PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Regeneron to invest in Rensselaer

Regeneron plans to invest approximately $800 million over seven years to expand its laboratory space, manufacturing capacity, and warehouse facilities at its Rensselaer, NY campus. The expansion will create 1,500 new full-time jobs in the area.

New York State, Empire State Development offered the company as much as$140 million in performance-based incentives, including $70 million in Excelsior Job Program tax credits. Regeneron markets Eylea for retinal diseases, which had $3.7 billion in sales in 2017. Regeneron is the largest biopharma company in New York State.

Regeneron president and chief executive officer Leonard Schleifer said, "Regeneron was founded as a proud New York company 30 years ago and we appreciate the continued commitment of Governor Cuomo's administration to make New York the ideal location to build and expand an innovative life science company. As our number of approved and investigational medicines continues to grow, our need for world-class manufacturing teams and facilities also increases. These state incentives, along with other state and federal policies, have helped Regeneron keep and expand our operations in New York State, which will benefit the local economy and help us achieve our mission of bringing new medicines to people with serious diseases."

Catalent Invests 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.

Krystal Biotech Opens Gene-Therapy Manufacturing Facility

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

On March 6, 2019, Krystal Biotech, a gene-therapy company specializing in dermatological diseases, officially opened Ancoris, a new cGMP facility at its headquarters in Pittsburgh, PA, for clinical and commercial manufacture of its lead product, KB103. A second, larger cGMP facility expected to be completed in 2020 to meet all anticipated future pipeline production requirements.

The new 4500-ft2 facility is designed to satisfy the necessary manufacturing requirements for clinical and commercial development of KB103, an “off-the-shelf” therapy being developed for people with dystrophic epidermolysis bullosa (DEB). KB103 is currently in a Phase II clinical study and data are expected in mid-2019.

In addition to the current cGMP facility, Krystal plans to initiate the second phase of its manufacturing strategy with plans to build a second, larger facility in Pittsburgh that will meet all anticipated future research, clinical, and commercial demand for future developmental pipeline products.

"Completing a successful trial run is another step towards our goal of becoming a fully-integrated gene therapy company and continue to fulfill our commitment to fundamentally treating rare skin diseases in a painless, convenient, and effective manner," said Suma M. Krishnan, founder and COO of Krystal, in a company press release. "This facility will be integral for our KB103 program, which we hope to rapidly progress through clinical testing as potentially the first-ever topically applied gene therapy for people suffering from DEB."

Cambrex Expands Analytical Capabilities at High Point

Cambrex Corp., a manufacturer of small molecule active pharmaceutical ingredients (APIs), and finished dosage forms, is investing $1 million at its High Point, NC site to add 1,300 sq.-ft. of analytical lab space and nine chemical research and development scientists, as well as six analytical research and development scientists. This investment follows the new $3.2 million, 11,000 sq.-ft. analytical lab, completed in April 2018.

The expansion will include the installation of an additional 10 ultra-performance liquid chromatography (UPLC) instruments, and is set to be completed by the end of 2018.

“Cambrex is seeing a significant increase in new projects, resulting in increased demand for analytical development capabilities within the Cambrex organization,” said Brian Swierenga, vice president, Operations and Site Director for Cambrex High Point. “This further expansion will not only increase Cambrex’s internal analytical capabilities and capacity, but will assist in getting new products to commercial launch faster.”

At the facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III. The site is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances.

The company has invested more than $9 million at the site since its acquisition of PhamaCore in 2016.

Rentschler Biopharma Completes Acquisition of U.S. Mfg. Site

Rentschler Biopharma SE, a CDMO for biopharmaceuticals, has completed the acquisition of a manufacturing facility from an affiliate of Shire plc. Rentschler Biopharma will continue to manufacture for Shire at the 93,000 sq.-ft. site in Milford, MA.

In addition, Rentschler Biopharma plans to further grow the development and manufacturing site to be leveraged as a CDMO for the development and manufacturing of complex biopharmaceuticals. The site has 70 employees that have been offered employment at the site. The site will be Rentschler Biopharma's first facility outside of Germany and a key part of the company's future growth plans. The purchase provides both expanded capacity and more flexibility to service client needs.

Dr. Frank Mathias, chief executive officer of Rentschler Biopharma, said, "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 U.S. 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."

Dr. Ralf Otto, chief operating officer 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."

Financial terms of the transaction were not disclosed.

PCI Invests in Automated Assembly of Autoinjectors

PCI Pharma Services (PCI) has unveiled plans to invest more than $20 million to support biologic medicines and advanced injectable delivery forms. PCI will begin by expanding its biotech clinical and commercial packaging and release testing capability at its Center of Excellence in Philadelphia. Part of the investment will also be used to expand cold chain capacity at numerous global locations to further support its existing biotech infrastructure.

The latest investment will include capacity expansion for cutting edge technologies for the labeling and assembly of state-of-the-art safety syringes, autoinjector and pen devices with integrated high speed cartoning, in-line serialization, as well as furthering its expansive onsite cold chain storage.

PCI’s injectable delivery form capabilities include ampoules, vials, cartridges and standard prefilled syringes, as well as advanced safety syringes, autoinjectors and pen devices with services including both simple and complex kitting for clinical and commercial applications. In handling biologic medicines, PCI maintains a comprehensive cold chain and ultra cold chain portfolio with temperature ranges from refrigerated 2-8°C, frozen -20°C, -40°C, -80°C and cryogenic temperatures of -196°C for advanced medicinal therapeutic products (ATMP), including cell and gene therapy medicines.

“I am pleased to share this news regarding our continued investment to support the needs of our biotech customers,” said Salim Haffar, chief executive officer, PCI. “It’s estimated that close to 40 percent of all medicines in pipeline development are biologic, and amazing new therapies are being developed and commercialized every day. With the development and commercialization wave of biologic medicines, the market is rapidly evolving. We are proud to be the partner of choice for drug development companies as they look to outsource these specialized requirements for clinical and commercial packaging.”

Fujifilm to Invest in Production

Fujifilm Corporation announced plans to invest approximately $90 million to expand its bio contract development and manufacturing organization (CDMO) business— Fujifilm Diosynth Biotechnologies (FDB). This investment will include the expansion of existing production facilities at its North Carolina location to support the growing needs of its customer portfolio. Additional investments are planned at the company’s other locations; details will be announced in the first quarter of 2019.

Fujifilm is investing in FDB’s facilities to increase production capacity to meet its growing customer demands. This new round of investments will include the addition of 2000L 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.

“We provide high-quality products and services through leading-edge, proprietary technologies in various fields,” said Takatoshi Ishikawa, director, senior vice president, general manager, bio CDMO division, Fujifilm Corporation. “Fujifilm is dedicated to supporting the biologics industry by providing flexible manufacturing capacity that supports our clients in getting medicines to patients.”

Wilmington Pharmatech to Expand

Wilmington PharmaTech, with locations in Newark, Delaware and Suzhou Jiangsu, China, is expanding – planning to hire up to 139 new employees and invest $18 million in a new state-of-the-science research and manufacturing facility, to be located on 2309 Sunset Lake Road in Newark, Delaware.

Wilmington PharmaTech, in operation since 2003, is a Contract Research/Manufacturing Organization that provides integrated services to pharmaceutical companies and biotech firms to expedite new pharmaceutical product development. One of their main offerings is manufacturing of Active Pharmaceutical Ingredients (API's) and related materials under cGMP, which is an important aspect in the drug development process that is required to ensure product quality and provide consistency during formulation and manufacture.

PharmaTech currently employs 37 full-time staff in the United States in several Newark locations including a 16,000 square foot building at 229A Lake Drive, a 50,000 square foot facility on Sunset Lake Road (previously owned by DuPont) and a 40,000 square foot building at Pencader Drive.

"Wilmington PharmaTech's expansion shows Delaware's distinctive strength in supporting biotechnology and pharmaceutical start-up companies and builds on a foundation that began more than 200 years ago with the DuPont Company," said Governor John Carney. "We remain committed to supporting job growth throughout Delaware."

Dr. Ke Li, PMP®, PharmaTech's Director of Operations, presented the company's growth plans to the Council on Development Finance (CDF) on Monday, February 25, including the plan to build a new, large-scale pharmaceutical production facility. Wilmington PharmaTech requested a $300,400 performance-based grant to support adding new jobs and a grant of $360,000 for assistance with capital costs.

"This marks the next wave of growth, positioning Wilmington PharmaTech as the leader in new drug manufacturing in the US," Said Hui-Yin Harry Li, Ph.D., President and CEO of Wilmington PharmaTech. "This expansion scales up operations and significantly enhances offerings to our clients in API manufacturing and related services. It also expands our portfolio of research, development, and potential commercial API services. PharmaTech's expansion plans fulfill the commitment to growth and its hallmark reputation for excellence for our employees, customers, partners and our community in the state of Delaware."

About Wilmington PharmaTech:

Wilmington PharmaTech is a fully integrated Contract Research/Manufacturing Organization (CRO/CMO) specializing in chemical process research and cGMP manufacturing, analytical method development and validation. The soon-to-be-built Active Pharmaceutical Ingredients (API) manufacturing will serve the growing pharmaceutical, biotech and virtual biotech startups and as a one-stop contract research and manufacturing service provider. T

About Delaware Prosperity Partnership:

Delaware Prosperity Partnership is a nonprofit that leads the state of Delaware's economic development efforts to attract, grow and retain businesses; to build a stronger entrepreneurial and innovation ecosystem; and to support private employers in identifying, recruiting and developing talent in the state of Delaware.

