Xellia Pharmaceuticals has acquired manufacturing facilities in Bedford, OH from a subsidiary of Hikma Pharmaceuticals, which will increase its production capacity for sterile injectable products in the U.S. Xellia has acquired substantial parts of the site including several new manufacturing units for sterile injectables, which are not currently operational. Hikma will retain the remaining facilities including the quality and development center, which has been operated by its subsidiary, West-Ward Injectables since it acquired the site in 2014.

The site was previously owned by Ben Venue Laboratories who ceased manufacturing in December 2013. Xellia says it plans to invest significantly in the facilities to resume manufacturing in the new units at the site and in the establishment and training of a new organization to operate the plant.

Xellia plans to begin commercial production at the site within 24-months. The facility will operate alongside the company’s existing sterile injectables production plant in Raleigh, NC.

“The U.S. is a very important market for us, and as a region with a strong manufacturing heritage and a uniquely skilled and specialized workforce, Bedford, OH is an ideal location to expand our manufacturing capabilities,” said Carl-Ake Carlsson, chief executive officer, Xellia. “Together with our production site and new U.S. headquarters in Raleigh, Xellia is in a great place to help make critical anti-infectives available to the patients that need them.” Xellia says it will recruit around 170 new employees across a range of departments including manufacturing, supply chain, distribution, quality, engineering, human resources and finance at the Bedford site over an initial twenty-four month period.

Xellia has acquired substantial parts of the site including several new manufacturing units for sterile injectables, which are not currently operational. Hikma will retain the remaining facilities including the quality and development center, which has been operated by its subsidiary, West-Ward Injectables since it acquired the site in 2014.

Chugai Pharmaceutical Opens a North American Hub in New Jersey

Chugai Pharma USA Inc. (CPUSA), a subsidiary of Chugai Pharmaceutical Co, Ltd. (Chugai), announced the opening of its new office, dedicated to translational clinical research, in Berkeley Heights, NJ. The new facility serves as the North American hub for Chugai, a research-based pharmaceutical company headquartered in Tokyo.

CPUSA is focused on early development and, in spring of 2015, established Chugai's Translational Clinical Research Division (TCRD). TCRD is Chugai's first global organization composed of functions in Japan, Europe, and the United States.

Chugai focuses on advancing treatment in oncology, bone and joint diseases, renal diseases, and autoimmune diseases. The company also maintains an alliance with Roche, leveraging its resources to pursue biopharmaceutical, antibody, and molecular-targeted research technologies as well as chemical synthesis technology.

Althea Building for Highly Active Bioproduction and ADCs

CDMO Ajinomoto Althea is opening a new facility to offer outsourced ADC (antibody drug conjugate) and HPAPI (highly potent active pharmaceutical ingredient) manufacturing, the Californian company has announced.

The contract development and manufacturing organization has begun retrofitting a facility it bought in May near its existing site in San Diego. It plans to open the site in Q2 2016, with full operations at the start of 2017.

The finished 57,000 sq. ft. plant will offer bioconjugation, formulation, purification, quality control, and aseptic fill-finish including lyophilisation. Construction includes measures for safe handling of very low OEL (Occupational Exposure Limit) compounds under high containment, aseptic and GMP conditions.

Althea said the site will offer clients contract services from early clinical phase to commercialization.

Althea’s head of ADCs, Jason Brady, said “Currently, there is limited capacity of high containment manufacturing in the United States. Althea is excited to make this significant expansion of our service offerings to address the needs of the ADC market as well as other highly potent products. Given our existing core capabilities in complex biologics formulation and aseptic filling, this investment in ADC and HPAPI fill finish manufacturing is a natural progression and logical step for Althea.”

Ajinomoto Althea was formed in 2013 when Tokyo-based chemical company Ajinomoto bought US CDMO Althea for $175m, including its biopharmaceutical production capabilities for microbial-derived recombinant proteins and plasmid DNA, upstream and downstream process development, analytical development, lyophilisation cycle, complex formulation, product release, ICH stability testing and cGMP vial and syringe filling.

Intertek's CA Bioanalytical Lab Expands

An expanded San Diego facility will support demand for preclinical and clinical development services driven by the growth in the antibody and biosimilar sector, Intertek says.

