong></p> <p>Quality risk management is a systematic process. The lifecycle can be split into Assessment, Control, and Review stages, and there should be regular communication with stakeholders throughout the lifecycle. A typical quality risk management process is described in ICH Q9 with a flowchart, and it is a good place to start when designing a strategy. An initial assessment can be performed based on previously mentioned tables and decision trees from the FDA and EMA guidelines. This can inform stakeholders early in the assessment about the studies that might be required for the project.</p> <p>The first step of the process is the Risk Assessment, which is further divided into a series of sections:</p> <p>• Risk Identification involves identifying the parameters that might affect the leachables by reviewing and brainstorming processes and materials.</p> <p>• Risk Analysis collates information to understand identified failure modes.</p> <p>• Risk Evaluation uses information gathered during the Risk Analysis to score the failure modes. • Risk Control covers where the risks are either accepted or experimental studies are planned based on mitigating risk appropriately.</p> <p>• A Risk Review reassesses the failure modes and re-scores them following any risk mitigations. Risk review can also be part of lifecycle management.</p>]]></content:encoded> </item> <item> <title>A Guide to Understanding and Performing all Appropriate Validation Steps When Adopting a New Endotoxin Testing Reagent</title> <link>https://international-biopharma.com/a-guide-to-understanding-and-performing-all-appropriate-validation-steps-when-adopting-a-new-endotoxin-testing-reagent/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 12:23:58 +0000</pubDate> <category><![CDATA[Volume 7 Issue 1]]></category> <category><![CDATA[Application Notes]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15861</guid> <description><![CDATA[Limitations of Common Endotoxin Testing Solutions The adaptation of in-house endotoxin testing for a pharmaceutical or medical device manufacturer can be a daunting task. Many small-volume manufacturers find themselves in one of two common situations. Either they are utilising a contract testing organisation (CTO) and paying a great deal of costs, or they have adopted […]]]></description> <content:encoded><![CDATA[<p>Limitations of Common Endotoxin Testing Solutions The adaptation of in-house endotoxin testing for a pharmaceutical or medical device manufacturer can be a daunting task. Many small-volume manufacturers find themselves in one of two common situations. Either they are utilising a contract testing organisation (CTO) and paying a great deal of costs, or they have adopted a solution that is set up by the manufacturer with much of the validation services outsourced.</p> <p>A potential limitation of these methods is cost. Utilising a CTO is appealing to low-volume manufacturers. However, it can be a limitation to expansion as testing costs increase with volume. A system that does not allow versatility in reagent usage can lock the client into manufacturers’ costs and price increases.</p> <p>However, an even bigger drawback to both situations is the lack of testing control and feedback that the user receives for each method. The disadvantage to the convenience of a contract testing service is the increase in time to results as well as greater limitations on the frequency of testing monitoring. In-house testing can provide results in an hour or less if needed. This nearly real-time feedback on the quality of the manufacturing process is invaluable to the trend monitoring of the manufacturing process.</p> <p><strong>Dangers of Improperly Performed Analytical Methods Validation</strong></p> <p>Real-time feedback can be provided by seemingly attractive solutions. Some solutions utilise outsourced verification data provided by the manufacturer. This provides the convenience of having preparatory tests being done offsite – outsourcing much of the validation. However, a great limitation of this method is that the routine testing takes place in a different location with different analysts, accessories, and accompanying instruments, which may not fully support the verification test requirements stated in USP chapter 85: “To assure the precision or validity of the turbidimetric and chromogenic techniques, preparatory tests are conducted to verify that the criteria for the standard curve are valid and that the sample solution does not interfere with the test. Validation for the test method is required when conditions that are likely to influence the test result change.” Although an outsourced standard curve may technically check the requirements, it assumes that changing “conditions that are likely to influence the test result” is not a factor between the different locations, personnel, equipment, and accessories in and with which the validation testing and the routine testing takes place.