PHARMACEUTICAL & BIOTECHNOLOGY

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Audentes to Build New Gene Therapy Plant

Audentes Therapeutics, a gene therapy developer recently bought by Astellas, will invest about $110 million to build a manufacturing plant in North Carolina, joining a growing list of drugmakers choosing to locate new drug production facilities in the state.

Pfizer, Bluebird bio and Novartis-owned AveXis all have, or are building, sites dedicated to making gene therapies in North Carolina, while Eli Lilly last month announced plans to spend $470 million on an injectable drug plant there.

For Audentes, the decision to invest in a new facility emerged from planning for when the biotech outgrows the capacity it currently has in a South San Francisco plant, according to Donald Wuchterl, the company's head of technical operations.

Audentes cast a wide net for where to place its newest facility, eventually choosing a small town southwest of Raleigh already home to one gene therapy plant, which Pfizer's now spending $500 million to expand.

The area is well known as a life sciences hotspot, due in large part to the universities located nearby in Durham and Chapel Hill. Increasingly, though, it's become a hub for manufacturing, particularly in gene therapy, and that proved a draw for Audentes.

Audentes Therapeutics, an Astellas company focused on developing genetic medicines, announced on Feb. 18, 2020 that it is building a gene therapy manufacturing facility in Sanford, NC for $109 million.

According to a company press release, the 135,000-ft2 facility will be constructed over 18 months and is expected to be operational in 2021. The facility addition will create over 200 new jobs for the company.

“Our investment in large-scale manufacturing has always been a cornerstone of our strategy to develop and ultimately deliver our important genetic medicines to patients as rapidly as possible. This new facility in Sanford will support the next phase of our growth as we establish a robust, global supply chain and expand our therapeutic and geographic scope as a part of the Astellas group of companies,” said Natalie Holles, president and CEO of Audentes, in the press release. “We are excited to join the vibrant biopharmaceutical research and manufacturing community that the state of North Carolina has established.”

“With our powerhouse research centers and highly skilled workforce, biotech pioneers recognize North Carolina’s role as a leader in the life sciences,” added North Carolina Governor Roy Cooper, in the press release. “Lee County is a perfect fit for Audentes as they seek to become a global leader in genetic medicines.”

"It was pretty clear that the Raleigh-Durham area was a front-runner," said Audentes' Wuchterl.

Gene therapy developers choosing North Carolina for manufacturing sites:

Company Novartis (AveXis)

Site location Durham County

Site size 170,00 square feet

Investment amount Approx. $200 million

Company Novartis (AveXis)

Site location Durham County

Site size 125,00 square feet

Investment amount $80 million

Company                    Pfizer
Site location                  Lee County
Site size                        Undisclosed
Investment amount        $600 million

Company Audentes

Site location Lee County

Site size 135,000 square feet

Investment amount $109 million

SOURCE: Company statements, filings

News of the investment comes about two and half months after Astellas agreed to buy Audentes for $3 billion, the latest in a string of gene therapy acquisitions.

Manufacturing was one attraction of Astellas to Audentes, and the Japanese drugmaker was aware of the biotech's plans to expand into North Carolina during deal talks, according to Wuchterl.

Producing gene therapies requires developers make both the therapeutic DNA as well as the viral shell used to deliver it. For companies developing treatments for neuromuscular diseases, as Audentes is, a one-time dose can comprise billions of viral vectors, making manufacturing a potential bottleneck for both clinical development as well as any subsequent commercialization.

Contract manufacturers like Lonza, Catalent and Thermo Fisher are an option, and Wuchterl said Audenetes considered whether outsourcing would make sense before ultimately choosing to expand on its own.

Audentes' most advanced therapy treats x-linked myotubular myopathy, a rare and usually fatal neuromuscular disease that affects infants and young boys. The biotech is currently making the experimental candidate at its South San Francisco site, but executives sought to backstop supply with another site that could support future growth too.

Astellas, which is testing its own gene therapies in preclinical studies, could benefit as well, although that's not the direct aim.

"This capacity is needed for Audentes' purposes, but it serves the greater good of the entire combined Astellas-Audentes gene therapy entity that has come to fruition from the acquisition," the executive said.

Construction will occur over three phases, Audentes said, the first of which will take place over roughly 18 months. More than 200 jobs will be created in connection with the facility, according to the company.

Avexis ‘Flexible’ NC Plant

AveXis has opened a gene therapy plant in Durham it says will be able to produce up to seven products simultaneously. President Dave Lennon talks timelines, capacity, and taking production inhouse.

AveXis and its owner Novartis have invested a total of $115 million (€106 million) into a site in Durham, North Carolina to support the production of US Food and Drug Administration (FDA) approved product Zolgensma (onasemnogene abeparvovec) and its pipeline of gene therapy candidates.

With the doors opening last week, president Dave Lennon discussed the firm’s wider gene therapy ambitions.

The site is in “a transition process,” Lennon said, “We have brought in all the equipment, the raw materials, getting everyone trained to be able to run the process. I just heard today the first cells have arrived that are going to establish the production process here at the site, and that should occur over the next six to eight weeks.”

AveXis will then need to demonstrate to the FDA that the product is stable and effective, and the same as what it produces at its fully operational site in Libertyville, Illinois.

“That process takes us from April to the end of the year,” said Lennon, “and then we’ll submit for licensure and that process can take anywhere from four to 12 months.

“We anticipate it will be on the shorter end because they know there’s interest in the product and having more capacity to supply the market. They don’t want us to have one site either because there’s always the risk that that site has an issue and then we can’t supply the market. That’s not a position the FDA wants us to be in either.”

As well as Durham and Libertyville, AveXis recently opened a site in Longmont, Colorado acquired from AstraZeneca last year, a product development facility in San Diego, California, and access to its parent company’s gene therapy capabilities.

“Every site has a different purpose. Our Illinois site was originally purpose built to be the supplying site for the marketplace for Zolgensma. Colorado was acquired for bulk expansion. It’s a big site. We set up the facility differently. We put more bioreactors in one room and it’s really made to produce larger quantities of material in each cycle, production cycle,” Lennon explained.

“The North Carolina site is really built with flexibility in mind. Each of the suites that are out there can run independent product. We can produce up to seven products simultaneously in this facility. That allows us a lot of flexibility to really invest this site into preparation of our pipeline.”

Despite the growing internal capacity, there is little chance of AveXis having excess capacity, Lennon said.

“We have so many pipeline assets already in our plan that we’re just waiting for this site to be ready to start producing that material here. I don’t believe we’ll have excess capacity. We already have plans for how we’ll use a lot of the capacity that we have.”

But with the new plants coming online, Lennon contract development and manufacturing organization (CDMO) Paragon Bioservices – now part of Catalent – could be at risk of losing a customer.

AveXis uses Paragon to produce clinical materials for AveXis’ Rett syndrome, Friedreich’s ataxia, and amyotrophic lateral sclerosis (ALS) gene therapy candidates, as well as some clinical and commercial supply of Zolgensma.

“Ultimately, we want to bring all those in house,” said Lennon.

Griffin Electric Completes Thermo Fisher Cleanroom Project

Wayne J. Griffin Electric Inc., a Holliston-based electrical subcontractor, has completed the electrical installation work at Thermo Fisher Scientific Inc.’s new cleanroom facility in Lexington. The 50,000-ssqure-foot facility was renovated to accommodate the development, testing and manufacture of viral vectors in order to treat patients suffering from rare diseases. The in-house scientists, QC specialists and production teams are using GMP practices in the company’s state-of-the-art lab space to accelerate the production of new drug therapies. On-site, the Griffin Electric team was responsible for providing temporary power during construction of the cleanroom. In addition to powering the facility, Griffin supplied lighting services, including fixtures and controls, as well as set up the wiring for the tele/data systems. The Griffin team also installed additional systems for fire alarm, clock, lightning protection and security within the facility. Serving as the project’s general contractor was Skanska USA Building Inc. of Boston, working directly with architectural and electrical engineering firm DPS Engineering of Framingham.

Covance Opens Genomics Lab in Indianapolis

Covance celebrated the grand opening of its new flagship Genomics Lab in Indianapolis, IN on February 14th. Co-located with its established Central Laboratory and Bioanalysis Lab, the site provides greater testing efficiencies and comprehensive scientific solutions to help biopharmaceutical companies develop therapies faster and with a greater probability of success.

The new Genomics Lab adds 16,000 square feet of new, dedicated laboratory space to deliver applied genomics solutions from single target to whole genome analysis. The laboratory also consolidates exploratory studies and biomarker development, patient management (CAP/CLIA) laboratory testing and Companion Diagnostic (CDx) development.

The state-of-the-art lab is one of several transformative investments from Covance in genomics, anatomic pathology and histology (APH), and flow cytometry testing solutions globally. It follows the 2019 opening of the Shanghai R&D Center, a near doubling of genomics testing capacity at the Covance Geneva location, and the opening of an APH laboratory in Japan. Additional investments and enhancements in genomics testing solutions are also underway at the Covance Singapore location.

With more than 250 approved therapies having pharmacogenomic biomarkers listed in their drug labels and more than 40% of recent drug approvals classified as precision medicines, genomics and other specialty testing are an integral part of therapeutic and companion diagnostics development.

Dipharma Strengthens CDMO Business

Dipharma Francis S.r.l., a contract development and manufacturing organization (CDMO) and a global manufacturer of active pharmaceutical ingredients (APIs), has completed a new cGMP quality control laboratory and c-GMP kilolab at its CDMO site located in Kalamazoo, MI.

The new state-of-the-art cGMP manufacturing suite strengthens Milan, Italy-based Dipharma’s CDMO offering and completes the range of exclusive services, ensuring continuity across the whole lifecycle of customers’ molecules, from preclinical to commercial stage.

The QC laboratory is designed and equipped according to latest pharmaceutical quality standards, with full CFR21 compliance for data integrity management.

“The new suite marks the achievement of a key milestone within the Exclusive Synthesis growth strategy and reinforces the company’s value proposition to provide reliable innovative solutions to customers: Dipharma Group is now able to cover the whole pharmaceutical chemistry services spectrum, from discovery to marketed drugs,” said Jorge Nogueira, chief executive officer, Dipharma Francis S.r.l. “Furthermore, I am pleased to highlight that, with the construction of the new kilolab, Dipharma implements cGMP capability at its American subsidiary Kalexsyn Inc., enhancing its range of exclusive services from CRO to CDMO.”

With an engineering batch already scheduled for production, Dipharma is currently assembling all documents required by FDA for Drug Establishment Registration.

Aphena Expands Bottling Capacity

Aphena Pharma Solutions Inc. has expanded its bottling capacity with the purchase of a new, high-speed, solid-dose bottling line with an integrated cartoner. The line will be available for new business starting May 1 at Aphena’s Cookeville, TN facility.

The new line will be dedicated to packaging solid-dose OTC products, both in the branded and private-label categories, and will create additional capacity in the range of 15 to 20 million bottles annually.

“We’ve installed this new line for growth capacity so that we can continue to stay ahead of our current and future customers’ needs,” said Eric Allen, Aphena’s executive vice president of sales. “It will allow Aphena to maintain a 50% capacity level for any new projects or surge capacity requirements.”

Aphena Pharma Solutions provides contract packaging and manufacturing solutions from two FDA- and DEA-registered sites in the U.S., and handles solid dose, liquids, gels, creams, ointments, foams, suspensions and lotions.

Aprecia to Partner with Purdue University for 3D Pharmaceutical Printing Projects

Aprecia Pharmaceuticals, a pharmaceutical company headquartered in Blue Ash, OH, and Purdue University's College of Pharmacy announced on Feb. 20, 2020 that they are partnering on future 3DP pharmaceutical equipment and medications. Aprecia was the first company to receive FDA approval, in 2015, for a 3D-printed medication.

"Aprecia’s mission is to maximize and expand its 3DP technology platform through global partnerships that will provide pharmaceutical solutions for unmet patient needs," said Chris Gilmore, Aprecia CEO, in the press release. "Purdue University is an esteemed institution, and we are confident that this partnership will advance our future in 3DP pharmaceutical research and development."

"Purdue University is committed to its investment in drug discovery and development as well as student and faculty enrichment that will continue to yield global advancement in medicine and healthcare," added Eric Barker, dean of Purdue's College of Pharmacy, in the press release. "As a College, our mission is to prepare the next generation of leaders in pharmacy. Partnering with Aprecia aligns perfectly with that mission. We are excited to combine our talented students and faculty with the successful researchers at Aprecia to work together to accelerate discoveries in this emerging field."

Dipharma Francis Completes Construction of new cGMP Suite

Dipharma Francis announced the completion of the new cGMP Quality Control laboratory and c-GMP kilolab at its CDMO site located in Kalamazoo MI.

The QC laboratory is designed and equipped according to latest pharmaceutical quality standards, with full CFR21 compliance for Data Integrity management.

“The new suite marks the achievement of a key milestone within the Exclusive Synthesis growth strategy and reinforces the company’s value proposition to provide reliable innovative solutions to customers: Dipharma Group is now able to cover the whole pharmaceutical chemistry services spectrum, from discovery to marketed drugs,” said Jorge Nogueira, CEO of Dipharma Francis. “Furthermore, I am pleased to highlight that, with the construction of the new kilolab, Dipharma implements cGMP capability at its American subsidiary Kalexsyn Inc., enhancing its range of exclusive services from CRO to CDMO.”

With an engineering batch already scheduled for production, Dipharma is currently assembling all documents required by FDA for Drug Establishment Registration.

