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LIFE SCIENCES: Research & Development / Manufacturing & Process

Our Life Sciences clients have seen their Industry and organizations evolve dramatically over the last decade or so. Right now, they find themselves in an extremely volatile period with increased pressure on financial performance as a result of increased regulatory scrutiny and lawsuits based on alleged product deficiencies, particularly within “Big Pharma”. Increased mergers and acquisitions by Big Pharma of Biotech-oriented companies, point out where the future of the industry might be: from the traditional molecular research and development to that using the living cell. The facility needs have changed also, and the design and construction of the newer facilities reflects this shift to cell based processes.

The trends appear to center around the following areas:

  • Biosafety research/development as a result of 9/11
    • Biotech and potential stem cell work
    • Diagnostics of germs and diseases
    • Vaccines and their uninterrupted supply
    • Nutritionals and food supplements as a result of the nation’s obesity problems
    • Universities are expanding their research and in some cases adding production
    • Commercial developers who are establishing incubator and research parks*

This plays into the strength of EI Associates. Located in the heart of the eastern US BioPharm Industry, EI has developed significant expertise in the design and construction of these cGXP facilities. Whether the facility houses research & development, pilot operations, bulk actives, OSD, parenterals/vaccines, packaging and finishing, warehousing, office/support or amenities operations, our staff has the experience to work with you to develop cost effective solutions that work.

*Information contained in IIR 2005 Life Science Industry report
Research & Development

Pipeline!! It’s what all the analysts and employees involved with the Life Science Industry is focused. What’s currently in R&D that will soon fill the Pipeline?

To get a product to the market is a long (in many cases up to 10 years) and expensive (Industry reports put the cost at $800 million +/-) proposition. New dramatic breakthroughs are thought to be in the newer cell-based applications, as the Industry as a whole is taking heat for the development of “duplicative drugs” that primarily tweak existing formulations enough to warrant a new patent.

Research & development laboratories are expensive to design and construct, with costs for BSL4 facilities exceeding $800 per square foot. Single disciplinary labs remain fairly common in the BioPharma world, because of the nature of their research. In the academic and consumer product sectors, though, multi-disciplinary labs are the order of the day. For almost all of the research being done, though, encouraging multiple research teams to interact is creating facilities that house several departments under one roof.

William VanWyk, AIA, CID
Senior Project Manager

For the last 30+ years, EI Associates has been planning, designing and constructing a wide variety of R&D facilities for Industry and Academia. These include:

  • Microbiology
  • Toxicology
  • Vivarium
  • Tissue Culture
  • Genetic Engineering
  • Organic Synthesis
  • Chemistry
  • Biology
  • Instrumentation/Analytical
  • Pilot
  • Formulation
A few of our success stories follow below.
Altana Inc. Bayer Healthcare Pharmaceuticals Berlex Laboratories Chanel, Inc. Colgate-Palmolive Company Actavis
TEVA Pharmaceuticals Vivus, Inc. Ohm Laboratories
Manufacturing & Process

Our clients within the Life Sciences Industry find themselves in a volatile situation in respect to their manufacturing facilities. As their pipeline products move closer to final FDA approval, they must plan ahead for the necessary production capacity, which could be as simple as reworking an existing line or as complex as designing and building a new facility.

Questions of where to locate the production facility are not so easy, due to substantial tax benefits of producing product in either Puerto Rico, Ireland or Singapore, or the next developing tax friendly country.

Also, new product development and emerging technology continue to strongly impact capital investment in existing and new facilities. Among these issues are:

  • Vaccine manufacturing
  • PAT (Process Analytical Technology)
  • Parenterals
  • High-potency Compounds
  • Pre-filled Syringes
  • S88 (control logic for batch processes)
  • Modular Construction
  • RFID

Depending upon the degree that any or all of these are incorporated into the production process, our clients have difficult decisions to make regarding the need for renovations, upgrades and new facilities. These critical projects demand teams with proven track records in developing successful solutions that fit those specific needs, which EI has been providing to our BioPharma manufacturing/process clients for over 60 years. A few of those success stories follow below.

Tarik M. Abdala, P.E.
Senior Project Manager
Hoffmann-La Roche, Inc. Musculoskeletal Transplant Foundation Novartis TEVA Pharmaceuticals VI Technologies