Business

Smart Modular Package Units for Single-Use Processing: Addressing Cost, Speed, and Flexibility Challenges in Biologics Manufacturing

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How to reduce costs, while still increasing speed, and flexibility in biologics manufacturing currently represent major issues for the biopharma industry. In this article, Burkhard Joksch, Product Manager Bioprocess Automation and Stuart Tindal, Product Manager FlexAct® Platform at Sartorius Stedim Biotech GmbH, detail the evolution of automation for single-use technology towards modular packaging units. They also including case studies of how these units can be used in real life cGMP processes, as well as explain the manufacturing and industry benefits…

March 14, 2019

Manufacturing Insights: Interviews from BWB 2018 Highlight Perspectives on Streamlining Manufacturing Timelines

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Addressing manufacturing and technologies strategies to accelerate market entry is one of BPI’s highlighted themes for 2019. In partnership with our conference colleagues in Informa’s KNect365 division, this already has been a shared theme, reflecting the general goals of the industry and related advice from its regulators. BPI’s summer 2018 preconference ebook included interviews by Dan Stanton (editor, BioProcess Insider) with speakers previewing their talks for the BPI Conference in Boston on 7 September 2018. Two of those conversations focused…

February 14, 2019

Aspects of Acceleration: Biomanufacturers Need Smart Strategies to Speed Products to Market

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No matter what the industry, it’s widely accepted that slow-moving companies give their nimbler competitors an advantage, allowing them room to dominate the market even if their products are not superior. “Me-too†products and their sponsors often are seen as followers rather than leaders — even if they offer improvements over what is already available. Fast movers are flexible and adaptive to a dynamic business environment. They capitalize on opportunities and navigate risks and challenges by responding quickly to changes…

February 14, 2019

Monetizing Innovations in the Biopharmaceutical Industry

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The biopharmaceutical industry has seen strong growth over the past 15 years, with a compounded annual growth rate (CAGR) of 6.7%. However, if you look at that growth in five-year intervals, it becomes apparent that the rates have begun to decline in many countries. Companies have withdrawn somewhat and put initiatives into place to curb further increases in the cost of drugs. The CAGR fell from 8.7% for the period of 2002–2006 to only 3.1% for 2012–2016. In our yearly…

February 14, 2019

Worldwide Biopharmaceutical CMO Capacity Analysis

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Contract manufacturing organizations (CMOs) are a core part of the biopharmaceutical industry, with commercial manufacturing making up about a third of marketed products. Here we examine worldwide CMO biopharmaceutical manufacturing (bioprocessing) capacity, concentrating on “mainstream†CMOs — defined as those providing primarily mammalian cell culture or microbial fermentation services for manufacture at any scale of proteins and antibodies. This analysis follows our recent article examining worldwide bioprocessing capacity status and trends (1). Survey Methodology The 2018 15th Annual Report and…

February 14, 2019

Partnerships in Immunotherapy for the Future of Cancer Treatment

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Immunotherapy seeks to harness the power of our human immune system to fight disease. In this rapidly evolving field, collaboration among different stakeholders is essential to bringing new treatments to market. Patient advocacy groups, researchers, hospitals, manufacturers, and government entities all are working together to translate promising new research into life-saving products. Types of immunotherapy include monoclonal antibodies (MAbs) and antibody derivatives, checkpoint inhibitors (immune-modulating proteins), cancer vaccines, T-cell therapies, and cytokines — so the approach involves a range of…

February 14, 2019

Elucidation: Better Biomarkers Could Power Precision Medicine for Autoimmune Disease

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Precision medicine has long been a tantalizing goal for the pharmaceutical and healthcare industries. Fields such as oncology and rare diseases have benefited greatly from implementation of genome-guided care. Drug developers likewise have made strides with biomarker-aided discovery programs and stratification for clinical trials. Current indications suggest that autoimmune diseases will be the next major focus of personalized medicine. The goal of precision medicine often is described as “getting the right drug to the right patient at the right time. 

February 11, 2019

Biosimilars: Challenging the Justifications for Clinical Testing

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The Biologics Price Competition and Innovation Act (BPIA) of 2009, describes the need for clinical trials as follows (1): “(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.†However, all the above studies are left…

January 30, 2019

Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data

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When a new medicine is approved, there is under a 25% chance that the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) will impose, as part of conditional approval, studies conducted to satisfy postmarketing requirements. US regulations governing such studies are found in the 2011 guidance document regarding “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (1).†EMA regulations are found in the 2017 “Guideline…

January 30, 2019

Biopharmaceutical Characterization,
Part 1: Biological Assays —
A Conference Report

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In late October 2018, KNect365 brought together more than 250 analytical specialists to discuss characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies, including BPI editorial advisor Nadine Ritter (president and analytical advisor of Global Biotech Experts). She began the final day moderating a special town-hall session where audience members could pose their regulatory questions to a panel of FDA reviewers, and she ended…

December 18, 2018