WuXi AppTec has opened its new 150,000-sq.-ft. biomanufacturing facility in Philadelphia, PA that could eventually employ an additional 200 manufacturing and support staff.

This facility is designed for cell therapy products that use viral vectors, such as chimeric antigen receptor T cell (CAR T cell) therapies, and will allow expansion of viral vector manufacturing to support gene therapy clinical and commercial programs and large scale production in 2,000L single-use bioreactors.

The new facility will supplement WuXi's existing 20,000-sq.-ft. cGMP cell therapy manufacturing facility, as well as a 50,000-sq.-ft. facility for the commercial manufacture of allogeneic and autologous cell-based therapeutics.

"Advanced therapies like CAR T-cells and gene therapy vectors offer significant new therapeutic options for cancer patients and those suffering from crippling genetic diseases. We are pleased to be at the forefront of this field, providing our partners with cutting-edge cGMP manufacturing capabilities and capacities," said Dr. Ge Li, chairman and chief executive officer of WuXi AppTec.

"We are proud to be an integral part of the biotech hub in the Navy Yard and an important center for the manufacturing of cell and gene therapies here in Philadelphia. With the capacity and capabilities we now have available, we can provide the integrated clinical and commercial manufacturing solutions needed by our cell and gene therapy customers," said Felix Hsu, senior vice president of WuXi AppTec's U.S. Business Unit.

Ei Launches EnDev Laboratories

Ei, A Pharmaceutical Solutionworks, has launched EnDev Laboratories, a standalone, full service R&D provider located in a 10,000-sq.-ft. lab with office space in Kannapolis, NC. Endev will have access to advanced scientific capabilities offered through the David H. Murdock Research Institute (DHMRI) and the ability to collaborate with researchers on campus to advance novel dermatological technologies.

The launch allows the company to broaden its scientific foundation for dermatological product development and add a skin biology research capability that includes early safety screening, drug delivery, and drug target engagement.

Endev offers topical research and development services that include early formulation screening; formulation development; analytical method development and validation, process development and scale up; project management; clinical and registration batch manufacturing; and regulatory affairs support.

Also, EnDev is fully integrated with Ei’s commercial manufacturing capabilities, offering early development through to commercial launch.

Ei’s chief scientific officer, Charles W. Gray, Jr., Ph.D., said: “The combination of the EnDev team’s experience in topical product development, the addition of advanced skin biology applications, and our expansion to best in class facilities at the NC Research Campus will significantly accelerate our progress toward creating the premier dermatology development capability.

Almac Group Invests in Global Expansion

Almac Group plans to expand its operations in Europe and North America increasing its global headcount to 5,000 by 2017. As part of its ongoing global growth strategy, Almac will invest a further £20 million at its U.S. headquarter site in Souderton, PA to expand its existing 240,000-sq.-ft. facility, in addition to leasing a 26,000-sq.-ft. office space in nearby Lansdale.

The expansion will create 312 new jobs across a wide range of functions and increases capabilities for its Sciences, Clinical Services, Clinical Technologies and Pharma Services businesses. The company received a funding proposal from the Department of Community and Economic Development comprised of a £1.3 million Pennsylvania First Program grant and involves substantial investment in new machine lines, computer equipment, software and an expanded cold storage area.

The company is also investing approximately £5 million to build an additional lab and office facility at its global headquarters site in Craigavon, Northern Ireland. About 170 existing employees involved in supporting drug research, development and manufacture will be transferred to the new building.

Also, an additional £2 million is being invested in the development of the Arran Chemical Company facility in Athlone, Ireland, which was acquired by Almac last year. The project will upgrade the existing site infrastructure and brings additional manufacturing capacity and assets on stream as well as more distillation and drying capabilities.

Almac currently employs more than 4,600 staff globally and is set to reach 5,000 by the end of 2017. This follows the recent £4.2 million expansion at its facility in NC.

Alan Armstrong, chief executive officer of Almac Group said, "Due to significant industry demand for our services it is essential we build capacity and increase headcount to ensure we continue to compete at a global level. This year we are celebrating our twentieth year in the US and we are excited to make a further commitment within the Pennsylvania State and throughout North America. We are also delighted to announce our further expansion plans across Europe as we continue to build upon our tremendous global success and we are looking forward to an exciting future.”

Catalent Breaks Ground to Expand Madison Biologics Facility

Catalent Pharma Solutions broke ground for a new $34 million expansion to its Madison, WI biologics manufacturing facility. When completed, the additional 22,000 sq. ft. of space will accommodate a new 2 x 2,000 liter single-use bioreactor system, allowing the company to support late-phase clinical and commercial production of up to 4,000 liter batches. The new footprint will also support expansion of analytical and process development labs, as well as additional office space.

The Wisconsin Economic Development Corporation (WEDC) has awarded Catalent with as much as $1 million in state tax credits over the next three years.

“Our continued investment in biologics capabilities is in direct response to market demand, where underlying growth for large molecules is expected to exceed that for small molecule drugs,” said Barry Littlejohns, Catalent’s president of Drug Delivery Solutions. “We are immensely proud of our facility, and the people here in Madison who have helped achieve our customers’ program milestones and move toward larger commercial programs.”

Catalent’s Madison facility, opened in April 2013, is home to the company’s GPEx cell line technology used to create high-yielding mammalian cell lines. Catalent provides development, manufacturing and analytical services for new biological entities (NBEs) and biosimilars from the site.

BioDuro Expands Spray Drying Mfg. Capacity

BioDuro, LLC has expanded its manufacturing capacity with the addition of an SPX Anhydro MicraSpray 150 to its suite of GMP spray drying capabilities at its San Diego facility. This expanded capacity will support larger scale spray drying programs to 100 kg scale.

BioDuro currently performs clinical manufacture using its MicraSpray 35, and this new addition is directly scalable and will boost capacity to 15 kg/hr solvent evaporation with industry benchmark control and reproducibility. This processing capability is supported by downstream technologies including roller compaction by Gerteis MiniPactor, blending, and tablet compression that can support batch sizes at the 1-100 kg scale.

