Source: PTSM: Pharmaceutical Technology Sourcing and Management
Issue 4,Volume 3
A roundup of manufacturing and service expansions for April 2007.
A roundup of manufacturing and service expansions.
Basel, Switzerland (Apr. 26)–Roche ( www.roche.com) outlined its production strategy for "Tamiflu" (oseltamivir) for treating the H5N1 avian influenza virus. Roche's manufacturing network for Tamiflu production includes eight Roche sites and 19 external manufacturing partners located in nine countries.
William M. Burns, CEO, Division Roche Pharma, outlined the company's current production plan."The manufacturing expansion went according to plan and Roche, together with external partners, now has the ability to produce more than 400 million courses of Tamiflu a year," he said in a company release. "To date, we have had orders from governments amounting to about 215 million treatments in total. Today, we can satisfy significant additional orders from governments and corporations and unless the demand picks up, Roche will be tailoring its production schedule accordingly. These measures include maintaining a buffer stock at all times while remaining in close contact with our manufacturing partners to respond speedily to a surge in demand."
Based on current government orders, Roche says it will start tailoring the Tamiflu production schedule while maintaining stock of intermediates and active pharmaceutical ingredients (APIs) along the supply chain. It said gearing production up to full capacity will be triggered by one of two events: (1) Roche inventories of oseltamivir, the API in Tamiflu, drop below target levels or (2) the World Health Organization (WHO) declares the pandemic has evolved to phase 4 (human-to-human transmission).
Spring House, PA (Apr. 19)–Johnson & Johnson Pharmaceutical Research & Development, LLC, part of Johnson and Johnson (New Brunswick, NJ, www.jnj.com), started construction of a new building on its Spring House, Pennsylvania, campus, that will add approximately 150,000 square feet in new laboratory, clinical development and office space to its existing facilities. The site will become Johnson & Johnson Pharmaceutical Research & Development's East Coast hub for discovery research and early clinical development upon its completion in 2009. Under the plan, Johnson & Johnson Pharmaceutical Research & Development, LLC, will retain 680 existing jobs at the site and expects to add another 120 jobs over the next three years.
Basel, Switzerland (Apr. 19)–Lonza announced plans for the groundbreaking of its expansion at its Portsmouth, New Hampshire mammalian biopharmaceutical manufacturing facility. The company will break ground for the 330,000-ft2 facility on May 17, 2007. Lonza is investing roughly $300 million for the project. The Portsmouth site is the company's largest scale mammalian cell culture plant commissioned to date by Lonza with total suite capacity of 93,000 L. Lonza is adding a 5,000-L bioreactor to the existing facility that is expected to come on stream in mid-2008.
Bloomington, India (Apr. 18)–BioConvergence LLC (www.bioconvergencellc.com), a provider of parenteral product development, CGMP materials management, and consulting services, is adding 20,000 ft2 to its existing 50,000 ft2 facility to accommodate growing demand, particularly in its CGMP materials management business unit. The expansion also adds 15 employees to its existing base of 21 full-time employees and includes a multi-million dollar investment in facilities and equipment.
Lafayette Hill, PA (Apr. 16)–Integrated Project Services (IPS, www.ipsdb.com) has opened two new offices, in Hyderabad and New Delhi, India. The offices offer access to a team of experts providing services such as drug development, technical consulting, facility design, process engineering, commissioning, and validation.
Barceloneta, PR (Apr. 10)–Abbott (www.abbott.com) officially opened Abbott Biotechnology Limited (ABL), its new biologics-manufacturing facility in Puerto Rico. The 330,000-ft2 facility will produce "Humira," Abbott's biologic agent for the treatment of arthritis and Crohn's disease. ABL received US Food and Drug Administration approval to commercially produce Humira for the US market in February 2007.
Thousand Oaks, CA (Apr. 3)–Amgen, Inc. (www.amgen.com) has provided a new schedule for the completion of a new manufacturing facility in County Cork, Ireland.
In 2006, Amgen announced plans to invest more than $1 billion in new process development, bulk protein production, and fill-and-finish facilities, with an initial target of beginning operations in the 2010 timeframe.
An Amgen official explained the company has outlined a revised schedule for starting operations based on a recently conducted periodic review of its manufacturing facilities. The bulk manufacturing capacity is scheduled to be operational in 2012, with regulatory licensure of the facility anticipated for 2013. The process development laboratories will be constructed in conjunction with the bulk facility or as needed to support start-up of the manufacturing capacity. The fill-and-finish capacity is scheduled to be operational by 2013, with regulatory licensure anticipated by 2014. Once fully operational, the site is expected to staff 1,100.
Wilmington, NC (Apr. 3)–AAI Pharma, Inc. (www.aaipharma.com) completed upgrades to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina. The upgrades were done to increase capacity and ensure that both facilities comply with European Union aseptic processing and testing guidelines.
Princeton, NJ (Mar. 28)–Laureate Pharma (www.laureatepharma.com) opened its new pilot plant in Princeton, NJ. The plant is designed for process development and production and purification of early-phase preclinical proteins.
London (Mar. 29)–GlaxoSmithKline (GSK, www.gsk.com) plans to invest EUR 250 million ($334 million) in its production site at Currabinny, Ireland over the next five years, according to a release issued by the Irish Development Agency (IDA Ireland, Dublin, www.idaireland.com).
The investment will support production for lapatinib, the active ingredient in GSK's "Tykerb," a new oral treatment for advanced breast cancer. In March 2007, the US Food and Drug Administration (Rockville, MD, www.fda.gov) approved Tykerb in combination with "Xeloda" (capecitabine), an anticancer treatment from Roche (Basel, Switzerland, www.roche.com), for treating advanced or metastatic breast cancer.
GSK Cork is a strategic global new product introduction site within GSK that manufactures the active ingredients of medicinal compounds. The Currabinny site was established in 1975 and employs more than 600 people. The new investment will create as many as 150 new high-level positions, according to IDA Ireland, an Irish government agency responsible for securing new investment from overseas in the manufacturing and internationally traded services sectors.
Singapore (Mar. 29)–The contract manufacturing organization Lonza Group (Basel, Switzerland, www.lonza.com) and Bio*One Capital (Singapore, www.bio1capital.com) broke ground for their large-scale commercial mammalian cell-culture manufacturing facility at Tuas Biomedical Park in Singapore. Bio*One Capital, the investment arm of the Singapore Economic Development Board (www.edg.gov.sg), is a biomedical sciences investment-fund management company. The facility will be Lonza's second large-scale mammalian manufacturing plant in Singapore and the third one globally that the company has built.
The construction of the first shell of Lonza Biologics Tuas was initiated in February 2007. The final build-out of the facility will be completed and become fully operational at the latest in 2011, in line with custom commitments, said Lonza in a company release.
The capital investment could amount to $350 million depending upon customer requests. Lonza Biologics Tuas Pte Ltd. will have up to four mammalian bioreactor trains, each with a flexible capacity of 1000-20,000 L, inclusive of purification units.