Jon C. Strauss

Sep 17, 2024 | bioprocessonline.com | Jon C. Strauss |Christopher Williams |Amanda Connor

Securing Your Cell Banks: Embracing Closed System Technologies for EU GMP Annex 1 ComplianceUntil the 1970s, mouth pipetting was common practice. Now, with regulatory changes from Annex 1, it's important to consider if your cell bank manufacturer is minimizing operator manipulations. Watch this webinar and learn about our efforts to create a closed manufacturing process that meets Annex 1 expectations effectively.

Sep 14, 2024 | bioprocessonline.com | Jon C. Strauss |Tim Sandle |Yadnyesh Patel |Jessica Carmen

AUGUST'S BEST FEATURED EDITORIAL9 Common Tech Transfer Pitfalls To AvoidMany issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each. Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. RecommendationsICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

Aug 27, 2024 | bioprocessonline.com | Jon C. Strauss

By Jon Strauss, FASTFORWARDBIO Once a biologic drug has shown sufficient promise in early in-vitro and in-vivo studies, it’s time for the drug sponsor to initiate first-in-human (FIH) trials. For a small biotech company, managing the multitude of tasks requiring completion to get medicine to its first patients can be daunting. Mistakes are expensive and time-consuming at their best and they may harm patients at their worst.

Aug 13, 2024 | bioprocessonline.com | Jon C. Strauss |Cory Lewis |Incog BioPharma

Discover the new speed of analytical testing services with KBI Biopharma's Analytics Portal – your single access point for quoting, ordering, sample submission, project status tracking, and data access. Leverage our global expertise in biopharmaceutical analytics to support you through every phase of your project, from early-stage development to commercialization. Skip the back-and-forth emails with your service provider. Simply log in and get everything done. Learn more here.

Jul 24, 2024 | bioprocessonline.com | Jon C. Strauss

By Jon Strauss, FASTFORWARDBIO To develop a biologics-based drug, a biopharma company will likely need to outsource the drug’s manufacturing process and analytical testing to an external manufacturer one or more times during the product’s development cycle. The process of moving procedures, knowledge, staff, and molecules from one place to another is called technology or tech transfer, and it’s riddled with pitfalls, which we will explore here.