The laboratory will allow customers and Malvern applications specialists to experience and use the company's range of specialist biophysical characterization systems in a working biopharmaceutical environment.

The applications lab was developed in partnership with Sevion Therapeutics, a San Diego-based biopharmaceutical company that discovers, develops and acquires next-generation biologics.

Sevion Therapeutics will host the laboratory for which Malvern will provide analytical instrumentation, training and continuing support. The lab came on stream in May 2015.

Malvern global business manager Paul Davies said: "As evidenced by the work of our Bioscience Development Initiative team, Malvern is absolutely committed to providing cutting edge analytical instrumentation that meets the needs of the biopharmaceutical industry.

"We work very closely with all parts of the pharmaceutical industry, but the highly dynamic nature of biopharmaceutical development and the rapid pace of change make it imperative that we have a fully functioning applications laboratory in an environment where there is access to real-world protein formulations and where our instruments sit within the workflow of a commercial enterprise.

Under the agreement, several different Malvern analyzers will be installed in the applications laboratory.

Initially this will include two microcalorimeters. These will be the MicroCal PEAQ-ITC and a MicroCal VP-Capillary DSC; a Viscotek TDAmax multi-detector size exclusion chromatography system; and a Zetasizer Nano ZSP for the measurement of size, electrophoretic mobility of proteins, zeta potential of nanoparticles and surfaces, and optionally the microrheology of protein and polymer solutions.

Further protein characterization technologies from Malvern's portfolio will be installed at future dates.

Sevion Therapeutics chief technology officer Dr. Jim Graziano said: "This venture provides a great opportunity for Sevion Therapeutics to access the latest biophysical measurement techniques and to help shape future developments.

"Malvern will provide extensive training and continuing support to our teams, and we will benefit both from having extended access to high value instrumentation and from Malvern's technology and applications expertise.

"We're especially excited to be adding differential scanning calorimetry to our armory and to being among the first to use the new MicroCal PEAQ-ITC system."

MicroCal PEAQ-ITC is the new-generation isothermal titration calorimeter (ITC) from Malvern.

ITC has become an essential technique in drug discovery and development and the new system is designed to deliver the enhanced functionality and robust performance required.

Its guided workflows with embedded help videos and advanced data analysis software make the system ideal for generating high quality data within a multi-user environment.

This new biopharmaceutical applications lab in San Diego adds to the list of Malvern applications laboratories in all major territories worldwide, underpinning Malvern's commitment to supporting customers in all industries and geographies.

Seventh Sense BioSystems Expands and Relocates Headquarters

Medford, Mass.-based Seventh Sense BioSystems Inc., which makes blood collection and diagnostic platforms, is expanding its manufacturing operations and relocating its home office.

“This new facility provides Seventh Sense with a unique opportunity to house all of its functions under one roof to support a successful product launch in 2016,” said Howard Weisman, president and CEO of Seventh Sense. “Demand for our proprietary painless blood collection device continues to grow and this move to our new manufacturing and office space will support our continued growth and expansion.”

Seventh Sense BioSystems’ new device is the TAP, a proprietary platform that draws capillary blood in a painless, one-step process without having to access a vein. It can be used across and integrated with a broad spectrum of diagnostic applications, the company reports. The TAP system penetrates the uppermost layers of skin through the use of micro-needles, collects capillary blood using a novel microfluidic extraction process, and stabilizes the blood with anticoagulant if required. The device has a visual indicator to confirm that collection is complete. The TAP platform is designed for fully automated, high throughput manufacturing.

SGS Fairfield Facility Upgraded to Biosafety Level 2

SGS Life Science Services facility in Fairfield, NJ has been upgraded to Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines. This comes after significant investment in facilities and staff training to handle virulent organisms for microbiological testing, chemical and raw material testing, and stability testing of pharmaceutical materials.

With the enhanced containment capabilities, the facility is now able to support the development programs of biotech and pharmaceutical companies involved in vaccines against pathogens such as Poliovirus, Rotavirus, Influenza A, and Hepatitis A, B and C, also drugs against bacteria which are increasingly becoming antibiotic resistant, such as Methicillin-Resistant Staphylococcus aureus (MRSA), NDM-1 Escherichia coli and Clostridium difficile.

The company can now work with a range of products at the Fairfield lab including both animal and human-derived samples such as blood (including serum, antibodies, and phagocytes) and tissue.

