Baxter will add 25,000 square feet and undisclosed equipment at the facility, spokeswoman Deborah Spak said. She did not disclose the cost of the project, due for completion in mid-2015.

The Mountain Home factory, one of the largest in Baxter’s medical products division, has 550,000 square feet and employs about 900 workers. When the expansion is done, employment will rise by about a dozen. The facility has been a medical-oriented operation since 1964.

The Mountain Home expansion is typical of Baxter’s frequent upgrades and expansions to “ensure that we are operating in a manner that delivers high quality products as well as efficiency and responsiveness to customer demands.” Said a company spokesman. The medical products unit’s applications include intravenous equipment and nutrition products, drug reconstitution systems, infusion pumps and inhalation anesthetics.

In late summer last year, Baxter announced an expansion at its Opelika, Ala., manufacturing location that will cost $300 million. The project is focused on boosting production capacity for dialyzers, a component for hemodialysis therapy needed by patients with kidney failure. The unit, part of Baxter’s medical products division, will add more injection molding equipment and more than double staff levels currently at about 170. Baxter is targeting project completion in 2016.

Baxter recently announced it will form a new global research and development center in Cambridge, Mass., for its biopharmaceuticals division. The division is now based at Baxter’s Deerfield, Ill., headquarters.

NeoStem Announces Expanded Cell Therapy Manufacturing

NeoStem, Inc., a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced the expansion of manufacturing services under an existing Services Agreement between its wholly-owned subsidiary, PCT, and Kite Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer.

Under the terms of the original agreement, PCT and its center of excellence for cell therapy process development, engineering and manufacturing, provided development and manufacturing services for Kite's lead eACT(TM) clinical development program. These services included technology transfer, process development, qualification and implementation of the manufacturing process. Under the expanded Services Agreement, Kite will receive these services through increased facilities and personnel at PCT's Mountain View, CA location that are contractually dedicated to Kite.

"We look forward to continuing our mutually beneficial partnership with Kite and to offering manufacturing service for the important cell therapy that they plan to advance toward the commercial market," said Dr. Robert A. Preti, Chief Scientific Officer of NeoStem and President of PCT. "The expansion of NeoStem's arrangement with Kite allows us to grow our Mountain View facility and to continue providing innovative, reliable and high quality manufacturing expertise to cell therapy developers who are researching potentially life-changing treatments for patients across many therapeutic areas."

"We are pleased that we have expanded our relationship with Kite and look forward to continuing to provide them with premium specialized immunotherapy manufacturing services. This arrangement with Kite will serve as a model for future collaborations between PCT and its clients," said Dr. David J. Mazzo, NeoStem's Chief Executive Officer.

"We have valued PCT's expertise, manufacturing facilities, and services, and we look forward to a continued productive relationship with them," said Dr. Arie Belldegrun, Chairman, President and Chief Executive Officer of Kite.

Catalent Pharma Solutions (CTLT)' Expansion in Kentucky

Catalent Pharma Solutions' $52 Million Expansion Brings Hundreds of New Jobs to Kentucky

Somerset, N.J.-based Catalent Pharma Solutions (CTLT) announced yesterday that it will invest $62 million to its Winchester, Ky. facilities, which will create 300 jobs. Recently the company completed an expansion of its Enterprise Drive facility, which added 80,000 square feet, cost $52 million and created 140 full-time jobs.

Doubling its footprint to 180,000 sq. ft. The expansion features newly installed fluid bed capacity, expanded analytical labs, and an advanced, open facility design that provides flexibility to support the requirements of new customer programs.

The expansion will accommodate the manufacture of complex, oral solid formulations. Catalent’s Winchester facility has experience in product development, technology transfer and commercial manufacturing, and has produced more than 3 billion tablets and capsules annually and launched more than 100 new products since its inception.

The expansion began in 2013 with a $35 million investment, followed by a subsequent investment in additional fluid bed capacity. The expansion will add as many as 140 new employees at the site, with potential to add further employees and capabilities in the future.

Catalent Pharma Solutions is a business unit of Catalent, Inc. (CTLT), a global company that develops and markets drugs, biologics and consumer health products. Worldwide, Catalent employs about 8,500 people, including 1,000 scientists, at 30 facilities across five continents. In 2014 the company reported more than $1.8 billion in revenue.

As incentive, the Kentucky Economic Development Finance Authority provided preliminary approval for tax incentives up to $4.5 million through the Kentucky Business Investment Program. It also approved tax benefits up to $700,000 via the Kentucky Enterprise Initiative Act. This lets companies recoup state sales and use tax on various construction costs and equipment.

“The Winchester facility has grown through its continued investment in technical expertise and capability, and through employing a flexible business model to support tailored manufacturing solutions for its customers,” said John Chiminski, company president and chief executive officer at the ribbon-cutting ceremony. “This flexibility, along with our proven track record of success with technology transfers and product launches, has clearly driven increased demand for manufacturing services at Winchester, and our latest capacity expansion allows us to manufacture substantial marketed products for both new and existing customers.”

Catalent announced on March 30, 2015, that it had acquired Pharmapak Technologies, a pharmaceutical packaging company based in New South Wales, Australia. This deal provides its existing facility in Braeside, Victoria with regional packaging capabilities. The Braeside facility manufactures oral dose products like softgels, Vegicaps capsules, and OptiShell capsules, which are delivered throughout Asia Pacific.

Catalent will continue to operate Pharmapak under that name and keep the approximately 100 employees, as well as its leadership team at its existing facility in Dee Why, New South Wales. “Catalent has made substantial recent investments in Asia Pacific,” said Mark Bisset, president of Catalent Asia Pacific in a statement, “with a new facility in China, and last year we celebrated our 40th years in Japan with a new laboratory and the build-out of more manufacturing capacity.”

PPD Opens New Chinese Central Lab

CRO Pharmaceutical Product Development (PPD) has opened a central laboratory in Shanghai, China, in order to meet growing client demand for scientific and technical services there.

The new facility, which has been established in association with Shanghai Clinical Research Center (SCRC), builds on the company’s previous collaboration in Beijing, China from 2008. PPD will now compete with other CROs with established central labs in China, including Icon, LabCorp and Medpace.

PPD may also be attempting to contend with the central labs leaders worldwide – LabCorp’s Covance and Quintiles, which recently formed a JV with Quest Diagnostics in the labs space.

The offerings of the new PPD site include safety and general lab testing, specialized testing, biomarker testing, and custom assay development and testing services. PPD also has clinical development expertise supported by 20 facilities throughout the Asia Pacific region.

The company noted that this latest central lab provides the same services as PPD’s other facilities in Brussels, Belgium; Highland Heights, Kentucky; and Singapore. The Belgian and Singaporean facilities saw an expansion of services back in 2013 to add microbiology testing to meet client demand.

All of PPD’s central labs use identical testing platforms, calibrators and reagents for all laboratory assays, as well as the same lot numbers of standards for calibration to ensure identical results regardless of where testing is performed.

“Our global network of central labs is committed to bringing value across the product development continuum,” said Andrew Cunningham, VP of global laboratory services at PPD.

The new facility is accredited via SCRC’s medical license issued by China’s Ministry of Health, as well as the College of American Pathologists, NGSP and ISO 15189 certifications—all of which are crucial to conducting clinical trials in China successfully.

In addition to central labs, PPD Laboratories also includes: good manufacturing practices (GMP) labs in Athlone, Ireland, and Middleton, Wisconsin; bioanalytical labs in Middleton and Richmond, Virginia; and vaccine sciences labs in Richmond and Wayne, Pennsylvania.

First Emerald Cloud Lab Production Facility Unveiled

“Cloud Lab” changes game for researchers with online access to state-of-the-art robotic lab equipment.

