PHARMACEUTICAL & BIOTECHNOLOGY

Aphena Pharma Solutions has completed its $7 million facility expansion and renovation in Easton, Maryland. The newly renovated, 30,000-square-foot facility and three large, high-end blending suites are open for new pharmaceutical business. Aphena’s Maryland campus supports liquids, creams, gels and suspensions.

While two new blending suites were originally planned, the company expanded that number to three. Housed in those three suites are two brand-new Feldmeier 1,000-gallon mixing tanks and a sister 100-gallon tank, which offer center agitation mixing and dual alternate directional side sweeps for scale-up and registration batches. In addition, the tanks are jacketed for heat and chilling and are pressurized for powder mixing.

“Adding these tanks and new capabilities will allow Aphena to increase capacity levels and handle 90% of the liquid-based pharmaceutical products on the market today,” said Eric Allen, Aphena’s EVP of Sales. “The smaller 100-gallon tank is 1/10 scale, making submission batches easy to scale per FDA guidelines.”

“The recent expansions at our Maryland and Tennessee facilities position Aphena to support significant future growth,” said Aphena CEO Shawn Reilley. “We are committed to investing aggressively as needed to ensure that Aphena remains an industry leader in terms of innovation and turnaround time.”

Novavax Expands Campus to Support Vaccine Development

Novavax is expanding its Maryland campus to support the company’s growth and the development of a COVID-19 vaccine.

Novavax currently occupies around 79,000 square feet of office and laboratory space in Gaithersburg. It has now entered into a 15 year lease for 122,000 square feet at 700 Quince Orchard Road, Gaithersburg, which it will use for manufacturing, R&D and office space. It will begin work on the new facility immediately with an opening scheduled for early 2021.

It has also lined up further space for the future through an aliate, 14 Firsteld Holdings LLC, which has bought a 9.7 acre parcel of land at 14 Firsteld Road, Gaithersburg.

Novavax’s vaccine candidate, NVX-CoV2372, has started a Phase 3 trial in the UK, while Phase 3 trials are expected to follow in the US and Mexico this month. It also has two ongoing Phase 2 studies which began in August, a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the US and Australia.

NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains the company’s patented saponin-based Matrix-M adjuvant.

The expansion will also advance Novavax’ influenza vaccine for global markets. The vaccine, NanoFlu, is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system; also using the MatrixM adjuvant. Novavax is currently focusing on advancing NanoFlu through global licensure.

The Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg are providing a combination of incentives, including conditional loans, grants and tax credits to enable the expansion.

Argonaut Manufacturing Services Completes First cGMP Run

New automated aseptic fill/finish line for clinical and commercial use was recently approved by regulators.

The fill/finish line complements other Argonaut drug product services including formulation, and a full suite of onsite analytical support.

Argonaut Manufacturing Services, a provider of drug product and reagent kit manufacturing for therapeutics, life science and molecular diagnostics, has completed their first cGMP run. This news comes soon after the announcement that the Department of Public Health, Food and Drug Branch (FDB) had inspected and approved Argonaut’s state-of-the-art new drug product manufacturing facility, permitting Argonaut to manufacture and ship pharmaceutical products. This formally cleared Argonaut’s new automated Bausch+Ströbel/SKAN isolator aseptic fill/finish line for clinical and commercial use.

The fill/finish line complements other Argonaut drug product services including formulation, and a full suite of onsite analytical support. With cGMP, FDA registration, and CFR820, 210, 211 and ISO 13485:2016 certifications, Argonaut’s team has the experience in drug product manufacturing for both clinical and commercial stage programs. Facilities include over 8000 square feet of cleanroom (ISO 7&8) with all operations integrated into a validated enterprise quality management (EQM) system.

“Following approval by the FDB, we were able to quickly and efficiently complete our first cGMP run,” said Eric Blair, chief commercial officer, Argonaut Manufacturing Services. “The client came to us via Avid Bioservices, a key drug substance provider and a valued Argonaut ecosystem partner. The client was pleased with the availability in our schedule, the performance of our advanced fill/finish line, and the collaborative approach of our experienced team members. New clients can look forward to the same high-quality fill/finish of their valuable product as well as effective communication throughout the strategic partnership.”

Seamless Speed to Market Drives Texas Hospital’s Growth

Learn why the Methodist Richardson Medical Center Vertical Expansion, in Richardson, Texas, was honored with a Gold Award in the 2020 Building Team Awards.

This two-story project, built atop a very active 191-bed hospital, was completed seven weeks early and 10% under budget. It added 150 all-private acute care beds, seven pre-op rooms and an operating room, and two post-anesthesia care beds. The construction was accomplished without a single reportable injury in more than 311,000 hours worked.

The expansion was the hospital’s response to its rapid growth since opening in 2014. Patients from 45 different Texas counties and even other states seek out Methodist Richardson for its services. Consequently, the hospital initiated this vertical expansion eight years ahead of its 2025 schedule.

Among the issues that this expansion grappled with was the hospital’s vehicular congestion, which preceded this project but also impacted its construction. The project’s first phase included building a $12 million, seven-level, 671-space parking garage, which opened before the Building Team could claim other surface parking areas it needed to accommodate tower cranes, trailers, and the materials lay-down area. The team delivered the garage in eight months.

To minimize interference with the hospital’s traffic, the Building Team implemented just-in-time material deliveries; any products that needed to be unloaded by crane had to be onsite before 9 a.m. The project’s trades had to be strategic and communicative about scheduling and sequencing.

The Building Team used 3D laser scanning, GPS, and conventional survey methods to support its 3D as-built structural model. These data enabled the Team to transfer column grids quickly from the existing hospital to the two new floors, thereby releasing steel fabrication packages ahead of schedule.

The use of technology, in fact, was prevalent throughout the project, and provided the owner with documentation that included a fully attributed BIM record model and 360-degree photos of the entire site during each construction phase.

Right from the start the hospital insisted that its fourth floor, which includes its NICU, nursery, and surgery recovery areas, could not be shut down entirely during construction. The Building Team also needed to come up with creative solutions to make the expansion appear aesthetically seamless with the rest of the building.

Planning and designing the expansion’s curtainwall was this project’s biggest single challenge. Extending the hospital’s existing curtainwall another two stories would have required opening the 4th floor to exterior elements, and would have added up to five months and $2.1 million to the construction schedule and budget, to say nothing of the lost revenue while that floor was not functional.

The Team considered four options, and ultimately went with a custom spandrel glass infill system to achieve the desired visual effect with minimal impact to the exterior envelope. The Team installed a new framing and glazing system that allowed contractors to perform their work on outside platforms without having use the building’s 4th floor interior for curtainwall tie-in access.

Erecting new steel on the roof of the hospital for the expansion was another problem to be solved without causing too much disruption to the 4th floor operations. The Building Team expedited the construction by sequencing the installation of stub columns: the roof would be opened at the embedded point, the four-ft-long stub column welded in place, and then the roof would be closed and resealed. This process was repeated over 150 times.

The use of stub columns allowed the Team to better control its exposure to the weather and manage the risk of water infiltration.

A plan was devised where no more than four rooms on the 4th floor were ever shut down at once. That plan included a Method of Operating Procedures to help the hospital’s staff understand the impact of a total of 21 major shutdowns and more than 100 minor shutdowns. Over 100 penetrations through the 4th-floor ceiling were made to install mechanical and plumbing tie-ins from that floor, which included “heavy involvement” by the hospital’s nursing staff for planning and coordination. This phase was completed seven weeks early. During this phase, the Building Team deployed over 1,500 5/8-inch-thick rubber mats to tamp noise and vibration.

Other noteworthy achievements that led our judges to bestow a Gold award on this project include the following:

• Typically on projects like this, the central utility plant equipment is installed during the later stages. What made this project unique is that, in order to support the new loads for the additional floors, the CUP equipment had to be built and online a year before the addition opened. Each piece had a long lead time, so installing them early offered benefits that included performing system tie-ins in ways that were flexible to the hospital’s schedule.

