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Cell and Gene Therapy Process Development

Process Development for Scaling Cell and Gene Therapy Manufacturing

Whether we begin with a knowledge transfer of your existing processes or develop a custom bioprocess from an R&D-based protocol, SK pharmteco’s Our process development experts assess manufacturability early on and recommend specific development actions. Learn about small molecule process developmentto streamline scale-up and the regulatory process.

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Viral Vector Process Development Services

Learn more about our viral vector manufacturing services

We work closely with you to develop the best manufacturing process for your viral vector to optimize your final therapeutic product. With experience across numerous vector types, adherent or suspension culture capabilities, and optimized purification processes, our cutting-edge facilities are fully equipped to streamline manufacturing and maximize quality.

Upstream Drug Substance

  • Suspension and adherent manufacturing capabilities for adenovirus, adeno-associated virus (AAV), lentivirus, and other novel viral vectors
  • Research cell and virus banking 
  • Process development, optimization, and characterization

Downstream Drug Substance

  • Viral vector purification capabilities across all processing steps: filtration, chromatography, and ultracentrifugation
  • Process development, optimization, and characterization

Drug Product & Analytics

  • High-throughput formulation development
  • Drug product process development and characterization
  • Compatibility, stability, and forced degradation studies

SK pharmteco supports partners in optimizing and scaling up cell therapy manufacturing processes, whether developing processes from the ground up or transferring established processes to our facilities. We take proactive steps to de-risk manufacturing and ensure readiness. These include leveraging the same equipment and scale during process development and tech transfer as in full CGMP production and drafting electronic batch records during pilot runs.

Drug Substance

  • Process scale-up (allogeneic) and scale-out (autologous)
  • Process development and optimization for early phase trials
  • Reduction of process length through optimization of activation, transduction, and harvest
  • Process closure and automation
  • Process characterization and validation as BLA-enabling activities
  • Technology transfer and pilot production for all phases
  • Technology transfer and CGMP readiness

Drug Product

  • Development of small- and large-scale harvest and formulation steps
  • Formulation and fill process automation and closure
  • Development of cryopreservation conditions for bagged and vialed drug product presentations at various scales
  • Container closure development
  • Pharmacy manual studies in support of clinical and commercial administration

IND-Enabling Preclinical Development Services

SK pharmteco’s IND-enabling preclinical package delivers end-to-end support for preclinical cell and gene therapy studies and includes off-the-shelf plasmids, custom plasmid manufacturing, 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

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