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Small Molecule Modalities

SK pharmteco supports biotech and pharmaceutical companies with innovative CDMO services for small molecule drug substances, including APIs, intermediates, and RSMs. Combining deep expertise in advanced chemistry with expanding capabilities in new modalities, we develop and scale complex processes for targeted and personalized therapies—helping you accelerate timelines, reduce risk, and advanced programs with confidence.

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Peptides

We support scalable peptide manufacturing using SPPS, LPPS, and hybrid approaches, combined with advanced purification technologies to deliver high-purity products for complex sequences.

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ADC Payloads & Linkers

With decades of experience in HPAPIs and linker chemistry, our team leverages innovative containment strategies to safely develop and scale complex, multi-step processes to advance your ADC therapies.

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Biocatalysis

We support the development of innovative biocatalytic processes using a library of over 6,000 enzymes, enabling highly selective, efficient, and more sustainable API manufacturing.

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.

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Small Molecule Modalities FAQs

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