At an event marking the start of construction on a new $65-million pharmaceutical manufacturing facility, Mayne Pharma shared additional details about the 126,000-square-foot oral-dose facility in Greenville, N.C.

The new facility will double the company’s U.S. manufacturing capacity and introduce commercial-scale fluid-bed processing capacity for modified-release bead/pellet drugs. Space within the company’s existing facility will be repurposed to expand contract analytical and formulation development services offered by Metrics Contract Services.

The $65 million strategic investment will fund:

A new, greenfield 126,000-square-foot, oral-dose commercial manufacturing facility adjacent to the company’s existing building. The new facility will more than double Mayne Pharma’s U.S. manufacturing capacity to support and accelerate organic growth.
The re-purposing of space within the existing facility, significantly expanding contract analytical laboratory and formulation development services capacity.
A new visitor and staff administrative center linking the two main buildings.

The new facility will house commercial manufacturing and packaging operations for Mayne Pharma’s generic and branded drug products. These operations also create new business opportunities for Metrics Contract Services (MCS) clients by offering expanded downstream commercial manufacturing services.

The expansion means Mayne Pharma can introduce commercial-scale manufacturing capability using solvent-based, fluid-bed processing technologies for modified-release bead/pellet products—an offering Mayne Pharma provides at its Australia facility. The company has seven modified-release products in the pipeline targeting markets with sales greater than $3.5 billion; three have been filed with the FDA.

“Mayne Pharma will triple its global fluid-bed processing capability once this facility opens, strengthening considerably our leadership position in oral drug delivery,” said Stefan Cross, president of Mayne Pharma USA. “The company will have greater flexibility to expand its modified-release product portfolio and support key existing product franchises that include Doxycycline, Morphine Sulfate and Erythromycin.”

The new building has been designed to allow for the safe handling of highly potent products at greater scale. Mayne Pharma has four highly potent products targeting markets with sales greater than $2 billion in the pipeline.

Regeneron Investing in NY Campus

Regeneron Pharmaceuticals has opened two new buildings at its headquarters in Tarrytown, NY, housing 300,000 square feet of lab and office space. The rapidly expanding biotech now occupies more than one million square feet of space at the site.

At the grand opening, which was attended by New York State Governor Andrew Cuomo, Regeneron said it plans to invest an additional $150 million to further expand the Tarrytown campus, which will result in at least 300 more jobs.

This new expansion project will construct a building of up to 192,000 square-feet that will include more laboratory and office space. With more than 4,000 employees around the world, the company says it has hired 1,200 this year alone, 945 in New York. The slew of investments is being spurred by the success of the blockbuster eye treatment Eylea.

"New York has been Regeneron's home since 1988, and the many scientific advancements made in our Tarrytown labs have yielded four approved treatments and an important pipeline of potential medicines for people with a range of serious diseases," said Leonard Schleifer, president and chief executive officer, Regeneron.

In 1988, Regeneron was launched as a biotech start-up in New York City and today is rated as the largest biotech company in New York State and the fifth largest in the world.

Plough Center for Sterile Drug Delivery Systems Facility Expands

A new drug manufacturing facility for the University of Tennessee Health Science Centre in Memphis, Tennessee is expected to begin construction in September 2015.

The new facility, which will be known as Plough Center for Sterile Drug Delivery Systems, will house pre-manufactured cleanroom pods for the manufacture and filling of clinical trial drugs. It will provide aseptic formulation and clinical trial drug compounding services on a contractual basis for the private sector.

It will be built in compliance with current good manufacturing practices (cGMP) to produce small-batch drugs in injectable and semi-solid dosage forms for preclinical Phase 1 and Phase 2 clinical trials.

The facility will be constructed by replacing the 32,000ft² warehouse located at 208 S Dudley Street, which was purchased from Dudley Properties for $750,000 in June 2011. The University of Tennessee filed a $3.7m permit application for the project with the Shelby County Department of Construction Code Enforcement in July 2015.

The sterile drug delivery systems facility will have total floor space of 32,000ft², which will include 17,200ft² of pre-fabricated sterile pods. It will also include three 800ft² pre-fabricated pods, which will serve as sterile environments for aseptic pharmaceutical manufacturing.

Pre-fabricated pods will include temperature-controlled and smaller spaces, which will give control over sterilization while preparing, compounding and filling pharmaceuticals at a small scale. There will be 10,000ft² of space dedicated to support labs, offices and training facilities.

The facility will manufacture orphan drugs developed to treat specific and rare diseases, and innovative drug delivery systems. It will provide training to students and professionals from the pharmaceutical industry, and government regulatory agencies in production.

Construction of the facility is expected to begin in September 2015 and is aimed for completion within 24 months. It will include renovation of the old warehouse, refurbishing the interior of the building, and updating the exterior.

G-CON Manufacturing Sales Engineering was contracted to build a multi-pod ISO Class 7 formulation and filling suite for the new facility in March 2015. The project team includes brg3s Architects, ETFC Architects, DPS Consulting, and DPS Engineering.

DPS Consulting will provide pharmaceutical consulting and guidance, while DPS Engineering will provide process architecture and design for the pods.

The facility will be constructed with an estimated investment of $16m. Plough Foundation contributed $4.5m towards construction.

Imprimis Registers Texas Site as an Outsourcing Facility

Imprimis Pharmaceuticals Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary compounded drug therapies, started construction on the company's Allen, TX, compounding pharmacy and plans to register the pharmacy with the U.S. Food and Drug Administration (FDA) as a 503B sterile outsourcing facility under the Drug Quality and Security Act (DQSA) of 2013. The DQSA was signed into law by President Obama on November 27, 2013 and created a new pathway, in which a compounding pharmacy can register with the FDA as an outsourcing facility.

Once the Allen facility begins operations as an outsourcing facility, physicians, hospitals and ambulatory surgical centers will have the opportunity to prescribe and receive certain of Imprimis' proprietary compounded formulations with greater ease and without the time delays associated with the current requirement of providing patient-specific prescriptions and related shipping times.

Imprimis' Texas facility is expected to be completed and dispensing certain prescriptions as an outsourcing facility on or before February 1, 2016. In the meantime, the pharmacy will continue its current operations without disruption of service during construction.

"We believe this is the future for sterile compounding pharmacies and we have been advocates of the new law and increased FDA oversight to ensure public confidence in quality and patient safety,” said Mark Baum, chief executive officer, Imprimis. “Fortunately, our Allen, TX facility was a very good candidate for a low cost upgrade to a 503B outsourcing facility given the quality of the existing compounding infrastructure we recently purchased.”

In addition, the company says it intends to open and qualify its larger, state-of-the-art Roxbury, NJ outsourcing facility during the first quarter of 2016.

Xcelience Opened New HQ

Xcelience has opened its new 71,000 square foot headquarters located at 4910 Savarese Circle in Tampa, FL. The building houses preformulation and formulation development labs and suites, as well as analytical and stability services.

Phillips-Medisize Completes Medical Facility Expansion

Phillips-Medisize Corporation has completed a 33,000 square-foot expansion to its New Richmond, Wis., medical facility.

The New Richmond facility is focused on the manufacturing and assembly of diagnostic and surgical products. The expansion includes additional controlled manufacturing and cleanroom space.

