PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Bio-Techne Announces Investment for New GMP Manufacturing Facility

Bio-Techne Corporation, a global leader in the development and manufacturing of Good Manufacturing Practices (GMP)-grade raw and ancillary reagents, announced a commitment to invest between $40 million and $50 million to expand its GMP-grade protein production capacity. This investment will fund a new facility that is specifically dedicated to supporting the large-scale production of GMP-grade materials, including E. coli-derived recombinant proteins, which are an essential component for many bioprocessing and cell therapy manufacturing workflows.

Cell and gene therapies show great promise for the future of disease treatment. The escalating number of clinical trials utilizing CAR-T cell-, hematopoietic stem cell-, mesenchymal stem cell- or pluripotent stem cell-based products emphasizes the need for the rapid global expansion of protein manufacturing. The current global GMP-grade raw material supply for cell therapy production and industrial large molecule manufacturing is not sufficient to meet future demands. By investing in a new state-of-the-art GMP manufacturing facility, Bio-Techne is anticipating and preparing for the growing demand of such raw material to support the recent and forecasted surge in Investigational New Drug (IND) filings for autologous and allogeneic cell therapies. This corporate infrastructure investment complements the 30-year history of Bio-Techne's R&D Systems™ brand as the industry leader in recombinant protein manufacturing.

Dave Eansor, President of Bio-Techne's Protein Sciences Segment, commented, "As the promising science behind emerging cell and gene therapy applications continues to demonstrate therapeutic effectiveness, the focus must now be on supply and scale. By investing in a new GMP facility, therapeutic manufacturers can be assured that the highly pure, bioactive R&D Systems GMP-grade proteins they rely on for their manufacturing process will continue to be available as their raw material demands increase through clinical trial, approval, and therapeutic commercialization."

Chuck Kummeth, President and CEO of Bio-Techne, commented, "The recent success of cell and gene therapies is very exciting. This investment solidifies our commitment to supporting the future of these new modalities by finding innovative and reliable ways to help companies gain access to scalable quantities and a reliable supply of high-quality, GMP-grade growth factors and cytokines for their manufacturing processes."

The investment in a new GMP facility is the latest announcement supporting Bio-Techne's cell and gene therapy initiative.

Sanofi Opens New Digital Manufacturing Facility in Massachusetts

Sanofi announced the opening of its new digital manufacturing facility in Framingham, MA, on Oct. 15, 2019. The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology, according to a company press release.

According to Sanofi, the new facility is 80 times more productive and will make medicines for two times the number of patients per year than a traditional factory, using technology that connects the production process with R&D. By utilizing paperless and single-use manufacturing technologies to replace the large-scale fixed stainless-steel equipment, the company’s carbon footprint is reduced with less CO2 emissions.

Additionally, the new location has the ability to quickly change from one manufacturing process to another, enabling the factory to manufacture biologics for the company’s Genzyme portfolio.

The facility is part of the company’s Framingham campus, a global hub for medicines that has been active for 30 years. The company has invested $400 million into R&D, biologics, manufacturing, and production improvements at the campus.

"We have been investing for some years to prepare for Sanofi's future. Our Framingham facility leads the way in delivering the next generation of biologics manufacturing, leveraging intensified, continuous processing in a fully integrated digitally powered facility," said Philippe Luscan, executive vice-president, Global Industrial Affairs at Sanofi, in the press release. "This opening demonstrates we are at the leading edge of innovation and manufacturing excellence, helping us to shape the future of both our company and the industry."

Sanofi plans to continue to expand its digital transformation initiatives in Canada, Brazil, Ireland, France, and Belgium.

Astellas Commits to Start-Up Innovation Cell and Gene Therapy Center

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced it will invest nearly $13 million into two innovation incubators operated by LabCentral, a premier United States-based laboratory facility for next-generation biotech start-ups. This initiative, combined with the more than $1 billion Astellas has previously committed to driving innovation in Massachusetts, contributes to the Boston-area life science community's ongoing efforts to accelerate the discovery and development of potential breakthrough therapies in areas of significant unmet need.

"Astellas has a long-standing commitment to the Boston-area life sciences ecosystem, where world-class talent are dedicated to turning innovative science into value for patients," said Kenji Yasukawa, Ph.D., President and CEO, Astellas. "Our presence in the greater Boston area comprises over 200 professionals across several locations driving innovation in regenerative medicine, immuno-oncology, mitochondrial function, genetic regulation and beyond. Accelerating early-stage scientific innovation in areas such as cell and gene therapy is a strategic focus for Astellas, and is superbly aligned with the mission of LabCentral to serve as a launching-pad for cutting-edge biotech and life sciences start-ups."

Astellas will invest $12.5 million to become the only pharmaceutical/biotechnology company among five Founding Sponsors of a new incubator, which will feature a core lab space where companies can easily conduct process development studies and a non-GMP pilot plant, being developed by LabCentral at 238 Main Street in Cambridge, Mass. The investment, announced at a ceremony with the Massachusetts Life Sciences Center and various elected officials, provides support to start-up companies and entrepreneurial founders seeking to create scientific innovation in areas of unmet need such as cell and gene therapy. The new incubator is expected to be operational in 2021.

