Avista Pharma Solutions has initiated a significant expansion and enhancement of its contract testing facility in Agawam, MA. This facility offers microbiology and analytical chemistry testing services as well as cleanroom services—supporting environmental monitoring, qualification and certification.

Expansion of the 26,000-square-foot facility includes a new microbiology laboratory equipped with isolator technology for sterility testing and expansion of the analytical footprint along with a laboratory support area with new autoclaves and glassware washers. Services offerings include raw material and finished product release testing, ICH stability and storage, container closure integrity testing (CCIT), water system testing and validation, cleanroom monitoring and risk assessments, microbial identification via both MicroSEQ ID (rapid 16S rDNA sequencing) and Vitek MS (MALDI-TOF), mycoplasma testing, antimicrobial effectiveness testing (AET), microbial enumeration testing (MET), endotoxin and bioburden testing and disinfectant efficacy qualifications.

The new sterility testing via isolator technology adds to the expanding service offerings for pharmaceutical manufacturing clients with facility expansion expected to be completed by June 2016.

“We remain committed to providing best-in-class microbiology, analytical chemistry and cleanroom services,” said Patrick Walsh, chief executive officer, Avista Pharma. “This expansion will complement our existing capabilities and will expand our industry-leading services for pharmaceutical and medical device clients.”

Alcami Expands Service Capabilities at Four U.S. Sites

Alcami, a provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, will expand service capabilities at its Charleston, SC, Edison, NJ, St. Louis, MO, and Wilmington, NC sites to offer identification of microorganisms using the latest MicroSEQ library and an Applied Biosystems/Hitachi 3500 Genetic Analyzer. This system is capable of identifying microorganisms to the species level.

"Genotypic microbial identification methods are theoretically more reliable than traditional identification methods because nucleic acid sequences are highly conserved in most microbial species," said Ted Dolan, chief operating officer, Alcami. "We are pleased to have the MicroSEQ system and its capabilities in-house, allowing us to better serve our customers."

The MicroSEQ Rapid Microbial Identification System uses a highly accurate phylogenetic approach for microbial identification based on the sequencing of the 16S rRNA gene for bacteria or the D2 region of the large subunit for fungi. Its validated bacterial and fungal libraries include over 3100 entries. The system is ideal for environmental monitoring, contamination investigation, root cause analysis, and raw material testing.

Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques. They are especially valuable for investigations of failures such as sterility test and media fill contamination. Alcami sites began accepting identifications April 1 and commercial offerings include a phenotypic evaluation when applicable, and a genetic evaluation through Gram Stain and rapid identification using the MicroSEQ.

BMS Opens Expanded Devens Biologics Facility

Bristol-Myers Squibb has completed a major expansion at its Devens, MA biologics facility designed to accelerate development of the company’s biologics portfolio

The $280 million investment adds new capabilities with a biologics development building for designing processes for the early production of investigational medicines, and a clinical manufacturing building to produce products to support clinical trials. The Devens site had previously focused solely on large-scale, bulk biologics manufacturing.

“Biologics are increasingly important in the treatment of serious diseases and a rapidly growing part of our company’s pipeline of potential new therapies,” said Lou Schmukler, president, Global Manufacturing & Supply. “Bringing together biologics development and clinical and commercial manufacturing on one campus will help accelerate the development of these innovative medicines for patients worldwide.”

The expansion initially adds 200 new jobs, and is expected to grow to approximately 350 over time. The two new buildings add approximately 200,000 sq.-ft. to the Devens site, which now comprises eight major buildings in a 600,000 sq.-ft. complex.

“This project represents a significant expansion in the site’s size and mission,” said Greg Guyer, senior vice president, Biologics Development and Operations. “It creates one of the world’s premier integrated biologics facilities, a biologics center of excellence for the company, for the Commonwealth of Massachusetts, and for patients.”

State University of New York, Buffalo State, Science Building No. 15, Buffalo, N.Y.

Cost: $107 million

Size: 124,000 sq. ft.

Team: CannonDesign (Architecture and Engineering), Bovis Lend Lease (Construction Manager)

SUNY Buffalo State has completed the second phase of a three-phase project to transform its science education facilities by consolidating multiple science departments into a single facility, establishing a hub for STEM curriculum.

Originally built in 1962, the 171,000 sf Science Building No. 15 undertook a $107 million expansion project to create a science complex that is one of the few interdisciplinary facilities in the SUNY system. Housing programs in biology, chemistry, physics, earth science, mathematics and science education, as well as a new planetarium and an interdisciplinary research institute focusing on the Great Lakes, the complex is designed for the collaborative efforts at the heart of 21st-Century science.

Phase 1 saw construction of a 96,000 sq. ft. addition along the building’s west side to house new teaching and research labs, faculty offices and instrumentation rooms. The four-story addition, completed in 2014, is connected to the existing structure with a three-story atrium. Phase 2 includes demolishing the building’s south wing, constructing a 61,000 sq. ft. addition and fully renovating its 63,000 sf north wing. This phase includes departmental offices, multi-use classrooms, physics research and instructional labs, a new science and mathematics teaching center and vivarium.

Phase 3 is scheduled to complete in 2018. It will include the “indoor campus link” that will connect outlying residence halls to the center of campus. Additionally, the research labs, classrooms, lecture hall and planetarium will be completed at the end of this phase. Remaining site work will also be completed, which will include a greenhouse with rainwater collection, a geological garden with integrated teaching space, and a “rain garden” near the main entry which will be used as a hydrologic-cycle learning tool.

An open, contiguous, modular floorplate accommodates all required lab functions. Bridging the new construction and existing Science Building, the atrium provides a venue to put science on display, and accommodates many social and group functions, including an annual science fair. Three above-ground floors of the addition accommodate wet labs, research and lecture labs, including a small vivarium in the lower level.

Designed for interdisciplinary collaboration, the projects fulfills a number of program objectives, including improved student access to faculty and department chairs, high-visibility spaces to promote the sciences among the student body, flexible and adaptable spaces to better attract and accommodate new faculty, and informal student interaction spaces to encourage learning outside of classroom and laboratory settings. The total cost for all three phases is expected to be $107 million, $53/ sq. ft. less than an entirely new facility.

Completion Date: 2018

EAG Expands Biopharma Analysis Capabilities

The demand for high-end biopharmaceutical analysis is being driven by biosimilars.

EAG has further invested in ABC Laboratories' capacity and analytical capabilities in order to help meet demand for high-end biopharmaceutical analysis.

The company is calling it a “major investment,” which is part of a previous multimillion-dollar capital investment in instrumentation. The announcement comes on the heels of EAG’s purchase of Analytical Bio-Chemistry Laboratories (ABC Laboratories), a Contract Research Organization (CRO) providing product development and analytical testing services for small and large molecule therapies.

"The pharmaceutical industry has a critical need for high-quality contract laboratory partners who can perform the complex analyses required to fully characterize a biopharmaceutical," said EAG's CEO, Siddhartha Kadia, Ph.D. "Since launching its biopharmaceutical offering in 2008, ABC had built a great reputation for its scientific excellence, but the company needed additional capital to strengthen its analytical toolbox."

According to the company, the FDA’s recent approval of the second biosimilar and the larger number of biotech drugs losing patent protection in the next couple years will drive up demand for these types of services.

"Biotech drug development requires different analytical techniques than traditional 'small molecule' pharmaceuticals, and interpreting study results requires deep insight into the mechanisms of biopharmaceutical behavior," said Prasad Raje, Ph.D., Senior Vice President of EAG's Life Sciences division.

"Our biopharmaceutical scientists have built a reputation for solving complex analytical issues for our clients," he added. "Having more advanced analytical equipment will enable them to get there faster, and simultaneously support a greater number of programs."

NC State Uni Lab will use LZ Lifescience's MES to Teach Future Biopharma Pros

North Carolina State University’s Biomanufacturing Training and Education Center (BTEC) will use software developed by LZ Lifescience to manage manufacturing operations under a deal announced.

A LZ Lifesciences manufacturing execution system (MES) will be installed at the BTEC laboratory, replacing the paper-based batch record system currently used.

Company vice president Christian Fortunel said BTEC’s decision to adopt an electronic system reflected a wider industry trend.

“There is a clear mind-set change in the biopharma manufacturing industry, with firms increasingly exploring ways to improve their operations by replacing paper records with electronic ones and accessing plant information in real-time.

“BTEC has recognized that dedicated training for current and future industry professionals is extremely important and we are privileged to be able to support the center with our expertise and technology."