“By including the BSL-2 guidelines into our biosafety plan at Fairfield, we now can offer both chemistry and microbiology related services to clients,” said Mark Rogers, vice president Life Sciences, SGS North America. “The ability to handle pathogens across both disciplines under one facility is more convenient for our customers and allows us to offer a greater range of testing capabilities to both existing and new clients.”

IDT Biologika Launches U.S. Vaccine Manufacturing Facility

IDT Biologika has dedicated its first U.S. vaccine manufacturing facility in Rockville, MD. The new facility provides a bridge between preclinical development and Phase II clinical trials with capabilities including, process development, cell banking, cGMP manufacturing, purification and formulation, and fill and finish.

The facility is BSL-2 compliant and meets both U.S. FDA and European Medicines Agency (EMA) standards. IDT shares the 75,000-sq.-ft. building with Aeras, a nonprofit, global biotech organization developing new tuberculosis vaccines, and is partnering with Aeras on process development and manufacturing of tuberculosis vaccine candidates.

“The Rockville facility marks a milestone for IDT Biologika as we expand our worldwide operations into the United States and continue our commitment to meet the vaccine development and production needs in key markets,” said IDT Biologika president Dr. Ralf Pfirmann. “With the new facility, we provide U.S. companies with a highly capable and experienced CMO-partner for phase I and phase II clinical vaccine projects right from the heart of the BioMaryland corridor.”

AstraZeneca Buying Amgen's Boulder Lake Center Facility

European biotech firm AstraZeneca said it's buying Amgen Inc.'s LakeCentre production facility in Boulder, Colorado, and will add 400 "highly skilled jobs" to the area.

Last year, Amgen announced it will close its Colorado operations by the end of this year. The LakeCentre facility was responsible for the creation of Amgen drugs Nplate and Prolia, and 10 years ago Amgen invested nearly $250 million establishing prototype production of those drugs.

AstraZeneca said it's going to start staffing the LakeCentre facility immediately to refurbish and make infrastructure improvements. Financial details of the transaction weren't disclosed.

"Once complete, the site is expected to be operational and licensed for commercial production by late 2017, providing for additional capacity within the company’s biologics operations," AstraZeneca said.

"This site will play an important role in our future commercial production and give AstraZeneca and MedImmune, our global biologics research and development arm, the flexibility and capacity to meet the needs of our rapidly growing biologics portfolio," said Pam Cheng, executive vice-president, operations and information technology at AstraZeneca, in a statement.

Sterigenics Invests in U.S. Irradiation Facility

Sterigenics, the leading global provider of contract sterilization, gamma technologies and medical isotopes, has announced a US$10m expansion at its facility in Gurnee, Illinois, US to add a new gamma cell. The irradiator will be ready for customer product validation in October of this year, with production to follow immediately.

‘Aligning our capital investments to support our customers’ growth strategies has always been a top priority for our company,’ said Michael Mulhern, CEO of Sterigenics. ‘Customers can expect Sterigenics to continue to add valuable global sterilization capacity going forward.’

‘Growing customer demand is driving this expansion,’ said Philip Macnabb, President of Sterigenics. ‘With this addition, we are adding gamma processing capacity of up to 5 million cubic feet per year in the Midwestern United States.’ The cell is modelled after Sterigenics’ other tote systems with dimensions of 24 x 48 x 40 inches. The product overlap system is extremely efficient and provides the capability to process numerous dose ranges and a wide variety of densities.

Regis Opens New Site

Regis Technologies recently opened a new potent compound suite (PCS) for custom manufacturing of highly potent active pharmaceutical ingredients (HPAPIs).

The company invested in this project to extend their custom cGMP offerings to the oncology market.

Regis operates a 36,000 square foot, cGMP facility in Morton Grove, IL. The PCS addition provides for small molecule cGMP manufacturing of potent compounds up to about one kilogram per batch. PCS targets small molecule oncologicals and linker payload projects for antibody drug conjugates.

The CMO says it spent two years designing and constructing the suite and preparing its team for the new potent compound capabilities. So far, 11 employees have completed the required hands-on training. To ensure retention and safe practices, Regis will require the PCS team to pass a safety review prior to each campaign. The PCS is now qualified and ready to host projects.

