Philanthropist and entrepreneur Paul G. Allen announced a commitment of $100 million to create the Allen Institute for Cell Science in Seattle. Founded to investigate and model the complex living machinery of cells, the nonprofit Allen Institute for Cell Science and its inaugural project, the Allen Cell Observatory, will accelerate disease research around the world by creating and sharing reagents, data and dynamic, predictive models of cells.

“Cells are the fundamental units of life, with every disease we know of affecting particular types of cells,” said Allen. “Scientists have learned a great deal about many of the 50 trillion cells in our bodies over the last decades, but creating a comprehensive, predictive model of the cell will require a different approach. We conceived of the Allen Institute for Cell Science as a catalyzing force to integrate technologies and approaches at a large scale in order to provide an exceptional resource for the entire scientific community. It is our hope that this effort will bring forward the treatment of different diseases.”

The Allen Institute for Cell Science will take a multidisciplinary, team science-driven approach to understanding a fundamental and yet elusive question in cell science: How does information encoded in our genes become three-dimensional living cells, and what goes wrong in disease? The inaugural project, called the Allen Cell Observatory, will produce a dynamic, visual database and animated models of cell parts in action that integrate information from across the cellular and molecular sciences.

Rick Horwitz will serve as the Executive Director of the Allen Institute for Cell Science. He served for 10 years as the Director of the Cell Migration Consortium, an NIH-funded multi-institutional, multi-disciplinary collaboration for studying cell migration, and spent the past 15 years in the Department of Cell Biology, as a Harrison Distinguished Professor and University Professor, at the University of Virginia, School of Medicine, where his lab investigated the mechanisms of cell migration and dendritic spine morphogenesis.

“Generating an integrated view of the cell with predictive power is an enormous task, and the Allen Institute for Cell Science will have the advantage of housing its large-scale efforts all under one roof,” said Horwitz. “This singular effort will make the integration of technology, models and data both more straightforward and more powerful.”

“The outcome of the Allen Cell Observatory will enable researchers to make predictions about cell behaviors, accelerating the fields of cell biology and biomedical research,” said Allan Jones, CEO of the Allen Institute for Brain Science.

The Allen Institute for Cell Science will focus its efforts on human cells in order to maximize future translation into disease research. The inaugural project will study the transition of induced pluripotent stem cells into heart muscle and epithelial cells, creating computational models of the cells’ behavior as the first part of the larger visual database.

"As we have learned more about the enormous complexity of cell chemistry in recent years, it has become clear that we will need both new types of data and new computational tools to understand even the simplest living cells,” said Bruce Alberts, prominent cell scientist at the University of California, San Francisco, National Medal of Science recipient and an advisor to the Allen Institute for Cell Science. “It is great news that the world's vigorous community of cell biologists and biochemists will have this important new resource to integrate information and facilitate discoveries."

By making its data, models and tools publicly available online, the Allen Institute for Cell Science hopes to lead the charge of open science in the cell science community.

“We plan to engage the global cell science community in developing and executing our projects,” said Horwitz. “And by openly sharing our data, reagents, databases and models, we will leverage and empower research by our colleagues around the world. I am thrilled to be at the helm of this exciting and challenging endeavor.”

The Allen Institute for Cell Science will be housed in the new Allen Institute building located in Seattle’s South Lake Union neighborhood. The seven-story, 270,000 square foot building, currently under construction, will also be occupied by the Allen Institute for Brain Science. The building is scheduled for completion in the fall of 2015.

Ferring Expands U.S. Ops

Ferring Pharmaceuticals has opened its new U.S. Operations Center in Parsippany, NJ. The facility recently completed the integration of staff into the new manufacturing suite and product development labs, which will house 275 employees across management, administration, commercial operations, manufacturing and R&D. Ferring plans to add more staff as the manufacturing facility comes online over the course of the next 18 to 24 months.

"This is just the start of an exciting journey of growth to come," said Michel Pettigrew, chief executive officer, Ferring Holding Inc. and president of the executive board and chief operating officer, Ferring Group. "We hope this new operations center stands as a symbol of our philosophy as a company – a place where our commitment to the science and to our patients is front and center; a learning environment where employees are encouraged to take initiative and stretch beyond their designated role; and a cornerstone of the community, dedicated to giving back."

"This grand opening serves as a reminder of our commitment to the U.S., NJ and to our long-term view on the science that can make a real difference in the lives of the patients we serve," said Aaron Graff, president and chief operating officer Ferring Pharmaceuticals. "As I watch our teams start to integrate into the new operations center, I already see the positive impact the space has on our ability to collaborate across functions within the organization and provide a premium workspace for our employees."

Peregrine Expanding CMO

Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.

Peregrine revealed plans to expand its subsidiary contract manufacturing business, Avid Bioservices, by more than doubling its capacity in Tustin, California.

Despite contract manufacturing revenue for the quarter being down 14% on the same period last year to $6.3m (€5.1m), CFO Paul Lytle told stakeholders the firm was experiencing increased demand for its mammalian cell culture services and needed extra capacity.

However, the decision to expand the site is also driven by the potential launch of Peregrine’s lead product bavituximab, a chimeric mAb bavituximab, currently in Phase III trials to treat patients with non-squamous non-small cell lung cancer.

“We are now at a time where we have anticipated manufacturing needs and exceed our current available capacity,” he explained on the call (transcript here ), and following a price analysis to compare the cost of adding new internal manufacturing capacity versus the cost of outsourcing bavituximab, the firm chose the former.

“The cost of outsourcing our manufacturing need is fairly equivalent to the cost of building this facility,” he said, but the expansion has the “tremendous upside from the manufacturing side of our business and also the upside of controlling our manufacturing destiny.”

Single-Use at a fraction of the price

Peregrine has so far spent about $2m in relation to the new facility and while not revealing how much the total project would cost, Lytle said the site will benefit from “more efficient and cost effective disposable technology,” reducing the utility costs associated with traditional biomanufacturing.

“It is also important to note that the cost of building and manufacturing a clean room that utilizes disposable one-time use technology is a small fraction of traditional facilities,” he added. Once complete, the new facility will include multiple single-use bioreactors with a range of up to 2,000L.

Clinical volumes of bavituximab are currently being made in Avid’s existing facility in both stainless steel and single-use bioreactors.

For the three months ending October 31, Peregrine reported a net loss of $12.1m, up 55% year-on-year.

Agilent, Baylor Open Mass Spec Center of Excellence in Waco Texas

Agilent Technologies Inc. and Baylor College of Medicine, both known for their expertise in metabolomics, are working together to advance research and training in this vital branch of the life sciences.

To that end, Agilent and Baylor have opened the Agilent Technologies Mass Spectrometry Center of Excellence as part of the Alkek Center for Molecular Discovery and the Baylor College of Medicine Core Laboratory in the college's department of molecular and cellular biology.

"Our collaborative relationship with Baylor and our shared investment in this new center will foster development of advanced research tools and new applications in metabolomics and integrated biology," said Carl Raimond, Agilent vice president of Sales and Field Operations, Americas Life Sciences. Dr. Bert O'Malley, director of the Alkek Center for Molecular Discovery at Baylor, said, "This decision by Agilent will be a major addition to the Alkek Center in the area of metabolomics and will greatly aid our metabolic R&D and service capabilities for the Texas Medical Center."

"The growing significance of metabolomics, not only in life science research but in many application spaces, has resulted in the need for more analytical capabilities," said Dr. Arun Sreekumar, co-director of the Alkek Center. "Baylor and Agilent have identified several areas of mutual interest-metabolomics, lipidomics, clinical research, disease research-where we believe we can make real progress together."