Pharma services firm Intertek launched its expanded GLP Bioanalytical Centre of Excellence in San Diego, California, offering 46,000 sq. ft. of laboratory space and new bioanalytical technologies.

The expansion was the result of growing demand for contract safety and efficacy services, according to Pharmaceutical Services Business Leader Mark Hammond said “reflects the fast growth of the biopharmaceutical market, in particular, therapeutic antibodies and biosimilars,” which have become a key focus for Intertek.

“Our expansion in new technologies will provide an enhanced level of bioanalytical information, helping [biopharma firms] to understand the safety, efficacy and mechanism of action of their drugs in development.”

He added the site’s upgrade in capacity and throughput for bioanalytical, biomarker, and cell-based capabilities will “expedite delivery of robust and efficient studies so our clients can make important decisions, faster.”

Headcount at the San Diego site has increased by 10 over the past year, but the firm says a further 30 new roles will be created the next two years.

The news comes as the latest in a line of expansions and investments at Intertek.

Last month, the firm opened 10,000 sq ft of additional lab space at its bioanalytical labs in Manchester, UK, and in May a new stability testing facility was launched in Cambridge, also in the UK.

This latest expansion “is an important step in our strategic growth plan for preclinical and clinical development support services,” Hammond said, adding that combined with the UK expansions customers now have “access to bioanalytical support in multiple regions.”

REST OF THE WORLD

Construction Starts at Cell Therapy Catapult’s Cell and Gene Therapy Center

The Cell Therapy Catapult, a UK organization dedicated to the growth of the UK cell and gene therapy industry, has announced the official start of construction for its 77,472 sq. ft.

(7,200m2) cell and gene therapy manufacturing center.

John Brown, Chairman of the Cell Therapy Catapult, marked the beginning of building work at a groundbreaking ceremony on the site attended by representatives from academia, healthcare, regulatory and industry interests across the advanced therapy sectors.

The Cell Therapy Catapult manufacturing center is due to be completed and opened in Stevenage in 2017. Its proximity to international air transport links at London Heathrow airport will enable time critical transport of the cells of patients to and from the facility. Innovate UK, the UK’s innovation agency, has committed £55m to the Cell Therapy Catapult for the creation of the center. It will generate up to 150 specialist jobs, and many more additional roles in the cluster that grows around it.

The UK government and Cell Therapy Catapult also anticipate that the center will attract considerable inward investment to the UK. The Cell Therapy Catapult cell and gene therapy manufacturing center will be the world’s first facility of its kind 'The Cell Therapy Catapult cell and gene therapy manufacturing center will be the world’s first facility of its kind.

I am very proud that it will be built in the UK,' said George Freeman, MP, UK Government Minister for Life Sciences. 'The UK is at the leading edge of the cell and gene therapy industry, with a disproportionate share of both world leading scientists and new developments in the field. It will also contribute to considerable additional inward investment to the UK. This has created an advantage upon which the country has to continue to capitalize. The center will contribute to the development of a large scale industry in the UK and the development of a cell and gene therapy cluster that will deliver both health and wealth to the UK.' Keith Thompson, CEO, the Cell Therapy Catapult, said: 'The manufacturing center will be a game changer for the UK cell therapy industry, as well as the future international availability of therapies for patients. Both UK and international companies will now be able to plan and spread costs via economies of scale for their manufacturing for clinical trials for the UK, European and global markets.'

Alphora Research Completes Analytical Laboratory Expansion

Alphora has completed a new 3,000 sq. ft. (280m2) analytical laboratory expansion, which provides additional workspace for equipment and personnel to support the Canadian company's growing business. The project also includes the upgrade of the data management system to EmpowerTM 3, providing a state-of-the-art platform for data and compliance management.

The company, based in Mississauga, Ontario, says the expansion will further support Alphora's clients’ API Technology Development programs, where comprehensive analytical understanding and control are essential for successful cGMP scale-up and to meet expanding regulatory expectations.

Alphora Research provides API technology development services to the pharmaceutical and biotechnology industries, including process chemistry, analytical development and validation services, and GMP scale-up. These services cover both early stage projects, where speed and quality are imperative, and later stage projects, where process economics and commercialization are vital. Alphora also provides niche commercial manufacturing and has conducted several validation campaigns in advance of market launch.

