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