PBS Biotech, Inc. Acquires Medical Devices Contract Manufacturing Firm Integrity CMI
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|Tuesday, 23 August 2011 15:00 (UTC + 2)|
Fast growth biotech firm acquires full-service medical device manufacturer with ISO 13485 certification and FDA registration.
Integrity CMI has extensive experience in design, assembly, testing, packaging and sterilization of medical devices and biotech products. The company has certified class 7 (10,000) clean room operations as well as non-clean room assembly and testing facilities. The added technical capabilities and factory space will significantly augment PBS Biotech’s manufacturing capability for disposable vessels, bags, and related plastic parts assemblies of single-use bioreactors under stringent clean room environmental controls.
“Integrity CMI is a powerful addition to the company adding substantial ISO and FDA certified design, manufacturing and test capabilities,” said Dr. Brian Lee, co-founder and CEO of PBS Biotech. “Oscar Garza and his team are experts at medical and biotech equipment production and have extensive engineering and manufacturing experience vital to the rapid growth of PBS,” he said.
“We are thrilled to become part of the PBS team and to contribute to making the industry’s leading single-use bioreactor products,” said Mr. Garza, the CEO of Integrity and a 25-year engineering and manufacturing veteran of medical and pharma firms including Baxter, Bristol-Myers Squibb, and Medtronic. “PBS Biotech is an exciting company on a path to become a industry leader providing biopharma with innovative bioreactors that can dramatically improve the development of drugs and vaccines and reduce costs. We are pleased to be part of the family and to help the company to its next level of success,” he said.
Over the coming weeks the two companies, located in facilities just a few miles apart, will reconfigure the assets and personnel to maximize design and engineering operations and build out the manufacturing facilities, which hold ISO 13485 certification and are FDA registered. The facility will focus on manufacturing the PBS disposable vessels and bags employing the industry’s highest quality levels and standards. This will allow PBS Biotech to internally control and document every step of the production process from raw materials, assembly, final test, packaging, and sterilization to insure product quality and traceability.
Rapid adoption of single-use bioreactors is occurring across all stages of the bioprocess as firms embrace single-use technology to drive out costs in both R&D and production while increasing process flexibility, operational efficiency and accelerating time to market. PBS Biotech offers a product line of bioreactors with the industry’s most advanced features such as ease of use, full scalability from lab to production, low shear by novel Air Wheel™ mixing mechanism and plug and play configurations. The bioreactors are used in developing and producing animal, insect, and plant cell cultures for creation of life saving and quality of life improving therapeutic protein drugs and vaccines.