Search results for " scientists"
Article
Ligand-Binding Assays and the Determination of Biosimilarity
In October 2014, the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group Biosimilars Action Program Committee published a whitepaper with recommenda…
Article
New Era for Generic Drugs
One result is the elevation of the relatively small Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) into a “super office” to accommodate a larger cadre of scientist…
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High-Throughput Process Development in an Historical Environment
The topic was “Lessons Learned in Building HTPD Capabilities” and comprised of a panel discussion and short presentations from five scientists, representing some of the leading companies in the HTPD a…
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must.
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein a…
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Raw Material Variability
Despite the courageous work done by the engineers and scientists, there is a rising tide of questions along the lines of ‘surely, there’s a better way?’ These investigations are expensive and energy s…
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Early Communication with Regulators is Essential for SMEs
It is, however, hard work for the regulatory agencies because many small companies (a high proportion of which are startups founded by individual specialists or small groups of scientists) tend to del…
Article
Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
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Article
Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…