Search results for " regulations"
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Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Critical Quality Attributes Challenge Biologics Development
Regulations and risk assessment
BioPharm: Are the regulations for CQAs and QbD different for biologics? If yes, how?
Das (BMS): The ICH guideline [(ICH) Q8 (R2)] is commonly followed for CQA a…
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Ensuring the Biological Integrity of Raw Materials
(2,3)
Global regulations, including those from the United States Department of Agriculture, the European Medicines Agency, and the FDA’s Center for Biologics Evaluation and Research (CBER) set sta…
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Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
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Microbiological Testing: Time is of the Essence
Amendments to the Sterility Test for Biological Products rule (21 Code of Federal Regulations 610.12), which establishes FDA’s microbiological testing requirements for biological products, have been p…
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Managing Biomanufacturing Capacity Expectations
He adds, “many countries have regulations requiring that at least a part of the manufacturing of the drugs sold is accomplished within that country, either directly by relevant legislation (such as in…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Cell-culture media are composed of multiple components, and therefore, it is difficult to develop specific identification tests for media as required by Code of Federal Regulations (CFR) 211.84. The d…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
For example, Chinese fire regulations demand a greater level of fire resistance than is typical globally, and in countries such as Korea and Japan earthquake-proofing measures may have to be implement…
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Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…