Cell and Gene Therapy CDMO Services
Innovative solutions for cell and gene therapies
SK pharmteco provides advanced cell and gene therapy manufacturing solutions, offering a full range of CDMO services including process development, CGMP manufacturing, regulatory support, and analytical testing. We deliver scalable, innovative solutions for cell and gene therapies, ensuring successful development and commercialization, helping bring life-changing therapies to patients efficiently and safely.
Explore Our Cell and Gene Therapy Capabilities
Cell and Gene Therapy Process Development
Efficient, scalable process development for cell and gene therapies, ensuring robust, compliant manufacturing from preclinical through commercialization stages, with seamless tech transfer and quality control.
Viral Vector Manufacturing
Scalable viral vector manufacturing with robust, compliant processes for AAV, lentivirus, and more. From preclinical to commercial stages, we ensure seamless tech transfer and quality control.
Plasmid DNA Manufacturing
Efficient plasmid DNA manufacturing with scalable, CGMP-compliant processes to support gene therapy development from preclinical through commercial stages, ensuring high quality and rapid delivery.
Cell Therapy Manufacturing
Scalable CGMP cell therapy manufacturing for autologous and allogeneic therapies. Our facilities support clinical to commercial production with seamless tech transfer, quality control, and supply chain management.
Cell and Gene Therapy Analytical Services
Comprehensive cell and gene therapy analytical services, offering customized testing for safety, identity, purity, potency, and stability, ensuring rapid release and regulatory compliance at every stage.
Regulatory Support
Expert regulatory support for cell and gene therapy CDMO services, guiding clients from clinical trials through commercialization, ensuring global compliance and successful regulatory submissions.
Working with SK pharmteco
A Flexible, Agile Approach
We understand that no two projects are alike. SK pharmteco helps partners meet unexpected changes and challenges on the path to market with a flexible, agile approach to working, ensuring that our solutions scale to fit your unique needs. Our partners’ success is our success — we’re willing to invest in your project with flexible terms and milestone-based arrangements.
Transparency & Trust
Our relationships are built on trust, transparency, and client-first collaboration. SK pharmteco’s experienced teams of cell and gene therapy experts work closely with you to build and execute the right solutions for your project while maintaining constant communication at every step. Our processes maintain a fully digital footprint, including electronic batch records and client dashboards, to allow complete visibility into safety and quality metrics.
Relevant Resources
Cell & Gene Therapy Events
Cell & Gene Therapy FAQs
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.
Contact us
We’re committed to supporting your development and manufacturing needs. Complete the form and someone from SK pharmteco will be in touch shortly.