Phillips-Medisize executives said the expansion is the result of the company’s double-digit growth and increased demand from customers such as Antares Pharma, Inc. and Exact Sciences. The company plans to add a significant number of new technical positions within operations, quality and engineering, along with several production employees at the New Richmond site both this year and early next year.

“We are very excited about the growth that we experience at Phillips-Medisize. Having the right facilities at the right time and place is one of the company’s strategic pillars as well as having the right and most creative employees on staff," said Matt Jennings, chairman/CEO of Phillips-Medisize Corporation. "We will continue to invest in this business based on our strategic plan that we put into effect more than four years ago.”

Headquartered in Hudson, Wis., Phillips-Medisize is an outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics and medical device, and specialty commercial markets. The company has annual sales of more than $600 million with 80 percent of the total revenue coming from drug delivery, medical device, primary pharmaceutical packaging and diagnostic products such as disposable insulin pens, glucose meters, specialty inhalation drug delivery devices, single-use surgical devices and consumable diagnostic components.

Phillips-Medisize employs more than 3,400 people in 14 locations throughout the United States, Europe, Mexico and China. The company also has design centers in Wisconsin, California, the Netherlands and China.

Lilly to Expand Indianapolis R&D HQ

Eli Lilly and Co. plans to expand its global R&D headquarters in Indianapolis, IN, adding 130,000 sq.-ft. to its existing complex. The $70 million investment will feature a multi-disciplinary lab that facilitates collaboration across multiple research functions. The new building is part of Lilly's continued growth of its Indianapolis footprint, which included a $400 million expansion initiated in 2013 to increase its insulin manufacturing capacity.

When complete in 2017, the new building will enable chemists and engineers to work together a collaboration-centric workspace with modelling, analytical and formulation scientists. The company’s strategy incorporates flexible labs that can adapt as research and technology needs evolve, as well as open, interactive meeting spaces that are meant to promote multi-disciplinary problem-solving. The lab will focus its efforts on small molecules (typically taken orally), which currently comprise about half of Lilly's investigational drug portfolio.

"We are excited to grow our presence in Indianapolis, which is home to our largest global R&D facility and where our research efforts began," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "Evolving our laboratories will position Lilly and its Indianapolis-based scientists to more efficiently discover and develop new treatments that will make life better."

This is Lilly's fourth R&D expansion this year. In May, Lilly announced it would build a delivery and device innovation center in Cambridge, MA, and in July, announced an expansion of its biotechnology center in San Diego, CA. Lilly is also expanding its presence at the Alexandria Center for Life Science in New York, NY.

Intertek Expands Bioanalytical Center of Excellence

Intertek has expanded its GLP Bioanalytical Centre of Excellence in San Diego, CA. The capacity and new technology expansion includes 46,000-sq.-ft. of labs, offices and sample storage for preclinical and clinical development of small molecule and biologic drugs. The investment in new bioanalytical technologies aims to expedite delivery of bioanalysis results for global clients.

The facility offers new technologies such as flow cytometry, which provides analysis of cells to help understand the mechanism of action of drugs and to help facilitate evaluation of drug stability and potency. Flow cytometry also provides a platform for assessing cell based neutralizing antibody activity in clinical trials, which is important in assessing potential adverse immunological effects.

Luminex technology will build on current high throughput and multiplexing capabilities to allow customized measurement of up to 100 analytes simultaneously using very small volumes of sample. Also, new liquid chromatography- mass spectrometry (LC-MS) instruments improve sensitivity and mass range for analysis of protein therapeutics.

Mark Hammond, Intertek Pharmaceutical Services business leader, said, “Our expanded GLP Bioanalytical Centre of Excellence in San Diego and new technologies provide a broader range of bioanalytical, biomarker, and cell-based capabilities services to meet our clients’ needs in preclinical and clinical bioanalysis, helping them to understand the safety, efficacy and mechanism of action of their small and large molecule drugs in development.”

REST OF WORLD

Construction Starts at Cell Therapy Catapult

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 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.'

Amgen’s Manufacturing Facility Expansion in Ireland

Amgen, a leading biotechnology company based in the US, 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

62,408 sq. ft. (5,800m²), 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 398,120 sq. ft. (37,000m²) facility specializes in secondary manufacturing activities such as formulation, liquid vial filling, lyophilization 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.

Stemedica Cell Technologies Expands by Taking over a Facility from Smith & Nephew

The deal gives Stemedica a production plant in Lausanne, Switzerland at a time when it needs to bring additional capacity online to support the expansion of its clinical trial program into Asia and Europe.

Smith & Nephew used the site for commercial-grade cell manufacturing, work for which it received the approval of the Swiss Agency for Therapeutic Products, the regulator also known as Swissmedic.

Stemedica has knowledge of the site from an earlier collaboration with Smith & Nephew. The collaboration entailed the transfer of Stemedica’s BioSmart Technology Platform to Lausanne and the performance of several engineering runs at the Swiss facility.

Management at Stemedica now plans to tailor the plant to the needs of their operation, which is focused on the production of allogeneic adult stem cells for use in the treatment of chronic heart failure, ischemic stroke and other diseases.

“We are currently working on our plans for recommissioning the facility,” said David Cheatham, business manager at Stemedica International. The plan will dictate what changes Stemedica makes to the plant and the number of employees it brings on board initially to staff the site.

Long-term staffing goals for the facility are already in place. “Once the facility is fully operational, I expect our staffing could be as high as 25 employees,” Cheatham said.

Stemedica is open to hiring people who used to staff the site for Smith & Nephew or anyone else who meets its requirements. “We will carefully consider all qualified applicants,” Cheatham said.

Stemedica expects to have the facility ready next year. Once that happens, Stemedica will have two operational facilities, with the new site in Lausanne joining a plant in the company’s home city of San Diego, California.

The establishment of a base in Europe will give Stemedica a location from which to produce stem cells for clinical trial sites in the continent and in Asia. As it stands, Stemedica is involved with clinical trials in a handful of regions of the United States, including Arizona, California and New York.

Stemedica has also worked with Novastem to treat patients in Mexico. The collaboration made headlines, not all of them positive, 11 months ago when the family of ice hockey legend Gordie Howe released a statement about Stemedica’s stem cell therapies.

The family said Howe was injected with neural stem cells and one day later could walk for the first time since he suffered a stroke, a response they described as “truly miraculous.” Other observers cautioned about reading too much into the experience of one patient.

Piramal Expands in Scotland

Piramal Healthcare UK Ltd. has invested £2.0 million to expand its manufacturing base at Grangemouth, Scotland, to manufacture Antibody Drug Conjugates for global markets. The new facility will add approximately 20 high-skill jobs and the company expects the investment will yield additional revenue of £3-5 million over a period of five years.

Scotland has become a globally competitive base for sustainable high-value manufacturing. Scotland’s globally competitive Pharma services sector includes more than 160 companies, a quality controlled environment, supportive clinical trial environment and high quality manufacture.

Piramal Healthcare site lead, Mark Wright, said, “Piramal has been growing its operations in Grangemouth since 2005 and currently employs around 140 people in predominantly highly skilled positions. We aim to scale up this facility in the next five years to maintain its position as a global leader in the production of Antibody Drug Conjugates.”

