PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Shire Opens Facility

Shire’s immune globulin infusion-producing facility will increase the company plasma manufacturing capacity by one third.

The US facility encompasses an area more than one million-square-feet and cost $1.2bn (€1.05bn) to construct.

Based in Stanton Springs, Georgia, the space currently employs 900 staff members, but once the site is fully operational, this will increase to approximately 1,500 full-time staff.

Shire’s immunology portfolio proved key when it released its second-quarter financials, revealing that the segment delivered 13% growth and noting that this included “significant contributions from our subcutaneous immunoglobulin portfolio.”

The output at the facility will be gammagard liquid 10% solution, which is created from human plasma and used to deliver antibodies to patients with primary immunodeficiency.

The US Food and Drug Administration gave the site approval in June to produce the therapy. At the time, a spokesperson for Shire told us that the new site would improve the efficiency of the manufacturing process.

The spokesperson explained, “With fractionation, purification and filling at the same plant, Covington has the potential to increase efficiency and speed in the manufacturing process to bring our plasma-derived therapies to patients faster.”

Plans for the site were originally begun through the company Baxalta, which was acquired by Shire in 2016. Now, Shire stands ready to be acquired by Takeda, meaning that the facility will have changed hands three times in as many years.

Astro Pak Space Coast Cleanroom

Cost: $7 million

Size: 38,000 sq. ft.

Project team: Loyd Contracting Company, Inc.

Astro Pak’s new Florida facility, located just outside of the Kennedy Space Center (KSC), has opened its doors for business in July 2018. The newly renovated facility in Titusville houses an AS9100 and ISO certified contract precision cleaning cleanroom.

The project marks the completion of the process that began when Astro Pak acquired Chemko Technical Services in 2016. Astro Pak supports on-site work at KSC on projects such as the ongoing work at the Mobile Launch Platform (MLP) in support of NASA’s upcoming Space Launch System (SLS), as well as meeting the needs for component cleaning at its cleanroom facility.

The Astro Pak facility houses a 15 ft. x 15 ft. tower with a 70 ft. vertical rise that allows the processing of hoses up to 60 ft. in length. The facility also houses an ISO 7 cleanroom and an accompanying ISO 6 lab joined by a spacious shop area with a 2-ton bridge crane. These facilities are further augmented by large aqueous processing tanks, a pre-clean area with multiple workstations, ultrasonic units, as well as hydrostatic, hydraulic, and pneumatic testing capabilities.

Astro Pak provides precision cleaning services back and processing in a controlled environment, cleanliness verification for particle count, TFS, NVR, vacuum sealed packaging, cold shock, and pressure testing. The facility can accommodate industry specifications including KSC-C-123J, CGA G-4.1-2009, ASTM G-93-03, IEST-STD-CC 1246E, and numerous industry and aerospace cleaning specifications. The facility is further supported by a state of the art cleanroom trailer, which allows for on-site support in addition to the in-house services.

Completion date: July 2018

Orchard to Build Gene Therapy Manufacturing Facility

Orchard signed a long-term lease agreement to build-out an $80m gene therapy manufacturing facility in Fremont, California.

The 150,000 square-foot facility for gene therapy manufacturing will significantly increase Orchard Therapeutics’ footprint in California.

The Fremont site will provide additional current good manufacturing practice (cGMP) manufacturing capacity for lentiviral vector and cryopreserved cell therapy products. Through this increased capacity, Orchard will be able to manufacture and deliver gene-corrected hematopoietic stem cells for a wide range of diseases to the global market.

A spokesperson from Orchard told us, “This new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability.”

The spokesperson further explained, “In terms of lentiviral vector and drug product development, it will also complement the capabilities of our existing vector and drug product manufacturing partners to support the potential launch of our gene therapy clinical product candidates.”

Orchard stated that the new manufacturing facility will increase capacity for the long-term supply of the company’s pipeline for its advanced clinical programs.

The spokesperson told us that Orchard expects to use approximately $80-90m (€70.4-79m) in net proceeds from its recent IPO to fund the design and construction of the facility. However, the spokesperson added that these costs do not include the cost needed to operate the site.

Orchard already has two California sites, one in Foster City and the other in Menlo Park – those two sites oversee the development and validation of the manufacturing of Orchard’s ex vivo product candidates.

Building of the new site is expected to begin in 2019, and the company expects to hire more than 100 full-time employees to support in-house manufacturing.

UPMC Heart and Transplant Hospital at UPMC Presbyterian, Pittsburgh, PA

Size: 900,000 sq. ft.

Project team: HGA (architect)

Pittsburgh’s evolution as a global center of medical science takes a dramatic step forward with UPMC’s investment in visionary approaches to healthcare. One aspect of that future arrives in 2022, with the opening of the UPMC Heart and Transplant Hospital at UPMC Presbyterian. The hospital’s bold architecture will communicate UPMC’s capabilities as a world-class healthcare provider.

UPMC and HGA’s transformative approach to hospital-based care includes using digital technology to simplify treatment and enhance person-to-person connections; providing natural spaces in concert with beautiful architecture to boost the healing power of a serene environment; and creating radically clear patient pathways and planning enhanced by nature and dramatic design.

The design invites patients, staff, families and neighbors to gather, mingle and celebrate at a dynamic urban crossroads overlooking 5th Avenue. The organization and design of patient rooms, work spaces for caregivers, public areas and amenities will draw from the energy of everyday life and the beauty of nature to create a dramatically inviting environment of care. Visitors will experience a natural refuge that offers amenities from retail to dining to wellness classes and more.

The project features a park within the hospital that includes a series of terraced gardens that both honor the site’s historic legacy as a place of “healing on a hill” and conceal important services and functional components. The entire entry experience, public circulation, clinical waiting areas, staff/visitor services and patient floors will enjoy park views and the healing power of nature.

In several places, both public and private, nearly invisible digital technology will be used to benefit patients and staff by creating more time and space to nurture person-to-person connections, and to enhance patient and family understanding of the myriad of healthcare choices.

Private patient rooms will include a continuous direct digital device that spans across walls and ceiling. Through this, rooms can be customized, individualizing the healing experience with scenery or personal photos; opting in to interactive rehabilitation classes; interacting with family from home and including visitors in a virtual physician consultation. Staff will use this interactive interface to access patient vitals, input information and consult doctor orders. This technology frees up floor space, improving the patient experience and staff efficiency.

The hospital will train the first generation of physicians and staff to harness the transformative powers of artificial intelligence. This group will interact with the HGA-designed “holodeck,” a nimble integrated technology space that supports diagnosis, treatment planning, team collaboration, teaching and information retrieval and delivery.

Completion date: 2023

Center for Life Sciences, Holyoke Community College, Holyoke, Mass.

Cost: $4.55 million

Size: 13,000 sq. ft.

Project team: Emily Rabinsky, professor of biology, biotechnology program coordinator; James Knapp, professor of biology; Dan Campbell, HCC director of Facilities & Engineering; Lia Sin Hew, associate, Dimella Shaffer (architect)

The Center for Life Sciences features a suite of new biotechnology classrooms and labs and what is believed to be the only ISO certified cleanroom at any Massachusetts community college; it is certainly one of very few at any college or university in western Massachusetts.

The cost of the project, including new equipment, was covered by a $3.8 million grant from the Massachusetts Life Sciences Center, supplemented by $750,000 from the HCC Foundation’s Building Healthy Communities Capitol Campaign.

The first-floor renovation involved the construction of new labs primarily for biotechnology, genetics and microbiology classes. Once it is fully equipped and operational, the CLS cleanroom will have a certification rating of ISO 8 (air quality of no more than 100,000 particles per cubic foot). Inside the cleanroom there will be a hooded biosafety cabinet where the sterility will increase to ISO 7, or no more than 10,000 particles per cubic foot.