• The hospital’s three air handling units (AHUs) continued to function during the construction. When the expansion was complete, the hospital was switched over to new AHUs. To do this, the Building Team built two floors of steel, connected the original ductwork to the expansion’s duct, set the new AHUs on the roof, and connected the power to the electrical rooms. Because the original AHUs—which were not meant for indoor use—would be completely encapsulated, the Team had to create temporary exhaust systems and roof drains to ensure the units remained functional and did not create hazardous conditions inside the building.

Dept. of Defense to Fund H&V Expansion

Grant will expand mask making capacity to 100 million.

The Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), has awarded a $2.5 million contract to nonwovens manufacturer Hollingsworth & Vose, to increase domestic production capability of filter media.

This industrial base expansion effort will allow Hollingsworth & Vose to increase production capacity to 100 million mask equivalents per year in Floyd, VA by October 2021, to support the production of filter media.

The DOD’s Defense Assisted Acquisition Cell led this effort in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force. This effort, funded through the HHS Coronavirus Aid, Relief and Economic Security (CARES) Act, supports domestic industrial base expansion for critical medical resources.

Vibalogics’ Virotherapy Manufacturing Facility, Boston, Massachusetts

Vibalogics announced the development of a late-phase clinical and commercial virotherapy manufacturing facility in Boston, Massachusetts, US, in November 2020.

The facility will improve the company’s capabilities to meet the rising demand for the development and manufacturing of complex viral-based products, expanding the company’s global footprint.

Vibalogics was acquired by Ampersand Capital Partners, a private equity company, in May 2019. The acquirer company will invest approximately $150m in the development of the facility, which will generate 100 jobs initially and up to 250 jobs over the next four years.

The plant is anticipated to be operational in the second half of 2021.

The late-phase and commercial virus manufacturing facility will be developed at 1414 Massachusetts Avenue, Boxborough in Massachusetts, located approximately 25 miles away from Boston.

It was a preferable option for the facility due to its access to the life sciences and economic cluster around Greater Boston and was suitable for the plant’s unique requirements.

World-renowned universities such as Harvard, MIT, Yale, Boston College, Wellesley, Boston University and Worcester Polytech are also close to Boston.

The 118,000ft2 manufacturing facility, with 30ft clear space, will be developed using state-of-the-art technology. It is designed for manufacturing commercial quantities of viral vectors such as oncolytic viruses and viral vector vaccines.

Catalent Invests in Harmans Gene Therapy Campus

To add five additional Phase 3 through commercial-scale manufacturing suites to support growing market demand.

Catalent is investing $130 million to add five additional Phase 3 through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD to support a growing customer pipeline and market demand.

The campus in Harmans, near the Baltimore Washington International (BWI) airport, comprises two state-of-the-art facilities that, when completed, will house a total of 15 gene therapy suites each designed to accommodate multiple bioreactors for commercial supply. The first Harmans/BWI facility on the campus was recently approved by the FDA for commercial manufacturing and is expected to have all 10 cGMP suites qualified and operational by the first quarter of 2021. The five new cGMP suites will be located in an adjacent building on the Harmans campus and are anticipated to be operational in the first half of 2022. The second Harmans building will also offer cold storage warehousing and additional office space.

Catalent’s Harmans/BWI commercial manufacturing campus is equipped with single-use manufacturing technology, and currently includes over 200,000 square feet of late-stage clinical and commercial-stage gene therapy production. Upon outfitting of the second building, the large-scale Harmans/BWI production campus will encompass a total footprint of approximately 350,000 square feet. The campus is one of Catalent’s five gene therapy locations in Maryland and houses multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms, together with fill/finish, testing, warehousing, supply chain, and central services capabilities.

“It is critical that we stay connected to the needs of our customers as they progress through the clinical pipeline. By increasing our late-stage manufacturing capacity at the Harmans campus, we will be able to meet demand through the medium term and take advantage of our shared resources, including the technical and manufacturing expertise that helped us reach the milestone of becoming an FDA-approved commercial partner,” said Manja Boerman, Ph.D., President, Cell & Gene Therapy at Catalent. “Catalent is committed to this journey with our customers as they bring life-changing therapies to their patients.”

Thermo Fisher Opens New Bioprocessing Center in St. Louis

Combines bioproduction and pharma services businesses to accelerate innovation and enhance productivity for biopharma companies.

Thermo Fisher Scientific Inc. has opened its new Bioprocessing Collaboration Center (BCC) in St. Louis, MO.

The facility is adjacent to the company's biologics manufacturing facility, which recently doubled production capacity with a $50 million expansion. The combined bioproduction and pharma services businesses aims to accelerate innovation and enhance productivity for biopharma companies, enabling them to meet the growing need for more flexible, scalable biologics development and manufacturing solutions.

In 2019, four in 10 drugs in development were biologics, driving demand for innovative development and manufacturing solutions. The BCC will bring together the company's GMP biologics manufacturing with its bioprocessing technologies including bioreactors, cell culture media, chromatography and analytical tools, among others. This collaboration aims to deliver new single-use bioprocessing technologies as well as drive critical process, data management and quality improvements that enable scale-up solutions for biopharma customers.

"Our St. Louis site is among the world's largest producers of biologics using single-use technology and the ideal location for this unique collaboration," said Michael Shafer, senior vice president and president, pharma services, Thermo Fisher Scientific. "These complementary businesses will work together to develop innovative bioprocessing technologies, products and services. This will enhance bioprocess workflows and enable our customers to take their products to market faster and with greater efficiency."

Merck KgaA's MilliporeSigma New Facility for Next-Generation Oncology Meds

MilliporeSigma's antibody-drug conjugate manufacturing boost follows plans to build a second viral vector facility in Carlsbad, California. (Jacobs Engineering)

Merck KGaA's MilliporeSigma unit more than doubled its gene therapy manufacturing capacity in April as it set its sights on the future. Now, the German drug maker is making a big down payment on a new manufacturing scale-up, this time for next-generation oncology meds.

MilliporeSigma will spend $65 million on a new commercial building near its Madison, Wisconsin, plant to boost production of high-potency active pharmaceutical ingredients (APIs) used to make antibody-drug conjugates (ADCs), the company said.

The 70,000-square-foot expansion will complement existing work at an additional ADC site in St. Louis—the first commercial ADC facility in North America designed to handle highly active materials, the company said.

The expansion will bring on 50 new full-time workers starting next year for MilliporeSigma, which is the life science business of Darmstadt, Germany's Merck KGaA and boasts a workforce some 22,000-strong. Completion of the commercial building is expected to wrap by mid-2022, MilliporeSigma said.

MilliporeSigma aims to position the new building as one of the largest dedicated high-potency API manufacturing facilities and will equip the site with containment areas to turn out next-generation linker and payload materials for ADCs, which have the potential to treat cancer.

Much like cell and gene therapies, ADCs have gained in popularity in recent years as next-gen cancer therapies with extremely strenuous manufacturing requirements.

Only nine ADCs were approved globally as of 2019, but the industry is expected to grow over the next decade and could reach $15 billion by 2030, according to a report by the European Pharmaceutical Review. Much of that work could be outsourced to dedicated contract manufacturers, which already handle 70% of ADC production, MilliporeSigma said.

British pharma GlaxoSmithKline snared approval for its own ADC, Blenrep, as a treatment for multiple myeloma patients who have already tried four other treatment options, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

Despite some eye toxicity concerns linked to Blenrep, SVB Leerink analyst Geoffrey Porges called the drug's approval "a significant milestone, and an accomplishment for the drug's developers," in a note to clients at the time. Porges forecasted $377 million in global Blenrep sales in 2021 and $1.93 billion in 2024.