Astellas also announced it will invest at least $450,000 over three years to become a Gold Sponsor of LabCentral's existing incubator located at 700 Main Street in Cambridge.

By supporting these incubators, Astellas can select, support and access innovation from leading start-ups creating healthcare solutions in its areas of focus.

Since 2010, Astellas has invested more than $800 million in, and committed nearly $500 million more to, Massachusetts-based innovation through the acquisitions of Ocata Therapeutics, Inc., Mitobridge, Inc. and Potenza Therapeutics, Inc., as well as the construction of a state-of-the-art headquarters for the Astellas Institute for Regenerative Medicine (AIRM) in Westborough, Mass. The new facility, expected to open in 2020, will enable AIRM to accelerate research and development in the field of regenerative medicine and cell therapy.

The impact of this agreement on Astellas' financial results in the fiscal year ending March 31, 2020 will be limited.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

GSK Invests in US Biopharmaceutical Manufacturing Facility

GSK announced a $120 million investment to expand its manufacturing facility in Upper Merion, Pennsylvania that will support the delivery of the company’s pipeline, bringing new medicines for cancer and other specialty diseases to patients faster. The investment at Upper Merion creates a technologically-advanced manufacturing hub that offers the flexibility and speed necessary when making today’s complex specialty medicines.

Emma Walmsley, Chief Executive Officer, GSK said: “These investments will support and accelerate the transformation of our pipeline to deliver the next generation of medicines and vaccines for patients who need them. This also underscores GSK’s longstanding commitment to making innovative medicines and vaccines here in the US.”

By bringing together the R&D and manufacturing teams in one facility in Upper Merion, we now have an even more highly skilled workforce, the technological and scientific capabilities, and the infrastructure to research potential new genetic targets and seamlessly manufacture them into new medicines. With R&D and manufacturing using the same equipment, data, and analytics, we are creating efficiencies that will significantly reduce the overall time to produce a new medicine.

The newly-outfitted manufacturing space is made to be more flexible than traditional pharmaceutical manufacturing equipment. Upper Merion uses emerging technologies in bioreactors, such as single-use and disposable components, which eliminates the need for complex retrofitting and sterilizing that is typical in most manufacturing plants. This simplifies and accelerates the process of changing from manufacturing one medicine to another medicine. A new analytical lab is also part of the facility, and the processes associated with quality and commercial testing have been streamlined to ensure medicines are ready for patient use as soon as possible.

Since 2017, GSK has invested close to $400 million dollars in US manufacturing capabilities across our vaccine and specialty portfolios, including today’s announcement. GSK has two significant R&D and manufacturing sites in Pennsylvania: Upper Merion and Upper Providence, employing approximately 3,500 people. In addition, GSK has its U.S. corporate headquarters at Philadelphia’s Navy Yard that employs more than 1,000 people.

The Upper Merion facility will initially be producing key pipeline assets. All products are currently in clinical trials and subject to clinical trial outcomes and regulatory approval.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

About GSK’s Upper Merion site

Upper Merion’s biopharma manufacturing site was constructed in 1996. The facility was designed to deliver products based in cell culture technologies. Over the past two decades, key GSK products like NUCALA have been manufactured at Upper Merion. In 2017, the company made the decision to utilize existing space at Upper Merion for the next-generation facility.

GSK Invests to Expand Vaccine Manufacturing

GlaxoSmithKline is investing $100 million in its manufacturing site in Hamilton, MT to expand the production capacity of key components of the adjuvant system used in several of GSK's vaccines, including SHINGRIX, which was approved by the U.S. FDA in October 2017.

The Hamilton vaccines facility currently manufactures components of GSK's essential adjuvant technologies, which this investment will expand further. GSK’s adjuvant systems help achieve a stronger immune response.

"For more than a decade, our Hamilton facility has supported GSK's adjuvant system development program," said Jack Bailey, president, US Pharmaceuticals, GSK. "By expanding the adjuvant system production capabilities in Hamilton, we will continue to deliver long-term and sustainable supply for key vaccines, including SHINGRIX."

GSK is investing in creating high-quality jobs in areas like R&D and manufacturing. The Hamilton site expansion is expected to add a combination of temporary construction and contracting jobs, as well as new permanent positions, including scientists, engineers and manufacturing and quality professionals.

"Thanks to the bi-partisan support of Governor Steve Bullock and the congressional delegation – Sens. Jon Tester and Steve Daines and Rep. Greg Gianforte – Montana is emerging as a hub for the biotechnology industry," said Bailey. "GSK is grateful for their leadership and the opportunity they have given us to create new jobs and expand our footprint in the state."

Hamilton is one of nine GSK manufacturing sites in the U.S., and 86 sites globally, that produce a variety of prescription medicines, vaccines and consumer healthcare products.

QuVa Pharma’s Pharmaceutical Manufacturing Facility Expansion, New Jersey

QuVa Pharma’s biotech pharmaceutical manufacturing facility in Bloomsbury, New Jersey, is undergoing significant capacity expansion.

The expansion will increase the size of the facility from 160,000ft² to 240,000ft².

QuVa Pharma’s biotech pharmaceutical manufacturing facility in Bloomsbury, New Jersey, is undergoing significant capacity expansion.