Cleanroom operations are expected to be incorporated into HCC’s credit-bearing biotechnology classes. Later this fall, HCC will also begin offering a new non-credit, professional development course called “Introduction to Cleanroom Technology.”

Grant funds and donations paid for new equipment including a high-end, research grade fluorescent microscope, like those used in the pharmaceutical industry; a micro volume spectrophotometer (used to measure small amounts of genetic material); and an electroporator (for genetic engineering).

Completion date: Aug. 31, 2018

Quotient Sciences Invests in New Facility

Drug development company Quotient Sciences has unveiled plans for a significant expansion to its operations in the U.S. with the opening of a state-of-the-art, 45,000-square-foot facility located near Philadelphia, in Garnet Valley, PA. The $15 million investment will create a center of excellence for early-phase formulation development and clinical trial manufacturing.

The Garnet Valley site will focus on developing small molecule oral drug products, supporting development programs from the preclinical stage through to clinical proof-of-concept. Seamless scale-up to late-phase manufacturing and commercial product supply will continue at Quotient’s nearby Chelsea Parkway facility.

“Our new facility was built in response to increasing customer demand for our early-phase formulation development and clinical trial manufacturing services,” said Mark Egerton, chief executive officer, Quotient Sciences. “The site was specifically designed to optimize our ability to work with highly potent and poorly soluble molecules that dominate the industry pipeline.

“The facility also increases our capacity to provide integrated Translational Pharmaceutics programs in the U.S., which deliver substantial benefits to customers including cost savings and reduced timelines to achieve proof-of-concept.”

The expanded formulation development, analytical and manufacturing capabilities enable biotech and pharmaceutical companies to access Translational Pharmaceutics programs working under an investigational new drug (IND) application. This approach integrates real-time adaptive manufacturing and clinical research. Drug products manufactured at the Garnet Valley facility can be rapidly supplied into global patient trials and clinical pharmacology units, using tailored batch sizes and flexible dose adjustments.

Quotient has comprehensive drug product expertise spanning all dosage forms, from liquids to solids, immediate-release to modified-release, and solubilization technologies including spray-dried dispersions, micronized and lipidic formulations. The new facility is also designed to handle both potent and non-potent products, with six high-potency GMP manufacturing suites.

BASi Expands GLP Tox Facility

Will more than double Mt. Vernon facility’s current capacity for the development of protein-based therapeutics

Bioanalytical Systems, Inc. broke ground on the expansion of its GLP toxicology facility on its 52-acre campus in Mt. Vernon, IN. It’s scheduled to open by the end of 2019, and will more than double the facility’s current capacity for the development of protein-based therapeutics.

“It’s really exciting to see shovels hit the dirt bringing us closer to this much-anticipated, state-of-the-art expansion,” said Philip Downing, senior vice president of preclinical services at BASi. “This upgrade, coupled with improvements we have made during 2018 to our environmental systems and infrastructure, allows us to add the needed capacity to grow the business and meet the needs of our clients, which is paramount, while contributing to the important advancements in research that drive our industry.”

Peter Kissinger, BASi founder and scientific adviser, added, “This expansion better positions BASi to support development of the most modern, targeted therapies for unmet needs in cancer and chronic degenerative diseases. It's an exciting time to see the benefits of decades of basic science now matter for patients."

The company is also in the planning phases for further expansion and added capacity moving into 2020.

In the past year, BASi has also made investments in the company’s pharm analysis lab to enhance its bioequivalence capabilities, bolstered its preclinical PK/PD services with upgrades to its lab in West Lafayette, IN, and acquired the operations of Seventh Wave Laboratories in St. Louis, MO.

Chapman University Opens New Science and Engineering Center

Chapman University’s 145,000 Keck Center for Science and Engineering opens today, Oct. 11, to help prepare students to meet the needs of the physics, medical, and engineering industries.

Designed by AC Martin, the facility emphasizes a cross-discipline approach that includes seven student collaboration areas, 45 research and teaching labs, 50 faculty offices, and an outdoor amphitheater. The design was inspired by Frank Lloyd Wright’s Prairie School architectural style and features transparent walls to provide insight into the work being done within the labs.

Among the Keck Center’s sustainability features are an innovative cooling system to decrease energy use, windows that electronically change tint to control heat and light, and a green roof that recycles 100% of storm water runoff.

BioDuro Opens San Diego Drug Discovery Center

BioDuro LLC, a global life sciences CDMO has established a new drug discovery center for chemistry and biology in San Diego, CA. The discovery unit aims to help drug developers advance into the clinic by allowing researchers to learn more about the chemistry and biology of their drugs earlier than ever before.

The new biology discovery unit features translational oncology and immuno-oncology capabilities centered around high fidelity patient-derived tumor models, such as in vitro 3D human tumor microenvironment (hTME-3DX Screen and Verify), or in vivo patient-derived xenograft (PDX). The site features immuno-oncology capability with development of patient-matched tumor/immune cell models, originating from more than 100,000 viable specimens. Additionally, the San Diego discovery center offers researchers a regional site for oncology studies requiring local capability. These new capabilities complement the company’s existing oncology footprint in Shanghai, including in vitro screening, in vivo cell line-derived xenograft (CDX), syngeneic and PDX.

CMC operations under the same facility provide drug product development, analytical testing and GMP manufacturing for clinical trial materials.

"The addition of the translational oncology site in San Diego allows our oncology clients to study their drugs in real patient-based tumor and immune cell models," said Thomas B. Broudy, EVP Translational Sciences. "These models more accurately represent the clinical population, and that helps our drug development partners to build confident clinical strategies—from cancer type to patient selection to combination approaches."

"San Diego is regarded as one of the largest biotech hubs worldwide, and its geographical location makes it readily accessible to our domestic and international partners," said Cyrus K. Mirsaidi, president and chief executive officer. "Expansion of our San Diego facilities, and growth of our Drug Discovery capabilities, reflects our commitment to providing continuous and innovative service offerings to reduce the time and cost of new drug development."

Particle Sciences to Open New Commercial Facility

Particle Sciences, a Lubrizol LifeSciences company, is opening a new commercial drug product manufacturing facility at the end of 4Q18 at its existing site in Bethlehem, PA. The $60 million investment is part of an overall business unit expansion that's expected to increase employment by 30 percent with jobs ranging from production and quality control positions to support functions such as analytical services.

The 5,000 sq.-ft. facility will leverage Particle Sciences’ complex formulations services and drug product manufacturing, allowing the company to offer customers a range of services from development through to commercial scale manufacturing.

The facility will accommodate both sterile and non-sterile finished drug products, such as ophthalmics, drug-device combination products, injectables, micro- and nanoparticulate formulations and lyophilized drugs.

The new space was purpose-built for more complex drug products and features state-of-the-art utilities to accommodate the production of Water for Injection (WFI) and clean steam for clean-in-place processes.

Dr. Robert Lee, newly-appointed president at Particle Sciences, said “Our new facility will extend our manufacturing capabilities to phase III clinical trial materials and commercial product manufacturing. Present and future clients will benefit from the wide variety of dosage forms that the facility can handle as well as our ability to accommodate the smaller commercial batch volumes that other CMOs will not take on.”

Klöckner Pentaplast’s Pharma & Medical Device Division Will Add to Global Production

Klöckner Pentaplast Announces $25m Investment in Capacity Expansion in North America capacity in North America.

“Our significant expansion plans reflect our dedication to servicing customers’ needs now, and in the future” says Tracey Peacock, President kp PMD. “The additional coating and laminating capability suitable for the production of Pentapharm and Pentamed packaging films will service the North American pharmaceutical and medical device industry. We are excited to support the growing high barrier product segments by investing in best in class coating and laminating capabilities, enabling new performance levels in barrier protection.”

kp PMD is investing $25 million over the next few years in technology and processes to ensure they deliver innovative, functional and safe products for customers. This investment in North America supplement earlier announcements by kp this year, highlighting their capacity expansions in Switzerland and Brazil. kp plans for the new capability in North America to be operational in 2020.