Alphora Canada Expands Lab Space

Alphora Research has completed a new 3,000 sq. ft. analytical laboratory expansion, which provides additional workspace for equipment and personnel to support growing business demands. The project also includes the upgrade of the data management system to Empower 3, providing a state-of-the-art platform for data and compliance management. The company says the expansion will support its 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 and late stage projects. Alphora also provides niche commercial manufacturing and has conducted several validation campaigns in advance of market launch.

Roche to Restructure Small Molecule Operations

Roche plans to close four manufacturing sites in Clarecastle, Ireland; Leganes, Spain; Segrate, Italy; and Florence, U.S. to address current underutilization as a result of its evolving portfolio. The company is looking into divestment opportunities for these facilities.

To support the manufacture of a new generation of specialized small molecule medicines—produced in lower volumes than traditional medicines—Roche is investing 300 million Swiss francs in a dedicated facility in Kaiseraugst, Switzerland to provide future technology requirements.

“With these changes we are responding to the evolution of our small molecule portfolio towards specialized medicines produced in lower volumes,” said Daniel O’Day, chief operating officer, Pharmaceuticals Division of Roche. “We are aware of the impact this decision has on our colleagues, and we will do our utmost to support them during this transition.”

The transition will begin in 2016 and is planned to end by 2021. Restructuring costs are estimated to be CHF 1.6 billion until 2021, of which as much as CHF 600 million will be in cash.

UK Center Installs Protein Purification Technology

The Centre for Process Innovation (CPI), a UK-based technology innovation center that provides services to small and medium-sized enterprises in the UK, has equipped the UK National Biologics Manufacturing Centre with Novasep’s BioSC Lab for protein purification. CPI’s services are intended to decrease time to market for novel products or processes. Within this framework, the CPI has been keen to introduce breakthrough continuous processes in the UK biopharmaceutical sector, CPI said in a press release. These technologies enable developers to reduce equipment footprint and increase process yields, thereby saving time and money.

“The National Biologics Manufacturing Centre has been designed to help companies of all sizes to develop, prove, and commercialize new and improved processes and technologies for biopharmaceutical manufacture,” said Chris Dowle, director of biologics at CPI. “The installation of Novasep’s BioSC Lab will be a valuable asset to customers using the center."

Novasep’s continuous biochromatography equipment, BiosSC Lab, can purify a few grams of proteins per day. This enables users to develop cost-effective, high-yield production processes while maintaining the same quality attributes of the protein. The equipment is flexible and supports any process operating mode, including batch, parallel batch, and continuous. It is specifically designed to quickly provide the operator with the best operational parameters for purifying and converting a batch biochromatography recipe into a continuous, optimized one. Its simulation software, BioSC Predict, frees the process developer to set the most efficient mode and parameters to purify biomolecules such as monoclonal antibodies (mAbs), blood factors, and other proteins.

Scientia Clinical Research (SCR) Facility, the University of New South Wales (UNSW), Australia

The facility will be collocated within a major research precinct that also includes the Prince of Wales Hospital, the NCCC, and the Lowy Cancer Research Centre.

Construction of the Scientia Clinical Research (SCR) facility at the Randwick Hospitals campus in the University of New South Wales (UNSW) began in November 2014.

The facility will accommodate early phase clinical trials to provide a full-range of specialties in cancer, ophthalmology, neurology, addiction medicine, rheumatology and pediatrics.

It will also provide investigation of medicines, biomedical equipment, devices and other procedures and treatments.

The clinical research facility is being constructed under stage two of Nelune Comprehensive Cancer Centre (NCCC) and Scientia Clinical Research (SCR) project as a member of the Bright Alliance, a partnership between Prince of Wales Hospital and UNSW Australia.

The Department of Planning and Environment gave planning approval for stage two of the building construction on 15 May 2014. The SCR facility is expected to be ready for operations by mid-2016.

Scientia Clinical Research (SCR) facility will be part of the ten level stage two building. It will be collocated within a major research precinct that includes the NCCC, the Prince of Wales Hospital and the Lowy Cancer Research Centre.

The research center will provide services to the biotechnology and the pharmaceutical industry. It will perform phase I to IV clinical trials for multinational and national pharmaceutical and biotechnology companies, as well as support small and medium trials initiated by co-operative trial groups and research investigators.

It will be connected to the Prince of Wales Hospital, Royal Hospital for Women and Sydney Children's Hospital through links at levels one and two of the building.

The facility will promote New South Wales (NSW) as a prime location for clinical trials and provide an opportunity for fast tracking new medical discoveries. It will help to bridge the gap between cancer patients, cancer services and basic and translational researchers.

It will also offer advice and assistance to academic researchers and clinicians on the design and conduct of clinical research.

The facility will provide benefits by enhancing skills and knowledge of clinical researchers and ancillary staff, and support better outcomes for patients by improving clinical standards. It will further provide opportunities for patients to be included in clinical trials, establish a support network for researchers to increase trial activity and share ideas.

In addition, the facility will improve research revenue to support funding of the local research infrastructure.

The SCR facility is estimated to be completed with an investment of $23.8m. It is jointly financed through the Therapeutic Innovation Australia and by the NSW State Government.

Stage two of the bigger project includes demolition of the existing radiation oncology building and construction of the new NCCC, SCR facility and Sydney Children's Hospitals Network levels. Bulk excavation works for the project were completed by May 2015.

The first stage of project construction started in 2012 and was completed in November 2014. It included construction of a new lower ground treatment area, including four radiotherapy bunkers, with three linear accelerators and connections from the radiotherapy treatment area to Prince of Wales Hospital.

A W Edwards was awarded the contract to provide construction services for stage two. Johnstaff, as project manager, will provide design development, contract documentation, administration, health planning, procurement and commissioning for the project.

Merck Serono Biopharmaceutical R&D Facilities Expand

Merck Serono laid down the cornerstone for the expansion of the research and development (R&D) facility within the new Pharma Square on the Merck campus in Darmstadt, Germany, in September 2015.

The expansion includes the construction of a new laboratory building that will accommodate approximately 200 employees to focus on accelerating innovation in R&D.

The new research building construction, which is part of ONE Global Headquarters (OGHQ) strategic initiative, is expected to be completed with an investment of €65m ($73.83m) and is expected to be completed by late 2017.

The OGHQ expansion project, which has been under construction since September 2014, is expected to create an attractive working environment to offer sufficient scope for creativity and innovation when it is completed by 2018. The OGHQ expansion also includes a new 4,000m² (43,040 sq. ft.) modular innovation center.

The biopharmaceutical research facility expansion at Darmstadt will include a new laboratory building that will span more than 172,160 sq. ft. (16,000m²). The newly expanded facility will unite different functions within R&D Discovery Technologies of Merck, including molecular pharmacology, medicinal chemistry, computational chemistry, molecular interactions and biophysics, protein engineering and antibody technologies, and protein and cell sciences.

The addition of the new laboratory building will be a significant element in the expansion of Merck's global headquarters at Darmstadt.

The new research building will enhance Merck's modern R&D activities in a single area to foster collaboration and innovation across disciplines to create ideal conditions for the advancement of biopharmaceutical pipeline. It will have an open and modern environment, and will be a driver of future growth as it will create new opportunities for discoveries that will bring value to patients and to Merck.