Previously, Fortunel has suggested drugmakers could increase their productivity by over 25% using the firm's MES.

BTEC is a training hub for biopharmaceutical professionals. It houses $12.5m (€11m) worth of industry grade technologies as well as a simulated current good manufacturing practice (cGMP) pilot plant facility.

The centre is capable of manufacturing biopharmaceutical products using cell growth and expression, recovery and purification processes in a sterile environment.

Gary Gilleskie, director of operations and teaching associate professor at BTEC said “Students will certainly benefit from hands-on exposure to a technology that is increasingly being adopted by industry.

“Through this experience, they will see the advantages that electronic batch records offer over more traditional paper-based systems.”

Braeburn Pharmaceuticals will Build Factory in NC

A drug-maker that spent six weeks deciding whether to scrap plans for a new North Carolina factory after the state passed a bathroom privacy law says it's going ahead.

New Jersey-based Braeburn Pharmaceuticals said it will build a $20 million manufacturing and research center in Durham County. The 50 new jobs paying an average of nearly $76,000 a year were announced just before state officials passed House Bill 2 in March. Braeburn said the law caused it to re-evaluate.

The company said in a news release it expects legal challenges will overturn the law.

The bill created a law that requires transgender people to use public bathrooms that match the sex on their birth certificates.

Opening of a Foundational Neuroscience Center for AbbVie

A ribbon cutting in Cambridge kicked off the opening of a Foundational Neuroscience Center by Illinois drugmaker, AbbVie. The new site, at 200 Sidney St., will be devoted to researching the biology behind Alzheimer’s disease, and the company says it will hire 50 scientists and clinicians to staff it.

The company already has almost 900 employees in the state, mostly at its global center for immunology research in Worcester.

CROMSOURCE Expands Operational Footprint and Management Team

CROMSOURCE, an international contract research organization (CRO) providing services to the pharmaceutical, biotechnology, and medical device industries, has announced the appointment of four senior executives to its Management Team. The appointments include: Dr. Troy W. McCall as Chief Operating Officer (COO), Debbie Kent as Global Head of TalentSource staffing solutions, Dr. Kerry Dyson as Global Head of Clinical Research Division and April McCall as Vice President of Commercial Operations. Additionally, CROMSOURCE announced the expansion of its North American presence with the opening of an office in Research Triangle Park in North Carolina.

"The addition of such experienced industry executives strongly positions CROMSOURCE for future growth. We are fully committed to offer our clients the expertise and services they need to be successful in their medical product development efforts," stated Dr. Oriana Zerbini, founder and CEO of CROMSOURCE. She added, "Furthermore, our new office in North Carolina will allow us to serve our clients better who are based in, and around, Research Triangle Park."

Cambrex Delayed API Plant Opening

An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.

Plans for the plant – known as Pharma 3 - were announced last February when the US active pharmaceutical ingredient supplier said the additional capacity was needed to support growth of its contract manufacturing business.

Originally, Cambrex predicted it would be operational “early” in 2016. However, the plan now is to bring the facility online by July according to CEO Steven Klosk, who said the delay was the result of late equipment deliveries.

“Pharma 3 is a large and complex project. It is not unusual at all for there to be delays of some type, meaning equipment from a supplier is late. Equipment comes in and maybe it's damaged and you have to repair it.”

The increase in demand for drug actives that prompted Cambrex to invest in Pharma 3 last year has continued into 2016 according to first quarter financials released last week.

Revenue for the three months to March increased 20% to $93.9m (€81.7m) due to higher demand for APIs. Margins also improved – from 37% to 41% - thanks in part to higher capacity utilization. Operating profit increased from $12.7 to $21.4m.

Cambrex reaffirmed its guidance for 2016 – 8% to 12% sales growth year-on-year and earnings of between $142m and $148m.

Klosk explained that Cambrex had already factored potential delays to the Pharma 3 project into its forecast. He also predicted that capacity utilization at the new plant will increase faster than originally planned when it does become operational.

In addition to updating on the Pharma 3 delay, Cambrex used its first quarter presentation to outline its plans for another expansion.

According to Klosk, Cambrex has already constructed the shell of a fourth API facility – Pharma 4 – at the Charles City site which he said will allow the firm to generate “another $40 million to $60 million in revenue when fully utilized.”

This was echoed by CFO Greg Sargen who said Pharma 4 would not be made operational before 2017.

“We'll get Pharma 3 up and running and see how that acceleration of the capacity utilization goes, see how orders come in on the back half of the year, see how some of our late stage projects progress.

“And probably towards the end of this year or early 2017 we'll have a much better bead on timing of Pharma 4.”

Lubrizol Adds Commercial Manufacturing Capacity

Lubrizol LifeSciences, a contract development and manufacturing organization (CDMO) for complex drug products, is adding commercial drug product manufacturing capacity at its Particle Sciences facility in Bethlehem, PA. The 18,000 square foot capacity will include both sterile and non-sterile space with complete lyophilization and filling operations. Among other things, the facility will be tailored for nano-milling and other complex processes.

"As part of our plans for continued growth in this market, we have accelerated the commercial expansion plans at Particle Sciences. The work has already begun, and we plan to be operational in early 2017 with some of the capacity already spoken for by clients with whom we are currently developing products," said Mark Mitchnick, LifeSciences' chief medical officer and Particle Sciences' chief executive officer.

Particle Sciences has developed special expertise in particulates and drug eluting devices. Over the last several years it has taken multiple products into the clinic on behalf of its clients and has a busy 2016 schedule of clinical trial material production in place.

"While the general contract manufacturing organization (CMO) industry has gone through considerable consolidation around standard dosage forms, LifeSciences has focused on complex processes such as nano-milling, high pressure homogenization, extrusion and micro-particle fabrication. We are clearly the leader in these areas with significant technology and infrastructure advantages. This current multi-million-dollar expansion further demonstrates our commitment and fills a gap in the global CMO space," Mr. Mitchnick said.

Deb Langer, vice president and general manager of Lubrizol LifeSciences said, "Along with expansion at several of our medical device manufacturing facilities, the addition of commercial manufacturing at Particle Sciences keeps us right on track as we grow Lubrizol LifeSciences into the premier pharmaceutical CDMO. Working closely with our clients, we leverage our deep material sciences expertise, global supply chain and operational excellence in the increasingly demanding pharmaceutical and medical device industries. We have penned multiple manufacturing and partnering agreements so far and look to enter into many more. Our corporate strength affords us a unique ability to structure such relationships."

EMD Serono to Expand Biopharm R&D Facility in Billerica, MA

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in North America, has announced a $12 million investment for the expansion of its R&D facility in Billerica, Massachusetts. The new building will span more than 30,000 square feet and accommodate approximately 120 new and current employees whose focus will be on accelerating innovation in R&D, with a focus on oncology, immuno-oncology and immunology.

"The purpose of this expansion is to advance innovation and knowledge-sharing across our R&D teams, with the goal of accelerating the discovery and development of new therapies for patients in need," said Luciano Rossetti, MD, Head of Global R&D for Merck KGaA, Darmstadt, Germany, at a groundbreaking ceremony in Billerica. "This investment is a reflection of our strengthening footprint in the Boston area and in the US as a leader in biopharma."

With approximately 2,000 R&D professionals working across four global R&D hubs—Darmstadt, Germany; Boston, US; Tokyo, Japan; and Beijing, China—Merck KGaA, Darmstadt, Germany endeavors to make a meaningful difference in the lives of people with serious medical needs.

"The growth of EMD Serono's Billerica campus over the past several years and its decision to continue to grow in Massachusetts is a testament to our state's leadership in biopharmaceutical innovation," said Robert K. Coughlin, President & CEO of MassBio, the life sciences trade association. "The company's long-standing investment here ensures that we continue to retain and attract the top scientific minds and that the medical advances that make a real difference in people's lives occur here in Massachusetts."

The new two-story, 30,000 square foot building will be an extension of the existing Sagamore Building and will feature amenities including open plan work areas, a central auditorium, and numerous meeting spaces including bleacher seating for spontaneous collaboration and interaction. In addition to seeking LEED certification to complement the Sagamore Building's Platinum LEED status, EMD Serono will also apply for the WELL Institute certification. The WELL Institute standards measures the human health and wellness of occupants in the building environment. If achieved, EMD Serono would have one of the first projects in the United States with that certification distinction.

Construction on the expansion is scheduled to begin in May 2016 with a planned completion date of June 2017. In addition to its R&D facility in Billerica, EMD Serono's corporate headquarters are located in Rockland, Massachusetts and in total the company has approximately 800 employees across the state.

