Continuing strong growth in demand for the company's active pharmaceutical ingredient (API) contract manufacturing capabilities is driving the need for more capacity. Cambrex expects to invest between US$45m and $50m during 2015, including a state-of-the-art cGMP production facility and related supporting infrastructure.

This project is expected to be completed in early 2016 and is designed to allow Cambrex to expand further quickly and efficiently its cGMP capacity as future growth requires.

The new manufacturing facility will initially add a total of 70m3 of glass-lined and hastelloy reactors, ranging in size from 7–16m3 along with 6m2 of hastelloy filter dryers to provide a flexible, multipurpose configuration.

The facility will be designed to the highest regulatory and safety standards, capable of handling potent APIs at an OEL down to 1µg/m3 and will significantly increase the company's cGMP manufacturing capabilities. The facility is also expandable with the ability to add additional capacity on a short timeline. The capacity is being added along with 45,000 sq. ft. of new fully cGMP, temperature and humidity controlled warehouse space.

'We are pleased to be expanding again so quickly in this competitive global pharmaceutical landscape,' said Joe Nettleton, VP of Operations of Cambrex Charles City. 'The need for increased API capacity comes on the back of strong market demand and high capacity utilization of our current large-scale assets. There is high demand for US-based suppliers with large-scale cGMP contract manufacturing capacity and world-class quality systems, and we have demonstrated that we are quite capable of meeting that demand.'

Shawn Cavanagh, Chief Operating Officer of Cambrex, agreed: 'In recent years, we have seen significantly stronger demand for the assets and capabilities that our Charles City facility has. We believe this expansion, combined with a very talented and experienced team, provides an ongoing foundation for our customers' small molecule product manufacturing needs and supports our goal of bringing our customers' products to market quickly.'

Juno Therapeutics Adds New Biomanufacturing Facility

Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.

The facility is expected to come online in early 2016 and will support Juno's planned JCAR015 multicenter clinical trial, additional clinical programs in Juno's pipeline, and the company's first commercial products. A company spokesman said the facility will be 67,799 square feet.

But the company doesn’t know how successful its manufacturing operations will be, noting in an SEC filing: “we have no experience as a company in developing a manufacturing facility and may never be successful in developing our own manufacturing facility or capability.”

Perhaps due to this lack of experience, Juno says it will continue to work with its existing CMO (contract manufacturing organization) partners to augment its manufacturing capabilities, and to enhance flexibility, provide redundancy, and increase capacity.

The manufacture of Juno’s biologics involves complex processes, including harvesting T cells from patients, genetically modifying the T cells ex vivo, multiplying the T cells to obtain the desired dose, and infusing the T cells back into a patient’s body.

“Our manufacturing process will be susceptible to product loss or failure due to logistical issues associated with the collection of white blood cells, or starting material, from the patient, shipping such material to the manufacturing site, shipping the final product back to the patient, and infusing the patient with the product, manufacturing issues associated with the differences in patient starting materials, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth, and variability in product characteristics,” Juno says, noting that even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions.

“If for any reason we lose a patient’s starting material or later-developed product at any point in the process, the manufacturing process for that patient will need to be restarted and the resulting delay may adversely affect that patient’s outcome,” the company warns.

And Juno also warns that the reagents that make up its clinical products, which are manufactured by smaller companies, may be difficult to come by in the future.

“Manufacturing our product candidates will require many reagents, which are substances used in our manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production,” Juno says. “We currently depend on a limited number of vendors for certain materials and equipment used in the manufacture of our product candidates. Some of these suppliers may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. We also do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all.”

Despite the potential difficulties, Hans Bishop, CEO and president of Juno, remains optimistic. He said in a statement: "The manufacturing expertise we are developing is key to our long term success, increasing our ability to run multiple clinical trials and commercialize our pipeline, and as a platform to introduce the various innovations we are investing in to optimize patient outcomes."

Enteris BioPharma Launches Contract Manufacturing

Enteris BioPharma has announced the launch of contract manufacturing located within its 32,000 square foot, FDA inspected and cGMP compliant facility in Boonton, New Jersey.

Equipped to ensure cost-effective, high-quality production of API using microbial expression systems, Enteris BioPharma offers pharmaceutical companies a full array of services to meet their manufacturing needs, from pre-clinical to commercial scale.

Brian Zietsman, President and CFO of Enteris BioPharma, commented, "The initiation of our contract manufacturing business is an important milestone for Enteris as we seek to fully maximize the assets and expertise that we acquired when the company was launched in 2013." Housed within Enteris BioPharma's 32,000 square foot facility is a fully integrated manufacturing plant for producing API at multi-kilogram capacity. The fermentation, purification and production support suite includes a 1,000 liter B. Braun microbial fermenter, 300 sq. ft. Millipore TFF membranes, an Alfa Laval disc stack centrifuge, a Rainee homogenizer, a complete downstream purification suite, multiple chromatography columns, a bulk tray lyophilizer and an explosion proof area for solvent handling and RP-HPLC. Enteris BioPharma's manufacturing capabilities are strengthened by significant technical expertise that enables the company to offer end-to-end program support, ranging from small scale pre-clinical programs to commercial scale API manufacturing.

Paul Shields, Ph.D., Vice President, Operations of Enteris, remarked, "From fermentation to harvesting and downstream purification through to stability testing, process validation, QA and regulatory support, Enteris has the technological capability and expertise to meet a wide array of customer needs and project specifications. With the initiation of our contract manufacturing services, Enteris offers pharmaceutical partners the ability to manufacture recombinant peptide and protein products using microbial expression systems in an FDA inspected and cGMP compliant facility located in New Jersey."

Repligen Completes Expansion of U.S. Facility

Repligen Corporation announced that it has completed an 11,000 square foot expansion of its U.S. manufacturing facility. The expansion includes a dedicated space for the production and assembly of Repligen's Alternating Tangential Flow System ("the ATF System"), the most recent addition to the Company's upstream bioprocessing product portfolio. The ATF System is a market-leading product line used to significantly increase cell density and product yield during the fermentation step of the biologic drug manufacturing process. The expansion includes areas for ATF System assembly, quality control and inventory, as well as cleanroom suites for the production of single-use ATF Systems in an ISO 7 environment that meets the high standards of Repligen's biopharmaceutical customers.

"This expansion satisfies our goal to rapidly transfer ATF System operations, which we acquired from Refine Technology of Pine Brook, NJ in June 2014, to our Waltham facility. This new space is designed to meet the highest standards of quality and service that our customers expect from Repligen, and will improve lead times for product delivery," said Walter C. Herlihy, Ph.D., retiring President and CEO of Repligen.

Tony J. Hunt, COO and named next CEO of Repligen added, "We are immediately addressing customer demand for the current stainless steel ATF System through our new manufacturing facility in Waltham and our expanded technical, service and applications support team, while continuing to execute on the development of a single-use version of the ATF System."

The facility upgrade also expands on areas dedicated to cell culture research and development as well as manufacturing and support of the Company's ELISA test kits and its OPUS(R) line of pre-packed chromatography columns. An additional 7,500 square feet is reserved for future expansion of the Waltham facility, allowing the Company to remain flexible and responsive to the needs of its biopharmaceutical customers and life sciences partners.

Medical Murray Holds Ribbon Cutting at New N.C. Facility

Medical Murray, a medical device development and contract manufacturing company, hosted an open house and ribbon cutting event recently, showcasing the firm's new design and development facility located in Charlotte, NC.

The open house provided guests the opportunity to meet with the Charlotte team and key personnel from the company’s development and contract manufacturing facilities located in suburban Chicago. The company is based in North Barrington, Il.

“The open house was a tremendous success and many company business leaders and supporters of the life science community were in attendance,” said Tanner Hargens, regional vice president and head of the operation. “We look forward to fostering relationships and working with medical device companies in supporting our mission of developing complex disposable medical devices to advance the betterment of patient care.”

Hargens has more than a decade of experience in medical device engineering and specializes in implants, biomechanics, biomaterials, and minimally invasive procedures. He also provides expertise related to commercializing medical products.

Jane Kearns, account manager for the Charlotte Chamber of Commerce, along with president and owner of Medical Murray, Phillip Leopold, facilitated the ribbon cutting ceremony.

Medical Murray is also working closely with North Carolina Biotechnology Center to foster growth of the life-sciences community in North Carolina, including biotechnology research, business, education and strategic policy. Key staff members from N.C. Biotech welcomed guests during the event.

The North Carolina Biotechnology Center is a private, non-profit organization headquartered in Research Triangle Park, with regional offices in Asheville, Charlotte, Greenville, Wilmington, and Winston-Salem. Founded in 1984 by the North Carolina General Assembly, it was, according to its founders, the first state-sponsored biotechnology initiative in the United States, merging the interests of the academic private and public sectors.

“We were delighted to be a part of this event and are fortunate to count Medical Murray among our newest assets in Greater Charlotte,” said Corie Curtis, executive director of N.C. Biotech. “The company has extensive knowledge in bringing intricate medical device products to market.”

Founded in 1996, Medical Murray specialized in developing and contract manufacturing unique complex catheter systems, permanent implants, and bioabsorbables for less-invasive vascular, urologic and surgical applications. The company's nano-molding capabilities feature patented molding technology of parts weighing less than 1 gram, according to company officials. Medical Murray also offers contract manufacturing facilities featuring four ISO 13485 Class 7 clean- rooms, and FDA registration to handle full sterilization, packaging and final distribution needs.

Mega Medical Complex Opens in San Francisco’s Mission Bay

The new UCSF Medical Center is actually three hospitals in one.

The University of California at San Francisco Medical Center officially opens an 878,000 sq. ft., six-story complex at UCSF’s 60.2-acre Mission Bay research campus that includes three state-of-the-art hospitals with a total of 289 beds. Ten years in the planning, the new medical center started construction in December 2010. It has approximately 300 employees and 500 physicians. About $600 million of the complex’s $1.5 billion cost was raised from private donors, including venture capitalist Ron Conway, who contributed $40 million to the complex’s 207,500 sq. ft. outpatient medical building with 180 exam rooms, which is expected to serve 1,500 outpatient visitors daily.

All told, the new medical complex anticipates 122,000 outpatient visits in its first year, 5,380 outpatient surgeries, 4,272 inpatient surgeries, and between 2,600 and 2,700 births. The new medical center focuses on caring for children, women, and cancer patients.

The UCSF Benioff Children’s Hospital San Francisco, with 183 beds that include a 50-bed neonatal nursery, handles all pediatric inpatient visits. The new facility includes a fully accredited K-12 school, and media platforms for room service, Skype, and social media.

The 36-bed UCSF Betty Irene Moore Women’s Hospital is the region’s first dedicated women’s hospital. And the 70-bed UCSF Bakar Cancer Hospital serves adult patients with orthopedic, urologic, gynecologic, head and neck, gastrointestinal, and colorectal cancers.

Among the technologies available at this medical center are telemedicine, robotics, and intra-operative imaging.

The complex includes 4.3 acres of green space, 60,000 sq. ft. of rooftop gardens on the third, fourth, and fifth floors; a 99,000 sq. ft. public plaza on Fourth Street; and 1,049 available parking spaces.

The location of the medical center on UCSF’s Mission Bay campus puts its physicians in close proximity to researchers and new biotechnology and pharmaceutical companies in the area. The new cancer hospital, for example, sits near the UCSF Helen Diller Family Cancer Research Building, where leading scientists are seeking causes and cures for cancer.

“The location was key to bringing the three hospitals together,” says Herb Moussa, AIA, LEED AP, Principal at Stantec Architecture, the project’s lead architect. (The Building Team included Cambridge CM as project and construction management consultant; William McDonough+Partners as Associate Architect; DRP Construction as general contractor; Rutherford & Chekene as the hospitals’ structural engineer; ARUP as structural and MEP engineer; CSW Stuber-Stroeh Engineering as civil engineer; EDAW AECOM as landscape engineer; and Teecom Design Group for communications.) All told, there were more than 200 architects, engineers, and contractors on this project. Moussa says they all worked at the nearby Integrated Center for Design and Construction. “Being able to work collaboratively made things go so much easier,” he said, in terms of addressing problems and issues. For example, the client decided that the interiors for the hospitals were too disparate, and wanted their look and color palette to be more uniform. That required “quite extensive” changes, says Moussa, which would have been even more complicated had the Building Team not been working closely.

