PharmaBio is a contract development and manufacturing organization that provides GMP‑compliant facility design, construction, and end‑to‑end manufacturing for cell‑ and tissue‑based therapies. It also offers regulatory support and a range of GMP‑qualified testing services, enabling biotech and pharma companies to scale regenerative medicine products efficiently and compliantly.
Funding
Funding not disclosed
Founders
Product
Problem
Developing cell‑ and tissue‑based therapies requires specialized, GMP‑compliant manufacturing facilities, validated processes, and regulatory support, which many biotech and pharmaceutical companies lack in‑house. This creates bottlenecks in scaling regenerative medicine products and delays patient access to safe, effective treatments.
Solution
PharmaBio operates as a contract development and manufacturing organization (CDMO) focused on regenerative medicine and other cell‑derived products. The company designs and builds cell‑processing facilities that meet Good Manufacturing Practice (GMP) and GCTP standards, then provides end‑to‑end manufacturing services, including cell expansion, formulation, and aseptic filling. In addition, PharmaBio offers a suite of outsourced testing services such as microbial safety, flow cytometry, ELISA, and SARS‑CoV‑2 assays, all performed under GMP conditions. By handling facility design, process development, scale‑up, and regulatory documentation, PharmaBio enables partners to advance their cell‑based therapeutics more quickly and cost‑effectively while maintaining product quality and compliance.
Target Audience
Primary customers are pharmaceutical and biotechnology companies, as well as academic research groups, that are developing regenerative medicine, cell‑based, or tissue‑engineered therapeutics and require outsourced manufacturing, facility design, and regulatory support.
Features
- GMP‑compliant facility design and construction for cell and tissue processing, including cleanroom layout and equipment qualification
- Full‑scale contract manufacturing for cell‑derived therapies (e.g., cell sheets, stem cell products) with aseptic processing and cryopreservation
- Integrated process development services covering cell expansion, differentiation, formulation, and fill‑finish
- Regulatory support for IND/CTA submissions, including documentation of manufacturing and quality control procedures
- Certified contract testing portfolio (microbial safety, flow cytometry, ELISA, SARS‑CoV‑2 testing) performed under GMP conditions
- Scalability from pilot‑scale batches to commercial production runs, with technology transfer assistance