Search results for " therapeutic"
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
In the past few years, there has been an increase in the number of therapeutic proteins in development and those that have received approval from regulatory agencies. Proteins are produced by gene exp…
Article
Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
Article
Framing Biopharma Success in 2016
The authors suggest that focusing R&D efforts on stable therapy areas and specialty therapeutics will add to scientific, regulatory, and commercial value propositions. Agility, flexibility, and a focu…
Article
Tools for Continuous Bioprocessing Development
have used microfluidic perfusion devices to study therapeutic protein production using Pichia pastoris (30). A perfusion filter (polyethersulfone) with a 1-cm diameter was incorporated underneath the …
Article
Antibody Purification Handbook
The diversity of the antibody-antigen interaction and our ability to manipulate the characteristics of the interaction has created many uses for antibodies and antibody fragments, both for immunoche…
Article
GMP Challenges for Advanced Therapy Medicinal Products
56: Application of Phase-Appropriate Quality Systems and CGMP for the Development of Therapeutic Protein Drug Substance (Bethesda, US, 2012).
About the author:
Sean Milmo is a freelance write…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
The latter can be difficult to detect, grow to high densities without adverse effect on cell morphology, and can impact a wide variety of cell functions, including changing response to therapeutics (1…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Since the first therapeutic antibody came onto the market in 1986, up to the end of 2014, 47 products have been approved in the United States or Europe for a number of diseases including various types…
Article
Biopharma Advances Demand Specialized Expertise
Due to the complexity of many biopharmaceuticals, their development and success as therapeutics requires a comprehensive range of scientific disciplines and expertise, which can be difficult to fully …