Tech Transfer and Quality Rule at BMS Tech Ops, Ireland

Nov. 9, 2005
The secret to Bristol-Myers Squibb's success in the Emerald Isle, says VP and GM John Nason, has been clear work plans and a focus on quality compliance.
Ireland has become increasing dependent upon its burgeoning pharmaceutical industry. Pharmaceutical ingredients account for 40% of Ireland’s manufacturing exports, Michael Ahern, junior minister for Trade and Commerce, said recently at the Pharmaceutical Manufacturing Workshop in Dublin — an event sponsored by PharmaChem Ireland, in partnership with ISPE, PhRMA and the European Federation of Pharmaceutical Industries (EFPIA).It was fitting that the conference’s keynote address was delivered by John Nason, VP and GM of Bristol-Myers Squibb’s Technical Operations in Ireland. BMS was one of the earliest companies to sow the seeds of the Irish pharmaceutical manufacturing boom, locating there more than four decades ago. BMS provided an early template for expansion of the sector, and remains one of the key players in the Irish pharmaceutical industry. The company employs more than 600 people among two manufacturing plants in Dublin and a distribution center in the west of the country.Nason focused on the challenges of operating in times of growth and change. An FDA advisory committee has recently issued positive recommendations for (Orencia) abatacept for the treatment of rheumatoid arthritis and (Pargluva) muraglitazar for the treatment of diabetes. Besides RA and diabetes, BMS is expanding its HIV/AIDS, oncology, Alzheimer’s and obesity medications.


“With a pipeline of new developments planned in these fields, it is important for BMS to manage the development and realization of the technologies involved,” Nason says. “This includes the transfer of technology from an R&D setting to a manufacturing setting.“We have a development group that speaks directly to the manufacturing group, with support from cross-disciplinary technical teams to ensure that the transfer is smooth,” Nason adds. This is part of an integrated technology plan where teams are assigned to the various tasks associated with commercializing a new technology and given clear responsibilities and deadlines to meet to ensure that drugs reach production quickly.The clarity of responsibilities is important to eliminate ambiguity or finger pointing. According to Nason, there is no hiding within the BMS technical transfer model. A detailed plan is designed for each product and followed through until launch.After one year, the teams system is working well. “There is better collaboration and we have seen better execution,” says Nason. “It is in its infancy and there are definitely pressures on individuals to deliver, but I am pleased with what I have seen.”Whether bringing a new technology into production or simply continuing with an existing product, quality compliance is an area where BMS remains vigilant. European standards continue to rise, Nason notes, and BMS Ireland has introduced a GMP Work Plan to eliminate any compliance gaps that may be present.The plan assesses various BMS work stations or “sites” against protocols developed by a mix of internal and external quality assurance experts. Those experts kept a sharp focus on regulatory guidelines when developing the protocols so as to help keep them grounded in a commonly understood context.BMS has appointed 13 dedicated specialists to do the assessments. They review internal reports on how sites manage cleaning, processing, computer systems and test methods and compare those against the protocols to generate site-by-site reports with recommendations on how to better meet quality criteria.With those recommendations in hand, sites have concrete objectives in terms of improving or maintaining quality. Progress against these objectives is measured within a schedule of regular update reports.Manufacturing is, of course, the final link that makes a therapy available for patients and, as Nason says, “the rest (technology transfer and quality control) comes to nothing if we don’t deliver to patients.”BMS has a launch plan cascade that identifies every step needed on the way to product delivery. This includes quality compliance, regulator communication, product-specific reviews and even gets down to simple factors such as factory equipment and warehouse space. The aim is to have production capacity ready the day a therapy becomes licensed.So-called network alignment is imperative. “We look at our network and ensure we have the facilities in place to support manufacture,” Nason says. “This could include the capacity to have lower cooling, for example. We need to have everything ready to go from start to finish, and that includes having contingency plans in place to account for any obstacles.”“The ultimate goal of this philosophy is to bring launch time down to as low as possible,” Nason says.BMS’ complex system of technology, quality compliance and manufacturing management is evidence that not only is the modern goal to meet regulatory requirements, but it is to meet them within a framework that optimizes quality and speeds delivery of medication to patients.
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Robert Love | Contributor