PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Newage Industries/Advantapure Using New Cleanrooms for Products

Following nearly two years of planning, preparation, construction and validation, team members at NewAge Industries/AdvantaPure are now using new cleanrooms to produce platinum-cured silicone tubing, molded components and Single-Use molded tubing assemblies. The products are manufactured for the biopharm, pharmaceutical and other clean application industries.

“This was a big undertaking,” noted Ken Baker, CEO of the employee-owned business. “We needed additional cleanrooms to manufacture more high-purity tubing and components to meet our customers’ needs, but we didn’t want to add a random room next to our other cleanrooms. This new area was designed and built from the ground up, with a vetted, product flow-through design for raw materials, extrusion, molding, quality inspection and packaging.”

The ISO Class 7 and 8 cleanrooms were built in existing space at the company’s headquarters in Southampton, PA, just north of Philadelphia. The manufacturing suites and inspection areas total 23,000 square feet, with another 20,000 square feet renovated for additional warehouse space.

NewAge invested $10 million in the project. Engineering, design and construction was performed by AES Clean Technology Inc. of Montgomeryville, PA.

“Our intent was to move and validate our manufacturing equipment in phases to avoid any production stoppages or product shortages. We accomplished that, but we also decided to add more extrusion equipment and mold presses. This equipment expansion will help us meet our customers’ current and future product demands,” said Baker.

NewAge/AdvantaPure’s key customers who have inspected the new cleanrooms have approved them for production of their orders involving AdvantaSil™ platinum-cured silicone tubing and reinforced hose, Single-Use molded tubing assemblies, and BioClosure^® container closure systems.

About NewAge Industries

In business since 1954, NewAge Industries manufactures plastic and rubber tubing in reinforced and unreinforced styles. The company maintains a large inventory of tubing and fittings for its core product lines, provides custom extrusion and fabrication capabilities, and services customers worldwide. In 2006, NewAge initiated an ESOP and became an employee owned company for the benefit of both its employees and customers.

The AdvantaPure division of NewAge Industries is ISO 9001:2015 certified and specializes in high purity tubing, hose, Single-Use process tubing manifolds, BioClosure^® container closure systems, and other molded components for the pharmaceutical, biopharm, biomedical, food, beverage and chemical industries. Products are manufactured, stored and shipped using methods that ensure product purity. Automated product identification systems, including gamma stable RFID tags and labels, are offered by NewAge’s Verigenics division.

Amgen Announces Rhode Island Biomanufacturing Plant

Amgen announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States (U.S.), will employ Amgen's proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets.

A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. Next-generation biomanufacturing plants require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

"Amgen has three decades of experience in biologics manufacturing, and we are proud of our track record of providing a reliable supply of high-quality medicines for patients around the world," said Esteban Santos, executive vice president of Operations at Amgen. "We are pleased to build the first commercial scale, next-generation biomanufacturing plant in the U.S., leveraging Amgen's capabilities and incorporating the latest technologies."

A comprehensive evaluation of global locations was conducted to select the location. Following recent U.S. federal tax reform, which provides company incentives to invest in innovation and advanced technologies, Amgen made the decision to locate the new plant in the U.S. Rhode Island was selected based on the historical success of the Amgen West Greenwich manufacturing facility, its capabilities and talented workforce, and quality of living for staff and potential to grow. The biomanufacturing plant will be built on the current Amgen Rhode Island 75-acre campus and is expected to create approximately 150 additional highly-skilled manufacturing positions and approximately 200 construction and validation jobs.

"I am thrilled that Amgen is planning to expand and bring new, highly skilled jobs to Rhode Island and further enhance the State's life sciences community and manufacturing expertise," said Rhode Island Governor Gina Raimondo. "We welcome Amgen's future health care advancements for patients around the world that will come from this new biomanufacturing plant."

Amgen opened its first next-generation biomanufacturing plant in Singapore in 2014. This type of plant offers a highly flexible, modular design which can be replicated in future facilities, which enables Amgen to increase production capabilities reliably with greater speed, productivity and flexibility. Within the plant, the equipment is portable, smaller and disposable, which provides greater flexibility and speed when manufacturing different medicines simultaneously. This eliminates costly and complex retrofitting inherent in standard facilities and allows Amgen to respond to changing demands with increased agility, ultimately impacting the speed at which a medicine is available for patients.

"We are excited that Amgen Rhode Island was chosen as the location to build the new biomanufacturing plant," said Tia Bush, vice president of Operations at Amgen Rhode Island. "It is a testament to our skilled, dedicated workforce and Amgen's continued presence in Rhode Island, which will enable ongoing collaborations with local academic institutions and the broader Rhode Island community."

The existing Amgen Rhode Island plant was licensed by the U.S. Food and Drug Administration in September 2005 and houses one of the world's largest mammalian protein manufacturing facilities. The facility manufactures commercial and clinical bulk drug substance. Amgen has invested more than $1.5 billion in its Rhode Island site, adding more than 500,000 square feet of manufacturing, utility, administrative and laboratory space to the campus. There are 625 full-time staff members employed at the Amgen Rhode Island campus.

Amgen Rhode Island has been awarded by the Providence Business News as one of Rhode Island's Best Places to Work more than 10 times since 2007.

Since 2004, the Amgen Foundation has committed over $4.8 million to support science education and community programs in Rhode Island.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Datwyler Chooses USA

One of the companies that chose the US as one of its key manufacturing sites is the Swiss-based international industrial supplier Datwyler. The company is currently building a new production facility in Middletown, Delaware, which is scheduled to start production in the second half of 2018. It will be their second US-based operation for healthcare, but the first facility to incorporate cleanroom manufacturing in accordance with the company’s own First Line standard. Other First Line aligned facilities are based in Alken, Belgium and Pune, India.

The decision for Datwyler to build a future-oriented manufacturing site in the US has, however, not been a singular, short-term decision. Opening a new facility which incorporates specific cleanroom manufacturing standards in the mid-Atlantic area of the US unifies the current trends and developments in the pharmaceutical industry: (1) the move to the US as a base for pharmaceutical manufacturing, (2) choosing the mid-Atlantic region — a pharmaceutical hotbed — as manufacturing location, and (3) the advancement of cleanroom manufacturing which also incorporates elements of digitization.

Moreover, the idea that local markets increasingly demand locally manufactured pharmaceutical components has been a driving force in the investments made by the company in the last years. That this particular trend is currently becoming strong amongst manufacturing companies shows the industrial supplier’s awareness of industry trends and developments. As CEO Torsten Maschke revealed: “As a globally acting company in the pharma industry, we need to not only observe trends but anticipate and shape them ourselves. With our new facilities in the very important markets USA and APAC, we feel we have done exactly that.”

The location of the newly built facility is defined by its history as a traditional stronghold of manufacturing, particularly in the pharmaceutical sector. The mid-Atlantic region, that includes New Jersey and Delaware for example, has long been a hotbed for pharmaceutical manufacturing. This development is not stagnating but getting stronger. A number of international companies such as Datwyler are expanding or moving operations to states like Delaware — an important trend in today’s global economy.

Companies expanding or moving to the US also provide a strong vision for the future, not only in terms of job creation but also in terms of research and progression in different industrial sectors. This is especially the case when these companies bring business to the US or future-oriented manufacturing technology that also includes aspects of digitization and digital features. In Datwyler’s case, the First Line manufacturing standard, a state-of-the-art cleanroom manufacturing concept.

