As a full-service clinical CDMO, CMAB can take your biologic from DNA to a finished product:
- Streamlined development of cell line using preferred Partners
- Process and Analytical Method Development
- Clinical manufacture of Bulk Drug Substance (BDS)
- Aseptic filling of clinical Drug Product
CMAB has a strong Process Development team offering a complete technical service solution for:
- cell line development,
- process development,
- formulation studies,
- engineering/scale-up production,
- analytical method development and qualification, and
- stability testing
The team also plays a key role in transferring the processes from process development to cGMP manufacturing and global regulatory support. Our team’s experience with a large number of Clients at various clinical and commercial stages and for use in multiple countries brings our Client first-hand expertise and knowledge to efficiently bring products from concept and into the clinic.
Experienced in a wide range of recombinant protein processes, including antibodies, fusion protein, enzymes and vaccines, CMAB’s scientists are particularly experienced in early stage product process development for fast-track development into IND filing and clinical phase I/II manufacture. We work with our Client to define the preliminary targeted product profile (TPP), identify phase appropriate critical quality attributes (CQA), and conduct early assessment of potential critical process parameters.
A systematic approach in risk analysis and quality by design is a standard in our process development activities. Through design of Experiment (DoE), our scientists will help determine the design space for the process from initial stages to late stage development and anticipate the process control/validation throughout the product life cycle.
Selection of the right expression system is crucial to the ultimate success of your product. CMAB’s scientists have broad expression system development experience and can either work with an existing system or support selection of an optimal solution. We offer and deliver proprietary expression systems through our Partners in an expedited timeline.
Our scientists are well verse in most commercial cell-line expression systems and can work with our clients to develop new process, optimize an existing process and prepare for scale up and manufacturing. We focus to develop high titer, easily scalable, and robust cell culture processes using well-equipped PD laboratories that can handle multiple cell culture process development projects in parallel
Upstream Process Development Activities include:
- Basal Media Screening Studies,
- Media Optimization Studies,
- Cell Culture Process Development in Bioreactors,
- Cell Clarification /Depth Filter Screening Studies.
CMAB’s scientists will conduct the downstream process development studies based on DoE to optimize a robust and scalable process that can increase yield, effectively remove impurities, and ensure product quality. CMAB has an established downstream process platform that can quickly bring our Client’s product efficiently into the manufacturing phase. CMAB’s process development facility is equipped with multiple ÄKTA systems of different scales to rapidly screen options, scale-up, and deliver materials for formulation and assay development.
Downstream processing will in general include an affinity chromatography step, ion exchange steps and/or mix-mode steps, a virus inactivation step (low pH or S/D incubation), a virus removal step (nanofiltration), and buffer exchange steps (ultra-filtration).
Our formulation scientists will establish conditions that suit your product.
- Drug Substance.
- Drug Product.
- Liquid and Lyophilized formulation.
- Preformulation and excipient screening
- Stress studies including freeze/thaw, extreme pH, elevated temperature, and light exposure.
At CMAB, the analytical capability is fully integrated with the process development team that results in faster analytical services support and method development and hence, speed to market.
CMAB’s scientists are experienced in analytical method development, qualification and validation; we have in-depth knowledge and knowhow in analytical characterization and comparability studies. We can provide all the methods required for IND filing:
- HPLC and UPLC: Protein A, SEC, IEX, Glycan profiling, Polysorbate, Sialic Acid, HIC, Reverse Phase.
- CE-SDS: Reducing and non-reducing, cIEF
- ELISA: HCP, Protein A residue, Insulin Residue, custom antibody binding for your product.
- PCR: HCD, Mycoplasma
- Cell-based potency assays customized to your product
- Structural analysis