Meanwhile, the ADC upgrade marks MilliporeSigma's second expansion of the year: Merck KGaA and its subsidiary in April made plans to invest $110 million to open a second viral vector facility in Carlsbad, California, slated to "more than double" MilliporeSigma's gene therapy manufacturing capacity, the company said.

The plans for that expansion followed a 2016 production boost at the Carlsbad facility that grew the site by 21,000-square-feet and added 16 modular bulk manufacturing cleanroom suites and two fill/finish suites for gene therapy, viral vaccines and immunotherapy products.

CoreRx’s New Product Development Centre, Florida

CoreRx, a contract development and manufacturing organization (CDMO) based in the US, unveiled a new facility in Clearwater, Florida, in April 2020.

The facility is the company’s International Centre of Excellence for the development of pharmaceuticals and its fourth facility on the ICOT campus. The company announced that it will continue to invest to sustain increasing demand from customers.

The product development center became fully operational in August 2020 and is expected to hire 35 new employees.

CoreRx is investing in new infrastructure, increasing product development capacity, and expanding capabilities to fulfill customer demand.

It previously invested in the expansion of three other buildings within the ICOT center complex, including the construction of nine new clinical manufacturing suites and installation of additional capacity to its primary and secondary packaging activities, including aggregation and serialization.

CoreRX’s new product development center is located within the ICOT campus at Myerlake Circle in Clearwater, Florida, US.

Spanning 26,000ft², the new facility includes approximately 5,000ft² of analytical laboratory space.

Expansion of the drug product development and manufacturing site allows customers to access more than 150,000ft² of space.

INCOG BioPharma Launches Central Indiana Ops

New CDMO is investing roughly $60 million to construct and equip a 60,000-square-foot facility in Fishers, IN.

INCOG BioPharma Services, a biopharmaceutical manufacturing services startup specializing in injectable drug products, has unveiled plans to establish its first manufacturing facility and global headquarters in Fishers, IN. To support its growth, the company plans to create up to 150 new jobs by the end of 2024.

“Indiana is globally recognized as a leader in life sciences, ranking second in the nation for total exports," said Governor Eric J. Holcomb. "As a state, we’re committed to continuing to fuel this sector by providing the business-friendly environment and skilled workforce that companies like INCOG BioPharma need to launch operations and create quality careers for Hoosiers. We're grateful INCOG BioPharma chose to establish its global headquarters in the Hoosier state and look forward to supporting their growth in central Indiana."

The company, which will serve as a contract development and manufacturing organization (CDMO) for the biopharmaceutical industry, is investing approximately $60 million to construct and equip a 60,000-square-foot facility in Fishers. The new building will enable INCOG BioPharma to launch its manufacturing operations, which will support biopharmaceutical companies in advancing and accelerating early phase clinical projects to commercial launch and routine commercial re-supply. With its investment, the company plans to purchase and install state-of-the-art equipment to operate in a controlled, cleanroom environment. INCOG BioPharma plans to break ground as early as December 2020 and be fully operational in the first half of 2022.

INCOG BioPharma plans to add more than 65 team members over the next two years and continue ramping up hiring as customer demand increases. Hiring will begin in early 2021 for positions in engineering, manufacturing sciences, quality assurance, human resources, project management and business development.

“Over the past several months, we evaluated several states and cities to identify the optimal location for our new venture," said Cory Lewis, founder and chief executive officer, INCOG BioPharma. "It became clear that the state of Indiana and the city of Fishers was the ideal location, given the vast amount of life science industry experience that exists in the state. By locating our business in Fishers, we will have access to a large talent pool of skilled and trained resources. INCOG BioPharma is excited to partner with the state of Indiana and the city of Fishers as we build a life science company with a passion for customer service and a long-term vision focused on sustainability for both our employees and customers."

“We’ve spent the last five years building Fishers to be an innovative, welcoming community for business,” said Fishers Mayor Scott Fadness. “Startup stories like INCOG BioPharma’s drive us to continue that mission. INCOG BioPharma will bring the type of high-quality, high-paying jobs that will bring further investment to our community. I’m grateful for the partnership and investment INCOG BioPharma has brought to the table and I look forward to having them call Fishers home.”

INCOG BioPharma will join more than 2,100 companies contributing to a strong and growing life sciences industry in Indiana. According to BioCrossroads and the Indiana Business Research Center, Indiana is the second largest exporter of life sciences products in the U.S. at $10.5 billion in total exports. Together, these companies support 56,575 Hoosier jobs with average wages of more than $102,000 annually.

“We are very excited to be launching our business in Fishers, Indiana, where we will provide development and manufacturing services to the global biopharmaceutical industry, supporting the delivery of critical therapies and vaccines to patients in need around the world,” said Tedd Green, co-founder and chief operating officer, INCOG BioPharma.

The Indiana Economic Development Corporation (IEDC) offered INCOG BioPharma Services up to $2.5 million in conditional tax credits based on its creation plans. These tax credits are performance-based, meaning the company is eligible to claim incentives once Hoosiers are hired. The IEDC will also provide up to $200,000 from the Industrial Development Grant Fund to support on-site infrastructure improvements. The city of Fishers will consider additional incentives, and Duke Energy approved incentives to offset a portion of the project’s energy costs.

Cordenpharma Colorado Completes Highly Potent API Lab Expansion

Capable of handling highly potent compounds with an OEL as low as 1ng/m3.

New highly potent API lab in CordenPharma Colorado.

CordenPharma has completed a new highly potent active pharmaceutical ingredient (API) laboratory in its Boulder, CO, facility.

CordenPharma Colorado has extensive experience and capabilities in the development and manufacturing of highly potent APIs from clinical to commercial scale.

“Our new laboratory in Colorado is part of a development capacity expansion to address the strong market demand,” said Jason Bertola, director of CordenPharma’s global highly potent and oncology platform. “This additional capacity benefits customers by expediting the onboarding of new projects.”

The new laboratory is capable of handling highly potent compounds with an OEL as low as 1ng/m3, and is already available to customers.

PPC Flexible Packaging Commissions ISO Class 4 and Class 7 Cleanrooms

This investment has been planned as PPC's third major capital project to support its growing healthcare flexible packaging franchise

PPC Flexible Packaging has announced the commissioning of its newest cleanroom packaging production facility located within the company's Payson, Utah manufacturing plant.

This investment marks PPC's third major capital project to support its growing healthcare flexible packaging franchise.

This latest expansion was essential to meet addressable cleanroom packaging market increases across all North American geographies but primarily the western region. The Payson operation will complement and provide redundancy for two existing cleanroom operations located in its mid-west Buffalo Grove, Illinois facility.

It is anticipated the facility will receive ISO Class 4 and 7 registration, mirroring all prior PPC Precision Clean operations and has been appointed with the latest technology, state of the art pouch and bag making production lines.

PPC Flexible Packaging has identified cleanroom certified flexible packaging as key product lines to serve its growing healthcare, medical, life sciences, pharmaceutical, critical environment components and microelectronics markets.

Thermo Fisher Builds Coronavirus Test Tube Manufacturing Facility

The addition to the Lenexa site brings on more than 300 full-time workers and has helped increased production to 8 million units per week. (Thermo Fisher)

To help meet the relentless demand for COVID-19 diagnostics, Thermo Fisher Scientific has stood up a new, $40 million manufacturing facility in six weeks.

The 120,000-square-foot plant at its Lenexa, Kansas site will be dedicated to producing viral transport media, the combination of buffering solution and plastic tubes that keep swab samples viable until they can be tested in the lab for the novel coronavirus.

Thermo Fisher was previously tapped by the U.S. government to provide large amounts of aseptic transport media, through a $381 million contract signed in May. That month, the company would ramp up production in Lenexa from 50,000 to over 1 million media-filled tubes per week.