Hitachi Chemical Opens New Cell and Gene Therapy Manufacturing Facility

Hitachi Chemical Advanced Therapeutics Solutions, LLC (“HCATS”), a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemical’s Regenerative Medicine Business Sector (“RMBS”) in North America, announced the opening of its new cell and gene therapy manufacturing facility in Allendale, New Jersey. The new facility is the company’s first to be designed from the ground up to meet the unique needs of commercial cell and gene therapy products and more than doubles HCATS’ existing manufacturing capacity in New Jersey.

The facility (“75 Commerce”) currently includes six classified environment rooms, with the capacity to add more rooms that can be specifically configured to accommodate growing client needs. The new facility includes state-of-the-art manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space. The company’s ongoing investment in facility expansion complements ongoing investments in the company’s Quality Systems and commercial expertise, all with the aim of meeting its commitments to existing clients with near-term expectations for commercial product manufacturing.

“The opening of this new facility marks an important milestone for HCATS and will offer a state-of-the-art resource for our clients as they commercialize cell and gene therapies. Access to this type of manufacturing space is needed across the industry to ensure the continued growth and momentum of these promising therapeutics,” said Robert Preti, Ph.D., President and CEO, HCATS, and General Manager, RMBS. “This facility will require up to 500 more employees to reach full operational capacity over the next several years, supporting our growing roster of clients.”

“I am excited for Hitachi Chemical Advanced Therapeutics Solutions’ future in New Jersey, and I have no doubt that their new, state-of-the-art facility will not only help New Jersey residents, but also contribute to expanding the innovation economy by bringing up to 500 new jobs to our state,” said Governor Phil Murphy of New Jersey. “With our highly educated and diverse workforce, New Jersey is the perfect location for expanding biotech firms like Hitachi Chemical.”

The leadership and employees of HCATS, along with officials of Hitachi Chemical and local dignitaries, commemorated the milestone with a ribbon-cutting ceremony on January 29 at the new facility.

About the Hitachi Chemical Regenerative Medicine Business Sector:

The Hitachi Chemical’s Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 200,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.

The Discovery Labs Create New CDMO for New Cell and Gene Therapy

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

On Jan. 22, 2020, The Discovery Labs, an MLP Venture company and provider of cGMP manufacturing, turnkey laboratory solutions, critical materials, and office space, and Deerfield Management, a healthcare investment management firm, announced that they have formed The Center for Breakthrough Medicines, a new contract development and manufacturing organization (CDMO) and specialty investment company. Under the new CDMO, the companies will invest $1.1 billion to build a manufacturing facility for cell and gene therapies.

The facility will be built on The Discovery Labs' 1.6-million-ft2 biotech, healthcare, and life sciences campus in King of Prussia, PA, where the CDMO occupies more than 40% of space.

The Center for Breakthrough Medicines will provide preclinical through commercial manufacturing of cell and gene therapies and component raw materials. It also offers process development, plasmid DNA, viral vectors, cell banking, cell processing, and support testing capabilities, all of which will be housed under one roof. The new facility is expected to provide instant capacity, according to The Discovery Labs and Deerfield.

This new manufacturing capability adds to The Discovery Labs market offering and complements the company’s biotech incubator, Unite IQ. The incubator offers immediate space to emerging life sciences companies and scientists, giving them the ability to grow from a startup to an enterprise company on one campus. The incubator and accelerator space at Unite IQ provides a comprehensive home for startups and provides resources needed to initiate business operations. Tenants are expected to utilize the discovery, development, testing, and manufacturing capabilities of the new Center for Breakthrough Medicines and will be provided the ability to forward integrate processes and analytics as well as seamless tech transfer from research lab to large-scale production.

Renovations are also underway to construct a total of 86 plasmid, viral-vector production, universal cell processing, cGMP testing, process development, and cell banking suites. The viral vector and cell processing suites will be fully compliant with both FDA and European Medicines Agency standards. All suites will offer the flexibility to meet client-specific workflows and will be able to adapt quickly to meet demand, according to The Discovery Labs. The CDMO is in the process of reserving capacity now for late 2020.

The Discovery Labs is also establishing The Colony, a unit that will provide custom-built discovery labs, breakthrough funding, sponsored research agreements, housing, and relocation for leading experts in cell and gene therapy. The unit will seek to work hand in hand with scientists from both academic and pharmaceutical institutions to unlock and expedite groundbreaking therapies. It will also seek to unlock institutional barriers that prohibit scientists from moving at a pace necessary in today's ever-changing therapeutic environment. The Colony will partner with institutions where these scientists currently work and will provide equity, license fees, and revenue sharing.

The Discovery Labs has also initiated a substantial hiring effort targeting highly skilled experts in the life sciences community, including experts in cGMP manufacturing. The company expects to hire more than 2000 team members within the next 30 months.

"The Center for Breakthrough Medicines will be serving companies from the earliest stages through commercialization. Its exceptional scale and offering will quickly relieve the production bottleneck for advanced therapies by reducing the time, complexity, and cost of commercializing vitally needed gene and cell therapies," noted Audrey Greenberg, board member and executive managing director for The Discovery Labs, in a company press release.

"Today brilliant scientists are advancing an unprecedented number of gene and cell therapy drug candidates. The real tragedy, however, is a scarcity of manufacturing know-how, which is complex and expensive," added Alex Karnal, partner and managing director of Deerfield Management and a board Member of The Discovery Labs, in the press release. "With its visionary business model, it is hoped that The Center for Breakthrough Medicines will help realize the promise of cell and gene therapies in time to treat the many patients who need them."

Pii Strengthens Aseptic Filling Capabilities

Pharmaceutics International, Inc. (Pii), a pharmaceutical contract development and manufacturing organization (CDMO), has expanded its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line.

Pii has installed a GENiSYS R filling machine from Automated Systems of Tacoma, LLC (AST), which processes pre-sterilized, ready-to-fill vials, syringes, and cartridges on a single machine specifically designed for small to medium scale aseptic manufacturing under cGMP. Integration of proven isolator-barrier and automated technologies provides a balance of flexibility and advanced system features, enabling processing of aseptic, toxic, and cytotoxic drug products.

"This automated solution enhances system productivity and controls contamination risk by minimizing operator intervention to the greatest extent possible, while providing unrivaled flexibility for aseptic filling of medium-sized clinical and commercial batches," said Samuel Chia, director of aseptic manufacturing, Pii.

Automated bag and tub opening, statistical and 100% in-process fill weight verification, and vial capping completely automate the aseptic fill-finish process. Operations downstream can include lyophilizer loading and unloading and vial capping, depending on product and application requirements.

Tom Ingallinera, vice president of technical support, Pii, advises that companies can benefit from the scalability of processes developed for the GENiSYS machine. "As customer's products progress through the clinic, the aseptic filling process can be scaled to larger filling lines with minimal tech transfer," he said.

The new line, installed with assistance from Automated Systems of Tacoma (AST), will be fully qualified to support vial and syringe operations by the end of Q1 2020, just one year after the initial purchase order was placed. Multiple programs in early to late-stage development have already been identified as candidates for transition to the new line.

"The new innovative aseptic filling machine will enable Pii to continue delivering aseptic products on very aggressive timelines," said Kurt Nielsen, president and chief executive officer, Pii.

Hank Nowak, vice president of business development, Pii, said, "With our Pharmaceutics Know-How and these expanded filling capabilities, Pii is positioned to deliver high quality and timely aseptic drug product for clinical and commercial needs. We look forward to working with existing and new partners on projects with batch sizes ranging from 1 L to 1,000 L."

Pii Expands Aseptic Filling Capacity with Fully Robotic Line

Pharmaceutics International has installed an automated filling machine from Automated Systems of Tacoma that processes pre-sterilized, ready-to-fill vials, syringes, and cartridges

CDMO Pharmaceutics International (Pii) has announced the expansion of its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line.

Pii has installed a GENiSYS R filling machine from Automated Systems of Tacoma, (AST), which processes pre-sterilized, ready-to-fill vials, syringes, and cartridges on a single machine specifically designed for small to medium scale aseptic manufacturing under cGMP.

Integration of proven isolator-barrier and automated technologies provides a balance of flexibility and advanced system features, enabling processing of aseptic, toxic, and cytotoxic drug products.

Samuel Chia, Director of Aseptic Manufacturing, said: “This automated solution enhances system productivity and controls contamination risk by minimizing operator intervention to the greatest extent possible while providing unrivalled flexibility for aseptic filling of medium-sized clinical and commercial batches.”

Automated bag and tub opening, statistical and 100% in-process fill weight verification, and vial capping completely automate the aseptic fill-finish process.

Operations downstream can include lyophilizer loading and unloading and vial capping, depending on product and application requirements. Dr Tom Ingallinera, Pii’s VP of Technical Support, advised that companies can benefit from the scalability of processes developed for the GENiSYS machine. “As customer’s products progress through the clinic, the aseptic filling process can be scaled to larger filling lines with minimal tech transfer,” he said.

The new line, installed with assistance from AST, will be fully qualified to support vial and syringe operations by the end of Q1 2020, just one year after the initial purchase order was placed.

Multiple programs in early to late-stage development have already been identified as candidates for transition to the new line. “The new innovative aseptic filling machine will enable Pii to continue delivering aseptic products on very aggressive timelines,” explained Kurt Nielsen, Pii's President and CEO.

Hank Nowak, Pii’s VP of Business Development, said that Pii can now produce aseptic drug product for clinical and commercial needs. "We look forward to working with existing and new partners on projects with batch sizes ranging from 1 L to 1,000 L,” he added.

Aphena Expands Bottling Capacity

Fujifilm Expands North Carolina Facility

Fujifilm Diosynth Biotechnologies (FDB), a biologics contract development and manufacturing organization (CDMO) with experience focused on the development and manufacture of recombinant biopharmaceuticals including proteins, advanced therapies, and monoclonal antibodies, held a ground-breaking ceremony on February 25, 2020 to signal the start of its North Carolina facility expansion project.

The 31,778 square foot addition includes the expansion of its cell culture and microbial manufacturing trains through the addition of new recover and purification suites. The North Carolina site will increase its cell culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50%. A new receiving warehouse is also included in the project.

"This expansion is a reflection of Fujifilm's continued commitment to grow its bio-CDMO business and FDB, to provide our clients with not only the skills, but also the infrastructure that will nimbly deliver their products to the clinic and beyond," said Martin Meeson, president and chief operating officer, FDB USA.

Stephenie Robertson, senior director of operations, FDB USA, said, "This project will enable us to further increase our capacity to efficiently meet current and future customer demands in a modern facility.”

The event was attended by representatives from local organizations including Economic Development of North Carolina, The RTP Foundation, North Carolina Biosciences Organization, North Carolina Biotechnology Center and the Morrisville Chamber of Commerce among others.

FDB expects that the increased production capacity will be ready for cGMP manufacture by mid-2021.

Frontage Labs Completes Exton Expansion

Frontage Laboratories, Inc. has completed the expansion of its bioanalytical laboratories in Exton, PA, adding 10,000 sq.-ft. of lab space and enhancing bioanalytical capabilities in biologics and small molecule drug development, biomarkers, cell and gene therapy, and high-throughput clinical sample management. The expansion brings the total lab space at the Exton site to 80,000 sq.-ft.

In addition to sample management and increased lab space, the company also enhanced instrumentation, systems, robotics automation, software and personnel capacity. A center of excellence supporting cell and gene therapy has been established which includes dedicated laboratories in DNA/RNA sample preparation, PCR, flow cytometry, and cell culture. The expansion provides greater biomarker, PK, and immunogenicity bioanalytical capacity to support large Clinical Phase II-IV studies.

Dr. John Lin, Ph.D., EVP of Frontage's Global Bioanalytical Services, "The expansion provides our clients with heightened biomarker and biologic services in a state-of-the-art facility to facilitate drug discovery and development. It enables Frontage to provide the enhanced capability and capacity for the bioanalytical support of the gene and cell therapies and late phase clinical studies."

Vigene Biosciences with ASC Therapeutics Open Lab and Research Facility

Vigene Biosciences recently opened its $20 million, state-of-the-art lab and research facility, and global headquarters in Rockville, MD. Vigene has also entered a major strategic partnership with the California gene therapy company, ASC Therapeutics.

Vigene provides viral vector-based gene delivery services and products; its mission to make gene therapy affordable. The company streamlines virus production from early conceptual stages to commercial manufacturing. The new 71-thousand square foot facility combines new manufacturing technologies and high yield production cell lines with the rigorous quality of cGMP and BSL-3.

Under the long-term partnership with ASC Therapeutics, Vigene will provide GMP manufacturing, including viral vectors and plasmid DNA, for its hemophilia A gene therapy clinical program, as well as a manufacturing platform for future gene therapy programs.

Vigene is listed on Inc. 5000 fastest-growing private companies in America for 2019 and 2018, named the 2018 ACG Emerging Company of the Year. The company started in Rockville, MD in 2012 with just five biotech experts. The company now employs 100, with plans to add as many as 80 more scientists, researchers and staff in the next year.

Contract Pharma talks with Dr. Jeffrey Hung, Chief Commercial Officer of Vigene Biosciences, about the strategic partnership, supporting manufacturing, and the future of cell and gene therapies. –KB

Contract Pharma: What are the main goals of the Vigene/ASC partnership?

Jeffrey Hung: The main goals of the Vigene/ASC partnership are twofold. First, we plan to support the current ASC clinical trial material manufacturing. The second goal is to provide the availability for GMP manufacturing capacity for the future clinical trial and commercial manufacturing for ASC. This partnership is an endorsement to Vigene’s GMP manufacturing capacity and capability for viral vectors in that ASC entrusts to Vigene for not only one project but also their pipeline of current and future gene therapy candidates.

