MabPlex USA San Diego Team
Founded in 2013, MabPlex offers an end-to-end solution under one roof from DNA to finished drug product by conducting all the steps in-house. The firm provides biologics development and manufacturing services to the pharmaceutical industry, including monoclonal antibodies (mAbs), recombinant proteins, ADC, and bi-specifics. The company’s services cover the entire spectrum - from gene sequencing to cell line development, process characterization, conjugation optimization, and cGMP commercial manufacturing of final drug product (DP) for biopharmaceutical companies.
As long as a client can provide the DNA sequence for the monoclonal antibody/proteins, MabPlex can enhance the early-stage development of products with its technical ability and customer-oriented service. The company performs code optimization to acquire the best expression level based on the sequence information. MabPlex constructs the entire gene into an expression vector, and it is offering a couple of proprietary cell lines in both China and the US. Following this cell line, the firm makes a research cell bank, and through the entire process, it also provides the analytical characterization for the cell line. Through the screening process, single clones are generated to ensure that it meets the regulatory requirement. MabPlex develops a full spectrum of analytical methods and quality validation. The cell bank developed can produce the expected proteins in the proper structure.
Further, MabPlex develops biological assays and ensures they have intended biological activity. The firm optimizes and categorizes the entire cell culture conditions to give the best productivity. The company provides small batches of material to the client for animal study or in-vitro, up to clinical phase one and phase two. MabPlex then creates a bigger batch for phases 1-3 and commercialization, and the batch goes through phases 3-4 to marketing.The firm provides the process characterization and validation package too. On the other side of ADC, MabPlex assists in determining the linker payload. During the process in the early stage, the company makes a non-GMP batch of antibodies and a batch of GMP linker payload to start the conjugation development.
Further, the firm scales it up to the GMP to support phase one and phase two ADC under the GMP conditions. Then, MabPlex develops an adequate formulation to maintain the longest stability and the storage condition for the drug product. “As long as there is a protein or antibody-based product, a client does not have to deal with multiple vendors for one product,” states Wei Chen, Chief Strategy Officer of MabPlex. The firm’s superior technical expertise allows timely and cost-effective delivery of innovative products, lowering the overall TTM.
As long as there is a protein or antibody-based product, a client does not have to deal with multiple vendors for one product
Unlike other vendors in the industry lacking a clear license from ATCC, MabPlex has a contract agreement for each stage of a product and strictly follows FDA guidelines. The cell line cannot be simply utilized unless it is proven safe for human use. The regulatory requirements for safety are ramping up across the US and Europe. Therefore, from any perspective, be it IP, regulatory, clinical, or supply chain in today’s era, MabPlex is a cut above the rest with its unique offering of a full package under one roof. Rapidly expanding its operations to meet the market need in China, the company is foraying into the global market with its expansion in the United States (US), positioning MabPlex as one of the few large-scale ADC production providers worldwide.