</p>]]></content:encoded> </item> <item> <title>Using Predictive Compliance Risk Analysis to Avoid FDA Penalties</title> <link>https://international-biopharma.com/using-predictive-compliance-risk-analysis-to-avoid-fda-penalties/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 12:20:22 +0000</pubDate> <category><![CDATA[Current Features]]></category> <category><![CDATA[Volume 7 Issue 1]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15858</guid> <description><![CDATA[In the complex landscape of global regulations, particularly within healthcare and pharmaceutical sectors, a robust compliance strategy is essential for maintaining the integrity of businesses amidst rigorous regulatory requirements. Organisations need to be both flexible and resilient, adept at navigating and anticipating the multifaceted and ever-changing aspects of global compliance standards. These standards are often […]]]></description> <content:encoded><![CDATA[<p>In the complex landscape of global regulations, particularly within healthcare and pharmaceutical sectors, a robust compliance strategy is essential for maintaining the integrity of businesses amidst rigorous regulatory requirements. Organisations need to be both flexible and resilient, adept at navigating and anticipating the multifaceted and ever-changing aspects of global compliance standards. These standards are often stringently enforced by regulatory bodies, with the U.S. Food and Drug Administration (FDA) being one of the most prominent and rigorous. Insights into developing a strategic framework for identifying and mitigating compliance risks is critical in today’s dynamic business landscape, where violations of regulations can lead to severe repercussions, far beyond minor setbacks, potentially jeopardizing the future of regulated businesses.</p> <p><strong>The Challenge of Disparate Quality Systems</strong></p> <p>In the intricate world of healthcare and pharmaceuticals, ensuring regulatory compliance across a complex network of operations is paramount.</p> <p>The integration of diverse and complex quality systems, often resulting from mergers and acquisitions, poses significant challenges for effective risk management in the pharmaceutical and healthcare industries. These fragmented systems can create inconsistencies in the compliance infrastructure, leading to vulnerabilities that are challenging to detect and more challenging to rectify. This fragmented approach to quality system integration can undermine the overall effectiveness of compliance efforts, exposing organisations to regulatory risks and potentially eroding public confidence in their commitment to safety and quality.</p> <p><strong>Uniting Global Quality Management Under Predictive Compliance</strong></p> <p>In response to the challenges posed by disparate quality management systems, enterprises in the healthcare and pharmaceutical sectors are increasingly adopting predictive compliance risk analysis. This advanced approach offers a cohesive and strategic method for managing regulatory obligations without the need for extensive overhauls of existing systems.</p> <p>Predictive compliance goes beyond merely reducing the likelihood of non-compliance; it enhances operational efficiency and refines the precision of internal audits. By centralising oversight across various locations and implementing forward-looking measures, organisations can achieve a compliance framework that is both robust and flexible, ensuring resilience in the face of regulatory audits.</p> <p><strong>The Role of Predictive Risk Analysis in Compliance</strong></p> <p>Predictive risk analysis represents a transformative approach to managing compliance obligations. Far from being merely an assemblage of advanced technological terms, predictive compliance risk analysis signifies a fundamental shift in strategy – from a reactive stance, addressing compliance issues as they arise, to a proactive one, aimed at foreseeing and mitigating potential breaches before they materialise.</p>]]></content:encoded> </item> <item> <title>Optimising Pharmaceutical Processes: A Guide to Lyophilisation Cycle Development</title> <link>https://international-biopharma.com/optimising-pharmaceutical-processes-a-guide-to-lyophilisation-cycle-development/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 12:16:28 +0000</pubDate> <category><![CDATA[Volume 7 Issue 1]]></category> <category><![CDATA[Application Notes]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15855</guid> <description><![CDATA[Lyophilisation, commonly known as freeze-drying, is a critical unit operation in the pharmaceutical industry used to preserve and stabilise both small and large-molecule drug products and biologics, including monoclonal antibodies, vaccines and peptides. Lyophilisation is a process that involves freezing a liquid drug product and then removing the frozen solvent via sublimation, providing a stable […]]]></description> <content:encoded><![CDATA[<p>Lyophilisation, commonly known as freeze-drying, is a critical unit operation in the pharmaceutical industry used to preserve and stabilise both small and large-molecule drug products and biologics, including monoclonal antibodies, vaccines and peptides. Lyophilisation is a process that involves freezing a liquid drug product and then removing the frozen solvent via sublimation, providing a stable solid matrix of the drug product and other excipients. This method is particularly suitable for heat-sensitive molecules, as it dramatically mitigates hydrolysis degradation found in liquid products, is more product-sensitive and practical than other drying methods and avoids the difficulties of multi-component powder filling.