Emulate’s New Headquarters and Laboratory, Boston, MA

The new facility has a total floor space of 20,000ft².

Emulate inaugurated a new headquarters and laboratory at Drydock Avenue in Seaport District, Boston, in February 2016.

The new facility, located in the existing innovation and design building, will be used as headquarters and for support of commercial activities, product development, and collaborative research programs for the company's proprietary organs-on-chips technology.

The proprietary technology helps to predict the potential efficacy and safety of drug candidates, and improves the drug development process.

The facility will accommodate 40 employees and can be expanded for 85 employees in the future. Facility construction began in 2014 and was completed within 18 months. It was opened for commercial operations in February 2016.

The headquarters, located in an eight-storey building, has more than 20,000ft² of total floor space. It is expected to provide the next stage of evolution as Emulate moves towards the industry launch of its proprietary organ-chips within an automated human emulation system.

It is equipped with laboratories to carry out support commercial activities, product development, and collaborative research programs for the organs-on-chips technology.

The headquarters will facilitate collaboration in Boston's biotechnology hub of pharmaceutical and biotech companies by offering organs-on-chips technology.

It can be used to establish strategic collaborations to use organs-on-chips technology to develop more effective and safer drugs, consumer products and foods, as well as improve patient wellbeing through new precision medicine and personal health applications.

Organs-on-chips technology, developed by Emulate, is a new automated living human emulation system that knows the inner workings of human biology by providing researchers ways to assess human responses with greater precision and detail.

An organ-chip the size of a USB memory stick made for the lung, liver, brain or kidney, contains tiny hollow channels lined with numerous living human cells and tissues.

It is a living, micro-engineered environment that recreates the natural physiology and mechanical forces that cells experience within the human body.

The lab-ready organic chips, instrumentation and software developed by Emulate will offer a system that supports effective innovation, design and safety of products across a range of industries, including pharmaceuticals, agriculture, cosmetics, chemical-based consumer products and precision medicine.

"The proprietary technology helps to predict the potential efficacy and safety of drug candidates, and improves the drug development process."

The company produces a range of products based on the organs-on-chips technology, including lung chip, liver chip, intestine chip, kidney chip and brain chip. The chips are comprised of micro-engineered environments lined with living human cells and tissues.

Local industry collaborators for Emulate include Johnson & Johnson Innovation Centre, Merck and academic researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University.

Based in Boston, Emulate creates living products to understand how diseases, medicines, chemicals and foods affect human health.

The company's human emulation system sets a new standard for recreating true-to-life human biology, which is being used to advance product innovation, design and safety across various applications, including drug development, agriculture, cosmetics, chemical-based consumer products and personalized health.

Emulate holds an exclusive license from Harvard University to a broad intellectual property portfolio for the organ-chips technology and related systems worldwide.

Novo Nordisk’s Diabetes Active Pharmaceutical Ingredients (DAPI) Facility, Clayton, NC

Novo Nordisk’s state-of-the-art global healthcare manufacturing plant at Clayton will be built over an area of 833,000ft².

Novo Nordisk broke ground for its new diabetes active pharmaceutical ingredients (DAPI) production facility in Clayton, North Carolina, on 28 March 2016.

The company is investing approximately $1.85bn in the development of the production facility, which is expected to be fully operational by 2020.

The project is expected to receive approximately $94m in tax rebates from Johnston County over a period of 15 years.

The investment is part of the company's strategy to invest approximately $2bn in production facilities in Clayton, US, as well as Malov and Kalundborg in Denmark.

The new DAPI manufacturing plant will occupy an area of 833,000ft²and will have a footprint of 147,639ft².

It is being built adjacent to Novo Nordisk's existing 452,084ft² (42,000m²) facility, which is involved in the formulation, filling and packaging of diabetes medicines. The existing plant also assembles and packages Flex Pen and Flex Touch prefilled insulin devices for the US market.

The new plant will produce APIs for a range of current and future GLP-1 and insulin products for Novo Nordisk.

Once the new plant becomes fully operational, the diabetes API production facility in Clayton will be named DAPI-US (Diabetes Active Pharmaceutical Ingredients-US) and will form part of the Danish diabetes API production facility in Kalundborg, which will be named DAPI-Denmark.

Athenex Biotech Plant, Dunkirk, New York

Athenex's new oncology manufacturing facility will occupy 300,000ft² area.

Athenex, in partnership with SUNY Polytechnic Institute, plans to build the high pharmacy oncology manufacturing facility in Dunkirk, New York, to manufacture sterile high-potency oncology drugs.

Construction on the project is expected to begin in the second quarter of 2017 and production is expected to begin in the fourth quarter of 2018.

The facility will be located off Lake Shore Drive East (Rte 5), northeast of the Dunkirk city line, in Chautauqua County. The state-of-the-art facility will occupy an area of approximately 300,000ft².

The plant will manufacture sterile high-potency oncology drugs in a specialized and controlled environment. Oncology pharmaceutical products, which are often listed in the FDA's drug shortage list, will be manufactured for sales worldwide.

The project is expected to generate 900 jobs in areas such as high-tech manufacturing, product formulation, regulatory and pharmacovigilance.

Athenex's partnership with New York State and SUNY Polytechnic Institute supports its presence and growth in the state and also contributes to the generation of high-paying jobs in different locations in western New York.

The oncology drug manufacturing facility is the first of its kind to be built in North America in the last 15 years.

Merck to Expand Cali Viral and Gene Therapy Plant

Germany's Merck has announced its intention to expand its viral and gene therapy production facility in Carlsbad, California.

The firm cited customer demand as the main driver for the investment, explaining that the plan was to add 21,000 square feet of production space, two fill/finish suites and clean rooms.

The expansion – which Merck said will increase current capacity by 90% - is due to be completed this year will support clinical and commercial production.

Merck said the expanded facility will work with both its cell-banking operations in Rockville, Maryland and its viral and gene therapy production capacity in Glasgow, Scotland.

The Carlsbad facility became part of Merck's manufacturing network through the acquisition of Sigma-Aldrich in 2014.

News of the expansion follows just days after Merck announced it had upped bioreactor capacity at its facility in Martillac, France in a move designed to broaden its biologics manufacturing offering.

Repligen to Expand Production Capacity

Repligen says it intends to build out a recently acquired German facility to support its European downstream technologies presence.

Early last month, Repligen acquired German life sciences company Atoll for $22.5m, expanding its chromatography column business and further diversifying its business away from the supply of Protein A ligands, used to make Protein A resin for the capture of monoclonal antibodies.

But the deal also brought the Waltham, Massachusetts-based company a manufacturing presence in Europe, and during a conference call to discuss Q1 2016 results, management said it plans to expand production at the former Atoll facility in Weingarten, Germany.

“We will now have a central European presence,” said CEO Tony Hunt. “We can invest and build out the Weingarten, Germany facility to not only manufacture the full portfolio of pre-packed columns but also be a customer facing hub for our direct portfolio of products, providing increased service and support for our European customers.”

Details of an expansion at the site have not yet been finalized, Hunt continued, but Repligen is likely to add in production suites for the manufacture of its entire range of pre-packed chromatography columns – from the Atoll MediaScout brand of pre-packed columns to Repligen’s own ready-to-use Opus range - in the first half of next year.

Expanded capacity in Germany would mirror a general strategy to grow capacity at Repligen’s site in Massachusetts.

The firm expanded the Waltham plant in 2013, adding 9,000 sq. ft. of capacity for its Opus products and followed this up with a $4m investment adding a further 11,000 sq. ft., completed last year. Hunt told stakeholders a third expansion has recently begun.

“We made a decision early in Q1 that we wanted to accelerate a new suite that we were adding in here in Waltham, so that came onboard actually at the end of April. We’re going to add two more production suites by the end of Q3 here in Waltham, which will give us a total of five production suites for Opus.”

For the first quarter 2016, Repligen reported sales of $25m, up 21% on the same period last year, and described by Hunt as “record revenue” for the firm, driven by increased demand for our proprietary products.

Raumedic Inaugurates New US Site

Raumedic, a manufacturer of tubing, molded parts, catheters and components for the medical and pharmaceutical industry, has inaugurated its new US headquarters in Mills River, North Carolina. The new high-tech development and production centre represents an investment of more than US$20m and will ensure the medical technology specialist's ability to produce customized and efficient polymeric products for the North American market.

During the first stage of expansion, customized tubing, molded parts and systems will be produced in 13,000 sq. ft. of cleanroom space in accordance with ISO 14644 Class 7.

