CAMARILLO, Calif., June 25, 2007 (PRIME NEWSWIRE) -- IntegrityBio, LLC (formerly known as Integrity Biosolution), a research formulation and contract manufacturing provider, announced at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, the opening of its Good Manufacturing Practices (GMP) fill and finish facility for the contract manufacturing of infusion- or injection-based products that are preclinical or entering Phase I and Phase II clinical trials for the biotechnology and pharmaceutical industries. The facility has the capacity to accommodate the manufacturing of up to 10,000 liquid formulation vials or 3,000 of lyophilized formulation vials per lot.
The new facility located in Camarillo, California, includes:
* A 2000 square foot cleanroom suite
* 285 square feet aseptic filling area validated Class 100 and Class
10,000 areas
* M&O Perry P1510 Filler with a diaphragm pump
* BOC Edwards SO/8 lyophilizer for batch sizes of up to 3,000 units
of 3 ml vials
* Getinge Steam Sterilizer and Dispatch Depyrogenation Oven
* Labeling and secondary packaging capability
* Release and GMP stability testing
* FDA registered
"IntegrityBio's opening of our GMP fill and finish facility is in direct response to the needs of our customers interested in leveraging our years of experience in product formulation and manufacturing to improve product development cycles," said Byeong Chang, Ph.D., IntegrityBio president and founder. "We are pleased to now offer this integrated service for our clients."
Through this new service, IntegrityBio's clients are able to access an integrated solution to their company's product development needs. From formulation research through early clinical manufacturing, requirements can be met from a single source. IntegrityBio expects to bring significant additional value and an expedited development and commercialization process for its clients' respective products.
IntegrityBio is strongly committed to high quality product, a timely delivery of milestones with accuracy, and excellent customer relations from the company's highly qualified and experienced professionals.
About IntegrityBio
IntegrityBio, formerly known as Integrity Biosolution and established in 2003 as a research formulation company, strives to improve human life through the integration of formulation research and drug delivery. The company's mission is to provide high quality contract formulation research and analytical services; high quality, cost effective contract manufacturing services; and to develop innovative drug delivery solutions for protein, antibody, and peptide biopharmaceuticals. IntegrityBio's clients include both early-stage companies and several of the world's largest biotechnology, pharmaceutical and medical devices. To learn more, please visit us at the AAPS Annual Meeting, June 25 - 27, 2007, in San Diego, California, exhibit number 215, or at IntegrityBio's website at www.integritybio.com.