This project’s challenge, he says, was to give each hospital its own identity without undermining the complex’s conceptual design and functionality. So there are separate entrances for adults. The children’s hospital is turned 10 degrees from the rest of the complex and has its own entrance, canopy, and drop-off area.

Moussa has spent most of his career designing hospitals, but this is his first with a pediatric building. He has a special affinity for Benioff Children’s Hospital, which in April 2010 treated his then nine-year-old daughter Sarah for swelling of the brain and seizures brought on by a sinus infection that spread to her eye. Moussa kept a journal of his daughter’s treatment, which he says informed his design of the new medical center. “It gave me an appreciation of what this hospital wants to be.”

A few days before opening its Mission Bay complex, UCSF Medical Center signed a letter of intent with Fresno-based Community Medical Centers to expand women’s and children’s services to California’s Central Valley, which has an undersupply of specialists.

SAFC Expands Irvine Facility

SAFC Commercial, a branch of the Sigma-Aldrich Corporation, recently announced they are expanding their facility capabilities to provide redundancy to the dry powder manufacturing supply chain. The dry-powder milling and blending for cell-culture media that occurs at the Lenexa, Kansas facility will also occur in the Irvine, Scotland locations. Liquid cell-culture media, buffers, and reagents are already prepared at the Irvine site.

The facility expansion will allow SAFC to create shorter lead times, increase storage capacity for finished goods, and support projects from “early clinical development through commercial scale using a globally consistent approach across all cell culture media manufacturing sites,” said Gilles Cottier, president of SAFC.

The Irvine expansion, announced in March 2013, was initiated as part of a five-year capital investment plan designed to support SAFC customers with critical products and services across the globe. Now fully validated, the site acts as the European counterpart to the Lenexa, Kansas, Center of Excellence for cell culture media manufacture and supply in the U.S.

SAFC's new dry powder milling and blending capabilities in Irvine are animal component-free and complementary to the liquid cell culture media, buffers and reagents that were already featured at the site.

"Irvine is one of the most modern and fit-for-purpose media facilities in the industry. With the expansion complete, SAFC is unique in its ability to support projects from early clinical development through commercial scale using a globally consistent approach across our cell culture media manufacturing sites in Irvine, Scotland; Lenexa, Kansas; and St. Louis, Missouri," Cottier said.

The site expansion concentrated on creating shorter lead times, improving flexibility and giving customers access to real-time information. Efficiencies in throughput and responsiveness were achieved by decoupling manufacturing processes and focusing on supply logistics, while progressive technologies for in-line monitoring and a process intelligence data historian system deliver transparency.

Storage capacity was also expanded, creating new material and finished goods warehousing space.

All construction work completed at the Irvine facility fully complies with appropriate U.S. FDA and EU cGMP requirements, as well as local safety and environmental regulations.

Prosolia expands Capacity

Prosolia, Inc. has announced that it had re-located operations to a new facility in Northwest Technology Center in Indianapolis, Indiana and that the company had received ISO 9001:2008 certification. The new facility includes office and production space, as well as, a state of the art mass spectrometry laboratory featuring Thermo Fisher Scientific and Waters mass spectrometers where it conducts research and customer demonstrations. The Quality Management System certification covers all of the company’s design, development, manufacturing and sales activities concerning equipment and associated services.

Certification to the ISO 9001:2008 standard requires an accredited third-party auditing organization to thoroughly review the Company’s policies, processes and procedures to ensure the company is committed to continuous improvement with a customer focus.

“Prosolia’s new office, production and laboratory facilities have allowed us to increase our capabilities in key areas that align with our current and future growth plans,” stated Justin M. Wiseman, Chairman, President & CEO of Prosolia. “Achieving certification to the ISO 9001:2008 quality standard is another important milestone for Prosolia and validates our unwavering commitment to developing and producing quality products and continuous process improvement.”

A bottleneck in life science research and chemical analysis is the time required for sample preparation. Sample preparation can be a tedious process that often involves multiple steps, delaying the time to a result, decreasing productivity and increasing the probability for error. Prosolia’s products eliminate this bottleneck by enabling direct, automated analysis of samples thereby reducing the requirement for extensive sample preparation and enabling faster time to results. These capabilities translate into lower laboratory operational costs and streamlined workflows.

Ash Stevens’ Riverview Facility Gains FDA Approval

Ash Stevens, Inc. has received FDA approval for its facility in Riverview, MI for the manufacture of Amotosalen, the API in Cerus Corp.'s (CERS) INTERCEPT Blood System. The INTERCEPT Blood System recently received FDA approval for ex vivo preparation of pathogen-reduced plasma and platelet components in order to reduce the risk of transfusion-transmitted infection (TTI).

"We are proud to be Cerus Corp.'s outsourcing partner for the development and manufacture of this important API. We have had a collaborative and highly productive relationship with Cerus for many years and we are excited to help provide this innovative product to patients," said Dr. Stephen Munk president and chief executive officer of Ash Stevens.

Dalton Expands Capabilities

Dalton Pharma Services has expanded its cGMP sterile powder filling capabilities with the addition of a high-speed automated sterile powder filling line to fill large commercial batches of vials. The new cGMP equipment will be installed in a dedicated suite with local Class A environment and isolator style containment.

The company is also adding intermediate scale cGMP sterile powder filling equipment to produce small to medium sized clinical trial batches. This mid-scale equipment will also be operated under a Class A environment and containment system. The new sterile manufacturing capacity is semi-automated and provides 100% check weighing for batches up to 10,000 vials, according to the company.

"The strategic decision to invest in specialized sterile powder filling was driven primarily by the demand in this market globally and by our existing customers," said Peter Pekos, chief executive officer and president, Dalton Pharma Services. "The significant investments we are making in these sterile manufacturing and development capabilities allow Dalton to maintain its leadership position in sterile powder manufacturing, and accelerate the application of these innovations to the leading-edge commercial pharmaceutical products of our customers."

SGS Completes West Chester Facility Expansion

SGS Life Science Services has completed the expansion of its facility in West Chester, PA, adding new instruments for advanced analytical techniques that have been installed and validated to support the structural analysis of proteins.

Traditionally, the West Chester facility has offered primary protein and glycosylation structural analysis, in addition to Circular Dichroism, used to determine secondary protein structure. The recent expansion includes Analytical Ultra Centrifugation (AUC) for determining protein aggregation, size exclusion chromatography with multi-angle laser light scattering for establishing molecular weight profiles, and Fourier transform infrared spectroscopy (FTIR) to examine protein secondary structure.

The facility now mirrors the company’s capabilities at its site in Wokingham, UK, including investigation of lot-to-lot variations, biosimilar comparability, and shipment excursion studies to monitor the stability and sensitivity of biological molecules under various storage conditions.

“This investment will allow SGS to keep up with our clients’ ever growing pipelines for biological therapeutics, and also for the numerous biosimilars under development,” said Mark Rogers, Senior VP, Life Science Services, SGS North America. “We have seen the demand for these services increase and, with the impending changes to legislation for marketing biosimilars, we envisage that the need for these analyses, in order to demonstrate similarity, will continue to grow.”

The investment follows increased analytical capabilities at its facilities in France, China, UK, India and the U.S.

Hackensack UHN and Seton Hall University to Form School of Medicine

Hackensack University Health Network (HackensackUHN) and Seton Hall University (SHU) announced that the two institutions have signed a memorandum of understanding to form a new, four-year school of medicine. This partnership will establish the only private school of medicine currently in the state and provide a significant economic boost to the region. The school intends to locate on the campus of the former Hoffmann-La Roche Inc. (Roche), a state-of-the-art biomedical facility, in Nutley and Clifton, New Jersey.

Establishing a school of medicine with the backing of two esteemed institutions will attract the best and brightest to the field of medicine in the State of New Jersey and help curb the critical physician shortage that the state and the nation currently face. By2020, it is estimated there will be a shortage of 2,500 physicians in the Garden State. HackensackUHN and SHU's joint venture to create a premier academic institution will help combat the physician shortage by providing key educational, research, and career opportunities to incentivize the next generation to pursue a career in medicine.

"We are excited to be taking this next step with Seton Hall University. Our academic reputations, combined with our clinical expertise, will guarantee the establishment of a world-class academic institution in the Garden State," said Robert C. Garrett, president and CEO of HackensackUHN. "New Jersey has long been known as a home to the healthcare and pharmaceutical industries, and it is imperative we continue to support our future workforce through a premier school of medicine."

"Seton Hall University has always been committed to academic excellence and servant leadership, Hackensack University HealthNetwork has always been committed to healthcare excellence," said Dr. A. Gabriel Esteban, president of Seton Hall University. "As a Catholic university with strong programs in the sciences, nursing, health and medical sciences, and health law, we are perfectly poised to create a school of medicine that will educate talented people in the diverse fields of healthcare." Garrett added, "The school of medicine will create thousands of highly skilled jobs for New Jerseyans in the years to come, attracting new businesses to relocate to our great state to take advantage of our highly skilled workforce. I look forward to partnering with Seton Hall University to making this school of medicine among the best in the nation."

The school of medicine will be committed to educational and healthcare excellence, cutting-edge research, high quality care, and the advancement of medical and health science educational imperatives.

Seton Hall's plan to integrate their nursing and allied health programs with the new school of medicine is not only innovative but mirrors how healthcare will be delivered in the future.

HackensackUHN's hospitals will serve as the primary clinical teaching sites for SHU and SHU-affiliated graduate education programs. Access to HackensackUHN's premier healthcare facilities and training programs will provide hands-on experience and incentivize highly-trained researchers and physicians to live and work in New Jersey upon graduation. The first class is expected to begin within the next three years.

"HackensackUHN and Seton Hall's vision to create this school of medicine is truly inspirational. Repurposing Roche's premier state-of-the art facility for this purpose is an excellent fit troche’s purpose of 'Doing now what patients need next,"' said Tom Lyon, vice president and site head, Roche. "Creating a pipeline of future healthcare professionals truly embodies Roche's vision and continues the positive healthcare-related legacy for the local communities. As we divest the site, we look forward to working withHackensackUHN and Seton Hall and the ultimate new owner of the Roche campus to help make the new school of medicine a reality.“

Subject to the New Jersey Economic Development Authority (EDA) approval, an agreement is expected to be finalized in early 2015.

DPT Enhances Capabilities with New High-Speed Filling Center

DPT Laboratories, a Contract Development and Manufacturing Organization (CDMO) specializing in semi-solid and liquid dosage forms, announces the implementation of a high-speed bottle filling center at its San Antonio location.

“We’re committed to investing in new capabilities and expanding services for our customers”

One of three DPT Centers of Excellence, the San Antonio location is purpose-built for semi-solids and liquids to support comprehensive pharmaceutical manufacturing needs. The new high-speed bottle filling center provides large-scale production capacity, and maximizes efficiency.

“We’re committed to investing in new capabilities and expanding services for our customers,” said Lyle Flom, Vice President and General Manager, San Antonio Site Operations. “The addition of this high-speed filling center supports current demand, provides for future growth and helps DPT maintain its leadership position in semi-solid and liquid manufacturing.”

The new line significantly increases the rate of production for finished goods bottle manufacturing — up to 200 units per minute — and creates opportunities for growth in its large scale bulk manufacturing areas. With increased throughput capability, DPT now has the opportunity to provide bright stock supply chain services to clients seeking an external solution to their private label manufacturing needs.

“Our regulatory and customer service track record speaks to our ability to effectively deliver our customer’s production needs today. This high-speed filling center will enhance that ability for years to come,” said Flom.

