GMP pilot production and vaccine development - product characterisation, process development and vaccine production facilities

Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands

The Institute for Translational Vaccinology (Intravacc)  is a government-based vaccine institute with over 100 years of extensive knowledge and experience in the field of vaccine development. We are striving for an integral approach to protect public health and reduce the deleterious effects of infectious and other diseases on human health through vaccination. To achieve this mission, our aim is to substantially reduce development risks and costs of new vaccines by bridging the translational gap between laboratory bench and market.
Intravacc is one of the few not for profit players in the vaccine field that has in-house experience with all the aspects of the vaccine value chain to bridge the gap between basic research and advanced clinical studies in man. Our core business is vaccine research and development. Our activities in this area have provided us with a wide range of knowledge, products, services and facilities pertaining to all phases, from concepts and platform technologies to vaccine proof of principle.

Within this framework, we provide Users access to laboratories and know-how for vaccine development. This includes upstream and downstream processing technology from laboratory scale to intermediate scale (max. 150L volume), vaccine delivery (adjuvant/delivery systems) and formulation technology (liquid, lyophilized or spray dried formulations), assay development and vaccine characterisation, bacterial and viral platform technologies and pilot scale GMP production in our pilot plant. Proprietary technology that we offer includes:
- A production platform for viral vaccines based on Vero Cell technology, including regulatory support and associated documentation. The platform has been successfully used for production and marketing of polio vaccines.
- A platform for adjuvation of bacterial vaccines based on outer membrane vesicles (OMVs)
- A proprietary platform technology for identification of immunogenic T cell epitopes
- A proprietary technology for freeze drying of vaccines
In addition, we provide scientific, technical and regulatory support in order to bridge the gap between vaccine lead and marketing authorization.

On-site access

Vaccine development: Upon request, access will be granted to Users for assay development, process development and downstream processing. Where sufficient expertise is available, the Users may have a guided access to certain technology and equipment. For dedicated equipment, specific analytics (MS, NMR, Biacore) and lyophilisation, trained staff will be provided by Intravacc. For BSL-3 access, adequate training is necessary. In collaboration with Users a plan for usage will be drawn.

GMP production: Upon request, access may be granted for Users to produce a vaccine batch in the pilot plant. Planning for usage of the pilot plant is done well in advance, preferably 1 year ahead.

Minimum qualifications: Bachelor of Science plus two years experience.

Modalities of access

Organisation short name:  Intravacc

Unit of access: The unit of access is depending on the nature of the request. The Users can receive:
- Vaccine development: Vaccine development within BSL1/2/3 Laboratory, including scientific, regulatory, technical and logistic support where necessary and based upon an agreed plan. For usage of specific equipment, dedicated staff is available to handle the samples.
- GMP production: Users will have access to all support that is necessary for producing vaccines at pilot scale. Intravacc staff is extensively experienced in working with Users from various countries and all background. Where necessary, translation services may be made available.

Quantity of access available: Based on the availability of laboratory space, 1 – 6 studies are offered.

Timelines: Depending on the nature of the request of the Users and based upon an agreed plan, in general 2 - 12 weeks.

Overview of access provided between January 2011 (1st call) and January 2013 (9th call):
Estimated number of users/User groups: -
Estimated number of projects: -
Access already provided: 0 (This service has been included to the TRANSVAC network in July 2012)                                   
Access still available: 1-6

Last call submission date scheduled for: April 2013 (Call number: 10)

Input – sample requirements

Depending on the nature of the request of the Users, description of the samples/information/documents required may include:
- Upstream, downstream or integrated process development preliminary description from User required for each candidate vaccine.
- Candidate vaccine lead with documentation on its known physico-chemical properties and the current used analytical methods to detect, quantify and characterise the candidate
- Summary of the overall development plan, including indication of time lines.

Output – deliverables to User

Depending on the nature of the request, the Users can receive:
- GMP-compliant reports
- Lead formulations, analytics and/or characterization profile for the vaccine candidate
- Outline of process description and performance
- Appropriate USP/DSP process
- Production of vaccine batches, GMP-compliant product, delivered as raw material, or in specific cases as product when downstream processing is available.

Contact

Prof. Claire Boog

Claire [dot] Boog [at] intravacc [dot] nl

+31-30-2742096