Emerald Therapeutics has announced the opening of its first Emerald Cloud Lab (ECL) production facility, ECL-1, in the biotech corridor of South San Francisco.

ECL-1 is a state-of-the-art life sciences laboratory that scientists can remotely access via the Internet where automated robotics conduct experiments exactly as specified by the user.

“The ECL is a virtualized laboratory and allows scientists to abstract away the manual labor currently inherent in scientific research,” said Emerald Therapeutics Co-Founder and Co-CEO, Dr. D.J. Kleinbaum. “Scientists are able to design and drive their experiments as if they were standing in front of the instrument themselves, giving them full control over the process without the grunt work and friction usually associated with research. We hope this system will empower people in the same way that Taiwan Semiconductor Manufacturing Company (TSMC) did in the semiconductor industry and Amazon Web Services (AWS) did in the IT world.”

Emerald unveiled the ECL in mid-2014 and announced that its invitation-only beta trial would begin in Q1 of 2015. Since then, the company built a new production facility from the ground up and installed over $3 million of scientific instrumentation including liquid handlers, mass spectrometers, HPLCs (high pressure liquid chromatography), flow cytometers, DNA synthesizers, epifluorescence microscopes, plate readers, lyophilizers and a few dozen others.

The ECL offers over forty different experiment types that its beta users can be running in under 48 hours. Over the next eighteen months, Emerald will be expanding the number of experiments to over 100, enabling scientists to do any standard in vitro life sciences experiment on the ECL, including Nuclear Magnetic Resonance (NMR), gas chromatography, flow chemistry, and DNA sequencing.

According to Dr. Brian Frezza, Emerald’s other Co-Founder and Co-CEO, all of the ECL’s automation is just a tool to gain full computational closure around each experiment. “Capturing everything relevant to the experiment in robotics allows us to ensure that every experiment has push-button reproducibility. In addition, we’re able to create a system that automatically captures extreme levels of detail about the experiments beyond just the raw data, including sample tracking, protocol information, controls and maintenance information, and environmental data. In many ways, the real value of our system is not in the robotics, but rather in the ability to capture, share, search, and reproduce experimental results.”

Dr. Frezza also explained that one of the keys to Emerald’s approach was its unique strategy for software development. “Every experiment interface is written and designed by scientists, for scientists,” said Frezza. “Our Scientific Development team includes people from a diverse cross-section of scientific disciplines and ensures that the interface people will be using was written by scientists who have done that experiment hundreds of times before.”

The ECL grew organically out of Emerald’s stealth therapeutic initiative. As a result, it is quite full-featured and well-tested: Emerald’s research team has already run over 500,000 samples through the system. One of the reasons this team has been able to handle such a large workload is the efficiency gains of running experiments through the ECL: individual scientists at Emerald run between ten and fifteen experiments per day, as compared to one to three experiments per day at other research organizations.

Now the company will start taking a limited number of users off its waitlist of over 300 scientists and labs that signed up after the 2014 unveiling, including scientists from Big Pharma, top universities, and biotech start-up companies. Customers will get access to both the experimental capabilities of the system and to its full suite of data visualization, analysis, and sharing tools.

One of the beta users is from the academic sector, Sanjiv Sam Gambhir, MD, PhD, the chairman of the Department of Radiology at Stanford University School of Medicine and a professor by courtesy in the departments of Bioengineering and Materials Science and Engineering at Stanford University.

An example customer from the biotech startup space is Ethan Oren Perlstein, PhD, founder and CEO of Perlstein Lab, a leading biotech startup, who is using the ECL to research orphan drug treatments. Perlstein has a PhD in molecular and cell biology from Harvard University, and was a Lewis-Sigler Fellow at Princeton University.

“Our biggest expense in 2014 was equipment, the next biggest slice was payroll and that’s the reality for any biotech start-up,” said Perlstein. “With the ECL, we can extend the work we do at our lab without the added equipment and staff. Emerald has developed a model that can have a huge impact on biotech research.”

Regene Acquires New Laboratory Facilities in U.S.

Regen BioPharma has expanded its research capacity with the acquisition of new laboratory facilities in La Jolla area of San Diego, California, US.

The new laboratory space, located within the Human BioMolecular Research Institute, provides Regen with access to molecular and cellular biology facilities critical to its cancer stem cell research.

The company has already started experimental studies in the new laboratory with an initial focus on performing pre-clinical experiments whose objective is the advancement of its cancer stem cell and telomere therapeutic pipeline.

Regen chairman and CEO David Koos said: "This laboratory space provides us with the capacity to conduct in-house developmental and pre-clinical research with regards to our extensive product pipeline.

"Given that DifferonC, a gene-silencing based therapeutic for treatment of myelodysplastic syndrome, is our next planned IND, and we have three other downstream pipeline products, it has become important to possess our own laboratory capabilities to most seamlessly and effectively perform critical experiments internally prior to engaging a GLP facility."

Regen is focused on discovering undervalued regenerative medicine applications in the immunotherapy and stem cell space as well as rapidly advance these technologies through pre-clinical and Phase I/ II clinical trials.

The company is currently centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.

Genentech Announces Expansion in Hillsboro

Biotech giant Genentech plans to invest more than $125 million to expand its fill/finish production facility in Hillsboro, resulting in up to 100 new skilled manufacturing jobs, the company announced.

The investment in sterile production operations will bring the total number of Genentech jobs in Oregon to more than 500 over the next five years, Larry Sanders, Genentech general manager and vice president of Hillsboro Technical Operations, said in a statement.

“This announcement is another indicator that this is an exciting time in Oregon’s history,” Gov. Kate Brown said in a statement. “Genentech’s investment in its Hillsboro campus and Oregon’s robust workforce underscore that Oregon is a great place for all businesses to build their future and for the biotech sector to grow.”

Genentech opened its Hillsboro plant in April 2010 as part of the company’s strategy to increase manufacturing capacity.

Genentech, which is headquartered in South San Francisco, is a unit of Swiss drug-maker Roche.

Tennessee’s LabConnect to Triple Laboratory Space

Central lab services provider LabConnect will be moving its operations center in Johnson City, Tenn., to a new 42,000-square-foot custom-built facility effective May 7.

With corporate headquarters in Seattle, LabConnect utilizes a network of more than 25 central laboratories on six continents, and the company’s services include routine and esoteric laboratory testing, kit building, sample management, biorepository and scientific support services for biopharmaceutical and contract research clients.

“We have grown every year since we were founded in 2002, and we are committed to maintaining our facilities with cutting-edge technology,” said Eric Hayashi, LabConnect president and CEO. “The new operations center will triple our current space in Johnson City. This will provide room for state-of-the-art sample management and biorepository capabilities as well as space for efficient kit-building operations, redundant backup power generation, administrative offices and meeting rooms.”

A detailed moving plan has been developed to ensure seamless business continuity, regulatory compliance and sample integrity, and LabConnect’s lab testing facility in Johnson City will remain in its current location.

The company also expects to add new employees to fill the new space.

Hayashi said, "The new facility will enable us to significantly expand our biorepository and kit building capabilities while at the same time providing space for the growth of our team...LabConnect is currently supporting clinical trials in 51 countries through its Johnson City Operations center."

New Catholic Hospital in Maryland

The 93-bed Holy Cross Germantown Hospital is the first new hospital to be built in Maryland in 25 years. The 237,000-sf acute care facility resides on the campus of Montgomery College, making it the first hospital in the U.S. to be co-located on a community college campus.

