Bionique, Cellipont team to advance rapid mycoplasma testing in CGT manufacturing
Bionique Testing Laboratories and Cellipont Bioservices have joined forces to promote the adoption and validation of rapid mycoplasma detection methods in support of cGMP manufacturing for cell and gene therapies.
Under the partnership, Cellipont will integrate rapid, validated mycoplasma detection technologies into its quality control (QC) workflows, while Bionique will provide specialized mycoplasma testing services — along with tailored product-specific validation support — to ensure regulatory alignment and accelerated batch release timelines.
Bionique CEO Gladis Zamparo said in a statement that her company is excited to support Cellipont in “navigating the challenges — including product complexity, limited batch yields, and dynamic regulatory landscape — associated with the release testing of these novel therapies by delivering efficiency and innovation through this partnership.”
Cellipont CEO Darren Head in a statement called Bionique the “gold standard” when it comes to mycoplasma testing. “Their unparalleled experience and collaborative approach are critical as we strengthen our QC strategies to meet the demands of modern cell and gene therapy production,” according to Head.
Bionique, part of the Biosafety Testing Services Unit of Asahi Kasei Bioprocess, is a global contract research organization that specializes in mycoplasma testing and validation services for the biopharmaceutical and life science industries.
Cellipont, a contract development and manufacturing organization, specializes in the advancement of cell therapies and offers comprehensive solutions from process development, analytical services, to large-scale commercial manufacturing.