Agilent is equipping the new center with two systems configured for metabolomics: an Agilent 6495 triple quadrupole LC/MS system and an Agilent 6550 iFunnel quadrupole time-of-flight LC/MS system with a switchable GC APCI interface. The systems include Mass Hunter software for qualitative and quantitative analysis as well as Mass Profiler Professional with Pathway Architect for bioinformatics and integrated multi-omic analysis.

Baylor and Agilent will use the equipment collaboratively to analyze samples, conduct research and train students. Both parties have enjoyed a long-standing scientific relationship, which has resulted in several published application breakthroughs in cancer metabolomics

Orchid Orthopedic Solutions Alabama Expands in Tennessee

Orchid Orthopedic Solutions Alabama LLC is expanding its manufacturing operations in Jackson, Tenn. The company, which provides contract design and manufacturing services for orthopedic, cardiovascular and dental implants, will invest $2.1 million and create 35 new jobs in Madison County.

Orchid established operations in Jackson in April this year. Due to increased product demand, the company will purchase additional equipment to increase manufacturing capacity and capabilities, and add to its existing workforce in order to meet the demand.

Orchid Alabama is a subsidiary of Orchid Orthopedic Solutions, a Holt, Michigan-based contract manufacturing organization.

Noxilizer Expands Contract Sterilization Operations

Noxilizer, a US specialist in room-temperature, nitrogen dioxide (NO2) based sterilization for life science manufacturers, has expanded its contract sterilization operations following growing customer demand and increased industry acceptance of the company’s NO2 sterilization method.

‘Manufacturers have quickly recognized the advantages of NO2. This expansion was mandated by a significant increase in customer feasibility studies alongside contract sterilization work,’ said Maura Kahn, Vice President, Business Development & Marketing at the Baltimore-based company.

NO₂ sterilization is gaining recognition as an alternative for pressure and temperature-sensitive products. This expansion was mandated by a significant increase in customer feasibility studies alongside contract sterilization work The company says NO₂ is safe and simple to use. It sterilizes with or without a vacuum and is effective at low humidity levels. In addition, the company says its contract sterilization services may provide cost savings to manufacturers with a fast turnaround of product. Cycle times are notably shorter, as lengthy preconditioning and post-exposure aeration phases of the cycle are eliminated with NO₂. In addition, packaged sterile product can be handled immediately after the cycle, allowing it to be returned to inventory quickly.

Noxilizer’s 16,000 sq. ft. facility, located within the University of Maryland BioPark, includes office, laboratory, manufacturing and contract sterilization space. The company offers a full range of services: testing, validation, cycle development and sterilization of medical devices.

Noxilizer performs sterilization of medical devices under ISO 14937:2009. Its sterilization operations comply with the U.S. FDA Quality System Regulation (21CFR820) and conform to ISO 13485:2003 for regulatory purposes.

Cirrus Pharmaceuticals to Invest in cGMP Manufacturing Suite in US

Cirrus Pharmaceuticals has announced it will be investing in a flexible current good manufacturing practice (cGMP) suite in its facility in Research Triangle Park (RTP), North Carolina.

Kemwell president of R&D Ninad Deshpanday said: "We will offer our clients cGMP manufacturing services for many dosage forms including inhalation, liquids, topicals and oral solids.

"We have completed the design phase and expect the suite to be ready to service customers by April 2015."

Kemwell's R&D division employs more than 175 scientists worldwide and provides services including formulation development, analytical development and validation to clinical trial manufacturing.

The team has experience working on early stage development programs for National Center for Education Statistics (NCEs), Abbreviated New Drug Applications (ANDAs), 505(b)(2) and product life cycle management projects for various customers worldwide, including virtual, small and big pharmaceuticals.

With the addition of the cGMP suite, Cirrus will extend its offerings in the US from contract development to manufacturing.

AstraZeneca to Expand Its Frederick Biologics Manufacturing Center

AstraZeneca announced plans to expand its biologics manufacturing center in Frederick, Md. The more than $200 million project will increase production capacity at the facility to support AstraZeneca’s maturing pipeline, and will help position the company to keep pace with a growing demand for the development and use of biologics, which currently represent nearly 50% of AstraZeneca’s overall pipeline.

“Biologics are an important part of AstraZeneca’s overall capabilities, in addition to our strengths in small molecules and protein engineering,” said Andrew D. Skibo, regional vice president of biologics supply for AstraZeneca. “Our global biologics research and development arm, MedImmune, has a robust pipeline of more than 120 biologics, including more than 30 in clinical development. The expansion of our Frederick facility will support the progression of drug candidates across our core therapeutic areas, ultimately aiding us in our efforts to make a meaningful difference in the lives of patients through scientific leadership and innovative new treatments.”

AstraZeneca’s Frederick biologics manufacturing center is an FDA licensed, large-scale cell culture production facility, with hundreds of thousands of square feet of administrative, production, warehouse, laboratory and utility space. The expansion project, which is anticipated to begin in December and expected to be complete in mid-2017, will add approximately 40,000 additional square feet of manufacturing, laboratory and administrative space. The expansion is also expected to bring a total of 300 new jobs to the site.

AstraZeneca’s Frederick manufacturing center is the largest biologics manufacturing facility within the company’s global network and portfolio of assets, and a worldwide industry leader in cell culture manufacturing. The site currently produces a pediatric medication, as well as other investigational biologic products.

The commercial cell culture production facility was last expanded in 2006 by MedImmune – since acquired for $15.6bn and incorporated as the global biologics research and development arm of AstraZeneca – when $250m was invested adding two commercial stainless steel bioreactors to, in part, increase volumes of childhood respiratory drug Synagis (palivizumab).

Along with Frederick, AstraZeneca has biologics capabilities in Philadelphia (Pennsylvania), Speke (UK), and Nijmegen in the Netherlands.

Jackson Laboratory Optimizing Lab Design

The Jackson Laboratory (JAX), based in Bar Harbor, Maine, operates at the forefront of genomic research. Tsoi/Kobus & Associates (TK&A)’s challenge as co-designer of The Jackson Laboratory for Genomic Medicine (JAX GM) in Farmington, Conn., was to ensure that the research environment can respond quickly to shifts in research focus that are necessary to support these advances in personalized medicine.

"The JAX GM is a cornerstone of the State of Connecticut's Bioscience initiative, to become a global leader in personalized medicine. The location and design of this building were carefully considered to symbolize JAX's fundamental role in this public-private partnership," says Jim Childress, FAIA, Partner at Centerbrook Architects. Located at the front door of the Univ. of Connecticut Health Center, Childress notes that "even the exterior of the lab was designed to be distinct, to illustrate the global reach of the world-class research done inside. The place is special."

The new facility represents JAX’s commitment to human genomic research, expanding on the organization’s historical business and research emphasis on the mouse as a model for investigating human disease. Because of this new investigation shift, the majority of the institution’s key researchers and principal investigators (PIs) would be recruited after the design for the building had been completed. This unknown user group with an evolving research focus became a crucial focal point of the design process, as well as JAX GM’s value proposition.

JAX’s vision for successful research endeavors is “fail fast, fail cheap”. This mantra suggests a heavy focus on dry, or computational science, as an integral partner to traditional wet bench science. This became the basis for assuming a 50/50 wet-to-dry ratio of PI programs for the lab. Initial expectations of 30 total PIs were increased to 34 at the start of construction. Yu-Hui Rogers, site director at JAX GM and member of the Human Genome Project research group, notes that classifying researchers as “wet” or “dry” is already outdated. “Most scientists today perform both types of research and some have heavier focuses on one area over the other,” says Rogers.

Jeff Schantz, AIA, Principal at Jacobs Consultancy, sees an industry trend toward dry research, “The ratio of wet to moist to dry space is rapidly changing. In an era of big data, interdisciplinary research teams include bioinformaticists working alongside wet bench researchers. The goal is to design research environments that can withstand the paradigm shifts as the science evolves.”