Holy Cross Health, a Catholic healthcare system in Maryland, opened its new 237,000-sf hospital in Germantown last October 1, thanks to a Building Team—led by SmithGroupJJR (architect), CBRE Healthcare (PM), and Whiting-Turner (GC/CM)—that simply wouldn’t give up, despite the obstacles it faced.

The 93-bed Holy Cross Germantown Hospital is the first new hospital to be built in Maryland in 25 years, the first new hospital in Montgomery County in 35 years, and the first in the U.S. to be built on a community college campus.

PROJECT SUMMARY

GOLD AWARD

Holy Cross Germantown Hospital

Germantown, Md.

BUILDING TEAM

Submitting firm: SmithGroupJJR (architect)

Owner: Holy Cross Health

Project manager: CBRE Healthcare

SE: McMullan & Associates, Inc.

MEP: Syska Hennessy Group

CE/Landscaping: Macris, Hendricks and Glasscock

GC/CM: Whiting-Turner

GENERAL INFORMATION

Project size: 237,000 gsf (93 beds)

Construction cost: $110 million; $200 million total project budget

Construction period: June 2012 to September 2014

Delivery method: CM at risk

Seven years ago, Holy Cross Health President Kevin Sexton asked SmithGroupJJR to explore a partnership with Montgomery College Germantown for a new hospital on its campus. The master plan had to go through two cycles to get the go-ahead from county commissioners; then the Maryland–National Capital Park and Planning Commission had to give its OK. By October 2008, Sexton had funding in the bag from Holy Cross’s parent, Trinity Health, and was ready to file a certificate of need. That’s when all hell broke loose.

First, a rival hospital system contested Holy Cross’s CON. Worse still, the recession forced Trinity to pull the plug on all construction in its system.

On its own dime, SmithGroupJJR convened a two-day “workshop” in San Francisco with Whiting-Turner and others to explore ways to build a more cost-effective “hypothetical” 100-bed hospital. They took their recommendations back to Sexton, and within a year, he had the green light from Trinity. Holy Cross Germantown had new life.

In the interim, Trinity had issued new mandatory design criteria: projects were to be held to no more than $750,000 and 2,100 sf per bed. The state also tightened up its CON requirements and gave the Building Team only 90 days to develop a CON package that would meet the new criteria.

Using ideas derived from the workshop, the team came up with a three-point plan: 1) split the facility into two components—a patient tower with diagnostic and treatment facilities, and a support wing; 2) specify discrete structural, mechanical, and utility systems for each component, which would reduce costs, simplify MEP distribution, and yield more total square footage; and 3) build a prefabricated modular central utility plant that would be exempt from the CON-mandated square footage, thus yielding more clinical space.

This design scheme resulted in 30–40% savings in the sf/bed ratio. In May 2012, the Maryland Health Care Commission unanimously approved the CON. Holy Cross Germantown breathed yet another life.

Holy Cross Health’s mission called for prudence, not opulence. To fulfill that goal, the Building Team used full-scale, furnished mockups for labor/delivery, med/surg, and ICU patient rooms to get feedback from clinicians. The resulting design saved costs by reducing the amount of casework along footwalls. In reviewing bathroom mockups, Whiting-Turner suggested constructing the concrete slabs with a three-foot-radius swale sloped to the shower drain rather than a rectangular depression. This saved $125,000.

Midway through construction, a new head of surgery asked the team to consider a same-handed approach to the surgical suite layout, rather than the customary mirrored floor plan. This complicated the above-ceiling coordination for medical gases, supply air, light booms, and supports, especially since the plumbing and electrical sleeves were already in place. The team constructed virtual mockups to coordinate the work, which was completed with minimal disruption.

New Parkland Hospital

The new 17-story Parkland Hospital is a seven-story clinical space that cantilevers 60 feet past the Women’s and Infants’ Specialty Health unit.

The new Parkland Hospital is big, with 862 private adult beds and 96 neonatal ICU beds. More than two million sq. ft. of space, and $1.27 billion in construction cost. Ten thousand employees. A hundred fifty minority/women/small business contractors. Five million man-hours in trades labor.

When it opens August 20, 30,000 visitors—speaking 77 languages—will stream through the new Parkland daily, 140,000 people will seek care in its ED annually, and 16,000 babies will be born there every year.

As the largest public healthcare project in the country to be built in one phase, Parkland “will serve as a standard for public healthcare development into the future,” said Lou Saksen, Senior Vice President for New Parkland Construction.

PROJECT SUMMARY

GOLD AWARD

Parkland Hospital

Dallas, Texas

BUILDING TEAM

Submitting firm: HDR

Owner: Parkland Health & Hospital System

Architect, interior architect, master planner: HDR+Corgan Joint Venture

Programming consultant: Blue Cottage

Structural engineer: AG&E Structural Engenuity

MEP engineer: HDR

Electrical engineer (power): MEP Consulting Engineers, Inc.

CM: BARA (Balfour Beatty Construction, Austin Commercial, H.J. Russell & Company, and Azteca-Omega Group joint venture)

GENERAL INFORMATION

Project size: 2.1 million sf

Construction cost: $1.27 billion

Construction time: October 2010 to October 2014

Delivery method: Collaborative project delivery (no contract)

In 2008, Dallas County voters overwhelmingly approved a $747 million bond issue to replace the 1950s-era existing hospital. The design team of HDR+Corgan, a four-firm construction management group known as “BARA,” and programmer Blue Cottage were tasked with creating a master plan for the 64-acre medical campus and a building design for a LEED-NC 2009 Silver hospital. Ground was broken in May 2010; construction was completed last October.

What sounds like a relatively smooth execution belies the complexity of the project and the Herculean effort the Building Team made to make it seem easy.

Using what they called “collaborative project delivery”—an IPD with no contract—the team held visioning sessions to picture the future Parkland from curbside to bedside. They brought in a consultant to coach them on teamwork. They co-located their workspace. They had estimators in place to make immediate evaluations of changes in costs. They set up a robust Patient & Family Advisory Council that had a real impact on program and design decisions.

They created three full-time “clinical liaison positions” staffed by veteran Parkland nurses, who acted as links to the medicine, surgery, and women’s services divisions. RNs “helped inform the entire design of the space,” said Kathy Harper, RN, MBA, EDAC, Parkland’s Director of Clinical Planning.

The team pulled out all the stops to solve a huge array of technical problems. They built mockups galore—a patient room, an OR, an NNICU room, a labor/delivery room—to gather feedback from hundreds of physicians, clinicians, and technicians. They prefabricated 750 bathroom units, 850 headboards, and three miles of MEP systems offsite.

When projections of ED use ballooned from a planned 100,000 visits a year to a possible 240,000, the team halted construction on the ED, redesigned it, and added a shelled bay of 12 exam rooms for future expansion.

When, in 2011, new hospital management asked for a “reexamination” of key design elements, the team enlarged ambulatory facilities on the main campus to meet anticipated demand. They reconfigured the radiology department into separate inpatient/outpatient units instead of a single unit as originally planned. They even redesigned the dietary kitchen so that patients could have 24-hour room service.

They standardized the ORs to allow for different types of equipment to be brought in, depending on the procedure. Conduits and cable trays were oversized. Floor-to-floor heights were bumped up to support future technologies.

According to Fred Cerise, MD, President/CEO, Parkland Health & Hospital System, “The legacy of this institution is cemented as an innovator in providing quality care for the medically underserved, as a leader in clinical expertise in specialties like burns and trauma, and as a pioneer of 21st-century transformational care processes.”

Unique Pharmaceuticals Launches Sterile Operations

Unique Pharmaceuticals, a 503B outsourcing facility, has initiated sterile compounding operations meeting the newly established federal guidelines.