Biomedical Research Facility, Grand Rapids, MI, Michigan State University (MSU)

In June 2015, ground was broken for the construction of a new biomedical research facility at the Michigan State University (MSU) College of Human Medicine.

The new facility will be located at the corner of Michigan Street and Monroe Avenue in Grand Rapids Innovation Park.

The Michigan State University Board of Trustees approved the biomedical research facility construction in February 2015. The project will create 728 jobs and will be instrumental in generating $95.6m in economic benefits to the area.

The biomedical research facility will be a six-story building with a total floor space of 162,800ft² that will be developed on 4.1 acres of seven acres of land. It will replace the existing Grand Rapids Press building.

It will include research programme spaces and five core labs, which will consist of bioinformatics, flow cytometer, long-term storage, and analytical and advanced microscopy.

The facility will have space to accommodate 260 members, including 34 principal investigators belonging to the MSU College of Human Medicine's scientific research teams. Up to 44 research teams can be accommodated at full-capacity.

The facility will be used to perform core scientific research on areas, including Parkinson's disease, Alzheimer's disease, pediatric neurology, autism, inflammation, transplantation, cancer, genetics, women's health and reproductive medicine. It will also carry out core research on skin cancer to help people live longer and better.

The new facility will benefit scientists at the College of Human Medicine and other partnering institutions of the MSU in collaborative medical research.

REST OF WORLD

Biocon Opens New Device Plant

Biocon has begun commercial manufacturing at its Bangalore devices facility to support the launch of its insulin pen product, Basalog One.

Indian Government officials were among the attendees at the inauguration of the device facility, as Biocon officially launched its once-a-day insulin glargine prefilled pen product Basalog One.

Manufacture of the drug-device has already begun at the 100,000 sq. ft. site, a Biocon spokesperson said, and the product will be available in India from next week.

“Biocon’s Basalog One, a long acting basal insulin glargine presented as an innovative, pre-filled pen, is the first product to roll out of this facility”. The product will be “competitively priced when compared to comparable products available in the Indian market” when it becomes available next week.

Biocon introduced a reusable insulin pen to India in 2011, but this combo becomes the first such product for the Indian market to be made entirely within India.

The device being made at the site uses a 3 ml cartridge and was designed in collaboration with Becton Dickinson (BD), while the insulin glargine - the drug substance for Basalog One – is also manufactured by Biocon in Bangalore.

The product is being priced at 749 Rupees ($11.3) and according to Biocon is “competitively priced when compared to comparable products available in the Indian market.”

The global insulin delivery devices market is set to reach $14.1bn in the next five years according to Biocon. Basalog One is launching in India, bit it is already eyeing markets further afield.

“As we expand our reach in global markets to provide access to affordable diabetes therapy options, Basalog One will form a significant part of our offering to people with diabetes in different parts of the world.”

Amgen’s Manufacturing Facility Expansion

Amgen is a biopharmaceutical company headquartered in California, US. It opened its newly expanded manufacturing facility in Dun Laoghaire, Ireland in August 2015.

The $300m expansion added new production facilities to the existing plant, enhanced its production capabilities and also made it a key location for Amgen's global operations.

The development was part of the company's long-term strategy to produce all of its medicines in the Dun Laoghaire site, to ensure continuous supply of Amgen's medicines for seriously ill patients worldwide.

Construction of the project, which was supported by the Irish government through IDA Ireland, began in April 2012, and created more than 500 construction jobs. The investment has created a positive impact on the Irish economy and also strengthened Ireland's reputation as a location of excellence for biotechnology investments.

The aseptic plant is located at Pottery Road in Dun Laoghaire, Dublin. Ireland, being the biggest biopharmaceutical development and manufacturing (D&M) location in the world, was strategically chosen for the expansion.

The expansion included construction of an 11,500m² (123,740 sq. ft.) production facility known as Production Module 3 (PM3) and a new cold chain warehouse spread over an area of 5,800m², (62,408 sq. ft.) and renovation of existing on-site facilities.

A new syringe filling facility was added to enhance existing capabilities of the plant.

Part of the expansion plan was significant research and development investment involving a major technology process enhancement aimed at transforming the plant into one of the world's leading biotechnology manufacturing sites.

The aseptic operations facility in Dun Laoghaire was originally owned by Pfizer until it was purchased by Amgen in March 2011. The 37,000m² (398,120 sq. ft.) facility specializes in secondary manufacturing activities such as formulation, liquid vial filling, lyophilisation and packaging. It also features laboratories and cold chain warehouses.

