Outsourcing Fundamentals For Emerging Biopharmas
One of the most important decisions you'll face in the early stages of your biopharma journey is whether or not to entrust a CDMO (contract development and manufacturing organization) with the development of your molecule. The quality, regulatory, cultural, and longer-term scale-up implications are heavy, and the checklist to ensure your outsourced partner operates as a true extension of your team is long. You'll need to vet their personnel, their finances, their facilities and equipment, their technology infrastructure, their quality and risk management strategies, their communication and transparency, their regulatory commitment and track record, and more.
Aseptic Systems Design: Looking To The Future
This e-book is our fourth collective effort and is a collection of nearly 60 years of experiences and being witnesses to and practitioners in this most critical care aspect of the pharmaceutical business.
Engineering & Building The Next Biotech Facility
Designing biopharma production systems and facilities presents daily challenges, given dynamic variables like diverse processes, product frailties, space constraints, evolving regulations from multiple countries, containment issues, and more. This ebook is a collection of articles, written by Herman Bozenhardt and Erich Bozenhardt, that cover the major aspects of the facility engineering “puzzle,” while offering some of the “how to” you’ll need to solve it.
Data Integrity In The Life Sciences
This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.
Unique Bioprocessing Challenges: Solvent Handling, High Energy, Potent Compounds, and Hazardous Materials
This e-book shares some of our experiences in the more hazardous areas, and in turn challenges you to look at your facilities and operations to apply some basic safe design philosophies to whatever you are working with, potent or not. We sincerely hope you enjoy them and continue to be safe.
Rethinking Bioprocess Facility Design
Download this free collection of articles and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas. Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook.