PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Progenics Acquires Orphan Radiopharmaceuticals Manufacturing Facility

New York-based Progenics Pharmaceuticals has announced the acquisition of a facility in New Jersey for the manufacturing of Azedra (iobenguane I 131). The acquisition of the radiopharmaceutical establishment was worth about US$8 million.

Mark Baker, CEO of Progenics, said: “This strategic transaction extends our leadership position in radiopharmaceuticals, establishing the infrastructure and manufacturing capabilities to label multiple types of isotopes, including iodine-131. With this transaction, we are building the capabilities to ensure the supply of Azedra.”

Azedra is the first and only FDA-approved radiopharmaceutical indicated for the treatment of pheochromocytoma and paraganglioma, ultra-rare cancers. This Somerset site serves as the launch facility for Azedra, while also providing manufacturing support for the company’s development stage radiopharmaceuticals, including the drug, 1095.

Progenics, an oncology company developing medicines and imaging analysis technology for targeting and treating cancer, has also secured the long-term supply of iodine necessary for the production of both Azedra and 1095.

The production of Azedra uses a proprietary ultratrace process, which concentrates the meta-iodobenzylguanidine (MIBG) targeted radiolytic activity by eliminating non-therapeutic “cold” MIBG molecules, giving Azedra a uniquely high specific activity.

Novartis’ AveXis Manufacturing Investment

AveXis, which Novartis bought last year for $8.7 billion, will more than double manufacturing operations in the U.S. to make gene therapies.

As an FDA action date quickly approaches for a gene therapy that Novartis snatched up last year, the biotech that is developing the treatment says it needs to more than double the size of its new manufacturing operations. AveXis now plans to have 400 employees and invest about $115 million in the North Carolina site.

AveXis, which Novartis grabbed in an $8.7 billion deal, announced it will invest another $60 million and hire another 200 workers for the site it is building in Durham, North Carolina. That is on top of the $55 million it last year pledged to invest in the plant when it first projected it would hire 200 employees.

“Continued investment in our infrastructure in North Carolina will allow us to manufacture multiple gene therapies simultaneously, helping us reach more patients, faster,” Andy Stober, senior VP of technical operations, said in a statement.

Initial plans were for AveXis to build a 170,000-square-foot facility in Durham which would primarily produce drug substance, while a 50,000-square-foot plant the biotech has at its headquarters outside of Chicago was expected to produce both clinical and commercial product. Construction on the new Durham facility began last year and is slated be completed in the second half of 2020.

A spokeswoman for AveXis said in an email today that the additional investment will be used to further develop the existing space for additional capacity.

Now a unit of Novartis, AveXis is working on developing gene therapies for rare neurological diseases—such as SMA, genetic amyotrophic lateral sclerosis and Rett syndrome. Its initial candidate, Zolgensma, is a gene therapy targeted at spinal muscular atrophy, or SMA Type 1, which is the leading genetic cause of infant mortality. The therapy has been granted breakthrough therapy designation and a priority review by the FDA. Its regulatory action is expected in May this year.

Novartis CEO Vas Narasimhan is making a sizable bet on new therapies like gene treatments and radio-drug conjugates as the drugs of the future. In 2017, Novartis became the first drugmaker to win an approval globally for a cell therapy—Kymriah. The new drugs also come with new and tricky manufacturing methods. The rollout of Kymriah has been hindered by a manufacturing setback that the company is working to overcome.

Shortly after Kymriah’s approval, Gilead Sciences’ won an FDA OK for its CAR T treatment Yescarta. Since then, Spark Therapeutics has also won an approval for blindness gene therapy Luxturna.

AGC Triples U.S. Biopharmaceutical Production Capacity

Officials at Tokyo-based AGC say the company plans to install an additional twelve 2,000L single-use animal-cell bioreactors at their Seattle AGC Biologics site, as well as establish a new contract development and manufacturing facility for microbial manufacturing, which was previously only operated in Europe and Japan. AGC Biologics is a CDMO subsidiary of the company.

The expansion is expected to triple AGC’s biopharmaceutical production capacity in the US while also “ensuring seamless operation of microbial and animal cell-based biopharmaceutical CDMO activities across the Japan, Europe, and the US regions,” explains Takuya Shimamura, AGC’s president. The total investment of this expansion is estimated to be about $90 million, with full-scale operations slated from July 2020.

“To continue providing our customers consistent top-level quality and service, AGC intends to pursue necessary acquisitions and capital investments in the synthetic and biopharmaceutical business, adds Gustavo Mahler, CEO of AGC Biologics. “We expect significant growth in demand during the coming years. By maximizing synergies among our operations, AGC will continue to pursue its goal of being a leading company that supports pharmaceutical companies, medical patients, and all of society.”

Merck KGaA to Expand US Biopharma R&D Facility

On Feb. 6, 2019, Merck KGaA announced a $70-million investment to expand its R&D facility in Billerica, MA.

The new building will span 145,000 ft2 and offer new laboratory and collaborative working space to accommodate approximately 400 new and current R&D employees focused on oncology, immuno-oncology, and immunology. When construction is completed in 2021, the building will offer wet labs, office space, and a cafeteria for the campus.

The company reports that the building will also be constructed to meet Leadership in Energy and Environmental Design (LEED) and WELL certifications. LEED is a preeminent program for the design, construction, and operation of high-performance green buildings. WELL is a building standard focused on improving people's health and wellness through built environments.

"Our talented and passionate R&D teams based in Billerica have been highly engaged in advancing a number of pipeline compounds,” said Luciano Rossetti, MD, global head of R&D for the biopharma business of Merck KGaA, in a company press release. “We continue to strengthen our innovation footprint in both the US and Darmstadt, Germany, where our global R&D headquarters are located, with the goal of delivering transformational value to patients around the world.”

Merck KGaA’s US presence includes three businesses—Healthcare, Life Science, and Performance Materials—with nearly 10,000 employees working in R&D, manufacturing, and corporate roles across almost 60 sites nationwide. Within the state of Massachusetts, more than 2800 professionals work across 10 locations. With this latest project, the company will have invested more than $150 million in infrastructure to advance biopharmaceutical R&D in Massachusetts in recent years, with more than 150 new jobs added to its US R&D hub in Billerica since 2011.

New Astra Zeneca Facility in Delaware

Delle Donne & Associates is planning to construct the Fairfax Research Center in Wilmington, DE. The three-story, 526,552 sq. ft. building will be leased to Astra Zeneca Pharmaceuticals. Bernardon has been selected as the consulting architect. The project is valued At $105 million.

