Pharmaceutical manufacturers: Biologics Good Practice Guide
Tampa, FL –With an increasing number of approved biological products on the global market many biopharmaceutical companies face additional challenges, especially during process development and manufacturing stages of product development. To help them meet these challenges, ISPE, a global not-for-profit society of pharmaceutical manufacturing professionals representing 25,000 Members, recently offered the
ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
The guide is intended to be a one-source document for pharmaceutical professionals seeking initial guidance on planning, production, packaging, distributing, and filing of biologics, according to Lisa W. Small, a leading member of the Development Task Team.
With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased. In 2005, a record 21 biological products received
U.S. Food and Drug Administration (FDA)
approvals, including therapies for treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders, ISPE says.
“In many instances, companies can benefit from having introductory guides, advanced guides, and best practice guides for use in the training and orientation of new personnel or personnel who are new to a particular area of investigation,” according to Small. “In this case, this good practice guide for biologics can provide a clear overview of planning, production, packaging, distributing and filing considerations needed when biologics are under consideration.”
The guide addresses issues that will confront any biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond, such as product and process development, manufacturing, investigational product supply chain management, quality control/quality assurance, and global regulatory requirements for biopharmaceuticals. Topics include methods and challenges surrounding recombinant therapeutic biological product development, including considerations during its use in clinical trials.
Potential audience includes those involved in:
Contributors to the guide are involved in the ISPE Investigational Products (IP) Community of Practice (COP) and have developed other guidance documents including the Introductory IP Guide, the Advanced IP Guide, and now this best practice guide. ISPE says its publications provide the practical, “real world” information to help companies build on current best practices to meet and exceed regulatory standards. ISPE Technical Publications are indispensable references for industry professionals and regulators worldwide. ISPE member price is $145; non-members can get it for $215.
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