Made Scientific

Made Scientific is a U.S.-based contract development and manufacturing organization (CDMO) specializing in cell therapy development and manufacturing. Headquartered in Princeton, New Jersey, the company operates a 60,000 ft² facility equipped with five ISO 7 / Grade B cleanrooms meeting US FDA and EU Annex 1 standards, plus dedicated process and analytical development labs, in-house QC labs, cryo-storage, and cold-chain management.

Core Capabilities

Development & Manufacturing Services:

• Process and analytical development for cell therapies
• GMP and non-GMP manufacturing from preclinical through Phase I–III trials and commercial enablement
• Aseptic fill and finish for cell therapy drug products
• Quality control testing and stability studies tailored to living products
• Regulatory consulting for IND and BLA submissions
• Cell banking and drug product manufacture

Cell Modalities Supported: T cells, NK cells, hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), tumor-infiltrating lymphocytes (TILs), exosomes, and other advanced cell therapies.

Technology & Automation:

• AI-driven robotic automation platforms (partnership with Streamline Bio)
• Automated bioreactor platforms for 2D and 3D expansion
• High-throughput suites with robotic automation in expansion areas
• In-process metabolite monitoring and predictive critical quality attribute (CQA) strategies

Expansion & Capacity: Recent 12,000 ft² expansion with 9,000 ft² of new GMP cleanroom space and high-throughput automation suites, adding approximately 5,000 manufacturing batches per year at full capacity.

Engagement Models

Made Scientific offers flexible partnership structures:

• Traditional & Dedicated Service: Turnkey solutions with platform processes or purpose-built technology transfer for all clients
• Hybrid Client-In-Plant Operations: Shared or dedicated lab, cleanroom, and equipment access for mid-to-late stage clients
• Custom Build-outs & Partnerships: Tailored lab, cleanroom, warehousing, and cold-chain solutions for late-stage and commercial clients

Workforce Development

Made Foundry workforce development program with three tiers: Core (in-person GMP training), Boost (virtual courses), and Scholar (academic collaborations).

Strategic Support

Backed by GC Corporation, a global pharmaceutical and biotechnology leader providing long-term strategic investment and global perspective.