QuVa Pharma is expanding its biotech pharmaceutical manufacturing facility in Bloomsbury, New Jersey, US as part of its multi-year growth spree to extend its pharmaceutical facilities beyond Texas.

The expansion will increase the company’s production and distribution capabilities at the New Jersey site.

Bain Capital Private Equity, an alternative investment firm, is supporting the development and expansion plans of the facility, along with other partners and external investors, including Silicon Valley Bank and Oxford Finance.

The current phase of the expansion will be completed by the fourth quarter of 2019, while the entire expansion project is expected to be completed by 2020.

QuVa Pharma purchased a manufacturing facility from Garibaldi Group, a real estate company, on July 2016 and purpose-built it to comply with the Food and Drug Administration (FDA) and other regulatory requirements.

The facility is strategically situated close to Route 78, Interstate 95 corridor and Newark Liberty International Airport, western New Jersey. It is well-connected to several distribution sites in Pennsylvania, Ohio, New York and New England, as well as numerous south-eastern markets. It is also suitably positioned for potential expansion in future.

QuVa Pharma’s existing manufacturing plant in Bloomsbury is an FDA 503B-registered facility covering an area of 160,000ft², featuring two interconnected buildings, with future expansion into a state-of-the-art 240,000ft² facility by improving the cleanroom. The facility expansion will be cGMP-compliant and added with operation capacity for running a second shift.

The facility will help to serve customers with a wide range of ready-to-use compounded sterile medications sourced from various starting materials such as FDA-approved pharmaceutical formulations and active pharmaceutical ingredients (APIs) and will also supply medicines during drug crisis.

The facility uses specialized sterile compounding technique for developing medication in an environment free from infectious microorganisms such as virus and bacteria.

“Bain Capital Private Equity, an alternative investment firm, is supporting the development and expansion plans of the facility, along with other partners and external investors, including Silicon Valley Bank and Oxford Finance.”

The technique is utilized to produce high quality compounded sterile products delivered to the hospitals present in the critical markets in the eastern part of the US.

Details of the existing facilities of QuVa Pharma:

The company has two 503B registered outsourcing facilities including one in Sugar Land, Texas, for aseptic manufacturing and another in Temple, Texas.

The facilities feature closed compounding units with restricted access to reduce product contamination risks. The products undergo extensive United States Pharmacopeia (USP)-71 testing to check sterility, as well as other potency and endotoxins, before the final delivery to the customers. The facilities follow some of the strictest standards for patient safety in the industry.

The facility was expanded to include two manufacturing suites (Suites 4 and 5) on September 2018, doubling the total output of the company.

Marketing commentary on QuVa Pharma:

Founded in 2015, QuVa Pharma is a pharmaceutical products supplier that serves as a national platform for offering sterile compounded preparations in the US, in various sectors including cardiovascular, anesthesia, obstetrics, general medicine and pain management.

The company also provides medical devices such as syringes, specialty class IV admixtures bags, cassettes for pumps and PCA vials.

The company is licensed to supply the compounded products, ranging from bulk drug substance to drugs for reducing drug shortage, into all the states of the country. Some of the most commonly requested medicines outsourced by the company are Morphine, Oxytocin, Fentanyl, Ephedrine, Epinephrine and Neostigmine.

Berkshire Sterile Manufacturing to Add Third Isolator Line

Berkshire Sterile Manufacturing (BSM) announces its plan to add a third isolator line to expand capacity for future commercial clients. BSM is a state-of-the-art fill/finish contract manufacturer providing formulation and sterile filling services to companies producing injectable medications for pre-clinical through commercialization.

Berkshire Sterile Manufacturing produces injectable medications using state-of-the-art technology. These medications are filled inside isolators to create a barrier between the manufacturer and the drug product [operator preparing to work on the isolator in bottom left]. This ensures all products are sterile and safe to inject. Robotic flexible fillers are used to fill and seal each medication.

The injectable medications are produced inside isolators with robotic flexible fillers that can be modified to fill three container types: vials, syringes, and cartridges. The company currently has two isolators in operation with a fill rate of up to 1200 units/hour. The third line will contain a flex filler with the ability to fill at a rate of 3000 units/hour depending on container and fill volume. The isolator and filling line will be linked to a depyrogenation oven (sterilization by heat), allowing for bulk vial use, with a vial washer located on the loading side of the oven. A rapid decontamination chamber will be included in the isolator for the introduction of pre-sterilized containers, and a high capacity lyophilizer (capable of producing 20,000 freeze-dried vials) will be also be connected to the isolator.

The company will also add a second ventilator autoclave (sterilization by pressurized steam) and a new water for injection system (WFI; sterile water system) to the manufacturing area to provide redundancy in BSM's systems. This will ensure all necessary equipment is available if one of the systems were to be placed out of order.

Inspection will be updated with a semi-automated inspection system to handle the greater volume of product. This system will roll vials, cartridges, and syringes past inspectors and robotically spin the containers. This system will prevent loss of time due to manual inspectors having to pick up, swirl, and put down containers, and it will improve consistency in the inspection process.