The Mills River facility has now been officially inaugurated according to company’s chairman Martin Bayer. The approximately 60 employees with whom Raumedic is starting up its new site were a key factor in the location decision. A majority of them have been working together for decades and have an extensive experience in the manufacturing of medical polymer products. The number of employees is expected to exceed 100 within the next few years.

'After only seven months of construction, with our new home for Raumedic, Inc., we have created an American company that is based on its own tradition and history,' said Bayer. 'We will fuse and develop German and American know-how in polymer processing in this region.'

FUJIFILM Diosynth Biotechnologies Opens New Laboratory Facility in Research Triangle

FUJIFILM Diosynth Biotechnologies U.S.A., Inc., a Biologics Contract Development and Manufacturing Organization with experience focused on the development and manufacture of recombinant biopharmaceuticals including proteins, vaccines, and monoclonal antibodies, completed the construction of a new three-story, 62,000 square foot state-of-the-art facility in Research Triangle Park, North Carolina. A ribbon cutting ceremony was held on May 9th, 2016. Members of the local government and biotech community were in attendance at the event.

“The construction and completion of this building reflects the continued commitment of our organization to provide our clients with the infrastructure to efficiently and innovatively bring their products to the clinic and beyond for the benefit of their patients,” said Steve Bagshaw, CEO, FUJIFILM Diosynth Biotechnologies.

The new building, called BioProcess Innovation Center, houses the company’s Process and Analytical Research and Development, Process Sciences and Stability groups. These will concentrate on delivering excellence in process invention, design and development and process and product characterization for our clients. They will also continue to innovate to further develop systems and approaches which rapidly lead to efficient, robust and high quality biomanufacturing processes.

“The design of the facility reflects our core philosophy of cross-functional collaboration to Research and Process Development which is a key differentiator of our company,” said Martin Meeson, President, FUJIFILM Diosynth Biotechnologies U.S.A., Inc. “Developer Alexandria Real Estate Equities, Inc., and General Contractor, KBR Building Group, LLC, brought a wealth of experience in life science building projects to this new addition to FUJIFILM Diosynth Biotechnologies, located at 6051 George Watts Hill Drive.”

MilliporeSigma to Expand Carlsbad, CA Viral and Gene Therapy Service Facility

MilliporeSigma has announced an expansion of its Carlsbad, California facility to meet growing demand for viral and gene therapy products.

Scheduled for completion in 2016, the Carlsbad campus will increase from 44,000 square feet to 65,000 square feet, with 16 modular viral bulk manufacturing cleanroom suites, two fill/finish suites and twice the warehouse capacity. The expansion will incorporate single-use equipment in a flexible, scalable format for clinical and commercial bulk drug production.

"We are building on our industry-leading offerings in the manufacturing and testing of innovative and complex products, underscoring our commitment to being a trusted, long-term partner of choice," said Udit Batra, CEO, MilliporeSigma. The company's new capacity at Carlsbad positions MilliporeSigma to seamlessly support customers from clinical to commercial scales, and is complemented by cell-banking services in Rockville, Maryland, viral and gene therapy manufacturing capacity in Glasgow, Scotland and global BioReliance® biosafety testing offering.

The Carlsbad facility - MilliporeSigma's flagship site for SAFC's viral and gene therapies offering - will remain fully operational throughout the expansion.

The Carlsbad campus features segregated fill/finish capacity for gene therapy, viral vaccine and immunotherapy products. MilliporeSigma's teams have decades of combined experience in the viral, gene therapy and biosafety testing sectors.

Allergan Breaks Ground on Waco Facility Expansion

Allergan has broken ground on a US$200m expansion of its facility in Waco, Texas. The expansion will add 322,000ft2 of manufacturing space to the current facility, nearly doubling its current footprint.

Once completed, the expansion is expected to add approximately 100 full-time jobs, with the potential for the expanded operations adding as many as 250 full-time jobs as the facility reaches full utilization. New positions that will be added include chemists, microbiologists, process engineers and production and maintenance technicians.

Additionally, the facility expansion will upgrade the company's manufacturing capabilities and capacity. It will add a new raw material dispensary, an automated bulk formulation suite and 10 new state-of-the-art production lines as well as warehousing space. Upon completion, the Waco facility will be capable of producing more than 40 different product formulations and will increase its production capacity by more than 50%.

The construction, commissioning and validation of the facility expansion and production processes are expected to be completed by 2020.

'Today's groundbreaking marks an important milestone for Allergan, strengthening our commitment to our people, operations and the partnership we have built with Waco and the Central Texas communities for 27 years,' said Brent Saunders, President and CEO of Allergan. 'This investment will add highly-skilled jobs to the Waco and Central Texas economies, elevate our manufacturing capabilities and increase our ability to provide more complex medicines to more physicians and their patients around the globe.'

Emory University, Atwood Hall, Chemistry Addition

Location: Atlanta, Georgia

Size: 70,000 sq. ft. addition; 40,212 sq. ft. renovation

Cooper Carry designed the 70,000 sf addition and renovation to Emory’s Atwood Chemistry Building. The project is a five-level facility that includes laboratories, offices, administration suite, teaching labs, conference rooms, a collaborative classroom, resource center and commons space. Included in the design is a four-story atrium that connects the existing building to the new addition. This space represents an effort to create a collaborative community of researchers, faculty, administrators and students. The new commons, atrium and exterior courtyard is the heart of the chemistry department and community.

During the construction process, research and classroom activities continued normal operation. This required careful coordination with the engineering and construction management teams to phase and execute with limited disruption of the ongoing activities. Featuring sustainable design and building techniques, the project was built to the University’s environmental stewardship standards and is certified LEED Gold.

Completion Date: Aug. 2015

Recipharm to Buy Kemwell's API and Formulations Business

Recipharm has agreed to buy Kemwell’s contract development and manufacturing business for a total of SEK1.7bn in two separate deals.

The deals – which are expected to close this quarter – will add Kemwell’s operations in Sweden, the US and India to Recipharm’s network.

Recipharm will pay Kemwell’s owner - Kemfin Holdings Private – SEK693m ($85m) for its operations in Sweden and the US.

In addition, Recipharm will pay SEK982m to Kemwell’s founder – the Bagaria family – for the Indian arm of the business.

The Swedish firm said the deals will give it greater access to US customers and the opportunity to offer reduced cost manufacturing through Kemwell’s operation in India.

CEO Thomas Eldered said "We now have a US footprint which we can use to further penetrate the world’s largest pharmaceutical market and the business in Sweden provides us with several opportunities for synergies.

"When we receive the approval in India, Recipharm’s customers will have access to very cost effective development and manufacturing capabilities able to serve international markets including the US."

Recipharm recently bought a 74% stake in India-based Nitin Lifesciences.

Eldered also confirmed the deals will strengthen the CMO's relationship with Pfizer, which is main customer supplied by one of the Kemwell facilities in Sweden.

He told analysts the facility provides Pfizer with “a fairly limited product range, but the volume in this product range is very high…This product has been off patent for several years but Pfizer has been able to maintain a strong presence in the market.”

Kemwell’s US drug development operation is based in Research Triangle Park, North Carolina. The unit employs 50 staff and provides 120 customers with development for inhalable drugs, liquid, semi-solid, solid and parenteral products.

In Sweden, Kemwell has a 210 strong team at its two production units in Uppsala. The operations manufacture and formulate active pharmaceutical ingredients (APIs). One of the production units was previously owned by Pfizer, which sold it to Kemwell in 2006.

Kemwell’s Indian business employs 1,400 people and provides development services as well as commercial manufacturing of solid, semi-solid, liquid and topical dose products.

PCI Synthesis Sets Up Polymers Development Lab

API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.

The Newburyport, Massachusetts-based active pharmaceutical ingredient (API) supplier announced the new service, predicting an advanced polymer-based materials development and manufacturing capability will expand its customer base.

PCI said the unit – which is based at its laboratory in Devens - is already developing a number of coating polymers, including some for drugs combining more than one ingredient, in addition to a number of coatings for medical devices and biodegradable implants.

CEO Ed Price predicted that the new unit would give PCI and advantage over its competitors, both near and far.

“PCI Synthesis is the only CMO in Massachusetts doing this kind of advanced cGMP polymer manufacturing, which is a big advantage for local life sciences and pharma firms, since we’re able to collaborate with them and their projects onsite. Advanced polymer manufacturing projects require sophisticated analytical techniques, and it is difficult to find that level of expertise.”

