Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Guide for biologics is released by the ISPE

The number of newly approved biological products has dramatically increased due to the rapid growth in the biopharmaceutical industry, reports the Intl. Society for Pharmaceutical Engineering (ISPE).

“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.”

With that in mind, the organization released the ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products, which is intended for pharmaceutical professionals looking for initial guidance about planning, production, packaging, distributing, and filing of biologics. That’s according to Lisa Small, chairperson for ISPE’s 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 www.ispe.org.

Separately, ISPE reports that its recently formed Packaging Community of Practice has grown to approximately 270 members. The Packaging COP 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. Its annual meeting took place at Caesars Palace in Las Vegas, Nov. 4-7, 2007.

Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report