Mebane Vies for Investment as Becton Dickinson Expands

A company codenamed “Project Skywalker” may invest $175 million in Mebane, NC.

Chris Haughton with Becton Dickinson, a medical technology manufacturer that moved from Burlington to 1022 Corporate Park Drive, Mebane, in September, told the Mebane City Council on Monday, Dec. 3, that the company plans to expand its current facility by more than 300,000 square feet over five years.

The $175 million investment, which would focus on manufacturing sample collection devices, would create as many as 116 jobs with an average salary of $65,000. It’s expected that would result in an additional $305,700 in property taxes for the city over the next decade.

In return, Mebane will offer a total of $2,640,000 in cash grants and waive permit, system development and inspection fees. The council was excited for the project, which would be one of the largest in a number of years.

Mayor Glendel Stephenson asked whether BD would be able to hire people off the street and train them for these new positions.

Haughton explained that the company would need skilled workers with degrees in relevant fields, but that they’re hoping Alamance Community College can help.

“The new product lines are a significantly higher technology than what we manufacture today,” he said. “As a result, [the team] has reached out to the local community college to establish programs for job training to make sure we have the skill sets that we need because it’s difficult to hire someone off the street to run one of these lines, which are quite technologically complicated.”

Nothing is set in stone quite yet.

At its own meeting Monday, the county commissioners set a public hearing for 7 p.m. Dec. 17 to consider incentives for the company at the county level.

Alamance is competing with Sumter, S.C., for the project, but Haughton said Mebane has developed a reputation for being “one of the best places to do business in the United States” because of the trained labor force and access to highways.

A decision is hoped for by early or mid-January, 2020.

Brammer Bio Invests in Florida Facilities

To establish more than 30 suites for clinical and commercial viral vector supply for a broad pipeline of gene therapies

Brammer Bio, a viral vector contract development and manufacturing organization (CDMO), has implemented a three-year, $200 million investment program at its Alachua, FL facilities, that will establish more than 30 suites for clinical and commercial viral vector supply for a broad pipeline of gene therapies and gene-modified cell therapies.

“Brammer’s vision is to enable innovators to bring these advanced medicines to patients. We are committed to continuing our investment in our world-class team and facilities for manufacturing gene therapies,” said Brammer Bio president and chief executive officer Mark Bamforth. “Brammer is uniquely positioned to support the dramatic growth of the gene and cell therapy sector through the application of our team’s deep technical and operational experience in developing and manufacturing gene therapies and gene-modified cell therapies.”

This expansion follows a doubling of its clinical capacity in Alachua in 2017, where the company employs more than 220 staff in a three-building campus totaling 80,000 sq.-ft. The site incorporates equipment and design concepts for process and analytical development for clinical trials and ultimately commercial scale manufacturing.

Brammer is conducting a further expansion of its first commercial facility in Cambridge, MA, increasing the number of commercial suites from 7 to 12, supporting up to 2,000-liter suspension and adherent processes. Construction will be completed in 1H19. Brammer acquired its Cambridge facility, as well as a distribution center in Somerville, MA, from Biogen in January 2017. These facilities are operated by a team of over 250 providing suspension processes to produce multiple vector products in support of late-stage clinical programs leading to commercial supply.

In Lexington, MA, Brammer is renovating a 50,000 sq.-ft. facility as its second commercial facility for adherent processes using the Pall iCELLis 500 platform. Construction will be completed 1H19.

SGS to Expand North American Capabilities

SGS is investing more than $1.7 million to expand its North American biopharmaceutical testing capabilities at its Lincolnshire facility near Chicago, IL. The investment in both expertise and equipment, will extend the biopharmaceutical testing services offered by SGS’s current U.S. and Canadian Life Science facilities. The new services will focus on quality control analysis and stability testing of biopharmaceuticals using state-of-the-art methodologies and instrumentation. Installation of all equipment will be completed in 1Q19.

The site currently offers a wide range of analytical services, and has adapted 313 cubic meters of stability storage to meet the lower temperature regulatory requirements for peptides and proteins. This additional investment will allow SGS to offer greater capacity for GMP biologics testing capabilities in North America for its biopharmaceutical clients.

“Because of its strategic geographic location, in what is a rich cluster of biopharmaceutical companies, strengthening the capabilities at the Lincolnshire laboratory will allow SGS to act as a local partner for innovators looking for expertise in biopharmaceutical analysis,” said James Nokes, Vice President of U.S. Agriculture, Food and Life at SGS. “SGS maintains its commitment to invest in its network of laboratories to offer integrated solutions, and evolve for both the local and global needs of its clients.”

This new development is part of a wider program of investments in the company’s global laboratory network. In August 2017, SGS announced a 50% expansion of its Lincolnshire laboratory, growing its footprint to nearly 58,000 sq. ft. Increases in extractables and leachables capabilities have also taken place at Fairfield, New Jersey, and Shanghai, China; while French facilities at Poitiers and Villeneuve-la-Garenne have seen investment in bioanalytical capabilities and elemental analysis respectively.

Avista Upgrades Facility to Expand Testing Capabilities

Avista Pharma Solutions, a Massachusetts based CDMO, has announced plans to upgrade its facility in Agawam, Massachusetts to increase its offerings.

The upgrades will allow for Avista to expand its analytical chemistry suite along with its compendial and raw material testing capabilities.

A spokesperson from Avista said that, by being able to broaden the testing capabilities, it positions the Agawam site as a “preferred provider for microbiological and analytical testing of pharmaceuticals and medical devices.”

Additionally, the contract development and manufacturing organization (CDMO) will open an office in the Boston metro area. This office will be an extension of the company’s microbiology, analytical and cleanroom service options that are available at its Agawam facility.

The upgrades will include a new 950-square-foot lab space. While not a building upgrade, the company will now offer a courier service to ensure that time-sensitive sample pickups from client facilities in the area are delivered swiftly for testing.

The expansion and upgrades to the facilities will allow an undisclosed number of more employees to join the company.

Avista was unable to share financial information regarding this expansion but said that “this [investment] is a continuation of Avista’s overall capacity expansion across all locations.”

Trilink Biotechnologies to Relocate to Expand Operations

TriLink BioTechnologies, a subsidiary of Maravai, that provides gene therapy services to researchers, has announced it will relocate to expand the company’s operations.

The company signed a lease on a new facility in Sorrento Valley near San Diego, California. The lease includes an option to expand further dependent on future growth.

David Weber, chief commercial officer of Maravai, said that the main driver behind this relocation was the demand for product outpacing the company’s current capacity. “It’s pretty simple, we’re just wearing a pair of pants that are too tight, and when I say demand I mean demand for nucleic acid, DNA and RNA, complex products,” Weber explained.

Per the expansion, the company’s current good manufacturing practice (cGMP) production capabilities will be relocated, which Weber said are also in high demand because of the number of gene therapy and nucleic acid-based treatments entering into Phase I and II clinical trials.

“All of those are at the forefront today and have a lot of visibility and initial success and potential future success, in terms of impacting human health,” Weber said.

The new facility can accommodate growth to more than 350 R&D, commercial and manufacturing employees from the company’s current 150 employees. Weber said, “We expect employee growth to continue and, assuming demand continues at the pace of growth as it is now, we will likely have to take more space to accommodate more lab space, as well as more people.”

TriLink will move into half of the 180,000-square-foot building in the fall of 2019, with the relocation completed by the end of the year. Maravai said that its growth has been occurring rapidly since the company acquired TriLink and made investments in it beginning in August 2016.

IPS to Provide Engineering Solutions for Althea's New Mfg. Facility

Althea recently expanded operations to include manufacturing of highly potent drug products as well as ADCs

IPS-Integrated Project Services, a provider of engineering, procurement, construction management and validation (EPCMV) services, was selected by Ajinomoto Althea to design aseptic filling suites at their new manufacturing facility in San Diego, CA to support the growth of the company's fill and finish capabilities.

To meet client and industry demand, Althea expanded operations to include manufacturing of highly potent drug products as well as antibody drug conjugates (ADCs) by developing a new state-of-the-art facility. Their new facility has been designed for safe handling and manipulation of highly potent compounds with very low OEL (occupational exposure limit), while maintaining aseptic conditions and cGMP compliance. The new 57,000 square foot facility will offer services from formulation to fill-finish and will accommodate all stages of development from pre-clinical production through commercial supply. The manufacturing areas support bioconjugation, formulation, purification, quality control, and aseptic filling including lyophilization.

IPS provided the conceptual and detailed design services and evaluated previous construction plans to ensure operational effectiveness. Althea's completed facility will offer a simplified manufacturing supply chain by providing conjugation and fill finish services at a single U.S.-based location, which will become a model for the industry in safely manufacturing potent biopharmaceutical products.

"It's exciting for IPS to be a part of this important project that will provide new therapeutics to patients around the world," said Mark Butler, president of the Americas, IPS. "Bringing our expertise in the biopharmaceutical industry to support a leading contract development and manufacturing organization as Althea helping people live longer and healthier lives is what drives IPS and our employees."

PMI BioPharma Launches Research and Mfg. Facilities

PMI BioPharma Solutions, formed in January of 2018, has established research and manufacturing operations at multiple sites in Nashville and Celina, TN. A fully qualified staff and lab will offer services from targeted protein research to Phase III clinical trial supplies.

PMI BioPharma Solutions began as an internal research, development, and manufacturing site for Berg, LLC, and has since spun off from Berg, LLC and expanded to offer a full range of R&D services associated with drug discovery and development.

PMI Bio's protein sciences express and purify proteins and develop assays around protein targets using NMR, SPR, crystallography, ITC, (TR)FRET, and DSF. They provide high throughput library screens and design, develop and test drugs in vitro and in vivo. PMI Bio's clinical trial production capabilities include bulk liquid manufacturing, aseptic fill and finish and non-aseptic fill and finish for small to medium-scale batches.

"While PMI Bio can offer multiple research and development services for clients, our two distinct areas of expertise are fragment-based drug discovery services and aseptic manufacturing. PMI Bio also has years of expertise in nanosuspensions using microfluidization technologies. We believe we are well suited to provide competitive, flexible solutions across the drug development space," said chief executive officer David Sunseri, Ph.D.

Emergent Initiates Expansion

Emergent BioSolutions has initiated a $50m multi-year expansion at the company’s Baltimore, MD-based fill/finish facility.

The expansion, expected to be completed in 2021, will see the addition of a new isolator enclosed fill line.

Groninger & Co. will install the FlexPro 50 filler with isolator technology and an integrated Christ lyophilizer at the company's facility in Baltimore. The line will have the capability to fill vials, syringes, and cartridges.

Additionally, Emergent BioSolutions will be adding a second autoclave to increase its sterilization capacity and provide manufacturing redundancy.

The addition also will provide new cold storage space to support 2-8⁰c and -20⁰c requirements, new stability chambers, new media fill incubators, and additional warehousing and office space, according to the company.

An additional 60 new jobs are expected to be created in the next three years, according to the contract development and manufacturing organization (CDMO).

BJ Hull, vice president, general manager and site head at the Camden facility, said in a press release: “This $50 million investment further demonstrates our commitment to meeting and exceeding the expectations of our customers as well as to stimulating economic growth and creating jobs in Baltimore.”

New Life Science Building at University of Washington

The University of Washington Biology department educates more STEM students than any other program in the state, and now it has a new centerpiece in the Perkins+Will-designed Life Science Building (LSB). The 207,000 sq. ft. facility features a separate 20,000 sq. ft. research and teaching greenhouse with 2,400 species of plants, and will eventually include a direct connection to the LSB.

LSB was designed for team-focused collaboration with offices, laboratories, and common-use spaces in close proximity to each other. The research and teaching areas are open, modular, and flexible to adapt to emerging research questions that require new methods and instruments. A suspended staircase with oversized landing areas further encourages collaboration while a courtyard and rooftop deck provide outdoors space for students and staff. Perhaps LSB’s most unique element is its elevator core that is wrapped in custom-milled slabs from 200-foot Douglas fir trees.

LSB is tracking to LEED Gold and features sustainability elements such as vertical glass solar fins on its exterior, operable windows for natural ventilation, chilled beams and waves, a water reclamation system for greenhouse irrigation, radiant floors, and rooftop solar panels. The vertical solar glass fins alone are anticipated to generate enough electricity to light more than 12,400 sf of offices throughout the year.

In addition to Perkins+Will, the build team included: Coughlin Porter Lundeen (SE and CE), Affiliated Engineers (mechanical and electrical engineering), Skanska USA (general contractor), McKinstry (mechanical contractor), VECA Electric (electrical contractor), and Gustafson Guthrie Nichol (landscape architect).

Astellas Invests in Cell Therapy Manufacturing

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.

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.

Amgen Begins Work on Biomanufacturing Site

Amgen has broken ground on the construction of its West Greenwich, Rhode Island-based 120,000-square-foot biomanufacturing facility.

The plant will cost $200m (€173m) and is slated to be completed in 2020, after plans were announced earlier this year due to the capital freed up by US tax reforms.

In the press release announcing the beginning of construction, Amgen refers to the facility as “next-generation” and so we contacted a spokesperson for the company to find out exactly what that means.

Building upon details revealed in the initial announcement, which noted that it could be built in half of the time of a traditional plant and operate at approximately half of the cost, the spokesperson revealed that the plant would feature: “a highly flexible, modular design which can be replicated in future facilities, and enables Amgen to increase production capabilities reliably with greater speed, productivity and flexibility.”

In fact, the construction of the facility is based on Amgen’s existing biomanufacturing facility in Singapore. The spokesperson stated that this facility boasts the following advantages over standard manufacturing facilities:

Details:

Next-generation facility size:

Approximately 75% size reduction with the same active gram output

Speed & Implementation:

¼ capital cost

½ construction time

Operability:

½ operating expense

Eliminates infrastructure for cleaning and sterilization of ~45 miles of pipe

Sustainability:

75% reduction in CO2 emissions

80% less energy and water consumed

Greater flexibility

One of the advantages of the site is that the equipment within is portable, smaller and disposable, which the spokesperson suggested “provides greater flexibility and speed when manufacturing different drug substances simultaneously”.

“This eliminates costly and complex retrofitting inherent in standard facilities and allows Amgen to respond to changing demands with increased agility,” the spokesperson added.

In regard to what products will be produced at the facility, the spokesperson was not able to reveal any details except that the facility would provide for the US and global market.

The new facility will create 150 jobs at the facility in Rhode Island, adding to the current 625 staff members employed at Amgen’s Rhode Island campus. To date, Amgen has invested $1.5 billion on the campus.

Novartis Doubles Investment in Avexis North Carolina Site

In addition to the $55m previously invested, Novartis will spend a further $60m in expanding AveXis’ site in North Carolina enabling the manufacture of multiple gene therapies simultaneously.

AveXis announced plans to create the manufacturing facility in North Carolina in June 2018, a project that would create 200 new jobs for the state.

“We welcome the new jobs and investment that AveXis brings to our region,” said North Carolina Representative, Zack Hawkins. “These jobs will add vitality to our community as this company works to bring new hope to families facing difficult health challenges.”

In return for Novartis’ investment, after it acquired AveXis in April 2018, the state government will provide the company $1.4m (€1.23m) reimbursement over 12 years, depending on tax revenues generated by the positions created at the facility.

Expansion in the Research Triangle Park area follows on from similar decisions by GSK, Biogen and Accord Healthcare.

Total investment by Novartis will reach $115m for the Durham site, which looks set to expand manufacturing capacity ahead of potential approval of AveXis lead candidate, Zolgensma (onasemnogene abeparvovec).

The gene therapy is currently being evaluated by the US Food and Drug Administration (FDA) under priority review for the treatment of spinal muscular atrophy (SMA).

“Our primary focus is to bring gene therapies to patients suffering from devastating rare neurological genetic diseases, such as SMA, genetic amyotrophic lateral sclerosis and Rett syndrome. Continued investment in our infrastructure in North Carolina will allow us to manufacture multiple gene therapies simultaneously, helping us reach more patients, faster,” said Andy Stober, chief technical officer of AveXis.

A decision by the FDA is expected by May 2019 on Zolgensma, and would potentially emerge as a competitor to the only current treatment on the market, Biogen’s Spinraza (nusinersen).

Allogene Builds Allogeneic CAR-T Site

Allogene enters a lease agreement to develop a 118,000 sq. ft. site for the manufacture of allogeneic CAR-T therapies.

The San Francisco, US, based company is aiming to take on a portion of its manufacturing responsibility by building a site to provide clinical trial supply, and potentially the commercial supply of AlloCAR T product.

Allogene Therapeutics anticipates the facility will be completed by March 2020, at which point the lease will officially begin. The company has signed a 15-year lease, with the option to extend by 10 years, dependent upon certain conditions.

Under the terms of the lease agreement, Allogene will pay $159,150 (€140,071) per month, with a 3% increase each year.

Currently, the company uses a contract manufacturing organization (CMO) for the manufacture of its clinical trial supply, which will remain a part of its long-term manufacturing plans, according to a statement.

Allogene’s activity in the chimeric antigen receptor (CAR)-T space will be watched closely, after it was founded by David Chang and Arie Belldegrun, former CMO and CEO of Kite, respectively.

Being able to produce CAR-T therapies through donated T cells, rather than through the process currently employed of using the patient’s own cells, could simplify the manufacturing process and prove more convenient for patients.

Current methods of manufacturing consistent, on-spec autologous CAR-T treatments has proven difficult, leading Novartis to divert investment away from traditional production to focus on its process for Kymriah (tisagenlecleucel).

Allogene acquired its pipeline of allogeneic products from Pfizer, which included 16 preclinical assets and lead candidate, UCART19. As a part of the deal, Pfizer holds a 25% stake in Allogene.

Cellectis is also eligible to receive clinical and commercial milestone payments, after Pfizer used its platform to build its CAR-T portfolio, including UCART19.

However, Allogene is not the only company in the race to bring an allogeneic CAR-T treatment through to market.

Celyad recently became the first company to have its application for investigational new drug designation for its non-gene edited allogeneic CAR-T accepted. Janssen is also working in the space, through its partnership with Transposagen.