"Our goal as a company is to meet and exceed industry standards," said Unique Pharmaceuticals chief executive officer Travis Leeah. "Meeting the new regulations is validation of our quality management system and our dedicated staff. We're embracing the future of our industry, investing in its continued success and are proud to be a pioneer among our competitors."

Unique Pharmaceuticals was among the first companies in early 2014 to voluntarily register with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility following guidance from the Drug Quality and Security Act (DQSA) which congress passed in late 2013. Passage of the DQSA brought definition to the regulation of the compounding industry by establishing a new oversight section of the FDA for "outsourcing facilities" like Unique Pharmaceuticals, allowing facilities to voluntarily register with the FDA under Section 503B of the Federal Food, Drug and Cosmetic Act. This new category of large volume sterile compounders is now held to quality standards and subject to routine FDA oversights much like drug manufacturers.

Unique Pharmaceuticals and Regulatory Compliance Associates Inc. (RCA), a team of experienced professionals from FDA-regulated industries including pharmaceuticals, cooperated with the FDA to demonstrate compliance with new compounding industry regulations. Unique Pharmaceuticals has recently undergone two thorough inspections ensuring compliance with the new requirements including an independent inspection and certification by RCA, and an FDA follow-up inspection. Earlier this month the Dallas District Office of the FDA, upon assessment of corrective actions, notified Unique Pharmaceuticals in a written letter that it had "no objection to the company resuming sterile operations."

"We're proud to partner with Unique Pharmaceuticals as they demonstrate industry leadership in their commitment to 503B quality," said Andrew Harrison, chief regulatory affairs officer at RCA. "As the regulatory framework for compounding pharmacies is maturing, Unique Pharmaceuticals has the early adopter advantage in the industry for showing dedication to sustainable compliance with the safety and quality standards from the FDA."

Previous regulations required compounders to meet United States Pharmacopeia (USP) Chapter 797 standards, which were monitored and enforced by state boards of pharmacy. Though Unique Pharmaceuticals continually met and exceeded USP requirements, the company spent much of 2014 re-engineering its facility, processes, procedures and testing to meet the new 503B Current Good Manufacturing Practices (CGMP) guidance requirements. The company enhanced the design of its facilities; invested in technology such as new cleanroom equipment and upgrades to the HVAC system; validated processes and equipment; made investments in human capital by adding staff with experience in CGMP and pharmaceutical manufacturing; and increased environmental and personnel aseptic monitoring from weekly to daily to ensure delivery of sterile compounded products.

"We've spent an intense nine months transforming our company in order to continue providing our customers, and ultimately their patients, with high-quality, safe, life-saving and life-sustaining medications," Leeah said.

PRA Health Sciences Launches Early Phase Expansions

In another sign that early phase research demand is picking up, North Carolina-based CRO PRA Health Sciences (PRA) is increasing its Phase I clinical footprint in the US and Russia.

Among the biggest of the four separate announcements on early phase research, PRA said it is opening an 11,000 square-foot outpatient facility at the company’s Salt Lake City, Utah site, focusing on psychiatry, neurology, pain and multiple other therapeutic areas. The new facility includes a dedicated pharmacy, clinical lab and surgical suites.

In addition, PRA is expanding Human Abuse Liability (HAL) study capabilities at its Lenexa, Kansas site. This expansion will help PRA to be the only CRO capable of conducting these specialized trials in more than one clinical pharmacology unit, the company claims.

Willem Jan Drijfhout, EVP of PRA Early Development Services, said, “We see demand from clients changing from studies in healthy volunteers, to studies in special populations and patients. Over the past years we have built up significant patient Phase I capabilities and the current investments are designed to diversify in type of patients as well as in geographic region.”

The company also plans to expand its US patient capabilities and service offerings by implementing operational site models in its Marlton, New Jersey, facility similar to those in its pharmacology operations in Central and Eastern Europe.

Drijfhout added: “The operated site model we have been running for many years in Europe in our Patient Pharmacology Services (PPS) division allows us to be flexible both in size of study and type of patients researched, enabling us to build the most optimal operational setup for each individual trial. We expect that in applying this model to our New Jersey facility we will see similar benefits.”

The expansion of early phase services come as others in the space have seen an uptick in market demand, though pricing has yet to follow suit. Drijfhout told us, however, that the type of studies involved at the sites due for expansion “are special in nature and as a consequence have less pricing pressure associated with them than regular healthy volunteer studies.”

In addition to the US-based moves, PRA is expanding its Patient Pharmacology Services into Russia. The first clinical trial application was recently submitted for a rheumatoid arthritis patient study and approval is expected next month.

“With PRA conducting more than half of its Phase I/IIa studies in patients vs. volunteers, these initiatives will further enhance our U.S. patient capabilities and service offerings,” added Randall Hein, SVP, Clinical Research Services.

PRA’s EDS business unit’s global capabilities now include: eight clinical pharmacology units, two bioanalytical laboratories, as well as dedicated clinical pharmacology, statistics, data management and pharmacokinetics services.

G-CON Manufacturing Selected to Build for UTHSC

G-CON Manufacturing has been selected to build a multi-POD ISO Class 7 Formulation and Filling Suite for the University of Tennessee Health Science Center (UTHSC).

The new facility in Memphis, Tennessee, will expand the capabilities of the UTHSC Plough Center for sterile drug delivery, which is currently used for process development, analytical and stability studies.

In addition, it will be used for hands-on training in aseptic processing and sterilization techniques.

UTHSC executive vice-chancellor Dr. Kennard Brown said: "The Plough Center hopes to become recognized for its ability to formulate and manufacture difficult to produce new drug products for clinical trials, and for paving the way for manufacturing medicines of the future such as antibody-drug conjugates, nanoparticles and bio-similars."

The PODs will provide approximately 1,800ft² of cleanroom space and incorporate areas for component preparation, compounding/formulation, filling and lyophilisation for use in manufacturing clinical and small-scale products.

An additional POD will provide approximately 760ft² of cleanroom space for the manufacturing and development of semi-solids products.

G-CON director of Sales Engineering Dennis Powers said: "UTHSC's selection is a reflection of the market's increased interest in combining aseptic filling processes within our cleanroom POD technology.

"Integrated designs like these can be replicated or redeployed anywhere in the world as needed."

G-CON was selected as part of a project team that includes brg3s Architects, ETFC Architects, DPS Consulting and DPS Engineering. DPS Consulting will provide pharmaceutical consulting and guidance, while DPS Engineering will provide process architecture and design for the PODs.

Bayer Invests in Berkeley, CA Site

Bayer HealthCare will invest $100 million in its Berkeley, CA manufacturing site to build a product testing facility that will support the next generation of treatments for hemophilia A.

"Building upon our legacy in hemophilia A, we are delighted to continue Bayer's leadership in working to bring treatment options to patients around the world," said Joerg Heidrich, senior vice president for Product Supply Biotech and site head at Bayer Berkeley.

"The new product testing facility will test Bayer's investigational products in accordance with rigorous global regulatory requirements," said David Weinreich, MD, head, Global Development, Specialty Medicine at Bayer. "With today's announcement, we are thrilled to further strengthen our commitment to the hemophilia A patient community that Bayer has served for more than a quarter century."

Bayer Opens Facility in Pikeville, NC

Bayer CropScience has opened a new $6.3 million, 150-acre breeding and trait development station in Pikeville, N.C. that will identify, test and develop new cotton and soybean varieties for the mid-Atlantic and Southern U.S. markets.

The Breeding and Trait Development Station at Pikeville is the first of several Bayer CropScience breeding stations throughout North and South America and the first to combine work on two crops. The facility will support the development and testing of Bayer CropScience’s FiberMax and Stoneville cotton varieties and Credenz soybeans for the mid-Atlantic region. The quality and yield of cotton and soybeans will also be evaluated.