The additions will be completed in 2020 to early 2021 and will offer expanded capabilities and better services to existing and future clients. "This is a win-win-win for our clients, the company and the community", stated CEO, Shawn Kinney. The expansion will create 60 high-salary positions in Berkshire County, Massachusetts, expand services to our current and future clients,

Pfizer Increased Investment in U.S. Manufacturing

Pfizer states, “We are experiencing an exciting new era in drug discovery and development with scientific advances that could result in future breakthroughs. To make this promise a reality, our manufacturing capabilities must keep pace with science today, and plan for what's coming next.

In 2018, we took an important step forward with the announcement of a $465 million investment to build a cutting-edge sterile injectable facility in Kalamazoo, Michigan. The 400,000-square-foot multistory building, known as Modular Aseptic Processing (MAP), will increase our ability to produce and supply important injectable medicines for patients in the U.S. and abroad.

"Our MAP investment helps ensure we continue to meet the evolving regulatory demands of every country where we do business," said Kalamazoo Site Leader Ron Perry. "Patients trust us to deliver the highest quality medicine in every dose."

The facility will incorporate technically advanced aseptic manufacturing equipment, systems and design, including multiple, self-contained modular manufacturing lines, and will create an estimated 450 highly skilled new jobs.

Groundbreaking is planned for spring 2019. Construction is expected to be completed in 2021, and production is expected to begin in 2024.

REST OF WORLD

Evonetix Relocates to New Facility in Cambridge, UK

Evonetix, a synthetic biology company previously located in Chesterford Research Park, United Kingdom, announced it relocated to a new facility in Coldham’s Business Park, Cambridge, UK on Oct. 30, 2019.

The new facility is 15,000 ft2, which includes 8000 ft2 of lab space and 7000 ft2 of office space, the company said. The company currently houses 40 employees and will look to recruit further staff to join its teams of physicists, electronics and software engineers, chemists, biologists, and molecular biologists at its new location.

“Synthetic biology has the potential to solve some of the world’s most intractable problems, but we require innovation in gene synthesis to accelerate progress,” said Dr. Tim Brears, Evonetix CEO, in the press release. “Our new office and lab space will enable integration of our teams of specialists to support the development and delivery of our highly parallel desktop platform, which will be available to every researcher to accelerate their ability to use biology on a scale not currently possible.”

Thermo Fisher Scientific to Acquire Manufacturing Site in Cork, Ireland, from GSK

Thermo Fisher Scientific Inc., the world leader in serving science, announced that it has entered into a definitive agreement to acquire a drug substance manufacturing site in Cork, Ireland, from GlaxoSmithKline plc for approximately €90 million in cash. The Cork site will expand capacity to meet customer demand for the development and commercial manufacturing of complex active pharmaceutical ingredients (APIs).

With more than 400 employees, the site produces highly specialized APIs for treating diseases including childhood cancer, depression and Parkinson's. Thermo Fisher will continue to produce APIs for GSK under a multi-year supply agreement and plans to expand use of the site to develop and produce complex APIs for other customers as well. The site contains 270 cubic meters of reactor capacity, 10 production buildings, an R&D pilot plant and lab infrastructure to support process development, scale-up and physical characterization of APIs.

"The GSK Cork site will enhance our API offering by expanding our development and commercial capabilities to provide much-needed capacity for APIs currently in development," said Michel Lagarde, senior vice president and president of Pharma Services for Thermo Fisher Scientific. "This transaction is another great example of our strategy to build on our strong foundation by adding capacity and capabilities to our pharma services offering through a combination of capital investments and M&A."

This announcement follows the recently completed acquisition of Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies. Thermo Fisher is also investing $150 million to expand its sterile fill-finish sites in Monza and Ferentino, Italy, and Greenville, North Carolina, and plans to complete the previously announced $50 million expansion of its St. Louis, Missouri, biologics facility later this year.

The GSK transaction, which is expected to be completed by the end of 2019, is subject to customary closing conditions, including regulatory approvals. Upon completion, the site will become part of Thermo Fisher's Pharma Services business within its Laboratory Products and Services Segment.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

J&J Opens New Ireland Manufacturing Facility

On Oct. 7, 2019, Janssen Sciences Ireland UC, part of the Johnson & Johnson family of companies, officially opened its new manufacturing building in Ringaskiddy, Co. Cork, Ireland, in a ceremony attended by Simon Coveney, An Tánaiste and minister for Foreign Affairs & Trade, Kathy Wengel, executive vice-president and chief Global Supply Chain officer, Johnson & Johnson, and Martin Shanahan, CEO, IDA Ireland, according to an IDA Ireland press release.

The expansion of the biomanufacturing site increases the company’s production capacity by an additional 205,516 sq. ft. (19,100 m2) and creates 200 new full-time jobs. Approximately 450 people were employed on-site during the two-year construction project.

“I’m delighted to attend the official opening of Janssen’s new manufacturing building, which marks the company’s ongoing commitment to Ireland and patients around the world. The life sciences industry makes a hugely significant contribution to the national economy in terms of jobs and exports. In 2018 alone, 33% of Ireland’s total exports were pharmaceutical and medical products, with Johnson & Johnson featuring as one of our single largest exporters. Finally, I would like to extend my congratulations to the team here in completing this exciting expansion and I wish them continued success in the future,” said Coveney in the press release.