REST OF WORLD

Thousand Oaks Expands Bio CDMO Business

Thousand Oaks Biopharmaceuticals, an integrated global chemistry, manufacturing and controls (CMC) organization including GMP cell culture media and biomanufacturing capabilities, has closed a $45 million Series A financing round to advance its phase II contract development and manufacturing organization (CDMO) operations; at the same it has started construction of its large-scale cell culture media (LSCCM) cGMP manufacturing facilities based in Haimen, Nantong, a part of greater Shanghai, China.

“Upon completion of the Series A financing, we are pleased that our achievements to date and promising future have been recognized by several renowned investors, including New Alliance Capital, ADDOR Capital, and Tenyall & Sumin,” said Shun Luo, chairman of Thousand Oaks. “This round of financing allows us to expand our integrated CMC services and to increase current media production capacity by building the world’s largest cell culture medium manufacturing facility.

We are very excited about this opportunity to further enhance our capabilities in CMC value chain including cell line development, process and bioanalytical development, and customized cell culture media development, so as to establish an integrated platform from DNA to clinical material supplies and successful regulatory filings, leading towards commercial manufacturing. We are able to establish strategic partnerships with customers to effectively accelerate the speed of biologics development from bench to market, benefit patients worldwide. Our goal is to become world class CMC organization enabling our partners to provide affordable and accessible biologics for humanity.”

Fujifilm to Acquire Large-Scale Biologics Manufacturing Site from Biogen

FUJIFILM Corporation announced that it has entered into an agreement to acquire Biogen (Denmark) Manufacturing ApS, a large-scale biologics manufacturing site located in Hillerød near Copenhagen, Denmark ("Biogen Hillerød") from Biogen for approximately US$890 million in cash. Upon closure of this transaction, Biogen Hillerød will become Fujifilm's fourth biopharmaceutical contract development and manufacturing site. The existing workforce at the site, which consists of approximately 800 employees, will be retained by Fujifilm. FUJIFILM Diosynth Biotechnologies, a leading Contract Development and Manufacturing Organization ("CDMO") with expertise in the development and manufacture of biologics and advanced therapies is responsible for all of the Fujifilm biopharmaceutical CDMO sites.

Biogen Hillerød is equipped with 6 x 15,000L bioreactors for the manufacture of cell culture derived biologics. This facility will significantly expand the capacity and capabilities of Fujifilm and provides a line of sight to large production volumes through "scale up", thus complimenting the current "scale out" manufacturing model implemented under its Saturn™mAb services. This acquisition demonstrates the clear focus of Fujifilm to deliver on its strategy to support projects from pre-clinical through commercialization with best in class assets capable of delivering very small to very large production volumes. FUJIFILM Diosynth Biotechnologies currently provides a line of sight to large scale production capacity (20,000L) for microbial derived biologics*, through its partnership with MSD, Brinny.

"At Fujifilm, our goal has always been to bring new value to society, through innovation and the creation of new technologies, products and services. We are pleased to contribute to the growing healthcare industry through this investment," said Shigetaka Komori, chairman and chief executive officer of FUJIFILM Corporation. "This significant investment demonstrates our continued commitment to grow the Bio CDMO Business and become an industry leader by combining resources of Biogen Hillerød and Fujifilm."

"Fujifilm is a well-respected leader in manufacturing biologics products and they share our pioneering culture," said Michel Vounatsos, Biogen's chief executive officer. "We are pleased to reach this agreement with them."

"We are proud to combine the talent and expertise of the Biogen Hillerød employees with FUJIFILM Diosynth Biotechnologies' capabilities as an industry-leading CDMO," said Paul McKenzie, Ph.D., executive vice president, pharmaceutical operations and technology at Biogen.

"We are so excited to welcome the Biogen Hillerød team into the FUJIFILM Diosynth Biotechnologies family," said Steve Bagshaw, chief executive officer of FUJIFILM Diosynth Biotechnologies. "These world-class facilities are rivalled only by the experience and capabilities of the Biogen Hillerød team with approximately 800 employees, and we look forward to leveraging these skills for the benefit of current and future customers."

Fujifilm has aggressively invested in its Bio CDMO business for increasing the production capacity and capability of process development at the sites of FUJIFILM Diosynth Biotechnologies in the U.S. and U.K. The company will extend the service of its Fill/Finish services in fiscal year ending March 2021 to include cGMP aseptic filling of recombinant proteins for its full service CDMO approach. In addition, it introduced next generation mammalian expression system, Apollo™ X that is capable of delivering industry leading titres in excess of 10 g/L. Through aggressive capital investment and the development of highly efficient and highly productive technologies, Fujifilm has expertise in the development and manufacture of a variety of biologics including recombinant proteins, monoclonal antibodies, viral vaccines and gene therapies, and it will continue to further expand the business.

In its pursuit to establish itself as a comprehensive healthcare company covering prevention, treatment and diagnosis, Fujifilm has made multiple strategic acquisitions over recent years that expand and diversify its healthcare portfolio; this was most recently demonstrated by the acquisition of Irvine Scientific, which became a Fujifilm company on June 1, 2018. The ability to identify and exploit synergies between its businesses is a key strength of Fujifilm and fundamental to its growth strategy.

This acquisition is expected to be completed around August 2019, subject to customary closing conditions, including the receipt of required regulatory approvals from competition authorities.

*1 Fujifilm signed an agreement for acquiring all shares of Biogen (Denmark) New Manufacturing ApS owned by Biogen Luxemburg Holding Sarl, which is wholly owned by Biogen. Through the agreement, Fujifilm will acquire all shares in Biogen (Denmark) Manufacturing ApS, which is wholly owned by Biogen (Denmark) New Manufacturing ApS.

*2 Subject to the quantity of incoming orders of Biogen Hillerød.

*3 Cell culture derived biologics are therapeutic drugs expressed by multicellular eukaryotes, whereas microbial derived biologics are therapeutic drugs expressed by single cellular prokaryotes.

*4 "Scale up" refers to a volumetric increase of a single production batch. "Scale out" refers to the production of replicate batches.

*5 SaturnTM mAb Solutions are services provided by FDB that provide a streamlined and cost effective approach for the development and manufacture of monoclonal antibodies.

About FUJIFILM Corporation:

FUJIFILM Corporation, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2018, the company had global revenues of $23.0 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship.

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham and Redcar, UK, RTP, North Carolina and College Station, Texas. FUJIFILM Diosynth has over twenty five years of experience in the development and manufacturing of recombinant proteins, gene therapies, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.

Bilfinger Delivers a Pharmaceutical Production Plant to Russia

Bilfinger Industrietechnik Salzburg, a subsidiary of the Bilfinger Group, has been awarded a contract by the Russian pharma company NovaMedica for the design and construction of three solution-preparation lines for the production of sterile, pharmaceutical dosage forms. This is the first contract Bilfinger Industrietechnik Salzburg has secured in Russia. The production facility to be constructed will turn out chemical and biochemical products, emulsions, and cytostatic agents under aseptic conditions.

Duncan Hall, Bilfinger’s Chief Operating Officer: “For us, Russia is a market of strategic interest. The production of pharmaceuticals increasingly is being localized as part of the Russian government’s ‘Pharma 2030’ strategy. This creates demand for high-end pharmaceutical production facilities, which is precisely what we have to offer in our engineering portfolio.”

The scope of delivery will include 15 mixing and buffer tanks with a capacity of up to 1,000 liters, as well as several isolators. Bilfinger will be responsible for the engineering, mechanical and electrical fabrication, automation and re-assembly work, as well as for on-site commissioning and acceptance testing (SAT). The fully automated production plant will be planned and built on the basis of an aseptic design and will meet the cGMP standards as well as the strictest international and Russian standards of quality. It will be controlled by means of a modern software system. The construction project is to be completed in 2020 and the first medicinal products are scheduled to be greenlit for industrial production in 2023.

The production plant will be installed in a newly built pharmaceutical complex within the Vorsino industrial park in the Kaluga region, 190 km southwest of Moscow.

The Russian pharmaceuticals firm NovaMedica was founded in 2012 by Domain Associates LLC, a leading US venture capital firm, together with RUSNANO, JSC. The company’s mission is to acquire intellectual property rights for innovative pharmaceutical products and technologies for the Russian market, to develop and implement its own R& D projects, and to build modern and GMP-compliant pharmaceutical production facilities.

Bilfinger Industrietechnik Salzburg specializes in the development and construction of process plants for the pharma and biopharma industry. Its range of products encompasses bioreactors and fermentation systems, as well as systems for the preparation and purification of solutions, downstream skids, CIP/SIP systems and water generation plants.

Pall Corp. Establishes Biotech CoE in Shanghai

Pall Corp. has established a Biotech Integrated Solutions Center of Excellence (CoE) in Shanghai, China. The CoE is a new facility for bioprocess engineering consultancy, technology demonstration, testing and training for China and broader Asia.

The facility is equipped with advanced bioprocessing equipment and automation platforms, and technological solutions for biomanufacturing, including single-use cell culture solutions, cell clarification using acoustic wave technology, chromatography using automated packing techniques, viral clearance, tangential flow filtration and mixer / container modules. It is designed to lead customers through the sequential stages of process flow and will serve as a center for new technologies, as well as a training facility for customers and Pall employees.