CP: What are the current manufacturing challenges and how can they be overcome?

JH: This is a billion dollar question. The manufacturing challenges lie throughout the process. Cell line productivity, upstream production, downstream purification, analytical services and QC testing. The solution is innovation, optimization and scaleup. Let me address them one by one from Vigene’s experiences.

Regarding innovation, we developed Vigene proprietary GMP level high productivity cell lines for viral vector production that has been demonstrated to be 2-3X more productive than current cell lines used by others. Regarding optimization, both the upstream process and downstream process can use more optimization to increase yield and reduce loss. From transfection we tested different transfection agents and different protocol, we have identified a protocol that generates 2-3X more productive than before. Regarding scaleup, Scaleup can save a lot on overhead, personnel and achieve lower cost per dose. To that end, Vigene built a state-of-the-art, up to 1000L, GMP production facility with full commercial production capability.

CP: What do you anticipate for the future of cell and gene therapies?

JH: We are only at the beginning of a new era. The future of cell and gene therapies is bright. We are going to cure many diseases including both rare diseases and large indications through a new generation of cell and gene therapies. I see a few trends in the future of cell and gene therapies.

The first one is that more and more pharma and biotech companies will develop a pipeline of cell and gene therapies to address a large set of unmet medical needs from rare diseases to cancer to Parkinson diseases. The second trend is that the manufacturing capacity will continue to expand to meet the demand from biotech and pharma companies. The favorable safety profile of AAV will prove very useful to translate a gene therapy concept to a clinical candidate quickly to benefit patients. Lastly, is the continued innovation both on the manufacturing process and basic viral vector biology to make gene therapy more accessible and affordable to the public. Vigene is definitely focused on this mission.

Jeffrey Hung, Ph.D.

Jeffrey Hung, Ph.D., is Chief Commercial Officer of Vigene Biosciences, a leading gene delivery company whose mission is to make gene therapy affordable. Dr. Hung orchestrated Vigene Biosciences’s acquisition of Omnia Biologics in 2016, a CMO specializing on GMP manufacturing of Viruses. Dr. Hung served as the Vice President of GenScript and was instrumental in growing the company before the IPO in December 2015. Dr. Hung was the Chief Marketing Officer at ATCC, the world’s largest biobank, before joining GenScript. Dr. Hung is the author of multiple patents, peer reviewed publications. Dr. Hung earned his Ph.D. from Cornell University, MBA from UC Berkeley, and BS from Peking University.

Catalent Invests to Expand Biologics Capacity and Capabilities

Catalent, Inc., the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced it has commenced a $200 million capital investment in its Biologics business to expand drug substance manufacturing capacity and drug product fill/finish capacity due to projected growth among existing and future customers. The investments, phased over a three-year program, will be undertaken at the company’s biologics manufacturing sites in Madison, Wisconsin and Bloomington, Indiana. This follows a recent 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 2,000 liter single-use bioreactor system, providing additional clinical and commercial production capacity at the 2,000 or 4,000-liter batch scale. Work is expected to be completed by mid-2021 and will more than double Catalent’s commercial biomanufacturing capacity.

Additionally, fill/finish capacity at the Bloomington site will be expanded by 79,000 sq. ft., with both GMP and non-GMP capabilities. A high-speed flexible vial line, utilizing both ready-to-use (RTU) 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.

“The expansions at both sites will support our customers’ development programs and commercial launches,” commented Barry Littlejohns, President, Catalent Biologics and Specialty Drug Delivery. He added, “Catalent’s continued investments in innovative technologies and flexible capacity allow us to offer the most comprehensive solutions to bring important and innovative treatments to market faster.”

Opened in April 2013 and recently expanded with the addition of a 2 x 2,000-liter single-use bioreactor suite and new laboratories, Catalent Biologics’ Madison facility specializes in development, manufacturing and analytical services for new biological entities and biosimilars. It is the home of the company’s proprietary GPEx® cell line development technology, used to create high-yielding mammalian cell lines. This year, Catalent celebrated a significant milestone when the tenth biologic therapy utilizing GPEx technology was approved for commercial use. The Madison facility was designed for cGMP production from 10 to 4,000-liter scale, providing flexibility in batch size to meet client needs.

Catalent’s 875,000-square-foot biologics development and manufacturing facility in Bloomington employs a growing staff of 900 employees, with deep expertise in sterile formulation and extensive biomanufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges. The site also recently achieved regulatory approval for a twentieth commercial product.

ABOUT CATALENT BIOLOGICS

Catalent Biologics provides advanced technologies and tailored solutions for biologic and biosimilar development, from DNA to commercial supply, through our extensive Biologics network including: Madison, Wisconsin; Emeryville, California; Kansas City, Missouri; Morrisville, North Carolina, Bloomington, Indiana; and Brussels, Belgium. For more information on Catalent Biologics, visit www.catalent.com/biologics.

ABOUT CATALENT, INC.

Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

Piramal Invests in Riverview Expansion

Piramal Pharma Solutions (PPS) has opened a new wing at its Riverview site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs). The total investment to upgrade the site was approximately $10 million and includes the new QC/analytical lab and two kilo-labs, as well as a doubling of the office space to support the growth at the Riverview, MI 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 ~250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, expands capacity. It was 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; lots of <5 kilos can be produced in this new facility.

Vivek Sharma, chief executive officer, Piramal Pharma Solutions said, “We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs. It’s another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease.”

Vince Ammoscato, vice president and Riverview Site Head, added, “This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market. We are equipped to offer ADC customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Kentucky site for sterile fill and finish.”

FLAMMA Acquires Teva’s Philadelphia cGMP Facility

FLAMMA acquires Teva’s Philadelphia cGMP facility marking entry into the US marketplace with labs & pilot plant.

Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that the company has acquired the Teva’s Chemical Synthesis Center in Malvern, PA in the Philadelphia area.

“The industry knows and respects the Flamma brand, yet some customers are apprehensive when considering the placement of a project overseas. Flamma understands this and feels that this will be a good option for those wanting to initially start a project close to home,” said Kenneth Drew, Ph.D., Sr. Director of North America Sales and Business Development.

“This facility will be a welcome addition to Flamma’s current customer base as well. Having a US cGMP facility provides further flexibility and options to customers as Flamma continues to grow its R&D teams. Using our unique model of Flamma Academy, we will be able to have R&D chemists from both Italy and China to spend time in the Philly area labs and understand what customers want a firsthand. It also helps to bring the entire company together by pairing Italian, Chinese and American scientists together. Flamma is the Thinking CDMO.”

GianMarco Negrisoli, President of Flamma Innovation (the R&D unit within the Flamma Group), noted, “This is another example of the strategic vision for Flamma. The goal is to be recognized by customers as a strategic partner that is ready to invest when and where customers need us to.”

40,000 sq. ft. the facility is in close proximity to Boston/Cambridge (1.5 h flight) as well as the greater New York/New Jersey area (1.5 h drive). Affectionately being dubbed “Flamma-delphia” for now, this extremely well built lab and manufacturing site possesses a cGMP Pilot Plant with hydrogenation capabilities as well as wet-milling, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite with isolators that have been classified 3b (Roche) or band 4 (Safebridge), 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs. Also, the site previously handled controlled drug substances (Schedule II to IV) and Flamma looks forward to reactivating the necessary licenses.

This site will be to be initially dedicated to the development and, production of APIs ranging from pre-clinical/clinical (Phases 1 to 3) and up to commercial phase (after future FDA inspection) with the scale being dependent on the forecasted quantities. Flamma plans to grow the site to 60 employees by 2023 and looks forward to attracting talented personnel

As part of the growing demands of the industry, Flamma has carefully examined various options over the past few years for growth. Flamma felt it was best to start a laboratory operation from the ground floor than try to incorporate an already existing business. By doing this, Flamma can continue to impart its unique culture to its employees from day one and bring value to customers knowing that the same family owned and run culture permeates the new site. This site will be able to quickly accommodate fast-tracked molecules and respond to the constantly growing analytical needs of today’s projects.

This milestone complements the Flamma 2020 Plan to bring value to customers who are looking for a home for their projects and have numerous options to move it forward at the right time. These options include moving projects later on to Flamma’s cGMP facilities in Italy, its cGMP facility in Dalian, China, or taking advantage of both by back integrating the project appropriately.

This acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug manufacturing license from the Chinese FDA. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high containment lab to handle genotoxic materials. Flamma intends to invest ~$10M USD to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.

iBio Launches Sterile Fill-Finish Services

iBio, Inc. has introduced cGMP sterile fill-finish capabilities for pharmaceutical products, including monoclonal antibodies, viral vectors, and other biologics, for preclinical and clinical stage programs. The operation is housed in the company’s 135,000 sq.-ft. manufacturing facility in Bryan, TX.

The sterile liquid fill-finish operation will incorporate in-line labeling, allowing serialization of vials as they are filled. Initial capacity supports 100 – 2,500 vials runs, with plans to expand to 15,000.

“Providing Fill-Finish services is a natural extension of iBio’s FastPharming biologics CDMO capabilities,” said Robert Kay, chief executive officer. “Given our ability to quickly deliver GMP and research quantities of active pharmaceutical ingredient (API), the addition of the fill-finish operation completes our rapid, end-to-end service offering.”

“We understand the needs of early stage companies, who often face moving targets for their timelines and support requirements,” said Nicolas Taquet, Vice President, Biopharmaceutical Manufacturing. “It is often problematic trying to identify available capacity for high-quality, small volume filling. We’re now in position to fill that need for our clients.”

Amgen Selects Location For R&D Facility

Amgen has signed a lease with BioMed Realty for a new 240,000-square-foot Leadership in Energy and Environmental Design (LEED) candidate facility in the Gateway of Pacific campus development in South San Francisco. The new location, currently under construction at Oyster Point, will house Amgen's Bay Area employees focused on cardiometabolic, inflammation and oncology, research.

"At Amgen South San Francisco, we are home to top scientific talent, integrating human genetics with core biology and molecular engineering to discover and develop first-in-class therapies," said Amgen's South San Francisco site-head Flavius Martin, vice president, research, oncology and inflammation. "The new location will foster even greater collaboration across our strong scientific team, accelerate the R&D process, and provide a venue for increased engagement with the Bay Area's abundant scientific and educational communities."

Amgen has been part of the South San Francisco biotech community for 15 years. The company's new home at The Gateway of Pacific campus will be a facility that boosts collaboration via modern work and laboratory spaces. The new site will include modular green wet labs and green molecular lab design. It will provide a flexible and a customizable state-of-the-art scientific research and development facility to support scientific research.

In addition to enhanced R&D laboratory and office space at the new nine-story facility, which is scheduled to open in early 2022, the new campus will house a variety of meeting spaces, an amenity center that includes a number of dining options, a health club and a variety of outdoor recreation areas.

Colorcon Expands Manufacturing and Completes Renovation

Colorcon, Inc., a global excipient company, has completed a major expansion and renovation at its North America production facility in West Point, PA. The multimillion-dollar investment enhances the supply chain robustness of products manufactured for the makers of solid oral dosage products throughout the U.S., Canada, Puerto Rico, Mexico, Colombia, Peru, Bolivia as well as the northern areas of Central and Latin America.

“The investment in our West Point facility brings together expanded material warehousing and new best-in-class quality control laboratories to the existing production capabilities,” said Simon Tasker, president Americas region, Colorcon. “This supports our future growth expectations, improves our environmental footprint and reduces supply lead times for our customers.”

Colorcon’s investment sees the consolidation of multiple legacy buildings into one, unified, manufacturing campus which will eliminate the need for off-site warehousing. The merging of these facilities will provide customers with the highest level of traceability on raw materials and finished goods produced at the site. There are also environmental benefits through the reduced transportation of materials between sites, diminishing traffic and noise in the area that surrounds the Colorcon property.

Martti Hedman, chief executive officer, Colorcon, said, “Colorcon’s West Point, PA, site is one of seven film coating manufacturing sites strategically located around the world and is an important component in Colorcon’s Business Continuity Plan. This multi-year investment helps Colorcon to further improve its service to the customers and is a good example of how Colorcon invests in new capacity ahead of demand.”

Alcami Acquires TriPharm Services

Alcami has bolstered its sterile fill-finish capabilities with the acquisition of TriPharm Services. The deal comes after a new state-of-the-art sterile fill-finish manufacturing center located near Research Triangle Park, NC and follows the recently announced $17 million expansion of Alcami's sterile fill-finish facility in Charleston, SC.

In conjunction with this acquisition, funds affiliated with Madison Dearborn Partners, Alcami's existing majority owner, made an additional equity investment to fund Alcami's growth plan and the former majority owner of TriPharm, Ampersand Capital Partners, rolled a portion of its TriPharm ownership interest into an ownership interest in Alcami.

TriPharm's facility bolsters Alcami's existing sterile fill-finish business, adding new prefilled syringe capabilities and isolator technology, while also providing incremental flexible sterile fill-finish and lyophilization capacity to meet growing industry demand. TriPharm's new manufacturing facility is expected to be operational beginning in the second half of 2020.

"Our combination with TriPharm is an important next step in the execution of Alcami's strategy to focus investments across our network to better serve rapidly growing specialized market segments," said George Van Kula, interim chief executive officer, Alcami. "TriPharm expands our existing capabilities and provides additional equipment lines that will allow us to better serve the fast-developing biologics market segment."

"As drug makers increasingly shift their focus toward more specialized, targeted therapeutics, and current injectable drug shortages hamper patient care, sterile fill-finish operations at proper scale are highly valued," said Patrick Walsh, chief executive officer, TriPharm. "Our Research Triangle Park facility is designed to address this highly specialized industry demand.

