Teaming up for innovative solutions

How does a pharmaceutical leader like Bristol-Myers Squibb (BMS) deliver viable solutions to help meet the challenges of Alzheimer’s, diabetes, hepatitis, HIV/AIDS, cancer and many of society’s other clinical needs?

One way is by keeping pace with the highest standards of manufacturing technology to support its product development pipeline. Most recently, this was reinforced by a facilities redesign initiative to combine early and late phase cGMP clinical manufacturing and development scale-up at the company’s new Pharmaceutical Development Center of Excellence R&D site in New Brunswick, New Jersey.

As part of that evolution, BMS launched its Clinical Supplies Manufacturing and Drug Product Technology Expansion Project, earning it the 2008 ISPE, Interphex, Pharmaceutical Processing Facility of the Year Award (FOYA) for Equipment Innovation.

Dual–phased approach
The BMS team of corporate and third-party planning, design and construction specialists followed a phased approach to the project, with a goal of creating a flexible facility for multi-product clinical scale manufacturing and processing of solvent–based and potent compound products.

Under Phase I, a 93,000 square foot Clinical Supply Operations (CSO) facility was created to support three key manufacturing functions: a parenteral area equipped with an isolated vial filling line to satisfy sterility and containment requirements; a second zone dedicated to handling OSD products within Active Pharmaceutical Ingredients (API) bands one through four; and a third facility for OSD band five drugs.

In addition, to help ensure product integrity and operator safety, the facility supports full containment for expanded Oral Solid Dose (OSD) operations, incorporating what has been described as the most flexible continuous barrier line in the United States. The new CSO complex is capable of processing oral solid dose batches of up to 400 kilograms and parenteral liquid-fill batches of up to 250 liters.

Phase II of the BMS project called for approximately 39,000 square feet of expanded capabilities to supplement existing OSD operations, and housed a new stand-alone Product Technology Center (PTC) for product development and scale-up. Typical PTC batch sizes can range from 20 kilograms to 100 kilograms. This facility is also designed to handle API band one through four operations.

Expanded oral solid dose operations allow BMS to manufacture Long Term Stability batches to aid in product scale-up and technical transfer to commercial manufacturing sites with batch sizes at least one-tenth of commercial scale.

The Product Technology Center is the first clinical facility to utilize continuous process sterile isolators, representing a significant advancement in integrating technology into drug development.

Collaboration a key to success
The need to coordinate and manage multiple disciplines was a key element of the BMS expansion project. Flexible, adaptable design, critical construction scheduling and tight budget management were imperative to the project’s success.

To accomplish a project of this magnitude, BMS called upon unique process and facilities engineering and construction talent. For project design development, master planning, construction documentation and administrative services, the company turned to IPS Incorporated, Lafayette Hill, Pennsylvania, a leader in the design of pharmaceutical manufacturing facilities.

In addition to the Facility of the Year Award, BMS was recognized with federal and state government health and safety awards throughout the project. Included among these was the OSHA Voluntary Protection Program Star Demonstration Site award for outstanding safety and health management.

Enhanced speed–to–market is among the many benefits BMS expects to derive from its new facilities. But increased capacity and technical innovation will also help the company meet vital future pharmaceutical development and pipeline needs of medical service providers and patients worldwide.

Sustainable Design and Green Building Tips for Biotech and Pharmaceutical Projects

Sustainable design and green building are becoming major factors in project development. While sustainable design does not necessarily have to cost more, it does involve a bit of planning to ensure it adds value. Whether the request comes from a client, or is simply a practice you would like to implement in your projects, there are a range of steps that can be taken, from very small to very large, to contribute to sustainable design. Below are several tips to serve as a guide during the design/build stages of biotech and pharmaceutical projects to contribute to sustainability.

• Plan Early to Establish Green Goals for your Project.
  The earlier you decide to build green, the more opportunities there are to incorporate cost-efficient sustainable solutions into the design. Having a plan will guide the project team in making decisions and provide an easy way to achieve the company's environmental goals and budget.



• Utilize the LEED® Score Card as a Guide.
  Whether you choose to certify your project or not, utilize the USGBC LEED score card to help establish baseline sustainability goals. The LEED guidelines are a great brainstorming tool and will stimulate the innovation process.



• Utilize Life–Cycle–Costing to Establish “Go/No Go” Hurdle Rates for Sustainable Options.
  For many projects first cost is very important, but being sustainable isn’t about the short-term. It’s about taking a long-term or a life cycle view.



• Site Building for Optimum Energy Performance.
  Utilize the site orientation to take advantage of passive solar energy savings and natural day-lighting.



• Consider an Energy Star Roof.
  Utilize a light color (white) roof to reduce heat gain to the built environment. Dark roofs can be 60% hotter than lighter color roofs and impact the selection of HVAC equipment required to cool the structure.



• Utilize Low-E Glazed Windows.
  Utilize low-E (emissivity) glass. Many manufacturers offer high-performance glazing systems. This higher efficiency glazing reflects more heat and at the same time allows more light to enter the structure. This improves opportunities for natural lighting and ultimately reduces the solar heat gain.



• Optimize Lighting.
  Utilize compact fluorescent and LED lighting to reduce the heat out put and improved efficiency. Take advantage of daylight harvesting. Consider occupancy sensors, and dimming ballasts.



• Utilize High Efficiency Motors and Variable Frequency Drives (VFD’s).
  EPA Studies have shown that VFD’s can save as much as 50% when compared to systems without them.



• Utilize Waterless Urinals and Low-Flow Plumbing Fixtures.
  On average an employee uses approximately 10 gallons of water a day. Green plumbing systems can reduce this to 2.5 gallons a day.



• Specify Recycled Content.
  Many manufacturers utilize recycled materials to reduce overall cost of raw material. There are a wide variety of products available. Incorporate a minimum % of recycled material in product specifications.