“As the biopharmaceutical industry moves from traditional batch or single-use processing to continuous bioprocessing solutions, Pall is poised to help customers reduce process development and production costs and drive significant improvements in efficacy and productivity,” president of Pall Corp., Jennifer Honeycutt, explained.

“Our investment in the new Shanghai Centre of Excellence is designed to give Pall customers options ranging from batch to single use and continuous bioprocessing solutions, depending upon where customers are in their journey. The goal is to provide technology solutions that meet their current needs, while offering some of the most progressive technological solutions for the future.” added Honeycutt. “By opening this state-of-the-art facility, we hope to unlock new opportunities for our customers based in China, and for any global customers looking to enter or expand their operations in the Asia Pacific region.”

Wuxi Biologics Begins Construction of Facility in Ireland

WuXi Biologics has begun the construction of new biologics drug substance manufacturing facility in Ireland on the Industrial Development Authority’s (IDA) greenfield site in Mullagharlin, Dundalk, Co. Louth.

Being the company’s first site outside of China that is supported by the Irish Government through IDA Ireland, this state-of-the-art “facility of the future” is designed to run both traditional fed-batch or perfusion process and continuous bioprocessing, a next generation manufacturing technology to be first implemented globally in this 26-hectare campus. When completed, a total capacity of 48,000L fed-batch and 6,000L perfusion will be installed, representing one of the world’s largest facility using single-use bioreactors, according to the company.

“We are excited to witness the construction of WuXi Biologics’ first global site,” said Chris Chen, chief executive officer, WuXi Biologics. “The commencement of this new facility symbolizes the significant start of our global biomanufacturing network to make sure that biologics can be manufactured at the highest quality, providing a robust supply chain to benefit patients worldwide. With this new project, we can actively work with all local partners to build this state-of-the-art biomanufacturing facility as a showcase to the entire global biotech community.”

Lonza to Establish Bio Mfg. Base in China

Lonza entered an agreement with GE Healthcare under which GE will deliver a biologics facility to Lonza in Guangzhou. The facility is part of a larger biomanufacturing initiative between GE Healthcare and Guangzhou Development District (GDD), and the agreement will be finalized when contracts have been signed with the GDD. The new facility will give Lonza Pharma & Biotech a strategic base in China to provide high-quality CDMO services in the country. Lonza plans to hire and train more than 160 staff.

By working with GE Healthcare to develop the new facility, based on the KUBio platform, an off-the-shelf biologics factory, Lonza plans to offer its suite of antibody development services and manufacture GMP-certified batches by 2020. The two companies will on the design of the 182,920 sq. ft. (17,000m2) site, which will include 69,940 sq. ft. (6,500m2) of lab space and one KUBio facility.

The labs will house Lonza’s platforms for cell-line construction, including the GS Gene Expression System, as well as process development, cell banking and pilot labs. The KUBio unit will enable small-scale GMP manufacturing equipped with GE Healthcare’s single-use biomanufacturing technologies, including 1,000 and 2,000L bioreactors, combined with Lonza’s automation platforms for clinical and early-commercial supply.

“This partnership is the ideal way for Lonza to bring our expertise and technology to China,” said Marc Funk, chief operating officer Lonza Pharma & Biotech. “The combination of a strong and experienced technology provider with a long history in China, together with a dynamic regional authority, means that we can rapidly offer services to customers and ultimately get innovative therapies to patients more quickly.”

“With Lonza coming on site, a hub of biotech is truly taking shape,” said Emmanuel Ligner, president and chief executive officer, GE Healthcare Life Sciences. “This agreement is yet another step in realizing our vision of enabling and supporting manufacturers of all sizes to quickly deploy capacity and meet increasing customer demand for biologics.”

MilliporeSigma Opens New M Lab Collaboration Center in France

MilliporeSigma has opened its new M Lab Collaboration Center in Molsheim, France. The center is MilliporeSigma's first in Europe and ninth worldwide, providing biopharmaceutical manufacturers with a shared, exploratory environment where they can collaborate with company scientists and engineers to help solve their challenges and accelerate development and production of new therapies.

"With the rapidly growing biopharma industry in Europe and demand for cost-effective therapies worldwide, customers will benefit from our expertise to develop processes for manufacturing drugs faster, safer and more effectively," said Udit Batra, chief executive officer, MilliporeSigma. "Our investment will accelerate the future growth of EMEA's biopharmaceutical industry."

The company invested $11 million in the 43,000 sq. ft. M Lab Collaboration Center to provide customers with a fully equipped, non-GMP pilot and bench scale lab and meeting center to help address processing development challenges without impacting their production line.

The company also has M Lab Collaboration Centers in the U.S., Brazil, China, South Korea, Singapore, Japan and India.

FLAMMA Opens New cGMP Kilo Lab in Italy

Flamma SpA, a CDMO that develops, manufactures, and commercializes small molecule APIs for the pharmaceutical industry, has completed the construction of its first cGMP Kilo Lab at its Chignolo D’Isola headquarters in Italy.

The cGMP Kilo Lab is currently being used for an internal Flamma project in conjunction with its Flow Chemistry Pilot Unit. Customers with projects are reserving production slots for later in 2019.

This investment is part of the Flamma 2020 Plan to bring improvement across its network of manufacturing sites. This Chignolo site adds another option when working with Flamma’s API site.

GianMarco Negrisoli, corporate development manager at Flamma and chief executive officer of Flamma Innovation, said, “The opening of a cGMP kilo lab not only increases capabilities of our facility but also allows our customers greater flexibility in working with Flamma. The ability to place projects in Italy or China and knowing that Flamma is actively managing all our sites is comforting to our customer base.”

Flamma will also begin construction of its new R&D building at our headquarters in Chignolo later this year. “This will quadruple our R&D space thus allowing to continue to grow our staff of researchers to serve the pharma industry and the demands of our current customers as well as future customers,” noted Kenneth Drew, Ph.D., Sr. Director North America Sales and Business Development. “The additional benefit of this addition is the ability to have a fully dedicated analytical building for our growing quality team.”

ACG Group Further Invests in Brazil with New Factory

ACG Group highlighted its expanded footprint in Brazil through the launch of a new capsules manufacturing plant in Pouso Alegre-Minas Gerais.

This latest factory is the second for ACG Group within Brazil, following the company’s acquisition of Nova Nordeplast in 2017. Both regional sites will serve the Latin America (LATAM) and neighboring areas.

“ACG Capsules is one of the largest capsule manufacturers in the world, servicing pharmaceutical and nutraceutical customers in more than 100 countries,” said Selwyn Noronha, CEO ACG Capsules. “The company already has a significant presence in LATAM, and following this investment, ACG will further be able to meet the growing requirements of the region.”

“ACG is extremely proud of this new facility, which demonstrates our long-term commitment to Brazil. As the fifth largest pharmaceutical market in the world, Brazil is a key strategic one for ACG. And the benefit of having local manufacturing will certainly strengthen ties with our customers,” commented Roberson Petrungaro, commercial director—LATAM, ACG Capsules.

The new factory spans an area of 150,640 sq. ft. (14,000 m2) and complies with the standards defined by the Brazilian Health Regulatory Agency ANVISA & GMP regulatory bodies.

Parker Biosciences Filtration Boosts UK Site with Opening of New Cleanroom

Manufacturing capabilities have been enhanced at the site with the launch of a new ISO Class 7 cleanroom facility in Birtley, UK

Parker Biosciences Filtration has introduced an ISO Class 7 cleanroom at the new site in Birtley. The new cleanroom 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.

The new 6,456 sq. ft. (600 sq. m.) cleanroom will not only complement the existing cleanroom facilities but also provide additional manufacturing capacity for single-use technologies at the UK site. The site already has 25,824 sq. ft. (2,400 sq.m.) of cleanroom facilities dedicated to the manufacture of filtration products and single-use assemblies.

Parker Biosciences Filtrations is part of Parker Hannifin. It designs, supplies and delivers whole systems for both upstream and downstream pharmaceutical and biopharmaceutical manufacturing.

Commenting on the new cleanroom, Mike Brailsford, General Manager at Parker Bioscience Filtration, said it “will shorten the supply chain for our global customers and enhance our ability to meet growing market demand for single-use assemblies in the biopharmaceutical manufacturing sector.”

This facility is part of the phased investment program at the site and in tandem with the launch of the new cleanroom, the Birtley site is getting a new manufacturing area for single-use sensing technologies used in biopharmaceutical manufacturing.

Once completed, the overall investment will also see an expansion of Parker Bioscience Filtration’s laboratory, office and warehouse facilities, and will improve the site's capacity solutions in Europe, the Middle East and Africa.

Sanofi’s Vaccine Manufacturing Facility, Toronto, Ontario, Canada

French pharmaceutical company Sanofi Pasteur has unveiled plans to build a new vaccine manufacturing facility in Toronto, Ontario, Canada.

Sanofi will invest more than €350m ($432m) in the state-of-the-art vaccine plant, which is the company’s largest facility-based investment to date.

The project was announced in April 2018 and construction is expected to be completed in 2021. The new facility is expected to commence operations in 2023 and will double the company’s vaccines output.

The new facility will enable Sanofi to support its pediatric and booster vaccines capacity to meet growing demand in the market. It will also strengthen the company’s Canadian operations.

The project is expected to provide up to 1,250 jobs.