The facility, with eight full-time and five to 10 contractors and seasonal staff, consists of four new buildings on a renovated former Bayer Healthcare site, including a 4,227-square-foot office building, a 13,057-square-foot processing building, a 13,904-square-foot equipment barn and an outdoor pavilion. Previous site buildings were removed to accommodate new construction.

“Our Breeding and Trait Development Station at Pikeville will have a significant impact on the way cotton and soybeans are grown and developed throughout this area of the country,” said Brent Styles, site and testing manager for the Breeding and Trait Development Station at Pikeville. “We place a high emphasis on quality management and seed stewardship, in order to ensure our cotton and soybean-related products are the most beneficial to growers.”

Ipsen Opens R&D Center

Ipsen's new research and development facility at 650 E. Kendall St. features a main area on the second floor with moveable, multi-colored glass panes.

There was a grand opening of a new Cambridge research site for Ipsen, a French drug developer now hoping to expand its profile as well as drug sales in the U.S.

The company hosted an event called “Creativity and Science” at its new research facility, the same building where Baxter International is opening a 400-employee research and development center for its planned spinout. Ipsen occupies the second floor and part of the fourth floor there, and the event served as a chance to show off the newly-renovated, brightly-lit space, one of three global R&D centers for the 4,500 employee company which was founded in 1929 by Henri Beaufour and remains mostly family-owned to this day.

While new to Cambridge, the company has been in Massachusetts for nearly four decades, until recently at an R&D facility in Milford. The decision to move into the heart of the state’s biotech innovation hub is hoped to help make it easier to recruit talent as well as to have a presence as it aims to expand its U.S. presence. Just a small fraction of Ipsen’s annual revenue, which is the equivalent of $1.3 billion, now comes from the U.S., and the company is aiming to increase that in coming years, according to company spokesman Rob Kloppenburg, spokesman for Ipsen.

The 60-employee Cambridge site is overseen by Leslie Sloan, vice-president of R&D Project Management and Analytics and president of Ipsen Bioscience.

The event itself featured Nobel Prize winners Robert Weinberg, biology professor at MIT, and Roger Guillemin, of the Salk Institute, and was modeled on annual events held by the nonprofit Foundation Ipsen annually to highlight cutting-edge biomedical research.

The company also announced a multiyear research alliance agreement with Harvard University to enable researchers at both institutions to work in areas of neuroendocrine tumors, neuromuscular disorders, and other areas within Ipsen’s area of particular expertise, toxins and peptides.

GSK to Establish Global Vaccines R&D Centre in Rockville, MD

British drugmaker GlaxoSmithKline (GSK) is planning to establish a new global center for vaccines research and development (R&D) in Rockville, Maryland, to further strengthen and expand its vaccines presence in the US.

The new vaccines R&D center in Maryland will be the company's third, in addition to those in Rixensart, Belgium and Siena, Italy.

It will expand the company's efforts to discover and develop new vaccines across a range of public health threats, including those relevant to the US.

GSK Vaccines president Luc Debruyne said: "Following the acquisition of Novartis's global vaccines business and in recognition of the vaccines knowledge and expertise in the US, we are pleased to expand our US presence with the creation of a world-class vaccines R&D center.

"This will drive innovation, and enhance our capabilities for new vaccine discoveries that protect the US and public health around the world."

In March 2015, GSK completed the $20bn three-part asset swap deal with Switzerland-based pharmaceutical firm Novartis, as part of efforts to dispose of non-core businesses and focus on bolstering core areas.

The new center will consolidate vaccines R&D activities currently conducted at the company's other US sites in Philadelphia and Cambridge.

The company said that major late stage development program, as well as vaccine discovery and new platform technology development will be led from the Rockville site.

Operations for vaccines are expected to be initiated at the new Rockville site as early as September 2015.

REST OF WORLD

New Lab Unveiled at Mintek NIC

A new R30m (322 sq. ft.) cleanroom facility has been unveiled at Mintek's Nanotechnology Innovation Centre (NIC) in Johannesburg, South Africa, to manufacture devices for the rapid diagnosis of illnesses such as malaria. The early diagnosis and treatment of such diseases can help to save lives, and having the cleanroom is a major step towards disease control in South Africa.

Commissioned by the Department of Science and Technology (DST) last December, the new cleanroom facility is designed to enable the NIC and South Africa's researchers to develop and fabricate nanotechnology-based diagnostic devices and tools for health applications and the containment of biological reagents.

The facility will also enable the center to produce nanotechnology devices and systems that meet the most stringent International Standards Organization (ISO) requirements, which makes it possible for the NIC to follow good manufacturing practice (GMP) guidelines and comply with pharmaceutical inspection conventions.

Unveiling the facilities, the Minister of Science and Technology, Naledi Pandor, said that the DST was greatly encouraged by the progress that the government had made since the launch of the National Nanotechnology Strategy in 2005.

‘When we launched the strategy, we set ourselves ambitious goals regarding the provision of clean water, reliable energy and improved healthcare. We are committed to doing this cost-effectively, and we remain committed to these goals and focused on their realization,’ she said.

Pandor added that reliable research equipment would enhance the development of nanotechnology based knowledge and innovation in South Africa.

Merck & Co.'s Plans for Facility in County Carlow, Ireland

Merck & Co. will invest €11.5m ($12.5m) at a plant in Ireland to manufacture its oncology drug Keytruda, an anti-PD1 mAb recently approved by the US FDA.

The 200,000 sq. ft. facility in Carlow, Ireland supports the biopharma firm’s global vaccine business, but Merck & Co. (known as MSD outside North America) is looking to use the site to manufacture and supply oncology biologics through this latest infrastructure investment.

“The site has historically been used to manufacture vaccines but will play a key role for our oncology products,” said MSD spokesperson Caroline Collins.

She confirmed the Carlow plant will be used to supply the US market with Merck’s humanized monoclonal antibody Keytruda (pembrolizumab), which became the first US anti-PD-1 (programmed death receptor-1) therapy approved by the US Food and Drug Administration (FDA) last September for patients with advanced melanoma.

Keytruda is currently in clinical trials for further indications, including non-small cell lung cancer (the license for which Merck submitted to the FDA last week), and is seen by the firm to be a key part of its growing presence in the oncology sector.

“We continue to fortify our oncology business unit as we prepare for potential launches in other tumors,” Adam Schechter, Merck’s President of Global Human Health said in February while reporting end of year financials (transcript here). “We are investing to be a global leader in oncology.”

While Keytruda is yet to have received licensing locally, Collins said Carlow would supply materials for ongoing clinical trials in Ireland.

The €11.5m expansion is the latest in a string of investments at Merck’s Carlow plant, totaling over €300m over the past few years, and the company says its continued commitment to Ireland is driven by the local talent and Government support.

The Irish Government announced recently it was offering grants in process development in order to remain competitive with other biomanufacturing hubs such as Singapore and Puerto Rico. It has also invested almost €60m into the National Institute for Bioprocessing Research and Training (NIBRT), to ensure the country has a high skill set for the biomanufacturing sector.

MSD’s Vice President of Biologics, Ireland, Brendan O’Callaghan related that Carlow has “hired over 200 people and brought them all through NIBRT and trained them in terms of aseptic processing technique and capability.”

However, it is unclear for now whether this latest investment will bring further jobs to the plant.

AbbVie Expanding Facilities in Barceloneta, Puerto Rico

AbbVie is investing $30m (€27m) in contract manufacturing facilities in Puerto Rico and plans to create 100 jobs over the next two years.

The pharma giant will expand its two existing sites in Barceloneta, on the northern coast of the island.