Sarepta Therapeutics Enters into Manufacturing Partnership with Paragon Bioservices

Sarepta Therapeutics has entered into a long-term strategic manufacturing partnership with Paragon Bioservices, which will provide Sarepta access to additional commercial manufacturing capacity for its micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy program, as well as a manufacturing platform for future gene therapy programs, such as Limb-girdle muscular dystrophy (LGMD).

“We are rapidly building a formidable gene therapy engine, the hallmark of which will be the establishment of our Gene Therapy Center of Excellence in Columbus, Ohio. Therefore, it is incumbent upon us to ensure that our ambition is matched with a sophisticated, robust and scalable manufacturing approach that can accelerate a steady stream of gene therapies to treat life-robbing genetic diseases for the near and long-term,” said Doug Ingram, Sarepta’s president and chief executive officer.

“Paragon is one of the few gene therapy manufacturers that has the expertise to develop and successfully manufacture complex biotherapeutics using commercially-scalable processes,” said Pete Buzy, Paragon Bioservices President and CEO. “As this agreement with Sarepta highlights, we have a world-class manufacturing team, we are seen as a center of excellence for gene therapy, and we are trusted by top biopharmaceutical companies.”

Paragon employs approximately 300 team members at two locations in Maryland. Paragon is constructing a new 151,000 square-foot, GMP gene therapy biomanufacturing facility, which will be online in February 2019 and is located in Anne Arundel County. It will include several 500L and 2000L single-use bioreactors for clinical trial and commercial material production. Paragon also has facilities at the University of Maryland, Baltimore (UMB) BioPark where the company currently provides full process, analytical development, and cGMP clinical manufacturing services from its approximately 100,000 square-foot facility. The BioPark facility complies with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) early-phase manufacturing requirements for biopharmaceutical manufacturing. The newly constructed facility is being built to comply with these regulations.

Datwyler Opens First US Production Plant

Datwyler has opened a Delaware, US, production facility that will produce pharmaceutical elastomer components for the biopharma industry.

The facility will be the Switzerland-headquartered company’s third facility, joining First Line plants in Alken, Belgium and Pune, India.

Omni Flex components will be manufactured at the plant, which are used in pharmaceutical containers and pre-filled syringes for biological products.

Further explaining what the technology involves, David Clark, vice president of operations for the Americas, told us Omni Flex provides “a lubricous barrier coating that does not require siliconization prevents interaction with leachables and extractables that could render the drug dangerous or ineffective.

“Omni Flex coated plungers are manufactured using a proprietary, flexible, fluoropolymer spray coating technology. The technology is designed to (1) be an inert barrier and (2) impart a low coefficient of friction for non-siliconized pre-filled syringe plungers,” he added.

The facility cost more than $100m (€87.35m) to construct and will create approximately 120 jobs in the Middletown, Delaware area. With this newest facility opening, the company states that it will be able to increase global First Line production 50% by 2020.

Discussing the location, Clark told us that the Middletown area is situated in a “pharmaceutical hotbed” where many of the company’s customers are located. In addition, he said that the foothold in the US will allow the company to access the largest market for rubber components in the industry and is of “strategic importance”.

In terms of what First Line production facilities offer, Clark detailed how: “The manufacturing concept is based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection, and a unique validated washing process. Furthermore, a zoning concept is implemented. Each zone has been meticulously designed and constructed in order to prevent bio-contamination and is equipped with material and personnel airlocks.”

He went on to detail that the plant is operated under a “zero-defect policy”, and offers the lowest endotoxin, bioburden, particulate, and defect levels available in the industry.

Cambrex Cements North Carolina Presence with Buildings Purchase

Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.

The company will expand its site in High Point, North Carolina, by purchasing a 35,000-square-foot building it is currently leasing, as well as an adjacent 45,000-square-foot building. Both of these buildings will be fitted with kilo-scale and pilot-scale vessels.

This facility expansion is in response to the growing customer requirements for clinical supply manufacturing, according to the company. The center will also work on the development of new technologies and engineering solutions.

A spokesperson for Cambrex said, “This gives us the opportunity to expand, adds additional capabilities and allows us the flexibility to meet future demand for our customers.”

Cambrex acquired PharmCore in 2016, now known as Cambrex High Point, to locate the company on this site.

In April of 2017, Cambrex announced that a $3.2m (€2.75m) construction project was completed on the site. This saw the completion of an 11,000-square-foot analytical laboratory and a new clinical manufacturing suite with 2000-liter reactors and a 0.6-square-meter dryer for clinical APIs.

“In April 2018, we announced a new analytical research & development laboratory, in addition to an investment in new continuous flow technology. In May 2018, we completed a pilot plant expansion at the High Point facility,” said the spokesperson.

In total, Cambrex has invested $5m in renovating the Cambrex High Point site. The company says that the High Point facility produces complex active pharmaceutical ingredients (APIs) and intermediates that require multi-step synthetic processes.

Avexis Expands Gene Therapy Manufacturing Capacity in Longmont, Colorado

Facility to become the largest of four state-of-the-art sites involved in manufacturing of AveXis gene therapies for pipeline of rare genetic diseases including spinal muscular atrophy

AveXis plans to offer positions to all approximately 150 employees previously employed at the site, and to announce further expansion of new jobs in the near term

Investment in the Longmont campus adds to existing $115 million investment in Durham facility, leading to creation of more than 1,000 US-based, high-tech, biologics manufacturing jobs by the end of 2019

Basel, April 1, 2019 -- AveXis, a Novartis company, today announced it signed an agreement to purchase an advanced biologics therapy manufacturing campus in Longmont, Colorado, further expanding AveXis' production capacity as it prepares to launch Zolgensma® (onasemnogene abeparvovec-xioi[1]) an investigational gene therapy awaiting global regulatory approvals for the treatment of spinal muscular atrophy (SMA) Type 1 and for future gene therapy treatments in development.

AveXis currently has a fully-operational state-of-the-art manufacturing facility in Illinois, is building a facility in North Carolina scheduled to be operational in 2020 and is expanding its product development capacity at its San Diego facility. The addition of the six-building Longmont campus consists of nearly 700,000 square-feet of space for biologic drug manufacturing, offices, laboratories, warehousing and utilities. Initial start-up activities in Longmont will include preparing the facility for scaling, manufacturing and testing of gene therapies and hiring staff.

"Our Longmont, Colorado, campus, along with our existing manufacturing sites in Illinois, California and North Carolina, will play a crucial role in helping us achieve the future manufacturing capacity required to meet the global patient need for novel gene therapies," said Andrew Knudten, Senior Vice President, Global Strategic Operations. "We have built a team with exceptional depth of experience, unified by a common mission: to positively impact the lives of patients and families devastated by rare and life-threatening neurological genetic diseases. We are eager to add the talented team in Longmont to AveXis, and we hope that they will choose to join us as we build world-leading manufacturing capabilities in gene therapy."

"AveXis' success requires not just medical breakthroughs, but innovations in R&D and manufacturing. With the opening of our fourth location in the US, we will create more than 1,000 high-tech biologics manufacturing jobs by the end of 2019," said Dave Lennon, President. "AveXis has now established leading technical manufacturing capabilities with the capacity to deliver our robust pipeline, as well as the flexibility to enter into multiple external partnerships as the development and manufacturing partner of choice in gene therapy."

About AveXis:

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, Zolgensma, is its proprietary gene therapy currently in development for the treatment of spinal muscular atrophy, or SMA. In addition to developing Zolgensma to treat SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

About Novartis:

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130,000 people of nearly 150 nationalities work at Novartis around the world.

Novo Nordisk to Build Manufacturing Plant in California

Novo Nordisk announced the establishment of a manufacturing site in Fremont, California, US to develop and produce stem cell-based therapies. The announcement follows the signing of a long-term lease on a good manufacturing practice (GMP) facility, previously operated by Asterias Biotherapeutics.