Under the purchase agreement, Amgen manufactures Pfizer's products at the facility for a certain interim period, while Pfizer leases a portion for some time. By owning the facility, Amgen saved 200 existing jobs and created 100 additional jobs.

Amgen is a leading biotechnology company engaged in the discovery, development and manufacture of innovative human therapeutics. It was one of the first companies to bring safe, effective medicines from the lab to the manufacturing plant to patients.

The company specializes in key therapeutics areas, including cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses.

Key functions of Amgen's manufacturing include process development, clinical and bulk protein manufacturing, formulation, fill-and-finish, distribution, as well as quality and regulatory compliance. Principal therapeutics manufactured by the company include Aranesp (darbepoetin alfa), Enbrel (etanercept), Epogen (epoetin alfa) and Neulasta (pegfilgrastim).

ShangPharma Pumps $60m into Qidong Biologics Plant

China Gateway Biologics, the contract manufacturing wing of Shanghai-based pharma firm ShangPharma, will operate the facility located in the Qidong Biopharma Industrial Zone.

“The [$60m] investment offers China Gateway Biologics the opportunity to grow to the next level as a full biopharmaceutical service provider from preclinical development to commercial scale,” said ShamgPharma’s CEO Michael Hui.

“We strongly believe the state-of-the-art single use facility conforming to Western standards will be able to support our international client base.”

The plant will be equipped with a 500L single-use mammalian cell culture train for clinical phase supply and two 2000L trains for commercial manufacturing, with fill & finish capabilities also available on site.

The facility is the first built in the dedicated Qidong Biopharma Industrial Zone and the investment was described by Qidong's Party Secretary Xu Feng as “a big milestone to establish Qidong as a biotech hub at the door steps of Shanghai.”

The site will also have preclinical research capabilities which will be operated by ChemPartner – ShangPharma’s contract research organization (CRO) business.

The news comes weeks after Beijing-based biopharma firm BeiGene announced it was building a 9,000m2 (96,840 sq. ft.) cGMP commercial biomanufacturing facility in the Suzhou Industrial Park (SIP) in Suzhou, China – about an hour West of Shanghai.

“This will be a truly cutting-edge, state of the art facility utilizing the leading technologies in biomanufacturing that will also meet the utmost regulatory standards,” the firm’s Head of Regulatory Affairs Wendy Yan said in August.

“Upon completion we will seek the necessary approvals to ensure our new site is fully compliant with regulatory procedures in all key global markets, including the United States, Europe and China.”

Construction Begins at Genovate Biotechnology

On September 22, construction of phase I of Genovate Biotechnology's Insulin Ecological Industrial Park began in Changzhou National Hi-tech District. Changzhou mayor Fei Gaoyun said the city and district governments and the relevant oversight authorities will do their best to provide support services, with the aim of doing what is needed to see construction completed and the facility put into production as early as possible.

Genovate Biotechnology (Changzhou) relocated to Changzhou Life and Heath Industrial Park in 2014. The plan to relocate was drawn up and initiated by a team led by Dr. Shen Chun, an expert and consultant associated with China's nationwide Thousand Talents Plan, and co-invested by Changzhou Life and Heath Construction Development Co., Ltd. and BVCF, a life sciences-focused PE firm with 20 years of experience in investing in Silicon Valley's bioindustry and the first overseas venture fund focusing on growth opportunities in the Chinese side of the sector. The company has exclusive ownership of the world's first insulin ecological commercialization and production technology. Genovate's target is to become China's first and the world's fourth largest insulin manufacturer, breaking the long-term monopoly held by three multinational giants in the Chinese and international insulin markets.

With a total investment of US$1 billion, Genovate's biologics project follows a plan based on a strategy that calls for a three-phased investment process meant to assure steady growth following the planning and design phase. Phase one of the facility, a 720,000 square-foot structure with an investment of 350 million yuan (approx. US$55 million), will contain a one ton fermentation tank production line, scheduled to be completed in 2018. Once construction is completed and the facility is put into full production, annual production is expected to reach 10 tons of insulin series products and APIs plus 1 billion bottles of preparations.