As DPT’s Center of Excellence for Semi-solids and Liquids, the San Antonio location provides cGMP pilot, clinical and commercial scale manufacturing for prescription and over-the-counter products. It includes a 60,000-square-foot cGMP aerosol manufacturing facility, a 225,000-square-foot raw material dispensing and distribution center and a 150,000-square-foot compounding, fill and finish area.

L.S. Skaggs Pharmacy Institute, University of Utah

Utah College of Pharmacy has been ranked among the top four institutes in the US by the National Institutes of Health (NIH)

L.S. Skaggs Pharmacy Institute is a new research facility opened in April 2013 for the College of Pharmacy at the University of Utah (U of U) in Salt Lake City in the state of Utah itself, US.

The institute is dedicated to interdisciplinary research and development of new drugs for the treatment of diseases such as osteoarthritis, cancer and epilepsy, as well as wound healing. It is part of the Health Sciences Center of the University of Utah.

The pharmaceutical research complex is named in the honor of Leonard Samuel Skaggs, who along with his family's ALSAM Foundation, contributed about $50m towards the new research Centre, in 2007.

Construction of the facility was started in August 2009 and concluded in April 2013. The project cost more than $75m.

"The project included construction of a new 30,000 sq. ft., five-story Pharmacy Research Building on the site of a former car parking lot."

The Utah College of Pharmacy has been ranked among the top four institutes in the US by the National Institutes of Health (NIH). It is also the second best in pharmaceutical research productivity (only behind the University of California) and received $23m from the NIH in 2011.

The institute has so far screened 30,000 epilepsy compounds leading to the development of 11 new medications for the disease through the Anticonvulsant Drug Development Program. The college also provides research on new medication and drug delivery systems.

The new facility has been a long delayed plan of the University of Utah to provide additional state-of-the-art wet and dry research laboratories for the College of Pharmacy.

The new building provides improved lighting, electrical and cooling systems to facilitate installation of larger equipment and enable rigorous research experiments to take place.

The project included construction of a new 30,000ft², five-story Pharmacy Research Building on the site of a former car parking lot. It is situated adjacent to the existing Skaggs Hall, the Pharmacy College facility built in 1965. The building was built with contributions from L.S. Skaggs, Sr.

The new pharmaceuticals research facility added two levels of unfinished open laboratory space, open research laboratories on another two floors, offices and conference rooms, a vivarium, a translational Centre, computer imaging laboratories, one level of underground parking, utilities and support spaces. It also accommodates the Utah Poison Control Center.

A new glass atrium connects the new facility with L. S. Skaggs Sr Hall and provides spaces for faculty and students to gather in the cafe or in small lounge areas. The four floors of atrium space have elevators and meeting and studying areas. The fourth floor houses a state-of-the-art call Centre and office suite for the Utah Poison Control Center.

The atrium also features an amphitheater for presentations and other events at its west entrance. It is anticipated to promote scientific and medical interactions. It will also provide structural stability for the existing hall. The entire complex is renamed as the L.S. Skaggs Pharmacy Institute.

The 150,000 sq. ft. research and educational complex brings together six different department facilities of the college lying across the campus under one roof. The facilities to be integrated include the department of Pharmaceutics and Pharmaceutical Chemistry, Pharmacotherapy, Pharmacology and Toxicology and Medicinal Chemistry.

The new laboratory facility is expected to consume nearly 30% less energy than similar university facilities. It is also expected to save about 79% of the domestic water through reuse techniques.

The building also features energy saving façades, shading systems, sensors, roof insulations and HVAC systems. It is anticipated that it will achieve LEED Gold certification.

James L. Sorenson Molecular Biotechnology Building, Utah

University of Utah's new innovation Centre, the James L. Sorenson Molecular Biotechnology Building, was officially dedicated in 2012.

NBBJ Architects and EDA Architects were selected in 2009 to design the facility.

The NBBJ/EDA joint venture was also the master plan designer of the pharmacy campus.

Construction of the building was carried out by Jacobsen Construction under a $54m contract with the State of Utah.

Van Boerum & Frank Associates (VBFA) was the mechanical engineer and Envision Engineering was the electrical engineer.

Psomas was the civil engineering consultant. ArcSitio was the landscaping engineer. Atelier Ten was the environmental design and building services consultant.

Other consultant engineers included Gale Bate, Colin Gordon, Dunn & Associates, Spectrum and CCP.

Georgia Tech, Engineered Biosystems Building, Atlanta

Georgia Tech’s Engineered Biosystems Building will provide 218,880 sf of flexible interdisciplinary lab space for researchers collaborating in the fields of chemical biology, cell therapies and systems biology. A principle goal of the design is to foster interaction between chemists, engineers, biologists and computational scientists from two separate colleges: the College of Engineering and the College of Science.

The building is developed with a highly utilized equipment corridor securely linking vertical circulation to every lab and support space while allowing wide transparency into research labs. The vivarium is located in the building’s basement, allowing for more transparent and publicly accessible spaces to occupy the ground level. Core facility access and expansion are critical to the success of interdisciplinary bioengineering facilities and have been carefully accounted. The vivarium incorporates a network of underground tunnels to enable future facility expansion. The project is seeking LEED Gold certification.

Project team was Georgia Institute of Technology (client/owner); Cooper Carry (architect/interior design).

The facility was completed in 2014.

Platinum Press to Open New Packaging Facility in NJ

Platinum Press, Inc. (PPI), a provider of healthcare packaging solutions for the pharmaceutical, medical device and animal care sectors, has acquired a new 60,000 sq.ft. packaging facility in Pine Brook, NJ, with approximately 55,000 sq.-ft. dedicated to manufacturing and operations, and 5,000 sq. ft. for office use.

The new facility will be fully equipped and staffed to produce the same printed packaging components as its headquarters in Grand Prairie, TX. The new plant will offer digital, flexographic and lithographic printing capabilities, including several large format insert/outsert folders. PPI expects the facility to become fully operational in 1Q15, and will employ approximately 40 packaging professionals.

“Many of our clients’ pharmaceutical packaging components are currently being shipped into the NY/NJ area,” said Tom Miller, president and chief executive officer of Platinum Press. “Opening a New Jersey facility with the same capabilities as our Texas plant will ensure complete redundancy, reduce shipping costs, improve turnaround time and alleviate weather-related shipping/production issues. The new Pine Brook, NJ location will also allow us to strengthen our position in the northeast market and better serve our expanding customer base.”

LSNE Successfully Completes PAI

LSNE recently completed a successful Pre-Approval Inspection (PAI) at its facility in Bedford, NH, with no Form 483 issued, and no observations noted by the FDA.

The site received approval to manufacture a commercial drug product for U.S. distribution. The facility is dedicated to the aseptic filling and lyophilization of a product that is currently on the market.

We are very happy with the positive results of the latest FDA inspection, which is another important milestone and further adds to our successful regulatory history. This approval is the culmination of years' worth of preparation and diligence and this success helps position us for our future growth. Specifically, we are looking to expand our analytical capabilities to better support all of our client's needs,” said Shawn Cain, chief operating officer, LSNE Contract Manufacturing.

LSNE has added capabilities across its three sites in 2014, and in 2015 plans to expand QC analytical testing capabilities, ICH stability chambers, add complex/potent compound handling capabilities, as well as increase manufacturing capacity.

Hospira to Close Clayton, NC, Production Plant

Hospira ($HSP) is making cuts to its manufacturing network. The Lake Forest, IL-based drug maker plans to close its facility in Clayton, NC, in June at a cost of up to 250 jobs and $15 million in severance payments and other employee-related costs.

Clayton has fared better than some of Hospira's other plants from a quality perspective--it overcame the technical barriers to reintroducing THAM and the FDA made no observations in a 2013 inspection--but the economics no longer make sense for the company. Hospira manufactures four products at the facility. Having forecast future demand for the products, analyzed the Clayton plant and assessed available capacity at other facilities, Hospira has decided to exit the site.

Production of the four drugs will now be discontinued or transferred to other facilities, either within Hospira's network or at third parties. Hospira expects the action to result in pretax charges of $45 million, one-third of which relates to payments for severance, retention and other employee-related costs. Hospira employs 250 people at the site, some of whom may find new roles within the company. Help is available for workers interested in transferring to other sites.

REST OF WORLD

Delta-IBN Life Science and Diagnostics Lab Opens at Biopolis

Delta Electronics INT’L and the Institute of Bioengineering and Nanotechnology (IBN) of A*STAR have announced the official opening of the Delta-IBN Life Science and Diagnostics Lab at the Biopolis. The lab aims to develop next-generation infectious disease detection kits through collaborative research projects undertaken by Delta, IBN, and local universities. Mr. Lim Chuan Poh, Chairman of A*STAR, was the Guest-of-Honor and officiated the opening ceremony together with Mr. Ping Cheng, CEO of Delta Electronics, and Prof. Jackie Y. Ying, Executive Director of IBN.

The Delta-IBN Life Science and Diagnostics Lab brings together IBN’s strengths in medical diagnostics, microfluidic systems and biological assays, and Delta’s expertise in microelectronics, optical devices, and global operations. The lab will focus on developing enabling technologies for improved infectious disease detection and personalized medicine. Current diagnostics require a long processing time and extensive, specialized laboratory equipment, and the lab will develop portable miniaturized all-in-one systems to provide on-the-spot, real-time detection results.

Due to the rapid growth in urbanization and globalization, the world is facing unprecedented challenges in providing healthcare. These challenges also bring forth strong demand for smart biomedical platforms, offering various opportunities in medical diagnostics, including in vitro diagnostics, imaging diagnostics, and vital sign monitoring. Delta believes that data generated from these smart platforms can be analyzed collectively to produce insightful information and knowledge for better healthcare.

The Singapore government’s commitment to develop the biomedical and life sciences industries corresponds with Delta’s belief in the biomedical sector’s future growth. This, coupled with Singapore’s political and economic stability, as well as its large, highly-skilled, and innovative workforce, makes Singapore an extremely favorable location for Delta to set up its R&D facilities.

The Delta-IBN Life Science and Diagnostic Lab is expected to have over 50 Delta staff, who will work on joint projects with IBN researchers. The lab has also started research programs with universities, such as Nanyang Technological University and the Singapore University of Technology and Design.

FEI and National Center for Protein Sciences Beijing Launch Training & Research Facility

FEI and the Tsinghua University Branch of National Center for Protein Sciences Beijing announce a collaboration to establish a joint new training and research program for cryo-electron microscopy (cryo-EM) in structural biology. With this joint program, the center will feature the first complete cryo-EM workflow in Asia for molecular and cellular structural biologists.

Cryo-EM has achieved a methodological breakthrough to structurally analyze a wide variety of protein complexes at atomic resolution level. This has been a very challenging and nearly impossible task with existing structural technologies, such as crystallography (XRD) and nuclear magnetic resonance (NMR), due to their technical limitations. This largely uncharted field can now be addressed with cryo-EM, and many new researchers will likely be entering the field. The Beijing center's training and research program will be developed specifically to meet this educational need in Asia.

"The ability to integrate three-dimensional (3D) molecular-scale information from cryo-EM with XRD results as well as NMR data enables researchers to visualize and understand the relationship between structure and function of molecular complexes that may hold the key for central biomedical questions," states Peter Fruhstorfer, FEI's vice president and general manager of Life Sciences. "Thus, the boundary conditions are created to gain ground-breaking new insights into the way living systems function, and may lead to promising pathways for the development of effective new medicines and other personalized molecular therapies."

"We are very enthusiastic about adopting FEI's workflow solutions into our core facilities," says Prof. Hongwei Wang, Tsinghua University. "This is a unique opportunity to establish a key collaborative reference site for China and the entire South-East Asia region. The adopted workflow solution opens the door to understanding the structure and function of whole classes of proteins and protein complexes that are simply beyond the capabilities of NMR and XRD alone. An integrative approach that incorporates cryo-EM enables us to begin to look for answers to some of the most important biological questions of our time."