Catalent Invests $200 Million in Wisconsin and Indiana Sites

Catalent announced on Jan. 7, 2019 a $200-million investment in its biologics business to expand drug-substance manufacturing capacity and drug-product fill/finish capacity.

The investments, phased over a three-year program, will be carried out at the company’s biologics manufacturing sites in Madison, WI, and Bloomington, IN. This follows a December 2018 announcement to invest $14 million in packaging capabilities at the Bloomington site.

Mammalian cell-culture capacity will be increased at Madison with the build-out of two new suites, each with a 2 x 2000-liter single-use bioreactor system, providing additional clinical and commercial production capacity at the 2000- or 4000-liter batch scale as well new laboratories. Work is expected to be completed by mid-2021 and will more than double Catalent’s commercial biomanufacturing capacity, the company reports.

Additionally, fill/finish capacity at the Bloomington site will be expanded by 79,000 ft2, with both GMP and non-GMP capabilities. A high-speed flexible vial line, using both ready-to-use components and bulk filling at a filling speed of 300 units per minute, will be installed along with a high-speed flexible syringe/cartridge line with a filling speed of over 300 units per minute, and a fully automated vial inspection machine.

Opened in April 2013, Catalent Biologics’ Madison facility specializes in development, manufacturing, and analytical services for new biological entities and biosimilars. The facility houses the company’s proprietary GPEx cell-line development technology, used to create high-yielding mammalian cell lines. The Madison facility was designed for cGMP production from 10- to 4000-liter scale.

The company’s 875,000- ft2 biologics development and manufacturing facility in Bloomington has 900 employees with expertise in sterile formulation and extensive biomanufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges.

Fujifilm Invests in Biopharmaceutical Production Capacity

Fujifilm plans to invest approximately JPY 10 billion (approximately US$90 million) to expand its biopharmaceutical contract development and manufacturing organization (CDMO) business, FUJIFILM Diosynth Biotechnologies (FDB), the company announced on Jan. 7, 2019.

This investment will include the expansion of existing production facilities at its North Carolina location. Further investments are planned at the company’s other locations.

Investments will include the addition of 2000-L single-use cell-culture manufacturing trains, cell-culture purification suites, and new microbial recovery suites to its existing facilities in North Carolina. These additions will increase cell-culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50% at its North Carolina location. The company expects that the increased production capacity will be ready for cGMP manufacture by early 2020. Fujifilm has committed to grow its CDMO business to meet a JPY 100 billion sales target by March 2024.

Orchard Therapeutics Announces New Gene Therapy Manufacturing Facility

Orchard Therapeutics, a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that it has signed a long-term lease agreement to build-out a gene therapy manufacturing facility in Fremont, California. The new 150,000-square-foot facility significantly increases Orchard’s California footprint and adds to the Foster City and Menlo Park, California sites, which oversee the ongoing development and validation of the manufacture of Orchard’s ex vivo gene therapy product candidates.

Once operational, the new site will provide significant additional CGMP manufacturing capacity for both lentiviral vector and cryopreserved cell therapy products, enhancing Orchard’s ability to manufacture and deliver gene-corrected hematopoetic stem cells for a wide range of diseases on a global basis. In addition to this expanded capacity, Orchard also plans to continue its close collaborations with the Company’s contract manufacturing partners.

“The expansion of our California operations to now include a manufacturing facility is a critical step in advancing Orchard’s capabilities to supply products for our ex vivo gene therapy programs,” said Stewart Craig, Ph.D., chief manufacturing officer of Orchard. “We believe that this new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability 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.”

The build-out of Orchard’s new manufacturing facility is expected to begin in 2019, and the Company expects to hire more than 100 full-time employees over the next few years to support in-house manufacturing efforts.

“Orchard’s new California manufacturing facility will provide enhanced capacity and long-term supply in support of our extensive pipeline beyond the Company’s most advanced clinical programs,” said Mark Rothera, president and chief executive officer of Orchard. “We are pleased to continue our growth in the Bay Area and look forward to welcoming additional technical and management talent to join our mission of transforming patient’s lives through gene therapy.”

About Orchard:

Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies.

Pfizer’s Sterile Injectable Production Facility, Michigan

In June 2018, Pfizer announced plans to build a sterile injectables production facility at Portage in Kalamazoo County, Michigan, US.

The new sterile injectables production facility will be built with an estimated investment of $465m. It is part of Pfizer’s $5bn investment in US-based capital projects following the enactment of the Tax Cuts and Jobs Act, which reduced corporate tax to 10%.

Construction of the new facility is planned for mid-2019, while completion is scheduled for 2021. The new facility is expected to commence production in 2024, following validation by regulatory agencies.

The new plant will enable Pfizer to manufacture critical injectable medicines for patients worldwide. It will also support the company’s production and supply capacity.

The project is expected to generate approximately 450 jobs in Portage. The governing body of the Portage County estimates that the new facility will generate tax revenue of approximately $26m and have a regional impact of $49.2m over the next 15 years.

The new facility will be developed on a site located within Pfizer’s existing Portage campus in Kalamazoo County, Michigan.

“The facility will be equipped with multiple sterile, self-contained mobile manufacturing lines to manufacture injectable drugs.”

Pfizer selected south-west Michigan as the ideal location for the new facility due to the region’s favorable economy and manufacturing environment.

The new sterile injectable production facility will be a multistoried facility covering an area of 400,000ft². It will feature state-of-the-art modular aseptic processing technology, equipment and systems.

The facility will be equipped with multiple sterile, self-contained mobile manufacturing lines to manufacture injectable drugs. Each processing module in the facility will be entirely segregated from the remaining manufacturing lines. The design will enable Pfizer to meet with the latest US Federal Drug Administration’s directive to produce injectable drugs in sterile and self-contained production rooms.

The project is expected to require significant upgrades to the existing utilities and other infrastructure on the Portage site.

The Michigan Strategic Fund (MSF) is supporting the development by providing a $1m grant through Michigan Business Development Program, an incentive program that creates qualified new jobs.

Portage City Council will provide the company with industrial facilities tax exemption credits, which reduces property tax for 15 years.

Pfizer will also receive withholding tax capture valued at $10.5m for approximately ten years under the ‘Good Jobs for Michigan’ program, an incentive program aimed at attracting large-scale projects to the state.

A total of 354 out of the 450 jobs expected to be generated by the facility will qualify under the program.