Changzhou National Hi-tech District is developing into an important cluster for the local pharmaceutical sector. With excellent transportation, comprehensive support from the local authorities and a first-class investment environment, the district has the beginnings in place for a new life sciences industrial park, attracting a number of renowned Chinese and foreign pharmaceutical makers

Merck Serono Expand R&D Facility in Germany

Merck's biopharmaceutical unit Merck Serono is investing €65m as part of the expansion of its research and development (R&D) facility in Darmstadt, Germany.

The amount will be used in construction of a new laboratory building that will span more than 16,000m² (172,160 sq. ft.) and around 200 current employees who will focus on accelerating innovation in R&D.

The new facility will bring together different functions within the company's R&D Discovery Technologies, including molecular pharmacology; medicinal chemistry, computational chemistry; molecular interactions and biophysics; protein engineering and antibody technologies; as well as protein and cell sciences.

The research building will be located within the new 'Pharma Square' on the Merck campus in Darmstadt, and is scheduled to be completed in the third quarter of 2017.

"When complete in 2017, we will offer our employees in research an open and modern environment that fosters collaboration and innovation across disciplines."

Merck executive board member Kai Beckmann said: "When complete in 2017, we will offer our employees in research an open and modern environment that fosters collaboration and innovation across disciplines.

"With this building, we are sending out another signal that the Darmstadt site will continue to serve as a core R&D Hub for Merck.

"In addition, the new laboratory building is an important element in the expansion of our global headquarters."

In order to advance its biopharmaceutical pipeline, Merck is uniting a significant part of its R&D activities into a single area, creating suitable conditions.

Merck executive board member and Healthcare CEO Belén Garijo said: "Over the next few years, we are poised to deliver the innovation discovered in our own laboratories to patients in need around the world.

"By continuing to invest in R&D with the expansion of our scientific infrastructure in Darmstadt, we are creating new opportunities for future discoveries that will bring value to patients and to Merck."

Earlier this month, Swiss start-up company Relief Therapeutics has entered an in-licensing agreement with Merck Serono to secure exclusive rights to develop and commercialize atexakin alfa, a human recombinant version of interleukin-6.

In preclinical trials, atexakin alfa has been shown to induce the re-growth of nerves and re-establish normal nerve conduction and sensory perception in various relevant animal models of neuropathies.

Initially discovered at the Weizmann institute (IL), atexakin alfa was first tested as a potential treatment for thrombocytopenia in chemotherapy-treated cancer patients, allowing the delineation of its safety and pharmacodynamic profiles.

Nexvet Secures Biomanufacturing Facility for Veterinary Biologics

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated biologics manufacturing facility in Tullamore, Ireland, the company announced on Sept. 16, 2015. The transaction is supported by the Irish Government's Department of Jobs, Enterprise & Innovation through IDA Ireland, their foreign investment agency.

BioNua Limited, a wholly-owned subsidiary of Nexvet, will run business operations at the 20,000 ft2 facility, which was previously devoted to producing human biopharmaceuticals. The facility has historically operated under an Investigational Medicinal Products License and a cGMP Manufacturing License from Ireland's Health Products Regulatory Authority and is equipped with cGMP grade clean rooms, water for injection, purified water, and clean steam generation systems. In addition, the facility is equipped with analytical and development laboratories. BioNua Limited will pay €1.75 million (US$1.98 million) to secure the manufacturing assets within the facility and has entered into a 10-year lease on the facility, with an option to purchase the building.

"The opportunity to assume full control of our manufacturing is compelling, as existing manufacturers may face regulatory uncertainties regarding the manufacture of human and veterinary products in the same facility. Securing this facility at a fraction of its replacement cost reduces this uncertainty and will significantly lower our development expenses and ultimately, cost of goods," said Mark Heffernan, CEO of Nexvet, in a press release.

BioNua will invest in state-of-the-art disposable biopharmaceutical technologies, which have a number of advantages over traditional bioprocessing infrastructure, including improved adaptability to product demand, reduced risk of contamination, and a reduction in required capital expenditure.

Swedish Engineering Firm to Design Russian Plasma Plant

MasterPlasma is building a 5bn RUB ($76m) facility in Vladimir, Russia for the manufacture of drug products extracted from human plasma and has signed a $1m agreement with Swedish pharma engineering firm KeyPlants for the design of the plant.

The facility is set to be operational by the end of 2017 and will process up to 600,000 liters of plasma annually.