A spokeswoman said the funding will mostly be spent on processing capabilities for immunology products.

One of AbbVie’s Barceloneta sites produces small molecule therapies, while the other makes biologics and active pharmaceutical ingredients (APIs), as well as large-scale drug services like tablet coating, granulation, hot melt extrusion, and prefilled syringes.

The government-owned Puerto Rico Industrial Development Company (PRIDCO) supported this latest expansion and has offered AbbVie incentives for building infrastructure and jobs.

The Executive Director of PRIDCO said Puerto Rico plans to encourage other investments in manufacturing and industrial development.

“AbbVie’s expansion reaffirms Puerto Rico as a global manufacturing powerhouse where talented people combine with pioneer technologies to create biopharmaceutical products that have a significant role in the lives of many people worldwide,” added Antonio Medina Comas.

Puerto Rico’s governor Alejandro García Padilla said AbbVie’s presence and expansion showed the company’s confidence in the area.

AbbVie has a third Puerto Rican facility in Jayuya in the central highlands. The site manufactures potent oral dose drugs, and performs mixing, compressing and packaging. The company employs approximately 1,000 people on the island.

Puerto Rico has a reputation as a biotech hub, partly driven by tax credits which historically have exempted manufacturing on the island from US taxes. AbbVie has been present in the territory since 1969.

But following a change in US law in 2010 which taxed offshore big earners, companies have started to pull out of the region. Novartis has announced it will close its Puerto Rican activity and outsource manufacturing and packaging to Eli Lilly by 2019.

Pfizer and Merck also plan to phase out many of their operations in Barceloneta by 2017.

Actavis bucked the trend last June with a $48m investment in solid dose and hormone manufacturing.

Puerto Rico’s utility costs and taxes must be controlled if the region is to retain pharma investment, a regulatory expert told in-Pharmatechnologist.com in 2013.

Almac to Relocate Protein Business

Almac will transfer its custom peptide manufacturing business to a site at the Edinburgh Technopole business park in Scotland’s capital in a £3.5m move designed to expand capacity.

The Northern Ireland-headquartered contract services firm announced the plan today, explaining it will shift protein production and process development operations from a rented site in Elvingston to a new purpose built lab.

A spokeswoman for the company said, "The move to the new site provides us with much more capacity to grow our current business lines but also to introduce new lines of business" citing specialist reagents and conjugation technologies for antibody drug conjugates (ADC’s) as examples.

Almac will spend £3.5m ($5.1m) to set up a 7,000 sq.ft. laboratory and office space at the Edinburgh Technopole with Government investment group Scottish Enterprise stumping up an additional £450,000 to back the project.

The firm also cited its 2013 protein tech focused agreement with UK-based TTP Labtech as evidence of growing demand for such services.

“There are currently 15 staff at the Elvingston facility and they will all be transferring to the new site. The aim over the next three years is to more than double the staff employed."

Almac will join contract research services firms INC Research and Solid State Solutions, which already have operations at Edinburgh Technopole.

Chris Mitchell, Associate Director of BEST Network and LaSalle Investment Management which manage the business park, told us "collaboration between occupiers in BEST Network’s science and technology centers is strongly encouraged. We believe businesses operate most successfully when they are part of an inspiring and synergetic community."

Novo Nordisk Opens New Insulin Manufacturing Facility in Russia

Novo Nordisk has opened a new manufacturing facility in Russia for the formulation and filling of insulin as a diabetes treatment.

This is the first and only greenfield facility for the manufacturing of modern insulin in Russia, according to Novo, which also says it has set up environmental targets for carbon dioxide emission, water consumption and use of energy.

"The factory was built to ensure that patients in Russia will continue to have access to modern insulin from Novo Nordisk. The factory furthermore supports the Russian authorities' Pharma 2020 strategy on local production of pharmaceuticals," said Henrik Bendix Dahl, General Manager, Novo Nordisk Russia.

The new GMP production facility, located in Technopark Grabtsevo in the Kaluga region of Russia, will add about 150 new jobs to the Russian economy and help to provide both Penfill cartridges and FlexPen prefilled insulin injection pens for the Russian market.

"The manufacturing facility in Kaluga is a sign of our long-term commitment to people with diabetes in Russia, where close to 10 million people have the disease according to local studies. With our investment in local manufacturing, we ensure availability of high-quality modern insulins to the people with diabetes in Russia who rely on our products every day," said Lars Rebien Sørensen, CEO of Novo Nordisk.

Novo Nordisk also has production sites in Denmark, Brazil – which was injected with $200m back in 2007 -- China, France and the US.

The company has been busy in recent months with its manufacturing operations. In October, the company was hit with a subpoena over a Danish insulin and hemophilia treatment manufacturing site over alleged issues. Also in October, the company bought a manufacturing facility in New Hampshire, where it’s looking to add 90 new employees.

The Danish drugmaker is also working to develop a new way to deliver insulin orally.

Ireland Aims to Attract Biomanufacturing with R&D Grants

Ireland is trying to compete in biomanufacturing with powerhouses like Puerto Rico and Singapore thanks to government-financed innovation in process development.

Barry Heavey, Head of Life Sciences at Ireland’s Industrial Development Agency (IDA), said a combination of R&D grants to multinationals, and activity at state-financed biotech centre NIBRT, is drawing big pharma players to manufacture in the country.

The NIBRT, the National Institute for Bioprocessing Research and Training, Heavey claimed Ireland’s competitiveness among biomanufacturers goes beyond just low corporate tax rates.

A series of IDA grants for R&D – usually spent on process development to support manufacturing – are bringing investment to the country, he told BioPharma-Reporter.com.

The agency supported Pfizer’s biologics process development at its facility in Cork, among many other grants.

Although Ireland has no home-grown pharma companies, it houses manufacturing facilities for Pfizer, Lilly, Mylan, MSD, Allergan, Bristol Myers Squibb and other drugmakers.

Encouraging these companies to have an Irish base has a knock-on effect of attracting foreign supplier companies and boosting indigenous ones, Heavey added.

“As multinationals are investing in process R&D they might decide to work with a ‘scrappy’ innovative small company.”

IDA’s R&D grants, and those from sister agency Enterprise Ireland, help “de-risk” multinationals’ relationships with small subsuppliers of equipment and technology, he said.

“That creates an opportunity for innovative subsuppliers to get into the Irish subsidiaries of multinationals.

“A lot of subsuppliers believe they have to go to corporate HQ to get the newest technology adopted, but if the Irish site is doing R&D and improving their processes they might be the logical place to go to get their technology adopted.

“If we give a grant Pfizer to do research and a subsupplier wants to make sure its tech is adopted by Pfizer, they will do innovative R&D in Ireland next to Pfizer.”

Companies like ProSys, an Irish manufacturer or sampling and containment equipment, have benefited indirectly from the grants by winning contracts with Pfizer, Healey said.

NIBRT also plays a big role in encouraging foreign investment, Heavey said. The institute takes in scientists from companies around the world – 3,300 so far – and trains them in biomanufacturing, including complex GMP surroundings.

Its clients include Pfizer, Lilly, MSD, Roche, and Janssen.

“The NIBRT facility offers training in a real-world environment, on real equipment. This de-risks the transition from trainee to employee,” said Heavey.

The centre also allows companies to road-test new technology and validate subsystems, with a focus on QC testing and bio-characterisation.

“EU policy now says if you want to stay competitive in manufacturing – you need to stay competitive in this environment.”

Heavey described NIBRT as creating “an ecosystem” of pharma and vendor companies drawn to the area looking to partner on QC work. “It’s a playground for B2B research collaborations.”

Sigma-Aldrich Opens Latest Singapore Biopharma Investment

Sigma-Aldrich has opened a cell culture Technical Center in Singapore and plans to expand further in the city-state with a cGMP distribution site.

