Search results for " guideline" in Articles / App Notes
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…
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Best Practices in Qualification of Single-Use Systems
Because chemical compatibility is determined by the concentration of contacting fluid, the nature of the polymer, the contact time, and temperature, Table II can only be used as a general guideline. W…
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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…
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Ensuring the Quality of Biologicals
As stated in the European Medicines Agency (EMA) Guideline on Similar Biological Medicinal Products (1), “Comparability studies are needed to generate evidence substantiating the similar nature, in te…
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In September 2014, the government rescinded guidelines issued the previous May that would have given the National Pharmaceutical Pricing Authority (NPPA) the power to set prices of non-essential medic…
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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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Regulatory Challenges in the QbD Paradigm
QbD is defined in the International Conference on Harmonization (ICH) Q8 guideline as "a systematic approach to development that begins with predefined objectives and emphasizes product and process un…
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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…
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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…