Masterplasma licensed protein extraction and purification technology from Canada-based ProMetic Life Sciences, but as the process technology for production of some of the coagulating factors is still under development, KeyPlants has to build in a certain flexibility in the design, said Tanja Sjödin, Regional Manager of Russia, CIS & Baltics.

“What makes the task even more complicated is the fact that MasterPlasma is in parallel constructing the building which will house the future facility, and this brings some limitations in the design efforts,” she said.

“According to ProMetic process the separation of flows - personnel, material, product, waste, ventilation - must be kept up not only between different products derived from plasma, but even between different production steps for each product,” she continued, adding: “What KeyPlants experts actually achieved already in the Conceptual Design study was the development of a principal new facility design – a know-how optimized for the Plasma Protein Purification technology.”

While ProMetic licensed the technology to MasterPlasma, the firm kept open the possibility to sell the products made at the Vladimir facility outside Russia, and thus the plant is being designed only for the use of FDA and EMA certified plasma products, such as Plasminogen – designed to provide replacement therapy for patients who suffer from a congenital lack of the normal plasminogen protein.

“Overall, this project is an perfect example of international business collaboration aimed to bring health to people in the whole world, and our company is very proud to be a part in it,” Sjödin said.

Russia Pharma 2020

MasterPlasma operates as part of the Generium science and Technology Park, and the Vladimir blood plasma facility developed is being developed within the framework of Pharma 2020, the state program of import substitution aimed at driving Russia’s own drug industry.

“KeyPlants has been on the Russian market for several years performing design studies and GMP reviews for both state owned and private pharmaceutical and biotech companies,” saod Sjödin.

“But by this contract we have achieved a principal new level: this project is supposed to become the flagship of the pharmaceutical industry in Russia.”

Novartis Improves Austrian Facility

The €150m ($172m) investment has added extra capacity to Novartis’s biosimilar and proprietary biologics network.

Novartis has invested over €2.2bn in its Austria over the past 20 years, and this latest investment adds a fill/finish facility to support its biomanufacturing operations.

“BioInject will be used for fill, finish and packaging of both Sandoz’ biosimilars as well as Novartis’s novel biologics,” said a spokesman for the Novartis subsidiary Sandoz.

“It will also add new in-house capabilities for Sandoz and Novartis in terms of device manufacturing,” he added.

At full capacity the plant will be able to fill around 18,000 syringes per hour and the specific products filled were not disclosed, we were told the site will be supplied with Sandoz biosimilar APIs and the finished products will be dispatched globally.

“We have our primary API manufacturing in Kundl, Schaftenau - both Austria - and in Menges, Slovenia.”

Novartis employs 4,600 staff in Austria, and this new facility will create around 100 new skilled jobs.

Earlier this month, Sandoz made history becoming the first company to launch a biosimilar in the US. Zarxio is a version of Amgen’s Neupogen (filgastrim) now available in the US at a wholesale discount of around 15%.

While the firm could not share further details about its manufacturing footprint, we were told that Sandoz leverages the “very strong in-house capabilities in biologics manufacturing” of its parents company. Novartis recently invested $500m in a cell-culture based plant in Singapore.

Last year, Novartis head of global tech, Juan Andres, spoke to delegates at a financial conference in London and explained the firm’s strategy of keeping the majority of its complex, biomanufacturing in-house.

“[Biologics] are going to be more problematic to outsource and will require more flexibility,” he said, adding the firm would only outsource the “easy side” of manufacturing, such as small molecules, generics and OTCs.

Novo Nordisk Building Production Plant in Iran

Novo Nordisk will build a device plant in Iran, its first production facility in the Middle-East region.

Novo Nordisk will build a manufacturing plant for its FlexPen prefilled insulin device in Iran to cater for the local market.

The Danish drugmaker has committed around €70m ($78m) to build a manufacturing plant in Iran, after signing a Memorandum of Understanding with the regulatory body the Food and Drug Administration of the Islamic Republic of Iran.

The finished facility is the first in the Middle-East region and will manufacture Novo Nordisk’s Flexpen - a prefilled disposable device for the delivery of Novo Nordisk’s long-acting insulin products – following the same procedures as at the firm’s other global sites, spokesperson Katrine Sperling said.

Furthermore, the decision to invest in Iran was taken due to the growing demand for insulin products in the country, she added.