While the pace of dry lab growth relative to wet lab growth can be debated, the more fundamental need was to create a space that can accommodate a wide range of scenarios: early wet-heavy hiring trends, technology and workflow changes and a potentially dry-heavy future environment. Finally, each of these scenarios must also be compatible with JAX’s emphasis on collaboration across all research platforms.

Unknown end users and rapidly evolving science creates both a short- and long-term planning challenge. One of JAX GM’s fundamental goals was to serve as a recruiting tool for top-tier research talent and, as such, the building is expected to be fully populated shortly after construction completion, however not in a timeframe that would allow users to participate in the design process. Designing for these challenges requires:

An experienced team of national lab planning experts.
An advisory committee to establish the guiding principles.
Flexible lab environments at multiple levels.

A strong knowledge base can also allow a hidden benefit to emerge from the problem of unknown users. The design process isn’t inhibited by users’ pre-existing notions of what their space should look like based on their current research environments. It takes courage and sound reasoning to manage expectations and sometimes justifiably deny the requests of extremely high-level, bright research scientists when discussing their space needs. Designers then listen and respond with solutions that meet the needs of many. The result is a more cost-effective, collaborative environment that’s planned for longevity and a variety of users, rather than tailored to the needs of a few specific users.

Working with design firms that have experience across the country provides owners with a broad base of knowledge and perspective that can be crucial in helping to shape the vision into reality. Alongside performing the most important task—listening—experienced designers and planners can facilitate:

Benchmarking.
Visioning.
Design of collaborative environments.
Determining appropriate balance of cost and flexibility.
An environment that prioritizes culture and people.

An advisory committee that’s consistently engaged from the very early stages of a project is critical to the ultimate success of the design. The group ideally should:

Provide a wide range of experiences and viewpoints with an international perspective.
Set standards and benchmarks for success.
Commit to long-term perspectives.

Flexibility is at the forefront of lab design. It has earned some negative connotations recently, as it can be seen as synonymous with expense. It also may seem overly simplistic to suggest that a space that can “do anything” is the answer to planning for the unknown. In reality, effective flexibility is ultimately a quest for simplicity. For the last 15 years, Apple has dedicated itself to the concept that simple solutions are the most elegant, sophisticated and difficult to accomplish compared to complex ones. Flexibility and simplicity in lab design is no different.

To further understand flexibility and determine its appropriate usage, it’s often useful to think in terms of scale. This suggests three separate definitions: convertible, adaptable and adjustable. Convertible labs in the largest-scale sense can change their entire program—from wet to damp or dry or vice versa. An adaptable lab is one in which the program remains the same, but the workflow and bench configurations can be modified to suit the needs of the research or researchers. Adjustable environments are ones in which the benches, shelving or other systems can be tweaked to accommodate new equipment or work style. Each scale of flexibility has a corresponding up-front cost impact. Determining the right usage requires a full lifecycle cost analysis that weighs future modification costs alongside initial investments.

TK&A worked extensively with JAX during the early project phases to understand the organization’s priorities, mission and expectations before beginning the process of designing the lab environment. By recognizing JAX’s commitment to collaborative environments and convertibility, the design team was able create a series of metrics to validate each design decision.

Labs today contain many of the same broad programmatic elements regardless of institution: traditional wet lab space, hard-wall support rooms and offices for researchers. Most institutions include dry computational space as a complement to the wet environment. Some prefer to locate the computational areas on a separate floor, or even a separate facility, since the mechanical needs for this space are more similar to office environments. Additionally, some institutions dedicate a portion of the space for less formal collaboration areas, which can take many different forms depending on need and level of emphasis. To fulfill JAX’s mission of a highly collaborative environment, it was desirable to locate both the dry labs and informal collaboration spaces directly adjacent to the wet labs. This became the focal point for the initial lab organization concepts.

Each of the three layouts, shown at the bottom right, solves the adjacency and convertibility requirements, but not all are equal relative to flexibility and collaboration. Pros and cons of each configuration are:

Bi-lateral layout:

Highly efficient.
Potential for isolation of PIs.
Limits spontaneous collaboration opportunities due to office and support zone locations.
Large hard-wall support zones prevent expansion of the lab environment.

Asymmetrical layout:

Reduces PI isolation by shifting offices to one side.
Allows more natural light into the lab.
Similar support zone and expansion issues.

"T" layout:

Breaks up the hard-wall support areas into smaller pieces.
Maintains reasonable travel distances to support zones.
Improved linear expansion capability along the exterior edges.

Ultimately JAX decided that the “T” layout met the needs of the institution most effectively.

A major impediment to large flexible areas is often the support rooms. Two considerations for these areas help to alleviate this pressure: challenge the traditional wet-to-support ratios, and make the support rooms themselves flexible. At JAX GM, the design team reduced the area of hard-wall support rooms and replaced it with an adaptable support zone—one that could serve as either wet lab or support space depending on the researchers’ needs. The remaining hard-wall spaces were designed as “flexible support rooms,” or FSRs. The FSRs contained basic fixed elements, such as a sink, but provided a variety of configuration options and MEP system connections to support different functions: fume hood room, tissue culture, microscopy and more.

The final project design incorporating all other site, building and systems considerations satisfies the need for easy modification at all scales within the context of a highly collaborative environment. Wet and dry lab areas, pictured above, are convertible depending on JAX GM’s growth; each lab area is fully adaptable to a myriad of workflow needs, and the lab casework is adjustable. Other small-scale considerations that contributed to the overall flexibility are:

Location of hard monuments (sinks, fume hoods, etc.).
Soffits designed to accept relocated partitions.
MEP infrastructure for wet lab space built in to dry lab areas.
Shared support resources—reduces individual scientist’s space needs.
Floor-to-floor height optimization.
Location of core resources.
Distribution of lab gases.
Component-based lab benches and systems.

A successful design can only truly be measured by its ability to function in the way the clients intended. To date, JAX has recruited 14 PIs mostly focused on wet science, representing 40% of their overall target. This wet-heavy hiring trend is likely to continue and will serve as the lab’s first significant test of its pliability. John Fitzpatrick, senior director of facilities services at JAX, is confident that the lab will respond as planned both through densification and potential conversion of dry lab space. Fitzpatrick also noted that a big reason for JAX’s focus on flexibility was the de novo nature of the facility.

The Jackson Laboratory is still at the very beginning of its new mission. JAX GM will officially open in October 2014, and users will quickly relocate from their temporary facilities on the adjacent UConn medical campus to their permanent new home.

Project team:

Prime Architect: Centerbrook Architects
Design Architect: Tsoi/Kobus & Associates
Lab Consultant: Jacobs Consultancy
Civil/Structural Engineer: BVH
MEP Engineer: BR+A Consulting Engineers|BVH Integrated Services
Landscape: Stephen Stimson
Construction Firm: Whiting Turner Contracting Company
Program Manager: Gilbane

Richard L. Kobus is a founding principal at TK&A with almost 40 years of experience in designing lab environments. Steve Palumbo is an associate at TK&A with over 10 years of experience with lab projects.

Suffolk County Community College Aims at LEED Gold

Suffolk County Community College (SCCC) leadership, local and state elected officials, community leaders and representatives of BBS Architects, Landscape Architects and Engineers and J. Petrocelli Contracting have officially opened the new, $29.8-million William J. Lindsay Life Sciences Building. The structure is aiming at LEED Gold certification.

The Life Sciences Building is the first new academic structure completed on the Ammerman Campus in nearly 50 years. It will house programs for students pursuing biology, marine biology, chemistry, environmental science and nursing degrees. A rapidly growing enrollment in life sciences disciplines necessitated the construction of the new facility. Approximately 5,000 students will attend classes in the building throughout the spring semester beginning in January 2015. The building will also allow for the expansion of science classes to include an additional 100 students in the spring and 300 students next fall.