The site in Biopolis Research Park will offer customer’s cell culture and pre-clinical services, as well as collaborating Sigma-Aldrich’s existing Singaporean commercial offices and production laboratories into one location.

Jason Apter, Vice President and Managing Director, Asia Pacific for Sigma-Aldrich, said the new site would “significantly enhance our ability to support our customers in the region more quickly and effectively by providing local technical solutions that are customized to meet their needs.”

Among the services available to Asian customers, the Center will provide cell culture media development and optimization services, and preclinical media manufacturing using the firm’s imMEDIAte Advantage platform which helps clients produce non-cGMP batches of material.

“We are partnering with biopharmaceutical companies that are looking to increase the efficiency of their R&D efforts, working with them to reduce the time-to-market, cost and risk in developing both new drugs and generic versions of existing drugs,” Apter added.

There has been a large amount of Big Biopharma investment in Singapore, including new facilities from Amgen, Baxter, AbbVie and Novartis. With many manufacturers benefitting from Singapore’s workforce and incentives from the Government – a roadmap was published last year looking at how the city-state can further support the fast growing industry further – it makes sense that biopharma service firms are also investing in the region.

Pall opened a Centre of Excellence in 2011, and in 2013 Thermo Fisher cut the ribbon on the first dry powder media plant in Singapore.

To further strengthen its presence, Sigma-Aldrich is also constructing a cGMP distribution centre in Tuas, expected to open later this year to provide end-to-end services to its South-East Asian clients.

“Our investments in Singapore play a crucial role in our strategy to better serve our regional customers and global players expanding into Asia,” said Gilles Cottier, Executive Vice President at Sigma-Aldrich.

“The country’s rapidly expanding biomedical ecosystem provides Sigma-Aldrich with access to talent and resources in an attractive and robust business environment like Singapore.”

LabCorp, Quintiles and Quest Diagnostics Combining Clinical Trials Lab Operations

Upon closing of the transaction, Quintiles will own 60% and Quest Diagnostics will own 40% of the new JV, which would have generated approximately $575m (€535m euros) in revenues in 2014. The transaction is expected to close in Q3 of this year. The central labs market is valued at nearly $2bn and is growing about 5% annually, Quintiles said.

Tom Pike, CEO of Quintiles, said in a conference call, “What we’re going to do is take our central labs services, genomics services and bioanalytical services and put them into the JV and that’s along with Quest’s assets in the clinical trial space.”

The combined scale of the new entity will benefit from the operational expertise and purchasing power, as well as the logistics and supply chain network of Quest, which serves half of the physicians in US hospitals, said Steve Rusckowski, CEO, Quest Diagnostics.

Pike also noted that customers will gain an advanced testing menu, including services designed to support trials and to enable end-to-end companion diagnostic development with regulatory, reimbursement and commercial strategies, particularly for biopharma customers’ precision medicine efforts.

Central lab tests have become more complex over time, Pike added, noting that out of the 41 novel drugs approved last year by the US FDA, nine have biomarkers associated with them. And more than half of all drugs in biopharma companies’ pipelines have a biomarker associated with them, he added.

Analysts were upbeat on the prospect of the partnership, as well. Citi Research's Garen Sarafian said in a note to investors: "The deal is a positive for Quintiles where we expect the added scale from Quest positions the companies more appropriately to compete with LabCorp for central labs business, particularly after the Covance acquisition."

Beyond the immediate opportunity in lab services support for clinical trials, Quintiles and Quest expect to benefit from opportunities to collaborate in other areas, as well, including new ways to enhance patient recruiting and retention for clinical trials; speed the validation, development and commercialization of companion diagnostics; enhance support of real-world late phase studies; and develop new population-health analytics and tools.

Pike added that over time, there will be synergies that could consolidate some mutual space as the integration of the companies move forward.

The joint venture will be led by Quintiles’ Costa Panagos, SVP, and John Haydon, VP of JVs for Quest.

South Africa Unveils Cleanroom to Fight Deadly Diseases

A new $2.5 million cleanroom facility has been unveiled at Mintek's Nanotechnology Innovation Centre (NIC) in Johannesburg, South Africa, which will allow for the manufacture of devices that permit the rapid diagnosis of illnesses such as malaria.

The early diagnosis and treatment of such diseases can help to save lives, and having the cleanroom is a major step towards disease control in South Africa.

Cleanrooms are essential for the fabrication and production of advanced devices and systems that require the concentration of airborne particles to be controlled to ensure that processes are not compromised by unwanted and/or unknown contaminants. Cleanrooms also allow the control of other variables, such as temperature, humidity, and pressure.

Commissioned by the Department of Science and Technology (DST) last December, the facility is designed to enable the NIC and South Africa's researchers to develop and fabricate nanotechnology-based diagnostic devices and tools for application in health and the containment of biological reagents.

The facility will also enable the center to produce nanotechnology-based devices and systems that meet the most stringent International Standards Organization requirements. This makes it possible for the NIC to follow good manufacturing practice guidelines and comply with pharmaceutical inspection conventions and cooperation.

Unveiling the facilities, the Minister of Science and Technology, Naledi Pandor, said that the DST was greatly encouraged by the progress government had made since the launch of the National Nanotechnology Strategy in 2005.

"When we launched the strategy, we set ourselves ambitious goals in respect of the provision of clean water, clean and reliable energy, and improved health care. We are committed to doing this cost-effectively, and we remain committed to these goals and focused on their realization," says the Minister.

The Minister added that reliable research equipment and research chairs in the field would enhance the generation of nanotechnology knowledge and nanotechnology innovation in South Africa.

Theravectys Opens New Facility

Theravectys, a clinical development biotechnology company that focuses on the development of therapeutic vaccines and immunotherapies, said that its manufacturing plant has obtained the status of a pharmaceutical manufacturing establishment, granted by the French National Agency for Medicines and Health Products Safety (ANSM). The new facility will be used to produce lentiviral vectors for clinical development purposes, from phase I through phase III, and will also be used to manipulate human cells in the context of chimeric antigen receptors (CARs) and t-cell receptor (TCR)-based cell therapies in the future.

As a result of the authorization, Theravectys has further strengthened its position as a leader in the lentiviral vectors field and has become fully operational for supplying comprehensive immunotherapeutic treatments that help stimulate and modulate the immune system from the initial vector design to the final release of clinical batches.

“The grant of the status of the pharmaceutical manufacturing establishment is a major achievement for Theravectys. We are proud of the team’s dedication to this project, which has allowed us to carry out the work and obtain the opening approval in just 12 months,” said head of quality assurance, Amel Hadri.

The new facility will be used to fulfill the company’s internal clinical development program needs, in addition to those of strategic pharmaceutical partners. In the coming months, Theravectys plans to produce cGMP lentiviral vectors for its first phase I and phase II clinical trials in oncology (adult T leukemia/lymphoma induced by HTLV-1) as well as for its differentiated CAR-T cell-based immunotherapy programs.

This investment will allow THERAVECTYS to control manufacturing costs and timelines, and will allow the company to better leverage the production processes for both research and clinical development material requirements.

The production site is designed in compliance with GMP and ISO standards. It consists of several independent production suites, including upstream and downstream process rooms, an aseptic filling suite, as well as a logistic zone that allows for GMP storage at various temperatures ranging from -80°C to 25°C. Additionally, the installation is comprised of a quality control laboratory.

The plant will be able to handle up to 24 active batches annually. Human cells will be cultured in suspension in up to 1,000-liter bioreactors, using synthetic medium and disposable materials. Proprietary specific quality controls have also been developed, such as RCL, lentiviral vector quantification, residual DNA characterization, fully internalized for better product qualification and more efficient batch releases.

