Custom Protein Manufacturing Service
Capitalise on innovative ideas using 25 years of protein expertise
BBI Solutions has over 25 years’ expertise working with customers and partners to develop and manufacture high quality proteins for a diverse range of applications with our Custom Protein Service.
The development of new raw materials is often perceived to be a lengthy and expensive process. However, we’ve learnt from our customers that the cost of developing and manufacturing in house can often outweigh the cost of outsourcing.
A flexible offering for customers looking to outsource the development of new, improved or existing products, BBI’s custom protein service delivers a protein development solution suited to your individual budget, application and required level of development.
A dedicated development team
By choosing to outsource your development work to BBI, our experienced team can develop your bespoke request using a design control matrix and produce a fully quantified and validated protein. This work is carried out in state of the art laboratories with next generation equipment to provide you with a protein to your exact requirements.
Why outsource to BBI?
Reliability and Performance -
Proven technologies and quality processes deliver consistent, stable products, and maximum value and yield on raw materials with batch sizes ranging from 100ug to gram quantities.
A service from a company focused on quality and underpinned by stringent quality assurance procedures in compliance with ISO13485.
With a network of global labs and hospitals we can access many diverse testing platforms, providing you with the exact analysis results you need.
Secure supply -
We have over 25 years’ experience sourcing human biologicals at our HTA approved site; you can be confident in a secure supply.
Our development process
BBI Solutions offers a flexible service at every stage of the development process. From providing trial batches for validation to long term manufacture, we aim to produce a product to your exact requirements.
Feasibility – The process would typically start with the Research & Development (R&D) team and various formulations and processes would be generated to arrive at a feasibility prototype product. During this stage a sound understanding of the critical process parameters would be gained in order to develop a robust process capable of consistently preparing a material of the required specification.
Development – Design optimisation of materials and processes and formulations are finalised. Our R&D and technical personnel are experts in full-scale manufacture and this helps us to ensure a smooth transfer to the manufacturing environment.
Verification – We conduct a variety of routine protein analyses such as enzyme assays, protein determinations, analytical chromatography, SDS PAGE. We work closely with you our customer in developing protocols to ensure optimised yields of the highest quality.
Validation – The process and product is fully validated according to regulatory approval guidelines.
New Product Development - We are continuously striving to improve our existing portfolio and use our expertise in developing both native and recombinant proteins. We have a range of novel biomarkers for you to sample for evaluation.
BBI can offer you the following services through our purpose built laboratories in the UK:
Licensed Human raw material collection and storage – Specific disease state fluid (urine, plasma, whole blood etc), human tissues
Molecular Biology – DNA design/cloning, mutagenesis, cloning screening and selection
Protein expression – Intracellular/extracellular expression, wild type/fusion proteins, E-coli, P-pastoris (electroporation), propogation with CIP fermentor (1, 10, 30L)
Protein extraction – Sonication and homogenisation and high speed centrifugation
Chromatography equipment – 2 AKTA Purifiers, 3 AKTA Prime Plus, AKTA Pilot with columns ranging in size from 1ml-100L. Analytical HPLC
Chromatography techniques - Size exclusion, Ion exchange, HIC, Affinity, metal chelate, fast flow or high performance gels, TFF and hollow fibre concentration/diafiltration
Lyophilisation – Pilot and high volume. Christ LC3, Virtis Genesis and Lyomax Systems
Protein Characterisation - Electrophoresis (SDS-PAGE, native, IEF, urea gels), immunoelectrophoresis and western blotting
Immunoassays - Siemens Immulite/DCA Vantage /ProSpec available in house. Partnership with approved laboratories for all commercial immunoassay platforms
Quality Control - Working to ISO13485 conditions
Qualified Staff - Speak to our highly experienced team of technical experts to determine your exact requirements.
Product Handling/Sampling – We offer special packing in line with your requirements. Products delivered as per customer specification, (freeze dried powder, protein precipitate.)