BBS won the commission in a competition that attracted numerous prominent design firms from across the nation. The 63,000 sq. ft. building creates a new identity for scientific education programs at the college by displaying the school’s inner works to passersby and visitors. The building is designed to integrate its teaching functions with the campus circulation by utilizing a major pedestrian path from the south, leading to the main quadrangle, to encourage transit through the building by students and faculty from all disciplines. The overall program also includes construction of a new 314 sq. ft. astronomical observatory at a separate location.

The Life Sciences Building’s location and design reflect and enhance the existing pathways and spatial relationships already in place on campus. Taking advantage of the changing grade of the site, a north entrance will receive students and faculty coming from the Riverhead and Smithtown Science buildings at the second floor level. To the south, where the grade drops one full story, another entry serves students and faculty arriving from the parking area to the southeast and adjacent athletic facilities to the southwest at the first floor level.

The architectural and planning concepts are fundamentally sustainable. The east-west orientation of the building minimizes summer solar heat gain. The integration into the land contours reduces the exterior surface area, and the overall space efficiency minimizes the material and construction resources. The high-efficiency mechanical and electrical systems are designed to provide safe and functional operation, while minimizing energy use. The BBS engineering team critically analyzed the air change rates required for each type of the interior spaces and optimized the mechanical system to accommodate the findings.

Other sustainable features of the structure include the “tight envelope” and high levels of insulation reducing the thermal losses; a natural storm water run-off management systems; high recycled content and locally sourced materials; and high efficiency lighting system with occupancy sensors.

In addition, a rooftop photovoltaic system will generate 144 kW of electricity and provide over 60% of the building’s electric needs, saving approximately $48,000 per year.

The school’s exterior brick veneer panels convey a sense of “earthen” physicality through the use of color, texture and pattern. This material reflects the look of existing brick campus buildings. However, in order to engage the mind of the observer, the façade features changing patterns. Aluminum and glass curtain wall surfaces the voids of the building, thus allowing high amounts of light to enter the interior.

Both the interiors and the site feature learning tools related to the building’s operations, design and function. The school’s interiors house kiosks and interactive boards displaying—in real time—the building’s sustainability data and power and HVAC systems’ performance.

The sustainability in site design is visible along the pedestrian paths and around the outdoor classrooms. The site features gardens, a contained drainage system and storm-water-collection swales with native, drought-resistant vegetation. Student gathering areas are located near the most interesting sustainable elements and main landscaping features of the site. The ecosystem of the site encourages study of nature.

The classrooms and labs feature custom-manufactured cabinetry by CampbellRhea, epoxy resin countertops, and Orion Style 8 1.5-gal chemical neutralization tanks underneath sinks. The flooring consists of vinyl enhanced tiles (VET), solid vinyl tiles (SVT) and carpet on the atrium’s six seating steps and in offices. Lab workstations include gas, air, power and water connections.

The site design embraces the overall project concept in many ways. It provides a highly sustainable environment that employs native plant selections to minimize maintenance requirements and provide biodiversity and habitat for indigenous fauna. The storm drainage system, a combination of natural and artificial features, accommodates the life sciences building and site as well as the main campus’ rainwater flows that currently enter the site. While designed to be sustainable and functional, this treatment also provides opportunities for educational experiences as displays of applied science. The functional purpose of the site, the way it is shaped, and the use of native grasses, perennials, shrubs and trees represents a reinvigorated appreciation of the natural aesthetic required for current and future sustainable and reasonable development.

The building is arranged with two wings around a central rotunda, which serves as both a transit and a gathering point for students. Each wing has a single lab corridor, which provides clear orientation, as well as efficiency and visibility.

The south-facing window wall has been designed to modulate and harvest natural light. Classroom spaces at the second and third floors feature internal glass walls to take advantage of light and views to the south. Seating opportunities in the corridors/public spaces provide settings for impromptu conversations or short breaks before entering classrooms.

The building’s layout provides a high degree of space efficiency. The two wing corridors provide direct access to all lab and support spaces. Stairways for egress at the ends of the two wings, and the central open stair, designed for dramatic architectural impact, ensure safe and convenient access to all floors.

The simple circulation systems and central core rotunda, as well as the mixed locations of the several scientific disciplines housed within the structure, encourage meetings and interaction among students and faculty. Additional informal meeting spaces along the lab corridors promote a dialogue and exchange of ideas among the building’s occupants.

The building’s first floor houses the main lobby; elevator shaft; three anatomy and physiology labs with prep rooms and 24 stations each, ranging in size from 1,214 to 1,331 sq. ft.; four flexible lecture halls ranging in capacity from 48 to 72 seats; faculty office; 1,706-sf main lobby student gathering space; 221 sq. ft. of corridor niche meeting spaces; and storage and utility rooms.

The lobby is designed as an indoor amphitheater cut into the slope of the building’s site. Classes can be taught in this space. The elevator shaft features interactive kiosks on each of the three building levels. The atrium video wall is made up of 16 NEC 46-inch LED ultra-narrow bezel monitors set up in a 4-ft by 4-ft grid. It is 13.43 ft wide by 7.6 ft high.

The second floor houses general, marine and microbiology facilities. These include six labs ranging in size from 1,214 to 1,331 sq. ft. ; prep rooms and assistants’ offices; a 630-sf faculty office suite and three 80 sq. ft. faculty offices; a 160 sq. ft. biology walk-in cold storage room; student gathering niche; a 24-station student computer room; a 14-station student project room; and support facilities. Each of the six labs feature 24 stations.

The building’s third floor features two 1,214 sq. ft. chemistry labs; two 1,214 sq. ft., 48-seat general classrooms; a 936 sq. ft., 24-station computer room; a 529-sf conference room; a

613 sq. ft. faculty lounge with a 22 sq. ft. kitchenette; two faculty offices; a reception area for administrative offices; department management offices; student gathering areas; mechanical, electrical and storage rooms and an outdoor vegetated roof.

BBS Architects, Landscape Architects and Engineers and J. Petrocelli Contracting have completed the $29.8-million William J. Lindsay Life Sciences Building at the Suffolk County Community College’s Ammerman Campus in Selden, N.Y. Image: Peter Wilk/Wilk Marketing Communications

The building also houses four environmental rooms, ranging in size from 40 to 160 sq. ft. and manufactured by Darwin Chambers Company. The interiors feature numerous sustainable and recycled materials. These include 1,200 sq. ft. of an unusual natural bamboo veneer wall paper, installed on the curved outside wall of the elevator shaft. This material was manufactured in Japan.

Lab spaces are designed using modular planning principles. Each space is essentially the same size to allow flexibility in layout and lab furniture components. Fixed functions such as sinks and fume hoods are located at the perimeter. Lab workstations include gas, air, power and water connections. The building’s mechanical system is sized to provide appropriate air changes for biology labs throughout the several life science disciplines. This solution reduces the energy use.

Construction

The structure features expansive curved exterior walls on south and north sides. The steel fabricator, manufactured and delivered structural elements in sections up to 20 ft long. Due to the curvature of the central section of the building and the unusual 5-in mullions between glaze panels, the support system for the exterior glass curtain wall was custom designed and manufactured. It features connecting clips welded to the building’s steel structure. Aluminum tubing, which supports the glass panels, is attached to the clips. On the south side of the building, the expansive glazed curtain wall is approximately 150 ft wide and 45 ft high. The glazing features energy efficient low-e glass. The crews installed it from an exterior scaffolding that matched the curvature of the wall. Thermoplastic Polyolefin (TPO) membrane roofing by Johns Manville completes the building envelope.

