Successful process development enables a smooth and rapid path from cell line development to commercial product delivery. In preparation for Current Good Manufacturing Practices (cGMP) production, the Process Development team designs manufacturing processes to support Phase I – III clinical trials and assesses how robust a process is, how it behaves as conditions are altered, and what the critical factors are for success.
Process Validation is then implemented at Phase III to secure a commercial quality process for delivering reliable product supply. The team is also experienced in optimization of individual steps in an existing set of unit operations to confirm the overall process is best-suited for cGMP production.
Preparing for cGMP Manufacturing
Althea’s process development scientists take a modular, Design Of Experiment (DOE), based approach to develop optimal fermentation and product recovery processes as well as downstream purification steps. Methods, such as high cell density fermentation, are used to increase product yield and manufacture high quality product in an efficient manner.
The Process Development group works hand-in-hand with our Analytical group to ensure the integrity of your molecule each step of the way. When the phase-appropriate process is fully developed, the complete manufacturing method is seamlessly transferred to the cGMP Manufacturing group to initiate scale-up manufacturing.
|Product Types||Recombinant proteins|
Antibodies and antibody fragments
|Key Services||Vector design|
Capture and polishing chromatography
Refolding and filtration operations
Client process technology transfer and optimization
Identification of critical process parameters
Development of process control strategies
|Fermentation and Primary Recovery Equipment||5L fermentors|
Dead end centrifugation
|Purification Equipment||AKTA Explorer and Purifiers|