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Health Research Authority
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REC Reference
07/H0304/114
REC Name
Cambridgeshire 1 Research Ethics Committee
Name of establishment responsible for the bank
Antitope Limited
Short title
Healthy Donor PBMC Cell Bank
Title of Bank
Healthy Donor PBMC Cell Bank
Contact Point Name/Address
Dr Tim Jones
Antitope Ltd
Babraham Research Campus
Babraham
Cambridge CB22 3AT
Contact Point Phones
01223 496190
Contact Point Email
tim.jones@antitope.co.uk
Types of Sample from living
Peripheral blood mononuclear cells (PBMC) isolated from human healthy donor buffy coats supplied by the Nation Blood Transfusion Service (NBTS) within 24 hours of blood draw. Buffy coat samples will be processed to isolated PBMC and then cryopreserved under liquid N2. Samples are perishable upon thawing to room temperature and need to be used immediately in in vitro T cell assays.

Approximately 800 buffy coats will be processed per year and all samples will be stored and used as described above. The PBMC Cell Bank will only be available for use in studies performed at Antitope by Antitope employees. Under no circumstances will samples be distributed to any 3rd parties. If PBMC samples are not used in studies within 3 years they will be destroyed according to the disposal protocol outlined in the "Cell Bank Maintenance Protocol". It is estimated that less than 10 healthy donor samples will be discarded via this route per year.
Types of Sample from deceased
NOT APPLICABLE
Intended use of Samples
The benefit of using protein therapeutics (biologics) to treat a wide range of diseases has lead to a very rapid expansion of research in this area. As a result biopharmaceutical companies have put considerable resources into developing new biologics with greater efficacy. There are a number of problems that have been encountered with the use of biologics that have not previously been seen when using small molecule compounds. One key area is the safety profile, in particular the capacity of the biologic to induce a patient immune response against itself. In some instances e.g. during the development of vaccines this can be a beneficial effect. However in many instances a patient derived anti-therapeutic response (immune response against the biologic) can be detrimental. There are several consequences of this unwanted immunogenicity which include reducing the efficacy of the biologic, allergic reactions in patients and even in some rare instances life threatening autoimmunity. It has been accepted that these responses are dependent on T cell help and by measuring the presence and potency of T cell epitopes in the sequences of biologics an assessment of the potential for immunogenicity can be made (Reviewed in Baker MP and Jones TD Curr. Opin. Drug Discov. Devel. 2007 10(2):219-27). As a result Antitope has developed an in vitro T cell assay technology that is being used to select lead biologics that have a reduced potential for immunogenicity. The T cell assays require the use of PBMC (a source of T cells and antigen presenting cells) from large cohorts of healthy donors. Indeed PBMC isolated from healthy donors are selected based on their major histocompatibility class II (MHC class II) allotypes to best represent the world population. There are considerable benefits in establishing a cell bank which will enable the selection of PBMC from donors to test of biologics in in vitro T cell assays:

1) Improving the efficacy and safety profile of novel biologics during preclinical development.
2) Assess the advantageous as well as non-advantageous immunogenicity of novel biologics.
3) Optimal selection of lead biologics during pre-clinical development.
4) Provide an assessment of the risk of immunogenicity of novel biologics before they are administered to patients.
5) Enable the optimisation (protein engineering) of biologics that have failed clinical trials or have limited use due to the induction of adverse immune reactions in patients.
6) Determine any potential links such as patient MHC haplotype and the risk of developing an immune response against biologics.

Antitope has developed an optimized T cell assay technology which uses healthy donor PBMC from the cell bank. Immunogenicity testing, in which PBMC are selected from the PBMC Cell Bank for use in T cell assays, is offered (via the Company website, specialist conferences presentations and targeted marketing practices) to pharmaceutical companies, biotechnology companies and academic research groups with the primary aim of providing a service (on a fee for service basis) in which lead biologics can be selected and developed into safe, efficacious therapeutics. The PBMC stored in the cell bank are only used for Antitope's in vitro T cell assay technology at Antitope's facility, and will not be available for any other use (including techniques of a sensitive nature e.g. cloning, stem cell therapies etc). Access to the cell bank is restricted to trained employees at Antitope.
Research to be undertaken
Investigations into the immunogenicity of biologic therapeutics, whereby T cells from anonymised healthy donors are used to assess the potential of a biologic for immunogenicity. This research is primarily focused on determining the safety of biologics in the healthcare industry and can be applied to the treatments for a wide range of diseases including (but not limited to):
Inflammation
Cancer
Infection
CNS
Decision
Favourable Opinion
HTA licence number
not yet received
Date published 21/04/2011