Search results for " biopharmaceutical"
Article
GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
Article
Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Due to their structural, physiological, and pharmacological properties, antibody fragments offer new biopharmaceutical opportunities. In the case of recombinant full-length antibodies with suitable Fc…
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A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
At the conference, there was a keynote lecture on this topic presented by Guy de Roo, from Synthon Biopharmaceuticals. Another conclusion I drew from the conference was that there is little news in th…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
Modular Manufacturing Platforms for Biologics
…ed by applying methods described in Federal Standard 209 may affect operations of a cleanroom” for biopharmaceutical processes. Thus, the company writes, a measure of both viable and nonviable partic…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Agency officials have urged biopharmaceutical manufacturers for more than a decade to adopt more reliable and efficient advanced manufacturing technologies capable of ensuring consistent high-quality …
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Drug Discovery and Development in India
In addition, venture capital and private equity have not been actively supporting such biopharmaceutical start-ups, leaving such companies to turn towards larger multinational pharmaceutical companies…
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Re-use of Protein A Resin: Fouling and Economics
In this thirty-second article in the “Elements of Biopharmaceutical Production” series, the authors present the outcome of a survey that was recently performed jointly by researchers at Indian Institu…
Article
Tackling Analytical Method Development for ADCs
“Cross-fertilization within the biopharmaceutical industry, particularly driven by the proliferation of ADC-focused conferences, workshops, instrument company webinars, etc., has lead to an increased …
Article
Labeling of Biosimilars
Critics of EMA’s policy on the issue, led by the European Biopharmaceutical Enterprises (EBE) and the European Association of Bio-industries (EuropaBio), claim that it is too close to that on the labe…