10.07.19 -- Abcentra Chief Looks Beyond The Clinical Horizon
Formulation and tech transfer present perennial challenges for biopharma. That's why they're focal points at Catalent. Learn how we're leveraging state-of-the-art automation technologies to enable high-throughput formulation development and how we are applying innovative approaches to process management to address equipment and materials challenges during tech transfer.
Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. While some of the largest biopharma companies in the world are now conducting pilots, several remaining obstacles must be overcome.
White Paper |
By Daniel Galbraith, Ph.D.,MilliporeSigma (Product Characterization)
The relationship between the basic physicochemical profile and biological activity — and how this relationship affects clinical performance — is a key component of making informed decisions, accelerating development, and reducing risk throughout the product life cycle.
By Madhu Raghunathan,GE Healthcare Life Sciences
Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems in the near future.
By Aryo A. Nikopour,Nitto Avecia Pharma Services
Extractables and leachables (E&Ls) safety assessments are among the most challenging review issues in an FDA application because they require a coordinated effort among chemistry, manufacturing, controls, and toxicology review staffs. Here's guidance on five common questions.
Case Study |
By Guy Matthews,Parker Bioscience Filtration
This article discusses the product development cycle of a system for bulk filtration of active pharmaceutical ingredients (APIs), how this development progressed from generation one to two, and the lessons learned along the way.
The LAL or Limulus test is used for the determination of bacterial endotoxins in a wide variety of samples. In this article, the biological process and the way it was used to develop the test is described.
Establishing a platform approach to process characterization ensures the entire process is robust, right the first time, and results in a highly consistent product to facilitate efficient BLA filing. This five-step process accelerates time to a robust and reliable commercial-scale process.
Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. One proven and particularly effective approach is to have pharmaceutical sales representatives hand carry samples to the health care practitioners within their territories.