Sanofi’s vaccine manufacturing facility will be located at Sanofi Pasteur’s Connaught Campus in North Toronto, which is the company’s headquarters for Canadian vaccine production and research and development (R&D).

Canada was selected as the ideal location for the new facility due to its strong legacy in vaccine R&D.

With a built-up area of 150,000ft², the new plant will feature equipment to manufacture tetanus vaccines and the antigens needed for the treatment of diphtheria. It will also manufacture five-component acellular pertussis (5-acP) antigen, which was researched and developed in Canada.

“The new facility is expected to commence operations in 2023 and will double the company’s vaccines output.”

There is a growing demand for vaccines indicated for the treatment of whooping cough in children and adults. The new vaccine manufacturing facility will enable Sanofi to launch the whooping cough vaccine in more than 30 international markets.

Sanofi’s vaccine manufacturing facility will receive C$70m ($55.5m) from the governments of Canada and Ontario.

A total of C$20m ($15.8m) from the $70m funding will be provided by the federal economic development agency for Southern Ontario (FedDev Ontario) through the Advanced Manufacturing Fund (AMF), a development program that supports Ontario’s manufacturing sector.

The remaining C$50m ($39.7m) will be provided by the Government of Ontario through the Jobs and Prosperity Fund, which was created to promote R&D activity and finance projects related to pharmaceutical research in the state.

Sanofi has also requested the Economic Development Committee of Ontario to approve a property tax incentive under the Imagination, Manufacturing, Innovation and Technology (IMIT) program, a business incentive program that encourages new investment and employment.

Sanofi’s Toronto campus was initially founded as Antitoxin Laboratory in 1914 within the University of Toronto. It was later expanded by opening a pharmaceutical farm in North Toronto in 1917.

The company’s Toronto campus specializes in the development and manufacture of life-saving medicines for the US, Canada and other international markets. Spread across 54 acres, the campus includes office space, R&D labs and various vaccine manufacturing facilities. It employs approximately 1,400 people in industrial and commercial operations, and R&D.

The Toronto site manufactures nine products for serious bacterial infections such as pertussis, diphtheria and tetanus. Vaccines manufactured for these diseases include Pentacel®, Pediacel®, Adacel®, Adacel®-Polio, Quadracel®, Daptacel®, Td Adsorbed, Td Polio Adsorbed, and Tubersol®.

BeiGene Biologics Manufacturing Facility, Guangzhou

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

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

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

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

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

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

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

The new biologics facility will be a 24,000l commercial-scale facility developed on a 1,076,000 sq. ft. (100,000m²) site. It will use GE’s KuBio™ FlexFactory pre-fabricated manufacturing line to manufacture biologics.

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

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

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

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

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

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

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

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

Boehringer Ingelheim’s New Tablet Production Facility, Ingelheim

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Marketing commentary on Boehringer Ingelheim:

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

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

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

MSD’s Biologics Manufacturing Facility, Swords, Ireland

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

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

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

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

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

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

The existing 341,092 sq. ft. (31,700m²) facility will be expanded to a gross floor area of approximately 43,700m². An existing 139,880 sq. ft. (13,000m²) warehouse will also be extended and transformed for manufacturing operations.

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

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

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

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

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

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

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

Marketing commentary on MSD’s operations in Ireland:

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

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

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

Symbiosis Secures FDA Approval

Symbiosis Pharmaceutical Services has announced the FDA approval for its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK.

Symbiosis recently hosted a successful inspection by the United States Government Food and Drug Administration (FDA) for the aseptic manufacture of viral vector products for commercial supply into the U.S market at its GMP manufacturing facility, which has been licensed by the United Kingdom governments’ regulators, the MHRA, since 2012.

Colin MacKay, chief executive officer at Symbiosis Pharmaceutical Services, said, “This FDA inspection milestone is directly supportive of our recently reported success in being awarded a £1.9m (US$ 2.4 m) grant from the UK governments’ funding body, Innovate UK, which was directed at strengthening the position of Symbiosis as a center of excellence as part of the viral vector drug development supply chain, and firmly consolidating the commercial viral vector manufacturing capability of the UK as a global leader in this field."

Symbiosis has been sterile manufacturing advanced therapeutic biological products since 2014, and routinely fill finishes viral vectors into vials using validated, bespoke, aseptic processes before subsequent QC testing, QP certification and the managed shipment of the product back to the sponsor for onward process for use in clinical trials or commercial supply.

As well as the growth of its specialist viral vector filling services, Symbiosis also services the demand for sterile fill-finish of conventional small molecule drugs in both liquid and lyophilized formulations for use in clinical trials, and also has direct experience of supporting fast-track commercial product registration.

Beigene Adopts GE ‘Turnkey’ Factory for Production

BeiGene will use GE Healthcare Life Sciences’ ‘off-the-shelf’ factory to manufacture monoclonal antibodies in Guangdong Province, China.

BeiGene said it would adopt the KUBio factory to increase large-scale production of its immune-oncology therapies, including investigational anti-PD-1 monoclonal antibody (mAb), tislelizumab.

“Once approved, our commercial mAb products will [also] be manufactured there,” BeiGene spokesperson Liza Heapes said.

KUBio is a pre-engineered facility designed around GE technology, such as the firm’s single-use biomanufacturing facility, FlexFactory. The current good manufacturing practice (cGMP)-compliant, modular construction can be built in approximately 18 months, and according to GE, can yield higher productivity by increasing the number of lots manufactured.

The first phase of the facility, located in the Ghangzhou region, is expected to be completed and operational by the end of 2020.

BeiGene is familiar with GE Healthcare’s bioprocessing range, having adopted the company’s FlexFactory platform for its Suzhou mAb plant in 2015.

GE Healthcare has co-developed a number of biopharmaceutical sites in China, including Pfizer, JHL, Cellular Biomedicine Group (CBMG) and Clover Biopharmaceuticals, however according to GE’s manager of BioProcess, Olivier Loeillot, the firm continues to focus on the global market.

“We are operating and collaborating with biopharmaceutical companies globally. The Chinese market is growing fast and therefore we are seeing many KUBio and FlexFactory installations in China,” he said.

Röchling Group Marks Expansion in Neuhaus am Rennweg

Röchling Medical has ceremoniously marked the expansion of its site in Neuhaus am Rennweg, Germany.

With the fabrication of a new production building to scale up existing production capacity, Röchling is laying the groundwork for the future growth of its medical division.

With Vice-chairman of Röchling Group’s advisory board Dr Carl Peter Thürmel in attendance, the new building was ceremoniously opened by Röchling Group and Medical division CEO professor Hanns-Peter Knaebel, who transferred the building to BU director medical Europe Joachim Lehmann and to Managing director BU medical Europe Alexander Stauch.

The Röchling Group is investing €35m in its Neuhaus am Rennweg site, creating around 70 new jobs for specialists and managerial staff in the process. The production capacities of Röchling Medical Neuhaus are being increased significantly and the market position of the specialist in manufacturing primary packaging for the pharmaceutical and diagnostics industries is being strengthened considerably.

The Röchling Group launched the medical division in 2016 to support its industrial and automotive divisions, as well as setting the scene for a clear strategic focus on developing and manufacturing high-quality plastic products for pharmaceutical, diagnostics, surgical and life sciences applications.

Röchling Medical develops innovative solutions across these sectors, strengthening its market position worldwide. Through intensive marketing efforts, this has spurred Röchling Medical on to win major projects necessitating the expansion of production capacity in the area of co-extrusion blow molding.

At its site in Neuhaus am Rennweg, a new production building has been built that houses the manufacture of primary packaging for pharmaceutical products under ultra-modern Class good manufacturing practice (GMP) C 11,836 sq. ft. (approximately 1,100m²) and Class GMP D 5,380 sq. ft. (approximately 500m²) cleanroom conditions.

Cancer Research UK Launches New Research Hub For Biotherapeutics

Cancer Research UK has launched a global center of excellence in London to facilitate research on biotherapeutics as a treatment option for cancer.

The new Cancer Research UK City of London Centre has received a £14m investment from the non-profit cancer research organization.

Researchers from University College London (UCL), King’s College London, Queen Mary University of London and the Francis Crick Institute have joined the center. The participants comprise specialists in imaging, clinical trials and tumor evolution.

UCL center lead Tariq Enver said: “Cancer won’t be cured by a biologist or a clinician alone.

“We need physicists, chemists, engineers and mathematicians – researchers from many different disciplines – to come together to tackle the disease in new and innovative ways. The Cancer Research UK City of London Centre will be a catalyst for this scientific collaboration.”

The center will focus on personalized medicine and work towards developing new biological therapies, including combinations with existing treatments, as lasting cures for cancer.

In addition, the hub is expected to provide cancer patients with improved access to biological therapies and will carry out research on a variety of tumors, including childhood cancers.

Cancer Research UK chief clinician Charles Swanton said: “We now know more about the genetic diversity within tumors, how they evolve, and the body’s immune response to cancer, than ever before.

“There’s a huge opportunity to use this knowledge to develop novel biological therapies that combat tumor evolution and to inform how best to use them in combination with other cancer treatments.”

The researchers will devise an approach to potentially extend the use of immunotherapies from treating children to patients of all age groups, irrespective of their cancer type.

Furthermore, the center will aim to provide new opportunities for partnership and training.

