Cell Therapy CDMO From Preclinical Stage To End Product
As a fully integrated cell therapy CDMO, we provide comprehensive oversight across all stages of the product development lifecycle and associated supply chain. Our capabilities span cell therapy process and analytical development through GMP-compliant manufacturing and commercial-scale production.
Supported by integrated quality control and advanced biologics testing, our multidisciplinary expertise enables rigorous control of product safety, quality, and potency. This framework ensures alignment with global regulatory requirements while sustaining operational efficiency and predictable manufacturing timelines from early development through commercialization.
Facility
Operating 25 ISO 7 (Grade B, US/EU-compliant) GMP cleanroom suites, we enable clinical-stage through commercial-scale manufacturing of cell therapy products for global markets.
Our infrastructure is designed to support scalable production, multi-product operations, and regulatory readiness across major jurisdictions, including FDA and EMA frameworks. This capacity allows for seamless progression from early-phase clinical supply to validated commercial manufacturing without the need for facility transitions or process requalification.
Advance Scalable, Regulatory-Ready Cell Therapy Manufacturing
As an experienced CDMO, we provide GMP-compliant manufacturing services across a broad range of autologous and allogeneic cell therapy platforms and starting materials. Our expertise includes marrow-infiltrating lymphocytes (MILs), dendritic cells (DCs), natural killer (NK) cells, T cells (including CAR-T), bone marrow–derived mesenchymal stromal/stem cells (BMSCs/MSCs), hematopoietic stem cells, and primary materials such as whole blood, apheresis and leukapheresis collections, tumor isolates, and related cellular substrates.
We also maintain operational experience in the handling and processing of tumor-derived materials (resections, biopsies, lysates), tumor-infiltrating lymphocytes (TILs), mobilized peripheral blood, buffy coat preparations, and other clinically relevant source materials.
Technology-agnostic and platform-flexible, we apply a phase-appropriate, data-driven development strategy aligned with global GMP standards for cell therapy manufacturing. Early integration of technology transfer planning, analytical comparability, and commercial scalability mitigates late-stage CMC risk and facilitates efficient regulatory progression.
Leveraging validated, closed, and automated manufacturing systems, our teams support the development of robust, scalable processes and analytical frameworks — whether for discrete stages or fully integrated end-to-end programs across the product lifecycle.
End-to-End Cell Therapy Supply Chain Integration
We recognize the operational complexity inherent to autologous and allogeneic cell therapy supply chains. Our integrated supply chain framework is designed to ensure secure, traceable, and time-sensitive coordination of materials, patient-derived starting material, and critical data across clinical and commercial manufacturing workflows.
Clinical Collection Coordination and Chain-of-Identity Management
We coordinate closely with apheresis centers, clinical sites, and collection facilities to enable compliant, timely, and secure procurement of patient-derived starting materials. Our capabilities include scheduling oversight, chain-of-identity (COI) and chain-of-custody (COC) management, as well as controlled harvest, formulation, packaging, and cryopreservation processes for both starting materials and finished cell therapy products.
Validated Cold Chain Logistics and Distribution
To preserve cellular viability, potency, and product integrity, we implement validated temperature-controlled storage and transport solutions across the full logistics pathway. This includes real-time environmental monitoring, qualified shipping systems, cold chain validation, and management of international shipping requirements, including customs clearance and regulatory documentation.
Regulatory Engagement and Clinical Trial Execution Support
As a strategic manufacturing partner, we provide structured regulatory support across the cell therapy development lifecycle. Our teams engage directly with global regulatory authorities to facilitate aligned communication, support submission readiness, and ensure manufacturing compliance throughout clinical development and commercialization.
We coordinate effectively with external Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and clinical collection centers to maintain operational continuity across multi-site and multinational programs. This includes regulatory documentation support, CMC alignment, inspection readiness, and cross-functional collaboration to mitigate development risk.
Leveraging extensive experience in cell therapy CDMO operations, we enable seamless progression from early-phase clinical trials through commercial launch, ensuring that manufacturing, regulatory strategy, and clinical execution remain synchronized — allowing sponsors to focus on advancing their therapeutic programs toward market approval.
Actcell Labs Inc
1361 Amsterdam Ave.,
Floor 3, New York,
NY 10027, USA
+1 888 4880155
support@actcelllabs.com