“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 approvals, including therapies for the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders,” says the Intl. Society for Pharmaceutical Engineering (ISPE). With that in mind, the organization has released the ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products .
The guide is intended as a document for pharmaceutical professionals looking for initial guidance about planning, production, packaging, distributing, and filing of biologics. That’s according to Lisa Small, chairperson for the (ISPE) Development Task Team for the project.
The guide considers issues that confront a biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond. The intended audience for the guide includes the following disciplines: Clinical supply/clinical trial materials, clinical research, manufacturing, project management, quality assurance and quality control, regulatory affairs, and R&D.
The guide is available to ISPE members for $145; $215 for nonmembers, by calling ISPE customer service at 813/960-2105, or visiting its Web site.
Separately, ISPE reports that its recently formed Packaging Community of Practice has grown to approximately 270 members. It is chaired by Linda McBride. Based in Tampa, FL, ISPE is a global not-for-profit society of pharmaceutical manufacturing professionals representing some 25,000 members in 90 countries. It will hold its annual meeting at Caesars Palace in Las Vegas, Nov 4-7, 2007.
--By Jim Butschli, Editor
