It’s critical that a clinical formulation have adequate stability for the duration of the study. Our formulation scientists can develop an appropriate clinical or commercial formulation for your product whether it is liquid or lypolphilized, vialed or in pre-filled syringes.
Our formulation development scientists are experienced in developing both liquid and lyophilized formulations, to ensure that a stable product is delivered to the clinical site and the patient. Using a DOE approach to formulation optimization they can quickly and efficiently develop the optimal formulation for your clinical or commercial needs. With our LyoStar II development lyophiliozer we can rapidly develop a lyophilized formulation when a liquid formulation is not practical. Whether liquid or lyophilized, formulations developed at Althea can be readily applied to production in our cGMP manufacturing facilities.
STABILITY
Althea Technologies provides a comprehensive stability program for clinical-stage products. We have qualified, monitored stability chambers at all temperatures typically used for protein real-time storage, as well as accelerated conditions. Our redundancy program includes back-up chambers and emergency power.With our comprehensive stability program development we can design, or help you design, a stability study that is appropriate for your protein and stage of clinical testing. This design includes everything from frequency of testing and choice of temperatures to identification of appropriate stability-indicating assays and stability-limiting product degradations.
biotech and pharmaceutical companies from pre-clinical development through commercial supply.
© 2009 Althea Technologies, Inc. All rights reserved.