Part II prequalification covers each drug substances and drug merchandise manufactured in BE. |Photograph courtesy: Association
Organic E. has obtained World Well being Group Part II prequalification for its novel oral polio vaccine sort 2 (nOPV2).
The Part II PQ covers each drug substance and drug product manufactured at BE, finishing the whole manufacturing chain for nOPV2 in a single built-in facility. The Hyderabad-based vaccine maker introduced on Thursday that this expands BE’s WHO-certified manufacturing scope past Part I, which obtained PQ in June 2024 for manufacturing medicines utilizing externally equipped drug substances.
BE stated it has already manufactured and equipped 700 million doses of nOPV2 to the product stockpile and shipped to a number of international locations the place immunization campaigns are being carried out to manage the outbreak of vaccine-derived poliovirus sort 2 (cVDPV2).
“When a polio outbreak happens, response time and vaccine availability decide how shortly the an infection may be stopped. Part II WHO prequalification allows full end-to-end manufacturing at our facility, making international provides extra resilient and in a position to reply sooner,” stated BE Managing Director Mahima Datla.
Greater than 1 billion doses of nOPV2 have already been administered worldwide, she stated, because it has improved genetic stability and is particularly designed for outbreak management.
This expanded certification provides WHO-certified built-in manufacturing capability for nOPV2, an necessary vaccine used to manage cVDPV2 outbreaks, considerably strengthening international outbreak response preparedness.
This achievement displays a multi-year, multi-partner international collaboration that included know-how switch, product comparability assessments, specialised testing, and an institution-wide manufacturing readiness program. “This progress displays the necessary contributions of PT Bio Farma (Indonesia), PATH, and the Gates Basis in technical and programmatic assist,” Ms. Datora stated.
