Cell and Gene Therapy CDMO Services

There are several key factors to consider when evaluating the strength of a potential CDMO partner for cell and gene therapy production. In this field of groundbreaking and innovative therapies, experience and expertise are critical — the CDMO should have extensive experience and expertise specific to cell and gene therapy development and manufacturing, with a proven track record of successful projects in these modalities. You should also look for a partner that can ideally provide end-to-end support for your project, from process development to analytical services and regulatory support. Additionally, a suitable partner must have comprehensive, advanced facilities and equipment, as well as a strong commitment to quality and regulatory compliance to ensure that your drug product will be safe for patients. Finally, the right CDMO partner should be able to provide flexible and scalable manufacturing solutions to seamlessly accommodate your changing needs as your therapy progresses through clinical development and commercialization.

Cell and gene therapy CDMOs help drug developers successfully prepare for and execute clinical trials in a number of ways. By providing expertise in process development, CDMOs optimize manufacturing processes to meet key regulatory requirements and produce high-quality therapeutic products. CDMOs can also expedite timelines by ensuring process development is conducted with clinical trial readiness in mind from the start. Once clinical trials are underway, CDMOs support partners with efficient and reliable CGMP cell and gene therapy contract manufacturing at scale, ensuring therapies are produced to the highest standards of quality.

Viral vector production is a critical component in cell and gene therapy manufacturing, particularly for therapies that use viral vectors as a delivery mechanism for introducing genetic material into target cells. Successfully producing viral vectors at clinical scale requires specialized expertise and infrastructure, making these capabilities vital to a strong cell and gene therapy CDMO partner. SK pharmteco boasts extensive expertise in viral vector production, from securing critical raw materials like plasmids, cell lines, and viral banks to right-first-time process development and integrated testing capabilities. Our proven viral vector manufacturing platforms, LentiSure™ and AAVelocity™, provide optimized, plug-and-play solutions that reliably deliver high-quality viral vectors to reduce time to market.

Yes, CDMOs play a crucial role in supporting clients with regulatory submissions for novel cell and gene therapies, helping to ensure that therapies meet regulatory requirements and can be brought to market efficiently. A cell and gene therapy CDMO can leverage regulatory expertise and experience in these modalities to help partners navigate the dynamic landscape of global regulatory standards, including the preparation of necessary documentation and facilitation of interactions with regulatory authorities. With robust processes in place, a CDMO can help partners demonstrate the quality, safety, and efficacy of their products and ensure CGMP compliance.

As a comprehensive cell and gene therapy CDMO, SK pharmteco has accumulated extensive expertise compared to more niche innovator companies that tend to focus on a single modality. The diversity of our experience enriches our regulatory support offerings, providing reliable benefits to our partners, especially smaller companies with limited exposure to regulatory bodies like the U.S. FDA and EMA. SK pharmteco has dedicated regulatory teams on-site, supporting partners with real-time process information and analytical data to apply to submission filings. We also utilize our strong relationships with global health authorities and collaborate with you to prepare filings in accordance with stringent regulatory requirements, minimizing any potential delays to your program resulting from the review process.