The building features concrete foundations and a steel structural frame. The foundation reaches up to 15 ft down on the north site of the building. During the excavation phase, the crews replaced the soil within the entire footprint of the building with control fill in order to ensure the required bearing capacity of the soil. Because the site slopes from north to south, the team installed an extensive shoring wall on north and east sides of the excavation site. The 300-ft long shoring system consisted of steel I-beam piles driven up to 30 ft down and connected by timber walls up to 15 ft high.

In addition to the glazed curtain wall, the building features contrasting aluminum panel sections and concrete masonry unit (CMU) and brick veneer exterior walls. In order to create a highly energy-efficient building envelope, the designers created a multi-layered walls that consist of an internal CMU wall, three inches of a spray-on thermal insulation, a two-inch air barrier and the exterior brick veneer.

The building’s roof houses six fans that serve 12 fume hoods in the labs, as well as four smoke purging fans. The rooftop systems also include six Trane cooling and heating units, each approximately 40 ft long and 10 ft wide. Each unit services a dedicated section of the building. The interiors also feature 145 VAV hot water space heaters that supplement the rooftop-based units.

Milliken Institute School of Public Health, George Washington Univ., Washington, D.C.

Located on Washington Circle, just a few blocks from the White House, this signature new 161,000 sq. ft. building houses some of the nation’s best known leaders from across the public and private health policy sectors. It provides a critical forum for experts to address today’s most pressing global health challenges. Eschewing the usual separation between offices and classrooms, the project combines these functions on each floor of the building around a central skylit atrium to deliberately promote interaction between faculty, staff and students. In another departure from conventional practice, informal student study and meeting areas are afforded pride of place by occupying a dramatic, glass-enclosed atrium overlooking Washington Circle.

The project incorporates numerous sustainable features, including a green roof, native plantings, low-flow plumbing fixtures, lighting controls, carbon dioxide monitoring and numerous local, rapidly renewable and recycled content materials. The building’s HVAC systems consist of both active chilled beam and mass air displacement technologies, enabling the project to realize a 36% improvement over the ASHRAE 90.1 2007 baseline. The project is LEED Platinum certified.

Project team: Payette (architect/landscape architect); Ayers Saint Gross (associate architect); Affiliated Engineers Inc. (MEP/FP engineer); Tadjer-Cohen-Edelson (structural engineer); Wiles Mensch Corp. (civil/site engineer); S.D. Keppler & Associates (LEED consultant); Atelier Ten (lighting designer); Zipf Associates Inc. (elevator consultant); Shen Milsom Wilke (acoustical/audiovisual); Rolf Jensen Associates (code consultant); R.W. Sullivan Engineering (fire protection consultant).

Shire to Relocate US Headquarters to Lexington, MA

Shire plc plans to relocate more than 500 positions from its Chesterbrook, PA site to Lexington, MA, which will now serve as the company's U.S. operational headquarters. The shift will occur in several phases beginning in 1Q15 with a targeted completion in 1Q16.

The transition is part of the company's 'One Shire' efficiency program aimed at streamlining business globally through two principal locations, MA and Switzerland, with support from a limited number of regional offices around the world.

Shire expects to save $25 million annually beginning in 2016. This site strategy also aims to align priorities between the commercial and R&D teams, as well as strengthen collaboration and cross-development of employees.

"Chesterbrook, the greater Philadelphia area, and the talent of our employees based there have been instrumental to Shire's growth and evolution," said Flemming Ornskov, M.D., chief executive officer. "We've made the decision to consolidate our U.S. operations in the Massachusetts area to streamline operations and drive further efficiencies in the way we run our business and serve patients. Shire has a great opportunity to combine our Chesterbrook and Lexington talent with the leading biotech resources in the Massachusetts area, and we consider ready access to these resources an important element in the future growth of our company."

REST OF WORLD

Siegfried Acquires Hameln Pharma

Siegfried Group has acquired Hameln Pharma in Germany, for CHF 60 million. Hameln Pharma, consisting of Hameln Pharmaceuticals GmbH and Hameln RDS GmbH, develops and produces sterile liquid pharmaceutical products for international companies, expanding Siegfried’s sterile filling segment.

The Hameln Group, and its remaining subsidiaries, plans to focus on its business activities with its own brand of injectable pharmaceutical finished products. The R&D site in Slovakia will also remain in the possession of the Group.

The acquired companies are located in the city of Hameln and employ approximately 500 staff, which Siegfried will take over. For 2014, Hameln Pharma expects sales of approximately CHF 85 million. To supplement its core business of contract manufacturing, Hameln Pharma offers a portfolio of services ranging from product and method development to dossier compilation and registration services.

Hameln Pharma has a modern production plant, including a sterile facility that began operations in 2008. In the future, Siegfried plans to continue to invest in the latest technologies at both of its sites in Irvine and Hameln, as well as move forward with the production of vials in Hameln.

The acquisition is part of Siegfried’s Transform strategy regarding both forward and backward integration. In 2012, Siegfried acquired Alliance Medical Products, Inc. in Irvine, CA, active in a comparable market segment as Hameln Pharma, and in October 2014, operating approval was granted for the new chemical production plant for APIs in Nantong, China. Also, at its headquarters in Zofingen, Switzerland, Siegfried is currently building a chemical production plant with a capacity of 100 cubic meters, which will replace older and less efficient facilities beginning in 2015.

Siegfried chief executive officer Rudolf Hanko, said, “The family-owned company looks back on a history of more than 100 years and, from both a technical and a cultural point of view, represents a perfect fit with the Siegfried Group, which celebrated its 140th anniversary last year. The new location significantly supplements our activities in the field of sterile filling. Our industry is in an intensifying consolidation process. Siegfried wants to and will play an active role in this.”

Bosch and Klenzaids plan joint venture in India Asia

Bosch Bosch Packaging Technology is taking a 49 percent share in Klenzaids Contamination Controls, an Indian manufacturer of processing, packaging and cleanroom technology for the global pharmaceutical industry. No financial details have been revealed, but the two companies say the aim of the joint venture is to extend their global reach, particularly in liquid pharmaceuticals and packaging machines for cleanroom environments.

Klenzaids will contribute its expertise in designing and building cleanrooms, processing technologies and peripheral systems, while Bosch will offer its strength in innovative filling technologies. Founded in 1978 and headquartered in Mumbai, Klenzaids generated sales of approximately €6m in 2013 and employs 350 people. The company supplies laboratories that meet biological safety class standards 2–4. Class 4 laboratories guarantee the absolute isolation of micro-organisms from the environment. It also offers isolators and processing technologies for the production of liquid pharmaceuticals. Despite our different regional backgrounds, Bosch and Klenzaids have a lot in common Bosch Packaging Technology, which last year achieved global sales of €1.1bn and employs around 5,600 people worldwide, has been developing, building, and selling vertical and horizontal flow wrapping machines for packaging food as well as filling and sealing machines for liquid pharmaceuticals at its plant in Verna, in the state of Goa, India, since 2012.

To date, the company has sold more than 1,500 packaging machines to leading brand companies in the food and pharmaceutical industries. The joint venture will be headquartered in Mumbai and is expected to employ 380 people. The plan is subject to the approval of the antitrust authorities. Friedbert Klefenz, President of Bosch Packaging Technology, said: 'We already have a long history of trusted collaboration with Klenzaids. The company is known for employing excellent people and for providing high-quality products and services.

