Guides

Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.

Language
English
Guidance Docs
Advanced Therapy Medicinal Product (ATMP) therapies include cells, engineered tissues, or the manipulation of the patient’s genome. This is in contrast with traditional manufacturing processes for compounds that are synthetically derived (i.e., small molecule) or proteins or peptides expressed by cellular systems (i.e., large molecule biopharmaceuticals). ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest.
Guidance Docs
Thisguide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.
Guidance Docs
The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner that meet their intended use.