Pharmaceutical Manufacturing Facilities Rapidly Becoming Obsolete
Posted: 10/21/2013 12:00:00 AM EDT
Jones Lang LaSalle reports the key considerations for transforming existing facilities to meet the rising demand for biologic medicines
Traditional pharmaceutical manufacturing facilities are being driven into dinosaur status as demand grows for biologic and biosimilar production. A new report from Jones Lang LaSalle offers key considerations for re-equipping facilities originally built for traditional chemical medicine production — a process that is anything but minor.
“Facilities staff with expertise in chemical labs may be surprised at the additional challenges of working in biologics facilities,” said Roger Humphrey, Executive Managing Director and head of the Life Sciences group at Jones Lang LaSalle. “As life science companies seek to expand into biologics and biosimilars, they will either need to re-train and certify support staff, or look to third-party facility management firms with successful track records of running these facilities.”
Demand for Biologics Means Demand for New Facilities
Development of biologics is big business, and getting bigger, with much of growth coming from demand for follow-on biologics—biosimilars and biobetters. A report from BCC Research values the market for biologics at about $162 billion in 2012 and estimates that sales volume would increase to $252 billion in 2017, representing a compound annual growth rate (CAGR) of 9 percent over five years.
In the past few months, several major biopharma companies have announced their intentions to build new biologic production facilities, typically costing $250 million or more. Some are building brand-new facilities on the sites of pharmaceutical facilities that are no longer needed because the patent expired on the name-brand drug that was manufactured there.
Facilities’ Critical Role in Regulatory Compliance and Consistent Production
Regulatory scrutiny of facilities practices is even more stringent in the realm of biologics than it is for chemical-based pharmaceuticals. Quality may vary greatly from batch to batch, and is directly related of the characteristics of the source materials, which must be appropriately stored. Facility and regulatory requirements are just as complex for biosimilars as for the biologics they seek to emulate, since a biosimilar may be based on an entirely different process and different kind of living tissue than the prior product.
Facility designs must be reviewed before a biologics program can be certified, and inspections may occur at any time to ensure that safety-related procedures are followed. Biologic biosimilar facility design reviews and compliance audits cover a range of facilities management activities, including the following:
1. Air filtration. Biologics facilities often require much higher air changes than other types of life sciences facilities, typically more than 20 per hour with no recirculation of air.
2. Air quality. Environmental monitoring is required to ensure that particulate counts remain within acceptable parameters.
3. Cleaning regimens. Floors, counters and other surfaces must be sterilized more frequently in biologics facilities than in many chemical labs, and multiple disinfectants must be used in rotation to prevent potentially dangerous organisms from developing a resistance to the cleaning solution.
4. Gowning areas. Facilities must have separate rooms or passages for “clean” entry and “dirty” exits from lab areas, and gowns must be removed and exchanged when going from one classification of space to another.
5. Temperature control. Maintaining a consistent temperature is important in any life sciences manufacturing facility or lab, but is even more vital when dealing with cells, tissue and other organisms.
6. Training. One of the most-common safety breaches found by inspectors is workers who are not properly trained and certified to work in biologics environments. This issue can disproportionately impact cleaning and maintenance staff, where turnover is likely to be higher than among scientists.
7. Waste handling. Some types of waste and consumables must be autoclaved before removal from the site. Sinks for liquid waste much have capped drains, and effluvient waste is subject to chemical kill before discharge.
Jones Lang LaSalle has a team of real estate and facility management experts dedicated to helping life sciences companies optimize and manage their real estate portfolios. The firm provides a comprehensive range of facilities management services to the life sciences community covering 70 million square feet of research, manufacturing and commercial space. Jones Lang LaSalle’s industry-leading full-service platform includes: integrated facilities management, engineering and operations, energy and sustainability, transaction advisory services, lease administration, project management and a new platform for integrating laboratory services, Labwell.
A leader in the real estate outsourcing field, JLL’s Corporate Solutions business helps corporations improve productivity in the cost, efficiency and performance of their national, regional or global real estate portfolios by creating outsourcing partnerships to manage and execute a range of corporate real estate services. This service delivery capability helps corporations improve business performance, particularly as companies turn to the outsourcing of their real estate activity as a way to manage expenses and enhance profitability.
For more news, videos and research resources on Jones Lang LaSalle, please visit the firm’s U.S. media center webpage. Bookmark it here: http://bit.ly/18P2tkv.
About Jones Lang LaSalle
Jones Lang LaSalle (NYSE:JLL) is a professional services and investment management firm offering specialized real estate services to clients seeking increased value by owning, occupying and investing in real estate. With annual revenue of $3.9 billion, Jones Lang LaSalle operates in 70 countries from more than 1,000 locations worldwide. On behalf of its clients, the firm provides management and real estate outsourcing services to a property portfolio of 2.6 billion square feet and completed $63 billion in sales, acquisitions and finance transactions in 2012. Its investment management business, LaSalle Investment Management, has $46.3 billion of real estate assets under management. For further information, visit www.jll.com.
How Does an Ingredient in Sour Candy Become a Blockbuster?
Herbal ‘Medicines’ Skimping on the Herbs?
EMA Delay Clinical Transparency
Global Medicine Spending to Pass $1 Trillion in 2014
The Key to Business Success: Do Things Differently
Clinicaltrials.gov Shutdown Reveals Importance of IT to Modern Medicine
Drug Quality and Security Act- New US Legislation for Pharma Tracking
Shutdown Lowdown: What Does a Government Shutdown Mean for Pharma?
4 Key Criteria to Consider when Outsourcing Safety Operations in Life Sciences Facilities
Stem Cells; the Future of Drug Development?
18th Software Design for Medical Devices
October 27- 28, 2014
Pharmaceutical Serialisation and Traceability
The Mövenpick Hotel & Casino , Geneva, Switzerland
November 4- 6, 2014
5th Annual Pharmacovigilance Asia Summit
Grand Copthorne Waterfront Hotel, Singapore
November 25- 27, 2014
How do You Maintain a Low Risk Global Supply of Drug Delivery Products in an Ever Changing and Uncertain World?
September 16, 2014
Global Pharmaceutical Serialisation and Track & Trace Open House
March 18, 2014