Prof. Wang adds, "This collaborative effort with FEI to establish a training program at Tsinghua University is a key step in developing the talented and knowledgeable researcher community we need to pursue and maintain leadership in this field."

Cryo-EM allows researchers to look at large proteins and protein complexes frozen in a near-natural state. In integrative structural biology, EM provides the larger, molecular-scale context for the atomic-scale results of XRD and NMR. FEI's unique workflow approach addresses all phases of the cryo-EM analytical process, including: sample optimization; cryo-sample preparation; image/data acquisition; image/data analysis; three-dimensional structural modeling; visualization; and presentation. The workflow is built around FEI's Titan Krios™, a highly automated, cryo-transmission electron microscope (TEM) designed specifically to meet the needs of structural biologists. In addition to cryo sample handling, the Titan Krios provides the long-term stability and unattended operation required for structural analyses, which may involve hundreds of thousands of images acquired over several days.

The Titan Krios TEM installed at Tsinghua University includes an integrated phase plate, which is a stable, durable solution that increases the contrast of sensitive biological samples and is available on most TEM platforms from FEI. A CorrSight^™ system will also be installed at Tsinghua, which is an advanced light microscope that integrates support of multiple workflows for correlative experiments. It enables quick chemical fixation directly from a live cell imaging experiment for subsequent analysis at the ultra-structural level. In addition, it also allows fluorescence imaging of cryo samples at high resolution to allow for identification of potentially interesting regions in the sample for analysis by cryo-EM.

Aesica Continuing FDA Approval for Manufacture and Packaging Sites in Germany

FDA inspection results means Aesica will continue to grow its manufacturing and packaging services for pharmaceutical products for the US market

Aesica, the global pharmaceutical contract development and manufacturing organization (CDMO), a division of Consort Medical plc, announces it has received continuing FDA approvals for both its bulk manufacturing and packaging operations in Germany. As a consequence, Aesica can continue to grow its manufacturing and packaging services for pharmaceutical products destined for distribution and export to the strategically important US market.

The approvals follow the successful FDA pre-approval inspections of the Zwickau site, which bulk manufactures pharmaceutical tablets, capsules and controlled release products; and the Monheim site, which houses logistics and distribution centers. In addition, both sites have also secured successful inspections from ANVISA for the Brazil market as well as from the German Health Agency.

Dr. Werner Schick, Aesica’s General Manager, Germany, commented: “We are extremely pleased that the FDA continue to approve our German sites for bulk manufacture and packaging. This is a testament to the quality of the technology, services and people at both of our German facilities.”

“These approvals will allow Aesica to substantially grow its contract manufacturing and packaging services for supply of pharmaceutical products to the US market.”

Zwickau manufactures in excess of 90 products produced from over 40 different APIs and has on-site process development and QC laboratories. At Monheim, Aesica currently completes packaging for 1100 SKUs, produced with multiple indications for all geographic markets.

SAFC Dry Powder Media Manufacturing Plant, Scotland, United Kingdom

SAFC, a business unit of Sigma-Aldrich Corporation, has opened a new dry powder media (DPM) plant at its Irvine manufacturing facility in Scotland, UK, in January 2015.

The new plant features two separate manufacturing lines that produce ACF dry powder media in batches.

The expansion adds dry powder milling and blending capabilities to the Irvine plant, which is an established center of excellence for manufacturing liquid media, buffers and reagents for the biopharmaceutical industry.

In addition, the facility features dry powder cell culture media to produce large-scale bulk dry powder media and reagents. It is designed to cater to the growing biopharmaceutical industry in European and Asia-Pacific markets.

The validated new plant now serves as the European counterpart to SAFC's center of excellence for dry powder media, and reagent manufacturing in Lenexa, Kansas.

The new state-of-art DPM manufacturing facility features warehouses with temperature-controlled storage areas for raw material and finished goods. Warehouses will be continuously monitored using a Facility Monitoring System (FMS).

The facility has new formulation suites with humidity control to support product lot formulation from small to large scale. Rooms will be continuously monitored for efficient operation. All process rooms in the plant have dedicated heating, ventilation and air conditioning (HVAC) systems where appropriate, and are controlled environmentally.

All equipment hold validated cleaning processes, including clean-in-place processes for fixed equipment and pipe work, clean-out-of-place processes for wash room, and an automated intermediate bulk container washer.

The facility also features a purified water plant and distribution loop producing European / US Pharmacopoeia grade water. Clean, compressed air and clean nitrogen will be supplied and distributed throughout the plant.

Manufacturing facilities, processes and technology at the new plant are similar to those at the Lenexa facility to ensure consistency in production quality at both sites.

The entire construction work at the facility complies with US Food and Drug Administration (FDA) and EU current good manufacturing practice (cGMP) regulations, and also with local safety and environmental regulations.

The plant produces animal component-free (ACF) media, which is complementary to the liquid cell culture media, buffers and reagents already being produced at the site.

In addition, the plant features two separate manufacturing lines. Line 1 is a pin type mill with a conical, auger screw pre-blender and tumble post-blender, capable of producing ACF dry powder media batches from 750kg to 6,000kg.

Line 2 is also a pin type mill with tumble pre and post-blenders, capable of manufacturing dry powder media batches from 25kg to 750kg.

The extended facility has been designed to meet increasing demand for integrated pharmaceutical development and commercial services.

SAFC's Irvine facility is an 118,360 sq. ft. (11,000m²) cGMP manufacturing facility featuring liquid production facilities, quality control laboratories, and temperature-controlled warehouses.

Core technologies at the plant include automatic aseptic filling of bottles and bags, validated steam-in-place (SIP) clean-in-place (CIP) and flexible manufacturing systems, as well as disposable systems, and a wide range of testing capabilities for raw materials and finished goods.

The plant manufactures custom and catalogue formulations, liquid media, reagents and downstream purification buffers of pack sizes from 5ml to 500l, and batch sizes up to 10,000l (bags) and 6,000l (bottles).

SAFC, which provides products and services for use in regulated pharmaceutical and biopharmaceutical applications, is one of the world's top ten chemical and biologics suppliers.

The company's product portfolio includes high-purity inorganic materials for high technology applications, raw materials and biologics safety testing services for biopharmaceutical manufacturing, and high-potent APIs and key intermediates for pharmaceutical manufacturing.

G-CON Manufacturing Selected to Build ISO 5 POD for Instituto Butantan

G-CON Manufacturing has been selected to build an ISO Class 5 POD for Instituto Butantan, a biomedical research center.

Instituto Butantan, based in Sao Paulo, Brazil, ordered the POD for use in clinical production of recombinant BCG, a product intended to be an improved treatment for bladder cancer.

Instituto Butantan is purchasing a standard size POD that is 3.66m x 12.80m x 3.51m.

The POD is designed to provide approximately 312 sq. ft. of cleanroom space, with a custom configuration for the filling and finishing of the clinical product.

This POD will be the first project to be delivered internationally by G-CON.

G-CON will provide shipping, delivery and installation of the POD. The company is also working with Instituto Butantan on other opportunities for applying PODs to help meet their future manufacturing needs

National Center for Single-Cell Research Established in Sweden

Science for Life Laboratory (SciLifeLab) has created the Swedish National Center for Single-Cell Biology, equipped with instruments from Fluidigm, the company said.

The new center will have six C1 systems, three CyTOF 2 mass spectrometry platforms, and one Biomark HD system. It will operate as three complementary nodes with one node located in Stockholm for the high-throughput streamlined microfluidics-based transcriptome and genome analysis of large numbers of individual eukaryotic cells.

The Stockholm site will offer single-cell RNA-seq on the Fluidigm C1 platform using the STRT protocol and a microtiter-plate format using SMART-seq2, Fluidigm said. The node will also offer single-cell DNA analysis. The facility will have four employees and is expected to be accessible to outside users in mid-2015. The Swedish National Infrastructure for Computing will provide computational resources.

Another node will be located in Uppsala for flexible, high-capacity single-cell genomics for smaller microbial cells, Fluidigm said. The third node, also in Uppsala, will be a proteomics facility based on multiplexed protein quantification technology.

SciLifeLab is a collaboration between Karolinska Institute, KTH Royal Institute of Technology, Stockholm University, and Uppsala University aimed at developing new scientific methods and workflows.

Pirbright Institute’s Biocontainment Facility

The novel scheme turns the typical containment lab building inside out, placing the high-containment spaces at the perimeter.

Warm materials, splashes of color, pleasing proportions, and lively design elements combine to create an informal, nonscientific aesthetic for the facility. The lab wings are clad in Siberian larch timber articulated by punched windows with colorful surrounds.

In the world of containment facility design, where safety protocols and engineering performance standards ultimately trump all other programmatic considerations, government agencies and research institutions have applied the same basic formula when planning their most sensitive facilities: build a box within a box and establish a series of strict safety protocols to ensure that any nefarious agents can’t get out—or in.

This bunker-like, box-in-box approach has been the template for decades—it just works. But is it truly the most efficient and effective way to conduct research? Does it offer a workplace that inspires its researchers and scientists to do better work? Does it foster the level of collaboration that today’s leading research institutions are pushing for? Does it help attract and retain the most talented researchers?

These are the questions that the leadership team at the Pirbright Institute—the world’s leading research agency in the study of foot and mouth disease and other viral diseases of livestock—pondered when planning its new Category 4 biocontainment facility (roughly equivalent to BSL-3 Enhanced standards in the U.S.) in the countryside of Surrey, England.

Formerly housed in a series of outdated, uninspired buildings spread throughout the campus in Surrey, Pirbright’s containment labs were inadequate and lacked the level of environmental control required for cutting-edge research. The institute looked to consolidate its facilities into a flagship building. Pirbright wanted to rewrite the formula for containment lab design by creating a facility that would be truly open, with daylight and views for everyone in the building (even those working in the most stringent containment zones), highly collaborative workspaces, areas of respite, and spaces for all-staff symposiums and meetings. Most importantly, the Biotechnology and Biological Sciences Research Council (BBSRC), as the strategic investor in the Pirbright Institute, wanted a lab that would breed new, inspirational science by bringing its researchers closer together.

Floor-to-ceiling windows flood the high-containment labs with natural light and offer scenic views of the Pirbright Institute campus. Extensive use of interior glass throughout the facility brings daylight further into the interior and creates a sense of connectivity among the spaces.

“Ultimately, I want to be able to say that I was involved in creating a building that led to the discovery of a breakthrough vaccine or a new approach to science,” says Alex Hewitson, Program Director and Head of Campus Delivery Program with BBSRC, the quasi-governmental agency that manages and funds the Pirbright Institute, along with seven other research groups across the U.K.

“Scientists have real down time, and they need this time to talk to other scientists,” says Hewitson. “We wanted a containment facility where scientists could come together in areas of research that currently lie untapped or unthought of.”

The institution needed a world-class Building Team that could execute its audacious plan. AECOM was brought on board as the project manager for the team: HDR (design architect/lab planner), Shepherd Group (design-builder), AECOM Engineering (SE/MEP engineer), Turner and Townsend (cost consultant), and Merrick & Co. (validation and commissioning consultant).

The design team’s radical plan for the 150,000 sq. ft. biocontainment facility—officially called the BBSRC National Virology Centre Plowright Building—centers on the basic idea of humanizing science. The scheme literally turns the typical containment lab building inside out. Work and collaboration zones—offices, conference rooms, and cafeteria—are at the center of the building; the high-level containment labs are at the perimeter. The lion’s share of work and meeting spaces is located within the containment zones, including a portion of the main cafeteria. This configuration greatly reduces the number of times researchers must transfer in and out of containment in a typical workday.

“When the researchers change out of their street clothes and gown-in each morning, they can do anything they need to do without having to leave the containment area—they no longer have to go back and forth 10 to 12 times a day,” says Brian Kowalchuk, AIA, LEED AP, Director of Design with HDR. “They’re required to shower out for five minutes at a time, so it’s a fairly robust and time-consuming routine to go in and out of containment. They’re saving a ton of time with the new facility, fostering a more productive environment.”

