PPD: Therapeutic, Fusion, E.Coli Recombinant Proteins Platform

Enzene Purification Process Development (PPD) team has extensive experience in the development, process characterization, and scale-up of a wide range of therapeutic proteins, recombinant enzymes, and peptides. These include recombinant monoclonal antibodies, antibody fragments, fusion proteins, chemically conjugated proteins, and synthetic as well as recombinant origin peptides. We have developed a novel platform technology that enables continuous processing and we are developing a fully connected continuous manufacturing process for the 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.

Capabilities

Process & product development initiatives are built to matching standards of purity (as per pharmacopoeial requirements wherever applicable), yield and cost-effectiveness.
Development of bench-scale process and scale-up for purification of recombinant proteins from E. coli, yeast, and mammalian expression 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, mixed-mode chromatography, etc.).
Preparation of material for toxicological studies and generation of data package as per given regulatory guidelines.
Scale down the model establishment and process characterization as per QbD requirements
Chromatography resin lifetime study
Hold time establishment and support studies for commercial-scale manufacturing
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.
Scale-up of protein purification processes up to 200 L perfusion process scale.
Evaluation of the techno-economic viability of the processes
Formulation development (liquid and lyophilized).
Tech transfer and developmental reports preparation.

Infrastructure

We use the latest equipment in our facility to achieve the high degree of accuracy and quality needed, supported by world-class infrastructures, such as

Fully automated chromatography systems: AKTA PCC (Four-column continuous mode), AKTA Pilot, AKTA Explorer, and AKTA Pure from Cytiva. Wide range of chromatography columns from Cytia, Millipore, etc.
Sartoflow advance, Cogent micro, and lab-scale TFF – Cross-flow filtration systems of Millipore and Sartorius makes.
Lab-scale batch centrifuge from Beckman Coulter.
Lab sonicator and high-pressure homogenizer from Sartorius and GEA.
Freeze dryer from SP Scientific.
Laboratory scale lyophilizer (Christ make) on which lyophilization recipes are developed and later on transferred to commercial-scale lyophilizer.
Filter integrity set-up from Sartorius.
Liquid particle counter for the finished product as per USP 787 and 788 from Haich
Offline monitoring systems for pH, conductivity, turbidity, etc.