The Indian Council of Medical Research (ICMR) and International AIDS Vaccine Initiative (IAVI) are scouting for an Indian vaccine company which can manufacture recombinant MVA based HIV vaccine by making use of the technology that would be transferred by the agencies through their Vaccine Development Partnership (VDP) Programme. The VDP has invited all Indian vaccine manufacturers to respond to its call by providing necessary details in a specific pro forma to the VDP. The agencies would scrutinize the applications and the ones meeting all required criteria would be considered for further negotiations, which may lead to a contract to manufacture the vaccine within the country.
ICMR and IAVI have set up VDP programme to develop preventive HIV vaccine (s) for India. VDPs are the cornerstone of IAVI's scientific program that link the researchers from academia or biotechnology companies with vaccine manufacturers and clinicians from the developing countries, namely India, China, Kenya, Uganda & South Africa. IAVI brings in expertise ranging from project management to regulatory affairs and infrastructure development for the clinical trials.
The VDP is presently in the process of identifying a vaccine manufacturer based in India who has the capability and would be interested in producing the recombinant MVA-based HIV vaccine. As a first step the agency has come out with a detailed pro forma questionnaire intended to enable VDP to have a better understanding of the applicants' capabilities and experience to manufacture the vaccine. This information, which is to be considered as highly confidential would be reviewed, and if meeting all the necessary criteria, would be followed with a meeting for further negotiations for manufacturing vaccines within the country, it is learnt.
Apart from the general details about the company, the pro forma seeks detailed information regarding the company's expertise in cGMP manufacturing of all kinds of vaccines like viral, bacterial and genetically engineered vaccines. The company is also to furnish details regarding the years of experience, annual capacity etc.
Expertise in handling animal cell cultures is another specific area in the pro forma. The pro forma would also demand the company to inform about its in-house expertise in quality control testing and also specify whether it is carried out as per USP/EUP/BP/IP/ or any other pharmacopoeia.
Brief description about the in-house animal house facility, expertise in aseptic filling capacity (vials, ampoules, syringes), lyophilization expertise & capacity, in-house expertise in labeling & packaging, vaccine storage capacity at various temperature levels, vaccine distribution system for with-in country & exports, regulatory experience, details about certifications, Organization Chart (Include capabilities in Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs).