Bio-manufacturing of antigens, antibodies and bioresearch materials

Transcription

1 Bio-manufacturing of antigens, antibodies and bioresearch materials Foetal Bovine Serum (FBS) Human AB Serum Chick Embryo Extract (CEE) Custom polyclonal antibody production Custom monoclonal antibody production Custom manufacture of cell culture sera, media and reagents Contract manufacturing services Pilot production runs for feasibility studies prior to cgmp production Full traceability for complete confidence Custom Services for Life Science

2 Your partner for customised bio-manufacturing Antibody Production Service Limited (APS) is an independently owned UK based company providing contract services to meet the growing demand of outsourcing production so you can focus on core activities. First class customer service: APS prides itself on delivering excellent customer care. We recognise the importance of regular communication with our clients throughout each and every project. Expertise: With over 30 years technical expertise in antibody production and cell culture industries, you can have confidence your project is in safe hands. Single-use technology: APS has adopted single-use technologies, enabling us to provide for the specialised needs of bio-manufacturing. Fully adaptable service integration and provision: Whether you have existing protocols, or require tailored support for your project, we provide a fully managed service. Clients are encouraged to visit our facilities and we welcome the opportunity to discuss projects in detail. APS are also open to client-led audits. Cell Culture Products Foetal Bovine Serum (FBS): APS FBS is manufactured at our facility in the UK in batches of up to 1000 litres. Each batch is filtered to triple 0.1 micron and undergoes stringent Quality Assurance prior to release. Full batch documentation is available, including certificates of Analysis and Certificates of Origin. APS can provide FBS from a wide variety of geographies to suit both budgetary constraints and research applications. APS FBS typically has endotoxin levels of below 10EU/ml with some batches having endotoxin levels of below 1EU/mL. Samples are available for batch selection. FBS is also available heat inactivated, gamma irradiated, charcoal stripped and dialysed. Human AB Serum: APS Human AB serum is collected from male donors only in the USA. This serum is collected in FDA registered facilities meaning that it is fully traceable and suitable for a wide variety of applications, including manufacturing. Serum is available either Off Clot or as plasma-derived/ Converted serum. APS Human AB serum is produced in batches of typically litres, sterile filtered to 0.1 micron. All donor units that form each batch are tested for HBsAG, anti-hcv, anti- HIV1 and 2, HIV-1, and Syphilis. Additional viral testing on both individual donors and pooled material is available to meet current regulatory standards for further manufacturing. Samples are available for batch selection. APS Human AB serum is also available heat inactivated, gamma irradiated, charcoal stripped and dialysed. Chick Embryo Extract (CEE): APS CEE is an undefined cell culture medium component providing essential growth factor components, used in the supplementation of certain growth media formulations. CEE undergoes stringent Quality Assurance testing to ensure that the product is negative for bacteria, yeast and fungi. Batches are tested for suitability by assaying the growth and the differentiation of mouse muscle cells. CEE is available as a standard formulation (with or without antibiotic) or as an ultrafiltrate. Samples are available for batch selection.

3 Custom Services With our in-house expertise and clean room facilities, APS also offers a wide range of contract services. Services can be tailored to individual specifications and requirements. Blocking sera: a wide range of blocking sera may be provided, either as bulk material or dispensed. Blood products: bulk quantities of animal derived blood material including plasma, sera, red blood cells or whole blood from a wide variety of species. Buffers: buffers can be produced, dispensed and labelled to predefined specifications. Cell culture media: media can be manufactured based on standard or custom formulations. Minimum volume requirement of 10L. Commercially available media can also be adapted. Cell culture media development and optimisation: APS provides qualified scientific expertise for the formulation of solutions and custom-made products for research and bio-product applications allowing for smooth transfer of processes and successful scale-up. Advanced media optimisation Media selection Qualifying key raw materials Development of formulation and scale-up Shortening of process development timelines Improving the yield of an existing process Cleanroom hire: The APS Cleanrooms are available for hire, after the required training, to Industrialists, Postgraduates, Post-doctoral workers, Research Staff, Technicians and Academic Staff. Both rooms are rated as Class 10,000 (ISO 7) with ISO 7 rated laminar flow hoods located above critical equipment. This means that dust and other air-borne contaminates are controlled to specified low levels. These ultra-clean conditions allow precision fabrication and characterisation of nanostructured devices. APS Cleanroom facilities are approximately 2.5m by 3.0m. The Cleanroom has 7.5m 2 of controlled space, with the associated service areas taking up a further 50m 2. This area is organised into 2 Cleanrooms, both with laminar flow hoods. Filtration: biological materials such as serum and plasma that have been aseptically collected from approved sites can be processed at APS. Filtration is performed using single use systems offering triple filtration to 0.1micron. Volumes can be processed from 1L to 1,000L for FBS, Human AB serum and other sera. Kit manufacture and assembly: includes the kit design, material sourcing, reagent production and packaging of kits. Lyophilisation: material can be lyophilised, capped and labelled as required. Quality assurances services: a comprehensive range of bioanalytical services including sterility, ELISA, endotoxin, bacterial and viral screening as well as species testing. Regulatory advice: with over 30 years experience in the field of antibody production, APS can provide advice as it applies under current regulations. Serum Sourcing: as well as processing client sourced material, APS can also source a variety of sera to defined specifications. Storage: facilities to store materials at ambient, +4 C, -20 C and -80 C, plus warehousing for off-site storage.