“Our manufacturing facilities in Cork are at the cutting-edge of delivering healthcare solutions, which is an important part of our Credo commitment to provide the highest quality products to patients. Our Ringaskiddy facility is an important part of our global manufacturing network and expanding our capabilities here will allow us to pursue innovative solutions that advance how medicines are manufactured so that we can be at the forefront of treating, preventing, intercepting, and curing some of the world’s most devastating and complex diseases,” said Wengel in the release.

“Johnson & Johnson is one of the largest life sciences and R&D investors in Ireland and is part of a thriving Biopharma sector in Cork. With a significant investment in expanding Janssen’s manufacturing capacity here in Ringaskiddy, the positive economic spin-off for the South-West region is considerable. On behalf of IDA Ireland, I would like to congratulate the Janssen team on successfully delivering a new, state-of-the-art manufacturing building in the heart of Cork’s life sciences hub,” added Shanahan.

Cambrex Opens QC Lab in Italy

Cambrex Corporation has opened a new 11,291 sq. ft. (120 square meter) quality control (QC) laboratory at its site in Paullo, Milan, Italy. The laboratory expands on the current QC facilities that analyze and test its generic API portfolio of products during development and manufacturing. The QC laboratory is now fully operational, having been authorized by the Agenzia Italiana Del Farmaco (AIFA).

The additional laboratory space will increase the efficiency of the QC department as the site expands the number of generic APIs in development. New instruments, including a polarimeter and infrared spectrometer, have been added, with the systems linked to secure, electronic data capturing software to allow full traceability in line with regulatory requirements.

“Our facility in Milan is the center of the Cambrex’s generic API business, and this investment is the latest in a number of steps we have taken at the site to increase its efficiency and flexibility as we look to grow the portfolio of products that we offer,” said Aldo Magnini, managing director, Cambrex Milan. “In the last year the company has made strategic investments to expand its capabilities in research and development, manufacturing, and now QC capabilities, as we look to take advantage of the opportunities that are arising in the generic market.”

Cambrex manufactures over 70 generic APIs which are produced to cGMP standards at the Milan site, where seven production departments are supported by a pilot plant, kilo scale plant and development and analytical laboratories.

Provepharm Builds Plant for APIs Supply Needs

Provepharm expands its facilities in order to manufacture its own active pharmaceutical ingredients, which will be used for molecule revitalization.

Contract development and manufacturing organization (CDMO), Provepharm Life Solutions, announced the completion of an expansion to its facilities in Marseille, France, with the building of an active pharmaceutical ingredients (APIs) production plant.

With a €9m ($9.9m) investment, the company built a 5,380 sq. ft. (500-square-meter) pilot plant within its 32,280 sq. ft. (3,000-square-meters) site, aiming to internally cover its supply needs for APIs.

According to the company, the APIs produced at the site will also be ‘transferable under license’ to all of the group’s industrial partners. The company expects current good manufacturing practice (cGMP) inspections at the site by the French Agence Nationale de Sécurité du Médicament, as well as by the US Food and Drug Administration.

Provepharm also stated that the expansion saw the recruitment of additional employees to be based on the site, which will begin operations in 2020.

Initiating operations at the newly-established plant is set to enable Provepharm to file applications for marketing authorizations of its products in several markets across the globe, the company stated.

Michel Féraud, Provepharm’s CEO said that the expansion is in line with the company’s “goal to fully control the production chain” in order to ensure patients’ access to medicines.

China and Russia Collaborate to Create Biologics Joint Venture

Shanghai Pharma and Biocad established a joint venture to commercialize the latter’s portfolio of biosimilars and biologic treatments for the Chinese market.

The creation of the joint venture was presided over by the respective prime ministers of each country, China’s Li Keqiang and Russia’s Dmitry Medvedev. The arrangement was finalized in June 2019 but announced by Biocad.

The joint venture (JV) will be named SPH-Biocad and will begin life with six biopharmaceutical products and $400m (€366m) in the bank.

Biocad will provide three biosimilars, focused on oncology and autoimmune diseases, and three biopharmaceuticals, an IL-17 antibody, a PD-1 antibody, and a GITR antibody.

Dmitry Morozov, founder and CEO of Biocad, said, "This is the largest international deal to date for Biocad. For many years, we've been looking for the right partner in China. Today, we are absolutely confident in having found the right partner.”

For its part, Shanghai Pharma will provide funds of $200.4m in cash to establish a 50.1% equity stake in the joint venture, with Biocad holding the remaining 49.9% stake.

SPH-Biocad will hold the commercialization rights for the six biopharmaceuticals in the Greater China region.

Shanghai Pharma stated that it will look to leverage the JV to cooperate with Biocad on establishing its R&D and manufacturing for its biopharmaceutical pipeline.

Further than this, Zhou Jan, chairman of Shanghai Pharma, said that the JV was a good example of both countries’ desire to work ‘closely and pragmatically’ in key areas.

The company also provided further details on its long-term plan, stating that in the next three to five years, the company wants to transform from a generics company to an ‘innovative pharmaceutical company’.

Its strategy to achieve this aim will involve increasing its R&D investment from 7% to over 10% of its total sales.

Vaccines Manufacturing Innovation Centre, Oxfordshire

VMIC will be located in the Harwell Science and Innovation Campus in Oxfordshire.

