b博金冠平台注册: MONTANIDE? Range
Selecting the right adjuvant is one of the keys to success of a veterinary vaccine in the field. Safety and efficacy balance must be taken into account, as well as the animal species and its sensitivity, the antigen (inactivated or live), its type (viral, bacterial, parasite) and its nature (crude extract, purified, recombinant, peptide, DNA), the desired immune response kinetics (short or long-term) and its profile (humoral or cellular), and the administration route (injection, mucosal, mass vaccination). Since the 70's, SEPPIC has been combining expertise and service to develop MONTANIDE? adjuvants adapted to the veterinary needs.
To meet vaccine developers' needs and to improve efficacy and stability of veterinary vaccines, SEPPIC has developed a wide range of ready-to-use adjuvants based on 3?technologies: emulsions, micro-emulsions and polymers.
These veterinary adjuvants are manufactured under International Pharmaceutical Excipient Council (IPEC) manufacturing guidelines in SEPPIC manufacturing sites of Castres (France) and Qing Pu (China).
MONTANIDE? safety and regulatory status
Based on toxicological tests and field experience, MONTANIDE? adjuvants are considered as safe for veterinary applications such as vaccines.
MONTANIDE? adjuvants and their components have been approved by the Committee for Veterinary Medical Products (CVMP) for use in immunological products. Their components are either included in the Allowed Substances table of the Annex to European Council Regulation (EU) No?37/2010 as substances needing no further Maximum Residue Limits (MRL) studies, or considered as not falling within the scope of Regulation (EC) No?470/2009 when used in a veterinary product.
The properties of the antigenic medium are crucial for both vaccine efficacy and safety. Each team developing a vaccine has to study the safety and efficacy profile of the formula under development according to local market acceptance criteria.
Services around MONTANIDE?
Expertise and know how
Bibliographic searches, vaccination protocols, efficacy screening on mice
Selection among pharmaceutical technologies (emulsion, polymer, solid form, etc.)
Selection of samples
Adapted to the model of the customer for vaccine stability and performance
From the laboratory to small and large scale industrial production
For specific antigens, delivery systems, new concepts
Training & worshops
Vaccine formulation, laboratory and pilot processes, quality control of adjuvants and vaccines
Regulatory affairs support
For vaccine registration, customs, etc.