Custom Enzyme Manufacture
BBI Solutions has over 60 years’ of expertise working with customers and partners to develop and manufacture high quality enzymes for a diverse range of applications.
We understand that the development of new products and raw materials for those products 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.
If you are looking to outsource the development of new, improved or existing products, BBI offers a flexible custom enzyme manufacturing service suited to your individual budget, application and required level of development.
Why choose BBI?
Cost effective solutions – Shorter time to market: Rapid development and scale up capabilities
Reliability and Performance – Proven technologies and quality processes delivering consistent, stable products, and maximum value and yield on raw materials
Choice and Flexibility – A fully integrated end to end service which can be delivered in whole or in part
Quality - A service from a company focused on quality and underpinned by stringent quality assurance procedures in compliance with ISO 9001:2008
A Safe Investment – Samples available at staged points and ‘go – no go’ decision points in place to minimise risk
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 small scale purification work conducted by the Research & Development team. 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 – This would typically involve an intermediate scale up of the process prior to full-scale manufacture. Our R&D 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 and Isoelectric focusing. We work closely with our customer in developing protocols to ensure optimized yields of the highest quality.
Validation - This is performed to establish that manufacturing/testing processes adopted by manufacture and testing of finished product can consistently produce product that meets end specifications.
Depending on our customers’ needs and the scale of production required, we will work with you to decide which of our facilities will best meet your requirements:
|BBI Solutions South Africa||BBI Solutions UK|
|Custom Development & Manufacturing||Custom Development & Manufacturing|
|ISO 9001:2008||ISO 9001:2008|
|High volume extraction capability||High purification capability|
|Equipment & process validation||Equipment & process validation|
|Medium/Large scale offering manufacturing flexibility||Small/Medium scale offering manufacturing flexibility|
|Optimised raw material selection & procedures – EDQM approved sources||Optimised raw material selection & procedures|
|ISO 8, Class 100,000 freeze dry facility|
BBI Solutions can offer the following through our purpose built laboratories in the UK and South Africa:
Specialists in sourcing and extraction of animal and plant products – We have extensive experience in sourcing raw materials worldwide to meet specifications tailored to our process requirements. Our batch sizes are from 50Kg up to 7ton per cycle. We have an Extraction capacity of up to 16000L, and offer downstream purification using custom specifications and/or proprietary methods.
Salt/solvent fractionation - Batch sizes of up to 5,000 litres.
Chromatography – Ion exchange chromatography up to 700 litres capacity, Affinity chromatography, Size exclusion chromatography, Hydrophobic interaction chromatography up to100L capacity.
Crystallisation – Highly effective protein purification using solvent and aqueous media.
Ultrafiltration – Volumes of 2,500 – 30,000 litres.
Freeze drying - Capacity of 48 – 420 litres per cycle, Automated shelf freeze driers, 2 x 60L and 3 x 100L capacity units.
Quality Control – In-process analysis & monitoring, Development of assay/test procedures e.g. enzyme activity, protein concentration, Microtitre based Kinetic assays, ELISA, HPLC, FPLC, SDS-PAGE & IEF analyses.
Qualified Staff - Speak to our highly experienced team of technical experts to determine your exact requirements.
Product Handling / Sampling - We offer special packing according to customer specification. Products delivered as per customer specification, (freeze dried powder, protein precipitate).
We also offer a Custom Protein Service, for the development and manufacture of individual proteins.