Regulatory Articles. App Notes, Case Studies. & White Papers

31. Successfully Producing Insoluble Proteins Using Inclusion Bodies 9/27/2022

    Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

32. Regulatory Convergence With Aurion Biotech 5/18/2022

    Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.

33. Flexible Expression Technologies For Mammalian, Microbial Proteins 5/3/2022

    Drs. Joachim Klein and Rebecca Michael from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s options for expressing and manufacturing complex biologic drugs.

34. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

    Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

35. Method Transfer – When, Why, How? 2/16/2022

    A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.

36. bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches 10/4/2021

    bluebird bio's Scott Cleve sat down with The Business of Biotech podcast to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

37. How Fulcrum Therapeutics Protects Its Data 4/20/2021

    Maintaining GxP compliance, creating a secure environment for collaboration, and ensuring there is a single source of truth are becoming more and more of a hassle. Read how Fulcrum has turned to technology to help automate many of these processes in order to streamline collaboration with third-parties and the organization of data into a single repository.

38. Current Data Privacy Regulations Impacting The Life Sciences Industry 4/20/2021

    The GDPR is a significant advancement of consumer data protection rights. The European member states agreed to a set of principles that would penalize organizations that don’t safeguard personal identifying information (PII). If your team or clinical trial operates in the EU, California, S Korea, Australia, or a dozen other countries, your data could be subject to strict privacy laws. Violating GDPR, PIPA, APP, or CCPA, among others, have serious consequences for your program. Learn how to mitigate risk and keep on the right side of regulators.

39. Q&A: Achieving BLA Success Using A Structured Approach 1/19/2021

    Drs. Jason Osman and John McGuire from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s structured approach to developing a CMC strategy.

40. Best Practices Guide To Data Privacy In Clinical Trials 1/6/2021

    As life sciences companies grow, so do the regulatory compliance requirements. These responsibilities extend beyond conventional health-related frameworks and into the realm of data privacy as well.