Cleanroom manufacturing will become even more important in the next few years. Whilst it is also used in other rubber and elastomer-processing industries, it is of particular importance for the pharmaceutical industry. Patient safety as one of the crucial factors for the industry, relies, to a great extent, on high-tech drug administration solutions and technologies which are produced more and more in a cleanroom environment. Certain key areas in cleanroom manufacturing will be the focus of further developments and innovations.

Human interaction in manufacturing will be reduced to a minimum to avoid possible contamination of the product. Automation — and therefore also digitization — will pave the way to even lower particulate levels and risk of contamination. In practice, this will be done through reducing operator handling and processing components throughout the molding process. This will also impact the rare occurrence of component defects significantly.

Every step of the production process will be subject to high-tech camera inspection, from the molding process to the washing and to the packaging of the components.

The very tight acceptable quality levels (AQL) in production and the security provided by their component partner will enable any client to deliver their drugs to the patient with confidence.

In summary, the trends described in the above article will be leading the way towards the US consolidating their position as pillar of pharmaceutical manufacturing. Locally based research and development will do its part to underpin this position. The coming years are bright for US based pharmaceutical manufacturing — and new facilities, research and development will further make it an integral part of the future of global health.

Aldevron Selects AES, Begins Construction of Cleanrooms

Aldevron has selected AES Clean Technology, a leader in the design, manufacturing, and construction of modular cleanroom systems, to design modular cleanrooms for Aldevron’s $30 million, 70,000 square-foot manufacturing facility in Fargo, ND. Cleanroom construction is now underway.

“Aldevron’s new facility is built with the AES modular cleanroom technology that delivers speed, cleanliness, quality and repeatable performance,” said Michael Chambers, Aldevron CEO. “Our building will be the world’s largest and most advanced plasmid DNA manufacturing facility. This project is part of our vision to provide clients with unsurpassed scale and quality. The site delivers on our strategy to maintain leadership in plasmid DNA manufacturing from discovery research through commercial production.”

The state-of-the-art facility includes:

70,000 square feet of space with 17,000 square feet of modular cleanrooms for cGMP production
Unidirectional personnel flow and airlocks within the cGMP production area
Emergency generator backup power for all production and storage areas
Integrated facility and environmental monitoring with automated alarms
Single-pass air for product dispensing and cell banking suites
ISO 8 processing suites with ISO 7 suites for cell banking and fermentation
Fully EU-compliant Grade A product dispensing area

Henry Hebel, Aldevron COO, added, “Aldevron is pleased to be working with AES, the recognized leader in cleanroom design and construction. Our design includes advanced independent air-handling and modular cleanroom systems to ensure our clients the highest possible quality and compliance. Our GMP capacity will double in the new facility and our fermentation scale will range from 10 L to 300 L single-use systems, with the ability to expand to 2,000 L under the same roof. This capacity and flexibility combined with Aldevron’s 20 years of experience and successful delivery of thousands of lots, including material for the manufacture of commercial products, solidifies our position as the global leader in plasmid DNA production.”

“AES is proud to be designing and building the cleanrooms for Aldevron’s new facility,” said Grant Merrill, AES Director of Project Development. “Our unique set of skills, coupled with our ability to deliver fully customized cleanrooms in an extremely rapid timeframe, will allow Aldevron to serve its growing client base with a reliable supply of cGMP products.”

Aldevron’s facility will be operational in the summer of 2018, with the company now scheduling work throughout 2018 and 2019.

About Aldevron:

Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from discovery research to clinical trials to commercial applications. These products are critical raw materials and key components in commercially available drugs and medical devices. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-Source^TM quality system. Company headquarters are in Fargo, ND, with additional facilities in Madison, WI and Freiburg, Germany.

BioSpectra Expands Manufacturing Capacity and Lab Services

BioSpectra announced that it has expanded its capacity for the synthesis and purification of active pharmaceutical ingredients (APIs) and excipients with low bioburden and low endotoxin (LBLE) requirements.

These products, intended for use in parenteral drug applications, are manufactured using the company’s manufacturing and purification systems, stringent environmental controls, strict process monitoring, robust quality and compliance programs, and comprehensive finished-product testing.

Product offerings, all of which are manufactured at BioSpectrea’s facilities in Bangor and Stroudsburg PA, include additional APIs and excipients being manufactured under proprietary contract agreements, LBLE excipients galactose, sucrose, and trehalose as well as GMP-compliant bulk biological buffers, process chemicals, and compounded solvents and solutions.

The additional APIs and excipients will be among the products launched in 2018 and added to the existing line.

BioSpectra has also expanded its quality control contract lab services portfolio to include inductively coupled plasma mass spectrometry analysis of elemental impurities required under United States PharmacopeiaGeneral Chapters <232> and <233> for all APIs and excipients for independent customer requests.

This additional capability is complemented by the company’s original offerings of internal raw material and finished product testing. Other lab services are also being made available on an independent, contractual basis, according to BioSpectra.

Sarepta Therapeutics Opens Research and Mfg. Center

Sarepta Therapeutics, a U.S. commercial-stage biopharma company focused on unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, has opened its Research and Manufacturing Center in Andover, MA.

The 60,000-sq.-ft. facility significantly enhances its research and manufacturing capabilities, expands its global commercial footprint, and advances its Duchenne muscular dystrophy (DMD) pipeline, which comprises an exon skipping platform and next generation approaches such as gene therapy and utrophin upregulation programs. The current focus of the manufacturing facility will be to advance Sarepta’s development pipeline, and by the end of the year, could have as many as seven investigational DMD treatments in the clinic.

Sarepta plans to expand its headcount in Andover by 100% in the next 12 to 18 months, adding approximately 50 employees.

“Since first moving to Massachusetts in 2013, Sarepta has benefited enormously from the Commonwealth’s talented and highly-educated workforce,” said Edward Kaye of Sarepta. “This expansion underscores our ongoing commitment to patients with Duchenne and investment in the vibrant Massachusetts economy. We are grateful to Governor Baker, the Massachusetts Life Sciences Center, MassBio, the Town of Andover, and other state and local officials who support our mission to serve the greater DMD community.”

Patheon to Expand Capabilities

Patheon plans to invest approximately $45 million at key sites across its global network to expand service capabilities.

The company’s recently acquired site in Florence, SC, will be adding commercial spray drying capabilities. The 15,000-sq.-ft. dedicated suite will contain two spray dryers delivering development and commercial scale spray-dried dispersion (SDD) services. The suite is expected to be online in 2019.

At the Bend, OR site the company plans to expand existing development SDD capabilities with a new cGMP analytical lab, manufacturing suite and additional development scale spray drying. Together, the expanded capabilities at the Florence and Bend locations will provide clients with services for products with solubility challenges, from development to commercialization.

Additionally, Patheon has invested in a new commercial sterile product manufacturing facility in its Monza, Italy site, which will house three, 40m2 lyophilizers with eight-headed integrated filling equipment for lyo and liquid formulations for small and large molecules, in a range of vial specifications. The equipment will have full CIP/SIP systems, auto loading for the lyophilizers contained in full RABs systems to ensure sterility.

Patheon also plans to expand its sterile product Pharmaceutical Development Services (PDS) at the Monza facility. The sterile suite will contain two 7m2lyophilizers and associated sterile vial filling line and analytical lab. This new facility will provide services for both small and large molecule injectable products (liquid and lyo formulations) and will be operational in mid-2019.

Also, at its Greenville, NC site, the company will expand packaging and serialization capabilities. The company has built a new filling and packaging suite and upgraded another of its packaging lines with new technology to improve efficiency and reduce change-over time. The newly constructed 4,800-sq.-ft. suite will come online this fall and features a filling and packaging line equipped with an Optel serialization system. The system includes cameras, pharma proof stations, line master, and bottle and bundle tracker equipment.