"With the continued rise in poorly soluble drug candidates coming out of discovery, the need to provide our clients with technologies that can overcome formulation challenges is a necessity. BioDuro has historically offered spray drying capabilities that enhance solubility of poorly soluble clinical candidates with proven 10-100 fold increases," said Cyrus K. Mirsaidi, president and chief executive officer at BioDuro. "The addition of the SPX Anhydro MicraSpray 150 will allow BioDuro to manufacture cGMP-compliant, pilot scale spray dried material with greater efficiency and reduced cycle times. We are excited to provide a more streamlined, cost-effective solution for our clients' drug development needs."

The MicraSpray 150 will be operational at the San Diego site in 1Q17, where the company houses its formulation development and clinical manufacturing operations.

Nitto Avecia Expands Capacities

Nitto Avecia Inc. (Avecia) is expanding its analytical development and oligonucleotide manufacturing capacities in Milford, MA, as well as drug product capacity in Irvine, CA and analytical development capabilities in Irvine and Marlboro.

Avecia, which specializes in nucleic acid manufacturing, is in advanced stages to build a new oligonucleotide drug substance manufacturing facility with additional capacity of more than 1.5mol. Earlier this year, a new 300mmol synthesizer was installed increasing the operational capabilities. In 2017 Avecia’s Milford site will have nearly 3 mol oligonucleotide cGMP synthesis manufacturing capacity operational including aligned downstream assets making it one of the largest cGMP oligonucleotide facilities in the world.

Avecia’s president Detlef Rethage, said, “Avecia takes pride that the experience and innovation found within Avecia allows us to bring the new manufacturing units online in a matter of months rather than years.”

Analytical development lab and office personal now staff a new 6,500 sq. ft. facility in Marlboro, which is complemented by Nitto Avecia Pharma Services, a new company created from the acquisition of Irvine Pharmaceutical Services and Avrio Biopharmaceuticals. Nitto Avecia Pharma Services located in Irvine, CA significantly increased Avecia’s analytical capabilities and support of drug product manufacturing.

Rethage said, “Nitto Avecia Pharma Services is the perfect complement to our oligonucleotide drug substance services and a key step in our strategic growth plans. Avecia Group now offers manufacturing and development services on the East Coast, West Coast and in the Midwest at our Cincinnati facility.”

Avecia anticipates adding many new positions during the next three months, specializing in microbiology, analytical chemistry, manufacturing, quality assurance and engineering.

SSB's New US bioanalysis Lab Opens

Sartorius Stedim Biotech (SSB) has opened a bioanalysis and biosafety testing laboratory in Boston citing US demand for services provided by its recently acquired division, BioOutsource.

The facility houses technology for Antibody Dependent Cell Cytotoxicity (ADCC), Complement Dependent Cytotoxicity (CDC) and Surface Plasmon Resonance (SPR) assays. It will also provide GMP-compliant in vitro and PCR-based assays for the detection of adventitious agents.

Plans for the laboratory were announced in 2014 a year after BioOutsource set up a sales office in the US.

SSB bought Glasgow, Scotland-based BioOutsource in April last, citing a desire to add contract testing services.

At the time the BioOutsource CEO Gerry Mackay hinted that being part of a larger organization would allow the contract research organization (CRO) to tap into demand in other markets, including the US.

He said: “As a part of this group, we will have the opportunity to work with more international customers particularly in areas like the United States and Asia where there is significant investment in biosimilar development and manufacturing.”

uniQure to Consolidate Operations

Gene therapy firm uniQure will consolidate its global manufacturing and cut up to 60 jobs in a bid to recue operating expenses.

The company announced it is refocusing its pipeline, consolidating manufacturing and reducing its workforce by up to 25% over the next year following a strategic review of its operations.

Over the next few months, all GMP manufacturing will be consolidated at the company’s 50,000 sq. ft. single-use facility in Lexington, Massachusetts which began operations last December.

This will include moving production of its lead gene therapy product Glybera (alipogene tiparvovec) from The Netherlands to the US, though a small R&D site will be maintained in Amsterdam, the firm said.

Glybera - its treatment designed to compensate for lipoprotein lipase deficiency (LPLD), made using insect cells and baculoviruses - became the first gene therapy to achieve regulatory approval in Europe in 2012.

The announcement sees uniQure refocusing its pipeline on hemophilia B, Huntington’s disease and liver-directed diseases, while it named the collaboration with Bristol-Myers Squibb in cardiovascular diseases – a deal which could potentially net the firm up to $2bn - to be a top priority.

As for the jobs, between 50 and 60 are set to go resulting in a cost saving of up to €6m ($.4m) annually.

“Additionally, the company expects to further reduce planned operating expenses by €11 to €15 million over the next two years through the focusing of its pipeline,” the company said in a press release.

While yet to present its third quarter 2016 financials, the firm reported operating costs in Q2 of €20m, resulting in an overall net loss of €19m.

“Based on its strong cash position and the above actions, uniQure believes its existing cash resources will be sufficient to fund operations into 2019.”

Johnson Hall for Chemical, Biological, and Environmental Engineering (CBEE), Oregon State University, Corvallis, Ore.

Cost: $34,718,000

Size: 62,441 sq. ft.

Project team: RFD (laboratory planner), SRG Partnership (architect)

Description: Johnson Hall will include 19,000 NSF of laboratory and laboratory support space for the School of Chemical, Biological and Environmental Engineering (CBEE) in this 62,000 GSF flagship building for the College of Engineering. Shared research laboratories are planned in neighborhoods to accommodate Microtechnology Processes, Advanced Materials Processes, Bioengineering/Biomaterials, and Environmental Engineering Processes. Laboratory support spaces will include controlled environment rooms, culture prep rooms, chemical analysis instrument rooms, surface analysis rooms, and device characterization and device fabrication laboratories. A specialized upper division Unit Ops laboratory will serve the undergraduate program, and provide student space for senior Capstone Projects, shop areas and analytical rooms.

Completion date: September 2016

Xellia Pharmaceuticals Commences Packaging and Distribution Operations

Significant milestone in achieving ultimate goal of commencing manufacturing of sterile injectable products at the site during 2018.

Xellia Pharmaceuticals (‘Xellia’), a specialty pharmaceutical company focusing on providing important anti-infective treatments against serious and often life-threatening infections, has received notice from the US Food and Drug Administration (FDA) allowing the company to commence packaging and distribution of drug products at its Cleveland, Ohio facilities.