Vaccine Manufacturing and Innovation Centre (VMIC) will be the first-ever dedicated facility for the development and manufacturing of vaccines in UK.

Vaccine Manufacturing Innovation Centre (VMIC) in Oxfordshire will become the first-ever facility dedicated for the development and manufacturing of vaccines in the UK, upon its completion.

VMIC will be used to develop vaccines against serious infectious diseases such as influenza, Ebola, Zika and Lassa fever.

The center is a joint development of three academic institutions, namely the University of Oxford, Imperial College London and the London School of Hygiene and Tropical Medicine.

It is also supported by leading pharmaceutical and healthcare companies such as Merck Sharp and Dohme, Johnson and Johnson and GE Healthcare.

The center was announced in December 2018 and its design work is currently underway. It will be fully operational by 2022, with first vaccines available for use later that year.

The purpose-built facility will require an investment of £77m ($98.1m) and is expected to generate up to 50 jobs for locals.

VMIC will be located within Harwell Science and Innovation Campus in the Oxford Science Park, Oxfordshire. It will form a part of the Harwell HealthTec Cluster, which comprises 1,000 people across 40 organizations.

Harwell Science and Innovation Campus is a science and technology campus spread across more than 710 acres, with the Science and Technology Facilities Council’s Rutherford Appleton Laboratory and more than 225 organizations present in it.

The campus is the UK’s biggest innovation hub and houses world-leading research infrastructure worth more than £2bn ($2.4bn). The site is well connected to Oxford and London, enabling the campus to partner with various leading universities.

VMIC will be a state-of-the-art facility, which will include several advanced laboratories and production facilities with cleanroom environment designed in compliance with Medicines and Healthcare products Regulatory Agency (MHRA) regulations.

Suites and filling rooms in the facility will be developed to be compliant with the latest current good manufacturing practices (cGMP).

HVAC zoning systems will be installed for controlling the environment, cleanliness and air pressure of the facility.

The 3D model-based building information modelling (BIM) process will be utilized for cleanroom designing, mechanical and electrical and process utility systems.

VMIC will accelerate the early-stage clinical development of the vaccine, while delivering the affordable, high-quality vaccine to patients. It will improve the development, manufacturing and application of novel preventive, as well as therapeutic vaccines and medicines against deadly infectious diseases, using mammalian cell culture.

The center will also offer the infrastructure required for the development of vaccine manufacturing processes of technology readiness level (TRL5-9+) scale. The processes will be developed based on the existing work at TRL2-4 and will be funded by the Medical Research Council and Biotechnology and Biological Sciences Research Council.

Additional capabilities for the large-scale commercial production of vaccines and emergency response to any threat, including epidemics or release of any biological agent, will also be present in the facility.

The center will also be used for the development of personalized gene therapies and oncology products, as well as to provide training to develop GMP-level vaccines.

UK Research and Innovation granted £67m ($81.3m) for the development of the facility under the UK government’s Industrial Strategy Challenge Fund (ISCF). The industrial partners will provide the remaining £10m ($12.1m).

WHP Engineering is providing design and development services for the facility. Derell Consultants, a consultancy services provider based in the UK, was subcontracted by WHP Engineering for the facility’s development.

Currie & Brown will provide project management and project control services for the facility.

GE Healthcare will provide bioprocessing expertise and training for the facility.

Cell and Gene Therapy Centre’s Renovation Completed

A North East construction engineering firm has completed a £16m expansion of a gene therapy center, which has doubled its capacity.

Merit, which works in the bioscience and pharmaceutical sectors, used its offsite technology to engineer pre-assembled controlled cleanroom modules at its manufacturing center in Cramlington, to reduce the impact of work and overall build time at Cell and Gene Therapy Catapult’s HQ in Stevenage.

The renovation was undertaken to enable companies to develop their manufacturing capabilities and systems for large scale, commercial cell and gene therapy supply. Companies currently collaborating at the center are Adaptimmune, Autolus, Cell Medica, Freeline Therapeutics and TCR2 Therapeutics.

The project has received over £75m of funding from investors including UK Government’s Industrial Strategy Challenge Fund; the department of Business Energy and Industrial Strategy, from Innovate UK, the UK’s innovation agency, and from the European Regional Development Fund.

Tony Wells, managing director of Merit, said: “Our close collaboration with the team at CGT Catapult was key to the successful delivery of this complex project.

We worked alongside them throughout the program using our proven expertise in next generation cleanroom manufacturing technology and advanced offsite fabrication capabilities to deliver high-quality cleanrooms that meet the stringent standards of the technical specification.“

Keith Thompson, CEO, Cell and Gene Therapy Catapult, said: “We are very pleased to be able to double the existing capacity of the CGT Catapult manufacturing center with help from our partners Innovate UK and the European Regional Development Fund.

“We would like to thank Merit for supporting the build out of this phase. Thanks to their expertise the new capacity will come online quickly, leveraging the existing MHRA licenses, installed quality and operational systems alongside the expertise developed by the Catapult and our collaborators at the center.”