The Pfizer Global Supply (PGS) campus in Kalamazoo County is used to produce sterile injectable drugs, liquids and semi-solid drugs, as well as active pharmaceutical ingredients (API).

Operating since 1948, the Portage site manufactures more than 150 products, including injectable anti-inflammatory medicine Solu-Medrol.

The site employs more than 2,200 people and is estimated to have an economic impact of $2.2bn in the region.

The new sterile injectable manufacturing plant will enable the Portage site to compete globally. Pfizer is also planning to invest $1.1bn in Kalamazoo County over the next five years to increase its sterile manufacturing capabilities and meet the growing demand for its products.

WuXi Biologics’ Biologics Production Facility, Massachusetts

WuXi Biologics plans to invest $60m in building the biologics production facility in Worcester.

In June 2018, Chinese biopharmaceutical company WuXi Biologics announced the development of a new production facility in Worcester, Massachusetts, US.

The company plans to establish the state-of-the-art clinical and commercial manufacturing facility with a $60m investment. It will be WuXi Biologics’ eleventh global drug substance manufacturing facility, its first overseas facility in the US and third outside China after Ireland and Singapore.

Development of the new facility is a part of WuXi Biologics’ global expansion strategy. The new site is expected to play a vital role in supporting the company’s global bio-manufacturing network, ensuring high-quality manufacturing of biologics to benefit patients globally.

WuXi Biologics is expected to hire approximately 150 people at the new facility.

The new production facility will be located in the Worcester Biomanufacturing Park at the site of the former Worcester State Hospital.

The Worcester Business Development Corporation (WBDC) has been reviving the area to increase biomanufacturing in the city, which was initiated five years ago.

Wuxi Biologics will be the first tenant at the biomanufacturing park and several of its partners are situated near the new site.

The WBDC plans to develop Worcester into a hub for biologic material manufacturing companies by demolishing old buildings and restoring roads.

The new production facility will span an area of up to 100,000ft² in size, including the installation of single-use bioreactors.

“Development of the new facility is a part of WuXi Biologics’ global expansion strategy.”

The facility will be equipped with a 4,500l bioreactor, two 2,000l conventional fed-batch cell cultures and one 500l perfusion-based continuous processing cell culture. An early-stage bioprocess development lab will also be incorporated.

The plant will be capable of handling continuous bioprocessing, a state-of-the-art manufacturing technology planned to be installed by WuXi Biologics for the first time in the US. The technology will be able to handle both clinical and small-volume commercial production.

The new production facility is supported by the Government of Massachusetts, the WBDC and the Massachusetts Life Sciences Center (MLSC).

WuXi Biologics is expected to receive more than $18m in state and local financial incentives, including a $5m state grant to a government agency in Worcester to develop the site for the facility and infrastructure such as roads in the property.

WBDC has leased the land to WuXi Biologics under an agreement that includes a rent abatement provision for five years. WuXi also expects to receive $1m in property tax relief from the Worcester city.

A $1m funding from the state is expected for more than four years to aid workforce training. A loan of $2.5m will be provided by the Massachusetts Development Finance Corporation to support furnishing and equip the building.

The local government also plans to provide personal property tax exemption of $7.5m. A tax waiver of up to $1m and a district improvement financing deal of $1.5m is also proposed.

WuXi Biologics:

WuXi Biologics is a global biologics service provider headquartered in China. Founded in 2014, the company is a subsidiary of WuXi App Tec.

In China, the company operates in Wuxi, Shanghai and Suzhou.

WuXi Biologics offers comprehensive, integrated and customizable services and solutions to the pharmaceutical and biotechnological companies worldwide. It assists the companies in the discovery, development and manufacturing of biologics.

Houston Methodist Hospital Embarks On Two Expansion, Renovation Projects

Houston Methodist Hospital has awarded two renovation and expansion projects to McCarthy Building Cos., Inc. A demolition, renovation, and expansion of the Houston Methodist Research Institute’s imaging suite and a build out of a new GMP cleanroom in the facility’s outpatient center will be the scope of the work in Houston.

A complete demolition on the first level, 16,500-square-foot imaging suite will begin at Houston Methodist Research Institute and the suite will be reconfigured and expanded. When completed, the unit will house three new pieces of imaging equipment.

The other project is a 5,000-square-foot demolition and build out of a new cleanroom on the third floor in the outpatient center. This will include approximately 1,500 square feet of a pre-fabricated GMP cleanroom space and 3,500 square feet of support spaces as well as renovations on level two and four.

Construction on both projects is expected to be complete in Spring 2019.

Plastikos Constructing New Facility

Plastikos announced today that it has started construction on a new 33,000-square-foot stand-alone medical manufacturing facility, located less than a quarter of a mile from the company’s Erie, Pa. headquarters.

Company officials expect the first phase of the project to finish in summer 2019.

Plastikos earlier in the decade expanded its existing headquarters by 17,000 square feet accommodate its medical business. But medical sales have since more than doubled, requiring additional cleanroom medical molding capacity.

The new facility will include a dedicated tool maintenance room, mold storage, metrology lab and office space. There will be 10 brand new medical injection molding machines, each with its own integrated three-axis robot and cavity pressure monitoring system.

Plastikos’ Manufacturing Manager, Rob Cooney, commented: “Our goal is to align this new molding facility with complementary capabilities and equipment that we currently utilize within Plastikos’ current ISO 7 cleanroom,” Plastikos’ manufacturing manager Rob Cooney said in a news release. “This standardization approach allows us to provide our medical customers with scheduling flexibility, along with several other proprietary benefits that we have seen in our earlier expansion efforts.”

Future phases of the expansion will include another 10 medical molding machines, bringing Plastikos’ total machine count to 55 molding machines.

“The new medical facility is being strategically designed to enable us to double the size of the new cleanroom molding floor, ultimately giving us the ability to accommodate 20 [additional] medical molding machines with another future planned expansion,” said Philip Katen, Plastikos president and general manager.

Arcturus Opens New R&D Facility

Arcturus Therapeutics Ltd., an RNA medicines company, has opened its new San Diego based research and development facility. The 24,700 sq. ft., San Diego facility, is more than twice the size of the company’s previous facility. It has approximately 80 employees and is designed to help Arcturus continue development and commercialization of therapeutics for rare, infectious, fibrotic and respiratory diseases with significant unmet medical need.

“San Diego is recognized as a center of excellence for the biotechnology industry, and Arcturus has been located here since its inception,” said Joseph Payne, president and chief executive officer of Arcturus. “We appreciate the numerous benefits of being a member of the San Diego biotech community and the increased access to a world-class pool of qualified science professionals.”