The notice follows a successful cGMP inspection by the FDA conducted under the procedures of the Modified Consent Decree that Xellia entered into with the FDA in April 2016. Xellia acquired the Cleveland site in November 2015. This notice demonstrates the significant progress that Xellia has made in bringing the Cleveland site back to compliance. The company can now initiate certain commercial activities at the newer part of the Cleveland site that involves labelling, secondary packaging and distribution of drug products manufactured at other sites.

As well as investing significantly in equipment upgrades and the facility design, Xellia has hired an experienced team of over 90 employees. This will be expanded to a staff of around 170 employees over the next twelve months as the company prepares to start the production of sterile anti-infective injectable products during 2018. Xellia is working closely with the FDA to ensure this is achieved.

Carl-Åke Carlsson, CEO, Xellia said: “The permission by the FDA to commence packaging and distribution of drug products at this site is a huge achievement for the Cleveland team on our journey towards resuming sterile product manufacturing. It is testimony to the expertise and dedication of our employees who have worked tirelessly to achieve compliance at the site.

“Once up and running, this facility will significantly increase our production capacity for sterile injectable products in the US, meeting the growing needs of our customers and helping to alleviate supply shortages for vital anti-infectives. We have already received considerable interest in our contract manufacturing services from both existing customers and new prospects.”

Xellia Cleveland will operate alongside the company’s existing sterile injectables production plant in Raleigh, North Carolina and Copenhagen, Denmark. The US is an important market for Xellia, generating over 40% of total sales in 2015.

Stephen F. Austin State University’s new STEM Building Breaks Ground

A large, 52-foot dome planetarium acts as the focal point of a new 87,000 sq. ft. STEM building being built at the heart of the Stephen F. Austin campus in Nacogdoches, Texas.

The STEM building, which was designed by Kirksey Architecture, is meant to be a landmark on the SFA campus with the goal of attracting “more STEM interest from potential students,” according to Steve Durham, Executive Vice President at Kirksey.

The new building will be linked with the existing chemistry, math, and science buildings via a landscaped science-themed corridor. In addition to its impressive 52-foot planetarium, the building will also include department administrative offices, collaborative classrooms, teaching and research laboratories, a large maker space with a machine and wood shop and an engineering lab, a rooftop terrace with telescopes, and various student spaces.

SFA anticipates the building will be open in the spring of 2018.

EAG Laboratories Opens Dedicated ICP-MS Lab

EAG Laboratories, a scientific services company that provides testing, analytical, and characterization services to life-science-related industries, announced on Nov. 3, 2016 a new high-throughput laboratory to test for elemental impurities in human drug products. The expansion includes six inductively coupled plasma/mass spectrometry (ICP/MS) instruments at its cGMP pharmaceutical laboratory in Columbia, MO.

Recommendations published in June 2016 by FDA seek to align US regulation with the International Council for Harmonisation (ICH) Q3D guidance and previously published United States Pharmacopeia (USP) requirements. The regulations affect manufacturers of brand-name, generic and over-the-counter drugs and require compliance by January 1, 2018.

“ICP/MS is the best choice for elemental metals analysis because of its high sensitivity, specificity and ability to monitor all metals simultaneously,” said EAG Senior Scientific Advisor, Wayland Rushing. “These instruments allow us to measure impurities more precisely and more quickly than older technology, and the new laboratory’s capacity and redundancy supports the high sample volumes we will see in the coming year.”

EAG’s facility in Syracuse, NY, also performs the initial survey screens required on drug product and drug substance, as well as ICP/MS method development services. Multiple EAG facilities worldwide can identify, characterize, and investigate sources of impurities that can occur in pharmaceutical ingredients, manufacturing processes, and packaging.

Marken Opens New Chicago Location

Marken has announced the opening of a new operational hub in Chicago, Illinois. The new hub expands Marken's capabilities in the US Northeast region by joining the existing New York, Boston and Philadelphia locations.

With convenient access to Chicago's O'Hare International Airport, Marken's Chicago team will strengthen relationships with its pharmaceutical clients and provide more operational flexibility within the Marken network. The new location will work in concert with its clients and investigator sites to collect and ship drug products, clinical trial materials and biological samples. The Chicago station will also facilitate the growing demand for direct to patient services and reliable handling of cell and gene therapy materials.

The opening of Marken's sixth facility in the US is consistent with the company's strategy to grow with the demand for more complex clinical services. Julia Tarasenko, Regional Director, US North East & Canada Operations, said this about the new location, "We are very pleased to be able to expand our footprint and open a new Marken facility in Chicago. By adding Chicago to our New York, Boston and Philadelphia operational centers, we are building a stronger and more nimble network in the United States. We will now be closer to our clients in the Chicago area and offer them the same high-touch, personalized services they have come to expect from us."

The Chicago branch brings the total number of Marken logistics locations to 45, including 10 wholly-owned and dedicated GMP depots built specifically for the clinical trial industry.

CutisPharma Unveils New Drug Research and Development Center

CutisPharma has announced the opening of a Research and Development center to house the company's expanding R&D team. The new center will provide office and laboratory space to facilitate the company's aggressive plans for developing products for FDA approval under its wholly owned subsidiary, RM Therapeutics.

"We are in the midst of a significant expansion of our research and development capabilities," said Steven Dinh, Sc.D, Executive Vice President and Chief Scientific Officer of CutisPharma. "Our new state-of-the-art R&D center provides us sufficient space to accommodate our growing team as well as significantly enhanced capacity to do in-house research with our additional laboratory."

CutisPharma celebrated the opening of the R&D facility during a special ceremony featuring Massachusetts Senator Bruce Tarrand other state and local officials. The new space is located in Woburn, less than mile from the company's headquarters in Wilmington.

"Our state has quickly and definitively become the epicenter for life sciences because of substantial capital investments in research and development," said Tarr, the Senate Minority Leader. "I applaud CutisPharma's initiatives to expand here because they directly impact gains in local employment, enhancements of the region's economy and ultimately the development of pharmaceuticals that can promote health."

CutisPharma has recently undertaken several significant initiatives to transition the business from its historical base in the pharmacy compounding market and toward development and commercialization of FDA-approved drugs.

In March of this year, CutisPharma announced the opening of a manufacturing center at its Wilmington facility and the completion of supporting activities to prepare the first NDA filing of the company's lead pipeline drug, RM-01, next year. In April, the company announced the initiation of a partnership with Dr. Reddy's Laboratories, which will allow for the acceleration of three additional drugs, RM-02, RM-03 and RM-06, toward FDA approval.

