From interleukins to gene editing nucleases, Akron offers comprehensive recombinant protein development and manufacturing under cGMP compliance
Our deep expertise in recombinant protein development and biomanufacturing has generated a diverse portfolio of liquid and lyophilized products to support maintenance, activation, expansion, and differentiation across cell types. We leverage decades of experience to solve the challenges you face in bringing your recombinant proteins under cGMP compliance.
Clone Development and Product Characterization
Whether you are transferring an existing clone or developing one from scratch, our experience with various expression platforms including E.coli, Pichia Pastoris, and CHO, among others enables the development of a robust, well-characterized product.
Establishment of Working and Master Cell Banks
Following the identification of a viable clone, Akron generates, tests, and releases Working and Master Cell Banks (WCB/MCB) per relevant ICH guidelines for viability, identity, purity, and if relevant, the presence of adventitious viruses, creating a solid foundation for production and future regulatory filings.
Process Development and Optimization
Akron evaluates raw materials (i.e. media, buffers, resins) and process parameters (i.e. fermentation conditions, chromatographic steps, filtration) to optimize expression and recovery while also defining the Critical Process Parameters that maintain the Critical Quality Attributes of the product. We only employ purification strategies common in pharmaceutical production, avoiding the use of affinity tags.
Process Validation and cGMP Production
Upon completion of an Engineering Batch, Akron executes Process Performance Qualification (PPQ) Batches, following the PPQ Protocol’s defined operating parameters, sampling plan, and testing requirements to confirm process design. With all requisite conditions regarding the product, process, and analytical methods met, production under cGMP can begin.
Modification, Formulation, Fill & Finish
With in-house lyophilization under sterile conditions and extensive liquid formulation expertise, Akron can formulate your recombinant protein in the optimal buffer and fill into your preferred primary packaging format to effectively integrate with your process. Moreover, we have extensive experience in PEGylation and other post translational modifications if required.
- OUR SCALE IS YOUR SCALE – from small-scale batches for pre-clinical development to large-scale batches to support commercial production
- TRUE cGMP COMPLIANCE – facilities compliant with relevant cGMPs, operating under the purview of competent national authorities that are party to the PIC Scheme
- STERILITY ASSURANCE – 0.2μ filtration, lyophilization under sterile conditions, and sterility release testing post-lyophilization (<USP 71>/<EP 2.6.1>)
- FORMULATION AND PACKAGING OPTIONS – expertise to optimize lyophilization cycles and establish liquid formulations stable at 2-8C, filling in vials, syringes, or bags
At Akron, our approach to developing novel cytokines and gene editing tools is to establish a strong foundation through extensive investigation and optimization, enabling a seamless transition to large scale production of pure and functional protein.
Contact our team of experts today to discuss your custom project requirements.