I am delighted at the prospect of a future together.' Hamish Shahani, Managing Director of Klenzaids, added: 'Joining forces and pooling our resources will give us a stronger starting position in the emerging Indian market. Despite our different regional backgrounds, Bosch and Klenzaids have a lot in common. Both place great emphasis on profitable growth, innovative strength, reliability, a motivated workforce, and strong value orientation.' Commenting on the agreement, Steffen Berns, President of Bosch India, said: 'Following the inauguration of our manufacturing unit in Verna, this is the second milestone for our packaging technology business in two years. I am extremely confident that this new partnership will further strengthen our product portfolio and market reach. The activities of both parent companies dovetail perfectly, and our pharmaceuticals unit as well as our customers will benefit immensely from this joint venture.

GSK Makes Investment in Australian Plant

GSK Australia is adding new blow-fill-seal machinery GSK Australia will invest AU$31m in the latest manufacturing technology to expand its Boronia site in the outer eastern suburbs of Melbourne. The expansion will include the introduction of high speed blow-fill-seal (BFS) machinery specifically developed for advanced aseptic packaging of sterile pharmaceutical liquids. This latest BFS machine will be dedicated to the manufacture of Ventolin (salbutamol sulfate) nebules for the treatment of asthma. The investment will allow the facility to meet increased demands from emerging markets such as China, Turkey and Brazil where patients want low cost, accessible asthma treatments, said GSK.

BFS manufacturing has been a focal point for GSK’s Boronia facility for 25 years and the new BFS machine is expected to become operational in January 2016. This announcement is part of a series of investments GSK has made in recent years to strengthen its manufacturing capabilities in both Australia and the UK. These include a previous investment of AU$60m in Boronia to advance the site’s BFS capability, new state-of-the-art equipment across a number of sites in the UK and the establishment of two new UK-based facilities specifically focused on using innovative technologies and supporting the business’s growing pipeline. BFS can be used in a range of therapeutic areas from the delivery of IV fluids and nebulizer solutions to injectable liquids as well as eye drops and nasal devices.

Romark Labs to Build Plant in Puerto Rico

Puerto Rico's governor says Florida-based pharmaceutical company Romark Laboratories L.C. is building a $110 million plant in the U.S. territory.

Alejandro Garcia Padilla says construction will begin in January and that nearly 200 jobs will be created in three years.

The new plant will focus on research, development and commercialization of molecular therapy to fight cancer and infectious diseases.

The announcement comes a day after animal health company Merial announced it would buy a Merck manufacturing plant in Puerto Rico that was being closed and retain its 200 employees. The plant is expected to manufacture and package Heartgard and Heartgard Plus products.

Merial is a Sanofi subsidiary with headquarters based in Lyon, France.

Eli Lilly to Sell Puerto Rico Manufacturing Facility

Eli Lilly and Co. will close one of its three manufacturing facilities in Puerto Rico at the end of 2015.

The Indianapolis company said it is closing its Guayama facility because the patents on some of the drugs made there have expired. That means new competition reached the market and its sales and prices dropped.

Lilly intends to sell the Guayama plant. Lilly said the 100 employees who work there will be offered jobs at another one of its facilities on the island, which are located in Carolina, Puerto Rico. Guayama is in the southeastern part of Puerto Rico, and Carolina is in the northeast.

The company said it will take a pretax charge of $170 million in the fourth quarter because of the planned closure. That will cost the company about 16 cents per share after taxes.

Eli Lilly has announced $240 million investments in its Carolina, Puerto Rico, facilities since late 2013.

Stelis Begins Construction of Facility in Malaysia

Stelis Biopharma has now commenced the construction of its customized, multi-product, biopharmaceutical manufacturing facility at Bio-XCell Biotechnology Park in Nusajaya, Johor, which is Malaysia’s premier park and ecosystem for industrial and healthcare biotechnology.

The company which is a wholly-owned subsidiary of Strides Arcolab and Bio-XCell had earlier inked a build and lease agreement with Bio-XCell for the construction of the building and part of the equipment of Stelis Biopharma’s 140,000 sq. ft biologics facility, for a total project investment amount of RM201 million or US$ 60 million.

The construction and fit-out of the facility is expected to be completed in 24 months and commercial operations are targeted to begin mid-2017 at Bio-XCell Park. The 140,000 sq. foot facility will incorporate ‘next-gen’ single-use bio-processing technology with both mammalian and microbial manufacturing suites. When complete, it will be one of the few regulated market approvable facilities in the region with end-to-end capability including sterile fill-finish across all formats. The facility will also house an R&D unit to conduct scale-up and process development studies.

“We have commenced work on the flagship biopharmaceutical facility in Malaysia. With its strong commitment to bio-economy, attractive incentives, quality infrastructure and enabling ecosystem, we are confident of making this our bio-manufacturing hub for regional and global markets” said Joe Thomas, CEO, Stelis Biopharma,

“The partnership with Stelis to build an advanced multi-product Biologics facility from the start, is seen as a first in Bio-XCell Biotechnology Park and timely given the close working relationship over the years. We are happy to see the 2nd bio-pharma project to commence which is expected to be commissioned in 2017,” said Rizatuddin Ramli, CEO, Bio-XCell, Malaysia.

It will manufacture and commercialize its internal and partnered pipeline of bio-pharmaceuticals besides cater to the demand for high-quality contract manufacturing and clinical supplies. At peak operations, the facility will employ 180 people in R&D, manufacturing, QA/QC, analytical and regulatory, of which a significant number will be local employees.

Bio-XCell’s park’s strategic location in the Iskandar region of Johor with its close proximity to Singapore and access to a network of world-class seaports and airports within a short distance will help tap into the unmet regional and global demand for cost-effective biologics.

Recipharm Acquires Facility in France

Recipharm AB and Flamel Technologies SA have entered into a long-term collaboration agreement under which Recipharm will purchase Flamel’s development and manufacturing facility in Pessac, France for €10.6 million plus working capital. The deal expands its pharmaceutical development capacity and technical capabilities to provide services to its customers in the region, including spray granulation and spray coating. The transaction is expected to close by the end of the year.

Recipharm will also provide development and manufacturing support to Flamel under a long-term services agreement. The partnership allows Flamel to retain access to the Pessac facility’s capabilities and provides access to Recipharm’s other facilities for the development or manufacture of their pipeline. Recipharm may also enter agreements with other companies and has an agreement providing royalty income.

Additionally, the companies have agreed to negotiate a contract whereby Recipharm will incorporate Flamel’s drug delivery technologies into its contract development business, and Recipharm has an option to negotiate with Flamel for the European rights to any product that Flamel plans to license for sale in the European market.

The Pessac facility is located in Bordeaux, France and is GMP compliant (FDA and ANSM-approved) for the development and manufacture of pharmaceuticals. The facility manufactures Flamel’s Medusa and Micropump drug delivery technologies and is equipped with three spray-coating machines, warehousing, analytical and QC labs, and equipment for polymer synthesis.

Thomas Eldered, chief executive officer of Recipharm, said, “I am delighted that we are now entering into a strategic partnership with Flamel and taking over a first class development and manufacturing facility in France. Development services are in many respects a ‘local’ business so having another centre in addition to Sweden should allow us to increase this aspect of our business. The commitment we are both showing towards each other is a clear demonstration of the bright future we see for this relationship. We are looking forward to supporting Flamel to fulfill their ambitions to develop and manufacture new products based on their proprietary technology.”

Mike Anderson, chief executive officer of Flamel, added, “The sale of the Pessac facility frees us from the time-consuming task of running a contract development manufacturing facility. This sale allows us to continue development of our proprietary products using our current drug delivery technologies at the Pessac facility and the option to utilize Recipharm’s commercial manufacturing capabilities elsewhere. Given Recipharm’s expertise, the investment in Flamel’s stock is a welcome endorsement of Flamel’s anticipated success moving forward

Eisai Opens UK Potent Packaging Facility

Japan-based Eisai has opened a new potent packaging facility at its EMEA Knowledge Centre in Hatfield, investing £8 million. The facility will handle the packaging of its investigational compound lenvatinib for the treatment of advanced thyroid cancer.

