WHO grants Phase II PQ to Biological E
Change
WHO granted Phase II pre-qualification to Biological E Limited for its Novel Oral Polio Vaccine type 2 (nOPV2), covering both the drug substance and drug product manufactured at the company’s integrated site.
Why it matters
Phase II pre‑qualification covers both the drug substance and the drug product manufactured at Biological E’s integrated facilities, completing the full manufacturing chain for nOPV2 at one site. This expands BE’s WHO‑qualified manufacturing scope beyond its earlier Phase I qualification for drug product only. Biological E has manufactured and supplied 700 million doses of nOPV2 to the global stockpile and shipped doses to multiple countries. nOPV2 is an oral polio vaccine type 2 designed for outbreak control with improved genetic stability and has been deployed in more than a billion doses globally.
Implications
- • Procurement processes requiring WHO pre‑qualification can accept nOPV2 supplies wholly manufactured at Biological E’s integrated site.
- • Regulatory inspections and qualification audits for WHO‑qualified nOPV2 production can be focused on a single integrated manufacturing facility.
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Regulatory Actions Supply Chain & Logistics Public Health Pharma & Biotech Diseases & Treatments