WuXi Biologics (HK:2269), a China-based global Contract Research, Development, and Manufacturing Organisation (CRDMO), announced on Monday that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted GMP certification to two of the company's manufacturing facilities in Wuxi for commercial manufacturing of an ophthalmic biologic.
After a four-day inspection, WuXi Biologics' Drug Product Facility 5 (DP5) and Drug Product Packaging Center (DPPC) successfully passed MHRA's assessment with no critical findings.
The company provides end-to-end manufacturing services for the ophthalmic biologic, covering both drug substance and drug product.
DP5, WuXi Biologics' first commercial pre-filled syringe (PFS) manufacturing facility, has production lines covering both clinical and commercial manufacturing. DPPC provides with end-to-end customised packaging services, fully compliant with international traceability code requirements. Both DP5 and DPPC have previously obtained approvals from major global regulatory authorities for the production of multiple biologic therapeutics.
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