Vaccine Maker's Toolkit: Strategies For Manufacturing And Supply Management

This collection of insights highlights strategies and guidance to ensure reliable biomanufacturing capacity and supply chains for the delivery of health technologies, even during crisis conditions.

Supply Chain Resilience: Strategies For A Post-COVID World

Resilience minimizes disruption. Biopharmaceutical supply chain strategies can be profoundly bespoke, but best practices like redundancy and quality risk management offer a starting point. The ideas in this collection of recent articles from Bioprocess Online can help shore up your own network in defense of the next upset.

Continuous Manufacturing Progress & Pitfalls

Get the latest expert takes on both the progress and the pitfalls of continuous manufacturing adoption in biopharma, with insight from Richard Chen (Eli Lilly and Company), Chris Hwang (Transcenta Holding Ltd.), Kelvin Lee (NIIMBL), and Andrew Zydney (The Pennsylvania State University), John F. Kokai-Kun (The United States Pharmacopeia) Nathan Parker (Parker Biopharmaceutical Consulting) and Parrish Galliher.

Are You Really Ready To Submit That NDA/BLA?

Are you ready to file an NDA or BLA? Are you really ready? Once your application is submitted, the scrutiny begins — from your preclinical data to your standard operating procedures to literally any other aspect of your business the Agency feels appropriate.

Risky Business: Managing Risk In Biopharma Manufacturing

Financial, scientific, and patient risks present at every turn. Why introduce yet more risk in the manufacturing suite? This e-book offers a collection of fresh insights from biopharma risk mitigation experts Peter H. Calcott, Ph.D. (Calcott Consulting LLC), James Vesper, Ph.D., MPH (ValSource, LLC), Ajay Pazhayattil (Capcium Inc.) and Emergent BioSolutions' Praveen Joseph and Ciona Forsythe. 

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

Growing demand and rapidly improving manufacturing technology creates an incredibly competitive biopharmaceutical environment. With that intense competition comes the necessity for biopharma companies to ensure the patent protection of their molecules early, and to plan strategically for protection beyond commercialization.

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.