Mammalian Process Development, Optimization, and Formulation Development
Utilize our extensive knowledge, state-of-the-art equipment, and proprietary technologies to advance and optimize the process supporting the development of your product.
With you on your biologics journey...
Why do mammalian process development, optimization, and formulation development?
The aim is to develop a production process for the target molecule, optimizing the yield, cost, robustness, operability, and scalability while providing a process that complies with current GMP guidelines.
Formulation development is a crucial area of the process to determine patentability, lifecycle and ultimately the product’s success.
3P’s process development, optimization, and formulation development services
We ensure that all raw materials for use in the final process are selected based on their compatibility with the products’ designated markets and are suitable for use in GMP manufacturing processes.
Upstream process development
We always use a fully traceable culture medium and with the continuity of supply a top priority. Depending on the exact requirements, we use commercial medium or prepare the medium in-house using approved ingredients. Cell culture conditions are examined through a series of small-scale experiments to determine optimal process conditions.
We clarify the material harvested from small scale bioreactor runs by centrifugation and a combination of filters. This clarified harvest is processed through a series of chromatography and filtration steps, to determine the optimal purification train for the product. We carry out viral filtration using standard equipment. Numerous experiments are conducted to define flow, pressure, area, and pre-filtration conditions. Ultimately, we derive a final process that matches your needs in terms of both yield and product quality.
Small-scale demonstration batches
We complete small-scale demonstration batches to establish process robustness and generate product for use as reference material for analytical methods development, formulation studies and initial stability studies.
We conduct a literature review and in silico analysis to support initial formulation conditions. This early analysis will be used to identify stability-indicating methods for subsequent stability studies. Formulation studies are carried out in accordance with the EMA CHMP/QWP/396951/2006 guidelines and use excipients (and/or other reagents) described in the relevant Pharmacopoeia.
What 3P will deliver?
We will utilize our extensive knowledge, state-of-the-art equipment, and proprietary technologies to advance and optimize the process supporting the development of the product. We will deliver formulation development while providing material obtained from the small scale runs when available.