He added that: “In addition, PCI is the only CMO in North America that can simultaneously develop and manufacture in one organization both the API and any polymer based technology that may be required for combination products which are becoming more and more prevalent for pharmaceutical development.”

PCI’s customer base has grown substantially in the past 12 months. In June last year the firm told us it had signed up a dozen new Boston-based biotech and medical technology customers.

NIH Clinical Center Issues Sweeping Reform to Improve Patient Safety

After a 2015 FDA investigation sparked sweeping reviews across multiple labs, a task force of independent experts has now concluded that the National Institutes of Health Clinical Center in Bethesda, Maryland needs major reform to ensure patient safety always remains top priority.

“Fortunately, there was no evidence then, and there is no evidence to this date, that any patients were harmed by these problems, but it was incumbent on NIH to act swiftly,” wrote Francis Collins, Director of the NIH, in regards to the FDA investigation last May.

In response to the investigation, Collins acted quickly to assemble the group of outside experts to evaluate the overall organization.

The panel released their recommendations, which included the creation of an outside hospital board to oversee the clinical center, as well as a new central office to coordinate research quality and safety oversight.

The report noted that the problems that prompted the FDA investigation and suspension of over 40 clinical trials last year were long-standing.

NIH announced that it was putting a pause on research work at two facilities–the first of which was Steven Rosenberg’s lab at the National Cancer Institute in Bethesda. Rosenberg is known for being a pioneer in immunotherapy and was using T lymphocytes to develop new cancer therapies when the work was halted. The second lab, the National Institute of Mental Health, also in Bethesda, suspended 15 studies.

The suspensions were the result of production shutdown of drugs that were intended to be administered to patients enrolled in clinical trials at each location. The drugs were found to be “not in compliance with quality and safety standards.”

“Continuous improvement is an essential part of hospital management, and this is an opportunity to strengthen our patient safety framework. These changes and improvements will help ensure that the Clinical Center will reinforce its commitment to patient safety and compassionate care, while continuing its record of extraordinary scientific accomplishments,” Collins concluded in a written statement.

The Clinical Center is known as the world’s largest hospital dedicated to clinical research.

Schuylkill Yards, Philadelphia’s New Innovation Hub

Developers announce updates for Schuylkill Yards, Philadelphia’s new innovation hub

Developers revealed the first major building at Philadelphia’s Schuylkill Yards, a $3.5 billion project for Drexel University.

Curbed Philadelphia reports that an exec from the developer, Brandywine Realty Trust, shared plans for a 700,000 sq. ft. property that will have a lab and offices.

The building will be one of the centerpieces for the project at University City, a section of the eastern edge of Philadelphia next to the Schuylkill River that houses Drexel along with the University of Pennsylvania and University of the Sciences.

With 14 acres of underutilized land and 6.5 acres of public space, SHoP Architects and West 8 will transform the neighborhood into an innovation hub. Schuylkill Yards will have a bit of everything: educational facilities, research labs, corporate offices, retail shops, and hospitality and cultural venues. The existing One Drexel Plaza will be turned into 1.3-acres worth of multifunctional public space.

“The plan envisions a new gateway to University City — one that is dynamic, diverse, open and inviting,” SHoP said on its website.

Along with the mixed-use buildings, the neighborhood will have 2 million sf of living areas, including one residential tower that will have both luxury and market rate units.

Developers expect Schuylkill Yards to generate economic growth for the city, due to its access to talented individuals and capital. A nearby Amtrak stop connects the district to cities in the Northeast Corridor, and it’s only seven miles away from the Philadelphia International Airport.

The lab and office building will not be completed until 2020 and the entire project will take 20 years to build.

REST OF WORLD

MilliporeSigma Expands Single-Use Facility

MilliporeSigma has expanded its state-of-the art single-use current good manufacturing process (cGMP) facility with the addition of a Mobius 2000L single-use bioreactor. With the new upstream suite at its Biodevelopment Centre in France, MilliporeSigma can now offer clients full process line cGMP manufacturing equipped with its own instrumentation and products.

'Our aim is to facilitate accelerated drug development and delivery via continued innovation and technical expertise by offering customers a complete end-to-end solution from clone to commercial production,' said Udit Batra, CEO of MilliporeSigma.

'Our unique offering gives customers the choice to transfer their production at any stage with the confidence that we will ensure the most efficient transition into commercial manufacturing – at either an existing facility or one we help them design.'

With this increase in scale and scope, the firm can advance recombinant products from cell line development through to late-stage clinical production. At the point of tech transfer to a contract manufacturing organization or other facility, clients can also leverage MilliporeSigma's Provantage end-to-end services which are available worldwide.

MilliporeSigma's Provantage solution includes process development, cGMP manufacturing, facility design, manufacturing equipment and consumables, process and equipment training, technology transfer and set-up for commercialization. The offering aims to minimize the risks for customers progressing from early clinical stages to commercial production helping to accelerate time to market and improve productivity and profitability.

Merck's life sciences division operates as MilliporeSigma in the US and Canada and has 19,000 employees and 72 manufacturing sites worldwide, with a portfolio of more than 300,000 products.

The Darmstadt, Germany based group operates as EMD Serono, MilliporeSigma and EMD Performance Materials in the US and Canada.

Selcia Opens Radiolabeled API Plant

Selcia has opened a production facility for 14C radiolabeled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.

The facility in Ongar, Essex will make labelled active pharmaceutical ingredients (APIs) that are used in pharmacokinetic studies.

Spokesman Dave Roberts said demand for specialist radiolabeling services has increased in recent years as a result of pharmaceutical industry cost cutting.

“In former times most drug were discovered by big pharma, who often had internal radiochemistry groups. Nowadays most new small molecules are now being invented by biotechs and small pharmaceutical companies which have no radiochemistry capability.

“At the same time big pharma are outsourcing more of their 14C GMP API production to companies like Selcia which have the prerequisite MHRA approved certification.”

He cited preclinical studies focused on the distribution and metabolism of drug compounds and environmental fate and dermal penetration studies as areas in which the firm is seeing strongest demand.

Another driver for the development of the new product site is growing regulatory concerns about safety, particularly in first-in-man studies.

“Safety, quality and regulatory requirements, and the need to ensure patient safety, have increased demand that radiolabeled material be qualified as 14C GMP API. “

Selcia is one of three companies to offer 14C labelled API manufacturing services in the UK. It works with pharmaceutical companies, the majority of which are based overseas.

The firm also works with other contractors Roberts said, explaining that it has relationships with “most of the leading CROs which use 14C radiolabeled compounds.

He added that: “The [pharmaceutical industry] client then has freedom to choose the most appropriate CRO, based on its specific expertise, for their radiolabeled study.”

Selcia currently employs a staff of 70 however, according to Roberts, the CRO plans to hire more.

“We are currently hiring new radiochemists and synthetic organic chemists who will work in the existing and new facility.”

York Partner with Industry for Drug Development

In partnership with Canadian pharmaceutical companies, researchers from York’s Faculty of Science have received a grant from the Natural Sciences and Engineering Research Council of Canada (NSERC) Collaborative Research and Development fund to advance the R&D of biopharmaceuticals. The funding is valued at more than $1.7M, including industrial and in-kind contributions.

Professors Derek Wilson (Chemistry), Sergey Krylov (Chemistry) and Chun Peng (Biology) have the bioanalytical and research expertise and together with Sanofi-Pasteur, Sciex, and Fluidigm Canada, they are launching the “Technology- Enhanced Biopharmaceuticals Development and Manufacturing” project, which will aim to improve tests for early-stage candidate drugs.

“We will develop a platform to rapidly determine detailed information about biologic drug candidates, including the nature of these molecules and specifically how they interact with their targets,” explains Derek Wilson, director of the Centre for Research in Mass Spectrometry and lead of the project. “Creating such a platform will allow pharmaceutical companies to greatly accelerate and improve the quality of their drug discovery and development processes, making it easier to bring much needed drugs to market.”

Wilson, Krylov and Peng are experts in the techniques required to carry out this project. The mass spectrometry and electrophoresis technologies that will provide the unique analytical backbone for the platform are products of Wilson’s and Krylov’s research programs. Peng will contribute her unique expertise in microRNAs to sub-projects related to vaccine development. From the industry perspective, Sanofi will share its drug development systems, Sciex will contribute its world-leading mass spectrometry instruments, and Fluidigm will offer their unique CyTOF technology.