“Iran is a large populated country, with millions of people with diabetes that gives Novo Nordisk the responsibility to be present in a sustainable way for the long term.

“Based on this, and the large potential of the local business coupled with increasing patient needs, we decided that it is worthwhile to make this investment in the country, rather than to continue to import our products.”

The GMP compliant site is set to take five years to complete and will create 160 jobs.

While the investment in Iran is not linked to a greater expansion in the region from a local production point of view, Sperling said the firm “will continue to increase investment into our Middle-East markets in a variety of ways to ensure we meet increasing patient demand in a sustainable way.

“This will be done through initiatives such as healthcare professional and patient education projects, R&D investments and public-private partnerships for diabetes care capacity building,” she continued, but added there have historically been issues in the region holding the firm back.

“Our most notable challenge in the middle east, has been, and continues to be rapidly changing security situation across the region, which in Iran’s case has not been an issue.”

The expansion is the latest investment in Novo Nordisk’s manufacturing network.

Last month, the firm pledged $2bn to build facilities in North Carolina and Denmark in order to support its diabetes pipeline. And in April, the company opened a production plant in Russia; its first and the first insulin facility in the country.

While Russia has a policy in place to drive local pharma manufacturing, the same is not the case in Iran, Rud von Sperling confirmed.

“There are no protectionist rules in Iran comparable to Russia, hence the decision to invest has not been based on this.”

Ross Expands China Operations

Ross Vice President of Corporate Operations Joseph Martorana announced that the company’s operations in Wuxi, China has added 30,000 square feet of manufacturing space and increased manpower to more than 165 full-time employees. Even with the increased manufacturing capability, Ross Wuxi, headed by General Manager George Lu, is poised for more rapid growth. Plans to relocate to a bigger facility are underway with the construction of a new 200,000-sq.ft manufacturing plant expected to begin in 2016.

Established in 1999 as wholly-owned subsidiary of Charles Ross & Son Company, Ross Wuxi builds planetary mixers, multi-shaft mixers, high-speed dispersers, pressure vessels, reactors and custom agitators.

Eight Ross production facilities are located around the U.S., China and India. The company has manufactured industrial mixing, blending, drying and dispersion equipment since 1842.

FAREVA Adds Fourth Site to API Network

FAREVA is taking over the former MSD site of La Vallée in Saint-Germain-Laprade in France, adding a fourth site to its API network.

La Vallée has been operating for 30 years, manufacturing complex APIs with a team of 130 employees. It has installations in production, quality control and environmental systems, with a total reactor capacity of 128,000 liters in large and small scale workshops, nearly doubling FAREVA’s API capacity from its existing facilities in Feucht, Germany, Val de Reuil, France and Romainville, France.

FAREVA plans to further capabilities at the site by investing approximately €25 million into an OEB 4 high-containment facility. Two separated compartments with 4,000 liter reactors and high-containment dryers will be operational mid-2017. Also, a hastelloy flow train for cryogenic chemistry at 2 to 10 cubic meter scale is also under development.

GSK Starts Work on Plant in India

GSK plant in India will make 8 billion tablets a year when operational in 2017.

GSK has started work on an anti-inflammatory and gastrointestinal drug production plant in Vemgal, India which will create 300 manufacturing jobs.

The manufacturing facility will be located at a 50 acre site in the Vemagal industrial area, Kolar district in Karnataka State in southern India.

Anna Carruth, a spokeswoman for the UK-headquartered pharmaceutical confirmed that construction has begun, stating “today was the laying of the first stone in the build.”

She said that: “The factory will make more than 8 billion tablets and 1 billion capsules a year in the areas of gastroenterology and anti-inflammatory medicines for the Indian market” adding that the site will employ “in the region of 300, once fully operational.”

Construction will cost around £100m ($153m) according to Carruth, who said: “The facility is part of GSK’s continued commitment to India, ensuring increased access to GSK medicines for people in the country.” The site is expected to be operational in 2017.

GSK was granted rights to use the 50 acre lot by the Karnataka regional government last year. In 2013, CEO GSK Andrew Witty said the firm would increase its presence in India.

The UK drug maker has not acquired the land. Instead it has been granted a 99-year lease by the regional Government, which opted to stop selling industrial plots to manufacturers last year.

Prior to that decision companies could either buy land outright or lease it for a maximum of 30 years.

McIlvaine Company

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