Search results for " drug"
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
By Alex Chatel and Jean-Christophe Drugmand
The gene therapy market is foreseen to reach over $3 billion and grow at a compound annual growth rate (CAGR) of 34% until 2023 (1, 2), which makes it o…
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Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
…d about traditional process development methods that can contribute to improvements for non-pandemic drug development applications
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Finding the Needle in a High-Dimensional, Information-Rich Data Haystack Can Be Time Consuming
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Biacore™ surface plasmon resonance (SPR)-based sensors are an essential tool in drug discovery. With these tools, scientists can detect and characterize low molecular …
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
While these novel biologics are filling drug pipelines, they are also challenging existing manufacturing processes in upstream, downstream, and analytical development.
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Updating Viral Clearance for New Biologic Modalities
For instance, Lonza has a short timeline offering (of 12 months) for filing an investigational new drug (IND) application, which includes a virus-reduction study. Generally, the samples for a viral cl…
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Process Development: 2020 Reflections and 2021 Possibilities
Shrinking timelines and an increasing number of drug candidates and corresponding experiments makes these approaches more necessary than ever. One efficient method is high-throughput process developme…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
In the letter, the agency details steps to ensure a separation between persons giving scientific advice to a drug developer and persons evaluating a market authorization application. The letter states…
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
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Understanding the challenges novel and diverse biological molecules can create and how to manage these challenges is key to ensuring they reach patients safely and eff…
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Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
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Step Up to GMP Manufacturing or Outsource to a CDMO: Considerations and Tips
Whether you are developing a new monoclonal antibody (mAb), cell therapy, gene therapy, or large-molecule biologic drug, the decision to tackle GMP manufacturing in-house or work with a contract devel…