Aeras is constantly producing new constructs that will also be made available following phenotypic, genotypic and stability characterization.
Aeras is also glad to provide shigella carrier strains with capsids expressing TB antigens under similar conditions.
The Aeras Release Assay group has developed methods and reagents for analysis of rBCG for overexpression of antigens. We are glad to provide protocols on how these studies are performed. We have developed methods for assay of perfringolysin expression by rBCG and are glad to provide protocols.
The Aeras Release Assay Group and the Process Development and Manufacturing Group with the aid of Aeras Statistics is developing methods based on statistical methodology to measure the numbers of cfu in a culture and validate cfu enumeration methods in rBCG vaccines. Aeras is glad to share our approach to this problem with interested investigators.
The Aeras Clinical Immunology Laboratory has developed validated cell separation, freezing and shipping protocols for cells to be used for cellular immune flow cytometry assays. We are glad to provide all protocols and details that we have for these procedures.
Aeras has developed methods for performing flow cytometry assays measuring TB antigen specific CD4, CD8 and INF ,. These methods have undergone phase I qualification and are currently in the process of being fully validated. We are happy to provide our phase I qualified protocols and the approach and methods we used for the phase I qualification to investigators interested in performing and qualifying their own flow cytometry assays. We are in the process of developing qualified assays against IL- 2, INF-, and TNF-, and will provide the protocols for these qualified assays when they are available. We are also developing phase I qualified assays utilizing tetramers which will be made available when qualified. Our assays generally use the plate method so that automation for large scale clinical testing can be performed. Critical assays will undergo full phase III standard validation. We will be glad to provide these procedures and protocols for these validated assays as soon as they are available.
Aeras is glad to discuss performance of these assays and their validation with investigators that feel they could benefit from our experience and we welcome discussion with investigators that can provide us with help and comment. The Aeras Process Development and Manufacturing group develops methods for cGMP growth, harvesting and preserving of Aeras rBCG vaccines and Aeras capsid vaccines. The facilities consist of manufacturing areas for process development at the 15 liter fermentation scale, harvesting and thousand vial lyophilization and other drying procedure scale. Aeras currently has a facility for production of phase I clinical materials. Aeras will complete an appropriately staffed cGMP manufacturing facility in February 06 with master seed and production seed capability, with air flow, materials, and waste flow and the other requirements including CIP/SIP of all processes, WFI, etc., to meet cGMP requirements for bulk production of live bacterial vaccines or other fermented bulk at a 30 , 300 liter scale. This factory will be capable of producing rBCG and other live bacterial vaccine bulks for phase I-III and as a licensed product for distribution.
The Aeras Process Development and Manufacturing group welcomes the opportunity to provide help and facilities for process development and production of vaccines for investigators for research and clinical purposes as availability of the facility allows. We are not permitted to produce live TB vaccine candidates even though they are attenuated but are willing to produce any rBCG vaccine or other live bacterial vaccines, bulks or supernatants for experimental use as well as for animal and human use.
Under the guidance of the Aeras Regulatory QA Group, the Aeras Vaccine Development Laboratories and the Process Development and Manufacturing Groups have developed and continue to develop numerous S.O.P.s to meet compliance with Safety regulations and guidelines, Recombinant Organism (GMO) guidelines, Current Good Manufacturing Practices (cGMP) guidelines including Installation Qualification (IQ) and Operational Qualification (OQ) validation of facilities and equipment. Aeras is glad to make these SOPs available to other laboratories and manufacturing facilities.
The Aeras Epidemiology and Field Site Development Group is currently supporting epidemiology cohort studies in infants and adolescents at a site organized by scientists at the University of Cape Town in the Western Cape of South Africa; similar studies will begin at a second site in southern India in late 2005/early 2006.
Aeras has supported one Phase I study of a recombinant BCG vaccine candidate in healthy adults in the US and will support additional clinical studies of recombinant protein, adenovirus and BCG vaccine candidates starting with Phase I in healthy adults in Q2-2006.
Researchers interested in TB immunology, epidemiology, diagnosis, and other areas related to TB vaccine clinical development and evaluation may be able to benefit from Aeras procedures, access to data and clinical samples collected by Aeras. First priority for all materials collected by Aeras in its epidemiology and vaccine clinical development studies must go to its TB vaccine R&D program. However, Aeras welcomes inquiries re availability of protocols and materials that may be of value for related research and for applying for grant support for such research.
Researchers interested in possible use of Aeras epidemiology and clinical trial protocols, data and samples for other research applications can direct inquiries to:
Aeras Global TB Vaccine Foundation
1405 Research Boulevard, Suite 300
Rockville, MD 20850 – less – More from ZoomInfo »