The site will support Novo Nordisk's increased commitment to develop stem-cell based therapies within type 1 diabetes and other serious chronic diseases. Once operational in 2019, the facility will fulfil the supply of stem cell-based therapies for Novo Nordisk's clinical trial programs.

"Our ambition is to develop stem cell-based therapies for a range of serious chronic diseases where we see significant unmet medical need," said Jacob Sten Petersen, corporate vice president and head of stem cell research & development (R&D), Novo Nordisk. "The reliable, large-scale supply of therapies is a vital component in our efforts, so I am delighted that we have established this facility that further demonstrates our strong commitment to this field."

In addition to the lease agreement, Novo Nordisk has secured a two-year non-exclusive license on Asterias' intellectual property relating to stem cell manufacturing technology. To facilitate collaboration between the two parties and enable Asterias to progress its own clinical programs, Novo Nordisk will sublease laboratory, manufacturing and office space within the facility back to Asterias until the end of 2021.

The establishment of the production site follows Novo Nordisk's announcement in May of an agreement with the University of California San Francisco (UCSF) in which it licensed a technology to enable the generation of GMP compliant human embryonic stem cell (hESC) lines in addition to the rights to develop these into future regenerative medicine therapies. Working in a GMP laboratory at UCSF, the partners are deriving cell lines that are defining a new quality standard in the production of stem cell-based therapies.

Novo Nordisk's R&D in this field is anchored in its recently established Stem Cell Transformational Research Unit, based in Måløv, Denmark. The unit oversees multiple partnership projects pursuing stem cell-based treatments for diabetes, Parkinson's disease, chronic heart failure and dry age-related macular degeneration (AMD). The new production facility will directly support these projects, enabling the future expansion of Novo Nordisk's stem cell research portfolio into the clinic.

Stem cell-based therapy is emerging as a treatment option for a number of serious chronic diseases. It has the potential to provide novel treatments for diseases with high unmet medical needs where no or inadequate therapy exists.

Pluripotent stem cells have an unlimited capacity for self-renewal and the potential to be differentiated into any specialized cell type in the body. The Novo Nordisk stem cell technology platform is based on human embryonic stem cells (hESC) that can be used for generation of cell products for a wide range of therapeutic indications.

Novo Nordisk will take over the lease of a manufacturing facility in Fremont, California, where the company will make stem cell-based therapies with optionally licensed technology.

According to the agreement, Novo Nordisk will pay US biotech Asterias Biotherapeutics $1m (€868m) to sublease the 44,000 square-foot facility through to December 31, 2021.

The site, located in Fremont, California, can be used to manufacture pluripotent stem cells, including human embryonic stem (hES) cells, under current good manufacturing practices (cGMP).

Asterias will maintain access to the site’s manufacturing, laboratory and administrative space during this time, to advance its neurological development programs.

The companies have also signed a $1m option license agreement for Asterias’ intellectual property (IP) relating to culturing pluripotent stem cells, such as hES cells, in suspension.

According to Asterias, the ‘Suspension Culture IP’ “maximizes the production capacity inside a cell culture vessel, allowing for bulk proliferation of hES cells in a more efficient and cost-effective manner, which facilitates commercial production of important products for use in human therapies”.

The announcement marks Novo Nordisk’s most recent investment in stem cell technology, following a licensing deal signed between the Danish firm and the University of California San Francisco in May this year.

According to the agreement, Novo Nordisk will use the university’s technology to generate human embryonic stem cell lines for the development of regenerative therapies.

In addition, last month Novo Nordisk announced plans to restructure global operations, which includes increasing stem cell research in Copenhagen, Denmark.

Contract Pharmacal Expands Campus in Hauppauge, New York

Pharmaceutical company Contract Pharmacal Corp. will invest $40 million to expand its operations in Hauppauge, New York.

According to the Suffolk County Industrial Association, the company plans to acquire and connect a 17,500 square foot manufacturing complex next to its current facility.

Contract Pharmacal would also increase its full-time employee count by about 150 to 1,513.

The IDA benefits include about $3.6 million in property tax breaks over 20 years, as well as sales tax breaks for the expansion. The company will not get tax breaks on the building acquisition.

“The proposed investment will help expand Contract Pharmacal’s manufacturing operations in Suffolk County and add a significant number of jobs to the local economy,” said Tony Catapano, Executive Director of the Suffolk County IDA.

REST OF WORLD

GSK Expands API Manufacturing Facility in Scotland

GSK has opened a manufacturing plant in Montrose, Scotland, where the firm will make APIs for its Ellipta respiratory medicines.

Alongside the firm’s site in Singapore, the £54m ($69.8m) Montrose facility will support the manufacture of active pharmaceutical ingredients (APIs) for a range of respiratory drugs; this includes combination asthma and chronic obstructive pulmonary disease (COPD) drug Relvar Ellipta (fluticasone furoate/vilanterol), also known as Breo Ellipta in the US.

Unlike GSK’s diskus inhaler system, which is used to deliver blockbuster asthma and COPD medicine Advair (fluticasone propionate/salmeterol), Ellipta can hold one or two blister strips, and as such, can be used to deliver drugs containing one or two APIs.

It is not expected that the highly-automated facility will significantly impact headcount. GSK employs around 1,000 people in Scotland, and 17,000 across the UK.

GSK has made a number of investments in Ellipta production since the inhaler received European marketing approval in 2013, including the construction of a £56m manufacturing site in Hertfordshire, UK, which opened in 2016.

According to Steve Dunlop, Scottish Enterprise CEO, the opening is a “fantastic endorsement” of Scotland as a location for business investment.

“Global companies like GSK choose to invest here because we have unrivalled talent to research, develop and manufacture innovative medicines that positively impact lives all over the world.

“We’ll continue to help GSK grow its business locally and nationally to create sustainable and inclusive jobs, and recognize its significant contribution to Scotland’s thriving life sciences sector,” he added.

The news comes weeks after GSK announced plans to reduce headcount at an API manufacturing plant in Ulverston, UK.

According to the firm, a review of the facility prompted its decision to “phase out” the manufacturing of active ingredients for sterile injections at the site – downsizing staff numbers by approximately 200.

Micronclean Building New Cleanroom Laundry in India

The multimillion-pound investment will see the construction of an ISO Class 5 cleanroom laundry service in Bangalore

UK's Micronclean has celebrated the ground-breaking ceremony of its ISO class 5 cleanroom laundry services in Bangalore, India.

The ceremony was the culmination of months of activity in selecting the correct site to be able to tap into India’s rapidly expanding pharmaceutical Industry.

Micronclean said the multimillion-pound investment will utilize its proven process technologies to deliver a GMP compliant cleanroom laundry service that will be unique in India. It will also be an opportunity to develop innovative new technologies that can then be used back in the UK operations.

Simon Fry, Chairman of Micronclean, said: ”We are delighted to have started the development of our Indian laundry after months of planning. We are committed to serving the growing Indian cleanroom market by offering a unique service that will bring quality and efficiency to our new customer base here in India. We see this as a valuable service offering, enhancing the regulatory compliances of the Indian pharmaceutical and biotech businesses.”

Attending the ceremony, British Deputy High Commissioner Dominic McAllister, said: “Micronclean has a product and service portfolio which ranges from laundered garment rental services for high-tech/pharmaceutical companies, to cleanroom supplies which are exported to over 30 countries worldwide. I welcome Micronclean’s entry into Karnataka."

McAllister added: "This is another example of UK industry support for ‘Make in India’. UK investment into India is strong and growing; the UK has been the largest G20 investor in India and third largest investor overall (after Singapore and Mauritius) since 2010.”

Micronclean is the largest privately-owned laundry company in the UK employing over 450 people and has been owned by one family since 1929, tracing its heritage back to the Skegness Steam Laundry in 1883.