"We have a proven blueprint for high-quality VTM production in Lenexa and look forward to bringing significant new capacity online as quickly as possible to continue the necessary testing ramp-up in the U.S.," Thermo Fisher’s chairman, president and CEO, Marc Casper, said at the time.

Frontida Biopharm Announces Highly Potent Contract Manufacturing Suite

Frontida BioPharm has announced the completion of a facility expansion to their oral solid dose manufacturing operations with the commissioning of a Highly Potent Compound Contract Manufacturing Suite. This addition features 1000 sq. ft. of readily available, hazard-certified production space.

Key service equipment and set-ups include a large scale Roller Compactor, Milling Room, Bin Blender, Tablet Press, and ingress and egress airlocks with enhanced personnel controls. Frontida will utilize these capabilities to streamline clients' goals for the development of flexible and scalable manufacturing processes for clinical trial materials through commercial product operations.

Highly potent compounds serve an increasingly significant role in numerous R&D landscapes and pharmaceutical intensive medical treatments, i.e., oncology, atrial fibrillation, osteoporosis. In order to produce these products, a thorough process of product risk analysis is required in order to maintain a consistent manufacturing balance between production scale, market distribution and demand requirements. As a key step to utilize this new suite, Frontida's manufacturing assessments will verify each highly potent compound's level of toxicity, potential personnel and facility exposure limitations.

"The addition of a highly potent suite at Frontida Biopharm leverages the internal know-how and capabilities of our existing product development and manufacturing teams. The expert personnel leading this 'suite' new expansion contribute an average of 20 years practical experience to every project. Each prioritizes the safety and well-being, OEL guidelines, effluent containment practices, responsible air emissions, and sanctioned waste removal needed in order to better serve our pharmaceutical clients," said Anthony Qu, Chief Operating Officer.

"This area will expand Frontida's capabilities to our customers, further assuring that our culture of excellence and production quality is maintained through high grade service options, and top-of-the-line technological advantages," added Renard Jackson, Executive VP of CMO Services

Early 2021 Groundbreaking Planned for Lincoln Yards Megadevelopment

Sterling Bay plans to break ground in early 2021 on the $6 billion Lincoln Yards megadevelopment on Chicago’s North Side. The first planned building is this eight-story office and laboratory facility at the south end of the 55-acre site, along the west bank of the Chicago River.

The building, which will house offices and lab space, will be at the south end of the sprawling former industrial site, CEO Andy Gloor said. The Gensler-designed building will be just north of a Home Depot store at 1142 W. North Ave., which is not part of the 55-acre Lincoln Yards parcel.

Work on the long-anticipated and controversial project, expected to bring thousands of employees and residents to the property, is nearing despite a pandemic that has all but stopped new real estate projects from getting underway.

No tenants are signed but Gloor said interest from biotech tenants gave Sterling Bay the confidence to begin work on the project.

Passage Bio Invests in Gene Therapy Manufacturing R&D Site

In combination with dedicated cGMP suite at Catalent, the new lab creates foundation for integrated AAV gene therapy manufacturing.

Passage Bio, Inc., a genetic medicines company focused on therapies for rare, monogenic central nervous system (CNS) disorders, has entered into a long-term lease to support Chemistry, Manufacturing and Controls (CMC) lab operations for the company’s gene therapy programs. The new lab, scheduled to open in 2Q21 at the Princeton West Innovation Campus in Hopewell, NJ, will initially focus on state-of-the-art analytical capabilities, clinical assay development and validation, biomarker assay validation and clinical product testing to support both viral vector manufacturing and clinical development.

The opening of the CMC lab is part of Passage Bio’s strategy to expand its internal manufacturing capabilities to support its lead gene therapy programs as they move into the clinic and advance toward commercialization. The CMC lab complements the recent opening of Passage Bio’s dedicated CGMP manufacturing suite at Catalent. These investments provide the company with the foundation for an integrated manufacturing supply chain with capabilities to advance multiple gene therapy programs to support clinical trials worldwide.

The 62,000 sq.-ft. lab space is intended to support analytics, process development, quality control and pilot manufacturing. The 1.2 million-sq.-ft., multi-purpose research and development and biologic/pharmaceutical manufacturing campus also provides Passage Bio with expansion opportunities for additional lab space and CGMP manufacturing operations. Passage Bio plans to add more than 20 new positions in 2021 at the new lab.

Alcami Site Expansion Nears Completion

Alcami’s 56,000 square foot expansion in Research Triangle Park (RTP), reached the first milestone of operational readiness with the start of GMP laboratory testing this month.

This brand-new site became part of Alcami when TriPharm Services was acquired in January 2020. 20,000 square feet will be dedicated to microbiology, formulation development, and analytical chemistry services. Specific investment has been made to offer powerful environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase 1 of the manufacturing facility in Q4 2020, which will bring the first two filling suites online and the next major milestone.

In support of this build-up, Alcami has added more than 30 employees to the RTP campus and 80 employees company-wide in 2020. Recruiting is ongoing for more than 60 additional positions across all Alcami sites. Alcami is working with the FDA to combine the new site with the existing Alcami laboratory located in Durham, NC, under a single FDA establishment identifier (FEI). The RTP laboratory and manufacturing operations are fully integrated under Alcami's established quality systems and oversight.

"Alcami offers a unique solution to current supply chain risks with redundant capabilities from an entirely US-based network of facilities that have regulatory qualification to supply major international markets," said Walt Kaczmarek, chief executive officer of Alcami. "We are pleased to provide modern, reliable manufacturing capacity to support the rapid growth of injectable pharmaceutical and biologic products."

Kodak’s Shift to Pharmaceuticals after Rival Fujifilm Made the Same Pivot

The U.S. government is loaning legendary camera maker Eastman Kodak $765 million to start manufacturing pharmaceutical products in a bid to increase U.S. self-sufficiency in response to the coronavirus pandemic, the company announced.

Kodak chief executive Jim Continenza told the Wall Street Journal that pharmaceutical ingredient production will eventually make up 30% to 40% of Kodak’s business.

Shares in Kodak more than tripled after the government loan announcement, pushing the firm’s market value from $115 million to $347 million.

In its leap from film and imaging to pharmaceutical production, Kodak follows the path of its erstwhile rival, Japan’s Fujifilm Holdings Corp. The two companies formed a near-duopoly on film photography for much of the 20th century, but Fujifilm has so far proved far more adept at reinventing itself than its American counterpart.

A Kodak engineer invented the first digital camera in 1975, but the company failed to recognize the technology’s potential. Fujifilm was quicker to pivot to digital, introducing the world’s first digital portable camera in 1988, and the Japanese firm was faster to diversify away from photographic film.

Fujifilm is also several steps ahead of Kodak in the pharmaceutical realm. Health care and material solutions made up 43% of Fujifilm’s total revenue in 2019, and the company aims to double its health care sector sales over the next few years.

The company acquired a medical diagnostic imaging company as early as 1986. Since then, Fujifilm has acquired several more pharmaceutical and biotechnology companies and fashioned itself into a major producer of medical equipment and drugs.

In 2006, it bought the company that became the drugmaker Fujifilm Toyama Chemical, which developed the antiviral Avigan, an early contender in the race to develop a COVID-19 treatment. (Inconclusive clinical studies earlier this month have dampened enthusiasm for Avigan, however.)

Fujifilm Diosynth Biotechnologies, a pharmaceutical manufacturer that Fujifilm acquired in 2013, announced that its Texas site will support production of a coronavirus vaccine candidate as part of Operation Warp Speed, a U.S. government COVID-19 vaccine development program.

Kodak, which dominated cameras and photographic film in the U.S. for decades, filed for bankruptcy protection in 2012 after years of struggling to adapt to changes in the industry. It rebranded as a technology company focused on printing and imaging for businesses after coming out of bankruptcy in 2013.

That both firms have pivoted from film to pharmaceuticals is not coincidence. Each firm says its experience manufacturing film and other photography products lends itself to drugmaking.

