Fill out the form below and an Althea Representative will contact you promptly.

All fields required.

Areas of Interest (Check all that apply)
Let’s Make Your Process

Drug Process Development

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 TypesRecombinant proteins
Fusion proteins
Antibodies and antibody fragments
Key ServicesVector design
Strain selection
Media optimization
Primary recovery
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 Equipment5L fermentors
Dead end centrifugation
Ultrafiltration/diafiltration set-ups
Purification EquipmentAKTA Explorer and Purifiers
Ultrafiltration/diafiltration set-ups

Process development teams work with client development teams to ensure scalable and cGMP ready processes. The teams support and perform Cell Line Selection, Fermentation Development and Primary Recovery and Purification Development.

Back to top