Merck Kgaa Renovates Global HQ With Opening Of Packaging Center

Merck KGaA held an opening ceremony at its new packaging center based within its headquarters in Darmstadt, Germany.

The new packaging center is approximately 162,000-square-feet of space, to be used for packaging and shipping the company’s current pharma portfolio to more than 90 countries.

Merck said that the site will also provide capacity for potential future pharma products currently in clinical development, such as evobrutinib in the area of neurology-immunology or tepotinib in the area of oncology.

An opening ceremony was attended by Stefan Oschmann, CEO of Merck KGaA, as well as Stefan Grüttner, minister of social affairs and integration for the German Federal State of Hesse, and Jochen Partsch, mayor of the city of Darmstadt.

According to the CEO in a press release that Darmstadt is the hub for the company’s manufacturing and it plans for future growth.

The new facility has eight fully automated packaging lines and robotized logistics, with the capacity to process over 210 million boxes of medicines per year. The design includes the incorporation of technology for tracking & tracing, and smart packaging to ensure that production can be adapted to patient demand.

Merck’s new pharma packaging center comes after an investment of €63m ($82.8m) from 2015-2018 and is part of a wider €1bn investment up to 2020 to renovate the company’s global headquarters.

Hovione Increases Production Capacity

New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment

Hovione has announced plans to increase production capacity in oral dosage forms at its Loures site, in Portugal, to strengthen its integrated offering.

As a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from drug substance to drug product.

Hovione's ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. This increase in capacity will help Hovione customers to consistently bring products faster to market.

Frédéric Kahn VP of Marketing and Sales at Hovione, said: “Hovione has a unique value proposition when it comes to processing amorphous solid dispersions. Our company has more than 15 years of experience in pharmaceutical spray drying and has produced hundreds of batches for clinical trials and commercial supplies."

"Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value added services they expect from us. They want to keep their product in the same capable hands. This investment shows our commitment to listen to our customers and continue to support their evolving needs,” said Kahn.

In parallel Hovione will be completing by the end of 2018, the qualification of its continuous tableting line at Hovione New Jersey, which will enable the site to offer end-to-end solutions for US customers that are keen to keep their supply chain local.

The capacity expansion program started in 2016 and will continue in the coming 5 years. In the first 2 years, Hovione has relocated its development services to a new center with 7000 m2 in Lisbon, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds.

Locally, the Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. Increasing the spray drying capacity at the site and starting the operation of a new drug product center equipped with oral dosage form and inhalation manufacturing capabilities.

In New Jersey, Hovione doubled the size of its development and manufacturing operations. In Cork the company also expanded its chemical synthesis capacity devoted to contract manufacturing.

Jost Chemical Starts Construction on Manufacturing Site in Poland

The new facility producing high purity salts will be located in Kościan, Poland

Jost Chemical manufactures high purity chemicals for the pharmaceutical, biopharmaceutical, nutrition and clinical nutrition industries.

The new 4600 m2 building will be strategically located in Kościan, Poland, with 3.523 hectares of land, the plant can be expanded to add more production capacity in the future.

Upon completion, the new facility will become a part of Jost Chemical’s integrated global network. This facility will produce high purity specialty salts intended for the pharmaceutical, biopharmaceutical, nutrition and clinical nutrition industries.

“The Jost team has built a solid reputation for superior product quality, thus our international customers have asked us to expand our footprint,” stated Jeff Lenger, Director of Sales and Marketing.

“To capitalize on this success, we are expanding our presence in Europe to ensure that we are well positioned to meet future growth projections in the region and maintain our high level of responsiveness.”

Jerry Jost, President, commented: “We are excited to expand our presence in Europe. We currently employ more than 300 team members and see our ongoing growth as a testament of our employees’ dedication and commitment to delivering top quality on time. Jost has a culture built around problem solving and collaboration.”

Construction for the new facility began in September 2018 with completion expected in the third quarter of 2019.

MSD’s Biologics Manufacturing Facility, Swords, Ireland

In February 2018, US-based pharmaceutical company MSD announced its plans to develop a new biologics manufacturing facility in Swords, Dublin, Ireland.

To be named ‘MSD Biotech, Dublin’, the new plant is part of the company’s plan to invest $12bn over a period of five years in capital projects. MSD plans to invest $4bn in Europe and $8bn in the US.

Construction of the new biologics facility will commence in 2018, and it is expected to open in 2021. The facility will play a crucial role in the development of MSD’s biologics-based therapies.

The project is expected to generate between 700 and 1,000 jobs during the construction phase, as well as 350 jobs during operation.

MSD’s new biologics facility will be developed on an existing pre-owned 15-acre site in Swords. The site formerly housed MSD’s women’s healthcare manufacturing business, which was transferred to the Netherlands in 2016. The site is also located close to the M1 and M50 motorways and the Dublin airport.

Ireland was selected as a location for the development due to an availability of skilled labor and high standards of operations.

The existing 31,700m² facility will be expanded to a gross floor area of approximately 43,700m². An existing 13,000m² warehouse will also be extended and transformed for manufacturing operations.

New laboratories and warehouse will be built and the existing production and packaging facilities at the site will be extended.

“New laboratories and warehouse will be built and the existing production and packaging facilities at the site will be extended.”

The facility will produce various therapeutics, including immune-oncology treatments and mammalian cell culture-based protein therapeutics. One of the key drugs planned to be manufactured at the new facility is MSD’s oncology drug Keytruda (pembrolizumab).

Having gained an increased number of approvals for multiple indications for Keytruda since its first US Food and drug administration (FDA) approval in 2014, the company has seen substantial growth in its sales. The firm decided to increase its production to meet rising demand.

Keytruda is currently being produced at its facility in the Netherlands and contract manufacturing facilities located in Germany and the US.

PM Group and Jacobs Engineering were appointed as consultants for the project, while HDS Energy was subcontracted to design, manufacture and install a steam plant energy facility at the Swords location in August 2018.

HDS Energy will also supply all the equipment needed for running the steam energy plant.

Known as Merck in the US and Canada, MSD has been present in Swords since 1990.

Ireland serves as a strategic location for the company for the manufacture and supply of pharmaceutical and biotechnology products for the global market. In Ireland, MSD operates facilities in Dublin, Cork, Carlow and Tipperary, employing more than 1,800 people.

MSD has invested in excess of $2.5bn over the past 50 years to expand its facilities in Ireland. Besides the new facility, the company has announced an investment of €280m ($325.8m) in the Carlow and Cork manufacturing sites in May 2017.

Chinese Firm Plans ‘First-In-Class’ Biologics After Manufacturing Investment

The second phase of Changzhou Qianhong Bio-pharma manufacturing project sees a further ¥1 billion devoted to increasing tablet and injection production.

The Chinese company announced that the expansion of the project is with the aim to create its own first-in-class biologic drugs – targeting developing treatments within oncology, cardiovascular and cerebrovascular

Phase one of the project saw the creation of a ¥1.2 billion facility that produces pancreatic kininogenase, heparin sodium and low molecular weight heparin, as well as compound digestive enzyme preparations and asparaginase. In 2017, the facility had sales revenue of ¥1 million.

The ¥1 billion ($145m) investment will see Changzhou Qianhong Bio-pharma add the production capacity to create 200 million tablets and 60 million injections at its facility. In addition, the facility will be able to produce molecular diagnosis reagents.

Products manufactured at the phase one facility are exported to more than 20 provinces across China, as well as international markets.

The investment comes amid an increase in the scale of China’s biologics manufacturing capabilities.

Internally, WuXi Biologics has begun a number of build-outs, which CEO, Chris Chen, told us is required to meet the growing demand for the manufacture of biologics. While companies based outside of the country, such as GE Healthcare and Sanofi, are also tapping into the potential of the Chinese market.

