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 Mycoplasma 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 Mycoplasma Testing Partner
Bionique has optimized the MycoSEQ Real-Time
PCR Detection Assay for mycoplasma testing.
Need to Rapidly Test
Advanced Therapies?
The unique nature of cell and gene therapy products, including limited production volume, limited shelf life, and other factors demand new approaches to mycoplasma testing.
Bionique has evolved the tools needed to address the unique product characteristics and requirements inclusive of rapid, reliable, and small volume testing assays. Bionique has developed a routine rapid, reliable and robust molecular method for testing of cell and gene therapy products with sensitivity comparable to the 28-day compendial methods.
In addition, Bionique offers custom assay development, phase-appropriate validation and CMC consultancy to support a rapid mycoplasma test method for lot release.
Would you like to learn more?
To obtain more information about our services
or to speak to a team expert contact us now.