The creation of a dedicated R&D center will provide new office and laboratory capacity to house the expanding team of CutisPharma's RM Therapeutics subsidiary and will further enhance the company's ability to bring its promising new drugs to the marketplace in an efficient and timely manner.

Weill Cornell Medicine and the New York Genome Center to Create Genomic Data Center

Weill Cornell Medicine (WCM) and the New York Genome Center (NYGC) were recently awarded a federal grant from the National Cancer Institute (NCI) to support a joint cancer genomics data center for the research and clinical interpretation of tumors. The grant will provide funding of $490,000 per year over the next five years.

The WCM-NYGC center will perform computational analyses examining DNA and RNA to understand the role of different mutations and to assess their clinical relevance in treating cancer. It is one of 11 specialized genomic data centers nationwide selected to lead the next phase of The Cancer Genome Atlas (TCGA), an initiative between NCI and the National Human Genome Research Institute, which has generated comprehensive, multi-dimensional maps of key genomic changes in 33 types of cancer. The TCGA’s cancer genomics database, comprised of more than two petabytes of genomic data, has been made publicly available and is helping the cancer research community improve the prevention, diagnosis, and treatment of cancer. By joining this national network, researchers at WCM and NYGC will gain early access to newly produced genomic data, as well as cutting-edge genomic analyses and methods.

The WCM-NYGC multidisciplinary team will be led by co-principal investigators Olivier Elemento, an associate professor of physiology and biophysics, associate director of the and head of the Caryl and Israel Englander Institute for Precision Medicine’s computational biology group at Weill Cornell Medicine; Mark Rubin, director of the Englander Institute for Precision Medicine and the Homer T. Hirst III Professor of Oncology in Pathology at Weill Cornell Medicine; and Michael Zody, senior director of computational biology at NYGC. The investigators have a broad range of complementary experience in cancer genomics — Elemento and Zody in bioinformatics and computational biology, and Rubin in molecular pathology.

“This is a very exciting collaboration between two outstanding institutions with complementary expertise,” Elemento said in a written statement. “The NYGC brings major computational infrastructure strengths and a world-class team of computational biologists. Weill Cornell Medicine brings extensive experience in the clinical interpretation of cancer genomes. It’s a perfect match.”

The goal of this joint center is to obtain new knowledge to understand the correlations between mutations and patient data for research and clinical cancer genomics. The aims of the research are: to analyze mutations to predict patients’ responses to immunotherapy, to facilitate identification of mutations that are driving disease and enabling cancer cells to grow, and to study the role of mutations involving large portions of chromosomal abnormalities

The team has already developed several analytical computer programs that interpret various types of mutations frequently found in cancer genomes and is poised to run these tools on data provided by the TCGA initiative. Over the course of the grant, researchers will develop complementary software and methods designed to improve functional and clinical interpretation of tumor profiles. This collaborative research will utilize Weill Cornell Medicine’s expertise in clinical genomics demonstrated by the first New York State-approved whole exome sequencing test and leverage NYGC’s unique computational infrastructure with more than 5,000 cores and 10 petabytes of storage and data management expertise.

GE Healthcare to Expand Westborough Facility

On Oct. 31, 2016 GE Healthcare announced a $7 million expansion project at the company’s single-use technology manufacturing facility in Westborough, MA. The expanded site will manufacture a range of single-use products, including cell growth bags. The investment will triple GE’s production-dedicated cleanroom capacity and upskill more than 300 personnel. The new film platform, developed in collaboration with Sealed Air expressly for biomanufacturing, supports cell growth and application robustness. It will be used in the manufacture of all single-use products at the Westborough site.

“Biopharmaceuticals are complex to make, requiring a dependable, consistent supply of high quality manufacturing technologies. Single-use is top of mind for our customers, for its ability to flex production to meet market needs,” Jan Makela, General Manager, BioProcess at GE Healthcare’s Life Sciences business said in a statement. “The launch of our new film with Sealed Air, the investment in single-use manufacturing in Westborough, MA, and the enlarged E&L capabilities in Sweden confirm our ongoing commitment to minimizing risk and assuring security of supply for our customers around the globe. Our enhanced position in single-use bioprocessing ensures we are fully prepared to support the industry’s rapid growth.”

EAG Opens Elemental Impurities Lab

EAG Laboratories has set up an elemental impurities lab in response to US FDA moves to align testing rules with ICH Q3D guidance and USP requirements.

The lab - located at EAG’s facility in Columbia, Missouri - houses six inductively coupled plasma/mass spectrometry instruments, which will be used to test drug ingredients and excipients for metal impurities.

The firm cited recommendations published by the US Food and Drug Administration (FDA) in June in which the agency outlined its efforts to align testing rules with International Council for Harmonisation (ICH) guidance and United States Pharmacopeia (USP) requirements.

The regulations – which come into effect in January 2018 – require that manufacturers of brand-name, generic and over-the-counter drugs

Elemental impurities are traces of metals that present in drug formulations as a result of the production process. The impurities can be harmful to patients, which is why regulators require that that drug firms measure and control for their presence.

EAG recently combined 11 of its brands, including ABC Laboratories, to reside under a single company.

Siddhartha Kadia, EAG Laboratories president and CEO said the life science market is a “key growth engine” for the company and that it will continue to invest, both organically and additively, in areas that complement the company’s offerings.

REST OF WORLD

Recipharm to Open New GLP Bioanalysis Lab in Sweden

Recipharm has announced an approximately $550,000 investment into a new GLP (Good Laboratory Practice) compliant bioanalysis laboratory at its development facility in Uppsala, Sweden, in response to growing customer demand.

The investment will see the opening of a 5,380 sq. ft. (500 square meter) purpose-built facility in November 2016, which the company says will become the largest GLP bioanalysis laboratory of its kind in the Nordic countries.

Recipharm’s development team in Uppsala specializes in medicinal chemistry, offering synthesis and analytical preclinical development services to drug development companies progressing products through clinical trials.

From its new laboratory, the contract development and manufacturing organization (CDMO) will increase its capacity, with the capability to process more than 10,000 plasma samples per week.