Sun Pharma Adds Sterile Manufacturing Line in Guwahati, India

Sun Pharma has installed a parenteral drug production line in Guwahati for the manufacture of sterile products.

According to the firm, the Rs 120 crores ($1.6m) investment will enhance Sun Pharma’s capacity to manufacture lyophilized vials, liquid ampoules, and eye drops at the 14-acre Guwahati site.

Located in India’s eastern state of Assam, the Guwahati facility also houses granulation, tablet compression, and capsule filling capabilities.

Sun Pharma’s managing director, Dilip Shanghvi, said this latest investment responds to a governmental push for increased industrial activities and employment opportunities in Assam.

“Sun Pharma is committed to the government’s ‘Make in India’ initiative,” Shanghvi told delegates at the production line launch.

“In the next few years, the Guwahati plant is expected to become of the largest facilities in our network to manufacture sterile products,” he added.

Despite manufacturing setbacks in Gujarat and Halol earlier in the year, Sun Pharma recently announced regulatory success in the US for two separate drug products.

In August, the firm launched its extended-release Kapspargo Sprinkle drug product for the treatment of hypertension, angina pectoris or heart failure.

The following month, Sun Pharma announced its eye disease treatment, Cequa (cyclosporine ophthalmic solution) had received US Food and Drug Administration approval.

Mammalian Plant Growing Asian Client Base, Says AGC

AGC Biologics has announced plans to build a mammalian cell culture facility in Japan, where the company says demand is growing for antibody-based therapies.

The current good manufacturing practice (cGMP)-compliant site will be added to AGC’s Chiba plant near Japan’s east coast. Operations are expected to begin in the third quarter of 2019.

According to the contract development and manufacturing organization (CDMO), the site will help serve a growing customer base in Asia.

“We have observed growing interest and demand from Japanese biopharmaceutical companies,” confirmed spokesperson Bob Broeze, adding that the facility will serve as a “a convenient option for the manufacture of protein therapeutics for Asian companies, as well as US and EU companies that seek production in Asia.”

Broeze did not disclose the cost of the facility, nor which vendor will supply its equipment.

AGC Biologics – born out of the integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics – has made a number of recent investments across its network.

In March this year, the firm announced plans to build new headquarters in Washington, US, and in August, released details regarding a manufacturing capacity expansion at a facility in Copenhagen, Denmark.

eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.

The clinical stage immunotherapy company will open a current good manufacturing practice (cGMP) facility to further work on its mRNA-based TriMix platform, which includes three mRNA encoding proteins that are used in its immuno-oncology products.

Wim Tiest, a spokesperson for eTheRNA, told us that the opening of this manufacturing facility will be a milestone in the implementation of the company’s strategy to develop TriMix-based immunotherapies. The TriMix platform was developed at the Vrije Universiteit Brussel (VUB) Laboratory for Molecular and Cellular Therapy.

He told us that TriMix gets its name because it is composed of three mRNA’s. The company has to ensure that these mRNA’s are in order, to implement them in its clinical development program.

eTheRNA states that it is one of the few companies that is capable of supplying mRNA of the quality required for clinical investigations, deciding to control the supply for its own clinical trials itself.

“Chairman Russell Greig confirmed that is quite unusual for a biotech to invest so heavily in manufacturing at this stage, which illustrates the particular situation and underlines the strategic importance,” said Tiest.

Tiest continued, “The €5m ($6.6m) investment in the mRNA production facility represents a commitment to the region from where eTheRNA is operating. Employment at eTheRNA has grown from 10 employees in 2016 to 44 today, of which about half are involved in the mRNA production and related activities (the other half are involved in research and development, with some general administrative functions as well).”

The new facility will have the capacity to manufacture up to 39 mRNA batches per year which should allow for the enrollment of an estimated 100 patients in clinical trials per year.

Chanelle Pharma Invests €86m

As part of the investment, Chanelle Pharma will build a €11m manufacturing facility for liquid generic products in Galway, for export to the US.

Ireland’s largest indigenous generics manufacturer announced the €86m ($99m) investment program at CPhI Worldwide this week.

According to the traditionally animal-focused firm – which entered the human pharmaceuticals space in 2000 – €50m of the investment will be dedicated to the research, development, and manufacture of human medicines.

Chanelle Pharma will build a €11m manufacturing facility in Galway, on Ireland’s west coast, to make liquid generic drugs for the US market, and spend €45m on R&D over the next five years, owner Michael Burke told us in Madrid, Spain.

Our human medicine business is responsible for around 50% of the firm’s annual turnover, he said, adding: “We have approximately 500 people employed and a strong pipeline in human pharmaceuticals – we hope to launch 55 products within the next five years.”

The company also plans to add 350 jobs during this time: “We have expanded our staff by over 70 people in the past 12 months, and have 91 vacancies at the moment in the company.

“The positions will be largely R&D focused, but will also include roles in quality control, quality assurance, production, and tabletting,” we were told.

Although headquartered in Ireland, where all manufacturing takes place, Chanelle Pharma has offices in the UK, research laboratories in Ireland and Jordan, and exports its products to 96 countries.

The firm also undertakes contract manufacturing of generic drugs in solid dosage forms, liquids and powders for pharmaceutical companies worldwide.

“We export the majority of our drugs,” Burke told us. “Our main strategy is to develop products and link with multinational and big generic companies that sell our products under their brand name.”

While he did not disclose identities, Burke did tell us Chanelle does business with the top ten generic companies – with approximately 75% of products being sold in Europe.

And how might the UK’s impending withdrawal from the EU impact this strategy? “We’re not particularly worried about Brexit,” he said. “It’s such a pity it’s happening; we’d love to see the UK as part of the European market.”

Arran Chemical Company Completes Stage II Of Its Strategic Plan “ADAPT”

Irish based Arran Chemical Company, has responded to client demand for the provision of fine chemicals, pharmaceutical intermediates and advanced building blocks by implementation of its three stage ADAPT (Arran Deploys Advanced Production Technologies) strategy through a multi-million Euro investment.

The investment is focused around increasing capacity, further application of its selectAZyme biocatalysis technology and implementation of flow chemistry. Arran is proud to announce the completion of Stage II of the strategy and the positive benefit to its global client base.

Following acquisition by the Almac Group in November 2015, Arran has completed a sustained program of investment in people and infrastructure to meet growing product diversity and production demands.

As reported in 2017, Arran’s manufacturing plant assets have been upgraded bringing total manufacturing capacity to approximately 85 m3 with vessels ranging from kilo laboratory scale to 8 m3. The final phase of investment will involve the introduction of specialist flow manufacturing technologies.

“With the completion of Stage II of our ADAPT strategy, we deliver on our promise to our clients to offer solutions which are economically sound, safe, scalable and high quality through the application of new capacity and enzyme technology.” said Prof Tom Moody, VP Technology Development and Commercialisation, Arran Chemical Company.

“We are determined to remain at the forefront of innovation to ensure our customers receive best-in-class solutions with uninterrupted supply. This will be further augmented with the initiation of Stage III and subsequent build of flow chemistry capabilities.”

IDIFARMA Adds Spray Drying for Highly Potent Drugs

GEA Niro Mobile Minor equipment up to Category 4 OEL/OEB now operational

IDIFARMA, a Spanish CDMO that specializes in niche and highly potent products, has added a spray drying service with the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its 4,000 sq.-ft. EU GMP plant. The equipment is now installed and qualified and will give Idifarma spray drying capacity for niche commercial products and clinical batches.

This follows a recent investment in both serialization and capsule filling capabilities.

Luis Oquiñena, general manager and co-founder of Idifarma said, “We are at the forefront of spray drying technology, providing contract manufacturing services for intermediate products and for oral solid drugs through to finished dosage forms. This is the latest strategic investment for Idifarma and is driven by significant client demand as the market looks for spray drying solutions to improve the bioavailability of poorly soluble drugs. Idifarma is proud to support our customers’ spray drying projects at different scales and contribute to accelerated drug development and manufacturing timelines.”