</p> <p>Biopharmaceutical companies have increasingly favoured lyophilisation for the formulation of their pharmaceutical products. Primarily, the driving factor leading to the increased use of lyophilisation is the ability to stabilise the drug product and excipients in a solid matrix, increasing the shelf life of the product. This, along with the removal of solvents, has a positive impact on storage and distribution requirements. For instance, many lyophilised drug products experience an increase in thermal stability and no longer require frozen storage. This provides a more cost-effective, lower-risk, and efficient way to optimise storage and distribution. This is particularly beneficial for drug products that are shipped to countries with tropical climates or lower infrastructure, where temperature may affect the stability of a product, and cold chain storage may not be available.</p> <p>As companies continue to pioneer new molecules and treatments, it is clear that the stability of these molecules has increasingly become a detrimental factor upon every iteration, and that lyophilisation is the pathway to a solution. At PCI, we believe lyophilisation cycle development is not only a science, but an art; each drug product that comes into the laboratory presents unique challenges, and the design of a cycle requires an understanding of individual chemistry, characteristics, and interaction to yield a high-quality product in every cycle. While there is a myriad of tools and techniques to perform, the below is an overall guide to the lyophilisation process and some of the steps needed for success.</p> <p><strong>The Lyophilisation Cycle</strong></p> <p>Lyophilisation involves a series of steps to achieve optimal product stability and quality. While there are individual intricacies within these steps, they can be broadly categorised into three phases: freezing, primary drying, and secondary drying.</p>]]></content:encoded> </item> <item> <title>Patients Are Waiting: Speeding Time to Treatment in Rare Disease</title> <link>https://international-biopharma.com/patients-are-waiting-speeding-time-to-treatment-in-rare-disease/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 12:11:43 +0000</pubDate> <category><![CDATA[Current Features]]></category> <category><![CDATA[Volume 7 Issue 1]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15852</guid> <description><![CDATA[Companies are overcoming challenges to develop, launch, and educate on new rare disease medicines faster. Rare diseases are no longer rare. Every year, people’s lives are upended by a diagnosis of one of 6,000–8,000 identified rare conditions, which collectively affect one in 17 people. Because a majority are genetic and appear early, more than half […]]]></description> <content:encoded><![CDATA[<p>Companies are overcoming challenges to develop, launch, and educate on new rare disease medicines faster.</p> <p>Rare diseases are no longer rare. Every year, people’s lives are upended by a diagnosis of one of 6,000–8,000 identified rare conditions, which collectively affect one in 17 people. Because a majority are genetic and appear early, more than half of these patients are children, and many are not expected to reach their fifth birthday. </p> <p>For patients left waiting, the stakes for new medicines are high. Yet, less than five percent of rare diseases have at least one approved treatment. Even when effective therapies and medicines exist, reaching the right patients in need is challenging. Survey data depicts a long and emotionally gruelling journey for those awaiting a diagnosis. For adults, it can take up to five years, and half will receive a misdiagnosis.<sup>1</sup></p> <p>Rare diseases challenge traditional ways of doing business. They require the industry to better identify target patient populations for trials and then keep them engaged during the course of the study, even across geographies. Once a medicine is approved, it is crucial to seamlessly transition from trials to treatment given the smaller patient cohort, as the physicians who conduct the trials often become prescribers. </p> <p>The good news is that the industry is making great progress in how medicines for rare diseases are developed and brought to market. From delivering better site support during clinical studies to greater connectivity between medical and commercial teams, companies are breaking down historic silos and cutting the time to treatment. Along with richer healthcare data and effective medical education for physicians on symptoms and treatment options, these advances will help those undergoing complex patient journeys.</p> <p><strong>Greater Focus on Patient Experience During Studies</strong></p> <p>Over half of orphan drug trials are eventually discontinued or fail to publish results after completion.2 Often, studies can’t recruit or lead to inconclusive results. When a trial gets off the ground, sites have to invest significant time in keeping a small number of participants engaged.</p> <p>Removing excessive system and process complexity will improve their efforts. For years, sites have voiced their concerns about the multiple disconnected tools they must navigate just to keep a study going. As one site leader explains, navigating unintuitive technology absorbs time from trial activities, and can make them feel like they’re asking too much from patients: “The technology shouldn’t be the trial itself, it should support the trial. It’s taking time away from what we want to do, which is taking care of our patients.” Simplifying the technology experience and reducing the admin burden will better meet sites’ and patients’ needs.