Celerion Expands Clinical Research to Nebraska Innovation Campus

Nebraska Innovation Campus (NIC) has announced a new partner. Celerion will move into this space on the campus in February of 2020.

Celerion has been conducting clinical research studies for over 50 years in Lincoln for pharmaceutical and biotechnology companies around the world, for investigational medicines currently in research and development, to treat a wide variety of illnesses and conditions.

The company will be located on the first level of the Rise Building, NIC’s newest building. An open house will be hosted at the Rise Building in March. This event will provide Celerion staff the opportunity to learn about ways to partner with faculty and students, and for visitors to learn more about pharmaceutical research opportunities at Celerion and the drug development process.

“Celerion is a great long-term fit for NIC,” NIC executive director, Dan Duncan. “Their clinical research expertise will be invaluable as the Nebraska Food for Health Center continues to develop and companies in the Biotech Connector mature.”

“Celerion is pleased to announce NIC as the location for our expansion,” said Phil Bach, vice president, global clinical research, Celerion. “We’re excited to take this next step to further our clients’ goals for drug development. This space will allow us to partner with top-notch students, faculty, and entrepreneurs at NIC and collaborate at the forefront of the biotechnology hub in Nebraska.”

GE Healthcare Viral Vector Manufacturing Facility, Worcester

GE Healthcare (GEHC) Life Sciences and the University of Massachusetts Medical School (UMMS) unveiled plans to set up a manufacturing facility for gene therapy in Worcester, US, in December 2019.

The facility will deliver high volumes of quality recombinant adeno-associated virus (AAV) vectors for preclinical research.

Day-to-day operations of the manufacturing facility will be managed by up to six professional staff, becoming fully operational in 2020.

The large-scale facility for viral vector manufacturing will be in the University of Massachusetts Medical School in Worcester, Massachusetts.

The location will be accessible from the Worcester Regional Airport (ORH), Logan International Airport (BOS), TF Green Airport (PVD) and Bradley International Airport (BDL).

Worcester campus is also accessible by multiple modes of transportation including bus, train and local taxi.

A total area of 3,220 ft2 will be occupied by the facility, equipped with a good laboratory practice (GLP) viral vector FlexFactory bioprocess platform for cell therapy manufacturing.

The AAV manufacturing facility in Worcester campus will eliminate the hindrances in the preclinical research work, also benefiting research workers who currently experience a waiting time of up to 24 months to receive enough vectors for their research work.

UMass Medical School and GE Healthcare partnership will address and overcome the challenges of gene therapy industry.

It will also enable researchers to access the processing technologies and obtain professional assistance of GE Healthcare’s staff.

The facility will provide state-of-the-art GE tools and AAV required for preclinical research that will progress the industry of gene therapy to provide therapies to patients.

In June 2018, GE distributed semi-automated cell therapy manufacturing platform FlexFactory, an end-to-end production platform, which scales-up and accelerates the cell therapy clinical trial manufacturing process.

FlexFactory employs single-use technology complemented by single-use tubing sets and multiple automation processes. It is suitable for either new or existing workspaces.

The manufacturing platform standardizes high-quality and large-scale manufacturing of cell therapies, developing cell immunotherapy drugs from the affinity and specificity of the T-cell receptors.

The collaboration will also enable the partners to offer the research facility to external customers to increase benefits for the research and development community while earning revenues to support the facility.

UMass Medical School operates 50 shared research core facilities that can annually generate $24m in revenues, including more than $9m from external customers.

External clients of the UMMS include biotech start-ups, academic institutions and well-established pharmaceutical companies.

UMMS also helps Massachusetts-based small companies through a five-campus consortium offering research technology. The program generated approximately more than $4m in 2018.

Marketing commentary:

GE Healthcare Life Sciences is involved in the development of tools and technologies for cell and gene therapy, bioprocess, genomics and cellular research.

Its products ensure pharmaceutical companies to perform biological analysis, research, development and production of advanced therapies and vaccines.

Founded in 1962, the University of Massachusetts Medical School is the only public health science academic center in Worcester, Massachusetts.

UMMS offers a range of courses, as well as hosts a variety of research activities in biomedical sciences, ranked as one of the leading medical schools in the country.

Nanoform Establishes US Subsidiary

Nanoform USA has been formed due to increasing demand for the Finnish nanonization company’s CESS technology

Nanoform, a nanoparticle medicine enabling company, has established Nanoform USA, a wholly owned subsidiary in the US. This is a natural progression for the company as it continues to increase the impact of its award-winning nanonisation technology and expand its pharma client base in the US.

The expansion coincides with increasing interest in Nanoform’s technology within the US marketplace and the company’s application for GMP status at its Finnish site, which is expected to further fuel demand for Nanoform’s proprietary CESS technology.

The establishment of Nanoform USA also follows the recent appointment of Sally Langa as Head of US Sales. Sally brings 30 years of valuable commercial experience in Pharma, having held senior positions at Catalent Pharma, Patheon and Halo Pharmaceutical.

Prof Edward Hæggström, Nanoform CEO, said: “We are tremendously excited to have officially established our presence in the US with a wholly owned subsidiary. This comes as a natural next step for our company as we continue to expand the reach of our nanonisation technology.”

Miguel Calado, Vice Chairman of the Nanoform Board, said: “I am thrilled we are establishing Nanoform USA Inc. With this strategic expansion, we now have a strong foundation on which to continue to grow our presence in the US.”

Cargill Funds Food Processing Cleanroom to Reduce Protein Waste

Cargill has partnered with the Houston Food Bank in Texas to donate a USDA-monitored food processing cleanroom

Cargill and Feeding America have partnered with the Houston Food Bank in Texas. Agricultural product producer, Cargill, is investing in a United States Department of Agriculture (USDA) cleanroom, a food processing space that is inspected and monitored by the USDA Food Safety and Inspection Service.

USDA cleanrooms enable the receipt of bulk format cartons of protein from industry partners that food banks can then convert to retail-sized portions.

Protein is the most difficult food group for member food banks to obtain for children and families who face hunger due to costs and short shelf life; however, it is a critical part of a balanced diet. This partnership helps to close this protein gap and reduce food waste.

Brian Greene, President and CEO of the Houston Food Bank, said: "With the new clean room, sponsored by Cargill, some of the barriers to providing much-needed protein for better lives will be removed."

USDA cleanrooms operated by Feeding America food banks will follow a hub-and-spoke model in which the "cleanroom central hub food bank" assists in the sourcing and distribution of protein for their own service area as well as "spoke" service areas served by other food banks.

On average, a 30' x 40' facility can help prepare 300,000 pounds of additional protein per year. The installation of a USDA cleanroom at one food bank helped to increase overall protein donations by 60%.

"This new cleanroom is a critical milestone in our efforts to address hunger, food loss and waste, and food safety," said Pete Stoddart, Cargill's corporate responsibility lead in North America. "This is just one of the ways we are improving communities through the power of food."

In addition to funding a cleanroom, Cargill recently donated $3 million to the Feeding America to support ongoing efforts to reduce food waste and improve access to produce and other nutritious food.

G-CON Facility Expansion for Superstructure Production

The new 25,000 sq. ft. area was designed for and is completely dedicated to superstructure fabrication, relieving a bottleneck that previously existed in our production process.

G-CON Manufacturing, the leader in prefabricated, flexible cleanroom solutions, announced the expansion of its manufacturing facility for POD superstructures in College Station, TX. Previously limited to manufacturing only 50 superstructures in-house and 50 superstructures per year through supply agreements, the expansion now allows construction of 200 POD superstructures per year, all produced in-house. The new production area features overhead cranes and an assembly line approach that allows for more efficient and safe production with better quality.

“Prior to this expansion, the lack of available space created a bottleneck for the G-CON College Station operation,” said Blake Williams, Vice President of Operations at G-CON Manufacturing. “The new 25,000 sq. ft. area was designed for and is completely dedicated to superstructure fabrication, relieving a bottleneck that previously existed in our production process. We are also proud of the fact that the new facility employs the safest, easiest, most robust method of fabricating units with the best in class overhead cranes, man lifts, welding equipment and safety equipment.”

As part of this project, G-CON also added a canteen for its manufacturing team giving them a place to relax during break and mealtime. The 2,500 sq. ft. canteen boasts modernized restroom facilities and a fully functioning kitchen for G-CON’s 100+ staff members.

About G-CON Manufacturing:

G-CON Manufacturing designs, builds and installs prefabricated cleanrooms. G-CON’s POD portfolio provides cleanrooms in a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD cleanrooms surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing once the production process reaches its lifecycle end.

REST OF WORLD

Vetter Consolidates Development Labs in One Location

Vetter decides to house its development laboratories together in Ravensburg, Germany, to modernize capabilities, with plans for further expansion.

The new building space was completed last year and sees Vetter’s development laboratories housed in one 19,368 sq. ft. (1,800-square-meter) facility in Ravensburg.

The facilities include non-good manufacturing practice (GMP) laboratory space and equipment, as well as a GMP analytical laboratory. In addition, the combined space will offer process development capabilities, as well as specification testing of packaging system, chemical-analytical and biochemical analysis and particle characterization.

In total, 50 employees will staff the building and the contract development and manufacturing organization (CDMO) noted that being housed under one roof will allow colleagues to “share expertise and know-how to improve and simplify information exchange.”

As well as improving cooperation, the merged lab space is expected to reduce handling issues and allow for the synchronization of processes, as previously development took place in different locations in Ravensburg and Langenargen.

Customers will benefit by being able to follow the development cycle of their project, suggested Claus Feussner, SVP of Development Service.

“Now [clients] can follow a complete development process and its individual steps, since it proceeds throughout the labs, all within the same building,” he said.

Though the new building is complete, the company will continue to expand within the space over the course of 2020 and will add further analytical equipment.

The investment in its European capabilities follows similar investment in its US operations, which saw it expand its clinical manufacturing facility in Chicago last year. The company also launched a pilot project looking at automating its packaging services.

Sphere Fluidics Expands Production of Surfactant

Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, has invested in the production and supply of its proprietary biocompatible surfactant, Pico-Surf, for reliable and stable droplet generation and processing.

UK-based Sphere Fluidics will expand operations to meet demand for large-scale commercial supply of the surfactant for use in a wide range of microfluidic application workflows.

Sphere Fluidics aims to increase production of Pico-Surf by three-fold in 2020, whilst maintaining standards, through significant investment of resources in manufacture and quality control processes, and workforce.

Dr. Marian Rehak, VP of Research and Development, said: “We are enthused by the increased demand for Pico-Surf, and eager to mobilize its production to meet demand. Whilst doing so, we will ensure its very high quality control standards are maintained, meaning researchers can continue rely on Pico-Surf to create droplets that are stable and reproducible.”

Rob Treanor, Director of Operations, added: “All our consumable products have been designed to be platform-agnostic, so they work effectively with a number of microfluidic systems.”

Pico-Surf is an animal-origin-free biocompatible surfactant optimized to support the formation of aqueous solution-in-oil picodroplets.

The unique and patented molecular structure of Pico-Surf stabilizes droplets, and retains and protects their cellular and molecular contents over a wide range of temperatures and biological conditions, helping to ensure high cell viability for improved assay performance.

Droplets generated using Pico-Surf show low end point interfacial tension and critical micelle concentration in comparison to other commercially available surfactants. The purity and quality of the surfactant also enables a more efficient droplet sorting process at low voltage. The ready-to-use surfactant is available in large batches or made-to-order with ensured lot-to-lot consistency.

Steriline Delivers Customized R&D Machines to Ferring

The Italian aseptic processing expert has created a vial capping, decontamination equipment and a robotic washing machine for vials and cartridges.

Steriline has revealed details of the product development that saw the aseptic processing expert deliver customized equipment for research and development (R&D) to Ferring, the Swiss pharmaceutical company with a global footprint.

Ferring Pharmaceuticals, a specialist in reproductive medicine, maternal health and in areas within gastroenterology, urology, endocrinology and orthopedics, partnered with Steriline to satisfy the need for a small-scale customized vial capping and decontamination machine for high potent freeze-dried drugs processing. Ferring also required a small-scale external washing machine for vials and cartridges.

The Steriline and Ferring collaboration started in June 2017. Both companies joined forces at the Ferring International PharmaScience Center (IPC) in Copenhagen, with the technical assistance of Jacobs Engineering Milan.

"We experienced a good and open collaboration between three companies: Steriline, Jacobs Engineering and Ferring IPC," commented Anders Magnusson, Senior Scientist & Project Manager, Pharmaceutical Development, Ferring IPC. "Together we found the way to develop good engineering solutions focused on functionality, flexibility and personal safety," he added.

Steriline developed a flexible and small-scale solution, which is different from what's currently available on the market. The equipment features a customized monobloc made of a vial capping machine (VCM50) and external decontamination machine (EDM-C), with the new application of a transfer shuttle for moving vials from the freeze drier to the capping machine, and a robotic washing machine for vials and cartridges.

"Developing novel equipment is known to be a challenging process," commented Helena Nicklasson, Vice President Global Product Development & Drug Delivery, Ferring IPC. "However, with the good collaboration of the three companies, the equipment is now in use, and I am confident that it will improve and increase the efficiency of our development process for new drug products," she added.

The project achieved yet another unique feature: the compact design of both machines allows for working under cRABS with common pressure control from the EDM-C.

Thanks to a continuous and open dialogue, the Steriline-Ferring-Jacobs team succeeded in finding solutions to all the different challenges they faced. For example, due to space constraint, the teams carried out a joint study for the application of a PUSH/PUSH filter and provided a safer filter change procedure from the inside of the EDM-C unit.

