Process Development, Optimization, and Formulation Development

Take advantage of 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 Microbial 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 cell culture medium with continuity of supply a top priority. We use either a commercial medium or make up the medium in-house using approved ingredients depending on the exact requirements. Cell culture conditions are examined through a series of small-scale experiments to determine optimal process conditions.

Downstream development

Depending on solubility, the protein is either expressed as inclusion bodies or in solution, and this will determine how we approach downstream activities. With inclusion bodies, we will screen solubilization conditions, refolding approach and refolding conditions, followed by the remaining purification train. We have the capabilities for various clarification strategies (centrifuges, depth filtration, etc.) and lysis (pressure, chemical conditions). We clarify the material harvested from small scale bioreactor runs by centrifugation and a combination of filters for soluble proteins. This clarified harvest is processed through a series of chromatography and filtration steps to determine the optimal purification train for the product. Ultimately, we derive a final process that matches your needs regarding yield and product quality.

Small-scale demonstration batches

We complete small-scale demonstration batches to show process robustness and generate product to be used as reference material for analytical methods development, formulation studies and initial stability studies.

Formulation development

We conduct a literature review and in silico analysis to support initial formulation conditions. This initial 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 we 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.

Our dedicated team of specialists will be happy to discuss any of your Process Development,Optimization, And Formulation Development needs. Contact us on +34 948 346 480 or email businessdevelopment@3pbio.com

  • It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.

  • It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.

  • It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.

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Let’s discuss your biologics journey.

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