“With the opening of our GMP manufacturing plant, the exclusive worldwide Intellectual Property (IP) license from the Institut Pasteur, and the sponsor of the first-ever vaccination trial performed in a human with lentiviral vectors, Theravectys has now become the only company in the world to offer a fully-integrated and protected cutting-edge lentiviral vector technology platform,” said chief executive officer of Theravectys, Renaud Vaillant.

Onyx Scientific Expands GMP Capabilities

Onyx Scientific is expanding its GMP space for its small scale API manufacturing services. The company will install a new Class 100,000 suite at its facility in North East England to meet client needs for Phase I/II GMP campaigns.

Onyx Scientific specializes in preclinical/clinical development projects and offers production of API up to 50l-100l under current GMP regulations, as well as earlier stage custom synthesis, lead optimization, solid state and analytical services.

Denise Bowser, commercial director at Onyx Scientific, said, “This latest investment will bring the total capacity at our UK site up to four dedicated GMP suites, which represents a steady but significant growth in this area over the past few years. Having an additional GMP suite at our disposal, it gives us even greater flexibility to assist our clients that are under increasing timeline pressure to deliver against their development programs.”

Intertek Clinical Research Services Moves to New Laboratory Facility

Intertek, a global leader in providing quality solutions to industries worldwide, has opened a new laboratory located in Hooton, in the north west of England. Previously located in Capenhurst, Intertek Clinical Research Services (CRS) has more than doubled the size of its laboratory. With this new location Intertek can accommodate and deliver larger projects for its customers, with capacity to develop new and innovative techniques tailored to its customers' needs.

Intertek delivers a wide range of in vitro oral care test methods including dental abrasivity, whitening, oral sensitivity, enamel erosion, remineralisation, cleaning efficacy and analytical support for clinical trials. The Hooton facility also incorporates the main administrative office for Intertek CRS, providing seamless management of the services offered in oral care, dermatology, nutrition and healthcare research.

This growth and investment, within an increasingly stringent environment for regulatory and advertising claims support, demonstrates Intertek’s determination to build on its reputation for quality and delivery of robust scientific data. The team of multidisciplinary scientists are committed to delivering a superior service, both regionally and internationally, and from this new location the CRS team can continue to excel in both routine and bespoke experiment design, tailored to meet specific objectives or claims.

Dr. Peter Hall, Laboratory Director at Intertek CRS, said: 'This new laboratory has been custom-built and equipped to give us the perfect environment for not only meeting, but exceeding our customer needs for now, and into the future. We are truly excited.'

UK's Leading Disease Lab Offers New Designs

A daring Building Team breaks the bunker mentality common to research containment with this light-filled, open facility in the English countryside.

To create an inviting, nonscientific aesthetic for the high-containment lab facility, the team incorporated splashes of color, timber cladding, and pleasing proportions into the exterior scheme.

Daily life as a researcher in the typical high-containment lab facility goes something like this: Arrive early in the morning at a nondescript building. Pass through security. Complete extensive containment procedures—shower-in, change clothes, etc. Finally, enter a dreary, largely windowless inner sanctum for eight to 10 hours of intense lab work. Any break from research activity—to grab lunch, attend a meeting, work on the computer—requires a trip out of containment, along with exit and re-entry procedures. On a busy day, researchers could repeat this cycle half a dozen times.

The Building Team for the Pirbright Institute’s new Category 4 biocontainment facility (roughly equivalent to BSL-3 Enhanced in the U.S.) thought there had to be a better way. With the goal of attracting and retaining the world’s top viral disease scientists to Pirbright’s campus in Surrey, England, the team, led by design architect and lab planner HDR, project/program manager AECOM, and design-builder Shepherd Group, set out to rewrite the rules of containment lab design. What the group ultimately delivered is unlike anything seen in an infectious diseases laboratory environment.

The 151,000 sq. ft. Plowright Building breaks free from the traditional box-inside-a-box containment lab approach by literally turning the building inside out. The lab spaces that normally would be located within the inner sanctum are located at the perimeter of the structure, where floor-to-ceiling windows flood the research spaces with natural light. At the center of the building are work and collaboration zones—offices, conference rooms, and a cafeteria—situated around a dramatic cylindrical, three-story, skylit glass atrium.

PROJECT SUMMARY

PLATINUM AWARD

BBSRC National Virology Centre – The Plowright Building

The Pirbright Institute, Surrey, England

BUILDING TEAM

Submitting firm: HDR (architect, lab planner)

Owner: Pirbright Institute, Biotechnology and Biological Sciences Research Council

Project/program 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 sf

Construction cost: $175 million U.S.

Construction time: July 2011 to October 2014

Delivery method: Design-build lump-sum price

To minimize the number of times researchers must transfer in and out of containment during a typical workday, the team located most of the building’s work and meeting spaces within the containment zones, including a portion of the main cafeteria. There, a 15-foot-high glass wall separates the containment dining area from the general eating area—a design feature that, for the first time, allows Pirbright to conduct all-staff meetings and symposiums without researchers having to leave containment.

To pull off this audacious scheme, the team worked hand in hand with the client to develop creative solutions to countless formidable problems. They include:

Maintaining an airtight seal at the perimeter. Solution: a custom concrete containment barrier, meticulously sanded and coated with a seven-layer custom-designed containment system. Steel frames for the building’s 2,182 through-wall penetrations (windows, doors, services, etc.) were cast into the concrete walls to accept gaskets that are vital to maintaining an airtight seal at each penetration point.

Applying a layered approach to containment that mirrors risk level. Solution: A negative air-pressure cascade moves from the lowest containment zones (RS0) to the most stringent zones (RS4) with once-through air that is exhausted through a HEPA air-filtration system in a penthouse floor above the labs. Sample and waste flow is one-directional. Samples come in at one end of a lab wing and waste goes out—through autoclaves—at the opposite end. The close-knit Building Team implemented numerous teaming and quality best practices—including factory acceptance testing, mockup testing, team scoring, 360-degree feedback, and clean builder procedures—to ensure the project went off without a hitch. The results are proof of the team’s success. The building opened last October, a week earlier than scheduled and under budget. More to the point, the facility is meeting Pirbright’s stated goal of attracting top talent. Since opening, the institute has more than doubled its research staff, to 350.

“This project showcases a truly innovative design approach to a containment facility,” said Building Team Awards judge Nathaniel Snydacker, PE, LEED AP, Vice President with Environmental Systems Design. “The collaboration between design team, owner, and construction team was readily apparent in the unique vision for this facility, allowing color and sunlight into what would typically be a cavern.”

Green Cross to Expand Biologics Market in Russia

Korea based biopharmaceutical company, Green Cross, has partnered with Nanolek, a Russian pharmaceutical company, for the commercialization of Green Cross' biologics in the Russian market.

Nanolek will obtain marketing authorizations and set up the production of a number of Green Cross' biologics. The production will be organized at Nanolek's facility, a biopharmaceutical complex built and equipped in compliance with EU GMP standards and launched in December 2014.

"This partnership is a perfect strategic fit for Green Cross' global business model," said Dr. EC Huh, president, Green Cross Corporation. "We are excited to work with the team at Nanolek, and to share in the longer-term commercial success of Green Cross' products as it enters Russia."

"Our project with Green Cross will make socially significant drugs more accessible and minimize the state's financial burden for the procurement of these drugs outside of Russia," said Mr. Mikhail Nekrasov, CEO, Nanolek. "Making possible the domestic production of a number of biopharmaceuticals is our contribution to the implementation of the government policy in developing the Russian pharmaceutical industry."

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com