Recro Gainesville Adds New Facility

Recro Gainesville has added a 24,000-sq.-ft. facility, which includes high-potent material processing space, near its existing 97,000- sq.-ft. contract development and manufacturing plant. The company is a wholly owned subsidiary of Recro Pharma, Inc., and a provider of pharmaceutical solid oral dose development and manufacturing services.

The expanded capabilities will allow Recro Gainesville to provide a broader range of services from formulation and development through clinical trial material (CTM) production for Phase I and beyond.

In addition, a specialized area within the new site will be opened by the end of the year to support clients with development through commercialization for high-potency compounds, a growing category of pharmaceuticals, which includes many immune modulation and anti-cancer agents.

“The new square footage allows for early feasibility studies, enabling clients to quickly determine the best formulation path forward at laboratory scale, and subsequent scale-up to the GMP manufacture of CTMs,” said Scott Rizzo, general manager of Recro Gainesville. “This added development capability will save our clients both time and resources.”

Altasciences Expands Bioanalytical Lab

Altasciences has completed its bioanalytical lab expansion, which will be dedicated to ligand binding and cell-based assays. Altasciences has been growing its bioanalytical services and the added, state-of-the-art lab area ensures capacity for bioanalysis solutions for both preclinical and clinical clients.

The new, larger space, is fully equipped for cell-based neutralization and functional assays for biologics and vaccines, as well as additional capacity for cell lineage and functional immuno-phenotyping by flow cytometry to support preclinical and clinical studies.

“The extension of our bioanalytical laboratory ensures that we are equipped to continue providing the excellent bioanalytical services that Altasciences is known for. As demand for our services grows, we are committed to expanding our infrastructure and ensuring our usual, on-time delivery,” said Marie-Hélène Raigneau, Altasciences’ executive vice president, Research Services.

BMP Medical Opening New Medical Plastics Manufacturing Facility

BMP Medical, a division of Biomedical Polymers, has announced the opening of their new medical plastics manufacturing facility located in Sterling, Mass. BMP Medical is a plastic contract manufacturing partner to leading medical device and diagnostic OEMs. The new 80,000 sq. ft., state-of-the-art facility will be a premier destination for injection molding, injection blow molding, two-shot, insert molding, and other packaging and assembly manufacturing services.

The manufacturing facility will serve as a hub for making BMP Medical’s full range of plastic manufacturing services available to the growing medical device and diagnostic manufacturing OEM marketplace.

REST OF WORLD

Emergex Secures R&D Facility in Oxfordshire

England's Emergex has secured a state-of-the-art research and development (R&D) facility at Milton Park, in Oxfordshire. Headquartered in Oxford, Emergex is a biotechnology company pioneering a novel approach to the development of vaccines for infectious diseases.

In addition, Emergex has announced the appointment of Dr Phillip Williams as Chief Scientific Officer (CSO) to lead the company's R&D operations on site.

A nanotechnology expert, Dr Williams has extensive experience in the field of gold nanoparticle development and has been involved in the production and validation of the world’s first up-scaling methodologies for nanoparticles of this nature.

Prior to joining Emergex, Dr Williams served as Principal Scientist at Midatech Pharma.

Storme Moore-Thornicroft, co-founder and COO of Emergex commented, "On behalf of the management team, I would like to welcome Phil and our newly appointed team of scientists to Emergex. We are looking forward to working together to effectively progress our vaccine candidates through the development pathway. These appointments, along with securing and further enhancing our own operational capability via this new facility, represent a real and significant milestone in the evolution and growth of our business."

The Milton Park facility provides Emergex with its own fully equipped and resourced in-house R&D capabilities. This gives the company overall internal control of all its vaccine development program.

Furthermore, key personnel at the site, who are experienced in the design, production and development of nanoparticles, have joined Emergex.

"It is an exciting time to join Emergex as several of its vaccines advance through preclinical development," said Dr Williams.

"As well as being designed to provide long-lasting immunity and to be easily administered, Emergex’s vaccines can be rapidly produced for testing and then cost-effectively manufactured, a great feat in the vaccines industry and one of which I am proud to be a part," he concluded.

Meissner Announces New Manufacturing Facility

On Feb. 1, 2019, Meissner Filtration Products, a developer, manufacturer, and supplier of microfiltration and single-use systems, announced plans to establish a new manufacturing facility in County Mayo, Ireland.

Meissner will expand an existing 34,000-ft2 advanced technology building constructed by the Industrial Development Authority (IDA) Ireland in Castlebar to 100,000 ft2. The company has also purchased the adjacent land to more than triple the facility’s current footprint, and plans to install a large, state-of-the-art cleanroom within the existing facility to be used for the manufacture of single-use systems (SUS). The new facility is expected to be operational in the first quarter of 2020. Initial operations will include SUS manufacturing, quality and regulatory, engineering, and customer service.

“We have seen substantial growth in our SUS portfolio over the past 10 years, and ensuring we have capacity in excess of customer demand is critical,” stated Christopher Meissner, CEO of Meissner Filtration Products, in a company press release. “Additionally, we acutely recognize the value of manufacturing proximate to our customer base as well as geographically diversifying our manufacturing footprint.”

Currently, Meissner has a manufacturing campus in Camarillo, CA, and a European logistics hub outside of Frankfurt, Germany. The company reports that the Castlebar facility will be its first manufacturing facility in Europe, creating over 150 jobs over the next five years.

Rentschler Biopharma Completes Acquisition of US Manufacturing Site

Rentschler Biopharma, a contract development and manufacturing organization (CDMO) for biopharmaceuticals, completed the acquisition of a manufacturing facility from an affiliate of Shire, the company announced in a January 3, 2019 press release. The 93,000-ft2 site with approximately 70 employees is located near Boston in Milford, MA, and it is the German company’s first manufacturing facility in the United States. Under the terms of the agreement, Rentschler Biopharma will continue to manufacture for Shire at the site.

“The acquisition of this modern facility fits perfectly with our strategy to further strengthen and secure our world-class CDMO position in a growing and changing market. The US is a key market for Rentschler Biopharma, and this site gives us a firm foothold in this important area of growth, enabling us to better meet our clients’ needs,” said Frank Mathias, CEO of Rentschler Biopharma, in the press release.

Dr. Ralf Otto, COO of Rentschler Biopharma, added: “We will continue to make investments in our business to ensure we have the advanced technologies to remain an innovation leader in the field and the capacity to remain competitive and grow with our clients. This includes future plans to qualify the Milford site as a multi-product manufacturing facility.”

