Process Development

Process Development for Large Molecule Drugs

Isolate, purify, concentrate, and prepare for transfer and scale-up with Prolytix. Not only do we identify process and product-related impurities, we also use our knowledge of these impurities to inform process improvements.

Services include downstream purification development, quality control processes, and production for monoclonal antibodies, plasma-derived proteins, recombinant proteins, and other large molecule drugs and drug products.

Using our protein purification and characterization expertise, Prolytix takes a consultative approach to develop a protocol optimized to meet your needs. We help develop and control an analysis plan to reduce the risk of out-of-specification results, increasing yield for more efficient large molecule drug development.

Our downstream process development capabilities include

Host Cell Protein Assessment

  • Monitoring HCP by using HRMS

Purification

  • Optimization of extraction and purification process

Formulation Support

  • Collaboration to help you transform your substance into a formulated therapy
  • Improve stability and functionality