Expert Insights On Cell Line Development

  1. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

  2. Best Practices For Designing Microbiology Experiments 6/23/2021

    A sound scientific approach can be taken for running experiments and qualification of microbiological methods. This article looks at factors to consider in drawing up assessment criteria for a microbiological test, including the limit of detection, specificity, and quantification. 

  3. From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs 6/9/2021

    The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.

  4. Outlook: Biotech In 2021 & Beyond 5/31/2021

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

  5. The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers) 5/21/2021

    What's ahead for gene therapy in the next decade? This article highlights six key questions and recommendations for the future of the industry. For example, what technologies should gene therapy companies evaluate beyond delivery vehicles, and how should a gene therapy be priced?

  6. Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs 5/14/2021

    Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop. 

  7. An Analysis Of The Gene Therapy Viral Vector Landscape 4/21/2021

    Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

  8. Culture Media Market Growth Drives Demand For New & Better Technologies 7/6/2020

    With a rise in bioprocessing demand, the market for cell culture media—an essential component of bioprocessing—has also seen a surge in the last few years. This column takes a deep look at the market as measured in BioPlan’s 2020 17th Annual Report and Survey of Biopharmaceutical Manufacturing,

  9. Implementing Single-Use At Bioprocessing's Core 5/20/2016

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. One of the biggest drivers in the current evolution of biological facility design is the implementation of single-use systems (SUS).

  10. QbD: A Framework For Improved Decision Making Throughout Drug Development 3/10/2016

    A frequent complaint of process engineers tasked with implementing quality by design (QbD) is the lack of information provided by their upstream development teams. For QbD to be  implemented efficiently, at least 80% of the knowledge needed for process development must be generated in the R&D phase and transferred downstream.