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ASK THE LAB EXPERT: Marin Biologic Laboratories CEO and Founder Tania Weiss

Interview with California Scientist and Business Leader

by | Mar 9, 2023

When not in the laboratory working with pharmaceutical and biotech companies helping them develop new ground-breaking and life-saving medicines, California’s Dr. Tania Weiss can be found playing her trumpet in two bands. Music, family, and travel are great loves of the biotechnology contract laboratory  Marin Biologic Laboratories (MBL).  Dr. Weiss founded Marin Biologic Laboratories in 1995. Her goal was to apply her enthusiasm for creative science as well as good scientific processes to a broad array of client projects. Her efforts have established both a diverse client base as well as a varied project list.

At the time she began her college studies at the University of Michigan in Ann Arbor, Tania did not anticipate that she would end up earning a B.S., M.S., and Ph.D. all in chemistry and biochemistry.    She assumed she would work in academia, but quickly moved into commercial consulting eventually creating her own research company.

“I was consulting for ten companies just learning the ropes.  I met a woman who not only believed in female entrepreneurs but had the means to support us.   She gave me a small loan to start up my own lab.  I fell in love with Marin, so I set up the lab there.  In 1999 we secured a large contract with a major healthcare company and that effectively launched the company. Since assays are critical to drug development we focused on that aspect of laboratory work.   “Assay development is quite complicated, and requires creativity, innovation, and scientific expertise to be good at it.”

“One of our clients had a complicated potency assay that was accepted by the FDA but needed improved reliability for their next phase of clinical development.   We made the assay more rigorous than previously done and simplified the method by qualifying the blood cell donors used for the assay and reducing the number of required readouts. The client, lacking this technical expertise in creating efficiency, asked us to be on the conference call with the FDA to describe and defend the new method. Our improvements were complimented and accepted. We have been running the assay for many years now for the FDA-approved commercial drug.”

Author

  • Forner FDA specialist and founder of Contract Laboratory, Pamela has extensive experience in quality assurance and regulatory compliance within the pharmaceutical and food industries. She has a strong background in applying USP standards to ensure product safety, efficacy, and purity and has expertise spanning analytical testing, process validation, and global regulatory compliance.

    View all posts

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