“As outsourcing of Pharma development and manufacturing services continues to grow, our customers will need even more advanced technologies and customized solutions to meet their business needs,” said Michel Lagarde, president of Patheon. “With the increasing marketplace pressures, pharma companies are looking to build more reliable, flexible and cost-efficient supply chains. With our focus on people, process and capabilities, Patheon is uniquely positioned to partner with pharma companies to achieve their objectives – cost effectively while delivering the highest quality.”

Novartis’ AveXis to Invest in New Gene Therapy Manufacturing Facility

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

On May 22, 2018, the North Carolina office of the Governor Roy Cooper announced that AveXis, a Novartis clinical-stage gene therapy company, will locate a new manufacturing center in Durham County, NC. The company is expected to invest $55 million in the facility, which will produce therapies to treat rare neurological genetic diseases and create 200 jobs, according to the governor’s office.

"We're proud to be the place where cutting edge work will happen on gene therapies to fight disease and improve people's health," Governor Cooper said in a press release issued by his office. “North Carolina has long been a leader in the life sciences, and AveXis’ decision further enhances the state’s expertise in this emerging field.”

AveXis, headquartered in Bannockburn, IL, was acquired by Novartis for $8.7 billion in May 2018. The company is currently developing a proprietary gene therapy candidate, AVXS-101, for treating spinal muscular atrophy (SMA) Type 1, a genetic cause of infant mortality. The company will create a variety of positions in Durham County, including engineers, manufacturing and quality control personnel, and supply chain specialists. The total payroll impact is anticipated to be in excess of $20 million annually when all new positions are filled, the governor’s office reports.

“Our primary focus is to bring gene therapies to patients suffering from devastating rare neurological diseases—such as SMA, genetic amyotrophic lateral sclerosis, and Rett syndrome—and continued investment in establishing our manufacturing infrastructure is a critical component to accomplishing this goal,” said Andrew Knudten, senior vice president of technical operations and chief technical officer at AveXis, in the press release. “As a long-established biotechnology hub that attracts the nation’s top talent, Research Triangle Park was an optimal location to expand our footprint and complement our existing state-of-the art manufacturing site in the Chicagoland area.”

The North Carolina Department of Commerce and the Economic Development Partnership of NC (EDPNC) led the state’s support for the company’s expansion. The North Carolina Biotechnology Center also provided technical due diligence and funding support for this project through a jobs-based grant.

The North Carolina General Assembly, the North Carolina Community College System, the North Carolina Biotechnology Center, Durham Technical Community College, Durham County, and the Greater Durham Chamber of Commerce all partnered with NC Commerce and the EDPNC on this project.

Q Laboratories Opens Lab Facility

Q Laboratories has opened its new 30,000-sq.-ft. lab in Cincinnati, OH. Completion of this new facility combined with the purchase of two existing buildings on adjacent property will comprise the Q Laboratories Campus allowing for continued growth and a more efficient workspace for its 130+ employees. With this expansion the company’s total square footage grows from 25,000 to 55,000, with plans to expand again in three to five years.

David Goins, chief operating officer, has been with the company for more than 29 years and has seen the company grow from a small regional firm to a large organization serving companies around the world. “We have been fortunate to have a fantastic team that has enabled us to continue to grow,” Mr. Goins said. “Opening this beautiful new building is a testament to the dedication of all of our employees and the excellence they bring to the lab each and every day. This is a proud day for all Q Laboratories employees, past and present. With any successful business, it takes talented personnel to make it work. Q Laboratories history is filled with exceptional people doing extraordinary work.”

Founded in 1966, Q Laboratories provides microbiology, analytical chemistry, and research and development laboratory services to the pharmaceutical, cosmetic, health and beauty care, and dietary supplement industries. The lab offers quality control and testing services for manufacturers and distributors, including method development and validation, pathogen detection, elemental impurities analysis, raw material qualification, microbial identification, and stability studies.

Mustang Bio Opens CAR T Manufacturing Facility

Mustang Bio, a Fortress Biotech company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, has opened a CAR T cell therapy manufacturing facility at UMass Medicine Science Park in Worcester, MA. The 27,000 sq. ft. facility will support the clinical development and commercialization of Mustang's CAR T product candidates and enable proprietary cell therapy research.

The initial build-out of the facility has been completed, and Mustang anticipates processing patient cells by the end of 2018. The facility will initially be used in the clinical development of Mustang's lead CAR T product candidates: MB-102 (CD123 CAR) in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm, MB-106 (CD20 CAR) in B-cell non-Hodgkin lymphoma, and MB-101 (IL13Rα2 CAR) in glioblastoma.

"We are pleased to announce the opening of our CAR T cell therapy manufacturing facility, which will enable us to process personalized cell therapies to be used in the clinical development and commercialization of CAR T products for the treatment of aggressive forms of cancer," said Manuel Litchman, president and chief executive officer, Mustang. "Moreover, establishing in-house cell therapy research capabilities will enable us to continue to differentiate our product candidates through innovation in cell processing and the evaluation of immuno-oncology technologies, like checkpoint antibodies and oncolytic viruses, in combination with our CAR Ts. We look forward to building our clinical and chemistry, manufacturing and controls teams in Worcester, and anticipate filing our first Investigational New Drug Application in late 2018 for MB-102 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm."

Pfizer to Build Cutting-Edge Sterile Injectable Facility in Michigan

Pfizer announced it will increase its commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. This U.S. investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients around the world.

Known as Modular Aseptic Processing (MAP), the new, multi-story, 400,000-square-foot production facility will also support the area economy by creating an estimated 450 new jobs over the next several years. This expands Pfizer’s presence in Portage, located in Kalamazoo County, where the company now employs more than 2,200 people at one of its largest plants.

“This investment is part of our overall plan announced in January to invest approximately $5 billion in U.S.-based capital projects as a result of the enactment of the Tax Cuts and Jobs Act. During the next six years, we expect to invest approximately $1.1 billion in Kalamazoo County – which is in addition to the $1 billion we have invested in the site over the past decade,” said Ian Read, Chairman and Chief Executive Officer. “Every day, we strive to enhance our ability to bring medicines to the patients who need them, and the new facility we are building in Michigan will help us continue to deliver therapies that significantly improve people's lives.”

“This investment will strengthen Pfizer’s leadership in sterile manufacturing technology and help meet growing patient demand,” said Kirsten Lund-Jurgensen, Ph.D., Executive Vice President and President, Pfizer Global Supply. “It also will create hundreds of highly skilled jobs, fortifying Michigan’s high-tech manufacturing environment.”

Ron Perry, Site Leader for the Portage plant, said the new sterile injectable facility will strengthen the site’s role in Pfizer’s global network. “Sterile drug product manufacturing is incredibly complex. This contemporary facility will combine cutting-edge technology and a highly talented workforce to assure we remain a trusted and reliable supplier of these therapies to patients.”

MAP will incorporate the most technically advanced aseptic manufacturing equipment, systems and design, including multiple, self-contained modular manufacturing lines. This allows the manufacturing line in each module to be entirely separate from all other manufacturing lines. Groundbreaking is planned for spring 2019, with construction expected to be completed in 2021. After the facility is validated by regulatory agencies, production should begin in 2024.

