News and Events

May 27, 2016

Lampire Biological Labs achieves Certification to ISO 9001:2008 and 13485:2003

by Lampire PR

Bucks County, PA -- Lampire Biological Laboratories recently achieved certification to ISO (International Organization of Standardization) 9001:2008 and 13485:2003 following a significant investment of time and financial resources. The new designation will provide Lampire with an important competitive advantage when seeking to better serve current clients and attract new business.

“Lampire is focused on customer satisfaction and how we can better meet our customers’ needs,” stated Holly Novak, Lampire’s Director of Quality Management Systems. “Obtaining ISO certification, not only provides state-of-the-art quality assurance, but will also improve cost effectiveness going forward.”

Lampire’s product offerings penetrate a diverse set of markets encompassing diagnostics, pharma, veterinary and academic research. Originally founded as a polyclonal antibody house, the firm is now truly multi-disciplinary and has become the “one-stop” shop for biotechnology raw materials, OEM manufacturing and contract research.

Lampire President Gregory F. Krug, commented on the certification:

“ISO certification was the next logical progression in the development of the Company,” stated Krug. “Three years ago, it became obvious that, as time went by, lack of ISO certification would first become an obstacle, then ultimately, a roadblock to growth. The business environment was already highly competitive and ceding ISO certification to our competition was an unacceptable alternative. Holly Novak was brought in to assume operational authority over the Lampire Quality Assurance program and, specifically, to direct the ISO project. The results speak for themselves.”

Krug went on to state:

“Lampire was already reaping benefits even before completion of the certification process. We closed a multi-year, multi-million dollar contract for raw material processing with a major pharma house predicated on, among other things, Lampire achieving full certification by 2Q2016. Further, the certification has resulted in receiving a green light to proceed with another Fortune 50 Pharma for a significant polyclonal antibody project at our Everett, Pennsylvania facility. Lampire would not have been considered for either project without ISO certification.”

Known primarily in the industry for custom monoclonal and polyclonal antibody production, Lampire has augmented its core business with self-funded research, one product of which is the OmniC3 Cell Culture Bag, an economical, self-contained cell propagation system.

Novak remarked:

“Certification to the ISO standards provides a significant addition to Lampire’s technological capabilities, and provides a firm quality assurance base to a diverse repertoire of products and services. We look forward to integrating this achievement into our business model.”

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