Parker Bioscience Expands Manufacturing of Single-Use Components

Parker Bioscience Filtration has expanded its manufacturing capabilities with the launch of a new ISO class 7 cleanroom facility at its site in Birtley, United Kingdom. The cleanroom, which opened this month, forms part of a major phased investment program at the Birtley site and will be dedicated to the manufacture of single-use assemblies used in biopharmaceutical manufacturing. The assemblies are supplied to customers fully assembled and pre-irradiated, ready for direct use in their cleanroom facilities in the manufacture of drug products.

In tandem with the launch of the new cleanroom, the Birtley site will add a new manufacturing area for single-use sensing technologies used in biopharmaceutical manufacturing. These allow users to monitor key process parameters such as temperature, pressure, and conductivity.

The new 6,456 sq. ft. (600-m2) cleanroom adds capacity for single-use technologies at the UK site, which already has 25,824 sq. ft. (2400 m2) of cleanroom facilities dedicated to the manufacture of filtration products and the manufacture of single-use assemblies. The new cleanroom strengthens the company’s ability to serve biopharmaceutical manufacturers in the European market and complements existing single-use assembly manufacturing operations in the United States. The company plans to also expand laboratory, office, and warehouse facilities at the Birtley site.

Parker Bioscience Filtration, which is part of Parker Hannifin, designs, supplies, and delivers whole systems for both upstream and downstream pharmaceutical and biopharmaceutical manufacturing. The company combines filtration, single-use fluid-handling systems, and sensors into automated single-use solutions.

Wood Wins Multi-Million Dollar Contract Supporting Glaxosmithkline In Germany

Wood is providing GSK Vaccines GmbH (GSK), part of GlaxoSmithKline Group, with engineering, procurement and construction management services for a new biotech facility to be built in Marburg, Germany.

The new multi-million dollar contract includes detailed design, procurement and subcontracting services, expediting and inspection of process equipment and packages, construction management, coordination of commissioning, engineering follow-up during construction, design qualification, as well as the overall project management.

Wood’s Environment & Infrastructure Solutions business has already completed outline design for the facility, which will produce bulk recombinant proteins used in meningitis vaccines. Completion of commissioning is scheduled for July 2019.

The contract builds on Wood’s 12-year relationship supporting GSK Vaccines GmbH across its global portfolio and is the second to be awarded under a five-year master agreement, signed in June 2016.

Robin Watson, Wood’s chief executive, said: “This new contract recognizes GSK’s confidence in our global capabilities and broad, innovative solutions, based on our strong track record of supporting them for over a decade in locations including Singapore, Belgium, Italy, France and Hungary.

“Our focus is applying our vast knowledge and expertise in designing and constructing vaccines facilities, to ensure the safe and efficient delivery of this significant project in Germany. We look forward to working in partnership with GSK on this contract, which is another significant step towards delivering our growth ambitions in the pharmaceuticals sector.”

Samsung Bioepis Expands in China Again

Samsung Bioepis announces licensing agreement with C-Bridge to bring ‘third-wave’ biosimilars to the Chinese market.

The partnership will see Samsung Bioepis license biosimilar candidates to C-Bridge Capital, including SB11 and SB12 – biosimilars to Lucentis (ranibizumab) and Soliris (eculizumab), respectively.

As part of the licensing agreement, C-Bridge, a venture capital company, will form its own biopharmaceutical company, which will be known as AffaMed Therapeutics.

Licensing Samsung Bioepis’ candidates will see C-Bridge pay an unspecified upfront fee, as well as royalties on any sales. The products will be commercialized exclusively in China.

“We want to play an important role in widening access to high-quality healthcare for patients throughout China. C-Bridge is the right partner for this mission as evidenced in its exceptional track record of successfully turning portfolio companies like AffaMed Therapeutics into leading biopharmaceutical companies in China and beyond,” said Christopher Hansung Ko, CEO of Samsung Bioepis.

C-Bridge revealed that it would gain access to the product SB3, which references Herceptin (trastuzumab) and has been approved by the US Food and Drug Administration and the European Medicines Agency.

The newly formed AffaMed Therapeutics will be led by Nathan Pang, who takes the position of CEO after previously being general manager for Sanofi China.

The deal marks the second time that Samsung Bioepis has reached out to companies in the Chinese market to commercialize pipeline products. Last month, the South Korean company agreed to partner with 3SBio, again for an undisclosed upfront fee, that will see the two firms work on clinical development and commercialization for the Chinese market.

The Chinese market for biologics is developing quickly due to regulatory changes in the country and the speeding up of the clinical trial process. This has led to more companies, such as Samsung Bioepis, making efforts to expand operation within the country.

ABEC to Supply China’s Biopharma Industry from Ireland

China has accredited ABEC to make and supply bioprocessing equipment from its Kells facility in Ireland.

The China Manufacture License (CML) recognizes ABEC’s Kells facility, located in County Meath, as a qualified manufacturer of pressure vessels and bioprocessing components. The plant is ABEC’s second to receive a CML, after its Missouri facility was accredited in 2010.

“ABEC was awarded the CML for its Kells facility after a rigorous audit of its vessel engineering, manufacturing and quality processes by the China Special Equipment Inspection & Research Institute,” said ABEC CEO Scott Pickering in a statement.

According to ABEC spokesperson Susan Cooper-Curcio, many clients in China will benefit from the CML, including WuXi Biologics, which recently added ABEC’s 4,000L bioreactors to its fully single-use site.

“We also see the Kells CML benefiting clients from outside of China who are investing there,” she added.

ABEC’s custom single-use range famously ‘broke the 2,000L plastic ceiling’ in 2015 with its 4,300L bioreactor, and again in 2017 with its 4,900L system.

This year, the firm has continued to invest in disposable technology, with an expansion of its Fermoy manufacturing facility in Ireland during February, and the addition of microbial fermentation capabilities to its single-use line in March.

Boehringer Ingelheim’s Integrated Asian Veterinary R&D Centre, Shanghai

Germany-based pharmaceutical company Boehringer Ingelheim’s veterinary research and development (R&D) center is located within its research and development (R&D) site in Shanghai, China.

Officially inaugurated in May 2018, the new facility was developed to strengthen the collaboration between Boehringer Ingelheim and animal health company Merial. The two companies officially merged in January 2017 and teams from both the firms now work together at the center.

