GMP Grade Solutions
for Cell Therapy

Each GMP protein is manufactured and tested in a GMP-compliant facility. Our GMP quality management system was developed and maintained in accordance with relevant cGMP and GMP guidelines.

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Adventitious agents contaminants within the final product of cell and gene therapies are a significant point of concern. To minimize external contaminants, a strict quality control system is necessary. GMP grade products refer to several GMP guidelines outlined by regulatory agencies and are performed periodically throughout the production and quality control process.

This includes:

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Our professional regulatory support team has experience working with therapeutic manufacturers across the globe, with customers in China, United States, South Korea, and more. CDE, FDA, and KFDA declarations have been submitted with our support. We provide the Regulatory support file documentation to assist customers at different phases of development and use for declaration requirements.

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your GMP Protein options?

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We advise cell therapy manufacturers to source either pharmaceutical or GMP-grade whenever possible. Our GMP-grade products are manufactured and tested in accordance with relevant international standards. * Raw material suppliers should have a certified quality management system (QMS) along with an ISO 9001 / 13485 certification. Independent audits, quality policies, and quality processes should be established to ensure quality that matches customer expectations. Cell therapy manufacturers should also perform due diligence by qualifying their suppliers through questionnaires, on-time delivery, SCAR, and other auditing activities. Documentation including certificates of analysis, certificates of origin, and other audit trail documentation should be received from each supplier and kept as records.

Cell therapy manufacturers should begin discussions with potential suppliers as soon as possible to avoid issues when entering production. Ensuring raw material suppliers have the ability to scale-up can prevent any last-minute changes that could require expensive revalidation studies.

Identifying a secondary supplier is also crucial. Although raw materials may look identical, there is no guarantee on how it behaves in your biological system. Do not assume that switching suppliers can be easily done – subsequent validation studies showing equivalence between raw materials from different suppliers is required. Identifying a secondary supplier can be an insurance policy if any issues arise with your primary supplier.

*International standards include:

The quality of manufactured cell and gene therapies is directly influenced by the raw materials used in their production, which, in turn, impacts the therapy’s impact and efficacy. Relevant regulations stipulate that the selection of raw materials should consider their necessity, rationality, and safety, preferably opting for materials approved for human use or meeting pharmacopoeia standards. Although safety and quality requirements for raw materials have lower priority in the initial preclinical stage, transitioning to regulatory-compliant GMP-grade materials becomes imperative during CMC or clinical conversion. This transition involves thorough testing, safety assessments, and process validation, demanding considerable time and effort.

If the same supplier is utilized, the physical properties and biological activity of premium-grade (PG) raw material ideally mirror those of GMP-grade, differing mainly in regulatory support documentation. Rigorous safety testing of materials interacting with patients is crucial, and confirming the consistency of manufacturing processes between PG and GMP materials is recommended. We ensure that both our PG and GMP products are derived from the same cell bank source, undergo strict quality control, demonstrating biological identity through extensive trials.

For clinical applications, an early shift to GMP is recommended, even during the preclinical phase, facilitating equivalence testing at a more manageable stage. Opting for an experienced supplier well-versed in quality management, protein biochemistry, analytical testing, and regulatory affairs is advantageous. Experienced suppliers aid in navigating changing regulatory environments, providing necessary documentation like a Drug Master File (DMF) to streamline regulatory processes. Audits of supplier facilities, preferably in person or online, strengthen the strategic partnership between suppliers and customers. Maintaining strict adherence to approved operating procedures, at least for three consecutive batches, ensures consistency and compliance with predetermined acceptance criteria for our PG products developed through the GMP product line.

Biological reagents are notorious when it comes to susceptibility to variability, especially cytokines and growth factors. Only after these reagents have been successfully developed and validated through multiple successive batches meeting the stringent outlined specifications, along with the establishment of a stable process and rigorous conformance assessment, can the product be moved into large-scale manufacturing and commercialized. This process forms a robust foundation in ensuring the consistency and reliability of GMP raw materials.

Furthermore, the manufacturing of products occurs within GMP facilities and under GMP quality systems, with strict control implemented through documented Standard Operating Procedures (SOPs) and trained personnel. This crucial information should be disclosed during audits. It is reasonable to request data from multiple batches to evaluate a supplier's capability to consistently produce a reproducible protein. Ideally, materials should be sampled from various batches to assess their consistency across the entire system. We identify standard batches and compare each new production batch to the established standard before releasing it to the market. This approach mitigates variability and ensures consistent product performance. Currently, we maintain excellent control over lot-to-lot differences, specifically in biological activity, within the range of 10-15%.

Safety regarding any raw materials employed in cell and gene therapy manufacturing is critical to ensure final therapeutic quality. This emphasizes the need for safety control to prevent contamination by exogenous factors. These ‘exogenous’ factors refer to inoculants, cell matrices, residual raw materials during production, bacteria, fungi, mycoplasma, and viruses.

The FDA recommendation of using the highest-quality materials means that all raw material suppliers should ensure that their materials or reagents are produced under the appropriate quality standards to mitigate any unreasonable risks to patients. This means that strict quality control of raw materials used in CGT production is a necessary measure to reduce the risk of external contamination and ensure the safety and efficacy of cell and gene therapy products. Expanding upon this requirement, the following requirements are outlined in various international pharmacopeias, including: