Small Molecules Small Molecule Modalities Biocatalysis

Biocatalysis

Biocatalysis is a sustainable, highly selective approach delivering exceptional chemo-, regio-, and stereoselectivity. Through our collaboration, we offer access to one of the world’s largest and most diverse specialty enzyme libraries, enabling scalable and cost-competitive biocatalysis-driven API production.

Broad Enzyme Library

Access 6,000+ unique enzymes for diverse transformations, including KREDs, IREDs, transaminases, EREDs, esterases, and more—expertly screened and rapidly scaled for your process.

Enzyme Optimization

Through our collaborations, access tailored, high-performance biocatalysts for your small molecule productions. These enzymes can be bioengineered and optimized to enhance activity, stability, and solvent tolerance.

In-House Analytical Testing

Our control strategies ensure enzyme release and analysis of the final product using ELISA, activity assays, and total protein (Bradford) testing to confirm clearance.

IND-Enabling Preclinical Development Services

SK pharmteco’s IND-enabling preclinical package delivers end-to-end support for preclinical gene therapy studies and includes access to a proprietary manufacturing cell line, streamlined process development services, and scalable preclinical vector manufacturing services, as well as regulatory support for INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) and pre-IND meetings.

This package:

Enables partners to generate high-quality material and data in months and positions them to move rapidly toward IND approval and CGMP clinical manufacturing
Supplies drug substance and drug product for proof-of-concept, toxicology, safety, and biodistribution studies, as well as method development, interim reference standards, development stability, and drug product development critical for IND packages
Employs similar processing techniques as would be used for full CGMP manufacturing, eliminating comparability risks associated with process changes

Additional analytical testing and regulatory services are available to prepare data briefing packages for INTERACT and pre-IND meetings. Upon completion of preclinical manufacturing, clients have full visibility into the data from execution, production, and purification — a critical data set for clinical program sponsors.

Learn more about our world-class analytical capabilities