Pfizer’s Portage site is a primary global supplier of sterile injectable, liquids and semi-solid medicines, and active pharmaceutical ingredients, producing more than 150 products. Its biggest product is Solu-Medrol, a widely used injectable anti-inflammatory medicine. The plant has been in operation since 1948, and Pfizer has had a presence in the community through the legacy Upjohn Company since 1886. Pfizer’s operations in Kalamazoo County generate an estimated annual economic impact in west Michigan of $2.2 billion.

About Pfizer Manufacturing:

Pfizer is a 168-year-old American company founded in Brooklyn, NY. Pfizer is a proud U.S. based manufacturing and supply company with more than 11,000 U.S. based employees. With 15 plants, the United States hosts more Pfizer manufacturing sites than any other country in the world.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

Charles River Bolsters Global Biologics Infrastructure

Charles River Laboratories has made several key expansions to its global Biologics Testing Solutions infrastructure to support the characterization, development, and release of biologics and biosimilars.

To increase capacity Charles River recently added a new, 73,000 sq.-ft. facility in Wayne, PA, more than doubling lab space at the company’s existing facilities in Malvern and King of Prussia, PA.

Certain lab operations conducted at Charles River’s Malvern and King of Prussia sites will begin to move to Devon Park early in 3Q18. The formal transfer of assays will be done in phases, and during the transition, both the Malvern and King of Prussia facilities will remain fully operational to ensure there will be no interruption of services.

In Malvern, PA, 2,800 sq.-ft. of new, state-of-the-art clean rooms dedicated to GMP microbial and mammalian cell banking are being added, increasing cell banking capacity by 40 percent. The company is also upgrading rooms for virus and vaccine production, and, added capabilities for high-volume and high-density cell banks as alternatives to traditional cell bank formats.

In Shrewsbury, MA, the company’s Analytical Center of Excellence (CoE), Charles River is combining and expanding the services offered in Malvern and Woburn, MA under one roof for faster method development and increased offerings. The CoE will also facilitate the continued expansion of analytical and protein characterization services.

In Erkrath, Germany, 4,500 sq.-ft. of new lab space will be designed to meet the special requirements of bioactivity testing, expanding offerings for the development, transfer, and optimization of bioassay methods, including support for lot release, stability testing, accelerated stress condition testing, and the comparability testing of biosimilar products.

Also, in Ballina, Ireland, additional assays have been introduced, including in vitro adventitious agent and mycoplasma testing, along with the full suite of in vivobiosafety testing methods. A new analytical lab has been opened, offering a portfolio of GMP assays for release testing, short- and long-term stability testing, and comparability testing for biosimilars.

“The high volume of biologics and biosimilars in development has led to a rapid increase in demand for our services. The continued expansion of our Biologics service portfolio and additional capacity will further enhance our ability to support clients’ development efforts from discovery through clinical phases and commercial manufacturing,” said, Greg Beattie, corporate vice president, Global Biologics Testing Solutions at Charles River.

Grand River Aseptic Manufacturing Purchase Land in Grand Rapids

Grand River Aseptic Manufacturing, Inc. (GRAM), a leading parenteral contract manufacturing organization, has signed purchase agreements to acquire land in Grand Rapids, Michigan, to add to its growing presence in life sciences, expand its manufacturing capacity and serve its growing customer base.

The 1.5-acre lot on Butterworth Street sits less than a quarter mile away from GRAM's existing manufacturing facility on Front Avenue near downtown Grand Rapids and is less than a mile away from its finishing facility on Godfrey Street. The land purchase will significantly increase GRAM’s existing 40,000-square-foot cGMP space. The purchase agreements are with two separate parties, subject to normal due diligence items, and are expected to close within 90 days.

The expansion will house a state-of-the-art cleanroom space, including new isolator technology, and will allow GRAM to serve its clients with high-speed, fully integrated manufacturing and packaging lines. “The substantial growth rate that we’ve experienced in the last several years has allowed us to match the needs of our clients and the industry. With that growing demand, we are excited to add more manufacturing capacity, while remaining a quality-focused organization,” said Tom Ross, president and CEO.

GRAM’s last addition to its pharmaceutical fill/finish footprint was in 2014 with the addition of a 28,000-square-foot facility. The 2014 expansion was in response to the need for more warehousing space, as well as a place for finishing activities. “As GRAM has grown and we have continued to add more capabilities, we’ve identified the need for more cleanroom space to serve our client’s needs and to meet the market demand in biologics and generic pharmaceutical markets,” said Nick Bykerk, vice president of business development and finance.

GRAM was formed in December 2010 and opened its doors in January 2011. In seven years, GRAM has increased its employee base from 16 employees in 2011 to over 160 employees today. The company is one of the fastest growing companies in the United States and was recently named by Inc. Magazine as the 9th fastest growing company in the state of Michigan.

“With the support of many in the West Michigan community, GRAM was formed to create a leading life science company as a contract development and manufacturing organization,” Ross said. “Over the period of seven years, we have been fortunate to recruit many talented employees all focused on meeting the stringent demands required to be a fully qualified, FDA-approved pharmaceutical company. With a culture wrapped around quality, we have achieved tremendous growth, and we now have the opportunity to expand in our community and secure a very bright future. This land purchase will be the first step in a major expansion for GRAM as we dramatically increase our pharmaceutical fill and finish capabilities and capacity.”

About Grand River Aseptic Manufacturing, Inc.

Grand River Aseptic Manufacturing, Inc. (GRAM), a parenteral contract manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics as well as controlled substances, GRAM’s expert project managers and modern facilities support pharmaceutical development and cGMP manufacturing, analytical testing and regulatory filing.

Moderna Opens Manufacturing Site for mRNA Therapeutics

Moderna Therapeutics, a clinical-stage biotechnology company, announced the opening of its new manufacturing facility in Norwood, Massachusetts in a July 17, 2018 press release. The digitally-enabled and environmentally sustainable 200,000 sq. ft. clinical-development manufacturing plant was built to advance Moderna’s pipeline of messenger-RNA (mRNA) therapeutics and vaccines. Designed to current good manufacturing practices (cGMP) specifications, the site gives the company the capacity to develop materials for preclinical toxicology studies as well as Phase I and II clinical development programs, and to manufacture, test, and run fill/finish operations for its portfolio of mRNA development candidates.

Moderna has 21 programs in its mRNA pipeline, including potential treatments for different forms of cancer, rare diseases, infectious diseases, and heart failure. The new site also houses the company’s Personalized Cancer Vaccine (PCV) Unit for individualized supply batches of mRNA for potential personalized cancer vaccines. By making this direct investment in PCV next-generation manufacturing, the company can reduce the time it takes to manufacture a dedicated cancer vaccine for individual patients in clinical trials.

“The Norwood site is core to our long-term strategy, enabling us to leverage the potential of our mRNA platform, control our supply chain, and provide the necessary scale and flexibility to support the development of high-quality mRNA medicines for patients in the decades ahead,” said Stephane Bancel, CEO of Moderna. “Opening this new manufacturing facility in Massachusetts was also important as it enables close collaboration with our development and research teams in Cambridge as we advance our mRNA platform and science. We are excited to continue to work with state and local partners, leverage the remarkable innovation and talent from the Massachusetts life-sciences and technology sectors, and create new biopharma manufacturing roles as we work to develop new medicines for people with serious and life-threatening diseases.”

More than 200 employees will work at the Norwood facility in a wide range of roles including production operations, manufacturing science and technology, quality control, engineering services, supply chain management, and process development. Moderna has hired more than 150 people (full time and contractors) for Norwood-based positions since the end of 2016, and the company plans to add close to 50 additional manufacturing roles in 2018.

