Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization committed to the success of our clients for process development, drug substance manufacturing and drug product manufacturing. In a single location, Althea has the capacity to support early-stage clinical requirements through commercial manufacturing. Althea is a leading expert in executing drug formulation and aseptic fill finish for vials and syringes.
Process Development – Successful process development enables a smooth and rapid path from cell line development to commercial product delivery. Althea’s complete range of Process Development capabilities offer the tools to address your needs, whether they be in producing small quantities of proteins for early testing or in developing robust, reliable and scalable processes that will enable a strong commercial advantage. In preparation for cGMP production, the Process Development team’s goal is to assess how robust is the process, how it behaves as conditions are altered, and what the critical factors are for success. Althea’s highly knowledgeable Process Development team will develop and characterize a robust manufacturing process to ensure consistent cGMP manufacturing performance for Phase I through Phase III, at which point Process Validation is implemented to secure a commercial quality process to deliver reliable product supply.
Bulk Drug Substance Manufacturing – Althea’s focused expertise and capabilities in cGMP production of microbial-based biotherapeutics make us one of the industry’s top leaders for microbial fermentation. Whether it is protein or plasmid production, Althea’s experienced staff can take your microbially-expressed product from cell banking to final filled product. The biologics manufacturing group at Althea has a highly experienced staff who work closely with the development group to ensure scalability to full cGMP production of drug substances. Our manufacturing facility is fully flexible and scalable with the ability to produce in 30L, 100L, and 1,000L fermenters. As your program advances in the clinic, you can be assured that Althea will provide the capacity and quality to scale your process to larger product volume requirements without changing facilities Althea can take your product through clinical development and commercialization.
Drug Product, Aseptic Fill & Finish – Althea offers a unique range of aseptic filling in vials or prefilled syringes to address production needs that span from small scale early stage clinical products to larger scale commercial products. Our broad range of equipment and expertise paired with our flexibility and responsiveness, provide you with the capacity to advance your projects through all stages of clinical and commercial development. The formulation scientists at Althea have extensive knowledge and expertise in manufacturing a variety of complex formulations, including liposomes & nanoparticles, conjugates, crystallized proteins, adjuvants, and viscous products. Althea offers cGMP lyophilization services in conjunction with our Fill Finish capabilities. If you have an existing lyophilization process, we will work with you to transfer and adapt your lyophilization cycles to our equipment.
Analytical Services – Althea’s analytical programs satisfy regulatory requirements and work to assure the success of the clinical program. Althea offers core services of method development and validation, product characterization, comparability studies, reference standard qualification and stability and release testing. The Analytical Scientists customize a phase-appropriate analytical program to the specific needs of your unique molecule to ensure a comprehensive understanding and characterization of the molecule for each stage of development and commercialization. With a thorough understanding of your molecule at an early stage in development, you can make process changes that are necessary for successful formulation, drug delivery, and fill finish. As your drug product advances through the clinic, Althea will design and execute analytical programs that support a full characterization of the drug product.
Posted Date: 7/3/2018
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