Process Research and Development
The team members of Process Technology Service (PTS) Department at KriSan Biotech have extensive experiences in pharmaceutical process research and development for small molecule, peptide, oligonucleotide, Antibody-drug conjugate (ADC) and Highly Potent API. PTS team works open-minded, scientifically and accurately with the Analytical Technology Services (ATS) team members to integrate the chemistry and analytical controls, into the process at each early developing stage.
All the process research works are well documented in a Process Development Report (PDR) that outlines the synthetic route, experiments and discussion, along with the supporting analytical data that confirm the development efforts. The PDR is an integrated scientific report supporting for the successful application documents in chemistry, manufacturing and control, accordingly; also, important historical data in continuous improvement and GMP change control management.
At KriSan Biotech process development, our commitment lies in fostering innovation, maximizing efficiency, and ensuring regulatory compliance throughout the clients’ entire production journey. We pride ourselves on providing an extensive range of process technology services that cater to your unique needs and requirements.
- Feasibility studies: We leave no stone unturned during these studies, conducting rigorous analyses to identify potential risks and highlight opportunities for success.
- Innovative synthetic route design: We strive for maximum efficiency throughout the synthesis process while maintaining the highest standards of quality.
- Development of reliable and scalable processes: Our methods undergo meticulous refinement until consistency, safety, and quality are fully assured at every scale.
- Regulatory filings support: We offer valuable expertise in document preparation alongside strategic insights to help streamline regulatory filings for accelerated approvals.
- New technology evaluation and establishment: We continually assess emerging innovations and actively support their integration into your processes—enhancing productivity levels and ensuring you stay ahead of the curve.
We are committed to providing our clients with the highest quality services and support, offering flexible and customized approach to meet the specific needs of our clients, and staying ahead of the curve to provide our clients with the latest technologies and solutions so they can achieve their business goals.