Purification Process Development:
Enzene Purification Process Development (PPD) team has extensive experience in the development, characterization and scale-up of a wide range of therapeutic proteins and peptides. These include recombinant monoclonal antibodies, antibody fragments, fusion proteins, chemically conjugated proteins and synthetic peptides. We have developed novel technological platform that enables continuous processing and we are developing a fully connected continuous manufacturing process for production of monoclonal antibodies.We are also specialized in recombinant enzyme purification, bio-catalysis and microbial conversion, enrichment of nutraceuticals and purification of complex phytopharmaceuticals.
- Process & product development initiatives are built to matching standards of purity, yield and cost-effectiveness.
- Development of bench-scale process and scale-up for purification of recombinant proteins from E.coli, yeast and mammalian systems.
- Development of novel refolding methods of recombinant proteins from inclusion bodies, for higher recovery.
- Application of multiple chromatographic operations for purification of recombinant proteins and monoclonal antibodies (e.g. ion exchanges, hydrophobic interaction, affinity, ceramic hydroxyapatite, metal-chelate, gel permeation,reverse phase, mix mode chromatography etc.).
- Scale down model and process characterization.
- Chromatography resin life time study.
- Use of tangential flow filtration (TFF) techniques.
- Continuous bioprocessing connecting upstream perfusion process to downstream purification.
- Virus removal and virus inactivation steps included in all processes and particular attention paid to the characterization of post-translational modifications such as glycosylation.
- DoE/QbD based process application using PAT.
- Scale-up of protein purification processes upto 50L.
- Evaluation of the techno-economic viability of the processes.
- Tech transfer and developmental reports and preparation of material for toxicological studies.
We use latest equipment in our facility to achieve the high degree of accuracy and quality needed, supported by world class infrastructure, such as
- Fully automated chromatography systems: AKTA PCC, AKTA Pilot, AKTA Explorer and other AKTA series. Wide range of chromatography columns with cold cabinet setup.
- Sartoflow advance, Cogent and lab scale TFF - Cross-flow filtration systems of various types.
- Single pass TFF.
- Lab scale and Batch centrifuge from Beckman coulter.
- Lab sonicator and High pressure homogenizer from Sartorius and GEA.
- Freeze dryer from Thermo scientific.
- Monitoring systems for pH, conductivity, turbidity, spectrophotometer from Thermo scientific, Hach..