Process Development Services

Process Development for Large Molecule Drugs

Prolytix is your partner for reliable large-molecule process development services. Isolate, purify, concentrate, and prepare for transfer and scale-up with our seasoned chemists and scientists. Not only do we identify process and product-related impurities, but we also use our knowledge of these impurities to inform decision-making and implement process improvements.

Our services include downstream purification development, quality control processes, and formulation development support for monoclonal antibodies (mAbs), plasma-derived proteins, recombinant proteins, bispecific antibodies, and other protein-based therapeutics.

Using our 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 ELISA and HRMS methods

Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs

Purification & Quality Controls

  • Determination of in-process acceptance criteria and action limits
  • Excipient quality control processes
  • 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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