Boehringer invested more than €19m ($22.7m) in the R&D center, which is the company’s third research facility. The other two are located in Europe and North America.

The R&D facility aims to develop solutions for the prevention and control of animal diseases in China and South East Asia.

The integrated R&D Centre is located in Shanghai’s Zhangjiang Hi-tech Park and covers an area of 35,508 sq.. ft. (3,300m²). The facility is currently involved in the discovery and development of 30 ongoing pipeline projects, which include some that have already reached a late phase of development.

Boehringer initially opened a veterinary research center in March 2012, which was focused on the development of solutions for livestock diseases. The center formed the base for the development of the new integrated R&D center.

The center is expected to launch five novel vaccines targeting the Chinese market by 2020. The veterinary R&D facility has recently launched innovative vaccines NNA and LDT3-A, which are indicated for the treatment of infectious bronchitis.

More than 110 researchers are currently working at the center.

The animal health business of the company develops vaccines, parasiticides and pharmaceuticals aiming to ensure that no animal suffers from a preventable disease. The unit is also engaged in the development of novel therapies for chronic diseases to manage and reduce disease progression in animals.

The biological R&D team of the unit is engaged in the production of vaccines for pigs, cattle, poultry, horses and companion animals.

China is considered the second biggest market for Boehringer’s animal health business unit. The region contributes to 6.4% of Boehringer’s global sales.

The new R&D facility was set up to further expand the presence of Boehringer’s animal health business in China. The company intends to collaborate with local academic institutions and universities to jointly contribute to the enhancement of its animal health industry in China.

Founded in 1885, Boehringer Ingelheim is one of the biggest pharmaceutical companies in the world. The company is headquartered in Ingelheim, Germany, and has 181 subsidiaries worldwide. It employs more than 50,000 people across all its facilities.

Boehringer operates a biologics manufacturing facility in Zhangjiang Hi-tech Park, which was opened in May 2017 with an investment of €70m ($76m). The company also opened an 8,000m² veterinary trial center in Taizhou in 2018.

Boehringer recorded revenue of approximately €18.1bn ($21.6bn) in 2017. The company invested approximately €3bn ($3.59bn) in R&D, which accounted for 17% of its total sales.

Boehringer’s animal health business unit has a sales turnover of more than €3.9bn ($4.6bn) and employs more than 10,000 team members worldwide.

Biogen’s Biologics Manufacturing Facility, Solothurn, Switzerland

Biogen’s new biologics manufacturing facility is being developed in Luterbach near Solothurn, Switzerland.

With an investment of approximately CHF1.5bn ($1.5bn), the state-of-the-art facility is aimed to meet increasing demand for high-quality protein-based drugs or biologics, which target severe neurodegenerative, haematological or autoimmune diseases. It is expected to triple Biogen’s biologics manufacturing capacity.

Biogen first announced plans to develop the facility in July 2015. The necessary land was acquired by the end of 2015 and a construction permit was granted in February 2016. A ground-breaking ceremony for the facility took place in January 2016. Operations are expected to be commenced in 2019.

The new facility is expected to create approximately 1,000 construction jobs and another 600 new jobs upon commencing operations.

Biogen’s biologics manufacturing facility is being constructed on the site of the former Borregaard pulp mill. The site was chosen as it fulfilled all the requirements for developing a sustainable biotechnology facility, including sufficient land.

Switzerland’s educational system, the availability of a skilled workforce and a supportive economic environment were other reasons considered when choosing the location.

The facility is also situated near Biogen’s international headquarters in Zug, Switzerland, and is expected to generate manufacturing synergies for the company.

Biogen’s biologics manufacturing facility is being constructed at a 258,240 sq. ft. (24,000m²) campus. The site will feature production buildings BMC1 and BMC2 along with a warehouse, laboratories and an office. The production blocks will be 28m-high and 60m-long.

“The new facility is expected to create approximately 1,000 construction jobs and another 600 new jobs upon commencing operations.”

The production building will also include an administrative block and supply building (CUB), as well as other smaller buildings, including a sprinkler control center and an emergency power system.

The new modular production facility will house two cell manufacturing lines, which will each be installed with four 15,000l bioreactors. The manufacturing lines will have a modular design, which will enable them to adapt to expansions to meet future manufacturing demands.

A total of 29,000m³ of concrete and 12,500t of steel is being used in the construction of the plant. The wall formwork of the building will be made of a system named Mammut 350. It will include a 3.5m high-format panel and have a formwork surface of 94 sq. ft. (8.75m²).

The production facility will require 101km-long pipes, 843km of cables, 2,600m-long dirt and rainwater pipes, four dirt and rainwater pumping stations, 600m-long extinguishing water pipes, 1,900m process wastewater pipes and 3,000m-long drinking water and hydrant pipes.

In addition, 250m of gas pipes, 45,000m-long electric cables and 85 electric shafts will be used.

The new ultra-modern facility is expected to produce biologics using a four-step production process. The first step will involve inoculation and seed train operations to culture the mammalian cells using cultivation vessels and bioreactors of different sizes.

The purification phase involves the removal of impurities using a series of purification steps to ensure the products’ purity and suitability to be used by humans. The product will then be transferred into specific containers and stabilized for final processing, which involves filling, labelling and packaging.

Jacobs was contracted to provide engineering, procurement and construction management (EPCM) services for the project, while ABEC was awarded a contract to provide the process equipment.

Burckhardt + Partner was subcontracted by Jacobs to coordinate the approval process, planning and realization of the administration building, while Mavo was commissioned to provide the design plan.

Marti Solothurn provided construction services, while Siemens provided building management platform Desigo CC.

MEVA Schalungs-Systeme provided the wall formwork and security system, while Bilfinger Industrial Services Schweiz was contracted to supply and install the heat and cold insulation for various plant components.

Other contractors involved in the project are WAM Planer und Ingenieure, Wanner, Terre Alpiq InTec, Gruner, Marti, STS Group, Geopoint, GRP Ingenieure, BSB + Partner, Farner Consulting, FOPPA and Amstein + Walthert Bern.

SGS Opening New Biopharma Testing Lab in Geneva

The analytical and bioanalytical contract solutions provider SGS is expanding its biopharmaceutical testing capabilities in Geneva, Switzerland.

SGS also provides Phase I-IV clinical trial management, with services including data management and statistics, PK/PD (pharmacokinetic/pharmacodynamic) modeling and simulation, pharmacovigilance, and regulatory consultancy.