The laboratory building will be constructed in compliance with the current good manufacturing practices (cGMP).

The Darmstadt R&D facility is the biggest manufacturing site of the Merck Group and produces pharmaceutical products and organic synthesis, inorganic materials and reagents. The facility has state-of-the-art production facility producing approximately half of all global tablet requirements and integrating scale-up and launch capabilities for future new chemical entities (NCEs).

Headquartered at Darmstadt, Germany, Merck Serono is a biopharmaceutical business of Merck. The company is engaged in the discovery, development, production and commercialization of prescription medicines, including chemical and biological origin in specialist indications.

It offers leading brands across 150 countries worldwide to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders, as well as cardiovascular diseases. It also delivers novel therapies in core focus areas of neurology, oncology, immuno-oncology and immunology. The company operates by the name EMD Serono in the US and Canada.

Merck Serono has more than 2,300 research and development professionals working across four R&D hubs located in Darmstadt, Boston, Tokyo and Beijing. The Darmstadt R&D facility expansion will enhance Merck's innovation in the laboratories to reach the patients in need around the world.

CanSino’s Ebola Vaccine Manufacturing Facility, Tianjin, China

Tianjin CanSino Biotechnology (CanSino) began construction of its first fully integrated Ebola vaccine manufacturing facility at Tianjin Economic Technological Development Area (TEDA) west zone in China in October 2015.

The new facility will be used for the development of innovative vaccine products for treating the Ebola virus disease (EVD). CanSino sought financing for the project from Qiming Venture Partners, Lilly Asia Ventures and other investors.

The total estimated investment for construction of the manufacturing facility is estimated to be ¥2bn ($315m), of which Lilly Asia Ventures' investment is $15m.

The new manufacturing facility will be spread over 699,400 sq. ft. (65,000m²). It will be built in compliance with China and World Health Organization (WHO)'s good manufacturing practice (GMP) standards and produce annual industrial output valued up to $600m.

The facility will produce ten quality human vaccine products, including the EVD vaccine, multivalent meningococcal and pneumococcal conjugate vaccines, as well as the DTcP vaccine. Its production capacity is expected to be more than 200 million doses a year.

The vaccine manufacturing facility broke ground for construction in October 2015. The first phase of construction is expected to be completed by September 2018.

The Academy of Military Medical Sciences of China discovered an Ebola vaccine, which was approved for clinical trials in December 2014. The vaccine is being developed by CanSino in partnership with the Beijing Institute of Biotechnology.

The clinical development of the vaccine is based on the Ebola virus strain that caused the 2014 epidemic. The Phase I double-blind, placebo-controlled study, which was conducted on recombinant adenovirus type-5 vaccine in Jiangsu province, China, enrolled 120 healthy adults.

Study results announced in March 2015 demonstrated that subjects administered with the vaccine reported 95% effectiveness in a low dose and 100% in a higher dose. Subjects are called to undergo further clinical trials in Africa to determine whether the vaccine's immune response is strong enough to fight off an actual Ebola infection.

The vaccine is currently undergoing Phase II clinical trials in Africa. CanSino submitted four clinical trial applications (CTA) for the vaccine to China Food and Drug Administration (CFDA), including adenovirus type 5 vector-based EVD vaccine, diphtheria and tetanus toxoids, component pertussis vaccine adsorbed, and polyvalent meningococcal conjugate vaccine.

Tianjin CanSino Biotechnology is a biotechnology company based in China. The company was founded in Tianjin Economic and Technological Development Area (TEDA) in 2009 and engages in research and development (R&D), manufacturing and commercialization of vaccine products for human use. It also develops quality vaccines for China and other emerging countries.

SGS Adds New Capabilities at Its Mississauga, Canada Lab

SGS Life Science Services has installed and validated instrumentation which uses frequency modulation spectroscopy (FMS) for headspace oxygen analysis of biopharmaceutical container closure systems, as well as imaged capillary isoelectric focusing (icIEF) for analysis of charge distribution and heterogeneity in biopharmaceuticals, at its facility in Mississauga, Canada.

FMS now forms part of SGS’s comprehensive package and container testing services, and has the advantage over traditional methods, which use dye ingress to monitor fractures within biopharmaceutical packaging, in that the test is non-destructive, reduces the variability of analysis and conserves valuable product for further testing. Oxygen detection is a more sensitive analysis method and is reproducible on fractures less than 10 microns in size, which limit dye-based testing.

icIEF analysis has become a key technology at the facility for determination of the charge distribution across biopharmaceutical molecules, lending additional versatility to the already strong, multi-platform capillary electrophoresis service offering. The test, which is vital for establishing charge heterogeneity during lot release and stability testing of biopharmaceuticals, is more sensitive than traditional slab gel IEF, and often provides superior resolution over traditional mobilizing icIEF or chromatographic charge profiling. It also allows more challenging samples, which are potentially difficult to focus or resolve to be analyzed, while dramatically reducing development times.

“By investing in these new services, we have the capability to provide clients with faster, more accurate results, while protecting the integrity of the supply chains of valuable biopharmaceuticals,” commented Michael Lindsay, Vice President Life Science Services, SGS Canada. “As a company, SGS is committed to investment in new technologies that benefit not only our clients directly, but also patient safety as a whole.”

Raumedic Opens New Plant in Germany

Raumedic AG has expanded its operational capabilities at its headquarters in Helmbrechts, Germany.

The 26 million-euro expansion was necessary to make room for research and development, quality management, laboratory, production and logistics, company officials noted in a news release. The firm added 2,250 square meters (24,210 sq. ft.) of Class 7 cleanroom space, certified according to ISO 14644.

The facility expansion will create an additional 190 jobs in the next several years and allow Raumedic to implement new customized projects at its technology center that focus on precision injection molding and fully automated assembly.

As part of its international expansion, the company is creating a $27.1 million production and technology center in Mills River, N.C. that is slated to open in January. Executives plan to gradually increase the total number of workers there to more than 100.

Raurmedic CEO Martin Bayer called the German plant expansion "an investment in the future."

Raumedic was spun off from Rehau AG & Co. in 2004. It develops systems and components for the global medical and pharmaceutical industries. The company also develops and produces pressure measurement systems for neuromonitoring, urology, gastroenterology and traumatology for clinical and practical applications.

Grifols Opens Operations Facility in Dublin, Ireland

Spanish firm Grifols, the world's third-largest plasma product manufacturer, has officially opened its US$100m Bioscience Division global operations center in Ireland.

Located at Grange Castle Business Park Dublin, the 22,000m2 (236,720 sq. ft.) operation will contain a warehouse and handle labelling, packaging and final conditioning for plasma, intermediate and finished products. It will also house regulatory and quality activities for plasma and plasma derivatives, as well as have a R&D global management office and administrative, commercial and financial operations.

The operation will house the central warehouse for all plasma coming from the US, as it has the capacity to store up to 1,150 pallets at –30ºC, and is equipped with quality control laboratories.

It will also be the central warehouse for intermediate and finished products, with capacity to store up to 3,000 pallets of products at a temperature of +5ºC.

It has four labelling and packing lines and Grifols expects to process about 10 million product vials in 2016. This amount will double in the long term.

The center is scheduled to be operational during the first half of 2016 and will generate approximately 140 jobs.

