Biotechnology

PE Magazine
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls; and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time and in full while managing cos
Technical
The implementation of a mammalian cell-based biopharmaceutical manufacturing process demands robust methods for knowledge handling, from early-stage development and technology transfer to production scale. Mathematical process modeling can summarize this knowledge as the relationships of critical quality attributes to critical process parameters using mathematical equations and sound...
Technical
Advanced therapy medicinal products (ATMPs) pose specific manufacturing challenges beyond those typically addressed by pharmaceutical chemistry. Often in current ATMP applications, a change in approach is introduced at some point in the development process out of convenience or necessity, which then results in a change in technology. This article analyzes the possibility of transferring a cell...
Training
Best & Brightest ATMP & Biotechnology Content from the 2021 Conferences 62 Presentations Featuring 29+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference...
Training
This new course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest....
Training
21 Presentations Featuring 8+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest...
Online Live
Online Live Overview Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the...
Features
Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,1  the quest for flexible...
  • 1Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.” BioPharm International 2, no. 9 (1989): 20–6.