“The project will enhance York’s research profile in biopharmaceuticals development and manufacturing and provide an exceptional, industry-linked training environment for graduate students and post-docs,” said Robert Haché, York’s vice-president research & innovation. “In addition, the technology and training that will emerge from this collaboration will meet the needs of the growing Canadian biopharmaceuticals industry.”

Biopharmaceuticals are drugs manufactured from biological sources and now represent the fastest growing segment of the pharmaceutical industry. But there is a major bottleneck in their development. Due to technological limitations and the molecular complexity of biopharmaceuticals, important details such as what a drug-target complex looks like are usually not available. This makes it difficult for companies to decide whether or not to pursue further testing of candidate drugs and it slows down drug development.

Zayed Centre for Research into Rare Disease in Children, London, United Kingdom

Construction of the Zayed Centre for Research into Rare Disease in Children in London, UK, began in March 2016. The research center will be located near Great Ormond Street Hospital (GOSH) and the University College London (UCL) Institute of Child Health (ICH).

The new research center will have the facilities for clinicians and researchers to work together to understand rare diseases, identify new and better treatments and manufacture innovative medical devices.

The facility is named in the honor of Sheikh Zayed bin Sultan Al Nahyan and being developed as a partnership between GOSH and UCL. The plans for the construction of the facility were approved by councilors at Camden Town Hall in March 2015. The construction is expected to be completed by 2018.

The research facility is located adjacent to Great Ormond Street Hospital, which treats approximately 1,300 children from more than 80 countries.

The new research facility will have a six-story building with a total floor space of more than 139,880 sq. ft. (13,000m²). It will have two set-back levels and be equipped with sophisticated laboratory facilities and a large out-patient facility spread across two floors.

The facility will include a variety of laboratories, specialist equipment rooms, and workspaces for experts to develop diagnostic procedures, manufacture gene and cell therapies, as well as create personalized medical devices. Two large laboratories will be located on the lower ground floor.

Cardiology and flow cytometry suites for the counting, storing and analysis of cells with laser technology will be included. Freezers and liquid nitrogen stores will also be part of the facility.

A good manufacturing practice (GMP) facility will be located on the fourth floor, which will carry out research on 6,000 known conditions, including cancers, cystic fibrosis and muscular dystrophy. It will manufacture specialist products for novel therapies, which will help develop regenerative medicine programme for children with absent or damaged tissues.

It will accommodate roughly 400 academics and clinical staff, as well as 150 laboratory bench positions. It will also house more than 200 patients and accompanying family members.

The facility will be constructed to achieve Building Research Establishment Environmental Assessment Methodology (BREEAM) certification. It will be equipped with a high-performance building envelope, which preserves heat and prevents damp.

Other sustainability measures include low-energy and motion-responsive lighting, water conservation systems and rainwater recycling, combined heat and power (CHP) plant, use of recycled materials for construction, solar panels at roof level to supplement the energy needs, and a green roof.

The £42m ($60.27m) design contract was awarded to Stanton William Architects. Other contractors associated with the project include Gardiner & Theobald as cost consultant and project manager, BHSLA as landscape architects, and Pell Frischman as structural engineer.

Hoare Lee is the services, environmental and BREEAM engineer, Turner & Townsend is the CDM coordinator, DP9 is the planning consultant, and Eckersley O'Callaghan is the façade consultant.

The total cost for the construction of the Zayed Centre for Research into Rare Disease is estimated to be £90m ($129.04m).

The project was initiated by the chairwoman of the UAE General Women's Union, Her Highness Sheikha Fatima bint Mubarak, the wife of the late Sheikh Zayed bin Sultan Al Nahyan, who donated £60m ($86.10m) for the project in July 2014.

Great Ormond Street Hospital Children's Charity will raise £20m ($28.70m) of funds, while a £10m ($14.35m) grant will come from the Higher Education Funding Council for England's Research Partnership Investment Fund.

Vetter’s New Production Facility, Ravensburg, Germany

Leading global contract development and manufacturing organization (CDMO) Vetter began construction of its new production facility at Schuetzenstrasse, Ravensburg, Germany.

The company broke ground for the new facility on 22 March.

The $79m project forms part of the company's $300m investment strategy for overall modernization, expansion and rebuilding of its manufacturing sites in Germany.

The new facility is expected to be completed by the first quarter of 2018 and will become fully operational in early 2019.

The new production facility will be a seven-story building occupying an area of 86,000ft². It will include a cleanroom equipped with supportive production systems, and technologies for filling bulk syringes and sensitive drugs, including biologics and ophthalmic.

The syringes prepared in bulk will have a number of customizable options that are suitable to the substance and primary packaging material components. Further customization is allowed in silicone levels and the entire process is flexible.

The cleanroom will be designed to achieve the sterility assurance level (SAL) to meet the standards required by regulatory authorities. It will employ an improved restricted access barrier system (RABS) concept, which combines the advantages of isolator for high-level sterility and RABS technology offering greater flexibility and higher capacity utilization.

The advanced technology of the cleanroom enables to achieve high-level sterility and capacity utilization of filling lines while running multiple products. The fully-automated decontamination process of the cleanroom will involve a three-hour cycle using hydrogen peroxide (H2O2).

The facility will also comprise on-site central material preparation area, office space for the production staff, and a staff canteen with roof garden.

Repligen to Expand

Repligen says it intends to build out a recently acquired German facility to support its European downstream technologies presence.

Repligen acquired German life sciences company Atoll for $22.5m, expanding its chromatography column business and further diversifying its business away from the supply of Protein A ligands, used to make Protein A resin for the capture of monoclonal antibodies.

Expanded capacity in Germany would mirror a general strategy to grow capacity at Repligen’s site in Massachusetts.

JHL Biotech Opens Biosimilars Manufacturing Facility in China

JHL Biotech (JHL), a biopharmaceutical company, opened the world’s first KUBio™ biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China.

JHL will use the KUBio manufacturing solution delivered by GE Healthcare to manufacture biosimilars1 and monoclonal antibodies (mAbs) for late–stage clinical trials and commercial supply. The facility will also provide process development and manufacturing services for JHL’s global customer base.

JHL and GE Healthcare partnered to complete the construction of the facility in just 18 months using GE’s KUBio manufacturing solution. KUBio is a prefabricated cGMP-compliant facility and process solution designed for scalable and cost-efficient manufacturing.

The biosimilars market is expected to grow significantly in China, reaching approximately USD 350 million in 2019, up from USD 44 million in 20092. Local manufacturing in China is a more affordable way to provide modern therapies for deadly diseases like cancer, which is the leading cause of death in China. In 2015, approximately 4.3 million new cancer cases were reported in the country. China's State Council’s 10-year action plan "Made in China 2025" recognizes biological medicines and medical devices as one of its key industrial focus areas.

Racho Jordanov, CEO and co-founder of JHL Biotech commented, “JHL Biotech’s mission is to make quality medicines affordable to more people, and we believe one of the greatest areas of need is in Asia. It was important to us to establish our scale-up manufacturing capacity in Asia with a manufacturing facility in China capable of producing biologics to a world-class standard. JHL’s new facility in Wuhan has the same standardized GE FlexFactoryTMtechnology as our existing site in Taiwan, which allowed us to quickly scale up to a capacity of 2,000 liters. JHL Biotech now has the largest volume of single-use cell culture capacity in Asia with the opening of our new facility in Wuhan.”

“GE Healthcare’s expertise in project management and delivery has been key in completing the factory in just 18 months, exceeding our demanding timelines and enabling us to accelerate our plans to produce next-generation biotherapeutics locally.”

Advances in diagnostics are leading to an improved capability for biopharmaceuticals to precisely and effectively address challenging diseases. Of the top 10 therapeutics on the market today, seven are biopharmaceuticals5. Their complex nature demands expertly developed processes to ensure efficient manufacture.

John Flannery, President and CEO, GE Healthcare commented, “We have been working closely with our customers and observing market needs carefully and, as a result, have created an innovative solution improving access to biopharmaceuticals all over the world. We are providing a complete manufacturing solution faster than anyone else, which means that JHL is able to enter the market with high-quality pharmaceuticals responding to a real market need in record time.”

Sterigenics Increases European Ethlyene Oxide Capacity

Sterigenics International LLC, a global provider of contract sterilization, gamma technologies and medical isotopes, and a portfolio company of Warburg Pincus and GTCR, has announced expansion at their Wiesbaden, Germany location. The expansion will increase ethylene oxide processing capacity by 20 percent and allow for additional future capacity expansion of an additional 20 percent. Construction will be completed by Q1 2017.

