At Bionique, “what we do” is very specialized and technical: we test biological products and raw materials for mycoplasma. To that end, our analytical assay development and validation services are available via traditional culture-based methods, real-time PCR assays, and the emerging applications of rapid microbial methods.

But what truly drives us – “why we do it” – is to partner with our biopharmaceutical clients, bringing to bear our decades of mycoplasma testing experience to provide consultative testing and validation solutions tailored to your product and the regulatory needs of tomorrow. 

Product modalities continue to diversify, from recombinant proteins to cell and gene therapies to new vaccine platforms. A range of mammalian cell lines abound from CHO to HEK293 to HeLa. Critical raw material sources are expanding to de-risk procurement and ensure supply certainty. Taken together, the expansion of products, cell lines, and raw material sources introduce additional risks of mycoplasma contamination into your development and manufacturing operation. At Bionique, it is our job to mitigate this risk, and we are laser-focused on ensuring the safety of your products.

From discovery to commercialization of your therapeutic, we partner with you to test cell banks, raw materials, unprocessed bulk harvest, and final drug product modalities ranging from monoclonal antibodies to cell & gene therapies. With Bionique, rest assured that we will test better. Together.

Our Testing Services

Our analytical assay development and validation services are available for traditional culture-based methods, real-time PCR assays, and the emerging applications of rapid microbial methods. 

From discovery to commercialization of your therapeutic, we partner with you to test cell banks, raw materials, unprocessed bulk harvest, and final drug product modalities ranging from monoclonal antibodies to cell and gene therapies. 

Mycoplasma Testing

Scientific Expertise

Collaboration

Your Testing Partner

Bionique has optimized the MycoSEQ Real-Time
PCR Detection Assay for mycoplasma testing.

Discover Bionique

Bionique Testing Laboratories, Inc. Names New CEO, Gladis Zamparo.

See Bionique’s press release here.

Bionique to expand after joining the Asahi Kasei Medical Team.

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