The bigger challenge, however, came up when the proposed standard washing machine (RA-V4) was still over-dimensioned for Ferring batch size. Steriline insisted and proposed the prototype of a machine studied explicitly as an alternative solution: a miniature robotic washing machine (RL-1) capable of handling vials and cartridges loaded from trays.

Again, through open dialogue and ongoing guidance to the client, Steriline met Ferring expectations about flexibility, price and delivery.

Every issue that came up during the project lifecycle was addressed promptly, and the RL-1 machine redesign was finally carried-out successfully. The full project implementation, from the kick-off meeting until the end of the site acceptance test (SAT) took only 18 months. A record time, considering all risks for designing, developing and evaluating prototypes for this kind of new customized machines.

"The area of R&D is very challenging with clients asking for support when there are new drugs to be developed," commented Federico Fumagalli, Chief Commercial Officer at Steriline. He continued: "We usually work on customizing our standard solutions or on developing the new ones according to the specific requirements. And this was exactly the case with Ferring."

Steriline has proven to be the perfect partner to design and plan together new solutions to satisfy all client's requirements, as proven by Ferring.

The success of this project is leverage by Steriline's accurate and widespread assistance and training service, and the exceptionally striking cooperation attitude of the teams.

Caldic Benelux Adds Third Cleanroom to Expand Filling Services

The Belgian pharmaceutical services company has recently invested in a third cleanroom to expand filling of flammable and non-flammable solvents.

Calcic Benelux has recently invested in a third state-of-the-art cleanroom, allowing expansion of its pharma capabilities. On top of that, the company is also expanding its dedicated pharma warehousing and repackaging facilities.

At its site in Hemiksem, Belgium, Calcic already has two fully equipped cleanrooms to serve the pharmaceutical industry.

Now in addition to Cleanroom 1, and Cleanroom 2, Calcic has made an investment to expand capabilities with a third cleanroom, which is currently under construction and is expected to be operative in Q1 2020.

This cleanroom is suitable for the filling of flammable and non-flammable pharmaceutical solvents into drums, IBC’s and even stainless steel IBC’s. In this ATEX Cleanroom, Calcic will be able to drum products as Ethanol EP, Aceton EP, Isopropanol GMP, and many other pharmaceutical-grade solvents.

Commenting on the reason for constructing this new cleanroom, Dries Segers, Business Development Manager Pharma Europe at Calcic, said: “We already have a strong footprint in the pharmaceutical market in Europe. With our new investments, we continue our goal of serving our customers even better. Calcic has always been focusing on what we call ‘full-service distribution’. Our aim is to offer customers more than just standard products in standard packaging. We want to go the extra mile and help our customers with product sourcing, special packaging, sampling and dedicated cleanroom fillings.”

“Cleanroom 1 is limited to filling Propylene glycol and Glycerin pharmaceutical grades”, said Dries. “We noticed that there is a demand in the market for dedicated cleanroom fillings of a variety of other pharmaceutical grade solvents: flammable and non-flammable, in different packaging types. With our new cleanroom we will be able to fulfill our customers’ needs to have their pharmaceutical products filled in a dedicated way to avoid any risk of contamination.”

Additionally, Calcic is expanding its capabilities for dedicated pharma warehousing and repackaging possibilities.

Currently the repacking of secondary packaging under controlled conditions is already a service Calcic provides to their customers along with dedicated storage of pharma products. Calcic is looking further into growing these capabilities, together with its customers.

Construction of Aerodynamic Antarctic Research Building Begins

The Discovery Building broke ground in late January 2020.

Construction has begun on a new research building for the British Antarctic Survey (BAS) designed to keep scientists safe in some of the most challenging conditions on the planet. The project is defined by its aerodynamic wind-deflecting roof and is due to be completed in 2023.

The Discovery Building broke ground in late January, to commemorate the 200th anniversary of the first sighting of Antarctica by British naval officer Edward Bransfield, and is led by the Antarctic Infrastructure Modernization Partnership, which consists of Hugh Broughton Architects (the firm responsible for the Halley VI), along with NORR Architects, Turner & Townsend, BAM, and Sweco. The project is part of an ongoing effort to modernize the BAS' Rothera Research Station on Antarctica's Adelaide Island.

The two-story, 4,500 sq. meters (roughly 48,440 sq. ft.) building will replace multiple existing buildings spread across the Rothera Research Station site which are deemed outdated or too costly to maintain. It will contain preparation areas for field expeditions, a central store, medical facility, offices, recreational spaces, workshops, and more.

The big eye-catching addition is that roof and wind deflector, which has been calculated to mitigate the effects of the harsh conditions. It's not enough to merely keep the scientists safe though, and efforts have been made to support their wellbeing and to minimize the effects of seasonal affective disorder too. This involves designing an open layout with adjoining workspaces, skylights that maximize natural light, and a bright vibrant decor.

Piramal Invests in Glass Facility in India

Piramal Glass, a niche glass packaging specialist, has invested $42 million in its greenfield project in Jambusar, Gujarat, India. The expansion plan includes one new furnace with seven new manufacturing lines across ~300,000 sq. ft. plant.

The upgraded plant caters primarily to high-end specialty spirit, food & beverage and pharmaceutical markets primarily for exports to countries in Asia, Europe and the US.

Piramal Glass is already catering to the high-end Specialty Spirits from its plant in the US. This facility will be one-of-its-kind in Asia as there is a growing need for high-end water bottles, spirits bottles and food packaging.

Piramal Glass with a global sales of $357m operates from India, Sri Lanka and the US through its four manufacturing facilities and several decoration plants. Globally, the company makes 1435 tons per day of glass from 12 furnaces and 63 production lines. 40% of its sales are in high-end Cosmetics & Perfumery market, 37% in Specialty Spirits market and 23% in pharmaceutical market.

The Jambusar plant already houses three furnaces with 23 manufacturing lines and produces 540 tons per day of glass. It currently employs 2,130 people and with this expansion, it will create additional direct employment to around 700 people.

Commenting on the investment, Vijay Shah, Vice Chairman at Piramal Glass said: “This will enable us to offer our premium customers in Asia, Europe and the US, innovative value-added glass packaging across high-end Specialty Spirits and Food & Beverage Industries.”

“This world-class plant equipped with cutting-edge technology rooted in the principles of digital manufacturing, will also create job opportunities in the region,” Shah added.

PM Group to Design Training Facility Expansion

PM Group has been chosen by the National Institute for Bioprocessing Research (NIBRT) to develop a design to expand its existing facility in Ireland. The expansion project will facilitate the training, research and innovation for the manufacture of Cell and Gene Therapy (CGT) medicines.

The commercial value of CGTs is forecasted to grow exponentially over coming years. As new pathways for disease treatment and cure command growing attention and investment, the total number of next generation biologics (the majority of which are CGTs) in the development pipeline reached 269 by the end of 2018, up from 120 in 2015.

Ireland has established a hard won reputation as a center of excellence in biopharma manufacturing mainly focused on monoclonal antibodies. However, the new wave of biopharma investments will include next generation biologics (mainly CGTs) which represent complex challenges to manufacture economically.

NIBRT and its partners established a CGT Forum in December 2018 to address these challenges, publishing a White Paper in May 2019, announced several CGT research collaborations and commenced CGT training activity in Q4 2019.

To further facilitate CGT training and research, NIBRT has appointed PM Group to develop a design to expand NIBRT’s existing facility in Dublin, Ireland. With this expansion NIBRT will be able to support the workforce development and research expertise that underpins global CGT manufacturing investments.

“PM Group is delighted to be appointed to work on the concept design of NIBRT’s new CGT training facility. It is an exciting next step and builds on our track record of innovation in the CGT space and our partnership with NIBRT,” said Eileen Lee, Dublin Office Operations Manager for PM Group.

Announcing the appointment of PM Group, NIBRT CEO, Dominic Carolan, said: “This design will position NIBRT to train our industry and educational clients in the current and emergent CGT manufacturing technologies as well as continuing expansion of our CGT research activities”.

PP4C Partners Build New Compounding Pharmacy in Eindhoven

Construction work for a pharmacy facility for the Catherina Hospital in Eindhoven, in the south of Netherlands, progresses well, Dutch construction company Brecon has reported. The project is being developed by the PP4C partners with the end of the year as the deadline for completion.

"The building's profile is becoming increasingly clear from the three-story building with a total area of 21,520 sq. ft. (2,000 m2)," said Geerd Jansen of Brecon International and a leading figure in the PP4C organization.

Kuijpers PHF and Cornelissen, the building contractor, have joined forces the realization of the building and the complete installation technology. The Brecon Group is in charge of the cleanroom and laboratories, including the complete furniture and finishing of the cleanroom floors.

The extensive air treatment will be installed by Kuijpers PHF and Assa Abloy has been entrusted with supplying automatic sliding doors. WERO have also joined the project and will be looking after correct cleaning, prior to the detailed qualification at the end of the year.

Jansen said a full report on the end result will be released in approximately 10 months.

Upon completion, the pharmacy will deliver ready-made sterile syringes to the hospital as well as individually tailored medication such as chemotherapy.

Astellas Pharma New Manufacturing Facility, Toyama

Provisionally the third fermentation building, the facility will be used to manufacture API of Astellas’ Prograf® (tacrolimus hydrate), an anti-rejection medicine for liver, kidney and heart transplant patients.

Construction of the API manufacturing facility will begin in April 2020 and completion is expected in August 2021.

Third fermentation building is anticipated to cost approximately JP¥10bn ($90.8m).

Astellas’ Toyama Technology Centre in Toyama, the capital city of Toyama prefecture in Japan, will be the location of the proposed manufacturing facility.

The site extends across an area of 2,055,160 sq. ft. (191,000m²) and includes a built-up area of 258,089 sq. ft. (23,986m²).

The API manufacturing facility will offer a total floor space of 77,687 sq. ft. (7,220m²) and include three floors above the ground level, equipped with advanced production facilities.

Third fermentation building will help increase the company’s production capacity to meet the projected demand for Prograf and ensure the steady supply of products.

Toyama Technology Centre commenced operations in 1992 and is involved in the production and packaging of Prograf capsules and granules and Protopic ointments. It manufactures Prograf APIs for Japan and overseas markets.

Prograf and Protopic products are used as medications for immunological diseases. The center also houses research facilities, and the company has plans to add facilities in future to manufacture bio-investigational drugs and commercial products.

Prograf is a calcineurin-inhibitor immunosuppressant prescribed for use with separate medicines to prevent organ rejection in patients receiving kidney, liver or heart transplants. It gained initial approval from the US FDA in 1994.

Developed by Astellas Pharma, Prograf capsules and granules are tacrolimus immediate-release drugs used for oral administration. In March 2019, the company launched Prograf Granules in the US as a therapeutic alternative for pediatric patients receiving organ transplantation. The firm supplies the Prograf immunosuppressant to approximately 100 countries.

Other brand names of tacrolimus hydrate offered by the company are Advagraf® Graceptor® and Astagraf XL®.

Prograf granules are available in standardized packets of 0.2mg or 1mg containing 50 units for facilitating precise dosing in pediatric patients. The product is also accessible as 5mg / ml injections for intravenous use.

Marketing commentary on Astellas Pharma:

Astellas Pharma is an international pharmaceutical company engaged in the manufacturing and marketing of pharmaceuticals, focused on providing innovative and reliable pharmaceutical products to improve the health of people.

Established in April 2005, the company is headquartered in Tokyo and employs 16,243 people as of March 2019.

Astellas Pharma follows a focus area approach to develop innovative medicines for diseases with unmet medical needs. It offers numerous products for the treatment of diseases, such as overactive bladder (OAB), acute myeloid leukemia (AML), prostate cancer and benign prostatic hyperplasia.

Astellas invests in research and development activities to bring breakthrough discoveries to patients. In addition to its R&D efforts, the company collaborates with biotechnology companies and academic research institutes.

Key therapeutic areas of interest include oncology, nephrology, neuroscience, immunology, urology, ophthalmology, muscle diseases, regenerative medicines, vaccines and gene therapy.

Immuno-oncology, mitochondrial function, antigen-specific immunomodulation and regenerative medicine are the four areas of primary focus at the company’s innovation sites in Cambridge and Marlborough, US.

The company operates through locations in North America, South America, Europe, Middle East and Africa (EMEA) and Asia-Pacific regions. It closed the acquisition of Adeno-associated viral vector (AAV)-based genetic medicines firm Audentes Therapeutics, in January 2020.

Phillips-Medisize’s Manufacturing Facility Expansion

Phillips-Medisize is expanding its existing global innovation and development (GID) center in Struer, Denmark.

Announced in January 2020, the expansion involves the addition of dedicated manufacturing development and clinical build unit at the site.

The project will expand Phillips-Medisize’s clinical manufacturing capabilities, allowing the company to meet growing demand from customers in the drug delivery device market. The Struer unit is anticipated to commence operations in the second quarter of 2020.

Phillips-Medisize’s manufacturing facility expansion details

The primary objective of the facility is to support clients in late-stage development of medium and high volume products.

It will feature an agile setup for cleanroom assembly and molding processes to serve the needs of customers, designed with 5,380 sq. ft. (500m²) of floor space to accommodate the cleanroom.

Expansion of the existing site will contribute towards expediting manufacturing and development of novel products while accelerating their availability to patients. Also, the facility will reduce launch risk for clients in the drug delivery devices domain.

Manufacturing development and clinical build unit will also boost Phillips-Medisize’s operations in Scandinavia and complement its existing activities in Copenhagen.