Grifols' Bioscience Division generated sales revenue of €2.5bn in 2014, or 75% of the group's total net revenue. It manufactures plasma proteins and focuses on promoting its therapeutic use.

Grifols says the project is the result of a growth strategy that has placed a strong emphasis on the internationalization and globalization of activities. The company generated 93.4% of its sales outside Spain in 2014, and the company currently has direct commercial presence in 30 countries and distributes its products in 100.

Chugai to Construct an Antibody API Manufacturing Plant

Japanese firm Chugai Pharmaceutical is to construct a new JPY37.2bn (approximately US$310m; €280m) plant for manufacturing antibody active pharmaceutical ingredients (API) in Tokyo.

The plant will produce high-mix, low-volume, late-stage investigational drugs and initial commercial products at the Ukima plant of Chugai Pharma Manufacturing, a manufacturing subsidiary of the company.

Chugai has been conducting new drug development under a strategic alliance with F. Hoffman-La Roche. In 2012, it established a research laboratory in Singapore, Chugai Pharmabody Research (CPR), focused on drug discovery research applying its proprietary antibody engineering technologies.

As a result of these initiatives, the need to continuously generate innovative drug candidates is expected to increase. Chugai has therefore reinforced its production capacity for investigational drugs, and a capital investment of JPY2.9bn has been ongoing since 2013 at the Ukima plant, aimed at doubling its production capacity for antibody drugs in order to accommodate the simultaneous development of drug candidates.

Chugai will invest in the new plant in Tokyo to increase its capacity to manufacture antibody API to meet the demand of initial commercial products in the future.

Having technology development and production at a single site will enable increased efficiency in production processing

'Chugai currently has several antibody projects under clinical development applying its proprietary innovative antibody engineering technologies. We are also actively conducting drug discovery research for antibody drugs at our domestic laboratories and CPR, and have several drug candidates close to the clinical phase. In order for us to promptly conduct simultaneous clinical development for these projects, we need to accommodate high-mix low-volume production of multiple investigational drugs,' said Hitoshi Kuboniwa, Senior Vice President and General Manager of the Pharmaceutical Technology Division.

'It is very important to organize the supply system from the late stage of clinical development to realize a fast commercialization in order for us to survive the severe competition in drug development. The research center for pharmaceutical process development is also located at the Ukima office. Having technology development and production at a single site will enable increased efficiency in production processing.'

As part of this new capital investment, six 6,000L bioreactor tanks will be installed at the Ukima plant. Combined with two existing 2,500L tanks and four 2,000L tanks, the plant will have a total capacity of 49,000L bioreactor tanks, with a consistent system from process development to production of antibody API of investigational drugs in late-stage clinical studies and initial commercial products at one site.

Construction is scheduled to start in January 2016, with operation scheduled for June 2019.

Uflex Expands Aseptic Packaging

Uflex predicated the Indian domestic aseptic packaging market will double from 8bn packs annually within 3-4 years

Uflex is expanding an Indian plant to move into aseptic packaging with the facility expected to be operational by April 2017.

The firm said the investment in Sanand, Gujarat will require an outlay of Rs. 1500 crores over the next three to five years. In the first phase of the expansion, the company will invest Rs 580 crore to set up an aseptic packaging line for liquid products.

The firm said it will be available to provide the packaging alternative to businesses dealing in liquids like milk, dairy products, and non-aerated drinks.

Uflex said the domestic market stands at eight billion packs from aseptic packaging material annually. This is expected to double in the next three to four years. A rise in the beverage market and an evolved consumer mind-set regarding use of preservatives has contributed to the growth, it added.

The plant will employ around 250 people in the first phase and on completion staff levels will rise to 3,000. It will produce seven billion packs per year for liquid products such as energy drinks, milk and juices.

Uflex said about 90 percent of the output will cater to the domestic market.

The factors supporting growth of aseptic packaging are a growing urban populace and rising demand for convenience food as well as technological advancements that have helped improve the functionality and range of applications, said the firm.

Aseptic packaging is a process in which a food product and its package is sterilized separately and then combined and sealed in a sterilized atmosphere.

Aseptic packaged products do not require refrigeration, can have a longer shelf life and be lightweight.

The Asia-Pacific region is estimated to account for the largest market share, according to an analysis from Reportbuyer.

North America and Europe have many established aseptic packaging companies because of willingness to take up capital intensive projects and availability of technical expertise.

The aseptic packaging market is projected to witness the highest demand from beverage manufacturers with cartons projected to account for the largest market during the forecast period to 2020.

Uflex already makes flexible packaging for solids, semi solids, viscous fluids, powders and granular materials.

Novo Nordisk Diabetes Plant Plans

Novo Nordisk is building a 2.1bn Danish kroner ($175m) insulin and obesity drug plant in Denmark set to employ 450 people.

The planned 10,300 sq. meter (110,828 sq. ft.) facility in Hillerød, north of Copenhagen, broke ground at Brennum Park.

The site will produce and perform fill-finish for insulin and Saxenda (liraglutide), Novo Nordisk’s recombinant DNA weight loss therapy. It will also have production capacity for existing and future diabetes treatments.

Diabetes care is Novo Nordisk’s biggest earner, bringing 21.6m Danish kroner ($3.2m) of revenue to the company in Q3 this year. Biopharmaceuticals earned 5.2m kroner ($760,000) in the same quarter. The company reported earnings of 88.8m kroner ($13m) last year.

“The investment in Hillerød underscores our long-term ambition to create and maintain jobs in Denmark. This year alone we have created 1,000 new jobs in Denmark, of which 500 are in production, primarily in Kalundborg and Hillerød,” said Henrik Wulff, executive vice president and head of product supply, Novo Nordisk.

Evonik Opens Expanded Production Facilities in Japan

Evonik has opened its newly expanded facilities in Ako, Japan, which will produce its SIPERNAT and CARPLEX lines of specialty silicas. The investment adds a 50% increase Japanese production capacity for specialty silicas, which the specialty chemicals company manufactures through DSL. Japan Co., Ltd. (DSL). Evonik has a 51% stake in DSL, a joint venture with the Shionogi & Co., Ltd. in Japan.

Applications for SIPERNAT and CARPLEX are used as drug carriers in pharmaceuticals, and as flow aids in powdered foods and thickener for toothpastes.

“The expansion will allow us to continue providing exceptionally high-quality silica that will support the growth of our customers in sophisticated sectors such as the food, cosmetics, and pharmaceuticals industries,” said Andreas Fischer, head of the Silica Business Line within the Resource Efficiency Segment.

Evonik is also expanding its global silica production capacities with a new facility in Americana, Brazil, and a new production plant for precipitated silica in the U.S., which is expected to be completed by the end of 2017.

AXIM Biotechnologies to Build Dutch Manufacturing Site

AXIM Biotechnologies Inc. will build a new 6,000 square meters (64,560 sq. ft.) manufacturing facility at the industrial estate Stichtsekant in the city of Almere, The Netherlands. In the next month AXIM Biotech will work with the builder and architects on drafting building plans and a detailed engineering building plan with respect to permit applications and subsequent approvals. After the final purchase of the land, AXIM Biotech will break ground on construction.