“This is a strategic investment for Recipharm as there is a real need for more GLP bioanalysis laboratories in the Nordic region,” said Fredrik Lehmann, general manager, Recipharm Development. "Bioanalysis requires specialist expertise and establishing the necessary capabilities can be a costly investment, proving a barrier to entry for many contract services providers. Having first started out in a collaboration with a subcontractor, we are now delighted to be able to expand our offering in-house to service an unmet need for bioanalysis capabilities."

In order to support the increasing demand of bioanalysis services, Recipharm Development in Uppsala plans to recruit several new PhD level chemists in the coming months and aims to more than double its team of 35 in the next couple of years.

Tetra Pak Invests in Vietnam Factory

Tetra Pak is investing in a new regional manufacturing facility near Ho Chi Minh City, Vietnam, prompted by increased consumption of liquid dairy and fruit-based beverages across Asia Pacific.

In 2016, the total packed liquid dairy and fruit-based beverage intake is 70 billion liters across ASEAN member states, South Asia, Japan, Korea, Australia and New Zealand. These markets are expected to grow at 5.6% per annum over the next three years.

Tetra Pak believes products in cartons will grow at a faster rate compared to glass bottles and cans.

The $110m facility, which is expected to start operations in 2019, will be Tetra Pak’s fourth packaging material factory in the region.

The factory will have an expandable production capacity of approximately 20 billion packs a year across a variety of packaging formats, such as Tetra Brik Aseptic (carton for long-life liquids, including milk and juice-based products) and Tetra Fino Aseptic (carton pouch).

Tetra Pak explained the facility will have “a strong focus on sustainability, adopting a host of global best practices to minimize the environmental footprint, including the utilization of a high proportion of renewable energy sources.”

It will complement Tetra Pak’s existing production facilities in Singapore, India and Japan.

Michael Zacka, regional vice president, Tetra Pak South Asia, East Asia and Oceania, said: “Together, the factories will enable the company to offer more innovations, efficiency and customer service to meet the rapid growth in Asia.”

NTU to Open Food Safety Research Centre in Singapore

A new research center to develop more efficient and sustainable food technology is in the pipeline at a Singapore University.

Nanyang Technological University announced that it will open the NTU Food Technology Centre (Naftec) to bring greater expertise across South-east Asia in providing risk, benefit and sustainability assessment to support the industry and regulatory agencies.

To do so, the center will perform research on antimicrobial resistance in microorganisms in food and patients in Singapore and across the region.

Researchers there also aim to study the health effects of microorganisms in the human gut and learn ways to improve their composition, as well as assessing the sustainability of food production systems.

NTU provost Freddy Boey said that the center will come at a particularly interesting juncture in the development of food science.

“We are starting to understand the importance of the different relevant entities in our food, such as microorganisms and active biochemical ingredients, and how these entities interact with our bodies.

“NTU will join forces with national and international researchers to grow this new understanding and support novel food technology solutions for better food and a healthier population in Singapore and the region. We have great expectations of what this Centre can do,” Prof. Boey added.

The announcement comes as new technology becomes available to deliver scientific breakthroughs, such as the introduction of systems based on international data exchange that can help implement new DNA sequencing databases.

The center, which will employ over 20 full-time researchers within the next year, will be led by Jorgen Schlundt and William Chen of NTU’s School of Chemical and Biomedical Engineering.

Prof. Schlundt said that the university’s wider research will be applied to food science and technology.

“This includes state-of-the-art methodology to investigate chemicals and microorganisms in food and evaluate their health effects. This means we can start our food-related research right away and be internationally recognized,” he added.

It has already started working with several Singapore agencies, including the Ministry of Health, the Agency for Science Technology and Research, Tan Tock Seng Hospital, the Agri-Veterinary and Food Authority and the National Environment Agency.

The center will receive S$1.5m (US$1.1m) in funding a year from the university, and S$1.7m in government funding over the next three years.

PPD Expands Lab Services in Ireland

Pharmaceutical Product Development, LLC (PPD) has expanded its GMP lab operations in Athlone, Ireland, as part of its ongoing efforts to meet capacity needs and expand its lab services offerings.

The lab has added 4,300 sq. ft. of new lab space for analytical testing of biopharmaceuticals and inhalation devices. The Athlone GMP facility now totals more than 41,500 sq.-ft. of analytical testing and support space.

“The expansion of the Athlone GMP lab represents our ongoing investment in the continued growth of our contract research operations in Ireland and around the world to provide our clients with best-in-class laboratory services and state-of-the-art facilities and instrumentation,” said David Johnston, Ph.D., executive vice president of global laboratory services for PPD Laboratories. “Our ability to deliver global scientific, technical and development expertise with expanded laboratory capacity enables us to meet the growing demand for these services in Europe, the Middle East and Asia-Pacific.”

The Athlone lab services include analytical testing services, method development and validation, stability testing, and quality control and release testing. The lab also provides regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms.

PPD opened the Athlone lab in 2010 and, with this latest expansion, will employ nearly 200 people at the facility.

Ashland Opens Excipient Facility in China

Now manufacturing its major brands of excipients in Nanjing to better serve China’s burgeoning pharma industry, Ashland has opened a new pharmaceutical excipient facility in Nanjing, China. Demand for polymer excipients, the substances formulated alongside the active ingredients of medications, is rising in China as the country’s pharmaceutical industry moves to modernize oral drug manufacturing and comply with new quality standards set forth in the 2015 edition of the Chinese Pharmacopoeia.

“Opening a world-class excipient facility in Nanjing is a testament to our willingness to partner with industry in China and to support the integrity and usability of pharmaceuticals produced in a country that is rapidly modernizing its healthcare infrastructure,” said William Wulfsohn, chairman and chief executive officer, Ashland.

William Zhao, general manager of specialty ingredients, greater China, said, “Opening a facility in Nanjing to manufacture the world’s most respected brands of polymer excipients within ‘tight’ world-class specifications is a vote of Ashland’s long-term confidence in the Chinese pharmaceutical industry,” he said. “Making a commitment to the Chinese market with a state-of-the-art facility, Ashland may now supply highly functional excipient technologies to manufacturers of oral pharmaceuticals and provide tailor-made formulation solutions that enable the delivery of vital health care to everyone in China.”