Oquiñena added, “We recently reported another successful inspection by Spanish authorities which means Idifarma will continue to offer EU GMP manufacturing and analytical services to our clients. Combined with our continued investment in new technologies this reflects our ongoing success within the CDMO market and our intent to further grow our business with specialized capabilities.”

Lonza Expands HPAPI Capacity

Lonza has expanded its highly potent API (HPAPI) capacity to support antibody drug conjugate (ADC) payload manufacturing. This HPAPI expansion encompasses two new manufacturing suites capable of handling compounds with occupational exposure levels down to 1ng/m3. The strategic ADC expansion allows the company to develop and produce all components of this growing cancer treatment: cytotoxic payloads, antibodies and the required linkers. The HPAPI and ADC payload expansion is expected to be on-line by the end of 2019.

The first of the two new HPAPI suites specifically supports a global biopharmaceutical partner by securing the long-term supply of highly potent ADC payloads. The second suite will be available to other customers for similar HPAPI and payload development and manufacturing programs. The expansion also increases Lonza’s capabilities to provide fully scalable HPAPI and ADC solutions from lab to commercialization, to help support the accelerated timelines that many drug programs in this category require.

“By ensuring critical supply for the treatment of cancer patients, we are supporting one of our global partners in the oncology field,” said Maurits Janssen, Head of Commercial Development of the API Business Unit at Lonza Pharma & Biotech. “Oncology continues to be the leading indication in biopharma and the main driver for bioconjugates. We continue to increase capabilities and capacity to meet the HPAPI development and manufacturing needs of our partners.”

“Our customers developing highly potent medicines need a partner whom they can trust to handle these toxic substances and to deliver in sync with their needs, whether for clinical or commercial supply,” said Gordon Bates, President Chemical Division at Lonza Pharma & Biotech. “Combined with our expertise in biologics development, manufacturing, bioconjugation and sterile fill/finish, this new capability will offer further solutions for companies developing complex therapies.“

Rentschler Fill Solutions Granted GMP Certificate

Rentschler Fill Solutions GmbH obtained the certificate of GMP compliance and the pharmaceutical manufacturing license for the European market from the Austrian Agency for Health and Food Safety on August 20.

Rentschler Fill Solutions offers the international biotech and pharmaceutical industry specialist fill and finish services which range from GMP-compliant aseptic filling and freeze-drying to extensive analytics.

Onsite, at the fully dedicated contract development and manufacturing organization, pharmaceutical and biopharmaceutical products are filled in vials of 2 to 50 ml for clinical and commercial use. The facility is designed for the flexible handling of small to medium sized batches of up to 60,000 vials and provides lyophilization capacity of 15m². Single-use equipment guarantees maximum product safety. Clients profit from comprehensive in-house testing, monitoring and analytics. The facility is designed to enable future expansion without interrupting ongoing operations.

“Rentschler Fill Solutions is a modern, forward-thinking fill and finish specialist with a high level of experience and process know-how, through every stage from the first clinical phases through commercial excellence. By designing the best and most efficient solutions for each drug product, we support our customers in achieving their goals,” said Reinhold Elsaesser, an executive manager of Rentschler Fill Solutions.

New CSL Behring Pharma Facility

XFLAM fire performance panels from Askin Performance Panels were specified for the new $64 million facility built for CSL Behring in Broadmeadows, Victoria. Designed by A5 Architects and built by Cockram Construction, the new facility was added as an extension to the existing premises to help meet the growing demand for its global critical care therapy.

A5 Architects specified Askin’s XFLAM fire performance panels for the external facades, internal walls, ceilings and pharmaceutical cleanrooms. Askin worked closely with Cockram Construction to install 23,900 square meters of XFLAM insulated panels.

A5 Architects Director Raymond Kenyon said, “Askin have a proven record with pharmaceutical cleanrooms and sterile environments, and their experience made it a logical choice for specification. One of the deciding factors in working with Askin products is the XFLAM panel. It has great insulating and strength properties, but most importantly its accreditations and fire performance mean our clients are easily approved for insurance, making life easier for everyone.”

Given the sheer size and detail of the project, there were several challenges. Continuous design changes meant responsive drafting and product manufacturing, while flexibility of site resources was an important factor in the project’s success. Effective communication onsite regarding site access and product movement was imperative since there were more than 150 tradespeople working at the same time, all with their own milestones.

To ensure the structural integrity of connections in the highly complicated design, Askin’s engineering resource was used throughout the build.

Askin provided a combination of complex airtight cleanrooms, with high-performance joints and connections to ensure a completely clean facility. All lighting and mechanical services were concealed, recessed and sealed off to meet client specifications of no visible mechanical fixings.

Additionally, custom-made door frames, stainless steel framed rapid clean doors, sliding doors, and ultra-clean single and double-glazed windows were specifically manufactured to suit the pharmaceutical environment.

Concealed fixings and flush finishes in all Askin door and window products allowed for ease of cleaning and sanitization in a highly sensitive cleanroom space.

A blend of XFLAM exteriors was used for the external cladding in both vertical and horizontal applications. The design created depth and shadow throughout the elevations while complementing the CSL brand.

The newly completed expansion of CSL Behring’s world-class manufacturing facility allows them to double the output of an in-demand blood plasma product for patients facing major surgery, trauma or serious infections and burns.

Ronald Schack, Project Manager – Cockram Construction Australia says, “It’s always great working with a group of people with a common goal and working with the Askin team was no exception on our CSL Behring project. Quality outcome focused, backed by support for design and delivery was what we wanted in a partner, and that’s what the Askin team delivered. It was a pleasure to work with a company whose values, performance and approach align with our own. It’s been an excellent outcome for all.”

Catalent Invests at Aprilia, Italy Facility

Catalent Pharma Solutions has completed the first phase of a $7.3 million investment to upgrade and expand its packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy.

The first phase, completed in August 2018, expanded and upgraded the facility’s integrated packaging capabilities, and commissioned the first of five new softgel encapsulation lines. The second phase to add a further four encapsulation lines, will bring the total number of lines to 23 and significantly expand production, drying, and inspection capacity for nutritional supplements and beauty softgels at the site. These four new lines are expected to be fully operational by January 2019.

“We have a long and proud history in softgel product development and commercial manufacturing,” commented Dr. Aris Gennadios, president of Catalent Softgel Technologies. “This investment is driven by increasing demand for nutritional and beauty products globally, and will enable Catalent to better serve these markets.”

BeiGene Biologics Manufacturing Facility, Guangzhou

BeiGene Biologics is developing a new biologics manufacturing facility in Guangzhou in the Guangdong province of China.

BeiGene Biologics is a joint venture under an agreement signed in March 2017 between BeiGene Hong Kong (95%), a subsidiary of BeiGene, and Guangzhou GET Technology Development (5%), which is an affiliate of Guangzhou Development District (GDD). The company will develop the facility through its subsidiary BeiGene Guangzhou Manufacturing.

The JV will provide financing for the research and development (R&D) of biologics in China in addition to developing the new facility. The total investment in the new facility and R&D is expected to be RMB2.2bn ($330m).

Construction of the facility was initiated in October 2017 and the first phase is expected to be completed and operational in 2019. The new facility will promote high-quality, large-scale manufacturing to increase biologics production and meet the growing demand for BeiGene’s products in the Chinese and global markets.

BeiGene’s biologics manufacturing facility will be located in Sino-Singapore Guangzhou Knowledge City (SSGKC) in GDD in Guangzhou. GDD is one of the initial 14 national economic and technological development zones that were approved by the state council in 1984.

The SSGKC is located roughly 35km away from the Guangzhou city center and 25km from Guangzhou Baiyun International Airport. It covers 123km² of land, with a start-up area of 6.27km². The SSGKC is aimed at attracting knowledge-based industries, including artificial intelligence, biotechnology and clean technology.