Founded in 2003 by Dr. Jan Oudenes, Alphora Research employs more than 90 people and operates an FDA inspected and approved operation totaling 50,000 sq. ft., including synthetic laboratories, analytical laboratories, GMP Kilo Laboratories, GMP Pilot Plant, GMP stability studies, and supporting QC/QA. Alphora also has high potency and cytotoxic capabilities.

New UK Facility to Accelerate Drug Discovery

From now, scientists working to design new medicines to treat a wide range of diseases will have access to a world-first facility based at Diamond Light Source – the UK’s national synchrotron science facility – for accelerating the process of developing novel compounds for drug discovery.

Prof Dave Stuart, Diamond’s Director of Life Sciences and Head of the Division of Structural Biology in the Department of Clinical Medicine at the University of Oxford, comments: “We are delighted to be able to offer the new XChem facility to both academic groups and drug development companies so that they can speed up the early stages of rational drug design.”

“Scientists are using Diamond to study a wide range of viral and bacterial infections, along with cancer, heart disease, diabetes and neurodegenerative conditions such as Alzheimer’s and Parkinson’s. While great progress is being made, on average it still takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace. Having a facility like XChem at the synchrotron is therefore a major step forward, allowing scientists to evaluate the equivalent of millions of compounds using just a few hundred much smaller compounds (named “fragments”). We believe it will give a particular boost to the combat of neglected diseases, where non-commercial research plays a major role, thereby greatly amplifying the impact of making available cutting-edge drug discovery technology.”

Though well-established, the screening technique has not to date has not been available in a central facility location to scientists from across the UK and beyond. Moreover XChem introduces a step-change in the sensitivity of the experiment, by harnessing synchrotron X-rays so that fragments can be directly observed interacting with the target protein.

This allows structural biologists to identify where drugs could potentially bind, to target that particular area for further research. The duration of the experiment has also been shrunk from months to days, through extensive streamlining by new technologies developed at Diamond and in partnership with the Structural Genomics Consortium at Oxford University, delivering unprecedented performance and making it possible to support a wide user base.

A key advantage for UK science is that this best-practice experimental procedure will now be available to large numbers of scientists from academia, along with researchers conducting R&D work for SMEs and large pharmaceuticals, all of whom are looking to advance their structural based drug design activity.

Dr. Frank von Delft, jointly head of the XChem facility and the partnering lab at Oxford University, remarks, “It is only a world-class national synchrotron like Diamond that makes such a facility conceivable, and it is its strong collaborative links with the UK’s universities that then leads to the creation of next-generation technologies like XChem.”

The integrated facilities on offer at Diamond place the UK at the forefront of life science research. Life sciences minister, George Freeman MP comments: “This development from Diamond shows the UK punches above its weight in the field of structural biology. The techniques on offer at XChem will save both time and money by swiftly identifying the most promising drug targets before more in-depth research takes place. This will help drive innovation in vaccine design, and the prevention of antibiotic resistance.”

John Barker, Vice President Structural Biology at Evotec, adds, “Building on an established relationship formed over many years of successful collaboration, Evotec and Diamond have worked closely to deliver the XChem platform for rapid identification of novel starting points for drug discovery campaigns for the drug discovery community. The new fragment-based discovery platform complements the breadth of techniques available at established companies, such as Evotec, while opening a new path to discovery for academic groups. Evotec is already making use of the XChem facility. Although details remain confidential for these early drug discovery campaigns, invaluable information is helping to progress multiple therapeutic targets for our international collaborators.”

A recent discovery that has the potential to benefit from the fragment screening facility has been led by a team of scientists from the University of Leicester. They have successfully solved the structure of the elusive protein pneumolysin.

This toxin, which is secreted by Streptococcus pneumoniae bacteria, is capable of killing cells. In doing so, it helps these bacteria, which are responsible for a range of serious illnesses including pneumonia, meningitis and septicaemia, to take hold in humans.

Funded by the Wellcome Trust and the Medical Research Council, the University of Leicester research was led by Professor Russell Wallis of the Departments of Infection, Immunity and Inflammation and Molecular and Cell Biology and Professor Peter Andrew, Head of Department of Infection, Immunity and Inflammation.

The crystal structure, published in the journal Scientific Reports, also represents a significant milestone for Diamond. Pneumolysin is the 3,000th protein structure to be solved at the facility and deposited in the Worldwide Protein Data Bank since Diamond came online in 2007.