Continenza told the Wall Street Journal that Kodak has a “long, long history in chemical and advanced materials” and said the company’s existing infrastructure will enable Kodak Pharmaceuticals “to get up and running quickly.”

Fujifilm, which launched its campaign to become a “total health care company” years before Kodak ventured into the space, has linked its history in photography to its success in pharmaceuticals. Fujifilm’s drug development efforts apply “proprietary technologies harnessed through Fujifilm’s long-standing operations in photographic films,” according to its website.

White House adviser Peter Navarro said the pandemic has revealed the U.S. to be “dangerously dependent on foreign supply chains” for essential drugs, and called the Kodak deal “a huge step forward towards American pharmaceutical independence.”

China is currently the world’s largest supplier of pharmaceutical ingredients, the active compounds used to make drugs, and U.S. imports from China have increased in recent years.

REST OF WORLD

Singapore-based The Wellness Fellows Launches Surgical Masks

The launch marks the first N95 masks manufactured by the company in an ISO Class 7 cleanroom environment.

The Wellness Fellows is launching a range of surgical masks made in Singapore's first ISO Class 7 cleanroom environment designed for the manufacturing of N95 and surgical masks.

Under the brand name, The Mask Fellows, these masks are manufactured from five production lines with a capacity to produce ten million masks per month. The factory will open its grounds for educational tours for a small fee so everyone can experience and witness first-hand how surgical masks are made.

"The Wellness Fellows is a group of individuals from diverse backgrounds, who came together to form a made-in-Singapore surgical mask factory, as we believed no one should be deprived of a mask. We want to produce surgical masks to the highest standards, and we spared no efforts to build a cleanroom facility with IOT (Internet of Things) like climate control and cleanroom monitor," said Founder and CEO, Daniel Chui. "We are probably the most professional surgical masks manufacturer with ISO 13485-2016 certification for medical device quality management system, well-rounded processes, trained personnel and differentiated product offerings."

"It is important for us to have certifications for ISO Class 7 cleanroom and for our masks to be certified with international surgical masks standards like ASTM F2100 and EN 14683 as it is pertinent to associate The Mask Fellows with quality and safety attributes that are synonymous with a made-in-Singapore brand. These accreditations and certifications have allowed us to export to other countries," he continues.

"When we manufacture these masks in a cleanroom environment where dusts, airborne microbes, and aerosol particles are passed out using HEPA filters, the end-products are high-hygiene face masks which we want to offer in Singapore and markets across the world. And we are honored to have Dr Leong Hoe Nam, an infectious disease specialist, as our medical advisor."

Chui further elaborates that in-line with the organization’s value of constantly innovating and evolving to be on pace with seasonal trends and noteworthy events, The Masks Fellows also boosts its product mix by constantly coming up with limited edition collectable surgical masks.

This year, the company designed the SG55 masks to commemorate "A Stronger Singapore", in celebration of our heroes, steadfast spirits and resilience in all times amidst the COVID-19 pandemic. The Mask Fellows is also the first corporate entity in the world to commit a portion of sales proceeds to ExtraOrdinary People on a sustained basis to help empower individuals with special needs.

Crown Biosciences Opens Facility in China

Crown Bioscience, a JSR Life Sciences company, has opened a new oncology-focused research facility in Zhongshan, China to satisfy increased customer demand.

Once completed, this new building will add more than 21,520 sq. ft. (2,000m2) of new vivarium space to support CrownBio’s in vivo oncology platforms, helping satisfy predicted near-term growth.

CrownBio’s products and services are used by pharmaceutical and biotech customers across APAC, North America, and Europe to accelerate and de-risk their drug discovery programs. With the significant and continued growth of CrownBio’s client base, the Zhongshan facility has been purpose-built to meet expanding study needs.

The research and drug development facility features BSL-2 laboratories and will include an ABSL-2 vivarium. Initial capabilities will focus on expanding cell line-derived xenograft model availability and study throughput, with an increased roster of cutting edge, translational oncology models becoming available. Full operational capacity is expected in early 2021.

“The establishment of our new Zhongshan facility demonstrates our continued commitment to our clients, to provide sustained rapid study initiation combined with robust cost-effectiveness,” said John Gu, chief operating officer at CrownBio. “Through our growth, we can more fully support our clients in their goals of more rapid and efficient cancer drug development.”

A site opening event and ribbon cutting ceremony took place on October 30, 2020.

Fareva Expands Sterile Production Capabilities

Grows footprint with site acquisition in France and Austria.

Earlier this year, on July 9, 2020, an agreement was reached with the Pierre-Fabre group for Fareva acquiring two pharmaceutical sterile manufacturing sites in France that the company expects to begin operation by the end of the year.

The Idron site has 200 employees and is dedicated to the manufacture of sterile injectable forms (pre-filled syringes, lyophilized and liquid filled vials). The factory has 10 commercial lines and a pilot plant that will be operating end of 2021. The core business of the site is to handle highly potent and biologics entities.

The Saint Julien-en-Genevois site is manufacturing monoclonal antibodies (MABs) with state-of-the-art single use bioreactor technology. On top of clinical trials lots manufacturing, the site allows the purification and the coupling of monoclonal antibodies with high potent actives (up to OEB 6).

Fareva has also entered into exclusive negotiations with Merck & Co for the acquisition of the Mirabel site in France. This site will broaden Fareva’s technology offering with its antibiotic injectable workshop. Additionally, it will allow to ensure fill and finish activities for ophthalmic products (BFS single doses) and freeze-dried products in vials. Those production capabilities are already available at the Fareva sites, Valdepharm, Fareva Amboise and Excelvision. It will provide a competitive advantage for high value therapeutic medicines: Fareva could offer two manufacturing locations, allowing Fareva’s customers to register in their market authorization dossier an additional manufacturer. This will mitigate the supply chain disruption risk for those critical drugs, which is expected by the authorities.

In addition, Fareva has just entered into exclusive negotiations with Novartis for the acquisition of the Unterach site, located in Austria. They are expert in high potent prefilled syringes, ampoules and lyophilized vials.

These new acquisitions increase Fareva’s technology portfolio, including into the high-potent and biologic market segments. These two categories represent the majority of the new drugs applications launched in the market over the last 5 years.

"We continue to invest significantly in the areas of sterile and oncology manufacturing, with the aim to increase our technology offering, from providing services from API to finished dosage forms,” said Bernard Fraisse, founder and president, Fareva Group. In this business, customers are seeking long-term relationships, and we will support this by adding to our existing network.”

Site acquisitions

Idron

• 200 employees

• Approved by Korea, Europe, US and Japan

• Sterile Liquids, PFS and freeze-dried vials

• High potent, biologic and conventional injectables

St-Julien-en-Genevois

• >30 employees

• Approved by Europe

• Monoclonal antibodies and conjugated monoclonal antibodies with high potent actives

• Single use bioreactors

Mirabel (to be finalized)

• 350 employees

• Approved by Europe and US

• Antibiotic injectables

• Sterile Liquids and freeze-dried vials

• Ophthalmic single dose

• Ability to expand

Unterach (to be finalized)

• 500 employees

• Approved by Europe and USA

• High potent prefilled syringes

• Ampoules

• Sterile liquids and freeze-dried vials

Eurofins CDMO Expands Drug Product Capabilities in Canada

14,500 sq. ft. expansion includes new development labs and GMP manufacturing suites.

Eurofins CDMO has expanded its existing drug product operation capabilities with the early 2020 completion of its new drug product development and cGMP manufacturing facility, located in Mississauga, Canada.

The expansion of Eurofins’ drug product operations spans 14,500 square feet. The assets include fully equipped state-of-the-art pre-formulation and formulation development laboratories, a development suite, multiple GMP manufacturing suites, clinical packaging, and warehousing. With the expansion, Eurofins CDMO can support development and clinical manufacturing of oral solid dosage forms, including highly potent APIs. The integration of drug product operations compliments Eurofins’ existing API development and manufacturing services by providing an enhanced Quick-to-Clinic drug product strategy designed to meet clients’ needs for phase I and II products.