4 Custom Polyclonal Antibody Production A fully project managed service providing a customisable and adaptable approach to polyclonal antibody production. APS provides a wide range of options which can be tailored to your exact specifications. Production services can be further combined with additional contract services depending on your project requirements and available in-house resources *. Species: Since the selection of a host species is determined by a number of factors such as the level of immune response and volume of serum required, a wide variety of host species are available. The most common species for pab production include rabbit, sheep, goat, mice and rats. Alpaca, llama and emu (eggs) are also available on request**. Antigen Selection & Preparation: With the selection of a suitable antigen being critical to the successful initiation of an immune response in the host animal, we can provide immunogen preparation support services, including peptide synthesis and carrier protein conjugation. Antigens can be derived from a variety of sources including bacteria, viruses, fungi, synthetic peptides and recombinant proteins. APS can also offer live antigen/virus polyclonal production - please contact us for more details. Immunisation Schedule: A standard immunisation schedule for the production of pabs is 77-days for rabbit and 98-days for larger animals ***. Sufficient antigen must be provided in order to meet the desired immunisation schedule for the selected species. The schedule can be extended as required, even during the course of the project. Species Minimum amount of antigen required Deliverable: Average serum yield per animal Rabbit 50µg of antigen (1mg/mL) x 6 immunisations 60-80mL Sheep/Goat 200µg of antigen (1mg/mL) x 6 immunisations 750-1,000mL Spleen preparations also available upon request. New - Alpaca Antibodies The benefits Camelids such as alpacas are unique amongst mammals in producing antibodies composed solely of two identical heavy chains. Their unique structure make them of great interest for basic research and therapeutic applications. Alpaca antibodies are robust, with the ability to withstand elevated temperatures and a wide ph range, extending both their in vivo and in vitro applications. Unlike human antibodies or those from other species, alpaca antibodies can survive the harsh environment inside cells, retaining the ability to seek out targets. This ability is of importance in the field of gene therapy and biosensor applications. Camelids are used to produce single-domain antibodies which because of the smaller size, are easier to transform into bacterial cells for bulk production. Single domain camelid antibodies are being used in drug discovery research including the treatment of Alzheimer s Disease and acute coronary syndrome. These antibodies also offer rapid tissue penetration and the ability to cross the blood-brain barrier. *Prior to any project commencing, a Justification Application must be completed and returned in order to acquire the necessary veterinary approval to proceed. **Availability of certain species is seasonal. ***Schedules can be customised. Should you require a longer schedule than the standard 77-days, additional husbandry costs apply. These are charged on a per day basis. All schedules are also sent for pre-approval and sign-off prior to any work commencing on the project. No project will be terminated without written consent.

5 Custom Monoclonal Antibody Production A fully project managed service providing detailed consultation throughout the stages of immunisation, cell line development through to optimisation, expansion and purification. Projects are broken down into defined stages enabling maximum flexibility in project design and deliverables. Production services can be further combined with additional contract services depending on your project requirements and available inhouse resources. Species: Mouse BALB/c are used for monoclonal antibody production. Antigen Selection & Preparation: Antibodies have successfully been developed to membrane proteins, haptens, peptides, soluble proteins and toxic agents. Schedule: Antibodies can be produced to Research Grade, Clinical Diagnostic Grade or cgmp production standards. Charges are based per round of serial dilution cloning as opposed to the best screened. This offers a greater level of flexibility and potential cost savings. Typically, a project will take from 6 to 12 months depending on the immunisation schedule and overall project complexity Ɨ. A typical ƗƗ schedule is as follows: Phase I Phase II Phase III Phase IV ƗƗƗ Process / Deliverable Antigen preparation and immunisation: Requires 1mg of antigen (1mg/mL) Deliverable: Spleen tissue or terminal bleed serum can be provided from additional targets if required Hybridoma development: Cell fusion and screening of candidate colonies via ELISA Deliverable: Typically candidate clones are identified Screening: Limiting dilution cloning and cryogenic preservation Deliverable: Results of each cloning stage can be supplied if required Large scale production of purified monoclonal antibody Deliverable: mg to g quantities of mab Estimated timescale in weeks Biomolecule services Peptide design and synthesis, conjugation, phosphorylation, tagging and other modifications. Bulk antibody production from customers own hybridoma to Research Grade, Clinical Diagnostic Grade or cgmp production standards. Downstream processing and purification and protein analytics. Cell line services including recovery, characterisation, optimisation, storage and transformation to serum-free conditions. Ɨ Prior to any project commencing, a Justification Application must be completed and returned in order to acquire the necessary veterinary approval to proceed. ƗƗ Schedules can be customised. All schedules are also sent for pre-approval and sign-off prior to any work commencing on the project. No project will be terminated without written consent. ƗƗƗ APS can also produce large volumes of purified antibody from customer cell lines.

6 Regulation of the use of animals in research All antibody production services are carried out in secure UK facilities by qualified licensees, under UK Home Office licensing to ensure the highest quality of care for the host animals, and the production of premium quality antibodies. All procedures are performed under veterinary supervision, meeting current ethical standards according to the Animal (Scientific Procedures) Act 1986 (ASPA), which has been revised to transpose European Directive 2010/63/EU. Central to the ASPA is a cost-benefit assessment which must be applied before any research project involving animals can go ahead. APS takes a novel approach to the three R s and actively pursues clearly defined objectives for the refinement, replacement and reduction of animals under its care. Accreditation Currently, APS runs Class 5 clean rooms validated to ISO :2012 guidelines for the aseptic processing of healthcare products that cannot be terminally sterilized. Processing of animal and human materials are handled in dedicated clean rooms. APS is a member of the International Serum Industry Association (ISIA). Custom Services for Life Science To learn more, contact Antibody Production Services Limited: Telephone: +44 (0) [email protected] Website: Address: PO Box 1519, Bedford, United Kingdom