The 31,200 sq. ft. (2,900m²) facility has hybrid packaging lines designed for highly potent, difficult-to-handle compounds, expanding the current Hatfield site by nearly 40 percent. The investment represents Eisai's long-term global business structure to make the UK a key hub. The Hatfield site is the company's EMEA headquarters and serves as a global supply center of excellence for key products.

Eisai has invested more than £150 million in the Hatfield site, which has more than 500 employees and the capacity to produce as many as 450 million tablets in 10 million packs each year. The new packaging facility will increase employment at the site by 10%.

"We are extremely proud of this new development at our EMEA Knowledge Centre. The UK is an ideal location for advanced manufacturing. We are committed to the life sciences industry in this country and it will continue to play a pivotal role in our commercial growth strategy," said Haruo Naito, chief executive officer of Eisai. "This new high tech facility enhances our capability as a center of packaging excellence for our growing product range."

Lenvatinib was granted orphan drug designation for follicular and papillary thyroid cancer by the European Commission and regulatory submissions have been made in the EU, U.S. and Japan.

SGS Life Science Services Announces Investment at its Mumbai, India

SGS Life Science Services, the leading pharmaceutical clinical and bioanalytical contract solutions provider, today announced that it is to invest in its Mumbai, India, facility, in a move which will see the current 14,988 sq. ft. (1393 sq m) laboratory more than double in size, to 42,975 sq. ft. (3994 sq m). The expansion is being driven by increasing demand for Full Time Equivalent (FTE) activities for key pharmaceutical customers, as well as more stability projects from both local operations of Multi-National Companies and overseas organizations.

The expanded laboratory will act as a dedicated cGMP pharmaceutical testing site and is due for completion and validation in Q2 2015.

The Mumbai facility, which is focused on stability studies and dedicated FTE models, will feature three new 100 cu meter capacity stability chambers, HPLCs, dissolutions, Gas Chromatographs and additional general laboratory instruments. Capacity at the site will grow from 423 cu meters to 723 cu meters, while the current 88 strong workforce will ultimately be augmented by an additional 39 members of staff.

“The expansion will bring additional facilities, expertise and personnel to serve our customers’ requirements in Asia,” commented Paul House, Managing Director of SGS India Ltd. “Upon completion, the Mumbai laboratory will be the largest stability testing facility in our Life Science Services network.”

With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I to IV clinical trial management and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.

Johnson Matthey Acquires Pharmaceutical Manufacturing Capacity in Scotland, UK

Johnson Matthey, a provider of pharmaceutical services, active pharmaceutical ingredients (APIs) and catalyst technologies, has announced completion of an acquisition of pharmaceutical manufacturing capacity in Scotland, U.K. The 1,172,840 sq. ft. (109,000 sq. meter) site was acquired to meet increasing demand for custom pharmaceutical services and active ingredients utilizing enhanced manufacturing capabilities.

Located in Annan, Dumfries and Galloway, the site was originally commissioned and constructed by Glaxo in 1980 and was most recently owned by Bakhu Pharma. The manufacturing capacity offers further opportunities to optimize efficiencies across Johnson Matthey’s existing global manufacturing assets, and the multipurpose capabilities strongly complement the company’s portfolio of complex chemistry, catalysis and process technologies. An immediate multimillion-pound refurbishment will soon be underway to update and enhance the operational and quality standards of the facility.

“This strategic site addition significantly increases our global manufacturing capabilities and capacity,” said John Fowler, Division Director at Johnson Matthey Fine Chemicals. “Combining the Annan site with our leading technologies will answer our customers’ needs for efficient production of pharmaceutical intermediates and APIs at the highest quality and compliance standards in the market.”

Refurbishment at the Annan facility is set to start in early 2015, and the site is expected to be fully operational by early 2016.

Ardmac to Build Cleanrooms for the National Biologics Manufacturing Centre

Cleanroom design and construction specialist Ardmac, based in Manchester, UK, has been contracted to deliver new cleanroom facilities at the National Biologics Manufacturing Centre (NBMC) in Darlington. Currently in the design phase, the project forms part of the Centre for Process Innovation (CPI), a Government-led initiative which aims to stimulate growth in manufacturing sectors across the UK through a network of technology and innovation centers.

Working alongside Archial Norr and Interserve, the project consists of full architectural design, product selection and construction delivery. The nature of the NBMC facility, which will provide contract manufacturing services to clients in the biosciences industry, means that the cleanroom must be flexible to allow the continuous changing of equipment and services for respective clients. The NBMC space also includes an exhibition hall with views into the new cleanrooms.

As part of this project, Ardmac will be providing opaque LCD smart glass on the windows to allow for observation and privacy when necessary. Ardmac Business Development Manager, Philippa King-Smith, said: ‘We are really looking forward to seeing the project go live on site. Our design team has worked well with the architectural leads to ensure the GMP areas provide many interesting features, all the while maintaining compliance. The Ardmac, Archial Norr and Interserve teams have worked extremely well together and we look forward to seeing this project through to completion.

Bristol-Myers Squibb to Build Plant in Ireland

Bristol-Myers Squibb has announced plans to expand its biologics manufacturing capacity by building a large-scale facility in Ireland.

The new manufacturing facility in Cruiserath, County Dublin, will produce multiple therapies for the biopharmaceutical company's growing portfolio of approved and investigational biologic medicines in therapeutic areas including oncology, virology and immunoscience.

Covering 322,800 sq. ft. (30,000 square meters), the facility will house six 15,000-liter bioreactors and a purification area as well as office and laboratory space. It will be built on the grounds of the company's existing bulk pharmaceutical manufacturing plant.

The full cost of the facility is anticipated to be about $900 million, matching the company's investment in its biologics manufacturing plant in Devens, Massachusetts.

When completed, around 350 to 400 scientists, engineers, bioprocess operators, quality specialists and other skilled professionals are expected to work at the Cruiserath facility. Construction is expected to take approximately four years, with the facility becoming operational in 2019.

Bristol-Myers Squibb said that biologic medicines are becoming increasingly important tool in the treatment of serious diseases and comprise more than half of the company's research and development pipeline.

"Our investment in this new facility reflects the strength of our business and the increasingly important role that biologic medicines will play in Bristol-Myers Squibb's future," commented Lamberto Andreotti, CEO of the company.

"For 50 years, Bristol-Myers Squibb has maintained a significant manufacturing presence in Ireland, and we look forward to building on that legacy through this significant expansion of our manufacturing capability." Andreotti added.

Beximco Pharma Receives GMP Approval from Health Canada

Beximco Pharmaceuticals, a fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, has received GMP approval from Health Canada. Beximco, based in Dhaka, is the first Bangladeshi company to receive GMP accreditation from the Canadian regulatory authority. The company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies. It employs 3,000 people and produces tablets, capsules, liquids, semi-solids, intravenous fluids, metered dose inhalers, dry powder inhalers, sterile ophthalmic drops, prefilled syringes, injectables, nebulizer solutions and oral soluble films.

This accreditation opens a new marketing opportunity for Beximco’s products in Canada. At the beginning of July, Beximco also received GMP approval from the Taiwan Food & Drug Authority (TFDA), again marking a first-time approval for a Bangladeshi company. Nazmul Hassan, Managing Director of Beximco Pharma, said: ‘Canada is an important market for Beximco Pharma and this approval marks a significant milestone for the company, further validating our high standards of quality and compliance practices. ‘This approval builds on our existing presence in key regulated markets and is an important step towards our aspiration to become a global generic drug player.’

Beximco is also certified by the European Medicines Agency (EMA) and has been exporting medicines to the EU since 2013. The company has also received approvals from the relevant authorities in Australia, Latin America, Gulf Nations, and South Africa, among others.