</p>]]></content:encoded> </item> <item> <title>Elevating Biomanufacturing Efficiencywith N-1 Perfusion Technology</title> <link>https://international-biopharma.com/elevating-biomanufacturing-efficiencywith-n-1-perfusion-technology/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 11:00:32 +0000</pubDate> <category><![CDATA[Current Features]]></category> <category><![CDATA[Volume 7 Issue 1]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15849</guid> <description><![CDATA[In the dynamic world of biomanufacturing, the quest for improved efficiency and productivity continues to shape industry advancements. Among these innovations, the emergence of N-1 perfusion technology stands out as a pivotal milestone, offering a practical pathway to enhance production processes and boost overall efficiency. N-1 perfusion operates on a simple, yet powerful principle known […]]]></description> <content:encoded><![CDATA[<p>In the dynamic world of biomanufacturing, the quest for improved efficiency and productivity continues to shape industry advancements. Among these innovations, the emergence of N-1 perfusion technology stands out as a pivotal milestone, offering a practical pathway to enhance production processes and boost overall efficiency.</p> <p>N-1 perfusion operates on a simple, yet powerful principle known as process intensification. This strategic approach aims to maximise the output of manufacturing facilities and streamline the timelines of production. While continuous processing has garnered attention for its efficiency gains, the traditional fed-batch culture remains a fundamental method in stable protein production using mammalian cell culture. In this context, techniques to intensify fed-batch processes, such as N-1 perfusion, present exciting opportunities for the advancement of biomanufacturing practices.</p> <p>The appeal of N-1 perfusion lies in its ability to support high cell densities with sustained exponential growth and viability. This capability extends beyond the production phase to include the critical aspect of seed train intensification – a fundamental process in bioprocessing. By enabling a significant increase in cell density, N-1 perfusion offers a way to streamline operations by reducing the size or number of required seed reactors, thereby optimising facility space and investment costs. At the heart of this strategy is the concept of seeding the fed-batch production bioreactor with substantially higher cell densities from the N-1 seed culture. This strategic shift in the early growth phase of production paves the way for streamlined timelines without compromising the essential growth and yield profiles of the final product.</p> <p>In this article, we delve into the practical applications of N-1 perfusion technology, showcasing its potential to transform biomanufacturing processes. Through real-world examples and data, we demonstrate how N-1 perfusion enables facilities to achieve higher productivity and improved efficiency – all while optimising resource utilisation and operational costs. Let’s now break down the discussion into key aspects of N-1 perfusion technology, exploring its suitability for various processes and products, considerations for implementation, its rising adoption in the industry, and future directions.</p> <p><strong>Suitable Processes and Products for N-1 Perfusion</strong></p> <p>N-1 (seed) intensification through perfusion technology proves highly beneficial where the goal is to enhance productivity without major alterations to the production process. The essence of N-1 perfusion lies in increasing the cell density in the pre-production bioreactor, denoted as N-1 (N being the production bioreactor). This increase in cell density is achieved more effectively using perfusion technology compared to routine batch modes.</p>]]></content:encoded> </item> <item> <title>Considerations on the Development and Manufacturing of Generic Peptides</title> <link>https://international-biopharma.com/considerations-on-the-development-and-manufacturing-of-generic-peptides/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 10:57:15 +0000</pubDate> <category><![CDATA[Current Features]]></category> <category><![CDATA[Volume 7 Issue 1]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15846</guid> <description><![CDATA[The development of generic versions of peptides such as Semaglutide, the drug substance inside Novo Nordisk’s blockbuster drugs like Ozempic®, Rybelsus® or Wegovy®, or Tirzepatide, the API in Eli Lilly’s Mounjaro®, has emerged as a significant area of interest and opportunity. However, generic companies face critical decisions regarding the choice between recombinant and synthetic semaglutide. […]]]></description> <content:encoded><![CDATA[<p>The development of generic versions of peptides such as Semaglutide, the drug substance inside Novo Nordisk’s blockbuster drugs like Ozempic®, Rybelsus® or Wegovy®, or Tirzepatide, the API in Eli Lilly’s Mounjaro®, has emerged as a significant area of interest and opportunity. However, generic companies face critical decisions regarding the choice between recombinant and synthetic semaglutide. The path chosen can significantly impact regulatory approval, safety considerations, and market competitiveness.