Gerardo Gomez

Jun 12, 2024 | bioprocessintl.com | Olena Chervonenko |Gerardo Gomez

Technology transfer is a sophisticated and complex undertaking that requires careful planning to ensure successful transition and regulatory compliance. The biopharmaceutical industry is concerned with two main types of technology transfer: scale-up and transfer to a different site (1, 2). Scale-up technology transfer often occurs within an organization or facility and involves moving a technology or process from a laboratory or pilot-scale environment to a larger manufacturing scale.

Jun 12, 2024 | bioprocessintl.com | Cheryl Scott |Olena Chervonenko |Gerardo Gomez |Narendra Sharma

As you read this, we’ll be deep into the preparation of our “Platform” issue for publication in August. So now may be your last chance to speak up through our online survey athttps://www.surveymonkey.com/r/NDJPPSK. If you haven’t already, I encourage you to drop in there and give us your thoughts now. We want to present the best picture of the biopharmaceutical industry’s current reality in that upcoming issue.

Apr 30, 2024 | flipboard.com | Gerardo Gomez

Sep 26, 2023 | bioprocessintl.com | Gerardo Gomez

eBook: Aseptic Processing — Reflections from the 2023 ISPE Aseptic Conference Biopharmaceutical products must be sterile. Protein biologics and now advanced-therapy medicinal products (ATMPs) usually are administered in ways that bypass patients’ natural immune defenses. Therefore, such drugs increase risks for introducing contamination to their recipients.