Among the cellulose-based excipients, Ashland will make available to China’s markets include those sold under the Klucel HPC, Benecel HPMC, Blanose CMC and Aqualon EMC trade names. The company also will make available a series of PVP-based polymer excipients, including Plasdone PVP and Polyplasdone PVPP polymers. All of these products are sold with a Registered Pharmaceutical Excipient Certificate, as required by the China Food & Drug Administration.

Alongside Ashland’s first ever pharmaceutical excipient production facility in China is an advanced quality control laboratory that contains equipment to measure and analyze products throughout the production process, including Thermal Fourier transform infrared spectrometers, Agilent liquid chromatography systems, and PE ICP optical emission spectrometers.

The quality control system design and advanced analytical equipment allow Ashland to test all excipient products in accordance with Chinese Pharmacopoeia quality standards. “Ashland has designed the excipient production facility in Nanjing to meet pharmaceutical excipient GMP standards, and that high level of manufacturing integrity is evident in outstanding product quality testing results,” said Mr. Zhao. “Moreover, our machines for each processing stage, including screening, grinding and packaging, are all global leading brands, and further support the manufacture of products that meet the same high standards as our world-class facilities outside of China.”

Wockhardt to Expand Manufacturing Capacity in Wales

Wockhardt has said it will build a sterile manufacturing and drug testing facility at its site in Wrexham, Wales.

The Indian active pharmaceutical ingredient (API) and drug firm will invest $12.4m in the site and create 50 jobs according to a report on the BBC news website.

Wockhardt will install a version of Broughton Software’s LabHQ LIMS at the new lab. The software is designed to facilitate "data integrity for regulatory compliance, increasing operational efficiency and reducing costs."

Peter Sheppard, Quality Standards Manager at Wockhardt, explained: “When we were considering upgrading our LIMS, it was imperative that any new system would satisfy the growing regulatory demands of the pharmaceutical industry, as well as deliver further efficiency improvements and cost savings to our business operation."

Slovakian CDMO Saneca Ups Capabilities

Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.

The deal will see the Slovakian contract development and manufacturing organization (CDMO) produce the controlled release pellets for one of the Menarini Group’s products from its facility in Hlohovec, about 50km northeast of Bratislava.

As part of the deal, Saneca is increasing the scale at which it can perform wurster coating – a technology for precision application of a film coating onto particulate materials such as powders, crystals, or granules - of the pellets.

The pellets themselves are made by extrusion spheronisation, “a method of wet granulation which makes strong dense pellets ideal for control release coating,” sales and marketing director Jeremy Drummond said. “The wet mass is extruded like spaghetti which falls on a rotating disc that rolls the broken ‘spaghetti’ into individual spheres.”

The firm’s technology will be used to produce enteric coated pellets aimed at preventing dissolution in the stomach, while allowing dissolution in the small intestine.

Drummond did not, however, disclose how much the firm would be investing to scale up coating

He did say “Saneca has many years’ experience using the technology,” and “this is [just] one specialized technology ideal for controlled release products” which the firm offers for manufacturing solid dosage forms.

The deal is the latest form the CDMO which inked a 20 generic product production deal with Xantis Pharma in July , and agreed to supply AMRI with opiate-intermediates in September last year .

FPS Announces Production Plant Expansions

FPS Food and Pharma Systems has announced it is expanding its production plant in Fiorenzuola d'Arda for greater flexibility and timeliness on production systems.

A leading company in design, manufacture, and installation of fine size reduction machines for micronizing and containment solutions for sterile and/or highly potent active pharmaceutical ingredients (API), FPS Food and Pharma Systems has disclosed the beginning of the plant's enlargement in Fiorenzuola d'Arda.

The expansion is designed to improve the production process management and allow a significant increase in production capacity.

Adjacent to the current facility, the new area is composed of approximately 32,280 sq. ft. (3000m2) covered and 32,280 sq. ft. (3000m2) uncovered land, which will be dedicated to the assembly and testing of FPS' systems. A further area will be dedicated to the assembly execution and storage of mock-up. An equipped cafeteria and training classroom will also be available soon, with technical workshops planned for 2017.

The venue was recently enlarged and modernized with the construction of a new offices area and a research and development (R&D) test center. The facilities' redesigns help it adapt to the company's needs.

FPS Food and Pharma Services' vice-president and technical manager Carlo Corsini said: "It's been months since the inauguration of the new area dedicated to the R&D and Test Center but, the steady development, has made necessary to plan, in few time, new works programed with foresight and carried out with determination in order to strengthen the logistics structure."

The company's president Giovanni Gianola added: "With the increase of production capacity of the site of Fiorenzuola d'Arda Plant, FPS renews its commitment to the improvement and development of micronisation and fine grinding systems, as well as containment solutions.

"We are proud of Italian excellence; we can confirm the current employment level and to show to our territory the new factory, which will allow us to be even more competitive for the benefit of our customers."

Almac Expands Commercial Packaging Facility

Almac Group announced that the company has expanded its MHRA/FDA-approved United Kingdom commercial packaging facility with the acquisition of a stick sachet packing line from Merz. The acquisition comes in response to growing demand for the specialist packaging solutions for pediatric drug products, specifically powders, minitabs, or granules into stickpack sachets, Almac said in a press announcement.

This investment was made in partnership with a long-term commercial US client who sought an integrated commercial manufacturing and packaging solution for the EU supply of their new pediatric formulation drug product. In line with EU Paediatric Regulations (EC1901/2006 and EC1902/2006), the US client implemented its pediatric investigation plan (PIP) and developed and launched an age appropriate formulation to meet infant patient needs, with Almac manufacturing the pediatric granules and performing primary packing into stickpack sachets and then into wallet cards.

The Merz SBL-50 stickpack technology is a fully automated forming, filling, and sealing machine capable of filling 80 stickpacks per minute. This flexible technology has capacity to process new pediatric drug products (powders, granules, and minitabs) that require this specialist packaging.

Evonik Expands Production Facilities

Evonik is expanding its production facilities in Birmingham, AL and Darmstadt, Germany for additional capacity to produce biodegradable polymers marketed globally as RESOMER and RESOMER SELECT. These poly-lactic-glycolic-acid (PLGA) copolymers are primarily used to manufacture bioresorbable medical devices and controlled-release formulations for parenteral drug delivery.