The digitally-enabled site connects information systems, robotics, and machinery to enable the continuous exchange of data and provide information on all manufacturing activities. Using advanced algorithms and analytics, over 7000 events are monitored in real-time to help increase efficiency, ensure quality, and maintain data integrity. The site has a paperless manufacturing environment.

As part of the company’s commitment to sustainability, the manufacturing facility was designed to achieve Leadership in Energy and Environmental Design (LEED) certification. Moderna is limiting energy use with advanced energy metering, LED lighting, and systems designed to reduce water usage by up to 25%. The site will have charging stations for nearly two dozen electric vehicles, and it will deploy air quality and efficient waste-management systems. Next year, the company will also add solar panels to provide renewable energy to the building.

“Our investment in Norwood brings us even closer to the industrialization of our mRNA platform,” said Juan Andres, senior vice-president of Manufacturing for Moderna. “Norwood will allow us to own the end-to-end production of materials, run multiple programs simultaneously, and produce more than 100 cGMP batches annually in an automated and digitally-integrated environment. We believe this provides us with an important advantage as we work to develop multiple pipeline candidates for patients and to scale capacity to meet individual program demands.”

AGC Biologics Expands Capacity

AGC Biologics, a clinical and commercial manufacturer of therapeutic proteins, is expanding capacity at its Berkeley, CA facility with the addition of a 2000L single-use bioreactor (SUB)

With this new 2000L SUB, the Berkeley facility has tripled capacity over the last three years, and now offers cell culture manufacturing in scales from 100L to 3000L, with both SUBs and stainless steel bioreactors. In addition to cGMP manufacturing, the facility provides cell bank manufacturing and storage.

While focused on early-phase, the Berkeley facility operates within the global AGC Biologics integrated platform, with support from each AGC Biologics site. This structure is designed to create a seamless transition from early-phase through commercial production.

"We've carefully assembled an experienced team that is tuned in to the unique needs of customers within the critical early-phase development stage," said Vy Nguyen, site head of AGC Biologics, Berkeley. "We continue to expand capacity and capabilities to meet the diverse requisites within the early-phase manufacturing arena, and we value the opportunity to support companies developing tomorrow's breakthrough treatments."

REST OF WORLD

Olon Acquires Manufacturing Facility in India English

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, announced the acquisition of a local generics chemical operations API manufacturing facility in Mahad, India, as part of a continuing expansion of its global footprint.

Paolo Tubertini, CEO of Olon, commented, "By acquiring a manufacturing base in India, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to develop new generic products for the Indian market. It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements.

"Following the acquisition of Ricerca Biosciences' Chemical Division in mid-2017 and the investment of more than €10 million to expand APIs manufacturing lines in the Settimo Torinese facility, - a leading-edge plant for development and production of APIs and advanced intermediates through microbial fermentation technology - we have now completed a further step in our strategic plan. To accomplish all the objectives listed in the Olon 3 years' development plan, we will move to the next target: to play an important role in the manufacturing of biologics API's."

The Mahad site, which supplies products to Sandoz, a division of the Novartis Group, is an established and reputable API manufacturing facility in India and provides a number of lifesaving medicines to the Indian healthcare system and patients around the world. As part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of Sandoz products manufactured in Mahad. No impact on jobs is planned and Olon intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base.

"We look forward to a seamless transition for employees, patients, customers, partners and other stakeholders," added Mr. Tubertini. "We are impressed by the know-how at the Mahad plant and intend to leverage their expertise to develop new opportunities in the pharmaceutical market, in India and elsewhere."

The acquisition of the Mahad API manufacturing facility is expected to be completed in early 2019, following a transition process. No financial details were disclosed.

About Olon

Olon is an Italian company world leader in the Active Pharmaceutical Ingredients (APIs) production, using synthetic and biological processes for generic market as well as in Contract Development and Manufacturing (CDMO). Recently the Dossier Unit has been enlarged, considering the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical Documents (CTD) dossier.

With a 2017's Turnover of 400 Mio$, Olon supplies more than 250 APIs for Generic market and more than 60 between API and chemical Intermediates under CDMO.

Thanks to 1,500 employees, and to the highly qualified R&D team - more than 200 people - Olon can offer complete integrated packages and services to support the full development of APIs based on strong knowledge in both Chemical and Biological process, all of them under a full cGMP and regulatory coverage - holder of about 130 active US DMFs and 50 granted CoS.

Always considering human safety and environmental security, Olon handles different and not-common manufacturing process technologies, such as Fluorination, Carbonylation and Fermentation.

Headquartered in Rodano (Milan, Italy), Olon has 9 manufacturing facilities - 7 located in Northern Italy, 1 in Spain and 1 in USA - compliant with international requirements, and 3 branch offices: Hamburg (D), Florham Park NJ (USA) and Shanghai (China).

All manufacturing sites are regularly inspected by the most important national and international Authorities, and regularly audited by our partners and customers. All plants are FDA-inspected and self-identified under GDUFA.

Pharma Technology Moves to Larger Facility

Pharma Technology Inc. (PTI), which produces tablet dedusters and capsule polishers combined with metal detectors and loading systems for pharmaceutical solid dose production, is moving its headquarters to a greenfield site half a mile from its current home in Nivelles, Belgium, the company announced in a Nov. 28, 2017 press release. At 60,000 sq. ft., the new facility is twice the size of the former facility.

The new facility will have a large R&D center for developing tablet dedusting, capsule polishing, and oral solid-dosage drug testing technology. The new facility also doubles manufacturing capacity and increases stocking space. A fully equipped demonstration lab will accommodate customer tests, factory acceptance testing, and special projects with containment (occupational exposure band 3) capacity. Leading up to the move, PTI has hired more than a dozen workers to bring its personnel count to approximately 75. A formal inauguration for the new plant was planned for March 2018.

Ferring Pharmaceuticals to Open New Facility

Ferring Pharmaceuticals announced that it is expanding its capabilities in biologics through a new biotech center which will be installed at the company’s existing headquarters and manufacturing site in Saint-Prex, Switzerland.

Over the next three years, Ferring will invest approximately 30 million CHF in the new Ferring Biotech Centre, which will incorporate discovery and development capabilities for monoclonal antibodies as well as biologics manufacturing capabilities.

Michel Pettigrew, president of the Executive Board and chief operating officer, Ferring Pharmaceuticals. “This significant investment in state-of-the art manufacturing and development technologies fits our strategy to address unmet patient needs in these areas, and will open up additional opportunities for Ferring to help people live better lives.”

In addition to the discovery, development and manufacture of new biologics, the active pharmaceutical ingredient (API) for Rekovelle® (follitropin delta), Ferring’s latest fertility treatment, will be manufactured at the new Ferring Biotech Centre.

Hovione Reports on Recent Capacity Expansion and Future Plans

Hovione reported recent capacity expansion and future plans in its sites in Portugal, Ireland, and New Jersey, the company reported in a press release on March 19, 2018. The capacity expansion program started in 2016 and will continue in the coming five years.

Since 2016, Hovione relocated its development services to a new center in Lisbon, Portugal, which is 15 minutes away from the Loures manufacturing site and is equipped to handle potent and highly potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation, and analytical development areas.

In this same period, the Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. In addition, one pilot and two large-scale spray dryers were installed at the site, and operation began of a new drug product center equipped with oral dosage form and inhalation manufacturing capabilities. The company also doubled the size of its development and manufacturing operations in the New Jersey site, providing it with capabilities from chemical and analytical development, through spray drying to formulation. The site now hosts 14 m3 of reaction vessel capacity with four independent trains, a pilot and a large-scale spray dryer, and a continuous tableting unit.

