Bio Products Laboratory is continually improving its plasma-derived products – helping to save thousands of lives in the UK and across the world. Production director Keith Prout talked to Bernie Sheehan
E very year, large quantities of plasma-derived products are used in the NHS. Around 5,000kg of albumin is needed to restore the fluid balance of burns or shock victims, 2,000kg of intravenous immunoglobulin is required for patients with immune disorders, and nearly half a million vials of blood-clotting products are used for haemophilia patients.
Many of these products are supplied by Bio Products Laboratory (BPL), the UK’s biggest supplier of life-saving plasma-derived products. BPL is a not-for-profit organisation, operating within the NHS and reporting to the Department of Health. As well as supplying the NHS, BPL also exports approximately 20 per cent of its output to over 30 international markets including South America and the Middle East.
“Our only starting material is human plasma,” explained Keith Prout, production director. “We obtain it from the US, where it’s collected, tested, frozen and transported to the UK. We normally process the plasma in batches of 6.2 tonnes per week. It’s a highly regulated business, the key objective being patient safety.”
BPL’s three main product groups are based on plasma proteins: albumin, clotting factors and immunoglobulin. “We also manufacture specific immunoglobulin products derived from hyper-immune plasma – from special donor pools offering specific antibodies. These specific immunoglobulin products are used to provide immediate antibody protection, for example, Anti-D is used to protect against Rhesus Factor problems in some pregnant women.”
The manufacturing process has four stages. First the plasma is thawed and stripped to produce the intermediates for the three main product groups. These intermediates are then purified and formulated using processes such as chromatography and ultra-filtration methods to produce bulk solutions. From here the products are sterile-filtered and aseptically filled into bottles and vials. Some products, such as
clotting factors, are freeze-dried at this stage. Finally, the products are packed and labelled. “Sterility and viral security are essential throughout the manufacturing process,” continued Prout. “We have a number of safety features, from the donor stage (all US plasma donors are registered and tested) through to the final product. We use techniques such as solvent detergent, virus filtration and heat treatments.” Samples throughout the manufacturing process are checked in BPL’s quality control laboratories, and finished product samples are also tested by NIBSC (National Institute for Biological Standards and Control) prior to release at BPL by a qualified person.”
The firm is based at a 30-acre site in Elstree, Hertfordshire, where it employs 425 people. An annual capital spend of £5-6 million includes regular upgrades to the facility, machinery and utilities. It has recently invested £1.6 million in a computer system to control the fractionation process and, as part of a four-year phased project, in the upgrading of the water-for-injection and purified water systems to maintain compliance with national and international Pharmacopoeia standards.
Fortunately, BPL has had a headstart in the area of lean manufacturing. “About 12 to 15 years ago we had a TQM programme which exposed the organisation to quality principles, lean tools and techniques, and we’ve embedded these in the organisation over time,” said Prout. “We’re now bringing ourselves up to date. We’re using different techniques in different areas where they benefit the business most.”
For BPL the prime objective is patient safety, and to achieve that it has to produce safe, quality products. It wants to increase productivity using lean, but not at the expense of compliance with the relevant legislation. The company recently brought in Stroud & Co management consultants to help it carry out a broad assessment of its manufacturing, quality control and support areas. “Then we did detailed assessments of key areas to see if we could unblock bottlenecks,” said Prout. “Process control is at the heart of lean manufacturing, and our process variation was too wide. By reviewing our equipment capacity and utilisation plans, we have significantly tightened our process control and process variation.”
Getting the right balance of skills is essential in a market/product-led company such as BPL. “About five years ago, it became clear that we had a disproportionately high number of home-grown people and lacked some of the academic skills the business needed,” explained Prout. “To address this, we targeted recruitment of science graduates at the technician level and we now have a far better skills balance.
“For college leavers, their interview is often the first time they come across industrial applications of science. We provide in-depth training for graduates to provide the transition from bench-top technology to industrial-scale technology. Using a specialist agency has expedited the recruitment process,” he added.
Wherever possible, BPL tries to develop and promote people from within the company. “We are preparing a training plan to better prepare people for promotion – for example from a technician to a manager. This will enable people to fully understand the skills they need to develop in their new role and maximise their development potential,” he explained.
Going forward, Prout emphasises the need to continue increasing lean manufacturing ability to improve yields, capacity, quality and product safety. He also believes developing BPL’s people is key. “It can make or break an organisation. We need to develop the right skills to meet business needs. The Government is saying it and we’re seeing it more and more in the marketplace.”