“We expect the global demand for biodegradable polymers to continue to grow in the coming years,” said Paul Spencer, head of Biomaterials at Evonik’s Health Care Business Line. “With this in mind, we are currently investing to increase the capacity of our production facilities in order to serve our global customer base.”

The company will add new building adjacent to its existing facility in Birmingham, with greater production capacity, as well as cleanrooms and a lab for polymer contract research projects. Commissioning is slated for late 2018.

The company will also be opening a new production line in Darmstadt, along with an applied technology lab to support medical device customers.

Premaitha Establishes First Service Lab Customer in Asia

Molecular diagnostics firm Premaitha Health announced it has established its first service laboratory customer in Asia. The lab, located at the Center for Medical Genomics at Mahidol University's Ramathibodi Hospital in Thailand, will now offer the firm's Iona test.

"Asia Pacific is a region in which we believe there is significant potential for non-invasive prenatal testing — to secure our first operational laboratory in Asia is an important strategic milestone," Premaitha CEO Stephen Little said in a statement.

Iona estimates the risk of genetic conditions in a fetus by analyzing cell-free fetal DNA from a maternal blood sample. It uses Thermo Fisher Scientific's Ion Proton platform and received CE marking about a year ago.

Premaitha noted that the Thai hospital will act as a regional hub for NIPT and can process samples from nearby countries as well.

The company has previously entered into Iona distribution deals in Chile, France, Russia, Greece, the Middle East, and India. In September, it reported annual revenues of £2.5 million ($3.2 million), up from £132,000 the year before, and sales of more than 17,000 of the tests to customers in the UK and Europe since its launch in February 2015.

Sanger Institute, Wellcome Genome Campus Open New Sequencing, Biodata Centers

The Wellcome Trust Sanger Institute opened two new buildings: a genome sequencing and genomics building called the Bridget Ogilvie Building, and the £42 million ($52.2 million) Biodata Innovation Centre at the Wellcome Genome Campus.

"The new buildings mark the next major step in the progression of our vision for this Campus as a global hub for genomics and biodata," Wellcome Trust Sanger Institute Director and Wellcome Genome Campus CEO Michael Stratton, said in a statement. "We have an ambition to translate and commercialize research findings, as well as inform and enable the [National Health Service] to integrate genomics into clinical care."

British Prime Minister Theresa May was on hand with other stakeholders to open the buildings. In a statement, May said the buildings "represent cutting edge British science and business in the modern era," adding, "We want the UK to be the 'go to' place for scientists, innovators, businesses and investors. This really is a very good example of that."

The sequencing facility at the Bridget Ogilvie Building is expected to specialize in everything from human to pathogen genomes. It will reportedly produce genome sequences for the Genomics England 100,000 Genomes Project, along with clinical sequences generated through the NHS in the context of genomic medicine.

The Biodata Innovation Centre, meanwhile, will foster genomic start-up companies stemming from research by local academics and international investigators and companies with a genomic focus. The Centre currently includes collaborations between scientists from the UK and companies originating in the US, Asia, and Europe.

"The Campus is home to research institutes, spin-out and start-up companies, academic-industry partnerships and Genomics England, all dedicated to driving and leading pioneering research and innovation and discourse in the sphere of genomes and biodata," Stratton said.

Almac Announces Global Expansion

The Almac Group is planning to expand its operations in Europe and North America with an investment totaling £27m across three sites.

The largest portion of the investment is a £20m expansion at the company’s Souderton, Pennsylvania-based headquarters. The money will help expand the existing 240,000-square-foot facility in addition to leasing a 26,000-square-foot office space in nearby Lansdale.

The announcement comes on the heels of the company’s £4.2m expansion at its facility in North Carolina.

“Almac’s continued growth comes as a direct result of the continued drive to both meet and exceed the needs of our customers,” said Almac CEO and Chairman Alan Armstrong.

“Across the companies there is an increased demand for the excellence that Almac can provide combined with a focus on the customer, leading to a requirement for growth in employee numbers and also investment in the latest equipment, facilities etc. in order to maintain our competitive edge,” he added.

Armstrong explained the expansion is across a range of Almac’s business units, including clinical services, clinical technologies, pharma services, and sciences.

“The jobs to be created span a wide range of functions including administrative, HR, scientific, management and operations,” he said, adding that this will enable Almac to continue “to provide high quality customer-centric services across all our business units.”

In addition to the £20 million investment in Pennsylvania, the company is also devoting £5m to build additional laboratory and office space at its global headquarters in Craigavon, Northern Ireland. Around 170 existing employees will be transferred to the new building.

Another £2m will help develop the Arran Chemical Company facility in Athlone, Ireland which Alamc was acquired last year.

According to the company, the project enables the upgrade of existing site infrastructure and brings additional manufacturing capacity as well as added distillation and drying capabilities.

Upon completion, the Almac Group expects to increase its global headcount from 4,600 to 5,000 by the end of 2017.

Merck Opens Pharma Plant and Plans Centre in China

Life Science Centre in Nantong will offer Merck products and services for the pharma, biopharma and life sciences industries

Science and technology company, Merck KGaA of Darmstadt, Germany inaugurated its €170m Nantong pharmaceutical plant, which is dedicated to producing high-quality pharmaceuticals on China’s Essential Drug List.

At the inauguration ceremony, Merck also announced a further investment of around €80m in a Life Science Centre near the Nantong pharma plant for the manufacture of high-purity inorganic salts, cell culture media products as well as ready-to-use media.

With the latest investment of around €80m, Merck will have invested a total of €250m in its production value chain in China's healthcare sector.

'China is of strategic importance to us as a key driver of our sustainable growth. In line with our long-term commitment to China, we have always been dedicated to localizing global expertise to make a meaningful difference to our patients and life science customers,' said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA in Germany.

'Combining the strengths of our two business sectors Healthcare and Life Science, the Nantong site is a pioneering initiative to foster a comprehensive value chain that will create better access to health, enabling us to support China’s evolving developmental and healthcare priorities.'

The Nantong pharma manufacturing site will produce Merck brands for the treatment of the major chronic diseases diabetes, thyroid disorders and cardiovascular diseases (Glucophage, Euthyrox and Concor). With the latest €90m investment, the facility will be able to achieve a production capacity of up to 10bn tablets a year by 2021.