“We are extremely grateful to the government of the province of Flevoland for allowing AXIM Biotech to establish manufacturing in Almere,” said George Anastassov, chief executive officer, AXIM Biotech. “The factory plans are compliant with the highest European and International standards and will produce unique pharmaceutical and nutraceutical products, all from agricultural hemp.”

AXIM Biotechnologies is planning the state-of-the-art Almere facility to feature a clean laboratory zone, storage areas, office and technical rooms as well as manufacturing facility furnishings.

AXIM's global manufacturing hub in Almere will have the capacity to process raw materials and manufacture the company’s hemp-based pharmaceutical, nutraceutical and consumer products, which are all based on their own intellectual property.

Project design and feasibility has begun and the company is targeting the completion of construction by 2017.

“This is an exciting time for life sciences as AXIM establishes a fully ‘green’ agricultural hemp-based biotech manufacturing facility,” said Lekhram Changoer, chief technical officer. “At AXIM, the hemp manufacturing byproducts will be used and result in a net negative carbon footprint that is beneficial to the environment.” AXIM Biotech holds exclusive rights to the world’s first patented cannabinoid release chewing gum and, with it, plans to conduct clinical trials for pain and spasticity associated with multiple sclerosis (MS) set in the EU. The company is focused upon unique proprietary delivery mechanisms for the introduction of cannabinoids (i.e. THC, CBD, CBG, CBN, etc.) and finding solutions for conditions for which there is currently no effective treatment.

Catalent Expands Cold-Chain Capacity at Shanghai Facility

Catalent Pharma Solutions announced plans to quadruple the cold-chain capacity at its existing clinical supply storage and distribution facility in Shanghai, China. The expansion comes in response to increasing demand from domestic and multinational pharmaceutical sponsors and contract research organizations (CROs).

Catalent says expansion work at the site has started and is due to be fully validated and operational by the end of 2015. The facility, which opened in 2013, was the first in China to provide end-to-end clinical supply solutions from clinical supply management, comparator/reference product sourcing, and primary packaging to clinical storage and distribution.

The cGMP site is also validated to support biologics requiring refrigerated and frozen supply-chain management and currently offers controlled room temperature, refrigerated, frozen, and ultra-low frozen storage environments.

The new expansion includes the quadrupling of existing cold-chain storage capacity, as well as new dedicated receiving, dispatch and packaging areas.

The facility is located in the Shanghai Free Trade Zone, close to the Pudong and Hongqiao international airports, and other key transport links across China and the broader Asia Pacific region. As a result, the site benefits from expedited customs and clearance processes, as well as the potential elimination of duties, taxes, and transportation delays.

Catalent has also added further packaging and low-temperature storage capacity to its Singapore facility, citing the need to support secondary packaging and innovative and flexible clinical supply services.

GE Ships Pre-Built Plant to China

As GE ships the world’s largest ready-made biomanufacturing plant to China, the team involved tells us modular facilities are in demand from Southeast Asian governments – and could hold the key to future pandemic treatments.

The prefabricated cGMP facility is the result of a partnership between GE Healthcare and the three year-old Chinese JHL Biotech. The prebuilt modules containing biowaste treatment facilities and clean rooms within a 25,824 sq. ft. (2,400m2) floor space were shipped from Stuttgart, Germany to Wuhan in China’s Hubei province in August. Bioreactors and chromatography equipment are expected to arrive between December and January.

Racho Jordanov, JHL CEO, said the site should be up and running by June – largely because the set-up allows validation to begin before the site has completed construction.

Validation for air conditioning, cleanrooms, and other operational qualifications can begin while the building is still being installed, while engineers in Sweden will remotely perform validate chromatography.

The process is extremely similar to that in JHL’s modular Taiwan factory which has been operating for more than two years. “We’re very familiar with the equipment, it’s just a different size. We know the software and the operating procedure,” said Jordanov.

JHL and GE plan to add a second manufacturing studio and a fill-finish plant to the Wuhan campus. Jordanov said his company has also been in talks to bring the modular tech to Vietnam.

Jordanov told us the pre-built, pre-validated model appeals to states seeking self-sufficient, low-cost pharma production.

“Our goal is to improve the speed to market and cost of the product by innovation, not by saving dollars on labor because we’re in China. We’re in China because the Chinese government requires that we manufacture products in China, even for IND [investigational new drug] submissions. If you want to be in the Chinese market and if you want to be treated as a domestic company, you have to be in China.

“My experience has been that countries that have national healthcare under pressure for the cost of very expensive biopharmaceuticals will try to adopt the technology so they’re not reliant on big pharma in Europe and the US.”

The trend echoes Brazil’s PDP (productive development partnerships) scheme, he said. The government contracts guarantee market share to API and drug manufacturers in exchange for a discount on the goods. “Similar things although not so formalized are happening all over China and Southeast Asia. China is so huge that every province is almost like a country.

“The province where we are [Hubei] is 80 million people. So that’s a good-sized European country. Every government, even the provincial government has an interest in reducing the cost of the imported medication. So we received support from China and Taiwan for being there. I think governments will continue at least for the next ten or twenty years to support the development of biotech in their countries.”

JHL and GE also told us the facilities could be used by governments to prepare for pandemics – a way to “stockpile capacity rather than stockpile a particular vaccine,” as one GE spokesman put it.

“I think it’s feasible to add capacity very quickly in regions of the world where the epidemic is flaring fastest,” said Jordanov.

“I think [modular manufacturing would] be a very useful concept when time is of the essence, because if you look back on history, Tamiflu was the only effective medication for the SARS pandemic; when Roche approached China for supplies, China requested the technology be transferred to China in order to manufacture.”

Almac to Expand Development Capacity

Almac Group is investing £16 million to expand its formulation and analytical development services at Charnwood Campus in Loughborough, a science, technology and enterprise park, with an operational start date targeted for 1Q17. Almac will occupy the formulation development and analytical testing facilities at the site, which will complement development & GMP services offered from its Craigavon NI Headquarters.

The Charnwood facilities were originally designed and built by a global Pharma company as part of its in-house formulation development, clinical manufacturing and analytical testing capabilities. Almac is recommissioning the facilities with operations focusing initially on expanding both non-potent and potent solid oral dose processing, creating approximately 180 new jobs in the next five years.

Graeme McBurney, managing director, Almac Pharma Services said, “As we experience increased client demand for our pharmaceutical development and niche commercial manufacturing services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and capability and further demonstrating our continued commitment to support our global clients in the development and manufacturing of their drug products.”

Pfizer Transfers Vaccine Technology for Production in South Africa

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of a vaccine against pneumonia-causing bacteria, the South African government announced in a Nov. 3, 2015 press release. Prevenar 13, which has proven to be effective in preventing pneumococcal infection in children from six weeks to five years and in adults of 50 years and older, will be manufactured at Biovac's new commercial-scale facility in Cape Town, with production due to start in 2020.

"This demonstration of successful technology transfer with Pfizer is one of the prerequisites for unlocking future technology transfers that will see Biovac becoming the major vaccine manufacturer in Africa," said South African Science and Technology Minister Naledi Pandor in the press release. The Minister said this strategy would alleviate South Africa's continued dependence on imports and the consequent threat to security of supply of essential vaccines.

