Products such as antitoxins, antivenins, blood, blood derivatives, immune serums, immunologic diagnostic aids, toxoids, vaccines, and related articles that are produced under license in accordance with the terms of the federal Public Health Service Act (58 Stat. 682) approved July 1, 1944, as amended, have long been known as “biologics”. However, in Table III, Part F, of the Act, the term “biological products” is applied to the group of licensed products as a whole. For pharmacopeial purposes, the term “biologics” refers to those products that must be licensed under the Act and comply with Food and Drug Regulations—Code of Federal Regulations, Title 21 Parts 600–680, pertaining to federal control of these products (other than certain diagnostic aids), as administered by the Center for Biologics Evaluation and Research or, in the case of the relevant diagnostic aids, by the Center for Devices and Radiological Health of the federal Food and Drug Administration.
Each lot of a licensed biologic is approved for distribution when it has been determined that the lot meets the specific control requirements for that product as set forth by the Office ▲of Regulatory Affairs▲ (USP 1-Dec-2025). Licensing includes approval of a specific series of production steps and in-process control tests as well as end-product specifications that must be met on a lot-by-lot basis. These can be altered only upon approval by the Center for Biologics Evaluation and Research and with the support of appropriate data demonstrating that the change will yield a final product having equal or superior safety, purity, potency, and efficacy.
Source from USP and Please refer to USP for details:
Polymer Vial for cell and gene therapies
RTU(ready to use) 2ml COP vial
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