Details of Phillips-Medisize’s existing manufacturing facility

The existing GID center in Struer, Denmark covers an area of 8,400m2 (90,560ft2). The facility is certified by the Canadian Medical Devices Conformity Assessment System (CMDCAS) and International Organization for Standardization (ISO) for the production of medical devices under a regulated quality management system (QMS).

Phillips-Medisize’s manufacturing facility also complies with the US Food and Drug Administration (FDA) 21 CFR Part 820 regulation and the standards of Japan’s Ministry of Health, Labour and Welfare (MHLW) and European Union’s MDD 93 / 42.

Phillips-Medisize’s product portfolio:

Phillips-Medisize offers front end innovation, clinical and commercial manufacturing, as well as design and development related solutions.

The company provides integrated services to facilitate end-to-end development of products at large scale, allowing clients to bring products to market faster with lower risk. The firm also possesses electronics integration, and printed circuit board assembly (PCBA) manufacturing and assembly capabilities. It embeds electronics into drug delivery devices to improve the effectiveness of therapies.

Phillips-Medisize leverages technology to advance the development of drug containers, providing direct use for patients, with accelerators classified into two types, drug delivery device technology accelerators and connected health technology accelerators.

Drug delivery device technology accelerators range helps in the development of injectors such as auto, pen, subcutaneous and wearable injectors. The accelerators also cover infusion devices, electronic patch pumps and cartridge and vial solutions.

Accelerators in the connected health technology category cover connected device and sensors, digital interfaces for end-users and a safe and compliant cloud database platform.

In the diagnostics market, Phillips-Medisize’s offering includes complete diagnostic devices, kits and sub-assemblies.

Phillips-Medisize is a subsidiary of interconnect solutions manufacturer Molex. The firm serves the pharmaceutical, medical device and diagnostics industries with solutions and services related to innovation, development and manufacturing. It primarily focuses on connected health solutions and drug delivery devices.

Headquartered in Hudson, Wisconsin, the company also provides primary pharmaceutical packaging services.

The company’s diagnostic product offerings include glucose meters, inhalation drug delivery devices, disposable insulin pen injectors, single-use surgical devices and diagnostic consumables equipment.

Phillips-Medisize has a workforce of more than 5,500 people and operates through 17 production facilities in the US, Europe, China and Mexico.

In November 2019, Phillips-Medisize opened a GID facility in Copenhagen, Denmark to support growth plans in areas such as wearable devices, injectors and connected health.

Phillips-Medisize also operates GID centers in Hudson and Fremont in the US, Struer in Denmark, Cambridge in the UK, Hillegom in the Netherlands, Suzhou in China and Bengaluru in India.

Groundbreaking for SCHOTT Pharmaceutical Packaging Plant

By breaking ground, specialty glass manufacturer SCHOTT has given the preliminary signal for the erection of a production facility for sterile polymer pharmaceutical primary packaging at its Müllheim site, Germany.

The state-of-the-art plant is to be built by 2022 with an investment volume in the three-digit million euro range and will then offer 100 additional jobs.

“The construction of this new production facility represents an enormous reinforcement of our site here in Müllheim. In addition to pharmaceutical glass vials, we will now have sterile, prefillable polymer containers and here in particular syringes, as a second pillar,” explained Site Manager Bernhard Langner. The new plant will be built on the existing plant grounds on an area of 118,360 sq. ft. (11,000 square meters). Besides the production building that will be equipped with the latest cleanroom technology, the new building project also includes a pilot center for developing innovations, a logistics center and an integrated administrative area.

“The city of Müllheim warmly welcomes SCHOTT’s expansion, which will further strengthen our prospering business location between Basel and Freiburg. We are particularly pleased about the high level of investment, the significant increase in jobs and the fact that SCHOTT is so clearly committed to our city,” said Martin Löffler, the Mayor of Müllheim.

With currently 280 employees, Müllheim is the only plant the SCHOTT Pharmaceutical Systems Business Unit has in Germany. It is part of a global network of 18 production sites in 13 countries.

“After we just significantly expanded capacity by adding new production lines at our competence center for polymer syringes in St. Gallen and recently completed the installation of the new lines there, the construction of the new plant in Müllheim represents another important step in the strategic expansion of our polymer business,” explained Mario Haas, Head of the Polymer Solutions division. The new production facility will meet the highest standards. The entire process, from injection molding and quality control to sterile packaging, will be automated and digitally connected in a state-of-the-art cleanroom environment. “By also using the principle of machine learning and artificial intelligence in inspection technology, we can use the data we have collected to optimize process parameters,” added Andreas Reisse, Head of the Pharmaceutical Systems Business Unit.

Prefillable syringes made of polymer are used for highly viscous drugs, emergency medication and intensive care medicine, among other applications.

SCHOTT is one of the world’s leading suppliers of pharmaceutical packaging made of glass and polymer. Every year, the company manufactures around eleven billion syringes, vials, ampoules and cartridges. This, in turn, means that, in purely mathematical terms, every person in the world comes into contact with pharmaceutical packaging from SCHOTT one and a half times a year.

Almac GMP Certification for Irish Site

Following an inspection at its Ireland site, Almac received compliance certification for its Almac Adapt Just in Time’ clinical packaging and labelling manufacturing services.

Almac Clinical Services, a unit of Almac Group, announced it has successfully undergone an inspection at its European campus in Dundalk, Ireland, resulting in a good manufacturing processes (GMP) compliance certification from Ireland’s Health Products Regulatory Authority (HPRA).

During the inspection, the HPRA examined the company’s suites and associated processes at the facility. The authority noted no deviations, while it also updated its manufacturing authorization to include secondary packaging capabilities.

The compliance regards the company’s Almac Adapt services. The program launched in June 2019 and is designed for time-sensitive medicine supply, including cell and gene therapies, oncology trials, immunotherapy, rare and orphan diseases.

Natalie Balanovsky, manager of the Just in Time Manufacturing Solutions division, said the service looks to address the ‘changing’ needs of the industry. When asked about how this is changing, she explained the industry is experiencing a rapidly growing and ageing population, to which science responds by developing personalized medicines.

Almac Adapt aims to enable customization of clinical supply, by postponing packaging and labelling until the site or patient’s need arises, with operations triggered directly by distribution orders.

According to the company, this method ensures finished patient kits are packaged, labelled and shipped only when needed, to reduce timelines, wastage and product shortages to ensure budgetary and protocol efficiencies.

Development of the service, as well as of the facilities that offer the same, has cost the company an investment of more than $5.7 million (£4.4 million). This figure includes expenditures at Almac’s sites in Craigavon, UK; Dundalk, Ireland; Pennsylvania and North Carolina, US; and Singapore.

Almac obtained the Ireland facility in 2017 and expanded it in 2018, as part of the company’s strategy to address challenges that may arise due to Brexit. To date, Balanovsky said, the site has empowered Almac to provide services to its customers, “guaranteeing seamless access to the European Union post UK withdrawal.”

EMA Approves Production Facility for Pharming’s Lead Product

Pharming Group N.V., a Netherlands-based biotechnology company, announced on Jan. 21, 2020 that it received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for its lead product, ruconest, for the treatment of hereditary angioedema, a disorder that involves repeated episodes of severe swelling.

With the facility officially approved, Pharming will now be able to release the product that was manufactured at the facility during the approval process for commercialization in the European Union, a company press release said. As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

“As we continue to see increasing demand for ruconest in the treatment of hereditary angioedema, we are pleased to announce the approval of our new facility, which will enable us to significantly increase production capacity for supply to patients in the EU,” said Sijmen de Vries, CEO of Pharming. “In addition, as a result of our recent re-acquisition of ruconest’s European distribution rights from Sobi, this capacity expansion will allow us to reach an even greater number of EU patients.”

According to the release, FDA is still reviewing the facility’s post-approval supplement for the distribution of ruconest in the United States. Approval for distribution in the US is slated for early 2020.

Catalent Expands Fill-Finish Capacity

Catalent announced on Jan. 7, 2020 the completion of the purchase of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility in Anagni, Italy. The sale was announced in June 2019.

Catalent will continue to manufacture the existing Bristol-Myers Squibb product portfolio currently produced at the site.

The 28,000 square-meter (305,000 square-feet) facility offers aseptic liquid and powder filling for biologics and sterile products for multiple vial sizes, and primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products. Catalent has also announced that it plans to make further investments in the site’s growth, the company reported in a press statement.

“The Anagni facility supplements our European commercial supply capabilities and will integrate well with our existing global early development and clinical supply sites to smooth the transition from development to commercial supply,” commented Alessandro Maselli, Catalent’s president and chief operating officer in the press statement. “Anagni provides our European customers with great biologics and oral dose capabilities that can help us reduce time-to-market, simplify tech transfers, and minimize program risk.”

BHP Opens New Elemental Impurities Testing Facility

Ireland-based BHP Laboratories, a provider of measuring, testing, and analytical services, now offers complete elemental impurities testing services for the medtech sector. The company made a significant investment in its facilities over the last 12 months with the introduction of an ISO 7 cleanroom for sample preparation and two state-of-the-art inductively coupled plasma spectrometers (inductively coupled plasma mass spectrometry and inductively coupled plasma–optical emission spectrometry) for the analysis of samples. The new facility was officially opened on Dec. 17, 2019 by Pat Breen, minister for Trade, Employment, Business, EU Digital Single Market, and Data Protection, Ireland.

The investment by BHP will allow the company to meet existing client needs and to further expand into United Kingdom and European markets.

“Our customers within the pharmaceutical and medical device industries are regulated by very strict quality control requirements and want to work with accredited and approved laboratories. They also want to reduce lead times for testing. Our investment comes on the back of significant growth in the number of customers looking for our services in the past few years,” said Dervla Purcell, laboratory manager at BHP Laboratories, in a company press release.

“The new cleanroom sample preparation facility along with the ICP [inductively coupled plasma] instruments complement our existing in-house techniques, such as GCMS [gas chromatography–mass spectrometry], LCMS [liquid chromatography–mass spectrometry], and HPLC [high-performance liquid chromatography], and allows us to offer a complete testing package to clients where time and compliance are critical,” Purcell added.

“As a premier independent and multidisciplinary laboratory in Ireland that is already employing [more than] 50 people, I am very pleased that it continues to expand its business in the Mid-West region. The work conducted by BHP ultimately allows the pharma, life sciences, and MedTech industries to continue producing innovative new products which will be sold on global markets. Collectively we are enhancing the competitiveness of the Irish economy while helping to create the jobs of the future,” said Breen.

WuXi Vaccine Contract

WuXi Biologics announced that WuXi Vaccines, its joint venture with Shanghai Hile Bio-technology, has entered into a strategic partnership with a global vaccine leader and signed a 20-year vaccine manufacturing contract valued approximately $3 billion, pursuant to which WuXi Vaccines will build a dedicated facility and supply commercial vaccine products for the global market.

Under the contract, WuXi Vaccines will build an integrated vaccine manufacturing facility including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC). The facility will be dedicated to manufacture one of its partner's vaccine products for the global market. The new facility is expected to be operational in 2022.

In Nov 2019, WuXi Vaccines announced $240 million investment to build the new vaccine manufacturing facility in Ireland. The facility is located within the WuXi Biologics Campus adjacent to the "Factory of the Future" biologics drug substance manufacturing facility which is scheduled for commercial manufacturing in 2021.

"This is a historic moment for WuXi Biologics and WuXi Vaccines as well as for the global vaccine industry. Due to process complexity, extensive analytic testing and rigorous regulatory standards, vaccines are difficult to manufacture, and process and quality control are extremely critical for the quality of the product. This partnership with a global vaccine leader to exclusively manufacture a vaccine for the global market, first of its kind in the industry, is a further testimony to the technical strengths and premier quality demonstrated by WuXi Vaccines," said Dr. Chris Chen, CEO of WuXi Biologics and Chairman of WuXi Vaccines.

WuXi Biologics Plans to Further Expand New Bioconjugation Center

WuXi Biologics plans to expand its new integrated biologics conjugation solution center to include commercial manufacturing in Wuxi City, China.

Last June, WuXi Biologics announced the building of an integrated biologics conjugation solution center, including process development and clinical manufacturing for Antibody-Drug Conjugates (ADCs) drug substance and drug product. This center is expected to initiate GMP manufacturing later this year. The new 5.5-acre expansion will enable cGMP commercial manufacturing for ADCs drug substance and drug product.

"We are quite excited to expand construction of this new integrated biologics conjugation solution center, which will further enhance our technical capabilities and manufacturing capacities in the fast-growing bioconjugation field," said Dr. Chris Chen, chief executive officer of WuXi Biologics. "With the strength of our ONE-stop service platform covering antibody, bioconjugation drug substance and drug product, WuXi Biologics will continue enabling our global partners to develop exciting ADCs to benefit cancer patients worldwide."

There are currently more than 20 ADCs being developed at WuXi Biologics. So far, WuXi Biologics has successfully advanced 11 ADCs projects to Investigational New Drug (IND) filing

Concept Life Sciences Opens New Niche API Facility

Concept Life Sciences has unveiled a new clinical niche commercial facility. The facility has been designed to support pharma and biotech companies throughout the development and manufacture of active pharmaceutical ingredients (API).

Located at Discovery Park in Sandwich, UK, the purpose-built facility offers a comprehensive range of services designed to allow partner organizations to take drug candidates through discovery, scale up and into cGMP-compliant production.