“This expansion represents the continued execution of our growth strategy,” said Michael Mulhern, CEO of Sterigenics International. “We will continue to pursue high impact acquisitions such as the recent addition of Nelson Laboratories, while at the same time, expanding our existing capabilities.”

“The Wiesbaden expansion is in response to growing demand for ethylene oxide processing in Western Europe,” said Philip Macnabb, President of Sterigenics International. “Wiesbaden has always been a premier facility and this expansion will not only address our short term need, but allow for growth for the future as well. This first part of this expansion will increase capabilities across all phases of the ethylene oxide processing from pre-conditioning, to chamber space and aeration.”

Opened in 2006, Sterigenics Wiesbaden provides routine ethylene oxide processing, rapid turnaround STAT service, process validation and laboratory testing.

Colorcon Building Film Facility in Brazil

Colorcon is building a film coating production facility in Indaiatuba, Brazil to service markets in South America.

The facility, construction of which is scheduled to complete in October, will produce film coating products for the pharmaceutical and nutritional products under good manufacturing practices (GMP) standards.

When operational in January next year, the Indaiatuba facility will work in concert with Colorcon’s technical laboratory in Cotia, Sao Paulo, which has provided formulation and development services to drug industry customers for 16 years.

A Colorcon spokeswoman said: “Brazil is a key growth market for pharmaceuticals” adding that the facility will also support customers in other South American markets.

The Indaiatuba plant will be Colorcon’s seventh film coating facility she continued, adding that the firm has film coating facilities in China, Japan, India, UK, US and Puerto Rico.

Colorcon’s most recent investment in Brazil was in 2010 when it added formulation development capacity at the Cotia laboratory.

The addition of two organic solvent processing rooms was prompted by customer demand for formulation development studies.

News of the Brazil plant comes just a few months after Colorcon’s last investment in South America.

In February, the firm opened a formulation laboratory in the Colombian capital Bogota

The facility houses a formulation lab and a service center and was designed to meet “internationally recognized certification for the containment and safe handling of Level II and Level IV active pharmaceutical ingredients (APIs)” according to Colorcon.

The Bogota service center is Colorcon’s fourth in Latin America. The coating technology and formulation services firm has similar sites in Argentina, Mexico and Brazil.

The firm closed a sales and distribution center it used to operate in Venezuela and granted distribution rights for pharma customers in the country to Algon Corporation.

Fermion Facility in Hanko, Finland

Fermion, a Finnish API CDMO, is expanding its API plant with 76m3 additional reactor space by 2018. The new, fully automated facilities can process HPAPIs requiring a containment level of 0.1µg/m3. The investment totals €30m and it is the largest in the history of the company.

2018 will mark the start of a new era in Fermion’s history as its plant in the south of Finland, Hanko, starts operating new API manufacturing facilities including 76m3 of reactor space, incremental to Fermion’s current total reactor volume of 320m3. With best-in-class automated systems, controlled material flows, isolators and smart infrastructure the new facilities can process not only standard but also potent APIs. There will be a reactor space of 25m3 for OEB5 compounds (containment level down to 0.1µg/m3) and the rest of the new capacity is equipped for compounds requiring a containment level of 1-10µg/m3.

With the new, modern facilities Fermion will be prepared to meet tightening regulatory requirements and be better positioned to support both current and new business.

Fermion’s President Arto Toivonen said: 'The expansion lifts Fermion to a new level in the global arena of API and especially HAPI manufacturing, improving Fermion’s capability to meet increasing demand. Fermion will continue to ensure high quality and delivery reliability of its products. The new unit alone will be able to produce 100 metric tons HPAPI per year increasing the total production capacity of Fermion to over 400 metric tons API/year. Fermion’s scale of HPAPI development and production will now be complete with capabilities from grams to tons.'

Fermion’s investment of €30m in Hanko is the largest in the history of the company since 1970 and also turns a new page in the history of the Finnish pharmaceutical industry.

The Hanko plant is Fermion’s largest production facility with an annual API capacity of approximately 300 metric tons. It supports the full scale of commercial API manufacturing, both generic and custom APIs. The plant consists of three operational units, two dedicated for intermediate production and the third, fully automated unit inaugurated in 2001 produces APIs. The plant is well equipped with dryers and mills for API micronisation and has a Buss loop reactor for hydrogenations as well as an on-site incinerator of VOC gases and a biological waste water treatment facility.

The expansion project already has a building permit and the planning is well underway. The actual construction will start in the summer of 2016 and the inauguration will be celebrated in Q2 2018. Times beyond 2018 may hold even more exciting news for Fermion as upon inauguration, the new facility will host empty, flexible space enabling the installation of a total of 25m3 of additional reactor space for special process technologies.

GSK's Ware, Hertfordshire UK Plant Operational

GSK has confirmed its new UK plant will continue to supply the US with Ellipta inhalers after capacity at its facility in North Carolina comes online this year.

GSK opened the £56m ($80m) plant — named Building U3 — in Ware, Hertfordshire at a site adjacent to its existing Ellipta manufacturing facility. The firm said together the plants will produce 37m inhalers a year by 2017 and supply multiple international markets.

A spokeswoman said “currently we supply over 70 markets from Ware, which is increasing monthly as more markets launch products from our Ellipta portfolio.”

GSK is installing a line for the dry powder inhalers at its facility in Zebulon, North Carolina in the US however the Ware facilities will continue to supply the US.

“Zebulon will come online this year with Ware continuing to manufacture for launch markets across the world" the spokeswoman said.

The Ellipta inhaler differs from GSK’s diskus system – which is used to deliver Advair – in that can hold one or two blister strips, with each blister containing a sealed single dose of medication.

This means it can be used to deliver drugs containing one or two APIs and – according to the authors of a GSK funded study – “enables the formulations for each product to be developed individually, since they are stored separately until the point of administration.”

Ellipta is used to deliver a range of GSK’s respiratory drugs, including the combination asthma and chronic obstructive pulmonary disease (COPD) drug Relvar/Breo, a version of the product called Revinity that is sold in Italy and the COPD monotherapy Incruse.

The Ware plant supplies the Ellipta device for these and will “also make clinical trials supply for the inhaled products which are in development” according to the spokeswoman.

CLEAN Reveals Plan for World-Class Super Laundry

CLEAN, a leading independent laundry company providing linen and workwear rental services, has revealed plans for a world-class linen laundry in Slough, which will be its tenth and largest in operation in the UK.

CLEAN operates in both the linen and workwear rental markets working with a wide range of businesses throughout the UK from the hotel, restaurant, catering, food manufacturing, engineering and pharmaceutical industries.

Set to open its doors for business in autumn 2016, the site will combine the latest laundry technology with increased productivity. With the acquisition of Paragon Laundry in January 2016 CLEAN now delivers 130,000 workwear items and 4 million linen items each week. With the addition of the purpose-fitted super laundry this will rise further, increasing linen production by 25% which equates to a further 1 million linen items laundered and delivered.

Situated in Slough Industrial Estate, the laundry will be custom-designed in collaboration with Kannegiesser – one of Europe’s largest suppliers of high quality laundry machinery – to transform the existing 42,000 sq. ft. space, which will create in excess of 200 jobs, adding to CLEAN’s existing 1,350 strong workforce. 'This is another significant development and a major step for CLEAN. We have taken everything we have learned from our flagship Camberley laundry, which has been in operation since January 2010, and enhanced further the new Slough laundry which will enable us to continue providing our customers with a world class and industry leading facility,' said Jason Miller, CEO, CLEAN. 'The new laundry will feature many new technological advancements, while embracing the environmental considerations, focusing significantly on the optimization of energy and chemical consumption.'

Innova Biosciences Relocates Lab

Bioconjugation services firm Innova Biosciences has relocated its UK sales and marketing operations citing growing pharmaceutical industry demand.

The firm moved its commercial team from its base at the Babraham Research Park in Cambridge, UK to a facility in Ashwell Point in neighboring Sawston.

The rational for the relocation was to allow Innova to expand both its sales operation and its services laboratory.

CEO Nick Gee said: “Innova has expanded its laboratory space to accommodate the need for increased and continuous development of new products based on our bioconjugation technology, in addition to the custom services offering which has also grown year on year.”

The firm specializes in bioconjugation services based on its antibody and labelling technologies.

The move comes a few months after Innova launched an updated version of its oligonucleotide linker technology – Thunder-Link – that is capable of attaching compounds to antibody fragments and small proteins.

Innova is not the only firm to cite growing demand for bioconjugation services as a driver for expansion.

