Search results for "biopharma"
Article
Process Development: What May Lie Ahead in 2018?
What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engineers? Here, we look at some of the most popular Process Development Forum articles …
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
The New World of Biopharmaceutical Manufacturing
By Jennifer Markarian
Without question, biopharmaceutical manufacturing has changed dramatically since 1977, when it was in its infancy. The ball really began roll…
Article
From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …
Poster
Heating-cooling and liquid-liquid mixing characterization at a range of volumes
Single-use mixers have been used in the past two decades in biopharmaceutical plants to replace the use of stainless steel vessels. Heating/cooling and mixing properties are the two key parameters imp…
Article
Evaluating E&L Studies for Single-Use Systems
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biopharmaceutical companies have increased the adoption of single-use systems (SUS) and components (i.e., polyethylene bag…
Article
Automating Processes in Upstream Processing
Biopharma companies are focused on 21 Code of Federal Regulations Part 11 assessments to document which aspects of the regulation are covered by the control system and which aspects may be covered via…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and development of robust, efficient, and economic purification strategies for new monoclonal antibodies (…
Article
Quality Systems Key to Lifecycle Drug Management
FDA officials plan to try again to offer regulatory relief in filing supplements and also in undergoing plant inspections for those biopharma companies that implement QbD and advanced manufacturing te…