A dramatic, three-story, skylit glass atrium at the heart of the building—a feature virtually unheard of in containment facility design—offers views into the containment areas that surround the space. The building’s glass curtain wall, skylit atrium, and abundant interior glass flood the interior spaces with natural light and provide scenic views of the campus, as well as visual connectivity to the work occurring inside the building.

“This is the first time a modern, high-containment lab has been designed with external windows directly into the containment areas,” says Mark Halstead, Project Management Director and Head of Science and Innovation with AECOM. “Every lab has full-height windows. Compare that to the traditional containment facility, where many containment areas don’t have windows at all.”

The second floor houses a cafeteria, called the “canteen,” which offers seating both within and outside the containment barrier. A 15-foot-high glass wall divides the room, yet permits a visual connection between the two dining spaces. It also allows Pirbright to hold all-staff meetings and symposiums without requiring researchers to leave containment.

Transparency and daylight—along with lively design details like a helical staircase off the atrium and splashes of color throughout the interior—combine to create a sense of informality and well-being in a facility where potentially life-threatening research work is being conducted. Visual and physical barriers typical of a containment facility are broken down. The most striking examples are the atrium and the second-floor cafeteria, called the “canteen,” where a 15-foot-high glass wall is all that separates the containment dining area from the general eating area.

“For the first time, Pirbright will be able to host all-staff meetings and symposiums on site in these dramatic spaces at the center of the building—without researchers having to leave containment,” says Kowalchuk. “They can take lunch, attend a conference, sit down to write their lab notes, hold a meeting, talk on their cell phones—all within containment.”

Kowalchuk likens the building’s containment strategy to peeling an onion. In meeting the U.K.’s stringent SAPO (Specified Animal Pathogen Order) level 4 containment standards, the team applied a layered approach, based on the risk level—RS0 to RS4—of a given space in the facility. The design mirrors the level of risk with this layered approach.

“Researchers start at the center of the building, where the collaborative spaces in non-containment or RS0 are located, and work toward the outside of the facility, where the highest-risk spaces are located,” says Kowalchuk. “Transitioning from one risk level to another does not necessarily require staff to shower in or out—it may call for simply changing shoes or removing gloves and gowns.”

The building is engineered with a negative-pressure air cascade that flows from the least risky to the most risky zones to ensure that no infectious virus could get out. All air is filtered through HEPA filters. Non-solid waste is processed through an in-house effluent plant; solid waste is autoclaved or passed through a fumigation lobby, greatly minimizing the risk of viruses escaping the facility.

All collaboration spaces are located within the containment barrier surrounding the oval-shaped atrium. Conference rooms and a shared computer lab are on the ground floor; unassigned write-up space and conference rooms on the first floor; and the cafeteria and outdoor patio on the top floor. A helical staircase connects these central collaboration spaces. Containment areas within the atrium are accessible to all researchers in the facility, fostering cross-disciplinary interaction.

The design themes of informality and humanizing science are further reflected in the building’s exterior scheme. The lab wings are clad in Siberian larch timber articulated by punched windows with colorful surrounds. The timber cladding helps to break the façade into more pleasing proportions and incorporates the rooftop mechanical space running the length of the building. A metal brise soleil divides the south-facing façade. On the opposite side, the facility’s main entrance is adorned with a timber-framed, glass-roof canopy, providing a warm, inviting design element to greet staff and visitors.

HDR’s game-changing design posed a slew of thorny issues for the team, necessitating new building details specific to this project to be designed and tested by the architects, engineers, and constructors. The construction team, led by Shepherd Group Construction Director David Crampton, needed to:

Develop a durable containment barrier that could deliver very low air leakage rates—a task made infinitely more difficult given the copious amount of perimeter glass.
Meet ultra-tight construction tolerance requirements for the 2,182 stainless steel frames cast into the concrete frame to allow services, windows, and doors to pass through the containment barrier.
Achieve stringent air leakage standards (0.0091 per m3/m2/hr. at 200 pascal, both positive and negative pressure) throughout the contained labs.
Design and install a robust mechanical and electrical system with controls that had the resilience to maintain containment under failure conditions.

The Building Team invested $1.5 million—roughly 1% of the project budget—to construct a fully functioning, two-story, 1,600-sf mockup of a typical three-person lab unit. There, the team tested nearly every component of the building—from the seven-layer containment coating for the concrete walls, to the performance of the low-air-leakage-rated doors, to the fastening system for the lab benching, to the mechanical systems.

Using the mockup, the team was able to perfect a gasket system for the through-wall penetrations. It involved casting stainless steel frames into the concrete wall at each of the 2,182 penetration points. Penetration elements—windows, doors, service ducts—were then bolted to the frame with a neoprene gasket.

This approach provided a solution that meets the stringent air leakage performance standards and can be easily serviced and maintained over the building’s lifespan. “If a window breaks or they need to get at a maintenance point to perform service work, they can reinsert a gasket and achieve the leakage rate again,” says Crampton. “We’re not dependent in any way on silicon mastics, which deteriorate over time, for the seal. This approach is repeatable, replaceable, and maintainable.”

Other quality control and performance management procedures included:

Factory acceptance testing. Manufacturers of major equipment and systems, such as boilers, chillers, generators, treatment plants, and autoclaves, were sent test packs and were asked to perform specific tests of their equipment for the Pirbright team. “All too often, equipment does not work properly,” says Crampton. “We wanted to be sure that when a piece of equipment arrived on site, it could be plugged in and it would work. This allowed us to move into commissioning with verified equipment performance, greatly reducing the risk to this phase of the work and the subsequent activities leading to validation and licensing.”

Site-specific quality measures. Nine signatures were required before concrete could be poured on the site, including sign-offs from the mechanical and electrical subcontractors, who were tasked with double-checking the accuracy of MEP service penetrations. “We also developed pretty extensive management systems for the crimped pipework,” says Crampton. “We were able to identify the individuals who worked on every pipe joint in the building. That way if there was an issue, we could go back and inspect all the joints that individual worked on.”

Clean builder procedure. In an unusual move—but one that all Building Team members agree was vital to the success of the project—Crampton instituted a “clean builder procedure” for the job site. Before setting foot on the site, workers were required to change into all-white uniforms—overalls, boots, gloves, hard hats—and don a “TEAM PIRBRIGHT” badge. This lab-like approach to construction operations reinforced the critical importance of the scientific work that would be performed there. “We tried to create a village-like culture,” says Crampton. “We provided a well-lit, warm, inviting environment to work in and first-class restaurant facilities on the site.” They even organized activities like soccer tournaments.

Following more than a decade of planning and nearly four years of construction, the BBSRC National Virology Centre Plowright Building opened its doors to eager scientists on October 31. The Building Team delivered the game-changing facility under budget and a week early—no small feat, given the complexity and size of the project.

Hewitson says early feedback from the Pirbright staff has been positive. “Many who were skeptical initially are now endorsing the project,” he says. “Our researchers lived through years where the business of construction overshadowed the science, but now they can say Pirbright lays claim to the best containment facility in the world.”

5 Ways Pirbright’s New Facility Advances Containment Lab Design:

1. “Inside-out” layout flips the typical box-in-box containment facility, placing the collaboration, writeup, and dining spaces at the center of the building, and the labs along the perimeter.

2. Extensive use of exterior and interior glass floods the interior spaces with daylight—even in the most secure labs—and provides scenic views of the campus, as well as visual connectivity to the work occurring within the heart of the building.

3. Offices, conference rooms, dining areas, and respite spaces are located within the containment zones, minimizing the number of showers researchers must take every day.

4. Layered approach to containment protocol simplifies the procedures for entering and leaving containment zones.

5. Warm materials, lively design elements, and splashes of color humanize the spaces and create a bold, almost nonscientific aesthetic.

“At Pirbright, researchers are working in high containment for up to ten hours a day,” says Mark Bryan, HDR’s Principal Laboratory Planner on the project. “This new facility provides similar services and degree of comfort for everyone in the building, including those in high containment.”

Conference rooms and a shared computer lab are on the ground floor.

The facility’s main entrance is adorned with a timber-framed, glass-roof canopy, providing a warm, inviting design element to greet staff and visitors.

Researchers enter the containment areas through a locker room outside of containment, where they store their street clothes, shoes, and accessories (only eyeglasses are permitted) and change into sterilized undergarments, scrubs, socks, and shoes. To get into the labs, researchers walk into an ante-room air lock. They are required to put on a lab coat over their scrubs, take off their shoes, and “step over” into a clean pair. Researchers leave the containment zone by retracing their steps back through the locker and shower rooms, where they remove their clothes, disinfect their glasses, and then shower for five minutes (red light/green light indicates when shower time minimum is reached), before dressing in their street clothes.

PROJECT SUMMARY

BBSRC National Virology Centre

Plowright Building

Surrey, England

Building Team

Owner: Pirbright Institute, Biotechnology and Biological Sciences Research Council

Architect, lab planner: HDR

Project manager: AECOM

Structural, MEP engineer: AECOM Engineering

Cost consultant: Turner and Townsend

Commissioning consultant: Merrick & Co.

Design-builder: Shepherd Group

GENERAL INFORMATION

Size: 151,000 sq. ft.

Construction cost: $175 million U.S.

Construction time: July 2011 to October 2014

Delivery method: Design-build lump sum price

Containment level: Category 4 (roughly equivalent to BSL-3 Enhanced)

U of Huddersfield Launches Genomics Research Center

The University of Huddersfield in the UK announced the creation of the Centre for Evolutionary Genomics with a £1 million gift from the Leverhulme Trust.

The gift for the research center comes as part of the trust's Doctoral Scholarships program, intended to train a new generation of scientists in the UK. Over five years, 15 doctoral candidates and two post-doctoral researchers will carry out wide-ranging research under the supervision of Professor Martin Richards and colleagues. The first cohort of five students will be recruited in early 2015 and will begin their fully funded research in October.

Research topics carried out at the center will include the origins of multi-cellular organisms, the prehistoric peopling and contemporary genetic variation of Atlantic Europe, and identifying DNA from human and animal remains.

Richards, an archaeogeneticist, will head the inter-disciplinary team that will form the Centre for Evolutionary Genomics.

Japan's Chugai Pharmaceutical to Invest

Japan's Chugai Pharmaceutical will invest $476 million over the next seven years to expand its research institute. The investment will make the center at Biopolis one of the biggest pharmaceutical research and development operations in Singapore. It will also "significantly boost the company's local employee base and antibody research and development pipeline", said Chugai Pharmaceutical, which is about 60 per cent owned by Swiss drugmaker Roche Holding, the world's biggest maker of cancer drugs.

Chugai, which is strong in cancer and arthritis treatments, reported a net profit of 50.98 billion yen (S$580 million) for the year ended Dec 31, on revenues of 461.11 billion yen.

Its Singapore research institute, Chugai Pharmabody Research (CPR), moved into Biopolis in 2012 and employs 70 people, focusing mainly on developing new antibodies. When it was set up three years ago, CPR said it had an original plan for a five-year investment of $200 million. "CPR has progressed as initially expected, and this additional investment will make it one of the largest pharmaceutical R&D operations in Singapore," Chugai Pharmaceutical said in a statement.

Biopolis at one-north in Buona Vista is home to top pharmaceutical, health-care and medical technology companies such as Abbott, GSK, illumina, Novartis and Procter & Gamble (P&G). Global consumer health giant P&G officially opened its $250 million Singapore Innovation Centre in Biopolis last year. It was described, at the time, as Singapore's biggest private research facility, with 500 engineers, researchers and support staff working across six stories and 344,320 sq. ft. (32,000 sq. m.)

