ISPE Releases Good Practice Guide For Biologics

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Biology / Biochemistry
Article Date: 01 Sep 2007 - 1:00 PDT

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ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals representing 25,000 Members, has released the ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products, its latest industry-impacting technical publication.

The ISPE Good Practice Guide for Biologics is intended to be a one-source document for pharmaceutical professionals looking for 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 the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders.

With the increasing number of approved biological products on the global market come major challenges for many biopharmaceutical companies, especially during the critical process development and manufacturing stages of product development.

"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."

This Guide will consider the major issues that will confront a biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond. The Guide is intended to provide readers with an understanding of issues surrounding product and process development, manufacturing, investigational product supply chain management, quality control/quality assurance, and global regulatory requirements for biopharmaceuticals.

The Guide specifically addresses the methods and challenges surrounding recombinant therapeutic biological product development, including considerations during its use in clinical trials.

The intended audience for this Guide includes the following disciplines:

-- Clinical Supply/Clinical Trial Materials
-- Clinical Research
-- Manufacturing
-- Project Management
-- Quality Assurance/Quality Control
-- Regulatory Affairs
-- Research and Development

The contributors to this Guide are all.

Actively 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 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.

The Guide is available for ISPE Member price: $145 / E110$, Nonmember price: $215 / E165, by calling ISPE Customer Service at +1-813-960-2105 or visiting http://www.ispe.org/biologics.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, U.S.; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore.

http://www.ISPE.org

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