Recipharm Acquires Flamel Technologies Facility in France

Recipharm, a Swedish pharmaceutical contract development and manufacturing organization, is to buy a manufacturing facility from Flamel Technologies in a deal worth €10.6m and has entered into a long-term collaboration with the Lyon, France-headquartered company.

Under the agreement, Recipharm will purchase Flamel’s development and manufacturing facility in Pessac and significantly expand its pharmaceutical development capacity and technical capabilities to provide easier access for development services to its French and other customers. Recipharm will also provide development and manufacturing support to Flamel under a long-term services agreement.

The deal adds new technical capabilities for spray granulation and spray coating. This new partnership allows Flamel to retain access to the development and manufacturing capabilities at Pessac and possibly use any of Recipharm’s other facilities for the development or manufacture of its proprietary pipeline. Recipharm will also assume development and manufacturing agreements with other companies and as well as an agreement providing a royalty income.

In a separate deal, Recipharm will invest €10.5m in newly issued Flamel Shares which corresponds to approximately 2.3% of Flamel shares. Development services is in many respects a ‘local’ business so having another centre should allow us to increase this aspect of our business

Recipharm also has an option to negotiate with Flamel for the European rights to any product that the French company plans to license for sale in the European market. The deal is expected to close before the end of the year.

Recipharm's Chief Executive Thomas Eldered said: 'I am delighted that we are now entering into a strategic partnership with Flamel and taking over a first class development and manufacturing facility in France. Development services is in many respects a ‘local’ business so having another centre in addition to Sweden should allow us to increase this aspect of our business.'

Mike Anderson, CEO of Flamel said Flamel’s primary objective is 'the development of products using its proprietary drug delivery platforms' and the sale of the Pessac facility 'frees the company from the time-consuming task of running a contract development manufacturing facility'. He added: 'This sale allows us to continue development of our proprietary products using our current drug delivery technologies at the Pessac facility and the option to utilize Recipharm’s commercial manufacturing capabilities elsewhere. Given Recipharm’s expertise, the investment in Flamel’s stock is a welcome endorsement of the company's anticipated success moving forward.'

Essentra Opens Labels and Manufacturing Facility in Wales

Essentra has officially opened its purpose-built labels manufacturing facility in Newport, Wales. This investment provides the company with a 52,000 sq. ft. facility from which to meet the growing demands of both existing and new business across its target markets.

It follows the announcement that the company is to acquire Clondalkin Group’s Specialist Packaging Division for around US$455m. The Newport site incorporates Essentra’s latest investment in digital printing and a cleanroom for production of primary packaging foils for the healthcare market.

To ensure the exacting requirements of this market are met for this new product, the cleanroom meets Class 8 ISO standards and is the first for Essentra. The factory also meets Essentra’s internal standards for quality, and has gained the triple certification of ISO 9001, ISO 14001 and OHSAS, as well as the BRC/IoP global standard for packaging and packaging materials.

The new facility was opened by Essentra’s Chairman Jeff Harris and Chief Executive Colin Day in front of employees and Economy Minister Edwina Hart from the Welsh Government, which provided £290,000 of business finance for the project. The site currently employs 66 people and has plans for further expansion. Jeff Harris, Chairman, said: 'Our Essentra facility at Newport represents a substantial investment in our label and primary packaging capabilities, and ensures we have the best operational footprint and necessary space to meet the growing needs of the healthcare and consumer packaging markets we serve. 'Our new site is a world class operation with the best in cleanroom technology, and builds on the strong reputation we have developed from our other locations in order to serve our customers worldwide.'

Essentra offers customer solutions from a broad range of capabilities for both secondary and primary packaging requirements. Authentication expertise adds layers of protection which can be tailored to address the brand protection needs of individual customers. Capabilities include the production of cartons, leaflets, foils, tapes, labels and tamper evident seals.

Amgen Completes Construction of Biomanufacturing Facility in Singapore

Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility.

Built in less than two years, the facility was completed in half the time required for conventional biomanufacturing plants thanks mostly to its use of single-use bioreactors, disposable plastic containers, continuous purification processing and real-time quality analysis.

The launch of the new biomanufacturing facility comes on the heels of the company announcing nine biosimilar project that could combine to drive $3bn in revenue. Amgen’s first biosimilar is expected to launch in 2017, followed by four more in 2019.

The company estimates that the new biomanufacturing capabilities will result in an estimated cost reduction of 60% or more per gram of protein.

In addition to the launch, the company also announced it will continue building more at the Tuas, Singapore site and will soon break ground on another facility where it will make carfilzomib, the active ingredient for the anti-cancer drug Kyprolis.

Amgen chairman and CEO Robert Bradway previously said the facility is on track to produce commercial products beginning in 2017. Bradway added: "Singapore is an ideal place to invest in such a pioneering facility because of its talented workforce and commitment to the biotechnology industry."

And Amgen isn’t the only company moving some manufacturing ops to Singapore. In February, AbbVie announced it would invest $320m in a production facility that will support the development of ADCs (antibody drug conjugates). Novartis also announced a new $500m cell-culture based manufacturing facility, while Pfizer, Lonza, Roche and Baxter all have commercial manufacturing facilities in Singapore, as well.

But Amgen’s facility is expected to use less energy and water and have lower solid waste and emission levels than a conventional facility, the company says.

AbbVie Buys Plant in Singapore

An API facility in Singapore acquired by AbbVie on the site where it is building a $320m biologics plant will support the firm's antibody-drug conjugate (ADC) pipeline.

The new facility will make small molecule active pharmaceutical ingredients (APIs) and is set to become AbbVie’s first manufacturing operations in Asia when it begins production in 2016. The acquisition, details of which were not disclosed, is located in Singapore's Tuas Biomedical Park on the same site where AbbVie announced earlier this year it is building a bulk biologics manufacturing facility.

Company spokesperson Adelle Infante said, “Both the biologics facility under construction and the small molecule facility purchased, will support AbbVie’s oncology and immunology pipeline and platform technologies such as antibody-drug conjugates (ADCs).”

An ADC comprises of a small molecule highly potent cytotoxic drug linked to a cancer-cell targeting monoclonal antibody (or an antibody fragment), and despite there only being two ADCs on the market – Seattle Genetics’ Adcetris and Genentech’s Kadcyla – about 45 molecules are in clinical development.

AbbVie has one ADC in development, ABT-414, an anti-epidermal growth factor receptor ADC being developed to target malignant brain tumours. ABT-414 was recently granted orphan status by the EMA and US FDA and in a conference call discussing Q3 results CEO Rick Gonzalez said the firm is “moving aggressively to start a Phase II study” of the candidate early next year.

AbbVie expanded a partnership in January this year , paying $25m to access Seattle Genetics’ pyrrolobenzodiazepine (PBD) dimer ADC technology and EC-mAb site-specific conjugation technology, but the company is far from the only Big Biopharma firm interested in such technology, with AstraZeneca , Pfizer , Eli Lilly , Novartis , and Roche all having invested in ADCs over the past 18 months.

But while an industry report on the Antibody Drug Conjugates Market 2014-24 published in August reported 70-80% of ADC manufacturing is performed by a third-party, AbbVie’s investment in Singapore shows intent to keep such operations in-house, according to Infante.

“This investment expands AbbVie’s manufacturing network and builds capacity to support pipeline products for patients globally,” she told us. “Singapore is supportive of manufacturing and offers an educated workforce [and this investment] provides geographic balance in our manufacturing network to ensure continuity of supply.”

Last week, fellow biologics maker Amgen announced it had completed construction of a $200m manufacturing facility also in Tuas, while Novartis is currently building a $500m cell-culture based plant in the Biomedical Park.

McIlvaine Company

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com