Chugai Pharmaceutical said it expects to have more than 100 employees by next year and expanded work spaces, allowing it to ramp up development of new drugs, while continuing its R&D activities. The company also praised Biopolis and the support it has received from the Agency for Science, Technology and Research (A*Star)

"Biopolis provides an excellent ecosystem for CPR to advance the research for generation of new antibody drugs," said Dr. Hisafumi Okabe, Chugai Pharmaceutical's vice-president and general manager of its research division. "With the great support provided by A*Star and the EDB, we have been able to build up our operations in Singapore much faster than expected, and assembled a talented and international research team comprising scientists from Japan, Singapore and several other countries around the world."

A*Star chairman Lim Chuan Poh said the move underlines Singapore's attraction as a research hub "with ready access to biomedical research talent". He said the country also offers world-class research capabilities and an environment that encourages open innovation through collaborations and partnerships.

WH Partnership Completes Cancer Facility for TC BioPharm in Glasgow

WH Partnership (WHP), a specialist design, engineering and construction company headquartered in Gateshead, Tyne-and-Wear, UK, has helped Scottish biotechnology scientists move one step closer to helping cancer sufferers extend their life expectancy.

WHP has recently completed TC BioPharm’s (TCB), new clinical manufacturing facility at Maxim Park, Glasgow, which processes patients’ own immune cells in an innovative treatment to target cancer and viral infections.

Built to comply with UK Good Manufacturing Practice (GMP) regulations, the multi-million pound 3,500 sq. ft. facility took 12 weeks to build from start to finish. It includes two cleanrooms, as well as process development laboratories and quality control suites. The facility has also been granted a license to produce human cell therapy products by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). TCB plans to treat the first cohort of patients during 2015, working alongside established cancer clinics throughout Scotland.

WHP’s Managing Director, Nigel Hall, said: 'We have gained a strong reputation for our cleanroom design and construction in the biotechnology industry and it is pleasing to demonstrate our expertise on a project as important as this one – especially so close to home.' Angela Scott, Operations Director at TCB, added: 'The team has done an amazing job building and commissioning our facility in record time. Not only has WHP built an impressive GMP facility in the heart of Scotland, it also ensured that costs were managed in a supportive and proactive manner. 'As TCB’s clinical outreach extends beyond the UK, WHP and TCB will jointly evaluate logistics of facility expansion on a geographical basis, using a combination of modular and mobile cleanroom systems that can be located in strategic areas to support planned treatment regimes.'

ICON Establishes Innovation Hub in Ireland

ICON plc has established a new global innovation hub in Ireland aimed at fostering the development of new technologies and clinical trial processes for faster access to large volumes of clinical data. The new hub will create 200 new jobs in Ireland, including roles in IT, data analytics, clinical science, project management, finance and human resources.

Ciaran Murray, chief executive officer, ICON plc, said, “Since our foundation in Dublin in 1990, ICON has grown to become a global leader in clinical research, employing 11,000 highly-skilled professionals in 40 countries. We have successfully built relationships with all of the world’s top biopharma companies and have been at the forefront of innovation in the design and conduct of global clinical trials. As innovation plays an increasingly important role in improving the outcomes of clinical trials, we are excited to reinforce our commitment to that goal by locating our global innovation hub in Ireland, one of the leading R&D and innovation centers in the world.”

Vetter Completes Construction Phase at Ravensburg

Vetter, a CDMO that specializes in the aseptic filling of syringes, cartridges and vials, has completed the first phase of the construction of a new, multi-functional building in Ravensburg, Germany. The €26m, (91,460 sq. ft.) 8,500m2 building, which will house hi-tech laboratories and workplaces for Vetter Development Services, as well as a secure data center, is expected to be fully operational by the beginning of 2016.

The investment is a direct result of increased demand by customers for support in drug development, as well as the need for enhanced company-wide IT systems, the company said. Through facilities located in Chicago, US, and Ravensburg, Vetter Development Service offers support in all phases of clinical drug development, including pharmaceutical analysis, process development, and clinical trial supply.

The new six-story building will contain labs for microbiological analysis, and spare capacity to meet future growth needs such as additional cleanrooms and labs. The new data center will have enhanced security systems and a safety cell that protects technology and data from external physical hazards, as well as a state-of-the-art gas extinguishing system to minimize damage in the event of an emergency.

'With this new building, we are addressing the growing demand of our customers in the area of clinical drug development and manufacturing,' said Thomas Otto, a Vetter Managing Director. 'Furthermore, with the installation of the sophisticated IT systems, Vetter will be well-prepared to meet future challenges that present themselves.'

Joint Open Laboratory Established by Waters & ChP

Waters^® Corporation recently announced the inauguration of its Joint Open Laboratory established together with the Chinese Pharmacopeia Commission (ChP) during an opening ceremony held in Beijing.

The analytic laboratory will be jointly operated by ChP and Waters^®. Focus areas include in-depth research of pharmacopoeia standards, development of testing methods, methods validations and basic and advanced technical training of pharmacopoeia detection methods. The laboratory is also anticipated to play a role as one of the national technical support centers in the field of Chinese pharmaceutical standards.

Speaking at the ceremony, Mike Harrington, Vice President of Waters Asia Pacific and European Operations, noted, "Our cooperation with ChP to open and operate this cooperative laboratory in China reflects our commitment to consistently push the boundaries of what's possible by helping to bring more resources to bear that enable innovations in China's pharmaceutical and biopharma industries."

"Our cooperation will meet the needs of ChP's development, while also responding to the demands of even further enhancements to pharmacopoeia standards and improved public drug safety," said Secretary General Zhang Wei of the ChP.

The joint open lab spans 400 square meters (4,304 sq. ft.) and is located within the laboratory building of the Beijing Zhendong Guangming Drug Research Institute. Outfitted with Waters'® chromatography and mass spectrometry technologies, the facility is set to support Pharmacopeia standards in China.

Recipharm Completes Serialization Solution in China

Recipharm has successfully completed a serialization project for China for a top ten pharma company. The new serialization regulation introduced by the Chinese regulatory authority has set strict importation deadlines with no flexibility on full compliance.

Recipharm developed an adaptable solution using a methodical approach to ensure compliance, and 57 serialized batches have been supplied since February 2014. Recipharm worked closely with the pharmaceutical customer to exchange ideas and information. New technology was also introduced and applied to ensure each individual box has its own 1D barcode and unique serial number.

Stéphane Guisado, general manager at Recipharm Fontaine said, “We are very pleased with the success of this China focused serialization project carried out for the pharma partner concerned. Traditionally, full compliance with China’s regulations, especially in the field of serialization, has proved to be a major challenge for the pharma sector. There is no room for compromise when it comes to meeting regulatory deadlines. Moreover, the time-lines set by laws have to be met in full and on time and are often imposed with relatively short notice regarding implementation lead time. Recipharm has now developed the skills and knowledge to provide a platform for delivering a serialization solution for all markets.”

Otsuka Establishes Australian Ops

Otsuka Pharmaceutical Co. Ltd., based in Japan, has established a presence in Australia with a new office in Sydney as part of an effort to build a larger, long-term presence in Australia and Oceania. These regions have been experiencing single-digit percentage growth in the past several years and were estimated at approximately $13 billion in 2012.

Otsuka focuses on the development of new drugs for central nervous system disorders such as schizophrenia, depression and Alzheimer’s disease, areas where patients in Australia and elsewhere need better treatments.

Otsuka Australia Pharmaceutical’s recently appointed managing director Kazushi Takemoto, said, “Otsuka is pleased and honored to be a participant in the Australian healthcare sector. We will strive to make a positive contribution with our products in areas of critical, unmet patient need. Our opening in Australia, which is Otsuka’s 27^th affiliate outside Japan, is an important milestone for Otsuka as the company continues to expand and fulfill its aim to help ease the burden of diseases on people around the globe.”

Vetter Completes First Phase of Major Facility Expansion

Ravensburg, Germany-based Vetter (Vetter Pharma-Fertigung GmbH & Co. KG), which fills and finishes pre-filled syringes, cartridges and vials, has completed the first phase of its new site in Ravensburg had been completed.

Estimated to be fully operational by the beginning of 2016, the new facility will contain high-tech laboratories and workplaces for Vetter Development Service, as well as a secure data center and additional office space for a total area of (91,460 sq. ft.)8,500 square meters. The 26 million Euro (U.S. $25.9 million) investment is a direct result of increased demand by customers for support in drug development, as well as the need for enhanced company-wide IT systems to meet future requirements the company is seeing today.

Vetter decided to expand its facility in Germany due to increased demand. The six-story building will contain laboratory space for performing microbiological analysis, and will also have sufficient spare capacity to meet future growth needs such as additional cleanrooms and labs.

The multi-functional building is also an investment in future-oriented IT systems which help Vetter meet the increasing quality and security needs of customers and regulatory authorities alike. For example, the new data center will have enhanced security systems and a safety cell that protects technology and data from external physical hazards, as well as a state-of-the-art gas extinguishing system to minimize damage in the event of an emergency.

“With this new building, we are addressing the growing demand of our customers in the area of clinical drug development and manufacturing,” said Thomas Otto, a Vetter Managing Director. “Furthermore, with the installation of the sophisticated IT systems, Vetter will be well-prepared to meet future challenges that present themselves.”

New Labs in Sierra Leone Africa and Middle East

Three new labs staffed by Public Health England (PHE) are now fully operational in Sierra Leone, adding much needed capacity in critical districts and relieving the bottleneck in testing.

Cases can now be identified much more rapidly, which will help to reduce the transmission rate. The labs opened at the end of last year and are based across the Ebola affected areas of Kerry Town, Port Loko and Makeni.

Each lab is staffed by teams of up to 16 scientists, drawing from PHE scientific staff and volunteers from other laboratories.

Prior to these labs being open, testing, diagnosing and isolating Ebola carriers could take five or more days. Tests are now being turned around in as little as 24 hours, saving crucial time in helping to distinguish people with Ebola from those who have malaria or other diseases. The labs, where blood samples and swabs from all over the country are tested for the deadly virus, are part of the UK’s wider response to the Ebola crisis led by the Department for International Development (DFID). PHE’s focus is now on supporting the WHO’s work to improve sample collection, including supporting the local district Ebola response centers, by providing training on how to take and package good quality samples and deliver them to the laboratory in a timely way to help prevent disease spread.

'Previously the affected countries lacked laboratory capacity, emergency operations centers, and disease surveillance systems. Communities were not aware (and some are still not aware) of what Ebola is, or how it is spread,' said Dr. Tim Brooks, head of PHE’s rare and imported pathogens lab. 'All of this meant that when the Ebola outbreak hit these countries, it hit harder and spread faster. The successful implementation of these three labs will play an important part in helping to turn the tide.'

Professor Paul Cosford, director for health protection at PHE, commented: 'We have robust mechanisms in place for detecting and responding to any usual infections within the UK, but ultimately the best possible defense will be ensuring the outbreak in West Africa is brought under control. The successful introduction of the new labs means is a key step to bringing the Ebola outbreak under control, and I thank the PHE staff and other lab volunteers who have worked tirelessly to get these three labs up and running.'

PPD Expands GMP Laboratory

Pharmaceutical Product Development (PPD), a US contract research organization, has added a new, state-of-the-art laboratory for cell-based assays to a portfolio of services at its GMP operation in Athlone, Ireland.

The laboratory provides bioassay testing with dedicated areas to support cell culture activities. The company says this expanded capacity will enable it to meet growing demand for these services from clients in Europe, the Middle East and Africa, as well as the Asia-Pacific region.

PPD has now duplicated the services already available in the US through its Middleton, Wisconsin, GMP lab. In addition to the new cell laboratory, the facility continues to provide solutions for product development as well as analytical testing services in method development, validation, stability, and release and quality control testing. The Athlone facility also provides regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.

'The expansion of our GMP laboratory represents PPD’s ongoing investment toward continued growth of our operations in Ireland in order to offer enhanced service capabilities to our growing client base in this region and throughout the world,' said David Johnston, PPD's Executive Vice President of Global Laboratory Services.

The GMP laboratory conducts testing for clinical and marketed programs spanning all phases of drug development, and supports PPD’s 30 years of global laboratory expertise. PPD opened its Athlone laboratory in 2010 and, once the expansion is complete, will employ nearly 150 people at the facility.

