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
…d 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 particl…
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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…