Russell Wallis said: “Our research is about a toxin called pneumolysin produced by a bacterium called pneumococcus (aka Streptococcus pneumoniae). Pneumococcal infections are the leading cause of bacterial pneumonia as well as the cause of a range of other life-threatening diseases such as meningitis and septicaemia. Pneumolysin is instrumental in the ability of pneumococcus to cause disease. The World Health Organization (WHO) estimated that more than 1.6 million people die every year from pneumococcal infections, including more than 800,000 children under 5 years old.

“The aim of the research was to find out how pneumolysin kills our cells, thereby causing tissue damage and contributing to disease. In particular we wanted to find out how multiple copies of the toxin assemble on the surface of cells.

“We managed to determine the structure of pneumolysin using a technique called X-ray crystallography, which enables us to see the individual atoms of the toxin. The structure not only reveals what the toxin looks like, but also shows how it assembles to form lethal pores.

“Ours is the first detailed structure of pneumolysin. This level of detail is important and useful because it enables us to begin to understand how the toxin works. For example, we can see which parts of the toxin come together during pore assembly. When we disrupt these contacts, the toxin becomes inactivated so it can no longer kill cells.

“Using crystallography beamlines at Diamond Light Source, our team has been able to determine the full-length pneumolysin at high-resolution (ten millionths of a millimeter). Down at this level, we can determine the molecular interactions on the cell membrane and work out exactly how the protein forms the pores that are lethal to the body’s cells. Having this knowledge is very exciting as it forms the basis for rational approaches to designing drugs that block assembly of pneumolysin pores to treat people with pneumococcal disease. The University of Leicester has recently set up a company, Axendos Therapeutics, to pursue this aim.

Dave Stuart adds: “This is a fantastic achievement for the Leicester group and a significant milestone for Diamond. We are one of the top synchrotrons in the world when it comes to the number of proteins that scientists are depositing in the Protein Data Bank. We have reached the 3,000th structure at a very exciting point in our development with several new life science beamlines under construction as part of Diamond’s Phase III expansion.”

He continues: “Ultimately, this work reinforces Diamond’s role as a vital source of structural information and demonstrates how integral science is throughout the development process, from fundamental work to delivering new drugs.”

Baxter Expands Fill-Finish Facility

Baxter International Inc.’s BioPharma Solutions business, a CMO that specializes in parenteral pharmaceuticals, has completed an approximately 19,368 sq. ft. (1800-m2) capacity expansion designed for oncology drugs at the company’s fill/finish contract manufacturing facility in Halle (Westfalen), Germany, the company announced on Nov. 12, 2015. Lyophilized cytotoxic therapies like the ones manufactured at Halle continue to be at the center of oncology treatment programs.

“Cancer incidence continues to rise, and this completed expansion offers not only capacity but innovative processes and technologies that will allow Baxter to stay at the forefront of parenteral manufacturing for oncology therapies,” said Burkhard Wichert, vice-president of manufacturing for Baxter’s BioPharma Solutions business, in the press release.

The updated facility includes new equipment combined with innovative disinfection systems and an optimized layout to improve efficiency, prevent contamination, and keep potential losses on the filling line to a minimum. Extensive use of glass throughout the expansion area significantly improves visibility for workers and visitors. The ongoing development of the Halle facility is the latest in a series of expansions at Baxter, including the addition of a new packaging line in 2013.

ManKind Pharma Plans Manufacturing Facilities in Northeast India

The Delhi company, which is not to be confused with US inhaled insulin developer MannKind Corporation, will spend INR2bn ($30m) on new manufacturing facilities in India in 2016 according to a report.

One of the new plants – which will make finished dosage forms for the Indian market – will be constructed at an as yet unchosen site in Sikkim, a mountainous State in the North West of the country that borders Nepal and Tibet.

Sikkim is popular with drugmakers despite the logistical challenges associated with running facilities in the Himalayas.

Under State law, manufacturers that set up in the region before April 2017 will not have to pay taxes on revenues generated by products made there for 10 consecutive years.

ManKind’s plant is scheduled to be operational next March. The firm will join Cipla, Sun Pharma, Zydus Cadila, Alembic, IPCA, Alkem Lab, Intas Pharma, Torrent Pharma and Unichem which all have manufacturing operations in the State.

