Process Development Services

Process Development for Large Molecule Drugs

Need efficient large molecule process development services? 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, as well as production for monoclonal antibodies (mAbs), 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 biologic development.

Our downstream process development capabilities include:

Host Cell Protein (HCP) assessment

  • Monitoring HCPs using HRMS

Purification

  • Optimization of extraction and purification process

Drug product formulation support

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