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, Bush loan, penicuik Penicuik, EH26 0PZ United KingdomAb Biotechnology Ltd is a well-established company with 10 years’ experience working in the biotechnology industry. Whatever your needs, we offer a one stop shop for the development and manufacture of high purity biopharmaceutical products to GMP grade. The Ab Bio production facility specialises in the cGMP commercial manufacture of biological actives. Ab Bio has been fully licenced for over ten years and has been subject to routine inspection by the MHRA. The facility consists of environmentally classified cleanroom suites for purification, viral inactivation, viral reduction and concentration. Product fill / finish can be carried out to achieve necessary microbial limits We can work with you to establish strategies using our extensive experience in purification of protein from native source, recombinant proteins or monoclonal antibodies. Using ÄKTA systems, we have the capability to produce up to gram levels of purified protein. The downstream strategy can be tailored to meet your requirements for viral clearance with the eventual goal of scale up and technology transfer to large scale manufacturing Working to the principles of GMP we can produce custom peptide up to gram scale and with quality of the highest purity. This is achieved using our state of the art PurePep® Chorus Synthesiser. We confirm that the material is produced to the highest quality by subsequent on site QC assessment of purity by HPLC and peptide ID with N-terminal sequencing and Amino Acid Analysis (AAA). We can also offer ICH compliant stability testing of your peptide in our GMP stability suite if required Ab Biotechnology’s assay development group has extensive experience in development and validation (ICH Q2(R2)) of methods to be used in qualitative and quantitative assays to support your in-process, release and stability testing requirements. This includes a wide variety of test methods such as HPLC techniques, Western Blots, gel electrophoresis methods and we also offer a standalone ELISA team. Ab Biotechnology has extensive experience of managing GMP stability packages of work. We can manage all of your stability programme needs from initial study inception, to QC testing and issuing of QA reviewed stability reports. If early phase support is required in relation to the establishment of stability indicating methods, our assay development team are on hand to help.
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