The company says this complement of services offers science-driven strategies which enhance the drug product performance of APIs, from IND enabling through to late stage programs. The new drug product facility allows Eurofins CDMO to offer all drug development services under one roof, achieving enhanced science faster.

Seqirus’ Influenza Vaccine Manufacturing Facility, Melbourne

Seqirus, an influenza vaccine maker, is building a new cell-based influenza vaccine manufacturing facility in Melbourne, Australia.

The facility will be a significant addition to the company’s global manufacturing and supply chain for the influenza vaccine, including the facilities in Holly Springs, North Carolina, US, Liverpool, UK, and Parkville, Australia.

The new plant will be utilized to manufacture influenza vaccines for both pandemics and seasonal vaccination programs, using advanced cell-based technology. It will produce products for the domestic market and export, help Victoria’s 1,000+ STEM workers, and have an estimated supply chain of more than $300m a year.

The development of the facility will cost approximately A$800m ($581.4m). Construction should begin in February 2021, while operations could commence by mid-2026.

It will create approximately 520 jobs during the construction phase and will employ several hundred people upon completion.

The Victorian Government will support the project to expand the globally active community of medical research and biotechnology in the state.

The influenza vaccine manufacturing facility will be in Tullamarine in the Melbourne Airport Business Park in Victoria, Australia.

It will utilize the airport’s transportation facility to supply vaccines round-the-clock.

Stelis’ Biologics Manufacturing Facility Expansion, Bangalore

Stelis BioSource™, a division of Stelis Biopharma, is expanding its biologics manufacturing facility located in Bangalore, India.

Expansion is a part of the company’s extended investment program, under which it already invested more than $100m in its Bangalore facilities.

The facility expansion is the manifestation of strong market demand and opportunities to establish an infrastructure for delivering economic outsourced biologics capabilities.

The investment program will create a global platform for biologics, vaccines, and pharmaceutical drug products.

Stelis BioSource’s 200,000ft2 state-of-the-art, integrated commercial biopharma manufacturing facility features microbial and mammalian facilities for cGMP manufacturing. The expansion will equip the mammalian facility with two 2,000l single-use bioreactor trains for CGMP manufacturing of mammalian drug substance.

Single-use technology reduces footprint, costs and time, enabling flexible and efficient manufacturing.

The facility incorporates 50l, 200l and 2,000l production line, fermentation capability, including handling batch, fed-batch and perfusion fermentation process, as well as dedicated pre-culture suites, media and buffer preparation rooms.

The facility features pre and post-viral segregation, filtration and single-use flow path- chromatography systems and controlled freeze and thaw system.

Carbogen Announces Investment in Switzerland and France

The facilities, located in Switzerland and France, will be phased in over the next four years

Carbogen Amcis has announced two expansion projects that will increase its manufacturing capacity.

In Switzerland, the project will be initiated in 2021 with construction of an API manufacturing facility at its Hunzenschwil site. The unit is planned to be operational by summer 2024.

“The facility is designed to provide space for Carbogen to grow over the next 10 years with the initial phase comprising of 12 new vessels (from 630 liters to 4000 liters) and associated filtration and drying capabilities,” said Stephan Fritschi, VP of Operations. “We have an impressive pipeline, and now our customers can benefit from more diverse offerings.”

The French site will be able to supply both clinical batches up to phase III and small-scale for commercial. There will be two automated lines.

In addition to the Swiss API manufacturing facility, additional investments are planned with a dedicated budget to improve some of the existing technologies and to increase the capacity of current Swiss sites, such as adding chromatography equipment, reactors in production and additional laboratories.

In France, 7 km from an existing site in Riom, construction will begin in January 2021 on a facility dedicated to custom development and manufacturing of parenteral drug products.

The facility will allow handling complex formulations, including range of APIs from biologics to any kind of highly potent compound.

Pascal Villemagne, VP of Sales and Marketing said: “Our new facility in Riom will not only enable us to support more customers, but will also give them access to innovative fill and finish technologies.”

The French site will be able to supply both clinical batches up to phase III and small-scale for commercial. There will be two automated lines: the first one for both liquid filling plus lyophilization and the second one dedicated to liquid forms. Development and analytical laboratories will be incorporated to support customer projects. Operations will commence during Q1 of 2023.

“Our objective is ambitious, nevertheless, we are taking a responsible approach to our growth in order to give the company and our employees a sustainable future. As an established leader in the pharmaceutical outsourcing industry for the past 40 years and with strong relationships with our customers, our company is ready to take this next step in capability and capacity. We are embarking on the expansions in order to secure Carbogen Amcis’s position,” said Mark Griffiths, CEO of Carbogen.

LSNE Expands Aseptic Fill Finish Capabilities in Europe

The news builds upon LSNE’s experience providing aseptic fill finish of biologic products for clients at its US facilities

LSNE Contract Manufacturing (LSNE) has announced the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical stage biotechnology based therapeutic products at its aseptic fill finish facility in León, Spain.

The products LSNE has provided aseptic fill finishes for clients at its US facilities include monoclonal antibodies, fusion proteins, replacement enzymes, plasmids, capsids, and oligonucleotides.

Shawn Cain, LSNE’s Chief Operating Officer said: “The authorization of biologic manufacturing for clinical drug product in both vial and pre-filled syringe (PFS) presentations is a vital step to our maturation of drug product manufacturing at our facility in Spain. This will provide the global market with more access to LSNE facilities for the manufacture of these high-value biologics, including monoclonal antibodies and other recombinant proteins”.

Jaime Del Campo, Site Head at LSNE-León said: “We are thrilled with this most recent milestone and our ongoing partnership with AEMPS. This is another big step forward supported by our industry leading quality and operations teams. We anticipate this authorization will have an immediate impact in our ability to support our client’s varied clinical programs and ensures long-term benefits to their future commercial supply.”

Europital is Opening a CRO Site in the UK

Europital, a Belgium-based provider of medical management services for clinical research and drug development, plans to open a UK contract research organization (CRO) facility. The company, opening the facility to meet growing demand in the UK biotech sector, reportedly anticipates compound growth of approximately 30% over the next three years.

The company also plans to add staff to its operational team at the site over the next few months. Additionally, it anticipates working with small- and medium-size companies to design and execute projects for first-human, Phase I and Phase II clinical trials.

Mohamed El Malt, Europital’s CEO and chief medical officer, said that the country’s biotech landscape has grown and evolved in recent years. “According to Venture Valuations' ‘UK Life Sciences Trend Analysis 2020’ report, since 2010 the number of therapeutically focused UK biotechs founded has grown steadily from 14 in 2010, to 29 in 2017,” he said. “Whilst Brexit has caused a sharp decline in the number of newly founded biotechs, the amount of venture funding for UK based biotechs has remained steady over the last 5 years hovering around the $1.1b – $1.2b mark each year, with only 2019 experiencing a more significant drop in funding to around the $716m mark."

El Malt added that while Brexit has affected overall investment in UK biotech activity, it remains the European country with the highest volume for life-science research. Further, he told OSP that his company is uniquely poised to handle future growth.

“We already partner with several biotechs in the UK, and what we have seen is that there is a clear gap in the market for small innovators looking for a science-focused CRO that can provide the detailed knowledge and therapeutic experience,” El Malt explained. “Gaining access to senior medical CRO expertise can be extremely challenging for the smaller innovators; what they need is a partner to bring a medical department with real-world trial experience to implement study design and protocols and be a scientific driving force behind project’s success.”

Company leadership anticipates staff will focus on serving partners in complex oncology indications, inflammatory diseases, immunology and infectious diseases studies. The UK site opening also will be used to leverage the company’s Phase III experience with clinical studies conducted at UK investigative sites.