In total, PPD’s operations in the Athlone Business and Technology Park amount to nearly 50,000 square feet, of which approximately 18,000 square feet is dedicated good manufacturing practices (GMP) laboratory space.

Catalent Expands Services in Germany

A coating and packaging expansion at a facility in Germany will feed the demand for end-to-end softgel services, Catalent Pharma Solutions says.

The planned addition of coating and blister packaging equipment is the largest single investment at the 360,000 sq. f.t. site in Eberbach, Germany, since Catalent acquired the remaining 49% of drug delivery firm RP Scherer from Gelita in February 2012.

The new equipment will coat softgels for controlled, enteric and targeted release, and push processing output to over 300 million capsules per year and, according to Richard Lackner, General Manager at the Eberbach plant, is a “timely” investment for the contract development and manufacturing organization (CDMO).

“As more customers look for integrated services from a single, convenient site, Catalent’s investment in softgel coating and packaging is timely,” he said.

“Its integrated, same-site softgel manufacturing and coating services enhance process efficiency and control, minimizing the time between encapsulation and coating, and therefore, maximizing product shelf life,” he continued, adding “Catalent will soon be able to provide end-to-end service to its customers from the Eberbach site, from development to shelf-ready.”

Financial details of the expansion were not revealed and Lackner did not foresee a large number of new jobs being created in Eberbach, but the investment is evidence of Catalent’s continued advancement of its drug delivery systems, he said, which, since the closing of the RP Scherer deal, has seen it offer oral delivery of macromolecules through its OptiGel platform, as well as offer new anti-abuse encapsulating technology.

As for market demand, Jessica Cao, Strategic Marketing Director for Softgel Technologies at Catalent, said the firm is seeing increased growth “driven by innovation in formulation, especially lipid-based formulations, including delivery of highly potent compounds, to overcome the bioavailability challenges of delivering poorly soluble drugs, and for modified and controlled release.”

In September, Catalent reported its end of year financials and its growth in revenue was primarily led by its softgel business.

The firm has recently invested in China and Brazil in order to support its softgel network, and Cao said its supply network now consists of 11 softgel R&D and manufacturing sites with the capacity to produce over 60 billion capsules annually.

Teva: More Biomanufacturing Space Needed

Teva must invest in its biomanufacturing network as the firm’s biologics aspirations grow beyond biosimilars, CEO Erez Vigodman told investors.

While Teva Pharmaceutical Industries is the world’s largest generic drugmaker with 2013 net sales close to $10bn (€8.6bn), the firm is also a self-proclaimed pioneer in biosimilar development having invested in R&D and manufacturing of such copycat biologics since 2000.

But at last week’s JP Morgan Healthcare Conference in San Francisco, CEO Erez Vigodman told stakeholders Teva’s strategy “goes beyond biosimilars,” citing its proprietary monoclonal antibody (mAb) Reslizumab – an interleukin-5 (IL-5) candidate being investigated to treat asthma exacerbations - recently showed positive Phase III trial results.

“We are asked a lot about biosimilars but basically the question is about biologics,” he said. “We see the prominent role of biologics in the industry in a way that gains more and more momentum.”

He added, however, that for Teva to produce biologics like reslizumab and LBR-101 – a Phase IIb anti-CGRP mAb acquired when Teva bought Labrys last June for $200m – the firm would need to expand its manufacturing network.

“We need basically biologic capabilities and development capabilities,” he told investors. “Teva is committed to develop the infrastructure which is required in order to basically tap the opportunities that will emanate from the biologic universe, it is critical in the industry.”

Teva has expanded its biologics network through acquisitions. The firm bought Sicor Biotech in 2004 which included a microbial site in Lithuania and plants in Mexico, China and Latvia that develop and manufacture biosimilar materials such as interferon alpha and human growth hormone.

In 2010, Ratiopharm was acquired and a mammalian cell culture manufacturing plant in Ulm, Germany was added and now produces versions of Amgen’s Neupogen and Epogen.

The company has also relied on third party biomanufacturers, signing a joint venture with Lonza in 2009 for the development, manufacturing and marketing of biosimilars, carried out at Lonza’s commercial scale mAb manufacturing facilities. However, this collaboration ended in 2013.

The need to grow its manufacturing network lies contrary with Teva’s efficiency drive which could see it halve the 75 production sites over the coming years in a bid to save up to $2bn annually.

Despite an interest in proprietary biologics, Vigodman said the firm was still focused on biosimilars and will use new infrastructure to “compete in a very successful manner in the biosimilar space.”

This was confirmed by Teva spokesperson Denise Bradley. “We are committed to strengthening our biosimilars portfolio, both on our own as well as through a possible partnership.”

She continued: “We are strong in Wave 1 biosimilars – those with no remaining patent protection – with revenues of roughly $400M. We maintain a limited program in Wave 2 biosimilars, or those products that will see patents expire between 2015 and 2020.

“Additionally, we have very early programs in Wave 3 biosimilars, or those that have patent protection beyond 2020.”

Roche Announces Investment on New Facility

Roche announced on Nov. 5, 2014 that it will invest 450 million Swiss Francs (approximately $467 million USD) on a diagnostic manufacturing facility at the Suzhou Industrial Park in Suzhou, China. The new facility will focus on producing immunochemistry and clinical chemistry tests for clinical laboratory testing.

“Roche is committed to investing in China and the Asia Pacific region. The new manufacturing site will enable us to meet the growing demand for our diagnostic products, ensuring our continuous contribution to the health of people in China and the Asia Pacific region,” said Roland Diggelmann, COO of Roche Diagnostics.

The Suzhou Industrial Park, developed in 1994, is a cooperation between Chinese and Singapore governments and spans 111.2 mi². The addition of a facility in the booming Suzhou area will increase the efficacy and reach of Roche manufacturing, according to the release.

“We are confident that by establishing our manufacturing footprint here in Suzhou close to our China operations, we can further increase our market responsiveness and contribute to the overall competitiveness of our business,” said Diggelmann.

The new facility is expected to be fully operational by 2018 and will employ more than 600 individuals. Roche is headquartered in Basel, Switzerland.

SGS Completes Glasgow Expansion

SGS Life Science Services has completed the expansion of its facility in Glasgow, UK, for the testing of cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines. The new lab enhances capacity and capabilities for cell culture testing, adding 500 m² (5,380 sq. ft.) to SGS’ existing center of excellence for viral safety, which now totals 1,124 m² (12,094 sq. ft.)

The lab employs approximately 45 scientific and quality personnel, and will offer a full range of validated bioanalytical methods to support the manufacturing, biopharmaceutical stability and lot release of drug product, including host cell protein, endotoxin, ELISA, western blotting and residual impurity testing.

The facility is equipped with Surface Plasmon Resonance (SPR) BiaCore T200 equipment to facilitate off the shelf and customized binding kinetics, and potency measurement of monoclonal antibodies and other recombinant protein-based biological medicines.

The new lab will also offer nucleic acid sequencing technologies and enhanced real-time PCR platforms to support viral safety and genetic stability assessment of cell banks for vaccines, gene and cell therapies. Additionally, to meet pharmacopeia requirements, SGS will undertake validated PCR assays for detecting mycoplasma contamination during drug product manufacturing.

“As the pharma industry becomes increasingly focused on large molecule biologics, so we are increasing our service capacity and capabilities in this area,” said Archie Lovatt, Scientific Director at SGS Life Science Services. “This is a rapidly expanding field where much broader and highly specialized testing expertise and equipment are required, to establish the safety of novel human therapies and vaccines, and one which we see as key to our strategic growth.”

Fareva Invests in Capacity

Fareva has added extra micronization capacity citing growing demand and the opportunity to work with customers earlier in the development process as the driver for the investment.

The French-privately owned contract manufacturing organization (CMO) has installed a Hosokowa Alpine Micronizer at a facility in Feucht, Germany that is operated by its active pharmaceutical ingredient (API) and oral solid dose division, Excella GmbH.

Excella, which was bought by Fareva in 2008, already had a Hosokowa Alpine Pin Mill for large volume processing. The new micronizer, in contrast, is designed for smaller volume work and will be used for high potency API particle production.

Fareva spokesman George Hlass said: “We’ve observed the trend that more of our customers require micronization for their HPAPIs.”

He added that: “Our customers see increasing value in simplifying their supply chain and the synergies associated with doing their API and OSD development and manufacturing at Excella.”

Fareva’s rationale echoes what fellow CMO Catalent said when it acquired API particle tech firm Micro Technologies last November.

At the time, the newly public US contractor told us customer demand for micronization is being driven by the drug industry’s focus on lower solubility BCS class II and IV APIs.

Fareva also said the additional micronization capacity “strengthens our one stop shop model,” under which Excella is responsible for producing both the API and the dosage form on customers’ behalf.

This also fits with observations about the Catalent investment. At the time John Kreger, an analyst at William Blair, said: “Particle size engineering is typically employed in the preclinical or Phase I stage of development—well before Catalent usually competes for a new molecule.

Translational Research Institute (TRI), Brisbane, Australia

Translational Research Institute (TRI) is a medical research facility located at the Princess Alexandra Hospital campus in Woolloongabba in Brisbane, Australia. It was constructed as a seven-story building for providing support for medical research, administration and teaching.

A 70,000 sq. ft. bio-pharmaceutical manufacturing facility was constructed next to the main TRI building. The new facility accommodates a mammalian biopharmaceutical production facility.

Construction began in October 2010 and the project was completed in 2012. The land for the facility was donated by the Queensland government.

The biopharmaceutical plant was built at a cost of A$65m ($50m) and was commissioned in October 2013.

"The TRI facility is located near the Pharmacy Australia Centre of Excellence. It cost $354m to construct."

The Translational Research Institute project is sponsored by a joint venture between the University of Queensland's Diamantina Institute, Mater Medical Research Institute (MMRI) and the Princess Alexandra Hospital's Centers for Health Research, along with the Queensland University of Technology's Institute of Health and Biomedical Innovation.

The purpose of the project is to increase the investment as well as commercialization of the medical breakthroughs in Australia, to improve disease-specific research networks of researchers and clinicians. In addition, the project is for improving the health standards of Australians by introducing new medical prophylactic therapies and treatments.

The TRI facilitates the discovery, production and testing of biopharmaceuticals and treatments. The research focus is on cancer, diabetes, obesity and liver diseases, as well as on inflammatory diseases such as HIV, malaria and bone and joint diseases.

The biopharmaceutical manufacturing facility assists new biologic drug developers to outsource the development, as well as provide technical and economical assistance. It houses a pilot plant to help bring newly discovered drugs to pilot commercialization.

It aims to ensure Australian bioresearch progresses quickly from the lab work to late-stage research in a clinical setting using high-purity material.

The TRI building has a space of 32,000 sq. ft.. It has seven stories, which include four floors of laboratory research, administration and teaching facilities. It houses approximately 700 researchers.

It also has an animal house, a cell therapies facility, staff support spaces, a large lecture theatre and advanced education facilities.

The facility is equipped with two in-building 11kV/415V substations, a 3.2MW, 11kV standby generator, plus 70kW of photovoltaics and intelligent energy. It is also provided with electrical and ICT components, such as a Tier 2.5 tertiary data center and F/UTP Category 6A structured cabling infrastructure.

Watpac Construction was awarded the building construction contract for the TRI facility in May 2010. The building was designed by Wilson Architects and Donovan Hill.

"The biopharmaceutical plant was built at a cost of A$65m ($50m) and commissioned in 2013."

Aurecon was awarded a contract to provide structural, façade, electrical, dry fire engineering and information and communications technology services for the facility.

The mechanical services contract was awarded to MultiTech Solutions. The contractor was responsible for design, documentation and contract administration.

In May 2010, Netherlands-based medical treatment manufacturer DSM Biologics agreed with the Australian Institute for Bioengineering and Nanotechnology to design, build and operate the biopharmaceutical manufacturing facility at the TRI.