New Cleanroom Facility Built at ADC Bio

A new cleanroom facility, designed and built by WHP, is a key part of ADC Bio’s construction of a new bioconjugation facility at its site in Deeside, North Wales, United Kingdom for the commercial production of antibody drug conjugates (ADCs). ADCs are a class of emerging biotherapeutics that require a bespoke infrastructure to ensure strict compliance with the highest global regulatory standards. The new facility, which includes support areas for washing, depyrogenation, thawing, and buffer preparation, is a stringently controlled environment operated under cGMP regulations.

WHP Engineering, a multi-disciplinary engineering company, was awarded the £5-million (approximately US$6.3 million) contract in December 2017. WHP’s scope of work covered the design and build, including test and validation of a state-of-the-art containment manufacturing cleanroom within an existing 6500-m2high tech facility, along with new quality control and process development laboratories.

Computer aided design work encompassed cleanroom architecture, mechanical and electrical components, and process and critical utilities systems. Complex, zoned heating, ventilation, and air-conditioning systems maintain segregation, cleanliness, air pressures, and other environmental controls, in compliance with regulations.

A key feature of the project was the installation of a bespoke, low-maintenance toxic waste system, developed by WHP to remove cleanroom waste to a holding tank, where it is transported to an off-site incinerator. This system incorporates dry break couplers to seal off both ends of the pipeline to prevent the possibility of any onsite contamination.

“The new cleanroom meets ADC Bio’s need to expand operations at Deeside beyond R&D to include safe, secure, and highly efficient manufacturing capabilities,” said WHP’s project manager, Chris Douglas, in a July 15, 2019 press release.

CMOs and CDMOs Expanded Services and Facilities in 2019

Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are constantly expanding, investing, and merging in order to provide their clients with the latest advancements and breakthroughs in services and technology. This article explores recent facility expansions and industry partnerships.

Facility acquisitions

In July 2019, Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill/finish facility from Novartis (1). The facility, located in Stein, Switzerland, will be the first sterile product finish/fill facility in Lonza’s network for clinical supply and commercial launch.

The current good manufacturing practice (cGMP)-approved facility, which became operational in 2009, has been used for sterile clinical drug product manufacture; it comes equipped with classified cleanroom areas, office, lab, utilities, and storage space. According to a press statement, Lonza will continue to produce drug products for Novartis while providing additional capacity for pharma and biotech customers for development, testing, and manufacturing for parenteral medicines. The facility can produce liquid and lyophilized dosage forms in up to 200L volumes.

In June 2019, Catalent agreed to purchase Bristol-Myers Squibb’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy (2). The 207,668 sq. ft. (19,300-m2) facility, located 100 kilometers southeast of Rome, opened in 1966. The site is used to manufacture and package cardiovascular, neuroleptics, anticancer, metabolic and anti-inflammatory medicines, non-penicillin-based antibiotics, antivirals, and analgesics. Catalent reports it will continue to manufacture Bristol-Myers Squibb’s current product portfolio at the site.

New facilities, expansions, and updates:

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland to add supplementary laboratory space that will double the current footprint. In a July 30, 2019 press release, the company revealed that the expansion will enable recruitment of 40 more scientists, adding to the already employed 50, and will also allow for potential future growth (3). The expanded facility fit out is expected to commence late August 2019, and the company has set a target time for completion as the end of the year.

“This strategic expansion, the increase in headcount, and the investment in new equipment will enable us to serve more customers in the solid-state screening market,” commented Mark Benger, Edinburgh site director, Cambrex, in a press release. “We have increasingly been asked by clients for additional services such as larger-scale crystallization, and we will now be able to provide these as well as adding greater efficiency and capacity at the Edinburgh site.”

The expanded facility will feature additional instruments and reactors for large-scale crystallization studies and solid form screening capabilities. Furthermore, the company states that plans are in place for the installation of new ultra-high-performance liquid chromatography and gas chromatography instruments, as well as additional process analytical technology tools.

STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announced in July that its Analytical Service Unit (ASU) in Shanghai and its API process R&D and manufacturing facility in Changzhou passed FDA inspections (4). According to a July 23, 2019 press statement, the company has passed seven FDA inspections since 2013 and has produced branded drugs marketed in 95 countries. Its ASU gives clients access to analytical method development, validation, and testing services from preclinical to commercial, and its API process R&D and manufacturing facility produced a variety of new technology platforms such as spray dried dispersion, continuous processing, oligonucleotides, and peptides.

“It’s a point of great pride that our quality systems allow us to be inspected at short notice by any applicable regulatory agency in the world. In this case, we received two separate inspection notices from FDA only seven days and five days in advance of the inspections, respectively. It’s an endorsement of the real time monitoring and quality culture we run across all parts of the company,” said Mei Hao, vice president of Quality at WuXi STA, in a press statement. “It’s another key example of the rigorous nature of our global standard quality systems. It is also another milestone for our platform, and in our efforts to have geographically integrated capabilities for both drug product and drug substance.”

Catalent is expanding the company’s global spray drying capacity through an agreement with Sanofi Active Ingredient Solutions, which gives Catalent access to spray drying manufacturing equipment at Sanofi’s Haverhill, United Kingdom facility (5). This agreement, announced on July 9, 2019, gives Catalent access to the Niro (GEA) PSD2 and PSD4 spray driers at the facility for customer projects. The facility includes clean area facilities for solvent and aqueous processing of potent or non-potent drug formulations, a secondary vacuum dryer, and integrated quality control and analytical capabilities. Catalent reports that the company can now offer spray drying solutions from early-phase development through commercial finished dose form manufacturing in Europe.