At the Cork site, Hovione is reinstating and renewing a production building with 157 m3 of chemical synthesis capacity devoted to contract manufacturing. Approximately half of this capacity will be ready for operation by May 2018.

Over the next three years at the Loures site, the company will add a new chemical synthesis and spray dryer building for contract manufacturing, with a total area of 45,192 sq. ft. (4200 m2) for 165 m3 of reaction vessel capacity and two large spray drying units, new formulation facilities that will enable the production of bigger batch sizes, and a new building that will host an additional 1,912 sq. ft. (1200 m2) of analytical laboratories.

This investment effort is being paired with recruiting and training new staff.

“This capacity expansion plan is far more than a matter of production capacity solely. It aims to reorganize sites with new buildings, renew existing facilities, and give operations the most advanced equipment in the market, to provide our customers and team members with the technology and the capacity they need to grow in a sustainable way. It is a significant effort and commitment from Hovione to stay ahead of and prepare for future demand,” said Nuno Almeida, vice-president of Engineering.

Samsung BioLogics Wins First Contract for Plant 3 Facility

Samsung BioLogics, headquartered in Incheon, South Korea, has entered into the first manufacturing contract for its Plant 3 facility. According to the company, the contract is valued at approximately $148 million, if the product is successful in clinical development and moves to commercial launch.

The Plant 3 facility was completed last November and has 180,000 liters total capacity and is expected to be cGMP operational by 4Q18.

TH Kim, chief executive officer of Samsung BioLogics, said, “We are excited to enter into this partnership with a fast growing company and very pleased to be chosen to provide a high quality life-saving product to their patients. As products from our Plant 1 (6 x 5,000L) and Plant 2 (10 x 15,000L) facilities mature, Plant 3 will be utilized to supply those with increasing demand to ensure that we continue to meet our client’s demand. We continue to discuss long term partnerships with multiple biopharmaceutical companies for Plant 3. As such, the utilization rate in Plant 3 may ramp up more quickly than anticipated.”

MilliporeSigma Announces Investment

MilliporeSigma announced an additional investment of $50 million to build a robust manufacturing and distribution platform in Asia over a span of two years. This investment follows the company’s November 2016 announcement of its $100 million Life Science investment in Nantong, China.

“In biopharmaceutical research, time is of the essence,” said Udit Batra, chief executive officer, MilliporeSigma. “Our investments in the important Asian markets of South Korea, India and China ensure that our customers have ready access to the products needed to develop new therapies and biosimilars that accelerate access to health for people everywhere.”

MilliporeSigma’s new South Korea manufacturing and distribution center, located in the Songdo district of Incheon, will include an infrastructure to facilitate the supply of its products to customers in Korea and advanced cell culture media manufacturing capabilities (imMEDIAte Advantage® Custom Media). Occupying a land area of 109,000 square feet, the new site is expected to be fully operational in Q4 2019. Another new center, located in Mumbai, India is expected to be completed in 2019, and will be 129,000 square feet with added capacity.

Recipharm Completes Blow-Fill-Seal Expansion at Kaysersberg Facility

Recipharm, the contract development and manufacturing organization (CDMO), announces its new Blow-fill-seal machinery is now operational following a substantial investment last year at its facility in Kaysersberg, France.

The EUR 18 million investment adds a new Blow-fill-seal high-speed filling and packaging line to the site, taking the total number of lines to eight and increasing the facility’s manufacturing capacity by 200 million unidoses/year.

In addition, the investment adds 25,824 sq. ft. (2,400 square meters) to the facility creating space for a further three machines, which will ultimately allow the site to manufacture over 1.2 billion unidoses/year.

Yves Buelens, General Manager at Recipharm’s Kaysersberg site, said: “This latest investment is in direct response to customer demand for single-dose and sterile manufacturing services, such as aseptic processing for eye care and ear care products, particularly from markets such as the US, Turkey, Australia and Canada. This project was supported by the Region Grand Est and the CCI Alsace Eurométropole as part of employment-related actions”.

“Recipharm has only owned the facility for two years and during that time have taken some very fast and positive decisions to invest in Kaysersberg. We have worked hard to develop a flexible service that can cater for even the most complex of projects. Adding the line to our facility will allow us to take on new customer projects more quickly, as well as continue to meet our current customers’ requirements. The additional space we’ve added also means we are also well positioned for further growth in line with future customer demand.”

The Kaysersberg site, located in Alsace, France, is a facility specializing in Blow-fill-seal technology for sterile liquids. The site manufactures single dose units and has an advanced aseptic process for sterile liquid packaging applications.

About Recipharm

Recipharm is a leading Contract Development and Manufacturing Organization (CDMO) in the pharmaceutical industry employing around 5,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 5.3 billion and the company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.

WuXi Biologics to Invest in New Singapore Biomanufacturing Facility

WuXi Biologics announced on May 22, 2018 that it will invest S$80 million (approximately US$60 million) and hire approximately 150 employees to establish a biologics manufacturing facility in Singapore. The facility will be the company’s tenth global drug substance manufacturing facility, its second site outside of China, and its first in Asia outside of China. The company is headquartered in Wuxi city, Jiangsu province, China.

This “facility of the future” will be built upon a new approach WuXi Biologics has pioneered deploying single-use bioreactors. A total of approximately 4500-L bioreactor capacity will be installed with two, 2000-L traditional fed-batch and one, 500-L perfusion-based continuous processing bioreactors. The facility will be able to handle both clinical and small-volume commercial production. The company will also build an early-stage bioprocess development laboratory.

“Singapore is acknowledged as a leader in the biopharmaceutical industry. The new site plays a key role in WuXi Biologics’ global biomanufacturing network to ensure that biologics are manufactured at the highest quality and with a robust supply chain to benefit patients worldwide. We are grateful for all the support local agencies and the talented people here have provided for us. With the strong support, we believe we can quickly push forward this exciting project,” said Dr. Ge Li, chairman of WuXi Biologics.

Parker Bioscience Expands UK Facilities

Parker Bioscience will undertake a multi-million-dollar phased-investment program throughout the remainder of 2018 to expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site, the company announced on May 16, 2018.

In 2017, it was announced that the Birtley facility would start the manufacture of the company’s automated bioprocessing systems, complementing existing production at its site in California. In 2016, the company introduced a new ISO Class 7 cleanroom at the facility, from which Parker Bioscience is now producing single-use manifolds incorporating tubing, bioprocess containers, filters, sensors, and other components for use in the bioprocessing industry.

The increased investment will enable Parker Bioscience to service its European biopharmaceutical markets more effectively by shortening the supply chain.

LMT Group Opens New Facility in Nanjing

After having been active in China for more than ten years and steadily building its presence there, the LMT Group of companies has now opened a new factory and administration building in the Chinese city of Nanjing. This investment will enable Fette Compacting to double its production capacity for tablet presses and LMT Tools to broaden its service offering for precision tools, the group said in a May 9, 2018 press release.

The new facility is 538,000 sq. ft. (50,000 square meters) in size, and operations officially began May 8, 2018. Before the opening of the new building, Fette Compacting produced approximately 100 tablet presses a year in Nanjing, which were delivered to customers worldwide. The new facility will enable Fette Compacting China to double its production capacity.

“We are firmly maintaining our current course of internationalization. That is how we can ensure the continued availability of state-of-the-art technology and comprehensive service to all the customers that want to engage in growth markets in China and other parts of the world and increase their international competitive edge,” explained Olaf J. Müller, CEO of Fette Compacting, in the press release.