The second new ManKind facility – which is expected to open next summer – will be built at a site in Behror in Rajasthan. The Indian drugmaker plans to make a range of active pharmaceutical ingredients at the facility (API).

ManKind – which already operates manufacturing facilities in Paonta Sahib in Himachal Pradesh - also plans to build a facility in Udaipur, also in Rajasthan, in 2017 or 2018 according to Managing Director Sheetal Arora.

Arora said that: “As we grow in size, we want to ensure that maximum production is in house.

“Though we have 14 manufacturing facilities in Himachal Pradesh [ten of which are operated by contractors], but as the tax holiday in Himachal has now ended, we have decided to set up the new units in Sikkim, which still has a tax holiday.”

Clariant to Build Moisture Control Device Plant in Cuddalore in India

The plant – which will be outside the city of Puducherry – will initially produce desiccant canisters for pharmaceutical packaging, however, the plan is to make Clariant’s full range of equilibrium sorbents, adsorbent polymers and oxygen scavengers in due course.

Clariant said the aim is to cater for “globally active generic and branded pharmaceutical companies operating in India” as well as local manufacturers.

The firm said, "We expect to break ground to begin construction in January 2016. The new plant is slated to be operational by 2017."

Clariant already has a significant footprint in Cuddalore and the Healthcare Packaging site will be co-located there for synergistic purposes.

Clariant also stressed the plant will comply with “all relevant cGMP and US FDA standards” suggesting it could supply products for markets outside the country.

This interpretation is supported by comments from Ketan Premani, head of Clariant healthcare packaging sales in India, who said: “India is the largest provider of generic drugs globally, making it a key market for Clariant’s desiccant products.

“We want to ensure that we serve our customers here as directly and efficiently as possible. When the plant is complete, they will now have the ability to procure Clariant’s global-standard products directly produced in India.”

The Switzerland-based specialty chemical firm has been building its business in large Asian markets in 2015. In March, it opened a new healthcare product packaging plant in Dongguan, China that it gained through the acquisition of VitaPac.

When the Cuddalore plant is up and running there will be a degree of overlap in terms of the products that can be made at Clariant’s manufacturing facilities. This is deliberate response to drug industry demand according to explains Matthias Brommer, Vice President and Head of Clariant Healthcare Packaging.

“More and more global pharmaceutical companies are instituting business-continuity plans, or BCP, to deal with possible market disruptions, both natural and man-made,” he said, adding that “This new plant will support our ability to provide the same products from multiple plants in Asia and around the world.”

News of the new Indian facility comes a day after Clariant formed a partnership with FreeThink Technologies that will focus on using the latter’s software tools to improve packaging technologies for the storage of sensitive pharmaceuticals.

It also follows Clariant's acquisition of a 30% stake in Brazilian health and personal care ingredients firm Beraca Ingredientes Naturais.

Waters Opens a Subsidiary in Malaysia

Analytical and downstream technology firm Waters has opened a subsidiary in Malaysia, citing the steady and consistent growth of biopharma in the region as a driver.

The company said its new subsidiary, Waters and TA Instrument technologies located in Kuala Lumpar, will be more effective in supplying its product portfolio to the region, in light of “steady and consistent increases in demand,” according to spokesman Jeff Tarmy.

Tarmy said the subsidiary “will support the full line of chromatography, chemistries, detection and informatics solutions from Waters Division and the full line of thermal analysis. rheology and microcalorimetry solutions from TA Instruments.”

While Waters Corporation supplies a number of industries with analytical tools, mass spectrometry and separations science equipment, around 60% of its revenues comes from the life science sector.

“These technologies are, and will be, supported for the full range of end markets, including biopharmaceutical applications.”

He added Waters has seen “dynamic development” in Malaysia and took the opportunity to “extend our support to our expanding customer base by establishing direct in-country operations.”

Malaysian Growth

There has been a drive within Malaysia to increase its bioprocessing capabilities, with the Government launching a bio-hub located at a 160 acre park in Johor in 2013. The Bio-XCell Biotechnology Park gives manufacturers the option to lease plots for production plants and easy access to utilities.

Indian biopharma firm Biocon too has invested in the country, building a RM 500m ($118m) insulin plant in Johor in 2011.