The new 200 square meter laboratory, slated to open by the end of Q3 2018, will be equipped with several instruments and complements the company’s existing 8,608 sq. ft. (800 square meter) facility.

Upon completion, the laboratory will offer full ICH Q6B physico-chemical characterization of biological products.

According to SGS, the expansion responds to the “growing need for biopharmaceutical studies during the early and late phase of characterization, as required by the ICH guidelines.”

Services to be offered include circular dichroism (CD), Fourier-transform infrared spectroscopy (FTIR), extrinsic and intrinsic fluorescence, analytical ultracentrifugation (SV-AUC), size exclusion chromatography with multi-angle light scattering (SEC-MALS), dynamic light scattering (DLS), and differential scanning calorimetry (DSC).

“To fulfil regulatory requirements, the biopharmaceutical industry increasingly expects its contract service providers to offer comprehensive characterization capabilities from a single location,” said Luc-Alain Savoy, managing director of SGS Life Sciences Geneva in a press release.

Novartis Further Invests in Cell and Gene Therapy Manufacture

Novartis plans to step up its capabilities of manufacturing cell and gene therapies with a new facility to be built in Stein, Switzerland.

The new facility will be built at a cost of CHF90m (€79m) and is expected to be completed by early 2020.

In terms of positions created, the company announced that initially 260 new jobs will be created, and this could rise to 450 new positions over the next three years.

In addition to this facility, Novartis is currently expanding its cell and gene therapy manufacturing base – just last month, Novartis announced that it had signed a manufacturing agreement with Cell for Cure to manufacture Kymriah.

The Paris-based company will adopt the same manufacturing process as Novartis employs at its US-based Morris Plain facility to create Kymriah. In the same press release, Novartis revealed that it expects Cell for Cure to begin manufacturing Kymriah for clinical trials and commercial purposes in 2019.

Alongside Cell for Cure, Novartis had already established a manufacturing site in Leipzig, Germany, which produces the same treatment for clinical trials worldwide and conducts post-approval manufacturing.

Adding the Swiss-based facility to its European manufacturing network was revealed shortly after Novartis received approval for its chimeric antigen receptor t-cell (CAR-T) therapy by the European Commission.

The two pieces of news are linked, with the new facility expected to play a role in manufacturing cell therapies, including Kymriah, for European patients.

The treatment was approved for use in pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy.

This will require an established manufacturing process in Europe, though the company stated that it would begin to treat patients initially in B-cell ALL before being able to deliver to the second group of patients.

Wasdell Group Set to Open New Ireland Facility

The Wasdell Group is opening a new facility in Dundalk, Ireland in spring 2019 following a €30m investment.

The 90,000 sq. ft. facility will allow Wasdell to offer quality control (QC) import testing for pharmaceutical products, as well as a variety of current and novel packaging technologies. It will also boost its storage and distribution services outside of the UK.

The facility will also futureproof the company’s operations in the event of a hard Brexit when the UK exits the European Union (EU) in March 2019.

“With our new facility, we are not only increasing our packaging and analytical testing capacity to better service new and future customers, but with Brexit on the horizon, we are ensuring challenges and costs are minimized by preparing for every eventuality,” Martin Tedham, CEO at The Wasdell Group said. ”This investment will provide our customers with a robust contingency plan, protecting critical supply chains and ensuring continuous supply of pharmaceutical products post-March 2019.”

The Dundalk facility is the latest phase in Wasell’s investment plan to increase capability and capacity and follows the announcement of its new £500K microbological and analytical laboratory at its Newcastle, UK, site.

”The facility also demonstrates our investment into the future of Wasdell, strengthening and preparing the company for forecasted growth. And, as growing pharmaceutical hub, Ireland also offers an abundance of local talent from a recruitment perspective with strong universities that will be right on our doorstep,” Martin Tedham said.

Building work on the site, which is expected to operational by spring 2019, began in August 2018. The new facility is expected to create around 800 job ranging from senior management to roles across operations, quality, technical, commercial, financial, warehousing, laboratory and production.

The Wasdell Group is also planning to build an additional facility close to the Dundalk site to expand its distribution offering.

Boehringer Ingelheim Builds $100 Million Facility for Complex Solids

Boehringer Ingelheim has a new vision for its production of solid meds and has started building a $100 million R&D and manufacturing facility in Germany to realize it.

The German drugmaker is investing €85 million in its Solids Launch facility in Ingelheim, Germany that will both develop and manufacture more complex tablets for global launches. Meanwhile, it has been moving production of what it calls “older, easier-to-manufacture drugs” to other sites worldwide since 2016.

The new facility, which is slated to be online in 2020, will have 75 employees working there.

The facility will incorporate new manufacturing methods, including continuous production and a contained production train to handle higher potent compounds. It also will have a flexible layout that allows for rearrangements of rooms and equipment to speed production starts, spokesman Matthias Michael Reinig said in an email.

“In Ingelheim, we are thoroughly committed to investing in technologies and processes with high added value. This means that we are not only establishing the centerpiece for global market launches of pharmaceutical innovations here, but also that we will continue to manufacture drugs that require highly complex production technologies,” explained Stefan Rinn, country manager for Germany.

The company is also incorporating into its new launch strategy the €34 million so-called “diabetes factory” it completed last year. Boehringer Ingelheim said beginning in 2020, the production of those drugs will be relocated to other countries like Mexico and Greece and the facility repurposed from the innovative drug launches.

Sanner Plans Expansion in Hungary

The German company will upgrade its machinery park, opening up new capacity for product manufacture and creating more jobs

Sanner, based in Germany, will expand its manufacturing activities in Budapest, Hungary. By upgrading and optimizing the machinery park, the company is opening up capacities for new products and additional jobs. The company manufacturers packaging and components for pharmaceutical, medtech, diagnostics and healthcare products.

In the past few months Sanner Hungária Kft has laid the technical foundations for the expansion, working to optimize the existing capacity.

Soon, further injection molding capacities will be available for new products. Sanner also plans to manufacture the desiccant capsules AdCap at both sites in Bensheim, Germany and Budapest, Hungary.

Extending the automated, camera-based final inspection will add to an increased efficiency in quality management.

“All these steps strengthen the position of the Hungarian site within the Sanner group,” said Volker Pfitzenreiter, Head of Production Europe at Sanner.

Sanner Hungária Kft was established in 1995 and has become the second, equally qualified European manufacturing site of the Sanner group. The GMP-compliant, SAP-controlled production is certified according to ISO 9001, ISO 15378 and BRC. Each year, a production volume of roughly €5 million is realized at the site, two thirds of which is exported to other European countries.

