Search results for "biopharma" in Articles / App Notes
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical manufacturing because it has a potential safety impact on the end user and because aseptic filling is a highly tec…
Article
Putting Viral Clearance Capabilities to the Test
Viral clearance studies assess the capability of a downstream process to remove or inactivate potential contaminants and are based on a scale-down model of a biopharmaceutical production process. The …
Article
Modern Manufacturing Key to More Effective Vaccines
He said these developments will “transform the biopharmaceutical industry” by boosting local production and supply of high-quality vaccines in developing countries, while also expanding capacity for r…
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 …
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…