The planned Life Science Centre will reinforce the leading position of Merck in inorganic salts for active pharma ingredients and excipients and cell culture media for the pharmaceutical, biopharma and healthcare markets in China as well as ready-to-use media for environmental and sterility testing.

Merck said: 'Life Science plays a key role in providing innovative solutions that address some of China’s most pressing manufacturing needs, from improving lab processes to developing innovative biomanufacturing processes.

'Life Science’s products, tools and expertise in water analytics and microbial testing enable us to make a valuable contribution to China’s water treatment and waste management initiatives,' the company added.

Lonza Opens State-of-the-Art Drug Product Services Labs

Lonza, a global leader in chemical and biological manufacturing, held the grand opening of its state-of-the-art pharmaceutical drug product services laboratories in the Stücki Science Park Basel (CH).

Scientists in the new 13,988 sq. ft. (1300m2) facility will focus initially on formulation development, drug product analytical development and quality control.

Approximately 75 guests and Lonza participants attended the ribbon-cutting event, which featured a tour of the facility, hands-on experimental stations, and a virtual reality journey into the world of drug product development, manufacture and administration.

Switzerland, and Basel in particular, has a thriving R&D environment: 'The new state-of-the-art facility can support not just global, established pharma customers, but also small startups like the ones that make their home in Basel.'

Richard Ridinger, CEO of Lonza, said: 'We chose Basel for Lonza’s first-ever drug product development facility because it offers us access to the latest technologies and world-leading experts in a central location, one that’s a hub of innovation in the pharma industry.'

He added: 'The addition of drug product development services to Lonza’s global offerings is the next part of our journey along the healthcare continuum, a step that moves us closer to our customers and their patients.'

The new drug product service laboratory teams, led by Hanns-Christian Mahler, utilize industry best practices to successfully advance customers’ drug product development programs.

In addition to providing services such as particle testing or container closure integrity testing to enable safer medicines, the Lonza hub offers services to detect trace impurities in pharmaceutical products, including extractables and leachables from plastics used in manufacturing.

All of these services are offered as standalone or as part of a comprehensive drug product development programme, comprising formulation, stability, primary packaging, process development and manufacturing, always with patient usability and safety in mind.

Rentschler Ups Capacity

Biologics CMO Rentschler has increased its single-use capacity by 50%, just weeks after opening a stainless steel facility at its site in Germany.

Rentschler now house two 2,000L and two 1,000L bioreactors at its single-use facility in Laupheim, Germany, while a facility at the same site - which opened in September - offers drugmakers two 3,000 liter stainless steel bioreactor systems.

The contract manufacturing organization (CMO) attributed the implementation of the new bioreactor to increased global demand for biologics manufacturing, and spokeswoman Marion Schrader said both big pharma and small biotech are looking for monoclonal antibody, antibody derived molecule, and biosimilar capacity. Having both single-use and stainless steel capabilities allows the firm to capture more of this market, she said.

“The clients have different demands with regards to the scale of production, product characteristics, flexibility as well as technology,” she said. “Rentschler actively offers both single-use and stainless steel biomanufacturing to be flexible and to respond to clients’ needs.”

While drugmakers can opt for single-use equipment for small scale commercial manufacturing of, say, orphan drugs, the new twin stainless steel system which began operations in September, can offer larger volumes.

The two recent investments mirror a spate of expansions for the German CMO, and as such, Schrader said the firm is looking to bolster its workforce.

“As we have made significant investments in new plant and facilities recently, the Rentschler workforce will continue to grow. Currently, Rentschler has a staff of 700 and we have an active on-going recruitment program.”

Wacker Opens Singapore Food Lab

The Singapore food lab is working on Asia-specific food and supplement solutions.

Wacker has opened its first Asia food laboratory and technical center in Singapore as it seeks to boost its nutraceutical and nutrition offerings.

The German firm is best known for its silicones and polymers for the construction and engineering industries, with its biosolutions business – which includes supplements and food products – responsible for only 5% of its global US$5.9bn sales.

But speaking in Singapore earlier today, Asia MD Patrick De Wolf said it had vast growth potential.

“This is why we are investing in the lab here,” he said. “Because we want to be closer to customers. Biosolutions is the youngest child for Wacker, so it is a huge step to have this technical center because we have seen in our other areas that this really drives business.

“We have had big successes in Europe, so why not in Asia?”

The firm, which first opened its Singapore office in 1984, says the center will focus on innovative food ingredients, dietary supplements and gum-based applications.

Key areas of focus include solutions for fat-free desserts, egg-free bakery goods, coconut milk powder without caseinate, vegan meat flavors and highly bioavailable curcumin.

“Asia is a focus market for the food industry and therefore for our innovative food ingredients and dietary supplements, too,” said Dr. Gerhard Schmid, president of Wacker Biosolutions.

“We are meeting our customers’ growing demand by enhancing our local services. With this facility, which is unique in the region, we can further augment our position as an innovative partner to the food industry.”

The company already operates dedicated food laboratories in the USA and Germany, and the Singapore lab will focus on applications involving cyclodextrins, cysteine and hydroxytyrosol suitable for the Asian market.

“The ring-shaped cyclodextrin sugar molecules, which Wacker bioengineers from corn and potatoes, can replace conventional animal-derived emulsifiers, and milk protein in instant coconut milk powder," added the company.

“Moreover, they can protect sensitive ingredients, such as vitamins and co-enzymes against harmful influences and increase the bioavailability of hydrophobic substances, such as curcumin.

In the supplement space, Wacker says its nature-identical hydroxytyrosol is suitable for use in hard capsules, energy bars and drinks.

“Hydroxytyrosol is a highly effective antioxidant that is claimed to have therapeutic effects on blood pressure and the immune and cardiovascular systems,” said the company.

Wacker is the latest in a long line of MNCs to base its main food and nutrition research facility in Singapore.

“With a highly fragmented Asia, it is clear that companies need tailor-made solutions to meet market needs. Consequently, the ability to innovate quickly becomes of utmost importance,” said Cindy Koh, director energy & chemicals, at Singapore Economic Development Board.

“Instead of opening labs in every market across Asia, economies of scale can be derived by having Singapore as a strategic base to drive application development for the region. Our access to markets and insights, as well as our research and development ecosystem of publicly funded research institutes and universities, offer opportunities for collaboration which can accelerate innovation yield and reduce cost.”

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com