Dr Paul Doyle, Chief Scientific Officer at Concept Life Sciences said: “Pharmaceutical and biotech companies of all sizes are demanding high-quality, early-stage manufacturing capabilities that can readily scale up target molecules from grams to kilograms, and then into cGMP-compliant API manufacture all while mitigating the risk typically associated with moving between different stages of the drug development process."

Doyle continued to say that the new specialist facility will strengthen support services to enable a boost in productivity and faster time to market.

With the new facility joining the company’s growing network of sites across the UK, Concept Life Sciences’ pharmaceutical manufacturing support services now comprise:

API process research and development, and cGMP – both small- and larger-scale plants, including the capability to provide demonstration, toxicology and clinical batches

Quality control release testing – a unique blend of high-end characterization techniques and standard chromatographic methods for raw material and finished product release in compliance with cGMP requirements

Stability studies – in line with the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

Out-of-specification investigations – identification of contaminants and impurities, materials characterization and responsiveness in emergencies to minimize production downtime

Extractables, leachables and sorption studies – testing of packaging to support regulatory submissions and packaging changes

Cleaning verification and validation – full cGMP-compliant capabilities to ensure optimal product protection

Occupational hygiene – sensitive surrogate testing using low-hazard compounds, air quality monitoring and safe handling of biological samples, as well as development, validation and analysis of air filter and swab samples

Environmental monitoring – effluent analysis, land contamination testing and emissions control

Symbiosis Invests $1.9M in UK Facility Expansion

Symbiosis Pharmaceutical Services has expanded its sterile biologics manufacturing facility in Scotland, UK by 25%.

The company has invested more than $1.9 million in the expansion of its Stirling site, doubling its current footprint with an additional 8,000 sq.-ft. of space to house administrative, management and operational teams, as well as the expansion of its manufacturing space and its supporting services infrastructure.

The new operational area also provides additional capacity for GMP-compliant manufacturing services for supply chain management, additional temperature-controlled storage, and the company’s first automated labelling and packaging equipment.

Colin MacKay, chief executive officer at Symbiosis said, “This represents another exciting step for Symbiosis which allows the company to continue to leverage its expertise in small scale clinical and commercial sterile manufacturing to drive future growth. The additional space has allowed us to increase our headcount from 60 to 90 employees in line with both customer demand and our ongoing growth strategy.

“The investment in the new facility is driven by the significant organic growth of the company as a result of its continued success in the niche market of sterile manufacturing of advanced therapeutic medicinal products (ATMPs) such as viral vector and other biopharmaceuticals. our customer base has grown by more than 25% in 2019 alone.”

The expanded facility, which was recently completed and is now fully operational, has been part-funded by a successful Innovate UK grant from the UK Government aimed at strengthening the UK’s viral vector biopharmaceutical drug development and manufacturing supply chain.

Sartorius, German AI Research Center Launch Research Lab

Sartorius and the German Research Center for Artificial Intelligence (DFKI) have established the Sartorius AI Lab (SAIL) research lab on the DFKI campus in Kaiserslautern. The lab will use artificial intelligence (AI) in Sartorius products and platform solutions being experimentally tested and further developed at SAIL.

“So far, advanced methods of data analysis have been used only to a very limited extent in the biopharmaceutical industry, in drug research and in production. This is one of the reasons that development timelines and costs for medical drugs are ever increasing. Better use of data through AI is a particularly promising approach for making significant progress in this area. Many customers are already using the powerful software we have been offering for two and a half years through our Data Analytics unit for specific applications in biopharmaceutical production. We aim to strongly expand this business activity and are therefore glad to have found DFKI, one of the most important international centers of excellence for AI and deep learning with more than 1,000 scientists, as strong partners to join us in developing such solutions,” said chief executive officer Dr. Joachim Kreuzburg.

SAIL is assigned to the DFKI research department of Smart Data & Knowledge Services headed by Professor Andreas Dengel and uses DFKI's deep learning hardware and expertise, which is unique throughout Europe. As a protected data room and independent data laboratory, SAIL is also open to Sartorius partners and customers as part of cooperation agreements, and the first projects have already been initiated. In addition, Sartorius and DFKI will use SAIL for training purposes, and DFKI employees will also be able to further their education in life science applications at Sartorius research sites.

Sartorius and DFKI intend to develop and employ machine learning and image and pattern recognition processes, among other technologies, for life science applications. For example, their researchers are working on new deep learning algorithms and methods for image recognition of cells and organoids, analysis and modeling of biological systems and for simulation and optimization of biopharmaceutical production processes. Sartorius provides extensive data for this purpose and sends specialists from its Corporate Research and Product Development units to SAIL.

Andreas Dengel, DFKI site manager in Kaiserslautern, said, "The DFKI transfer labs are developing new service modules with artificial intelligence for various markets and target groups. For two years, we have been using our AI hardware equipment, which is unique in Europe, for application-oriented research we conduct together with renowned companies such as Allianz, Continental, Hitachi and IAV. I am very pleased that we are entering the life science tools market as a partner with the global player Sartorius."

Bayer, Nuvisan to Open Small Molecule Research Center

Bayer plans to shift a significant portion of its Berlin-based small molecule research activity to Nuvisan. The latter company provides clinical study, laboratory and contract manufacturing services.

Nuvisan provides clinical, laboratory and contract manufacturing services. The company has six sites in Germany and France, along with monitoring operations in the US, Argentina, Brazil and Peru.

Joerg Moeller, head of research and development for Bayer AG’s Pharmaceuticals Division and member of its executive committee, said the firm hopes to build a “strong, full-fledged research unit” with Nuvisan.

“Nuvisan shares our vision that the new research center can become an important player in research partnering based on the joint know-how and capabilities of our highly qualified scientists,” Moeller said.

The new research entity housed at the center reportedly will create 400 jobs in the area. Capabilities across the drug discovery chain include lead discovery, medicinal chemistry, pharmacology, drug metabolism and pharmacokinetics, investigational toxicology, and animal management.

Dietrich Bruchmann, Nuvisan CEO and managing partner, said the capabilities of the German facility will empower a “high-performance research team” by offering access to specialized technology.

“The acquisition of the research unit and its location at the Bayer R&D campus will create an operational hub in the scientific excellence cluster in Berlin and allow us to significantly accelerate the drug development process from discovery to clinical trials,” Bruchmann said.

According to Bayer, the partnership will enable the company to focus its efforts on R&D flexibility and productivity. Bayer intends to continue additional research activities and corporate functions at its Berlin-based Pharmaceuticals Division.

The arrangement marks the latest in a series of partnerships Bayer has formed with other entities in the past few months. In late January 2020, the firm inked a five-year deal with Schrodinger to develop molecule-design software. A few weeks earlier, Bayer expanded its work with Evotec on developing women’s health drugs.

STA Pharmaceutical’s Manufacturing Facility, Changzhou

STA Pharmaceutical (STA), a subsidiary of WuXi AppTec, opened its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China, in January 2020.

The facility will serve as an integrated platform to support the development of oligonucleotide APIs from the preclinical phase to commercial-scale manufacturing.

The manufacturing facility covers an area of more than 30,000ft² and is at WuXi STA’s site in Changzhou.

Oligonucleotide APIs up to 1mol / synthesis run will be in production at the facility, with the manufacture of various oligonucleotides, including RNA, DNA, peptide conjugates (PPMO) and morpholino oligonucleotide (PMO).

STA will also leverage its small molecule process chemistry organization to support the development of next-generation oligonucleotide manufacturing technology.

STA opened Changzhou campus in early 2016 to expedite the development and commercialization of products to meet customer demand.

Changzhou site passed multiple inspections conducted by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA).

The campus employs more than 200 scientists and is expected to add 1,000m3 of reactor volume. STA plans to increase the workforce at the site to more than 500 scientists and add seven multi-functional plants in the near feature. The 39-acre site will allow STA to achieve a two-fold expansion of its research and development (R&D) capacity and increase its manufacturing capabilities up to four times.

STA is developing Changzhou site in multiple phases. The campus houses an R&D building, administration building, a large-scale manufacturing plant, supporting units and additional structures.

The site supports the peptide process R&D and manufacturing of oligonucleotides, small molecules and peptides from laboratory to commercial scales.

Wuxi STA uses its small-molecule CMC (chemical, manufacturing, and control) technology to provide a one-stop platform for oligonucleotide innovators.

Integrated Changzhou campus successfully cleared two Food and Drug Administration (FDA) inspections in 2018 and 2019, with the first completed in May 2018 and the second in July 2019.

The existing facility comprises AKTA OligoPilot™ 100 (Synthesis), AKTA Avant 150 (Purification), AKTA crossflow (Ultra-Filtration) and laboratory to cGMP production scale freeze dryer. The company uses analytical techniques such as UPLC / MS, LC-MS, HPLC, UPLC, LC-MS / MS, GC / MS and ICP-MS.

Marketing commentary on STA Pharmaceutical:

STA is a pharmaceutical contract development and manufacturing organization (CDMO), providing solutions and services for small molecule for APIs and finished dosage forms.

The firm has commercial drug product manufacturing capabilities. It performs clinical batches manufacturing, primary and secondary packaging and labelling. Currently, the company has operations in China and the US.

Based in Shanghai, the company employs more than 1,000 highly skilled research scientists who are involved in route scouting, process development, and developing control strategy for intermediates, Regulatory Starting Materials (RSMs) and APIs.

Wuxi STA’s manufacturing facility in Shanghai Jinshan has a reactor volume of 400m³. The facility has received approvals from eight global regulatory agencies to undertake the production of APIs and advanced intermediates to date.

Regulatory bodies include the US FDA, the European Medicines Agency (EMA), the China Food and Drug Administration (CFDA), Australia’s Therapeutic Goods Administration (TGA), Swissmedic, Health Canada, Japan’s MHLW and New Zealand’s MPI.

STA merged with WuXi AppTec’s Pharmaceutical Development Services (PDS) division in July 2017.

GE Healthcare’s Manufacturing Facility, Grens, Switzerland

GE Healthcare is building a manufacturing facility for cell processing kits in Grens, Switzerland.

The plant, announced in January 2020, is expected to be fully operational in 2022.

It will be primarily used to produce single-use kits, serving as an integrated complex for the company’s research, engineering and service teams. GE Healthcare intends to use its operations in the country to meet the demands of cell and gene therapy customers.

The facility will also expand the firm’s cell processing kits production capacity, expected to employ up to 200 personnel.

Located in Signy Park in Grens, Switzerland, the facility will cover an area of 79,194 sq. ft. (7,360m²).

The site is situated 300m away from the Nyon exit of A1 motorway and 18 minutes away from the Geneva international airport.

Signy Park will spread over an area of 73,000m² and will house offices and school campus.

Details of GE Healthcare’s manufacturing facility:

The facility will produce single-use kits for the Sepax and Sefia cell processing systems offered by GE Healthcare Life Sciences.

A Centre of Excellence with a cell and gene therapy manufacturing capability will be built at the site, providing training for the company’s European customers and undertaking educational programs. The manufacturing facility complex will also support a research and development team.

The Swiss site will allow GE Healthcare to pursue the development of advanced products and cater to anticipated global demand in the cell and gene therapies market.

It will also help the company to attract the best talents in the region to boost its research and development efforts.

Sefia cell processing system is a multi-functional platform by GE Healthcare’s Biosafe Group in September 2016, which supports cell processing during the manufacturing of cell therapy products.

It is highly flexible and functionally-closed laboratory instrument used to simplify processing steps such as isolation, washing, concentration, harvesting and final formulation in cell therapy manufacturing process.

Sefia will allow customers to isolate cells from up to 800ml of apheresis products, allowing users to select steps and run required operations. It will also provide the capability to harvest up to 10l expanded cells using continuous-flow technology. Users can combine multiple steps, running them in sequence automatically. The functionally-closed approach can help companies avoid the risk of contamination.

Sepax CPro cell processing system is a functionally-closed system that enables the user to automate the steps involved in the workflow of cell processing.

In upstream processing, users can concentrate, purify, isolate and transduce the required cells. The instrument is for subsequent use along with appropriate protocol software and kit in downstream to harvest, wash, re-suspend and divide the products.

Both systems include a combination of hardware, optimized protocol software and a dedicated kit for the processing of cells.

PremierCell or FlexCell Sefia protocol software can be used with Sefia S-2000 instrument, as well as alongside PeriCell C-Pro, PlateletFree C-Pro, CultureWash C-Pro, SpinOculation C-Pro and Dilution C-Pro, among other Sepax C-Pro software protocols.

The SpinOculation C-Pro protocol software released in December 2019 streamlines process validation and decreases variability encountered in the cell transduction step.

Single-use kits of Sepax C-Pro cell processing system include CT-49.1, CT-60.1 and CT-90.1.

Both systems are CE certified and good automated manufacturing practice (GAMP)-compliant.

Dutch-Swiss developer Nemaco manages the construction and design of GE Healthcare’s manufacturing faculty.

Marketing commentary on GE Healthcare:

GE Healthcare is an American multinational medical technology and life sciences firm that provides a range of products and services for medical research industries.

Headquartered in Chicago, Illinois, US, the company develops medical technologies, digital systems, tools and data analytics to serve the needs of professionals in the healthcare industry.

The Life Sciences division of the company focuses on accelerating the discovery, manufacturing and use of therapies and precision diagnostics. It provides tools and technologies to assist researchers and companies in cell and gene therapy development and commercialization, as well as in genomics and cellular research.

GE Healthcare offers design solutions tailored to meet the requirements of customers, licensing agreements and contract manufacturing services concerning reagent preparation and kit manufacturing. The company provides a range of services including preventive maintenance of equipment, asset management over the life cycle, validation services and bioprocess development services.

