SHERIDAN, WYOMING – November 10, 2024 – Akron Bio, a recognized leader in biomanufacturing, continues to expand its capabilities in the field of recombinant protein development and manufacturing. With decades of experience and an unwavering commitment to quality, Akron offers comprehensive services designed to meet the needs of clients across the biotechnology, pharmaceutical, and gene therapy industries. By combining cutting-edge technology, cGMP compliance, and a deep understanding of recombinant protein production, Akron is poised to deliver innovative solutions for complex biomanufacturing challenges.
Comprehensive Services for Recombinant Protein Development
Akron Bio specializes in the development and manufacturing of recombinant proteins under stringent cGMP (current Good Manufacturing Practice) compliance. This approach ensures that every product is developed and produced to meet the highest industry standards, whether for pre-clinical research, clinical trials, or large-scale commercial production.
"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," said a company spokesperson. "We leverage decades of experience to solve the challenges you face in bringing your recombinant proteins under cGMP compliance."
Akron Bio’s recombinant protein development process is built on a foundation of scientific rigor and technical expertise, offering clients both the flexibility and reliability they need at every stage of development.
Clone Development and Product Characterization
One of Akron’s key strengths lies in its ability to support both new recombinant protein projects and the optimization of existing products. The company’s extensive experience with various expression platforms, including E. coli, Pichia pastoris, and CHO cells (Chinese hamster ovary), allows Akron to provide tailored solutions for a wide range of applications.
"Whether you are transferring an existing clone or developing one from scratch, our experience with various expression platforms enables the development of a robust, well-characterized product," the Akron spokesperson explained.
By leveraging its diverse set of expression systems, Akron ensures that the final product is of the highest quality, fully optimized for the client’s needs, and ready for the next stages of development and manufacturing.
Establishment of Working and Master Cell Banks
As part of its comprehensive approach, Akron also offers services for the establishment of Working and Master Cell Banks (WCB/MCB). Once a viable clone is identified, Akron takes the necessary steps to generate, test, and release these cell banks according to the relevant International Council for Harmonisation (ICH) guidelines. These rigorous testing procedures ensure that the cells meet critical quality attributes, including viability, identity, purity, and, when necessary, the absence of adventitious viruses.
"By generating and testing these cell banks in compliance with ICH guidelines, Akron creates a solid foundation for production and future regulatory filings," the spokesperson said. This foundation supports the long-term success of clients’ products and ensures regulatory acceptance at every stage of development.
Process Development and Optimization
To optimize the recombinant protein production process, Akron Bio evaluates a wide range of variables, including raw materials, media, buffers, and process parameters such as fermentation conditions and chromatographic steps. This optimization is critical in defining the Critical Process Parameters (CPP) that maintain the Critical Quality Attributes (CQA) of the product.
"We only employ purification strategies common in pharmaceutical production, avoiding the use of affinity tags," noted the spokesperson, emphasizing Akron's commitment to using only the most reliable and industry-standard techniques to ensure product purity and efficacy.
cGMP Production and Validation
Akron’s process development does not end with optimization; the company also executes rigorous process validation to ensure that every product is manufactured under strict cGMP conditions. This includes conducting Engineering Batches and Process Performance Qualification (PPQ) Batches to confirm the process design and verify that all defined operating parameters, sampling plans, and testing requirements are met.
"Upon completion of an Engineering Batch, Akron executes PPQ Batches, following the defined operating parameters to confirm process design," said the Akron spokesperson. "Once all requisite conditions are met, production under cGMP conditions can begin, ensuring the final product is ready for regulatory submission and clinical use."