Biosimilar Manufacturing solution center

31. Why Location Matters 1/5/2023

    While many factors can dictate the choice of a CDMO partner, the CDMO's location can have a significant influence on the communications channels, facilities, and skillsets that a potential partner has to offer.

32. CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance 12/21/2022

    While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

33. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

34. Make The Service Agreement Work For You And Your CDMO 12/14/2022

    Knowledge of the applicable rules and legal challenges, as well as ways to ensure the enforcement of proprietary rights, requires companies to invest in negotiating and drafting robust and balanced CDMO service agreements. This article provides practical tips (for both the principal and the CDMO) for drafting these vital legal agreements.

35. 4 Key Takeaways For Combination Products As We Move Into 2023 12/13/2022

    The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.

36. Pursuing A “Biologic Revolution” With Vaxxinity’s Mei Mei Hu 12/9/2022

    In a recent episode of The Business of Biotech, Vaxxinity's Mei Mei Hu explored how traditional vaccines and biologic therapies are converging to improve access to treatment on a global scale.

37. Introduction To Tangential Flow Filtration 12/7/2022

    Tangential flow filtration (TFF) is a rapid, efficient method for separating and purifying biomolecules. Learn about TFF, typical TFF system configurations, ultrafiltration fundamentals, applications, system selection considerations, and more.

38. Where Do We Stand On Adopting Continuous Manufacturing For Biologics? 12/5/2022

    Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.

39. Longhorn’s Path To A Universal Influenza Vaccine 12/2/2022

    Thanks to the long-term planning of one biopharma family and some help from the U.S. Army, a universal influenza vaccine is coming soon to a clinical trial near you.

40. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

    Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.