Novasep announced its intention to invest €10m ($11m) in a bioconjugation facility, explaining that its decision was prompted by a desire to expand its antibody-drug conjugation (ADC) production and development offering.

In January, US contract manufacturing organization (CMO) and rumored takeover target Catalent licensed rights to conjugation technology developed by Swiss drug manufacturer Roche.

And in February Novozyme’s subsidiary Allbumedix sought to bolster its albumin bioconjugation tech through an exclusive agreement with University College London (UCL) spin-out company Thiologics.

Agilent Opens Proteomics Lab with Australia's Monash University in Malaysia

Agilent Technologies has announced a partnership with Monash University Malaysia to open a jointly-run laboratory for proteomics, metabolomics, and multi-omics research.

Under the terms of the agreement, Agilent will provide hardware, software, staff training, and technical support for the Integrative Biology Laboratory, which will feature Agilent's iFunnel technology and a 6550 quadrupole time-of-flight liquid chromatograph/mass spectrometer. Agilent will also provide the Australian university's Malaysian campus with early access to new microarray technology and will collaborate with the school to design arrays for its screening and research projects.

"With the Agilent mass spectrometer at its heart, this laboratory will help strengthen our current proteomics, metabolomics and small-molecules research capabilities," Monash Malaysia Professor Dato' Anuar Zaini said in a statement.

The new laboratory expands the partnership between Agilent and Monash, which created a microarray laboratory at the Malaysian campus in 2011. The new lab, which will be housed at the university's Jeffrey Cheah School of Medicine and Health Sciences outside Kuala Lumpur, will conduct workshops and training for local and international scientists.

Lilly Starts Continuous Manufacturing

Eli Lilly will pump €35m ($40m) into a new facility in Ireland focused on the continuous manufacturing of its APIs.

The new plant in Kinsale, County Cork is expected to open early next year and will become Lilly’s worldwide center of excellence for continuous manufacturing of Active Pharmaceutical Ingredients (API) through this investment.

“The team is highly motivated to undertake this project as it offers a significant new opportunity for the site,” said Chris Langan, general manager at the site. “The company is amongst the industry leaders in the development of this technology, and it is an exciting project for everyone involved here at the site.”

This is the latest investment at Kinsale, hot off the back of Lilly’s new commercial scale biologics facility, a 240,000 sq. ft. plant which opened last year at a cost of €330m.

The pharmaceutical industry has been slow to adopt to continuous manufacturing as companies remain averse to switching to new processes and equipment, while lacking the talent and clear regulatory guidelines to do so.

But over the past few years, industry has taken a number of strides in shifting to more continuous methods for both small and large molecule.

A ten-year collaboration between Rutgers University and J&J’s Janssen to implement has produced a continuous manufacturing line at the pharma firm’s facility in Puerto Rico, while GSK, Pfizer and Novartis have also invested in developing such technologies.

In a White House report on the state of US manufacturing published this week by the Subcommittee for Advanced Manufacturing of the National Science and Technology Council, continuous manufacturing was high-lighted as a way of improving “the agility, flexibility, and robustness in the manufacture of pharmaceuticals.”

However, while the report says such technology is promising at the laboratory scale, it adds the technologies and equipment enabling continuous manufacturing at the commercial scale are not widely available or accessible.

“Consequently, continuous manufacturing technology is currently in need of further interest and resources from industry, government, and regulatory authorities to translate proofs-of-concept to widespread commercial adoption.”

The report also notes the US Food and Drug Administration (FDA) will be essential in bringing about the shift from batch to continuous manufacturing, “using scientific and data-driven methodologies to facilitate future approvals, thereby encouraging commercial adoption of continuous manufacturing.”

Novo Nordisk Expansion in France

Novo Nordisk has announced plans to expand an insulin production site in France in the latest investment in its manufacturing network.

The Danish firm said it planned to invest more than €100m ($113m) at a site in in Chartres, France which is dedicated to production of Novo Nordisk’s insulin drugs and insulin injection devices.

“We have built a very strong organization in France, and our site in Chartres is today one of our most important strategic production sites,” Novo Nordisk’s CEO Lars Rebien Sørensen said in a statement. “With the coming expansion we will further strengthen Chartres' position in our global product supply organization.”

The current 333,560 sq. ft. (31,000m2) Chartres site boasts around 1,100 employees but this investment will grow the workforce over 20%, adding roughly 250 jobs when it becomes fully operational. This is expected within four years.

The investment follows over €300m spent by the firm on its French production network over the past 15 years, and comes as the latest multi-million dollar investment in Novo Nordisk’s global network.

In 2015 alone the firm committed up to $2bn to expand an API plant in North Carolina and a drug product plant in Denmark in support of its oral GLP-1 analogue pipeline. Meanwhile the firm broke ground on a $225m plant in Denmark set to manufacture haemophilia drugs, while announcing plans for a $78m insulin production plant in Iran, and opening a site in Russia.

The year before the drugmaker invested $100m at its Bagsværd, Denmark purification plant, and acquired an 180,000sq. ft. bioprocessing facility in New Hampshire off Olympus Biotech.

The firm previously stated it was unique among the Big Pharma companies in the fact it manufactures nearly all of its products in-house.

“Some components for device systems are outsourced,” spokesman Mike Rulis said last year, “and the API for one of our smaller products is in-licensed [Prandin, a tablet for type 2 diabetes, made by Boehringer Ingelheim],” but everything else is made by Novo Nordisk.

“It serves us well as we can apply and control our same systems such as IT and quality globally,” he continued, and, when asked about the problem of over-capacity experienced by a number of other Big Biopharma firms, said the strategy of gradual expansion has meant it has never been in such a situation.

Merck Opens Irish Plants

Germany’s Merck has opened a chromatography media facility as part of a €55m investment in Ireland supporting growing demand for its Protein A resin.

The total investment was spread across Merck’s site in Carrigtwohill, Cork, and sees the firm add a specialty membrane facility along with the chromatography media plant to its life science consumables business.

According to the firm, the membrane plant will be the location of choice for the development and manufacture of all future Merck Life Science membrane products, while the media plant will provide the site with advanced technological capabilities, becoming the main supplier for Merck’s chromatography business including the Protein A capture media ProSep.

“ProSep media has been used for more than 25 years in purification of monoclonal antibodies. The business has grown with the advent of approval of monoclonal antibody therapies within the biopharmaceutical industry,” a spokesperson from the firm told us.

“The Cork investment signifies Merck Life Science’s continued expectations for continued growth of monoclonal therapies and products like ProSep to support them.”

Merck is not the only firm to have expanded its capacity for downstream media. Protein A resin manufacturer Purolite recently announced plans for a new 100,000L facility in Wales , UK to support its media product Praesto, while GE Healthcare expanded a cell culture site in Austria to support its downstream consumables business.

“Downstream processing end users continue to push trends like process intensification, single-use and continuous processing,” Merck said.

“Downstream processing products focus on eliminating bottlenecks and improving economic. This includes high capacity incompressible protein A resins which lead to an efficient operation of continuous chromatography unit operations.”

The facilities are officially open.

Sanofi to Expand Biologics Site in Belgium

Sanofi will spend €300m on expanding its biologics site in Geel, Belgium, furthering the French drugmaker's commitment to driving biologics forward by adding to its manufacturing and commercial capabilities.

Through the investment, Sanofi plans to adapt and expand existing production capabilities to support the firm's pipeline of monoclonal antibodies.

Upgrades to the site will include the development of new laboratories focused on quality control and manufacturing sciences.

'This investment not only strengthens our goal of becoming a leader in biologics but also represents our focus on patients' needs,' said Philippe Luscan, Executive Vice President, Global Industrial Affairs and President of Sanofi in France.

'We have a robust development pipeline of biological molecules, including monoclonal antibodies, and this investment furthers our work and expertise in key disease areas such as cardiovascular disease, rheumatoid arthritis, and atopic dermatitis.'

Sanofi and its biologics arm Sanofi Genzyme, have already invested €600m in the Geel site, which began industrial biotech activities in 2001.

The site currently handles the global production of a protein therapy for Pompe disease, a rare, genetic muscular disease that is often fatal. The protein therapy is produced using cell cultures in large bioreactors, followed by a purification process.

Through this latest investment, more than 86,080 sq. ft. (8,000m2) of manufacturing floor space will be added, enabling the site to increase its overall production capacity and diversify to other drugs and therapeutic areas.

In support of this expansion, Sanofi intends to recruit 'highly-skilled biotechnology professionals' to fulfil a range of job functions.

Sanofi said it aims to launch several biologics in the coming years.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com