One of the challenges the industry faces in the region is a relative shortage of staff with the knowledge and skills necessary to serve clinical research clients.

“Finding qualified candidates for hiring into the clinical trial industry has twin challenges of a limited and expensive talent pool,” El Malt explained. “Qualified clinical research associates (CRAs) who conduct monitoring at investigator sites, need very specific skills, such as very sharp critical thinking, the ability to travel to various research sites and relevant therapeutic experience.”

Retaining qualified staff and training them on new skills also is important, El Malt added. Making them feel valuable can help them remain, he said.

“Surveys have found that the most important driver of satisfaction is feeling valued; knowing that the clinical professionals' work is contributing to the company and to society,” he explained. “Participating in breakthrough research or helping a new medication or treatment get to market is a powerful motivator.”

Sai Life Sciences’ New Research and Technology (R&T) Centre, Hyderabad

Contract development and manufacturing organization (CDMO) Sai Life Sciences inaugurated its new research and technology (R&T) center in Hyderabad, India in August 2020.

The new R&T center increases Sai’s capabilities to offer improved scientific solutions to global innovators in pharmaceutical and biotech markets, serving as the hub for the company’s integrated discovery and development services.

Inauguration of the facility marked the completion of the first phase of a more than $150m investment plan between 2019 and 2023 under Sai Nxt, an organization-wide initiative designed to turn the company into a new generation CDMO.

Sai Nxt focuses on upgrading the company’s R&D and manufacturing facilities, boost automation and data systems and improve safety and quality levels.

In January 2020, Sai started hiring more than 300 scientists with expertise in synthetic organic or analytical chemistry and experience in pharma R&D. The roles being filled through the recruitment are in areas of process R&D, analytical R&D, biology, DMPK, and toxicology.

Spanning 83,000ft², the new research and technology center is located adjacent to Sai’s current R&D facility in Genome Valley, Hyderabad, in the state of Telangana. Life science is a major focus area of the Telangana state government.

Sai Life Sciences’ new research and technology (R&T) center is designed as an innovation corridor, with the arterial corridor running through the building providing the space for collaboration between different cross-functional teams.

The facility features an aesthetic environment developed with green spaces to allow scientists to work in a comfortable setting.

Bushu Pharmaceuticals’ Manufacturing Facility Expansion, Misato, Japan

Bushu Pharmaceuticals unveiled a new expansion program for its pharmaceutical manufacturing facility in Misato, Japan, in August 2020.

With the estimated investment of $100m, the new capital program will expand the company’s footprint, capability, and range of services to the clients. The program will be implemented over the next five years.

The additional capacity and inspection lines in the facility will facilitate the entry of greater volume of bulk goods into the country, making the clients’ logistics and supply chain processes competent.

Established by Eisai in 1981, the Bushu Pharma’s Misato facility is located in Misato-machi, Kodama-gun, in Saitama prefecture.

The site covers an area of approximately 1,861,480 sq. ft. (173,000m²), divided into a pharmaceuticals manufacturing area and welfare facilities area, including a gymnasium and park.

The facility has a floor area of approximately 613,320 sq. ft. (57,000m²), encompassing a solid dosage manufacturing building, an injectables building, a warehouse, and a quality control (QC) space.

The expansion program of the manufacturing facility includes the addition of a new cold chain warehouse facility spanning 41, 964 sq. ft. (3,900m²). It will be utilized to store temperature-controlled sterile drugs and biologics for export to the market in Japan.

The ground-breaking ceremony of the new cold chain center was held in September 2019.

Metsä Board Launches Excellence Centre

Metsä Board said it will use the center to further its goals to accelerate material and packaging innovation.

Growing consumption and demand for more sustainable packaging is boosting the need for new innovations. To develop solutions for packaging today and into the future, Metsä Board, part of Metsä Group, has started up operations in its new Excellence Centre at the bioeconomy site in Äänekoski, Finland.

The company said it will use the center to further its goals to accelerate material and packaging innovation and provide a collaboration platform for customers and technology partners globally.

“As the amount of packaging continues to grow, new, sustainable solutions are needed to replace fossil-based materials and ensure circularity. The Excellence Centre concept enables paperboard and packaging solutions that look at the entire value chain, and not just at its separate parts. With the material knowhow, competence and tools now available, we can optimize performance throughout the packaging lifecycle,” says Mika Joukio, CEO of Metsä Board.

The Excellence Centre, which covers 16,140 sq. ft. (1,500 square meters), includes R&D facilities, a packaging design studio, a customer feedback center and a laboratory providing more than 100 different measurement methods and analytics. The facility also includes a virtual store and a computer-aided engineering (CAE) tool to allow simulation and analysis of packaging performance.

Metsä Board said virtual collaboration workshops have also been developed to enable joint development and co-creation if physical meetings are not possible.

“Renewable and recyclable fresh fiber paperboard can be utilized for packaging in many ways. Fiber-based packaging has a lot to offer, and together with our partners and the new Excellence Centre, we are able to explore the possibilities even more comprehensively. I am excited about the opportunities this will bring for today and the future,” Joukio said.

Äänekoski’s bioeconomy ecosystem includes a next-generation bioproduct mill, a paperboard mill, plywood mill, the Pro Nemus visitor center, and a textile fiber demo plant.

City of Mississauga Applauds Roche Canada Jobs Investment in Life Sciences Industry

Hoffmann-La Roche Limited (Roche Canada) has announced a major jobs investment into Ontario’s life sciences industry that will bring up to 500 highly skilled and specialized full-time positions to the City of Mississauga. Roche Canada’s $500 million dollar investment over five years will establish a Global Pharma Technical (PT) Operations site at its Mississauga pharmaceutical headquarters.

“At a time when Canada and the world are looking to the life sciences sector to lead in testing, treatment and post-pandemic economic recovery, I am proud that Roche Canada has decided to grow and expand their business here in Mississauga,” said Mayor Bonnie Crombie. “Roche is a global pioneer in pharmaceuticals and diagnostics. Not only will this investment support jobs and attract talent, it also reinforces Mississauga’s position as a global, internationally recognized leader in life sciences. Our local economy has greatly benefitted from our thriving life sciences sector, a place where researchers can not only make medical breakthroughs but where products can be commercialized and brought to market.”

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system.

“Mississauga was selected for this investment based on a strong competitive business environment, exceptional talent pool, and a government committed to fostering growth in the sector,” says Ronnie Miller, President and CEO of Roche Pharmaceuticals, Canada. “We applaud the hard work done by the Government of Ontario and the Premier’s Office to foster a business environment that can compete internationally to attract investment opportunities, and Roche’s commitment to add up to 500 specialized positions is a direct result of these positive changes. Without the support of all three levels of government, the Mississauga Board of Trade, Life Sciences Ontario, and Invest in Canada, who are all active advocates for a thriving sector, this investment would not have been possible.”

Mississauga is the second largest Life Sciences Sector in Canada by employment, with more than 470 companies employing over 25,000 people.

“Mississauga is the first Canadian municipality to have a five year Life Sciences Cluster Strategy and Action Plan that focuses on establishing Mississauga as the premier Canadian destination for the commercialization of life sciences products, technologies and services,” said Bonnie Brown, Director of Economic Development. “Our commitment to growing Mississauga’s Life Sciences cluster has been instrumental in helping us achieve our economic goals and attracting new investment.”

Roche Canada states the investment will create new and exciting employment opportunities, in particular for recent graduates of Ontario’s strong science, technology, engineering and math academic institutions who will have the opportunity to impact the development of Roche’s medicines from early stages through to patient use around the world.

Sirio Europe Invests in Brandenburg Site

The plant upgrades form a part of a wider drive at Sirio to implement sustainable manufacturing processes, the company says

Sirio Europe has announced the completion of a major overhaul of its Brandenburg site with advanced manufacturing and green technologies.