The news comes following a strong year financially for Waters in Asia, according to CFO Gene Cassis.

He told delegates at the Stifel Health Care Conference, the firm has seen both recurring revenues and a strong growth rate in its Asian business.

“We've also begun to see that culturally paying for service is becoming much more understood and acceptable in some of our larger Asian markets.”

Samsung Biologics Doubling Capacity with Third Korean Plant

Samsung Biologics has invested $740m to build a third facility in Korea, adding a further 180,000L of mammalian cell culture capacity.

The original facility at the site in Songdo, South Korea, has a mammalian cell culture capacity of 30,000L – six bioreactors of 5,000L – and a second plant set to go online early next year will add 150,000L more (ten bioreactors of 15,000L).

But now Samsung says it intends to double the capacity through a third facility at the site through an investment of 850bn Korean won ($740m).

“Our new facility, which will be completed by September 2018, will have 180,000L of capacity for mammalian cell culture in the biopharmaceutical industry,” said spokesman Changsik Park.

He added the firm currently has 1,000 staff but a further 700 will be employed, representing the rapid growth of the company’s biomanufacturing footprint.

The contract development and manufacturing organization (CDMO) manufactures biologic products for Swiss firm Roche and Bristol-Myers Squibb from the site.

The firm signed a ten-year contract to manufacture the latter’s monoclonal antibody cancer drug Yervoy in 2013 , and the following year extended the agreement to make several other unnamed biologics from the Songdo, Incheon site.

The CDMO has also said it intends to offer biologics manufacturing to other customers, and this expansion should open up the capacity.

The site, once fully online, will have a capacity of 360,0000L making it one of the largest bioprocessing sites in the world.

Fellow Korean CDMO and biosimilar developer Celltrion has 140,000L of capacity at its Incheon site, but has planned a further 90,000L, while Swiss CDMO Lonza, has around 105,000L of capacity at its mammalian Portsmouth, New Hampshire site.

But the added capacity is unlikely to support the manufacture of Benepali, a biosimilar version of Amgen’s Enbrel (etanercept) being developed by Samsung Biologics’ joint venture with Biogen, Samsung Bioepis.

The JV has said it will use Biogen’s Hillerød, Denmark firm for the commercial manufacture – a 90,000L capacity stainless steel site which also makes Biogen’s own range of biopharmaceuticals, including Tysabri and Avonex.

Wockhardt Received a GMP Certificate from the UK’s MHRA for its Facility in India

The contractor announced the certificate in a statement filed with the Bombay Stock Exchange.

“The Company has undergone recently an inspection at its L1-Chikalthana, Aurangabad manufacturing facility by UK MHRA and have received a communication confirming the closure of the inspection and issuance of an unrestricted GMP certificate,” the firm said.

This was confirmed with the European database of GMP compliance, which shows the certificate, was issued on November 27, six weeks after the MHRA inspection which at the time Wockhardt said resulted in no critical observations.

The plant – which makes generic drugs and antibiotics – has previously been the subject of considerable regulatory criticism.

In October 2013 it was banned from exporting products to the UK after the country’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a certificate of non-compliance due to cGMP violations.

A month after the MHRA’s original suspension, the plant was hit by the US Food and Drug Administration (FDA) which issued an import alert in November 2013 , banning exports of all but five essential medicines made at the site.

In January this year the ban expanded to include all active pharmaceutical ingredients (APIs) made at the facility.

Hovione to Upgrade Plant for Oral and Inhalable Formulation Site

Hovione will spend $10m refurbishing a plant acquired from a Portuguese generics company to create an oral and inhalation formulation site.

The API and ingredients maker says as part of an expansion plan to grow its specialized formulation capabilities, it has bought a facility in Loures, Portugal from generic pharmaceutical company Generis, which it intends to refurbish and incorporate with its ongoing operations.

“The overall investment which includes the acquisition, refurbishment and new equipment will amount to $10m (€8.8m),” António Dinis, Hovione’s Director of Marketing and Communication, told this publication.

“We plan to totally refurbish the facility and create new oral and inhalation formulation development labs, analytical labs and production areas.”

While the site will be mostly fitted with existing Hovione production equipment, Dinis said the most important addition will be a small volume precision capsule filling machine with appropriate containment systems to handle highly potent compounds.

