The Pivotal Alliance

Ab 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 company has well equipped laboratories and a MHRA licensed GMP manufacturing facility used for the production of biological medicinal products and investigational medicinal products in accordance with our MIA and MIA (IMP) licenses respectively.

Peptide Synthesis

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.

Quality Control Testing

The Quality Control department offers expertise in testing medicinal substances and products at various lifecycle stages including early product development, in-process, release and ongoing stability indicating analysis.

Protein Purification

We can work with you to establish strategies using our extensive experience in purification of protein from native source, recombinant proteins or monoclonal antibodies.

Assay Development

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.

Polyclonal Antibody

Ab Biotechnology offers a one stop shop for production and purification of polyclonal antibodies. We are happy to offer advice on immunogen choice, and depending on your requirements can manufacture peptides, perform purification of proteins or work with our extensive network of proven suppliers to meet your bespoke manufacturing needs. Once a strategy is agreed we can coordinate immunisation programs of work, perform downstream purification and manage QC testing of final product. We can also help to establish stability of your products utilising our in-house stability capabilities.

Stability Testing

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.

GMP Manufacture

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.