July 1, 2009
While CMOs have traditionally been used to play a critical role in the manufacture of drug product, Althea has evolved beyond being a role player to a strategic development and manufacturing partner that can drive value to a client’s product or product candidate. As drug development costs are always increasing, a properly integrated development and manufacturing scheme can significantly decrease development time and expense, while increasing the probability of clinical success and product differentiation. To allow clients to leverage such an integrated development plan, Althea has greatly expanded its expertise and capabilities across the spectrum of product development activities and manufacturing scale.
Product Development: Process Development, Formulation Development, Lyo Cycle Development
Understanding that every product is unique, our process development team uses DOE and QbD methodology to develop CGMP-ready processes that are optimized to yield the highest quality product in the most efficient way possible. And in order to have a successful development program, it’s essential to have a formulation that guarantees delivery of a stable product to the patient. Our formulation expertise assures that you will have a stable product, whether it is liquid or lyophilized. For those products that require the added stability of lyophilization, our development team will optimize the lyophilization cycles needed to ensure a stable CGMP product. To leverage the “integrated development plan,” processes are developed that can be readily applied in our CGMP manufacturing facility.
Analytical Program Design: Analytical Method Development and “Just-in-Time Analytics”
Our “Just-in-Time Analytics” program assures that at any given point in your drug development cycle, you’ll have the appropriate level of analytical capability and product understanding in place — with no over-expenditures in the early stages of the development cycle and no surprises in the later stages. We develop solutions that are based on a combination of platform technologies that we have in-house and the specific requirements of your drug development program.
CGMP Bulk Drug Substance Production: Recombinant Protein and Plasmid
Being able to retain the same manufacturing partner throughout clinical development and into commercial supply reduces risk, cost, and time in getting your product through the clinic and into the market. Althea has the capacity to support clients with small volume, early stage non-GMP and CGMP drug substance, as well as late-stage and commercial volume of bulk drug substance (BDS). This scalable capacity drives product and process-specific familiarity, reducing the risk of transferring the process to another facility. Along with the reduced transfer requirements comes less cost and time in the generation of high quality and consistent CGMP product for each subsequent stage of development.
CGMP Fill/Finish Injectable Product Manufacturing: Vials, Syringes, and Lyophilization
Scalable manufacturing for aseptic fill and finish of injectable drug product provides similar benefits as previously mentioned for BDS. However, the integrated manufacturing capability of BDS and fill/finish at scale and in a single location allows clients to leverage a single manufacturing facility as they enter the clinic and as they move product onto the market. This drives efficiency in manufacturing scale-up, reduction in risk and cost associated with product transfer, and much more efficient project management as clients are able to build lasting working relationships with Althea’s dedicated Project Management Organization that will last the entire life cycle of the product.
A Strategic Partner
Althea Technologies has the expertise, capability, experience, and stability to serve as the strategic development and manufacturing partner of choice for the biopharmaceutical industry. Find out how Althea can drive value for your product or development program.
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