Bionique has a GMP-registered site fully dedicated to assay development services with a focus on validation of novel rapid molecular-based technologies for mycoplasma detection. With over 30 years of experience, you can rely on our R&D validation experts to develop and implement a validation strategy of an alternative method for CMC purposes to facilitate your path to clinical and commercial success of your unique biologic.
A phase-appropriate approach is applied to the development, validation and technical transfer of analytical procedures in accordance with FDA, EMA, and ICH guidelines.
Our Contract Services
Assay Development and Validation
Bionique offers exceptional scientific depth to support the development of novel assays, with a particular specialization in emerging rapid molecular-based methods to meet the unique testing challenges and requirements for cell & gene therapies. Our project managers work with your scientific team to understand your specific needs, such as intended application, product characteristics, stage of drug development and applicable regulatory requirements. Our comprehensive knowledge and experience with these technologies allows us to offer a full spectrum of validation services to expedite the implementation of a rapid method for in-process monitoring and lot release testing in conformance with current regulatory guidelines and expectations.
Analytical Method Comparability Studies
During comparability studies, Bionique demonstrates that an alternative method for the detection of mycoplasma is equivalent as a replacement of the current compendial procedure.
Transfer of Assays and Analytical Methods
We ensure that a custom assay or analytical method that we have developed for you is successfully transferred to your or your CDMO’s analytical department.
Stability Studies
Hold time stability studies are performed to establish time limits for which biologic materials may be held under specified environmental conditions, thereby informing recommended storage conditions, shelf life, and retesting intervals.
Custom Study Design
Our experience with mycoplasma detection studies across a wide range of raw materials, cell banks, and therapeutic modalities can be leveraged to design custom studies that meet the needs of your novel therapeutic. Connect with our experts to discuss your specific study design needs.
Regulatory Consultancy
When mycoplasma testing issues arise in your product license application, process design, or ongoing manufacturing, support and expert advice is often required. To that end, Bionique also offers regulatory consultation services for any questions related to mycoplasma testing of your product within your manufacturing process.
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