“A positive error culture and actively involving the employees in the continuous optimization process is paramount,” Pfitzenreiter said.

“Only as a team can we achieve our growth goals and advance the location expansion in a positive working atmosphere. Due to the significant restructuring and optimization process, we are currently also looking for new colleagues, who want to become part of the Sanner team in Budapest.”

Hovione Expands Production Capacity of Oral Dosage Forms

The Portuguese CDMO has announced plans to improve production capacity by bringing in commercial scale equipment for blending, tableting and coating.

The new equipment will work alongside existing smaller scale equipment to offer customers a “one site shop” to take products through the development process to market.

The contract development and manufacturing organization (CDMO), headquartered in Loures, Portugal, began its expansion project in 2016 and stated that this will continue for the next five years.

The first step of this process began with moving its development services to a 7,000 m2 facility in Lisbon, where the company handles potent and highly potent compounds.

Frédéric Kahn, VP of marketing and sales at Hovione, explained, “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.”

The CDMO announced that the capacity expansion would be completed alongside the qualification of its continuous tableting line, which it expects to be completed by the end of 2018.

Hovione completed its continuous manufacturing installation at its New Jersey, US, site at the end of last year – after doubling the size of the development and manufacturing operations.

CRC Announces Contract Wins in Wales

Clean Room Construction (CRC) has said it has been awarded contracts to build various facilities across Wales. Details of these projects, however, have not been disclosed.

One project, CRC said, is to build a new manufacturing facility for MicroPharm, the antivenoms maker. A second project will see the company design a new ISO 8 cleanroom facility for Ortho Clinical Diagnostics (OCD) at Bridgend for its immuno-assay and immuno-haematology products.

CRC also said it will design, supply and install two separate airlocks for the blending/decanting area and main warehouse at Ecolab in Neath, including a goods inward inspection booth.

All three projects are scheduled for completion by spring 2019.

“Clean Room Construction is proud to be working with the best of British science and technology companies that are specialists in their respective fields, leading the way in identifying groundbreaking solutions for the manufacture of antivenoms, early screening of diseases and water hygiene solutions around the globe," said Steve Lawton, CRC Managing Director in a statement.

ILC Dover to Open New Production Facility in Blarney, Ireland

Flexible containment solutions provider ILC Dover is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland.

The building will be operational in Q1 2019 and outfitted with 4,000ft2 of ISO 7 cleanroom capacity and 6,500ft2 of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines.

When at full production, the company expects to hire 60-70 new ILC Dover employees.

The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.

ILC Dover’s president and CEO Fran DiNuzzo expressed enthusiasm about the new launch: “The expansion of our production capabilities in Ireland will allow us to better serve our global customer base and strengthen our position as the leading single-use powder handling solutions provider to the global pharmaceutical and biopharmaceutical marketplace.”

Vice-president and general manager of the company’s pharmaceutical division Curtis Gingles added “Clients of ILC Dover will be happy to see that we’re focused on providing additional capacity located in the region with expanded technical resources. The market for our products is experiencing incredible growth and this expansion will ensure we can keep up with the growing demand for the high-quality products used in manufacturing lifesaving therapies.”

In addition to production space, the new facility will contain state-of-the-art offices, meeting rooms and a product demonstration area for client visits.

Concept Life Sciences Expands GLP Capabilities

Concept Life Sciences, a drug discovery, development and analytical services company, has expanded its regulatory GLP (good laboratory practice) capabilities at its Dundee and Bradford sites. The MHRA has confirmed the extension of Dundee’s in vitro capabilities to cover a range of additional assays, and Bradford can now offer a range of integrated GLP regulatory studies to further support pharmaceuticals, medical devices and healthcare.

The services offered now covers compounds going through pre- and post-clinical regulation studies, eventually up to IND. The company’s regulatory offering now includes assays for enzyme activity, microsomal inhibition, metabolite identification, and cell culture, including hepatocyte induction studies.

The extension is part of a phased plan to expand GXP compliance (including GLP and GMP) at Concept’s facilities across the UK. Concept’s GXP compliance plan will increase the services it offers for the manufacture of API (active pharmaceutical ingredient) material, and enable the group to support the development of compounds from the discovery stage to full IND packages.

John Handley, chief operating officer, Concept Life Sciences, said, “The extension of our GLP accreditation by the MHRA in both Dundee and Bradford enables us to further expand the growing portfolio of services we offer to our clients. The accreditations reflect Concept’s ongoing strategy to implement GXP compliance across multiple sites, and to grow as a company.”

Astellas Invests in Cell Therapy Manufacturing Buildout

The company will construct two facilities in Japan and relocate its regenerative medicine facility in the US.

Astellas, headquartered in Japan, is bolstering its manufacturing capabilities for cell and gene therapies, in line with its R&D and investment push in the space.

In a statement, the company stated that it is engaged in research of “new modalities such as cell therapy, next-generation vaccines and gene therapy”. This strategy has seen the company acquire Quethera, a gene therapy company, and stem cell tech earlier in the year.

With its expanding portfolio, it announced two facilities would be built in Japan: a center for active ingredients for biopharmaceuticals and a center for the production of clinical trial materials (CTM).

The former will cost ¥10bn ($88.4m) and will occupy 86,080 sq. ft. (8,000 m²) of space in the Toyama prefecture. The construction is expected to be completed by September 2019, with the facility able to produce antibodies and cell therapies for the Japanese, US and European markets.

The latter will be based in Tsukuba and will see ¥5bn invested to enable the production of material for early-stage clinical trials, with the facility covering 19,368 sq. ft. (1,800 m²). The company explained that being able to produce its own clinical trial material would reduce development timelines once the facility is operational in March 2019.

“It will become possible for the company to supply CTM in a flexible and timely manner necessary to progress development programs in various modalities. This is expected to contribute to the shortening of the total time from development to product launch,” said the company in a statement.

Massachusetts relocation:

The biggest investment for the company will be the relocation and renovation of its Astellas Institute for Regenerative Medicine subsidiary in the US, costing ¥14bn. The plans will see the unit remain in the state of Massachusetts but move to a new location that holds a total floor space of 258,240 sq. ft. (24,000 m²).

The upgraded facility will be able to provide CTM in the field of regenerative medicine and cell therapy. According to the firm, the capacity of the site could be scaled up to meet the demands of commercial production. Work has already begun on the new site and will be finished in January 2020.

McIlvaine Company

Northfield, IL 60093-2743

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

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