July 18th 2025
Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.
Optimization, scale-up, and validation ISSUES in FILTRATION of Biopharmaceuticals, Part II
September 1st 2004Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.
Editorial—Welcome to Our PMP Series
August 1st 2004What were you doing on the evening of July 20, 1969? If you are at least a baby boomer, you were probably watching Neil Armstrong take "one small step for man, one giant leap for mankind." Sputnik aside, the birth of that monumental achievement probably began with the same question that sparked so many other great feats: "What if?" Where would civilization be if someone periodically hadn't had the imagination and the courage to ask that question, whether their field of expertise was aeronautical engineering, architecture, or biotechnology?
Optimization, scale-up, and validation issues in Filtration of Biopharmaceuticals, Part 1
August 1st 2004Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include:
Regulatory Beat: Politics vs. Science in Biomedical R&D
July 1st 2004The debate over drug importation is a prime example of politics trumping science as members of Congress reject the consensus of scientists and policy experts that opening US borders to therapies from abroad raises serious public health concerns.
Operations Excellence: BioPharma Consortium Meets in California and the Netherlands
July 1st 2004Although there are many differences between the industries, especially related to regulatory requirements, there are enough similarities that the future of biopharmaceuticals with respect to contract manufacturing might look much like the semiconductor industry.
Upgrading a Pharmaceutical Laboratory to Part 11 Compliance
May 1st 2004FDA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1
Editorial—Sustainability for a Long-Distance Race
April 1st 2004It may take take more than a decade to bring a new drug to market, but it's still a race from the bench to the shelf. It's easy to think of the race in terms of a sprint, like a six-second dash from one end of the pool to the other, especially during crunch times when you're rushing to meet deadlines. However, developing a biologic drug is a much longer race, more like a 400-meter medley. If you've ever competed in one, you know it's a test of endurance that requires a long-distance mind-set, strategic thinking, and a complex combination of skills.