Earlier in 2019, Catalent announced a $40-million investment in its Winchester, KY facility, which includes commercial-scale spray drying with high-potent handling capabilities and other increases to the site’s capacity.

In July 2019, Lonza completed a $15-million expansion of its oral solid-dose (OSD) development and manufacturing capabilities at its Tampa, FL site (6). The expanded site will integrate services across early-stage product development, clinical trial material manufacture, and commercialization.

A new product development and quality control laboratory area adds 13 processing suites. Two new commercial packaging suites feature low-humidity environments and serialization for tracking and tracing of commercial products.

New manufacturing suites and dedicated sampling and dispensing areas capable of handling highly potent compounds were also added. In addition, Lonza renovated the cGMP manufacturing cleanroom facility and 25,000 ft2 of the existing cGMP OSD manufacturing cleanroom facility.

Lonza also announced an expansion of its Visp, Switzerland facility after the approval of an antibody-drug-conjugate (ADC) produced at the site. This is the third ADC approved from the bioconjugation facility, according to a July 24, 2019 press statement (7). The additional space will provide customers with launch and commercial manufacturing and will serve the early clinical phase market for bioconjugates.

The company is currently working on bringing bioconjugates to market, specifically developing and manufacturing expression systems with site-specific integration vectors to a simplified supply chain with the option of all elements under the same quality system. By 2020, all materials will be located at a single site through IbexTMSolutions and the highly-potent API facility.

“With 11 INDs completed, and now three out of five commercially available ADCs supported by our bioconjugation facility, we see the need to expand in readiness for the new wave of therapies our customers are developing,” said Karen Fallen, head of Mammalian and Microbial Development and Manufacturing for Lonza, in a press statement. “Many bioconjugates are on expedited programs, and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and payload, will reduce risk and increase speed on the path to market.”

Fujifilm Irvine Scientific is planning to open a third manufacturing facility in Tilburg, The Netherlands. The new facility will support bioproduction and cell- and gene-therapy markets (8). The new facility, part of Fujifilm Manufacturing Europe’s center, will support cGMP manufacturing of annual component-free, dry powder media, liquid media, and downstream bioprocessing liquid.

On June 20, 2019, CDMO Piramal Pharma Solutions announced the opening of a new wing at its Riverview, MI, site, into which the company has invested $10 million to upgrade (9). The new wing will produce high-potency APIs (HPAPIs) with low occupational exposure levels (OELs).

The upgrade includes a new quality control (QC)/analytical lab and two kilo-labs in addition to a doubling of the office space to support growth at the Riverview site. To date, “the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m3,” at scales ranging from grams to approximately 250 kilos, according to the company.

The new wing, with its two kilo-labs and QC/analytical lab, strengthens the company’s position in this area. “The new wing is designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m3 and as low as ~20ng/m3.” Materials will primarily be produced in this new wing at kilo-lab scales, and significant amounts of <5 kilos can also be produced.

Partnerships:

In July 2019, Catalent Biologics announced that it has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma (onasemnogene abeparvovec-xioi) (10).

Under the terms of the agreement, Novartis company, AveXis, will have dedicated manufacturing space at a new commercial manufacturing center near Baltimore–Washington International Airport, which has been established by Paragon Gene Therapy—a unit of Catalent Biologics. In addition, Paragon Gene Therapy will provide process development for the clinical supply of additional viral therapies within the AveXis pipeline.

Zolgensma is a gene therapy that has already been approved by the US FDA for the treatment of SMA and includes treatment of patients who are pre-symptomatic at diagnosis. The therapy works by replacing the defective or missing SMN1 gene, which halts disease progression, with a one-time intravenous infusion.

This agreement builds on Catalent’s previous investments in the gene therapy area. In May 2019, the company purchased Paragon Bioservices. And in June 2019, Catalent announced that the Paragon Gene Therapy unit would purchase the vaccine manufacturing equipment and facility assets and assume the leases of two Novavax product development and manufacturing facilities in Gaithersburg, MD.

More than 100 Novavax manufacturing and quality employees will transfer to Paragon. In addition, the companies announced an agreement in which Paragon will provide process development and manufacturing services for some Novavax programs.

In the press statement, Novavax noted that the approximately $18 million sale will enable the company to focus on advancing two products, NanoFlu and ResVax, through clinical development and regulatory review.

“This alliance is a true win-win-win for Paragon, Novavax and our employees,” said Stanley C. Erck, president and chief executive officer of Novavax, in the press statement. “This mutually beneficial transaction allows Paragon to quickly support the growth of its gene therapy development and manufacturing business and simultaneously offers Novavax a strategic and cost-effective approach to addressing its manufacturing needs into the future.”

In more Paragon news, Amicus Therapeutics, Inc. and Paragon Gene Therapy entered into a strategic manufacturing agreement in July for clinical manufacturing capabilities and capacity for multiple active preclinical lysosomal disorder programs currently in development in collaboration with the University of Pennsylvania (Penn) (12).Penn will collaborate with Amicus throughout the process, and current research and development production related to active preclinical lysosomal disorder programs will be transferred to and developed at Paragon.

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