“This facility will be integrated into our Loures site in Portugal, Hovione’s largest,” he continued. “With this investment Hovione wants to offer its customers the option to get their clinical supplies or small volume commercial supplies from the same site where they already produce their API or solid dispersion.

“This facility will also complement our inhalation franchise allowing us to go end to end from the device to the final dosage.”

The news is the latest in a series of expansions for the Portuguese ingredient maker. Earlier this month, the Portugal-based ingredient supplier announced it was investing in its API facility in New Jersey, adding capabilities to handle highly potent compounds.

And in July, the firm increased its spray-drying capacity at the Loures plant by 20% through the addition of a new unit capable of producing between 50 and 200 metric tons per year.

Syngene Testing Capacity and Capability Expansion

Syngene says it will invest in new capacity and capabilities, including a viral testing facility, as it reports strong results in its first quarter post-IPO.

Syngene International Limited, the contract research and manufacturing services (CRAMS) wing of Indian drugmaker Biocon, was spun-out as a standalone public company in August after an initial public offering which the firm said raised over $1.15bn.

“The resounding oversubscription [31 times] of the IPO has reflected the trust and confidence of the investor community in Syngene’s value proposition,” Biocon’s Managing Director Kiran Mazumdar-Shaw said.

“India’s only publicly listed Research Services Company” reported sales for the second quarter FY 2016 of 26bn INR (($403m), a 28% y-o-y increase, while the bottom line grew 29% to 290m INR.

But the firm also revealed its plans for growth through additional capacity and capabilities in the discovery and development space.

“The key ongoing investments in these areas include a new research center, a formulation center and a large molecules manufacturing unit at our current site,” the firm said.

“In terms of new capabilities, we are currently investing in a viral testing facility and an oligonucleotide pilot plant. These investments continue to be on track for commissioning in the near to mid-term.”

The firm has also upped its manufacturing services, investing in a new commercial-scale unit at Mangaluru, India which CEO Peter Bains said “has helped us keep pace with the increasing requirements of our clients."

According to spokesperson Sandeep Nair, Syngene is strongly placed in the Indian as well as the global CRO space.

"We are the largest CRO in India and also amongst the largest in Asia offering a wide range of integrated services across the drug discovery, development and manufacturing continuum," he said.

"Syngene is the only CRO in India offering such a broad range of integrated services across small and large molecules. What gives Syngene an edge in the research and manufacturing service space is its excellent pool of scientific talent, world class infrastructure, and an impeccable track record of quality compliance."

AstraZeneca China Named 2015 Facility of the Year Awards Overall Winner

AstraZeneca won the 2015 Facility of the Year Awards Overall Category for its project at Taizhou, China

AstraZeneca China has been honored as the 2015 Facility of the Year Awards Overall Winner at ISPE’s Annual Meeting in Philadelphia, PA.

The winning project, AstraZeneca China’s market supply solid dose facility located in Taizhou, China, was built to manufacture five billion tablets of high-quality, affordable medicines each year for the China market. The 533,000 sq. ft. facility was completed in a record time of 20 months, coming in 18% under budget and maintaining an exemplary safety record of 3.26 million hours worked without a recordable incident. The project represents Phase 1 of a planned three-phase, greenfield site development in the new pharmaceutical center city of Taizhou.

'The Taizhou supply site project is the perfect representation of the FOYA programme,' said ISPE President and CEO John Bournas.

'AstraZeneca China’s mission to deliver high-quality pharmaceuticals to China’s growing population was carried out seamlessly through first-rate global engineering and operational organization. It demonstrates visionary pharmaceutical excellence undertaken in an emerging market.'

AstraZeneca China’s project team impressed the judges with its clear strategic plan. The team incorporated lean design principles to eliminate operational inefficiencies and deliver optimum manufacturing performance. And, with a 99% active pharmaceutical ingredient (API) removal rate from API containing waste water, the facility far exceeded local environmental regulations.

The Taizhou supply site project was built to support the Chinese government’s 'Healthy China 2020' program to provide universal healthcare access to all of China by 2020. With two additional phases expected, the Taizhou supply site has the potential to expand to nine billion tablets a year, placing AstraZeneca in a position to supply China with medicine for more than one billion people.

McIlvaine Company

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