Biomedical & Medtech Manufacturing

Manufacture of biologic drug substance — monoclonal antibodies, recombinant and fusion proteins, and vaccines — grown in mammalian cell culture or microbial fermentation, purified and released as bulk. Buyers select on modality, expression system and bioreactor fleet, captive-versus-CDMO model, and FDA, EMA and HSA inspection record under PIC/S GMP.

GMP production of living therapeutics — autologous and allogeneic cell therapies, viral vectors and plasmid DNA. Buyers select on modality, platform and scale, stage from clinical-trial material to commercial supply, and captive-versus-shared-versus-CDMO contracting model under HSA's cell, tissue and gene therapy product regime.

Assembly of devices and components in controlled environments where airborne particle counts are regulated to ISO 14644 classes. Covers gowning, filtered air, and contamination control for implants, catheters, diagnostics, and optical and electronic parts. Buyers select on certified cleanroom class, particle-monitoring records, and quality system certification.

Contract process development and GMP production of medicines for pharma and biotech clients that lack their own plants or want to flex capacity. Buyers select on modality coverage, stage from preclinical and clinical material to commercial supply, capacity and technology, and FDA, EMA and HSA regulatory track record.

Aseptic transfer of a purified drug substance into its final sterile container — vial, prefilled syringe or cartridge — sealed, optionally lyophilised, inspected and released. Buyers select on container format, lyophilisation capacity, small-versus-large-molecule filling, isolator or RABS containment, and aseptic-process-simulation and PIC/S GMP record.

Contract production of medical devices and their components under a certified quality system. Work spans injection moulding, precision machining, assembly, and electronics integration for Class I to III devices. Buyers select suppliers on ISO 13485 certification, device-class and regulatory experience, cleanroom capacity, and traceable design and manufacturing records.

Manufacture of small-molecule active pharmaceutical ingredients (APIs) by chemical synthesis and their formulation into oral solid dose and other finished forms. Buyers select on API-versus-finished-dose scope, containment and high-potency (HPAPI) capability, batch-versus-continuous technology, and PIC/S GMP licensing under the Health Sciences Authority.

Design and production of sterile barrier packaging that protects medical devices through sterilization and distribution. Formats include pouches, trays, and Tyvek-lidded systems produced by form-fill-seal and heat sealing. Buyers select on ISO 11607 validation, seal-integrity testing, and compatibility with ethylene oxide, gamma, or steam sterilization.