MAT Delivers Containment Facility to UK University

Medical Air Technology (MAT) recently completed a high specification containment level 3 (CL3) facility for a leading UK university that wanted to expand its research capability. The new laboratory, situated on the top floor of the ten-story faculty building, was partially funded by charitable donations and is part of a major ongoing refurbishment program.

The biological research programs planned for the suite using known CL3 pathogens meant that compliance with Advisory Committee on Dangerous Pathogens (ACDP) and Specified Animal Pathogens Order (SAPO) standards and the Security of Laboratories (part 7 of the Anti-terrorism, Crime and Security Act 2001) was paramount.

MAT was involved from design through to commissioning and handover, working closely with the client to ensure that the design was tailored to suit their particular requirements and the limitations of the site.

The turnkey suite comprises of a dedicated LPS 1175 SR4 high security lobby and CL3 anteroom leading to a 807 sq. ft. (75m2) CL3 laboratory. A new CL2 laboratory of 506 sq. ft. (47m2) also forms part of the suite.

The ventilation design was for a 100% fresh air-conditioned air supply plant, integrated with microbiological Class II safety cabinets incorporating automatic air bypass to ensure a constant negative pressure suite. An emergency fail-safe air bypass arrangement linked to the roof-mounted AHU air supply plant ensures that in the event of an AHU shutdown, the suite is able to maintain negative pressure airflow.

MAT also installed dedicated CO2 supplies for incubators, full system controls and integrated building security systems. Integrated formaldehyde cabinet and laboratory fumigation systems enable the client to fumigate the safety cabinet and laboratories independently. CCTV, intruder and personnel safety alarms were included for extra security. The laboratory suite was also modified to suit disabled workers, with the addition of a washroom with disabled access.

The job presented particular challenges due to the location of the new laboratory on the top floor, for example the cabinet extract ductwork had to be installed through the roof of the facility, and much of the ductwork throughout the suite had to be fire rated. In addition, all work had to be undertaken around active laboratories within the faculty. Stringent health and safety, and installation methods ensured the works were carried out safely and the project completed on time and to budget.

Containment laboratories must be designed and built so as to prevent or control the exposure of laboratory workers, other persons and the environment to the biological agent in use.

A CL3 laboratory is required when handling human pathogens that may be transmitted via inhalation, that often have a low infectious dose to produce effects and that can cause serious or life-threatening disease. These pathogens include HIV, hepatitis B, yellow fever and rabies. CL3 laboratories are the highest containment level laboratories in common use in the UK and the point at which certain features to ensure appropriate containment must be incorporated into the design.

CL3 containment features primary and secondary barriers to minimize the release of infectious organisms into the immediate area and the environment. Every CL3 laboratory has two physical layers of containment:

The primary barrier, which contains the hazard at source through the use of equipment such as microbiological safety cabinets

The secondary barrier, which protects the people and the environment through a combination of design and operating procedures such as air handling and restriction of access.

The CL3 laboratory is an airtight, gas-tight, leak-proof room that uses specialized airflow design to prevent the escape of hazardous pathogens. Design and maintenance of these spaces is complex, and should only be carried out by a specialized contractor like MAT, with a thorough and proven understanding of the myriad of requirements and regulations and the ability to deliver a safe and compliant facility.

Telstar Supplies Isolators to Finnish Pharma Company

The life sciences equipment provider Telstar has delivered six high containment multi chamber, multi functional isolators to Orion.

All the isolators provided to the pharmaceutical company Orion, have been developed by Telstar as multi chamber units to contain specific operations related to sampling, dispensing, mixing and blending of multiple API’s, and excipients for a wide range of products.

The package of isolators was recently completed with a unit in which mixing of liquids and blending of powders were introduced into their process requirements. A challenging technical requisite solved by integration of a multi-purpose docking port for the mixing and blending requirements, a height adjustable ATEX rated mixer, heater pad and split butterfly valve.

A key challenge for all the projects was that the isolators had to be designed for multi-products, with multiple sizes and shapes of containers, including GMP and cleanability as one of the most relevant issues to avoid cross contamination. Telstar incorporated a semi-automatic detergent wash system to clean and dry the isolators in a short time for faster changeover from product to product.

In addition, the weighing requirements were very stringent and it was essential that the weighing system communicated directly with the dispensary management system of the pharmaceutical company. In some cases, the pharmaceutical process requires that the product be weighed into bags via split butterfly valves, however the exposure level the valves were capable of attaining was deemed too limited.

Consequently, Telstar enclosed the offload process in a dedicated isolator chamber, which presented additional ergonomic issues due to the operator position and the weights involved. To solve this issue Telstar provided a unique lifting system coupled with a live product weighing station.

Each and every isolator underwent thorough ergonomic trials with Orion’s operators to ensure all aspects of the processes involved were considered and indeed possible in the final design.

Finally, all the isolators have been designed and manufactured with multiple filtration and fan systems to maintain stringent operating parameters.

“One of the most positive points from all the five contracts is that the key people from Orion and Telstar have stayed the same throughout. The relationship and understanding of each other has developed over the last 6 years, including the workshop and site technicians at Telstar, who know exactly what the client expects from each isolator”, said Tony Rhodes, Sales Manager at Telstar's Technology Centre for Barrier Isolation System in Dewsbury,UK.

Fusion Antibodies CRO Awarded Invest NI Grant to Double Capacity, Workforce

The Northern Ireland development agency Invest NI has awarded Fusion Antibodies a grant worth up to £213,000 ($283,231), which will help the CRO double its capacity and employee count.

The grants – totaling up to £213,000 ($283,231) – were awarded by Invest Northern Ireland, a development agency for the Northern Ireland region which helps fund growing businesses and provides local support.

A spokesperson for Fusion Antibodies said the agency is a “significant shareholder in Fusion.”

Headquartered in the Belfast city center of Northern Ireland, Fusion Antibodies is a contract research organization (CRO) providing antibody engineering services.

“The funds will be used to create up to 28 additional jobs and support additional business development over the next 24 months,” said a company spokesperson.

With an additional 28 employees, Fusion Antibodies’ workforce is expected to reach 55.

“The grants will help to fund the expansion of the team and they are currently in the process of doubling the capacity of the laboratory and office space, which should be completed by the end of the summer,” the spokesperson added.

Awards and investments:

Fusion Antibodies announced receipt of a previous grant from Invest NI. Additionally, the CRO in May secured a Medical Research Council (MRC) award to develop a new antibody drug for the treatment of pancreatic cancer in collaboration with Queen’s University Belfast researchers at the Centre for Cancer Research and Cell Biology (CCRCB).

Fusion Antibodies became one of three companies in Northern Ireland to trade on the London Stock Exchange in December 2017, at which time it announced the plans for expansion. The company raised approximately £5.5m ($7.3) via a conditional placing through its nominated advisor and broker, Allenby Capital Ltd.

Primate Research Drives Alpha Genesis Expansion in Europe

Alpha Genesis is investing more than $2m in its European operations to help meet a demand for Zika, Ebola, and flu vaccine development.

The Alpha Genesis Primate Research Center (AGPRC), the research division of Alpha Genesis Incorporated (AGI), is expected to “take on” additional European business commitments, according to the company – as it looks to continue expansion efforts.

Greg Westergaard, PhD, AGI president and CEO, said the investment of more than $2m in staff and infrastructure has allowed the company “to make significant inroads across this highly competitive area.”

The expansion will support demand for new vaccines to combat diseases such as Zika, Ebola, and new flu strains, Westergaard said.

“The ability to conduct such research in Europe is more constrained than in the US, and Alpha Genesis employs scientists with specialized skills in high-demand research areas,” he added.

According to the company, it will conduct contract research projects with rhesus and cynomolgus macaques to accommodate “explosive demand for work with nonhuman primates across Europe.”

Westergaard expects demand for its research services to increase by an average of 20-25% per year over the next decade.

“Primate research is integral to the development of new cures for human diseases and is of great benefit to people of all ages throughout the world,” he said.

AGI said a number of its customers “will move an increased portion of their studies to AGI’s European outreach operation in 2019.”

According to the company, the move is expected to see AGI's European research business increase by more than 75% percent to more than $4m per annum over the next 18 months.

The company in 2016 invested $2m to expand its South Carolina facility and add 30 jobs to support its primate breeding capabilities

Wasdell Opening New Ireland-Based Facility

With plans to “futureproof” its service offerings, Wasdell is investing €30m in a testing and distribution facility in Ireland – a growing market and gateway into Europe and North America, says CEO.

The outsourcing services provider is opening a new facility in Dundalk, Ireland in Spring 2019 following a previously announced €30m ($34.7m) investment.

Wasdell will offer quality control (QC) import testing for pharmaceutical products as well as various current and novel packaging technologies with the addition of the 90,000 square foot facility.

The addition also will boost its storage and distribution services outside of its headquarters in the UK.

According to the company, the facility also will “futureproof” following a potential hard Brexit when the UK exits the European Union (EU) in March 2019.

“Having facilities in different countries gives you a lot of protection and allows for flexible operations. By implementing a global quality system across our sites, the standard of GMP [good manufacturing practice] will be consistent,” said Wasdell CEO Martin Tedham.

With a presence in Ireland, the company will be able to conduct EU release testing, to help ensure continuous customer supply regardless of Brexit negotiation outcomes.