The new facility is expected to enhance the development of the biotechnology industry in the region while promoting its economic growth.

The new biologics facility will be a 24,000l commercial-scale facility developed on a 100,000m² site. It will use GE’s KuBio™ FlexFactory pre-fabricated manufacturing line to manufacture biologics.

“General Electric was contracted to supply its state-of-the-art KuBio™ bio-manufacturing equipment for the new facility.”

The KuBio™ is a single-use configurable modular factory, which bolsters upstream and downstream bioprocessing efficiency at reduced costs. It delivers a prefabricated facility with a ready-to-use production line within 18 months, which is less than the traditional time period of approximately 24 to 36 months. The prefabricated modules can be easily assembled at the site into a functional bioprocessing facility.

The new facility will use genetically modified cell line co-developed and licensed from Boehringer Ingelheim as the core raw material for manufacturing biologics.

BeiGene Biologics will contribute RMB200m ($30m) and GET will contribute RMB1bn ($150m) for the development of the biologics manufacturing facility. GET’s contribution includes cash in equity investment of BeiGene Biologics and a shareholder loan, which may be converted into equity of the JV.

The company has also borrowed RMB1bn ($150m) from a commercial bank for the construction and operation of the facility.

In addition, the Guangzhou government will provide support in the form of funding and providing the right business environment for the development and operation of the facility.

BeiGene awarded the procurement and construction contract to Cockram, while PM Group is responsible for providing site master planning and engineering design services.

PM Group is collaborating with EDRI, a local design institute, to complete the project.

General Electric was contracted to supply its state-of-the-art KuBio™ bio-manufacturing equipment for the new facility.

Boehringer Ingelheim’s Biopharmaceutical Production Facility in Vienna, Austria

Germany-based pharmaceutical company Boehringer Ingelheim is constructing a new large-scale cell culture (LSCC) facility at its site in Vienna, Austria.

Boehringer announced plans to construct the new production facility in December 2015, with an estimated investment of €700m ($746m). Construction started in April 2017, while operations are scheduled to begin in 2021.

The investment is part of Boehringer’s strategy to expand and strengthen its biopharmaceuticals network. It will enable the company to respond to the rapidly growing demand for biopharmaceuticals.

The project is expected to create more than 500 new jobs in Vienna.

The new biopharmaceutical production facility is Boehringer’s first expansion project at its Vienna site and will include an energy center, a biopharma logistics center and a biopharma production and quality building.

The facility will be used to produce active ingredients using cell cultures and will be capable of handling capacities of more than 150,000l. It will also be Boehringer ’s fourth plant to handle cell culture technology, alongside the Biberach (Germany), Fremont (US), and Shanghai (China) sites.

“The new facility will develop biopharmaceutical medicinal products for contract manufacturers and expand biopharmaceutical production in the region.”

In addition, the new facility will develop biopharmaceutical medicinal products for contract manufacturers and expand biopharmaceutical production in the region.

Boehringer is currently producing medicines at the Vienna site using micro-organisms such as yeasts and bacteria. The new facility will be the first to use cell culture technology at the Vienna site.

During its civil engineering phase in July 2017, the project required the excavation of 6,900 truckloads of material.

Boehringer completed the roof of the biopharma production and quality building in September 2018. Construction of the energy center is expected to be completed by the end of 2018.

Special equipment is being used for construction, including six rotary drilling rigs, two diaphragm wall units, five rope excavators and ten tower cranes with lifting heights ranging from 30m to 83m.

Boehringer Ingelheim selected German construction company PORR Bau as the main contractor for the project under a €20m ($21.4m) contract. Work includes foundation engineering, dense construction pit enclosure, earthworks and other civil engineering activities.

Precast concrete elements provider Peikko Austria was awarded a contract to supply corbels, beam shoes, composite beams and other connection items.

Austria-based civil engineering services provider AXIS Engineering Services is leading the structural design of the new facility, while Architect Podsedensek is handling the architectural design works.

Austrian pre-fabricated concrete products manufacturer Franz Oberndorfer is supplying precast elements for the plant.

Wolf Theiss has been appointed as legal advisor to Boehringer Ingelheim for the planning and construction contracts of the project.

Marketing commentary on Boehringer Ingelheim’s Vienna site:

Boehringer Ingelheim’s Vienna site is responsible for the development of prescription medications and veterinary drugs in Austria. It also serves as a cancer research and biopharmaceutical research center.

The Vienna site houses the Research Institute of Molecular Pathology (IMP) facility, which was opened in March 2017. It also houses Boehringer Ingelheim’s contract manufacturing business, BioXcellence™.

The site currently employs 1,629 people, which is expected to increase to 2,100 upon completion of the new facility.

Boehringer Ingelheim’s New Tablet Production Facility, Ingelheim

Pharmaceutical company Boehringer Ingelheim is constructing a new tablet production facility in Ingelheim, Germany.

A ground-breaking ceremony for the facility was held in August 2018.

To be 100% financed by Boehringer Ingelheim, the plant will cost an estimated €85m ($97.2m). Upon completion in 2020, it will employ more than 75 people.

Boehringer Ingelheim will produce innovative drugs at the new facility for launch in the global market. All the contractors to be hired will be based in or around Ingelheim.

Construction of the new facility marks one of the many new investments announced by Boehringer Ingelheim in 2018 to increase its research and development (R&D) and production capabilities. The company is also developing a €230m ($266.4m) biologicals development center (BDC) within its Biberach site in Germany.

Boehringer Ingelheim also announced plans to develop two facilities in France, including a €200m ($235m) production center for veterinary health in July 2018 and a €65m ($80m) avian vaccines production facility in April 2018.

Boehringer Ingelheim’s new tablet production facility will be located in the town of Ingelheim, which is located in the Mainz-Bingen district of Rhineland-Palatinate.

This state was chosen due to its thriving chemical and pharmaceutical industry, which generates one of the highest turnovers in the region and is an important driver of economic growth.

Also known as Solids Launch facility, the project will develop new manufacturing techniques for tablet preparations and produce them for launch worldwide. It will enable Boehringer Ingelheim to keep the entire value chain of research, development and manufacturing within Germany.

“The development is part of Boehringer Ingelheim’s strategy to focus on innovative and flexible technologies and processes.”

The new production facility will be equipped with a contained production train to handle highly potent compounds. It will also feature a flexibility-driven layout, which will enable rooms and equipment to be rearranged as required in order to quickly start production by the anticipated time. Highly complex production technologies such as continuous manufacturing will be used at the facility.

The development is part of Boehringer Ingelheim’s strategy to focus on innovative and flexible technologies and processes. The company plans to move the production of older drug forms to its other facilities located worldwide.

Boehringer’s Ingelheim site is considered to be one of the largest pharmaceuticals production sites in the world. The facilities are engaged in pharmaceutical production and packaging.

In 2017, a €34m ($40m) diabetes medicines production facility was developed at the site for manufacturing novel antidiabetic agents. Following the new development, Boehringer plans to relocate production of diabetes drugs to other countries such as Mexico and Greece by 2020.

Ingelheim is also home to a packaging center developed with an investment of €49m ($69m). The facility comprises 14 packaging lines with a production capacity of more than 250 million medicine packages a year.

In addition, the Ingelheim site houses an office building named BI5, which is one of the company’s biggest administrative offices. It is designed to conserve energy and minimize its carbon footprint.

Founded in 1885, Boehringer Ingelheim is one of the 20 biggest pharmaceutical companies in the world. Headquartered in Ingelheim, Germany, the company is engaged in the development and manufacture of human and veterinary pharmaceuticals.

Boehringer Ingelheim manufactures a range of prescription medicines for cardiovascular, diabetes, oncology, respiratory and central nervous system (CNS) disorders, as well as consumer healthcare and animal health products.

The company operates through 181 subsidiaries and employs more than 50,000 people across all its facilities.