GE has been operating in the healthcare industry for more than 100 years and employs approximately 50,000 employees in more than 100 countries globally.

Allergan Opens Biologics Facility

Expansion of Irish site comes as acquisition deal with AbbVie nears its close

Allergan recently opened a new €160 million state-of-the-art Biologics 2 facility at its Westport Campus in Co. Mayo, Ireland. The new facility will create 63 jobs and enhance Ireland’s position as a global hub for Allergans’ flagship products, including the blockbuster Botox. The new facility and famous cosmetic skin injection brand will soon fall into AbbVie’s hands with the conclusion of the ongoing regulatory approval process for AbbVie’s acquisition of Allergan anticipated in the first quarter of this year. The new facility brings Allergan’s total investment in Ireland since it began operations in the country to more than €750 million.

The Biologics 2 facility at Allergan Westport will feature new manufacturing suites to meet growing global demand for Allergan’s flagship products. As part of a strategic expansion to support the next generation of biologics innovation it will feature a new state-of-the-art microbiology and cell-based laboratory with world-class technology and research and development capabilities to support advances in discovery, development and manufacturing.

Coinciding with the opening of the Biologics 2 facility, Allergan recently marked the shipping of the 100 millionth vial of Botox from the Westport campus as Allergan marked 30 years since the product first received FDA approval.

“It gives me great pride to mark the global opening of our Biologics 2 facility here in Westport as we embark on the next chapter next chapter of growth and innovation for Allergan’s botulinum toxin brand and other biologics products,” said Wayne Swanton, executive vice president of global operations, Allergan. “The sensitivity of biologics in the manufacturing process is like no other. It requires a level of exactness in manufacturing and handling throughout the whole supply chain around the world, which is truly unique. That journey starts here in Westport on the west coast of Ireland with a team of over 1,300 passionate and highly skilled people who have been integral to growing our products to the scale we see today and delivering impact for patients.

Paul Coffey, vice president global manufacturing (eyecare and biologics) and site lead at Allergan Westport, said, “This €160 million investment underpins Allergans commitment to advancement in the biologics arena and we are delighted that Ireland is home to this strategic expansion. Our Westport campus is the largest and most complex in Allergans global network. Our new biologics facility, added to our existing biologics facility, will allow us to meet continued global demand for Allergans flagship products. With the addition of a new microbiology and cell-based laboratory too, the team here in Westport are looking forward to contributing to product innovations that will make a difference to patients’ lives all over the world and maintain our position at the forefront of the global biopharma industry.”

Merck Invests in Biotech Facility

Merck has unveiled plans to invest €250 million in a new facility in Corsier-sur-Vevey, Switzerland. The new Merck Biotech Development Center will be dedicated to biotech development and manufacturing for clinical studies. Driven by the growth of the healthcare business sector R&D pipeline, the company says this investment will help to sustainably secure capacity and high agility to deliver clinical trial material in a cost-effective way, contribute to accelerated development timelines of new biological entities, and address the increasing manufacturing complexity of the next generations of biotech compounds.

"This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines," said Stefan Oschmann, chief executive officer, Merck.

Located near Merck's current biotech commercial manufacturing site in Corsier-sur-Vevey, Switzerland, the Biotech Development Center will bridge together research and manufacturing. The facility will consist of a building providing a total of 168932 sq. ft. (15,700 square meters) of development space bringing together a cross-functional team of approximately 250 employees spread across different sites today, responsible for advancing Merck's biotech R&D pipeline by ensuring that Merck's next generation of biotech therapies are available for clinical trials on time, on quality and on quantity.

Equipped with the most advanced digital solutions and highest technological standards, including continuous manufacturing and laboratory automation, the Biotech Development Center will offer a flexible-by-design infrastructure to readily adapt to emerging needs and technology evolution, as well as open workspaces enabling collaboration, creativity and innovation.

The Biotech Development Center will showcase Merck's science and technology across its three business sectors, including Life Sciences' process solutions for clinical manufacturing and pilot plant operations. The construction of the building is expected to be completed in 2021 and the Biotech Development Center is anticipated to be fully operational by the end of 2022 following validation by regulatory authorities.

PSL Invests in UK Facility for Process Optimization of Microsphere Drugs

The Liverpool facility will be designed to mirror the existing services currently provided by another facility in Philadelphia, US

Powder Systems Ltd (PSL) has announced its investment in a new Centre of Process Excellence (COPE) at its UK facility in response to the growing demand from global pharmaceutical manufacturers for providing additional process optimization of their microsphere drugs.

Microspheres or micro-particles are complex drug formulations combining an API with an FDA-approved polymer such as PLGA. Microsphere drugs enable the sustained release of APIs into patients over prolonged periods of time, varying from weeks up to several months.

Despite their benefits for millions of patients around the world, microspheres are notoriously known to be difficult to process and develop for drug manufacturers.

The new COPE facility will officially open on September 2020. The facility will be opened as part of the upcoming Microsphere Summit organized by PSL in Liverpool (9–10 September). Drug manufacturers will be attending from Europe, America and Asia.

The facility will be designed to mirror the existing services currently provided by another COPE facility that opened in Philadelphia, US, in 2015. It will focus on optimizing complex drug formulation processes such as filtration, drying, yield recovery and scale-up of microspheres.

“We are seeing an increase in demand from global microsphere drug players, including big pharma and generic manufacturers, for a range of additional process services to be completed prior to delivery of our technology at their production sites,” said Amanda Gowans, CEO of Powder Systems Group.

The new innovation center will be located inside PSL’s current production facility located in Speke, Liverpool. It will be designed to enable drug manufacturers to run their specific drug process in a non-GMP manner hence offering the flexibility to troubleshoot and exploring new process concepts in a separate facility without impacting their actual production line. It will offer an intermediate step towards successful drug development and ultimate commercialization.

Gowans said: “[The facility] will also streamline [customer] drug development and reduce any potential delays due to unnecessary trouble-shooting on site. Our hands-on approach and passion for finding the best solution will help deliver projects successfully and solve the toughest problems - together.”

"With a range of technical capabilities and expertise in complex drug delivery developed over the last three decades, PSL engineers and scientists are looking forward to working side by side with our industry partners and taking on their formulation and production challenges in this new facility," Gowans added.

AstraZeneca Invests in Australian Site

AstraZeneca plans to invest $133 million in its Australian manufacturing site as demand for its respiratory medicines in China has grown. The company plans to expand its facility in Sydney suburb North Ryde, New South Wales, which will create 250 new jobs and increase the site’s annual exports to AU$4.4 billion over the next four years. This expansion follows the company’s $67 million investment in 2017 to grow the site.

AstraZeneca employs more than 1,000 people in Australia and New Zealand. The company also has an on-site commercial organization that spans corporate affairs, distribution, finance, and marketing. The Sydney site delivers medicines to Australia, Asia-Pacific countries and other markets globally.

Marchesini Expands Packaging Business

The Marchesini Group has taken over 100% of Schmucker, a company from Gorizia, in northeastern Italy, that specializes in building stickpack packaging machinery for the food, pharmaceutical and cosmetic markets.

Established in1977, Schmucker started operations as a small workshop on the border between Italy and Slovenia, where the two Schmucker brothers set up a small business to design systems for the food industry.

Over following years, they built single-line and multiple-line packaging machines for sticks filled with liquid, powder, granular, cream and gel products.

The growing demand of multinational enterprises, alongside experiments on cutting-edge prototypes, convinced the company to diversify the reference markets, which boosted its growth impressively.

Today, Schmucker employs 80 people and its turnover in 2017 was €10.5 million, with a share of 80% in exports.

Pietro Cassani, Marchesini Group CEO, said: “Just like we did for the other acquisitions, Schmucker too will continue to be managed by its founders to guarantee business continuity, to safeguard the local suppliers and to pass on their know-how."

Marchesini’s acquisition of Schmucker came after that of Dumek, a company specialized in designing processing machines for cosmetics, of Vibrotech, working in the field of infeed and positioning systems for automated industrial processes and of SEA Vision, a leading manufacturer of inspection systems used in the pharmaceutical anti-counterfeit sector.

Similar to the previous transactions, the acquisition of Schmucker is aligned with Marchesini's expansion strategy, which is also occurring on the internal lines too with the launch of the Beauty Division and the new rapid prototyping department, which was inaugurated on 25 May this year.

Commenting on the Schmucker business, Cassani said: "The single-dose stickpack market is very interesting. Over recent years, it has moved from food to pharmaceuticals, also thanks to the ease-of-use and to a size that saves 20-30% of packaging material compared with the sachets sealed on four sides”.

CEO Enrico Schmucker, added: “We are honored to belong to an enterprise such as the Marchesini Group. We are convinced that we will provide an important contribution to the Group’s expansion strategies thanks to our skills and our team”.

The two companies have already started to work together. At the Achema tradeshow in Frankfurt, Schmucker exhibited a sachet line, which has been sold to SIT in Trezzano sul Naviglio, an Italian contract packer that exports most of its production.

Schmucker follows last month’s acquisition of 80% of Creinox, a company in Ariano Polesine (Rovigo) that works with stainless steel, especially to product containers and tanks for the pharmaceutical, cosmetic and food industries. Creinox registered a turnover of €1 million in 2017.

Greif Completes Investment in New IBC Facility

Greif, an industrial packaging products and services specialist, has announced the official opening of its new, multimillion-euro, intermediate bulk container (IBC) plant in Ede, the Netherlands.

Developed in close cooperation with Greif’s longstanding industrial packaging partner Tholu, the facility has been designed to offer customers the very latest IBC technologies available to the market, with a specific focus on the food industry.

Situated adjacent to Tholu’s IBC reconditioning site the modern, fully enclosed facility includes a warehouse and production plant with two IBC lines. In total it is 968,400 sq. ft. (90,000 sq. m.).

Equipped with cleanroom blow molding capabilities, the plant complies with the Global Food Safety Initiative (GFSI), Hazard Analysis and Critical Control Point (HACCP) and ISO 22000-4.

Luca Bettoni, Greif EMEA IBC and plastic product manager said: "We are extremely excited about this new venture, which marks another step in our roadmap to become the world’s best performing customer service company in industrial packaging. Located in the heart of the Netherlands with excellent transport links means we are ideally placed to serve customers in the Benelux region and allows us to offer them our full portfolio of GCUBE IBC solutions.”

This latest investment follows the opening of Greif’s state of the art IBC facility in Mendig, Germany. Further investment in new facilities across EMEA is planned in the next few years, including Russia in 2020. Greif currently has nine IBC facilities across EMEA and 13 globally.

LC Packaging Opens Second Production Facility in Bangladesh

LC Packaging opened its second Dutch-Bangla Pack flexible intermediate bulk container (FIBC) production facility in Bangladesh. The new facility creates 650 high-quality jobs and includes a 43,040 sq. ft. (4,000 sqm) cleanroom that will enable the facility to double annual production capacity of Food Safe and Pharma Clean FIBCs.

Dutch-Bangla Pack (DBPL) is an equal joint venture between LC Packaging and local Bangladeshi shareholders. The expansion was mainly fueled by growing demand in the market and continuous investments in sales and distribution activities at LC Packaging in Europa, Africa and beyond.

In addition, the commitment of the shareholders to the growth of the company is a key driver in the business expansion.

Abdul Mumit, Managing Director of Dutch-Bangla Pack, said: “We see demand especially growing in value-added FIBCs in the food and pharmaceuticals industries. Our facility is highly qualified to produce these Food Safe and Pharma Clean FIBCs.”

The facility began FIBC production in 2008 and recently, DBPL has received a prolongation of their certification for the manufacturing of FIBCs for the high care food segment. This reflects the company’s investments in cleanrooms and the Foodsafe Assurance Program.

The new facility is also expected to create a total of 650 additional high-quality jobs. The first 230 employees have already been engaged at the new facility. Abdul Mumit: “A significant feature of DBPL is that the job creation is aimed not just at manual production, but also value-added functions. Both product and process-based R&D is carried out in Bangladesh, with critical support and collaboration from LC Packaging headquarters in The Netherlands.”

Novo Nordisk Plans API Manufacturing Expansion

Novo Nordisk has announced plans to invest DKK 800 million ($117m) in upgrading and expanding facilities at its production site in Kalundborg, Denmark. The facility has also been a significant contributor to the company’s environmental agenda.

The facilities currently manufacture a range of products for diabetes treatment and will be rebuilt and expanded to allow for future production of these products as well as the next generation of diabetes products.

The projects are expected to be completed in 2022.

“This investment in our production facilities highlights our ambition to continue strengthening our presence in Denmark and Kalundborg. Today, we manufacture around half of the world’s insulin in Kalundborg where we have been present for 50 years,” said Michael Hallgren, Senior VP for Novo Nordisk production in Kalundborg.

The 1,200,000-square-meter site currently employs more than 3,000 people and is the world’s largest insulin manufacturing facility, producing more than 50% of all global insulin.

Hallgren explained that since the turn of the millennium, Nordisk has invested more than DKK 16 billion ($2.3bn) in these facilities. Nordisk also recently released its financial report for 2019. The report stated that capital expenditure for property, plant and equipment in 2019 was DKK 8.9 billion ($1.3bn) compared with DKK 9.6 billion ($1.4bn) in 2018.

The report also stated: “In 2019, total emissions across operations and transportation was 306,000 tons CO₂. Emissions are expected to decrease significantly in 2020 due to various renewable energy projects, including solar power across all US operations, wind power in Europe and green steam in Denmark.

Compared to 2018, waste decreased by 13% in 2019. This was due to a decreased amount of both ethanol waste and organic residues from the production of API in Kalundborg.

McIlvaine Company

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

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