Featured Outsourcing Editorial
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2024’s Market Outlook For Cell & Gene Therapies
2/9/2024
RSM is back for the third consecutive year to provide an outlook analysis of the cell and gene therapy market. This article discusses the 2024 state of the macroeconomy, its effects on cell and gene therapy companies, growing approval pipelines and approvals, funding factors, and the unique prospects for the market.
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PROTACs And Molecular Glues: Rethinking What Is Possible
2/9/2024
This article explores the potential of novel small molecule approaches to address undruggable targets in oncology, including PROteolysis TArgeting Chimeras (PROTACs) and molecular glues, and how they work.
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Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity
2/8/2024
It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.
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FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
2/6/2024
Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.
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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.
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Osmotic Controlled Release Oral Drug Delivery: A Closer Look
2/2/2024
Osmotic controlled release drug delivery is not often spoken about, but it is a useful oral drug formulation technology. This article shares the mechanisms of the elements of oral dosage, including the semi-permeable membrane, pore-forming agents, and more, as well as advantages and applications of this type of drug delivery.
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When In The Product’s Life Cycle Does Continuous Manufacturing Make Sense?
2/1/2024
This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.
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It's Time To Dethrone CHO When It Comes To mAb Production
2/1/2024
Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.
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Novel Approaches For Obtaining High-productivity Clones
1/30/2024
Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.
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Indo-U.S. Collaboration Can Accelerate Drug Discovery — Here’s How
1/30/2024
Innovation in drug discovery can suppress development costs, ultimately improving patient access. Collaborations between India and the U.S. promise to accelerate that innovation on several fronts.