"Preventing pneumococcal disease is a priority for Pfizer in South Africa,” said Jennifer Power, the South African country manager for Pfizer, in the release. “We have already seen great results since vaccination was introduced and we are pleased to partner with Biovac, sharing best practices, knowledge, and skills to continue to make a real difference for patients. We are confident that this partnership will help ensure the sustainable supply of our pneumococcal conjugate vaccine for patients in South Africa."

Biovac CEO Dr Morena Makhoana said the company is committed to developing and establishing a strong and locally relevant vaccine capability, specifically vaccine process and product development in South Africa. “We believe that this partnership with Pfizer will strengthen our ability to deliver a potentially life-saving vaccine for South African children, as well as accelerate our technological knowledge in vaccine development."

"The launch of the local manufacture of pneumococcal conjugate vaccine is a stepping stone to the ultimate dream of developing our own vaccines on the continent, for the continent," added Health Minister Dr. Aaron Motsoaledi, in the release.

The partnership facilitates technology transfer from Pfizer to Biovac in compliance with international GMP standards. The process involves the formulation (combining 13 different strains or serotypes of Streptococcus pneumonia bacteria) and filling a syringe with this combination vaccine. These prefilled syringes will be a new technology for Biovac. Pfizer will also implement a skills-transfer process that will result in Biovac employees being able to continue with manufacturing the vaccines after the transfer period.

lmac Buys Biocatalysis Partner Arran, Expanding Capacity and Services

Almac has acquired Arran Chemical Company to further grow its biocatalysis services and increase its large-scale intermediates capacity.

The acquisition, financials of which have not been divulged, will see contract development and manufacturing organization (CDMO) Almac bolster its production capacity and biocatalysis services offering, and according to the firm was “the natural step” following a long working relationship with Arran.

“Almac has been working with Arran on multiple projects over the past five years. Our relationship has evolved from a sub-contractor relationship to a preferred partner, leading to a more strategic partnership over the past year,” said VP of Business Development

Denis Geoffroy.

“This acquisition became the natural step as Almac needed access to larger scale capacity to manage the growth of its biocatalysis business but also to gain more expertise in large scale manufacture.”

Arran’s site in Roscommon, Ireland adds a kg-scale lab, a multi-purpose pilot plant and a large-scale manufacturing plant to Almac’s biocatalysis offerings.

“Several biocatalysis processes are already implemented at Arran, now as one company we are planning to continue along the same model and grow both businesses,” Denis said.

Based in Craigavon, Northern Ireland, Almac has been increasing its biocatalysis services over the past few years to deal with demand from pharma customers.

“We have seen a trend from Pharma companies looking more and more for the ‘one stop shop’ model,” Denis explained. “Combining Almac Biocatalysis technology with Arran large scale expertise offers further integration to our client’s supply chain management.”

In 2013 , a partnership with Queen’s University, Belfast, led to the firm being awarded the accolade of ‘outstanding’ by the Knowledge Transfer partnership (KTP), which allowed the CDMO to offer its customers fully integrated services.

And earlier this year, the firm invested a further $7m (€6m) into another R&D venture with Queen’s to discover faster ways of accessing new enzymes with the properties needed for scale-up chemistry.

BASF Begins Production at German Intermediate Plant

Production has begun at a BASF facility in Germany to help feed the growth in pharma demand for specialty amines.

Amines are chiral intermediates used as building blocks for the production of pharmaceuticals, as well as having functions in the construction, automotive, and crop protection industries.

BASF’s new facility in Ludwigshafen, Germany, commissioned in April 2014, has begun production and is set to make around 12,000 metric tons per year of 15 different amines from the chemical firm’s portfolio.

Spokesman Klaus-Peter Rieser would not disclose how much capacity would be dedicated to pharma companies, but said the firm is seeing growth for amine intermediates in the industry.

“BASF expects a CAGR of 5% for specialty amines in strategically relevant markets 2015–2020,” he said.

The firm manufactures around 200 different amines from under its ChiPros brand and says it supplies the world’s most extensive portfolio of such products.

Rieser confirmed this, saying “BASF holds a globally leading position with specialty amines generally, [and] plans to further support the growth of its customers in the pharmaceutical industry globally.”

The site will supply predominantly European demand.

“With the new plant, we are responding to our customers’ growing demand for specialty amines, particularly in Europe,” said Stefan Blank, President of BASF’s Intermediates division.

“We have decades of experience in developing and manufacturing amines and with the current expansion we are extending our global leadership in these versatile intermediates.”

Other BASF amine-making facilities are located in Schwarzheide in Germany, Antwerp, Belgium, Geismar, North America, and Nanjing, China.

Pharm-Olam Expands to Larger Polish Facility

Pharm-Olam International Ltd., a multi-national, full-service clinical research solutions organization (CRO) to biopharmaceutical and device industries, has relocated its Polish location to a larger office to accommodate for its growing staff.

“We have seen a significant increase in interest in running trials in Poland and we are expanding our offices to accommodate the current and future workload,” said Sanjiv Suri, chief executive officer, Pharm-Olam. “When we opened our first operating office in Poland in 1995, we had to convince potential sponsors to place their trials in this emerging country.

Nowadays, Poland is near the top of the list of countries that sponsors know can produce high quality data, on time. Our staff numbers in Poland have increased over the past few years and we anticipate a 25% growth of our staff in Poland to meet upcoming demand.” According to Pharm-Olam’s Poland country manager, Janusz Rupinski, “With a population of almost 40 million people, Poland offers rapid recruitment in most therapeutic areas. When combining the extensive population with experienced investigational staff and the efficient transfer of study supplies as an EU member state, Poland is primed for extensive growth in the clinical trial arena.” Dr. Rupinski said as of September 22, 2015, there were approximately 1,150 Phase I-IV active clinical trials ongoing in Poland. Of these trials there were 396 trials registered in 2014 and 329 in 2015 to date.

PRA Health Opens New Bioanalytical Lab

PRA Health Sciences (PRA) has opened a new, bioanalytical lab in Assen, the Netherlands. The 33,000 square foot facility adds 25% more space than PRA’s previous lab, includes investments in new small and large molecule equipment, and allows for bioanalytical process efficiencies.

The new lab is also located near PRA’s Phase I clinics in Groningen and Zuidlaren, providing access and analysis of time-critical samples and execution of adaptive trials.

“We are proud to offer our clients industry-leading, high quality, high science laboratory services in this new and innovative environment,” said Peter Ketelaar, PRA vice president of Global Bioanalytical Laboratory Services. “The new facility is a testament to PRA’s commitment to excellence and our passion to advance clinical development.”

WuXi PharmaTech Launches Medical Device Testing Services in China

WuXi PharmaTech has announced that its Laboratory Testing Division (LTD) has launched preclinical medical device testing services in China. These services are being offered for Chinese and international clients for their product registration with the China Food and Drug Administration (CFDA) and for Chinese clients for product registration in global markets.

LTD's preclinical medical device testing services in China include a complete portfolio of biocompatibility, microbiology, and chemistry testing services. Major tests being offered include in vitro cytotoxicity; acute, sub-chronic and chronic toxicity; irritation; sensitization; hemocompatibility; implantation; genotoxicity; carcinogenicity; effects on reproduction, including development effects; extractable and leachable testing; and chemical characterization. WuXi has been a leader in providing preclinical and clinical medical device testing services in the United States for many years.