The TRI project was financed by $140 m from the Australian Government, $107m from the Queensland government and $50m from Atlantic Philanthropies. Queensland University of Technology provided $25m and University of Queensland funded $10m.

Australia's Government agreed to provide funding of $10 million for the biopharmaceutical manufacturing.

Biotec Completes Clinical Supply Facility Expansion

Biotec Services International, a PCI company, has completed validation of their clinical supply facility expansion, which adds almost 50% to the company’s clinical trial packaging, storage and distribution capacity.

The company increased refrigerated storage and packaging capacity by more than 400%, and more than doubled capacity to handle and store cell therapies and other advanced drug products. Additionally, the company has acquired land adjacent to its current site for future capacity and capability expansions.

Packaging Coordinators Inc. (PCI), a global provider of drug development services, acquired Biotec in September 2014 as part of ongoing investments in solutions for difficult development challenges, such as temperature-controlled packaging and distribution. The Biotec site specializes in the management of temperature-sensitive products, and has expertise in handling products at temperatures ranging from +25ºC down to -196ºC.

Dr. Fiona Withey, managing director, UK Clinical Services at PCI said, “Biotec’s business has grown as a result of our expertise in the packaging and distribution of temperature-sensitive biopharmaceutical products, and our ability to efficiently manage our clients’ projects regardless of their size. By increasing our temperature-controlled capacity, and designing flexibility into our operations, our recent investments illustrate our continued commitment to these key attributes of our business.”

Randox Announce Plans for New Science Park

Global medical diagnostics company Randox, has unveiled its plans for a futuristic manufacturing and R&D facility in County Antrim. The £161 million project, which includes a £29 million capital investment for the redevelopment of the site, will accelerate the development of new products into a wide range of clinical needs, such as various cancers, stroke, heart disease and neurodegenerative disorders, through more efficient, high specification manufacturing and the provision of state-of-the-art R&D laboratories.

Randox leads in the research, development and manufacture of pioneering medical tests and cutting edge diagnostic equipment, with customers in clinical, toxicology, veterinary and food safety markets in more than 145 countries.

The award-winning biotechnology firm, with headquarters in Crumlin, County Antrim, recently purchased the former British Army base at Massereene, in Antrim town, which will be redeveloped to house the new center of manufacturing and R&D, now renamed, Randox Science Park.

Randox Science Park will become the company’s prime manufacturing site, complementary to its manufacturing operations in Manchester, Republic of Ireland, India and the USA. Randox has a range of more than 2000 products, including advanced diagnostic tests, quality control sera, analyzers and the company’s revolutionary BioChip Array Technology; many of which will be produced at this next generation facility.

This considerable investment will also lead to the creation of 540 high value job opportunities, over the next four years.

In addition, the site will feature a Transformative Healthcare Centre from the Randox Health division; giving the public direct access to Randox’s ground-breaking tests, as well as offering private GP appointments and specialist clinics, run by some of the UK’s chief medical consultants.

At a launch event, Randox showcased its plans for Randox Science Park. Guests including Northern Ireland’s First Minister, Peter Robinson, Deputy First Minister, Martin McGuinness and Enterprise Minister, Arlene Foster, were briefed on the company’s impact on global health and vision for the future.

Speaking at the event, Randox Managing Director, Dr. Peter FitzGerald said: “The creation of Randox Science Park is fundamental to Randox meeting the health challenges facing populations across the world. We are an innovation led company, focusing more than 30 years of skills and experience on delivering accurate, rapid and quality diagnostics across a range of clinical disciplines; from stroke and heart disease, to cancer, neurodegenerative disorders, respiratory infections and so on. We must continue innovating, through our people, through our knowledge and through our technology; Randox Science Park gives us the platform we need to do this.

“Randox innovation underpins our achievements, allows us to diversify, allows us to target fresh markets and fuels our exports and Randox Science Park will be at its core. This investment and expansion reinforces our dedication to improving health worldwide and our commitment to the UK economy. It is about the future of diagnostic medicine, we are beginning 2015 as we mean to continue.”

The expansion includes the creation of manufacturing, scientific and engineering opportunities on a major scale, as well as business support posts; the investment will also grow Randox’s sales and marketing capabilities. In addition, the 540 new jobs, with an average salary of £30k per year will generate £16.2 million in annual salaries, representing a significant boost to the UK economy.

The company said it was already engaging with universities across the UK, to access high caliber graduates for the world class opportunities at Randox Science Park.

Regional development agency, Invest Northern Ireland is supporting the £29m Randox capital redevelopment of the site, with an investment of £4.7 million

Crown Expands Precos Site

Crown Biosciences has announced plans to double capacity at a site operated by its Precos division.

The expansion at the site in Nottingham – financial terms of which were not disclosed – will increase capacity for both in vivo and in vitro preclinical drug research according to a Crown spokesman.

He said the “increase in animal capacity is to allow for more studies to be run” adding that “we’re also establishing new models and broadening collections of cell lines, PDX, syngenic models focused on breast, prostate and ovarian cancers.”

Precos' core businesses are its orthotopic and metastatic modelling technologies, imaging services and patient-derived xenograft (PDX) models. The firm was acquired by Crown in July 2013 as part of the contract research organizations (CRO) strategy of building in Europe.

This strategy was cited as a driver for the facility expansion by the Crown spokesman, who said: “Europe seen as central to Crown’s growth” adding that client demand had also been a factor.

He also said the Precos site’s “proximity and access to expertise models of Caucasian cancer types,” but did not go into specific details.

The facility in question is located near the University of Nottingham where the PDX technology was developed.

US-headquartered Crown will rename Precos Crown Bioscience UK and, according to its spokesman, has already gone on a hiring spree in preparation for the facility expansion.

He said: “Additional scientific and technical staff were brought on and trained during Q4 2014 to allow for the new capacity to be operational as quickly as possible.”

AstraZeneca R&D Centre and Corporate Headquarters, Cambridge, United Kingdom

The proposed site will be located on the Cambridge Biomedical Campus (CBC) in Cambridge, UK.

British-Swedish pharmaceutical and biologics company AstraZeneca intends to build a new global R&D center and corporate headquarters on the Cambridge Biomedical Campus (CBC) in Cambridge, UK, in 2015.

The project is part of the company's strategic move to establish global R&D centers in the UK, US and Sweden to improve its pipeline productivity and biopharmaceutical innovation.

AstraZeneca will invest approximately £330m ($500m) to build the facility, which is expected to employ approximately 2,000 highly skilled employees.

Construction of the facility, which will be AstraZeneca's new global corporate headquarters, is expected to be completed by 2016.

The facility was commissioned to produce the active pharmaceutical ingredient (API) rosuvastatin calcium for the worldwide supply of the once-a-day dyslipidaemia treatment Crestor.

The new facility on the CBC will occupy approximately 11 acres and benefit from the central Cambridge location and strong infrastructure links. The project includes the construction of a global R&D center, an R&D enabling building, and an energy center.

Features of the global R&D center will include high-tech labs with glass walls to enhance visibility, a number of open spaces, as well as pathways to encourage collaboration within the company and CBC campus.

The R&D enabling building will host operations to support AstraZeneca's scientific work including regulatory affairs and commercial units. The energy center will be equipped with power generators, heating and cooling systems, IT and other telecommunications systems.

AstraZeneca's small molecule and biologics R&D activities and protein engineering capabilities carried out at MedImmune, the biologics arm of the company, will be consolidated in the new facility.

Scientists from AstraZeneca and MedImmune will work together to advance science in core therapeutic areas.

The new site will become the company's biggest center for oncology research. It will also conduct research on respiratory, inflammation and autoimmune diseases, cardiovascular and metabolic diseases, as well as conditions of the central nervous system.

The center will also accommodate a number of pre-clinical research capabilities of the company. Other global functions will join the R&D teams at Cambridge upon completion of the building.

"AstraZeneca will invest approximately £330m ($500m) to build the facility, which is expected to employ approximately 2,000 highly skilled employees."

AstraZeneca unveiled designs for the proposed new global R&D center and corporate headquarters in July 2014. The shape of the new building is inspired by historical colleges in central Cambridge, which are typically designed with less height than traditional colleges and includes enclosed central courtyards.

The entire building will be constructed in a single loop to provide short connections. It will feature modern and innovative workspaces to ensure collaborative working.

The roof of the building will replicate a saw-tooth roof, which continues through the façade and aims to unite the visual aspect of the building.

A proposed two-story disc structure of a unique oval shape creates an uninterrupted protected walk along the building. The disc will have laboratories and other amenities with a porous ground floor, and provides a spatial feel by framing a central courtyard.

A courtyard will be open to the public and feature three main entrances to the building, while the center of the courtyard will have large trees and green lawn providing places for recreation and informal meetings.

The building's internal design elevates visible science in a synergetic environment. Laboratories are separated from work and other spaces by semi-transparent partitions.

The first and second levels of the building will have a ring area overlooking the central courtyard, leaving a large number of spaces and arrangements, while the roof will bring natural light into deep floor plates.

AstraZeneca campus on the CBC will comprise a north and south plot. During the first phase of construction, the R&D center and corporate headquarters with a central courtyard will be built on the north plot, while the R&D enabling building and energy center will be constructed on the south plot.

The next phases include the development of a series of buildings on the south plot with an enclosed park, similar to the courtyard on the north plot. Consistency in design throughout the north and south plots will unify all buildings.

AstraZeneca is obtaining Building Research Establishment Environmental Assessment Methodology (BREEAM) Excellent status for the proposed site. The site will feature labs that adopt best practices in low energy design and the largest ground source heat pump in Europe, while the majority of the buildings on the site will have green roofs.

AstraZeneca selected Swiss architect firm Herzog & de Meuron Basel to design the new facility in November 2013.

Piramal Approves Expansion for Manufacturing

Contract manufacturer Piramal recently approved a $20m capacity expansion for hormonal and antibody drug conjugate (ADC) manufacturing at its facilities in Morpeth, UK, and Grangemouth, Scotland.

The expansions come as the company also recently invested $40m in new equipment and technologies and related infrastructure. The company said the investments were part of a broader plan to better serve its customers.

On the ADC side, Piramal has invested steadily from a 2011 capacity expansion to a $2.5m expansion in 2013.

In addition, the company recently completed a $10m green field facility to double its discovery services capacity.

Roche to Acquire French Biotechnology firm Trophos

Basel Switzerland-based Roche has agreed to acquire French biotechnology firm Trophos, in a bid to expand its neuromuscular disease portfolio.

As part of the deal, Roche will pay an upfront cash payment of €120m to Trophos's shareholders, as well as additional contingent payments of up to €350m based on achievement of certain predetermined milestones.

Established in 1999, Trophos developed a cholesterol-oxime based chemistry platform. It was supported by a syndicate of private equity funds including ACG Management, OTC Agregator, Amundi Private Equity Funds, Turenne Capital, Sofipaca and Vesale Partners, as well as the French Muscular Dystrophy Association (AFM).

Roche chief medical officer Dr. Sandra Horning said: "This acquisition highlights Roche's commitment to developing medicines for spinal muscular atrophy, a serious disease with no effective treatment.

"Roche will pay an upfront cash payment of €120m to Trophos's shareholders, as well as additional contingent payments of up to €350m based on achievement of certain predetermined milestones."

"We will build on the work done by Trophos and the French Muscular Dystrophy Association to advance the development of olesoxime and to bring it to people who live with this devastating condition as quickly as possible."

Trophos's portfolio includes proprietary screening platform generated olesoxime (TRO19622), which is being developed for spinal muscular atrophy (SMA), a genetic neuromuscular disease in children.

Olesoxime is an investigational medicine, which is designed to protect the health of motor nerve cells.

According to Roche, olesoxime's Phase II clinical trial in SMA demonstrated a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as reduced medical complications associated with the disease.

Trophos CEO Christine Placet said: "SMA is a grievous disease with a huge impact on the daily life of patients and their families, who are currently left only with supportive care."

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