Minakem Opens New High Containment Facility

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

Minakem, the contract development and manufacturing division of Minafin, announced on June 19, 2018 that it is in the final qualification run to open a new, closed-controlled environment, high-containment production facility in August 2018. This high-class production facility is among only a dozen of its kind in the world; roughly half are located in Europe.

The new facility, based at the Louvain-la-Neuve plant in Belgium, extends Minakem’s capacity to develop and manufacture high potency API (HPAPI) compounds, such as antibody drug conjugate (ADC) toxins, from small-scale development to full GMP batch releases. Minakem’s facility will be equipped with a preparative chromatography system that allows the isolation and purification of target molecules at varying scales, from milligrams to hundreds of grams, geared to addressing a range of needs from routine activity to analytics. Equipment in the facility consists of nine fume hoods and a double-barrier of protection in the form of new generation glove boxes in room that are dedicated to dry powder handling and weighing, air locks, HEPA [high efficiency particulate arresting] air filters, and cascading flow. Minakem’s HPAPI production will be carried out with an occupational exposure limit (OEL) below 0.1 μg/m3/8h.

“The Louvain-la-Neuve site has handled highly potent molecules for decades. Specialized training, adequacy of housekeeping measures, and engineering controls are the pillars in the effectiveness of containment,” said Amadeo Ferreira, R&D manager at Minakem, in the press release. “This new investment allows an increased capacity to integrate new projects as well as handle the most highly potent molecules on the market. These measures are requested by our customers for use in ADCs at 10 ng/m3 levels. The entire team is proud to be part of the future generation of drugs aimed at treating cancers.”

Minakem based the design of the laboratory on its own expertise and input from customers and equipment suppliers. It used a risk analysis approach to define a suitable way to work with highly potent compounds while maintaining great flexibility. It will start operations in the new high-containment facility in September.

Upperton to Offer cGMP Spray Drying and Clinical Trials

New 15,000 sq. ft. facility to house R&D, QA and manufacturing departments

Upperton Pharma Solutions has relocated to larger, self-contained facilities at Highfields Science Park, adjacent to the University of Nottingham, UK. The move to new premises, according to the company, underlines its rapid expansion and will enable it to develop its own cGMP manufacturing capabilities for early phase clinical trials.

The 15,000 square foot facility will house all of the company's R&D team, as well as its fast-growing quality assurance and manufacturing departments. Within the building is a cleanroom suite suitable for cGMP manufacture, and a pilot plant for non-GMP intermediate scale manufacturing. Upperton plans to have an MHRA license for clinical trials manufacturing by Q3 of 2018.

The relocation and expansion will allow the company to offer a full integrated pharmaceutical development service, from early feasibility studies through to cGMP manufacture to support clinical trials.

The extended range of capabilities includes: cGMP manufacturing for clinical trials, release testing and QP release; a range of additional powder handling and filling capabilities; enhanced dosage form development service; and expanded analytical service.

Constantia Flexibles Expands Southeast Asia Presence

Constantia Flexibles Group is investing in new technology at its flexible packaging subsidiary in Vietnam to expand its product portfolio. Ho Chi Minh City-based Oai Hung Manufacturing Joint Stock Co. will install a new printing machine and a laminator that represent a single-digit million euro investment.

The wide printing machine will have reverse printing capabilities and the duplex solvent-based adhesive laminator, which will be located in a cleanroom facility, is able to produce high-adhesion structures required for premium sachet and pouch laminates. The new technology is expected to go on stream during the second half of 2018.

"We are very happy with the integration of Oai Hung into our global network and the investment will open up new business opportunities in the buoyant Vietnamese and fast-growing Southeast Asia region," said Pierre-Henri Bruchon, executive vice president and head of the pharma division, Constantia Flexibles. "The new technology will allow Oai Hung to diversify its leading foil-based pharmaceutical portfolio based on GMP standards."

Constantia Flexibles' Pharma division is the world's second largest flexible packaging manufacturer for the pharmaceutical and home and personal care (HPC) industries. It operates production sites in Austria, Germany, Italy, Spain, the UK, Belgium and Vietnam. In 2016, Constantia Flexibles acquired 51% of Oai Hung, which is Vietnam's largest supplier of aluminum-based blister foil.

Thermo Fisher to Build Pharma Services Facility

Thermo Fisher Scientific is expanding its footprint in the EU and investing $35 million in a state-of-the-art pharma services supply chain facility in Rheinfelden (Baden) Germany.

The new facility will leverage the latest technology and modern infrastructure to increase European capacity for cold and ambient clinical trial materials in support of complex clinical research and so meet the growing needs of customers. The facility will be scalable for mixed-use space and provide a strategic logistical location for shipping either by road or air.

The company expects to start construction in Q4 2018 for the 860,000 sq. ft. (8,000 square meter) facility at the 279,760 sq. ft. (26,000 square meter) site with an anticipated completion within 12 to 18 months. Once complete, this new facility will provide up to 200 new jobs locally. The investment includes the option for additional expansion with the potential for doubling the footprint.

"This is an exciting time for our business, and it reinforces our commitment to best serve our clients globally. By creating a best-in-class supply chain facility in the EU, we open new opportunities to support client and patient need," said Astrid Frank, vice president and general manager, Europe, Fisher Clinical Services.

The company's decision to expand is in response to a growing demand for global clinical supply services, worldwide. The new facility will also serve to address GDP guidelines, Clinical Trial Regulations Annex 6 and the new Falsified Medicines Directive 2019. This GMP/GDP facility builds on the company's existing footprint of 20 purpose-built cGMP facilities globally.

Special Report / Expansions in Cell Culture Facility Offerings

Recent investments show expansion activity in cell culture facilities.

The upstream cell culture sector has seen expansion activity recently as some contract biomanufacturers invest in their cell culture facilities. Major projects announced in the past year include Lonza’s new Ibex solutions that the company is building in Visp, Switzerland, to support multiple technologies, including monoclonal antibody (mAb) cell culture, and FUJIFILM Diosynth Biotechnologies’ new cell culture laboratories in Teesside, UK, among others.

Lonza investment in modular facility

Lonza is building Ibex, a complex of five modular buildings providing 1,079,000 sq. ft. (100,000 m²⁾ of surface area. Construction began in June 2017. The first two buildings are due to be finished and ready for outfitting by mid-2018 and expected to be fully operational by 2020. In addition to Ibex, Lonza has previously built and licensed mammalian facilities in the United States, United Kingdom, Spain, and Singapore (1).

Ibex solutions is a new biological development and manufacturing concept that couples flexibility in facility build-out with tailored business models leveraging the company’s expertise and service network in Visp, according to Marc Funk, COO, Lonza Pharma & Biotech.

“Ibex biomanufacturing comprises a modular, technology-independent development and manufacturing complex that is capable of supporting activities across multiple technologies, including mammalian, microbial, cellular, and bio-conjugate, from late drug discovery to manufacture,” Funk says.

The complex will be able to operate at capacities varying from single-use to large scale, depending on customer requirements, according to Funk.

In addition to infrastructure and know-how, Ibex offers flexible models to match and adapt to individual customers’ expectations and forecasts, according to Funk. The availability of a modular complex with pre-built shells means time-to-market can be reduced by 12 months or more, he asserts.

One of the two initially finished buildings at the new complex will be occupied by Sanofi, Funk says. This move is in line with a joint venture that Sanofi and Lonza entered into in February 2017. The two companies are jointly investing approximately CHF290 million (US$298 million), split equally between them, for the joint venture (2). The second of the two buildings will house a mix of customer-dedicated suites and have capacity for polysuites.