WuXi's operations in Shanghai and Suzhou have successfully passed inspections by the FDA, CFDA, and OECD and audits by many clients for GLP studies. The company has the world-class laboratory and AAALAC-inspected animal facility headed by a highly experienced international management team and staffed by well-trained technicians.

"China's medical device industry is growing rapidly, and WuXi is committed to providing domestic and international medical device companies with the same high quality of testing services in China that we have provided for years in the United States," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech. "This new service offering brings WuXi one step closer to achieving our vision of offering a complete platform of R&D services for global life-science companies."

Roche's Chugai Investing In Antibody Production Capacity

Chugai Pharmaceutical will add 36,000L of antibody production capacity at its plant in Tokyo.

The Ukima site currently has two 2,500 L tanks and four 2,000 L tanks for the production of antibody API, but a JPY 37.2bn ($310m) investment will see the firm – a Japan-based subsidiary of Swiss Pharma Giant Hoffmann–La Roche – add six 6,000L bioreactors, pushing total capacity to 49,000L.

The reactors will be installed from January 2016 and completed in July 2018, and the expansion is to be used for the commercial manufacture of Chugai’s antibody pipeline.

“Chugai currently has several antibody projects under clinical development applying its proprietary innovative antibody engineering technologies,” said Hitoshi Kuboniwa, General Manager of Chugai’s Pharmaceutical Technology Division.

“We are also actively conducting drug discovery research for antibody drugs at our domestic laboratories and Chugai Pharmabody Research, and have several drug candidates close to the clinical phase. In order for us to promptly conduct simultaneous clinical development for these projects, we need to accommodate high-mix low-volume production of multiple investigational drugs.”

On top of the Ukima Site, Chugai also has mammalian cell culture capabilities at Utsunomiya in the northern Kantō region. The site has eight 10,000L stainless steel bioreactors and is the largest biologics production facility in Japan.

UK's Precision Medicine Catapult Plans Six Centers of Excellence

The UK's Precision Medicine Catapult announced the initial locations for its six regional centers of excellence: Belfast, Cardiff, Glasgow, Leeds, Manchester, and Oxford.

The six centers will make up a nationwide network coordinated from Cambridge, with each center acting as a regional hub for precision medicine programs. Each center will establish a physical presence and recruit locally to build teams of experts to collaborate with government, academia, and local healthcare systems and companies.

The Cambridge headquarters will offer expertise in core areas such as data analytics, clinical trials, regulatory affairs, healthcare economics, and business services.

"Project development work has been ongoing across the UK and we will be launching offices and related programs over the coming months," Precision Medicine Catapult CEO John McKinley said in a statement.

The network, launched in July, is partially supported by Innovate UK, a government-funded agency.

Xbrane Acquires Italian Primm Pharma and Signs Iranian Pharmaceutical Deal

Xbrane, a commercial-phase Swedish biopharmaceutical company that specializes in high demand complex generics, has announced the acquisition of Italian Primm Pharma and the completion of a breakthrough distribution deal for its lead complex biogeneric pharmaceutical, Spherotide, with the Iranian company Pooyesh Darou.

Primm Pharma specializes in the development and production of pharmaceutical formulations for slow release injections and has a portfolio of five slow release biogeneric candidates. The lead product, Spherotide, will primarily be used for the treatment of prostate cancer and endometriosis and will be available in emerging markets from mid-2017.

‘With the acquisition of Primm Pharma, we are able to broaden our expertise in the field of high demand complex biogenerics. Primm Pharma has unique expertise in microsphere-based drugs and a lead product, Spherotide, which we believe will become the world's first slow-release biogeneric for a prostate cancer drug,’ commented Martin Åmark, CEO of Xbrane Biopharmaceuticals.

The Primm Pharma acquisition extends Xbrane’s current portfolio to eight development candidates. It reflects the company’s mission to bring affordable biogeneric versions of the latest biological drugs to patients suffering from critical diseases in under-served markets. Xbrane estimates the initial value of this market for its portfolio to be around US$10bn.

Earlier this month, the company signed an agreement with Pooyesh Darou to introduce Spherotide into the Iranian market. ‘We are delighted to have signed this agreement and to work with Pooyesh Darou, one of the leading biotech companies in the Middle East. Pooyesh Darou has an impressive track record of reaching near full penetration in Iran with generic products. Iran is a very interesting market with a population of 80 million, of which more than 90% are covered by publicly funded healthcare. We see it as an ideal first market for our high demand complex biogenerics,' added Åmark.

AstraZeneca Opens Russian Plant

The site in Kaluga will produce around 40 million packs and 850 million tablets for the Russian market

AstraZeneca has opened a $224m manufacturing site in Russia it says is the largest foreign pharma investment in the country.

In 2011 , AstraZeneca pledged $150m (€133m) to build a formulations and packaging manufacturing plant in Kaluga, about 150km southwest of Moscow, saying it wanted to be “in Russia, for Russia.”

Four years on, and with the investment now totaling $224m, the Anglo-Swedish Big Pharma firm has opened the site which – once fully operational in 2017 – will produce around 40 million packs and 850 million tablets for the local market.

According to the firm, this is the largest foreign investment seen in Russia in the construction of a new pharmaceutical facility, and in a statement CEO Pascal Soriot said: “This opening builds on our investments in clinical research and scientific collaborations in this important country and serves to reinforce our long term commitment to Russia.

AstraZeneca is one of a number of Big Pharma firms investing in Russian plants in order to capitalize on the country’s Pharma 2020 program which aims to reduce reliance on pharma imports and encourage local manufacture.

Pharma 2020 was launched by then Prime Minister Vladimir Putin in 2011, who at a conference in Russia last month pushed for industry to rally behind the scheme in order for 90% of medicines taken in Russia to be made locally by 2018.

“As Pharma 2020 is focused on the development of an innovative pharmaceutical industry in Russia, establishing the facility contributes to improving access to socially important medicines for Russian patients,” said an AstraZeneca spokesperson.

Earlier this year, Novo Nordisk opened its first facility in the country – a greenfield insulin plant also in the Kaluga region – while the country has also seen investments from GSK, Teva, and Novartis, all looking to access the Russian market.

Athenex to Construct Two New Plants in China

US-based Athenex, formerly known as Kinex Pharmaceuticals, has agreed with the Banan District in Chongqing, China to build two new drug manufacturing plants, for which Banan will provide the funding for the land and the construction. The specialty oncology pharmaceutical company will equip the facilities.

No financial details have been revealed.

Flint Besecker, Athenex Board Director and Chief Operating Officer, said the expansion allows Athenex to grow its existing high potency oncology active pharmaceutical ingredient manufacturing capacity, which it acquired through the purchase of Polymed/Taihao in Chongqing, China, which is 'capacity constrained'.

The new API plant will be approximately five times larger and add significant capacity, and according to Besecker, is 'an important next step in assembling a world-class global pharmaceutical supply chain in the oncology area and will complement our US-based manufacturing strategy'.

The agreement also establishes a framework for a translational medicine collaboration with the Polytechnic University of Hong Kong, an existing Athenex R&D partner. Athenex announced the in-licensing of the global rights to an innovative oral absorption technology from the Polytechnic University in February this year.

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