“We will not be offering a partial solution by putting a limited scope MIA [manufacturing import application] in place and by building a facility with a full MIA we have the capability to manage customers complex supply chains,” said Tedham. “In short, they can take advantage of a full-service offering.”

Export business accounts for approximately 75% of Wasdell’s current turnover – and its customer base is expected to continue to grow significantly in the US, according to the company.

“The Irish market is interesting because it’s a very useful gateway not only into Europe but also into North America, which is helpful when doing business with US clients and why a lot of companies are establishing a presence there,” said Tedham.

“We chose Ireland because of these transport links, it’s ideal really given our customer base. In addition, we expect the Irish market to continue to grow over the next few years,” he added.

The facility – which broke ground August 2018 – is expected to create around 800 jobs, including senior management, as well as various roles across operations, quality, technical, commercial, financial, warehousing, laboratory, and production.

It is expected to be fully operational by spring 2019. Tedham said, “We currently have a number of customers that are filing products with the new facility, which is a good sign of things to come.”

Plans to build an additional facility close to the Dundalk site to expand the company’s distribution offering are also underway.

The new Dundalk facility is the most recent addition as part of the company’s investment plan to increase its capabilities and capacity. Wasdell in June of this year announced a new £500K ($642K) microbiological and analytical laboratory at its Newcastle, UK, site.

Avara Acquires Sterile Mfg. Facility from Sandoz

Avara Pharmaceutical Services has closed on the transaction with Sandoz to acquire the largest sterile manufacturing facility for injectable medicines in Canada, as part of a continuing expansion of its global footprint.

"This acquisition represents an important addition to the Avara portfolio and further expands our sterile processing capability, which is in very high demand," said Timothy C. Tyson, Avara's chairman and chief executive officer. "It comes with a market leading development capability and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements. We are excited to transition this Sandoz world class center of excellence into a world class center of excellence for the contract development manufacturing market."

The proposed acquisition of the sterile manufacturing facility and the adjacent development center located in Boucherville, Quebec, became effective as of September 1st. It follows Avara's acquisition of another sterile facility in the past year, one from Pfizer Inc. in Liscate, Italy, and one solid dose manufacturing facility from GlaxoSmithKline in Aiken, South Carolina. It will bring the number of manufacturing and development sites operated by Avara worldwide to ten: two in Canada; three in the United States, including corporate headquarters; one in Puerto Rico; one in the UK; one in Ireland; one in Italy; and one in France.

The Boucherville site is the biggest injectables production facility in Canada and provides a number of strategic and lifesaving medicines to the Canadian healthcare system, mostly hospitals. As part of the asset purchase agreement, the parties signed a long-term supply contract to guarantee continuous supply of products manufactured in Boucherville. No impact on jobs will occur and Avara intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base.

WHP Wins Contract with Oxford BioMedica for Cell and Gene Therapy Cleanrooms

New facilities will be constructed for Oxford BioMedica's viral vector manufacturing center. The project builds on WHP’s relationship with the British company

WHP Engineering has secured the design, construction and project management contract of a new viral vector manufacturing center for Oxford BioMedica. New cleanroom facilities will enable the gene and cell therapy company to expand its bioprocessing operations and manufacturing capabilities.

The new facility is being established in a former Royal Mail sorting office in Oxford, UK. Phases one and two of the expansion comprise the specialist conversion of the building into GMP cleanroom suites, fill and finish of the production areas, as well as completion of offices, warehousing and quality control laboratories.

The multi-disciplinary engineering company is responsible for both design and build, including testing and validation, which encompasses WHP’s integrated services. The design includes a full 3D building information model, including cleanroom architecture, HVAC, monitoring and evaluation systems, and process and critical utilities systems.

The specialist areas have been designed in full compliance with the Medicines and Healthcare products Regulatory Agency and conform to ISO cleanroom standards. This includes the use of zoned HVAC systems to maintain segregation, cleanliness, air pressures and other environmental controls. CT understands the cleanrooms will meet ISO 7 and 8 classification.

The WHP team have finalized the detailed design and is commencing construction.

Oxford BioMedica awarded WHP the contract for the design and installation of the original pilot plant for the LentiVector delivery platform at its Yarnton premises in 2015. As a result of the successful delivery and operation of this initial project, WHP was then appointed for this current, larger and more complex project.

Ian Lichfield, Chief Executive of WHP, said: “Continuing our association with Oxford BioMedica and being able to play a part in the successful development of these life-changing and cutting edge new medical technologies is fantastic for WHP.

“Every cleanroom development requires scrupulous attention to detail in terms of design, engineering and installation and it is particularly satisfying that the duty of care and quality of installation we provided on the original lentiviral vector manufacturing plant has resulted in our involvement in this new and exciting project.”

Oxford BioMedica expects long-term demand for these therapies. The new site has been designed to meet these needs.

WFS Pharmagreen Finalizes Blueprints For Cannabis Research And Production Facility

WFS Pharmagreen is in the final stages of plans for a new cannabis research and production facility. The wholly owned Canadian subsidiary of Pharmagreen Biotech has completed the design and is now finalizing engineering plans for the new building.

The 62,000 sq. ft. cannabis/botany biotech complex building nestled on 25 acres (10 hectares), near Vancouver, Canada is targeted for completion in the summer of 2019. The facility will use engineering and construction to create a secure, eco-friendly and semi-automated tissue culture, cleanroom laboratory, extraction and distillation, and research facility.

This cannabis biotech complex will provide for the annual in-vitro production and supply of over 10 million cannabis tissue cultured plantlets and ready-to-grow starter crops for licensed commercial grow operations, micro-cultivators as well as for the Canadian retail markets and the international markets with its licensed proprietary hemp strain plantlets.

Medicinal formulations researched and developed at the center will be made available under the Pharmagreen Biotech brand.

The licensing for the cannabis/botany biotech complex as both a dealer and producer is pending approval under Health Canada’s Access to cannabis for Medical Purposes Regulations and the Office of Controlled Substances. Upon approval, it will allow for several original, complimentary and cannabis services:

The cannabis/botany biotech complex will employ between 80-100 persons on site. The primary focus is to produce pesticide/fungicide-free, with no genetic drift tissue cultured plantlets using the proprietary in-vitro “Chibafreen Process”.

This micro-propagation technology developed by Botanical Research In Motion (BRIM) is for use by Pharmagreen in its biotech centers, for new growth plantlets from any existing plant strain while limiting genetic variance and mutation. It allows for large-scale production of precise and consistently robust quality suitable plantlets.

On site R&D at the center will continue to enhance existing micro-propagation techniques for cultured plantlets and help refine developing protocols for a variety of cannabis strains for indoor and outdoor cannabis growers. Application of this botanical tissue culture technology may also be adapted for any plant species to benefit sustainable agriculture needs beyond simply the various specific cannabis species.

BRIM has developed a proprietary industrial hemp strain named “CBD DANA” which will be made available for large-scale production for both domestic and international markets produced and sold via Pharmagreen’s biotech complex. This strain contains a high cannabidiol content of 10-20%, less than 0.3% THC and a unique profile of active terpene and alkamide entourage constituents.

Cold storage capacity utilizing (BRIM’s) proprietary Cold Storage technology will provide for long term plant tissue sample preservation and banking of specific live plantlet strains for future research and production, will be another service provided at the biotech complex.

Energy efficient greenhouse space will further allow for year-round nurseries safeguarding cultured and developing plants for all growing seasons.

The complex will provide analytic services, genomic characterization and testing of botanical material for industry certification and also include commercial-scale plant distillation and extraction capacity for producing botanical oils and other active medicinal constituents.

This complex may serve as a model for future build-outs in other parts of the country and abroad. Its facilities for large-scale production, research and storage of genetically identical, disease and pest-free plantlets with consistent and certifiable constituent properties, ensure the highest standards for safety and quality of cannabis as medicine.

Sanofi Manufactures Radiotherapy Nanoparticles

Sanofi agrees to produce French start-ups’ nanoparticle drug candidate indicated for the maximization of radiotherapy at its French site.

Per the agreement, Sanofi will manufacture, industrialize, and produce AGuIX – the radiosensitizing nanoparticle under clinical development for solid tumors, discovered by French start-up NH TherAGuIX.

Production of the drug will be done in both clinical and commercial batches by Sanofi at its Aramon, France site.

A spokesperson for Sanofi said that start-up companies are interested in partnering due to its industrialization capabilities and relationship with health authorities.

“On Sanofi’s side, working with innovative and agile partners enable us to improve our ways of working, to get involved on new technologies," they further explained.

Sanofi stated that its Aramon facility has been certified by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (JPMDA).

Géraldine Le Duc, CEO of NH TherAguix, said in a statement that this partnership will enable large scale batch production for clinical trials and will be a major step forward in the development of the company, “at the crucial moment as we enter Phase II.”

The first clinical batches of the product are expected in September 2019. The drug candidate will be entering a Phase II study on the indication of brain metastases.

AGuIXis a nanoparticle that, according to the spokesperson, could enhance the ratio between X-Ray dose delivered to the tumor and normal tissues during radiotherapy by interacting with the X-ray.

“Presently no drug that could interact with radiotherapy and maximize its effects are available for the patients” the spokesperson explained.

McIlvaine Company

Northfield, IL 60093-2743

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

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