FUJIFILM cell culture laboratory expansion

In the third quarter of 2017, FUJIFILM Diosynth Biotechnologies, a biologics contract development and manufacturing organization (BioCDMO), opened 10,000 ft² of newly built cell-culture process development laboratories in Wilton Centre, Teesside, UK. The laboratories were built through a JPY 1-billion (US$8.9-million) investment, part of a greater JPY 14-billion (US$125-million) expansion announced by the BioCDMO’s parent company, FUJIFILM Corporation, in April 2017 (3).

The Wilton facility is located close to the company’s site in Billingham, UK, which allows for easy access to both facilities.

“There is great scientific talent in the Northeast of England which is a perfect synergy with the Process Development expertise that we have been developing over the past 25 years,” says a FUJIFILM official. “We are excited to be part of a growing industry and the part we play in growing our industry.”

Although the BioCDMO says it has intention to invest further in growing its process development capabilities, it has no concrete new investment plans at present.

The new laboratories are dedicated to supporting activities in the company’s Saturn mAb Platform, which is designed to enable rapid access to process development and manufacturing capacity.

“The foundation of FUJIFILM Diosynth’s Saturn mAb Platform was built on its 25+ years of analytical and process development and manufacturing experience. The platform has built-in best practices, from our Apollo expression system to the latest high throughput process development technologies for process development,” the official says.

“The platform is adaptable to customer’s existing cell lines as well. Once the platform has been proven to work for a customer’s monoclonal antibody, FDB [FUJIFILM Diosynth Biotechnologies] de-risks the production as we will guarantee performance,” the official adds.

“From a GMP [good manufacturing practice] perspective, the Saturn mAb Platform offers a dedicated high-capacity mAb-only manufacturing facility with a simplified off-the-shelf supply chain and batch documentation,” the official explains.

In addition to the Wilton facility, FUJIFILM Corporation’s overall JPY 14-billion (US$125-million) investment includes an expansion in the US at its site in Texas. The company completed a JPY 10-billion (US$89-million) cGMP production facility in April 2017 for its FUJIFILM Diosynth Biotechnologies Texas (FDBT) unit.

This facility was built in part with funding from the Biomedical Advanced Research and Development Authority, an office of the US Department of Health and Human Services. FUJIFILM plans to invest an additional JPY 3 billion (US$27 million) to outfit the Texas facility with mammalian cell-culture bioreactors (4).

The FDBT facility is scheduled to start operation in 2018 and will be the manufacturing center of excellence for the Saturn mAb Platform. It will have an initial cell-culture capacity of 6000 L via three 2000-L bioreactors. The facility is designed to allow for future expansion that can accommodate up to 24,000 L of upstream capacity to meet clinical and commercial demands.

FDBT was acquired by FUJIFILM in 2014 through its FUJIFILM Diosynth Biotechnologies USA subsidiary and became a wholly owned subsidiary in March 2017.

Other cell culture investments

In addition to Lonza and FUJIFILM, Sartorius Stedim Cellca, a part of Sartorius Stedim Biotech, also recently announced an investment in a new cell culture facility.

In September 2017, the company started construction on a new EUR 30-million (US$36-million) Cell Culture Technology Center in Eselberg, Germany, which is scheduled to be completed by the end of 2019. The location of the new facility places it in the northwestern scientific hub headquartered in Ulm, Germany (5).

The company has thus far been operating in a rented building in Laupheim, Germany. The new facility will approximately double the company’s space, and the new location will provide closer proximity to universities and research institutes in Ulm’s Science Park, according to the company.

The company purchased the property, which spans more than 64,560 sq. ft. (6000 m²⁾, at Science Park III in Eselberg in November 2016. The Cell Culture Technology Center can be expanded by a further 53,800 sq. ft. (5000 m²⁾⁾ as needed, according to the company.

Sartorius Stedim Cellca, which develops cell lines and protein production processes, licenses technologies for the production of proteins, and offers cell culture media, currently employs around 90 people. The company intends to expand its workforce to more than 120 people over the medium term (5).

Further investment in cell culture capabilities includes pharma major Novartis. In August 2016, Jacobs Engineering Group, a provider of technical, professional, and construction services, was awarded a $100-million contract to expand Novartis’ biotechnology center in Huningue, France. The expansion project is scheduled to be completed by 2020 and adds cell-culture bioreactors to the site (6).

Jacobs is providing engineering, procurement, and construction management services and will increase the site’s production capacity by 70%.

In addition, it will create a second line of purification that allows for multiple drugs to be manufactured simultaneously. At 376,600 sq. ft. (35,000 m²⁾, Novartis’ Huningue site houses one of the largest production facilities for mAbs produced from mammalian cells (6).

Another expansion move involves Sumitomo Dainippon Pharma, an Osaka, Japan-based pharmaceutical company, which boosted its cell-culture production capabilities.

In April 2017, the company formed a deal with Hitachi, a Japanese business solutions provider, to supply automated cell mass-culture equipment for regenerative medicine using human induced pluripotent stem (iPS) cells (7).

The equipment supplied supports Sumitomo’s research into making practical use of dopaminergic neural progenitor cells. The equipment consists of single-use consumables, such as bottles, tubes, and cell culture dishes.

The iPS cells can be cultured and differentiated efficiently because they can be manufactured in large amounts automatically and be observed under closed sterile environment, according to Hitachi (7).

In addition to supplying the equipment, Hitachi has formed a joint research deal with Sumitomo to evaluate the validity of processing methods that will be adjusted for practical use of the automated cell culture equipment.

The companies aim to use the equipment for the clinical treatment of patients with Parkinson’s disease with human iPS cells. iPS cells have the ability to be developed into different types of tissues and organs and can be potentially used as regenerative medicine to repair wounded cells.

References

1. Lonza, “Lonza Pharma&Biotech Launches Ibex Solutions—An Innovative New Concept in Biological Manufacturing and Development [2],” Press Release, July 26, 2017.
2. Lonza, “Sanofi and Lonza Enter into a Strategic Partnership to Establish a Large-Scale Biologics Production Facility [3],” Press Release, Feb. 27, 2017.
3. FUJIFILM Diosynth Biotechnologies, “FUJIFILM Diosynth Biotechnologies Opens Dedicated State-Of-The-Art Cell Culture Process Development Laboratories in Wilton Centre [4],” Press Release, Sep. 12, 2017.
4. FUJIFILM, “FUJIFILM Increases Production Capacity and Establishes New Process Development Facilities with JPY14 Billion ($130M USD) Investment to Support Growing Market Demand [5],” Press Release, Apr. 18, 2017.
5. Sartorius Stedim Biotech, “Ground-Breaking Ceremony for Sartorius Stedim Cellca [6],” Press Release, Sep. 28, 2017.
6. Jacobs, “Jacobs Awarded Contract for Novartis Biotechnology Center Expansion in France [7],” Press Release, Aug. 11, 2016.
7. Hitachi, “Hitachi is Selected by Sumitomo Dainippon Pharma for Automated Cell Mass Culture Equipment for Regenerative Medicine Using Human iPS Cells [8],” Press Release, Apr. 10, 2017.

Article Details

BioPharm International
Volume 31, Number 1
January 2018
Pages 20–22

Citation

When referring to this article, please cite as Feliza. Mirasol, “Expansions in Cell Culture Facility Offerings,” BioPharm International 31 (1) 2018.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com