Search results for " guidelines"
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Regulatory guidelines require extensive analytical testing side by side with the innovator drug, including full glycosylation profiles (3). Similarity to the innovator drug is paramount; this must beg…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Test procedures and acceptance criteria for CQA analysis have been described in regulatory guidelines for biotechnological/biological products (6, 7).
Late-stage development starts with set up and…
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Aseptic Processing: Keeping it Safe
…me standard as for products authorized for marketing,” according to the European Commission’s EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use Annex 13, I…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Drug Discovery and Development in India
In September 2014, the government rescinded guidelines issued the previous May that would have given the National Pharmaceutical Pricing Authority (NPPA) the power to set prices of non-essential medic…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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Article
Regulatory Challenges in the QbD Paradigm
The underlying principles of science- and risk-based process and product development and commercialization are also reflected in the contents of the quality guidelines ICH Q8 Pharmaceutical Developmen…
Article
Report from the 6th International HTPD Conference
Desired topics for the next conference included machine learning, more about new modalities but most dominant were requests for regulatory guidelines in using mechanistic modeling and examples of fili…
Article
Report from the 12th Plasma Product Biotechnology Forum
Hence, PPTA stressed the importance of science based and harmonized regulatory guidelines, and Dominika presented several examples of discrepancies and inconsistencies.
Kedrion’s Director of No…