• Quality Management Systems Execution

    Quality management systems (QMS) aren't a plug-and-play proposition. Ensuring your QMS investment contributes to the ultimate goal of meeting patient needs—while meeting regulatory compliance expectations along the way—your QMS infrastructure needs to be set up, integrated, and engaged strategically and consistently.

  • Patent Trends In Biologics

    Advances in biotech manufacturing are making the production of many biological therapies, such as antibodies, vaccines, and even cell therapies, easier and more cost-effective than ever. Biologics account for more than a quarter of pharmaceutical production, and that share continues to grow. Most forecasts peg global biologic therapies annual revenue at a figure north of $7 billion by 2025.

  • COVID-Fueled Reform At The FDA

    One of the many lessons the biopharmaceutical industry has learned in the wake of the COVID-19 pandemic is that we can move fast. Really fast. Much faster than we ever thought possible.

  • Biopharma Supply Chain Considerations 2021

    Before COVID-19 asked us to drop everything and reallocate so much of the biopharma industry's collective attention, fast-approaching requirements of the Drug Supply Chain Security Act (DSCSA) were already placing stress on biopharma supply chain professionals. Notably, biopharmas were busy working to meet the Act's upcoming aggregation requirement, which goes into effect in a little more than two years and calls for a process of creating hierarchical relationships between unique identifiers assigned to packaging containers. It's all part of the November 27, 2023 interoperability timeline, which calls for the entire supply chain (including manufacturers, repackagers, distributors, and dispensers) to demonstrate the unit-level traceability and aggregation requirements mandated by the Act.

  • 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.