</p> <p><strong>The Importance of Generic Competition</strong></p> <p>GLP-1 agonist drugs were developed to treat Type II Diabetes but became blockbusters after getting approved or prescribed off-label for weight loss. An analysis of electronic health records shared with CNN by Epic Records estimates that around 1.7% of all Americans have been prescribed a semaglutide medication in 2023 alone, reflecting a nearly 40-times increase over the past 5 years. In a Fierce Pharma article published in September 2023, J.P. Morgan’s market projection for GLP-1 drugs was $71 billion by 2032, with Novo and Eli Lilly each accounting for 45% of its sales. Pfizer’s CEO Albert Bourla, Ph.D., estimated that the market could reach $90 billion by 2031.</p> <p>The demand for semaglutide is growing faster than Novo’s efforts to build up capacity, creating shortages in the supply chain and negatively impacting access to Type II Diabetes patients. As of May 2023, Ozempic® and Wegovy® are both listed on the FDA’s Drug Shortages list. To make it worse, the FDA issued a form 483 after inspecting Novo’s Clayton facility between July 6 and July 13, 2023, flagging manufacturing shortfalls at the Danish drugmaker’s production plant in North Carolina, where Semaglutide API is manufactured for Rybelsus®. In December 2023, the European Medicines Agency issued an announcement on the shortage of Ozempic explaining that <em>“Increased demand for Ozempic coupled with capacity constraints at some of the manufacturing sites have led to shortages. Although the company is taking mitigating measures, the shortage is expected to worsen in December 2023 and continue throughout 2024. It is uncertain when supplies will be sufficient to fully meet current demand.” In January 2024, in the UK, the NHS England and the Department for Health and Social Care issued a National Patient Safety Alert to address supply issues with GLP-1 RA medication, stating that “The global shortage in supply is partly due to a surge in off-label prescriptions of the drug semaglutide being issued for weight loss, which is exceeding supply.”</em></p> <p>Seven out of 10 adults and three out of 10 children in the United States are overweight or obese, according to the Centers for Disease Control and Prevention. Total annual medical costs for obese adults are an average of $1,861 higher than medical costs for people with healthy weight. That amount increases to $3,097 for a severely obese adult. By 2035, half of the world’s population – about four billion people – will meet the definitions of being overweight or obese, according to an estimate from the World Obesity Federation. While weight management and sustainable weight loss could drive significant health savings and improved health outcomes, quantifiable results will likely take time.</p>]]></content:encoded> </item> <item> <title>5,000L Single-use Bioreactors:The Next Generation in Biologics Manufacturing</title> <link>https://international-biopharma.com/5000l-single-use-bioreactorsthe-next-generation-in-biologics-manufacturing/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 10:50:07 +0000</pubDate> <category><![CDATA[Volume 7 Issue 1]]></category> <category><![CDATA[Application Notes]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15842</guid> <description><![CDATA[The Thermo Fisher Scientific HyPerforma™ DynaDrive™ Single-Use Bioreactor line is suited for volumes ranging from 50L to 5,000L. Optimised for modern cell culture processes in a scalable, ergonomic design, the platform allows intensified, flexible manufacturing, enhanced by high-power input per volume, and better volumetric mass transfer performance. This whitepaper highlights the features and benefits of […]]]></description> <content:encoded><![CDATA[<p>The Thermo Fisher Scientific HyPerforma<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> DynaDrive<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Single-Use Bioreactor line is suited for volumes ranging from 50L to 5,000L. Optimised for modern cell culture processes in a scalable, ergonomic design, the platform allows intensified, flexible manufacturing, enhanced by high-power input per volume, and better volumetric mass transfer performance.</p> <p>This whitepaper highlights the features and benefits of the DynaDrive<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> SUB platform and explains how any new or existing facility can leverage the platform to achieve expected development and manufacturing objectives. From pre-clinical trials through commercialisation, manufactures and companies looking to outsource their biologics can use the DynaDrive<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> SUB to gain maximum efficiency and flexibility across a wide range of processes, cell lines, and molecules.</p> <p>As scientific advancement in biopharmaceuticals continues to rise, so will the market. By 2030, total biologics revenues are expected to be worth $450 billion – up from the $285 billion biologics revenues seen in 2020. This rapid and continual growth has created a demand for therapeutics, expanding indications for biologics, and the growing portfolios of biosimilars. While these projections are good news for patients and makers of therapies, growth always comes with new challenges. In this case, the industry must learn how to deploy efficient, flexible manufacturing technologies that can respond to many variables. These variables include the proliferation of new biologics, rapid shifts in annual volumetric requirements, and improvements in cell culture strategies.</p> <p>A new generation of single-use bioreactors (SUBs), built to deliver high-volume performance, addresses many of these issues. This innovation outperforms existing 2,000L SUBs that were once the only cost-effective alternative to stainless steel bioreactors.</p> <p><strong>Redesigned for Higher kLa Through Better Mixing Performance</strong></p> <p>Most SUBs with legacy designs have a single agitator attached to the top or bottom of the bag. Neither design mixes to a high degree of homogeneity, which can lead to product gradients and quality issues. The DynaDrive<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> SUB, however, has a redesigned agitator shaft that spans the entire length of the bag – this new design contributes significantly to the technology’s reliable turndown ratio of up to 20:1.</p> <p>Prior to the introduction of DynaDrive<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> SUB, most turndown ratios on SUBs ranged from 2:1 to 5:1. Fast forward to today’s needs, many modern processes use higher producing cell lines and greater sophistication in process design. The need for greater oxygen transfer and mixing has become even more critical in process development.</p> <p>One way to improve the oxygen transfer rate (OTR) is to increase agitation, thereby distributing gases more efficiently in a bioreactor. Many traditional SUBs, particularly at larger scales, are excessively challenged in terms of OTR for intensified processes and higher viable cell densities, making scale-up unfeasible.</p>]]></content:encoded> </item> <item> <title>Enhancing Process Flexibilitywith Automated Filling</title> <link>https://international-biopharma.com/enhancing-process-flexibilitywith-automated-filling/</link> <dc:creator><![CDATA[theArchitec]]></dc:creator> <pubDate>Tue, 16 Apr 2024 10:41:35 +0000</pubDate> <category><![CDATA[Volume 7 Issue 1]]></category> <category><![CDATA[Application Notes]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=15839</guid> <description><![CDATA[During the production and filling of highly complex biopharmaceuticals in cell and gene therapy, precise flow measurement and accurate air bubble detection play a crucial role. Flow meters and air bubble detectors ensure consistently high product quality to provide patients with effective and safe drugs. Using the example of the RoSS. FILL platform, developed by […]]]></description> <content:encoded><![CDATA[<p>During the production and filling of highly complex biopharmaceuticals in cell and gene therapy, precise flow measurement and accurate air bubble detection play a crucial role. Flow meters and air bubble detectors ensure consistently high product quality to provide patients with effective and safe drugs. Using the example of the RoSS. FILL platform, developed by the Austrian company Single Use Support, ultrasound specialist SONOTEC explains how non-contact clamp-on flow meters and air bubble detectors can significantly increase the accuracy of automatic filling.</p> <p><strong>Challenges in Aseptic Filling</strong></p> <p>Accurate and efficient filling of biopharmaceuticals in single-use bags, bottles, or vials is crucial. Even the smallest deviations in the filling volume can have a huge impact on the production process, or finally on the patient‘s therapy.</p> <p>For example, if a liquid needs to be frozen for transport, overfilling or an inconsistent volume of single-use bags seriously increases the risk of bag leakage and product loss. In most cases, it is absolutely important that a patient receives exactly the same volume of medication per injection.</p> <p>Operational errors in aliquotation processes often occur due to manual intervention or limitations. The major challenges in aseptic filling are:</p> <p>• Accuracy</p> <p>• Consistency</p> <p>• Flexibility</p> <p>• Scalability</p> <p>By implementing automated filling solutions with leading flow measurement technology, product and material loss, human errors, as well as the risk of contamination can be significantly reduced, while process flexibility can be substantially increased.</p> <p><strong>Solution Provider: Single-Use Support</strong></p> <p>Innovative automated fluid management solutions provided by the company Single Use Support set a new standard in biopharmaceutical manufacturing.</p> <p>The company offers specific expertise and fast solutions in processes regarding cell and gene therapies (CGT) but also commercial bulk drug substance handling and vaccine manufacturing transfers, and drug productions. With its expertise and advanced bioprocessing solutions, Single Use Support has become the market leader in the accurate filling of very small volumes in single-use bags.</p> <p><strong>Highest Accuracy for Better Operator‘s Control</strong></p> <p>With its fill & filtration platform RoSS.FILL, Single Use Support offers unlimited scalability for aseptic filling from laboratory to commercial production. The modular platform is designed for filling multiple smaller and larger volumes between 1 mL and 1000 L into single-use bags or bioprocessing containers.</p> <p>For low-volume dispensing at a commercial scale, accuracy and repeatability are essential. To achieve a filling accuracy range of even less than ± 1 mL with the RoSS.FILL platform, Single Use Support decided to implement SONOTEC‘s SONOFLOW CO.55 V3.0 ultrasonic flow meters. The sensors are easily clamped on the tubing and measured without any contact and therefore without any risk of contamination or leakage.</p>]]></content:encoded> </item> </channel></rss> If you would like to create a banner that links to this page (i.e. this validation result), do the following:
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