The company has installed HVAC systems, individual drying chambers, vegetarian softgel manufacturing equipment and a block heat & power plant.

“One of the reasons behind the investments was that we wanted to be at the forefront of implementing greener solutions and energy-efficient manufacturing for our pharma customers. So, while implementing new equipment, we also explored how we can improve the plant’s sustainability,” said Dominique Baum, Managing Director at Sirio Europe

The HVAC systems increase the plant’s manufacturing capacity while reducing the risk of product contamination. By using only individual drying chambers, the company can control the temperature of individual products, which is more energy-efficient and improves the softgel drying process. The vegetarian softgel manufacturing line has been installed – transferring technology from Sirio’s Guangzhou plant – in response to the growing demand for plant-based nutraceuticals.

The site upgrades will be supported by an block heat & power station, which the company estimates to increase power output by up to 50% through combined heat and power (CHP). The technology captures and recycles heat into thermal energy to power the manufacturing equipment.

Baum said: “Installing the heat block & power station is a huge business benefit in terms of reducing energy consumption. For example, softgel production uses a lot of energy as strict parameters need to be adhered to – through CHP we can now manufacture softgels at a lower cost. But installing the heat block was also the right thing to do in terms of looking at ways to make manufacturing as sustainable as possible”.

Sirio says it exclusively sources ingredients from certified, sustainable suppliers, and are members of a number of certified sustainability groups, including the Friends of the Sea (part of the World Sustainability Organisation) and Marine Stewardship Council.

VMIC Chooses BES to Help Fast-Tracked Vaccine Facility

Boulting has been chosen to fit out a new facility for the not for profit organization established to provide the UK's first strategic vaccine development and advanced manufacturing capability.

BES, the specialist in design and construction of advanced environments for the pharmaceutical and healthcare sectors, has been appointed to fit out the new Vaccines Manufacturing Innovation Centre (VMIC), which is being fast-tracked for early completion in 2021 due to COVID-19.

A not for profit organization established to provide the UK's first strategic vaccine development and advanced manufacturing capability, VMIC has taken a leading role in advising Government teams on vaccines manufacturing in response to COVID-19.

BES is working collaboratively with principal contractor, Glencar Construction

Based at Harwell Campus in Oxfordshire, the organization’s new 79,624 sq. ft. (7,400 sqm) specialist manufacturing center will enable vaccine developers to refine their processes, prepare vaccines for clinical trials, and scale-up for mass production in the event of any future public health emergencies.

This Government-funded project was already planned prior to the pandemic, with completion originally scheduled for 2022. The urgent need to produce vaccines at scale to fight future pandemics has prompted the project handover to be moved forward by 12 months.

A Government grant of £93million ($120m) was awarded to VMIC in May 2020 to fast track the build and expand its manufacturing capacity. The highly specialist facility will form a key element of the Government's future pandemic response and, when completed, will be capable of producing 70 million pandemic vaccine doses in just four to six months.

With more than 18 years' experience of delivering complex pharmaceutical environments, BES will leverage the expertise of its multidisciplinary team to provide design coordination and internal fit-out of pre-clinical development laboratories, vaccine manufacturing suites, cold storage and filling areas.

Working collaboratively with principal contractor, Glencar Construction, BES will provide integrated process, architectural, mechanical and electrical services to meet the challenging program and complete the state-of-the-art center to the highest standards.

Steve Marsh, Managing Director of BES, said: "Effective vaccines play an important role in public health, and the new VMIC facilities will enable the UK to respond quickly to new health risks, including pandemics, by enabling large scale production of vaccines for both clinical use and emergency response."

Eddie McGillycuddy from Glencar Construction said: "Delivering this project will be a major milestone in achieving improved resilience to the pandemic and to any future public health challenges. We are delighted that BES has joined our team and we look forward to rapid progress on site."

COO of VMIC, Chris Lucas, added: "Delivering the VMIC facility during a pandemic is challenging, and the need to fast-track the project by a year has resulted in a level of complexity unparalleled in construction. With their level of expertise, BES will form an important part of the collaborative group delivering this project of national importance."

TRI Opens Clinical Cleanroom Facility in Australia

The Translational Research Institute's T3 Cleanrooms manufacturing and training facility has been designed to help significantly increase workforce skills in cleanroom processes and advanced manufacturing

The Hon Karen Andrews, Minister for Industry, Science and Technology has opened the Translational Research Institute's (TRI) new clinical cleanroom manufacturing and training facility, T3 Cleanrooms, and the inaugural MTPCareers Symposium.

The new cleanroom facility will significantly help speed-up the translation of Australian medical innovations into clinical practice, and will be available to researchers, start-ups and companies to manufacture sterile products on a small scale.

Professor Scott Bell, CEO of the TRI, said that the T3 Cleanroom facility is the outcome of a successful partnership with Australian biotech, Vaxxas, to secure funding from MTPConnect to build clinical manufacturing and training capacity.

"Based in dedicated commercial space at TRI, Vaxxas worked with us to identify a critical gap in medtech manufacturing and skills for companies needing to scale-up production for clinical trials, which led TRI to develop the unique T3 Cleanrooms," said Bell.

Having access to this vital facility is enabling Vaxxas to progress its innovative vaccine technology from preclinical to clinical trials and is a great example of the translational pathway that exists at TRI to foster the commercialization of Australian medical innovations.

"Importantly, while based at TRI, Vaxxas has secured millions in funding from the US Biomedical Advanced Research and Development Authority (BARDA), Merck and the Bill and Melinda Gates Foundation to support human clinical trials of its micro-patch technology to deliver vaccines worldwide."

MTPConnect CEO, Dan Grant says the Growth Centre's funding is improving critical research infrastructure to global standards to help accelerate the translation of new medical innovations, while also boosting the workforce skills of Australia's new generation of scientists.

"Giving Australian researchers and start-up medtech and pharma companies access to high value infrastructure such as GMP cleanrooms and small-scale manufacturing facility is a game-changer, keeping successful start-ups like Vaxxas here in Australia rather than moving development overseas. The TRI cleanroom fills the gap from the lab to the clinic, enabling discovery, production, and clinical trials and treatment to be available in one place," said Grant.

"We know that Australia has a workforce skills shortage in cleanroom processes and advanced manufacturing, so setting up the clinical manufacturing training hub at the TRI is a targeted way to build our sovereign capabilities and develop more career opportunities for our best and brightest talent," Grant added.

Australian start-ups

A recent survey Australian medtech and biotech start-ups and SME's found that these companies need ongoing collaboration with research; access to clinical trial facilities and patients; and access to cleanroom manufacturing facilities and skilled staff to scale up production for clinical trials.

"It is TRI's ability to provide these essential facilities and services that has resulted in current commercial space being oversubscribed and a waiting list of young biotech companies wanting to be based here," said Bell.

"We're also actively looking at opportunities to replicate our clinical manufacturing facilities at a larger scale to cater for the successful innovations and growing scale-up requirements in the med tech area, which is a significant gap for these emerging companies looking to be based in Australia," Bell added.

Autolus Expands Operations at CGT Catapult Manufacturing Centre

Autolus Therapeutics are further expanding their operations at the Cell and Gene Therapy Catapult (CGT Catapult) manufacturing center, and are collaborating with CGT Catapult to achieve licensure for the commercial manufacture of their CAR-T cell therapies. This collaboration facilitates the company’s plans to manufacture CAR-T cell therapies for both clinical and commercial supply and the CGT Catapult and associated UK supply chain will gain new capability and expertise, adding to the favorable cell and gene therapy ecosystem in the UK.

Autolus are a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer. They are one of five collaborators to have established their large-scale manufacturing operations at the CGT Catapult manufacturing center in Stevenage, UK.

The facility, which has recently doubled in capacity, provides infrastructure, expertise and a surrounding cell and gene therapy ecosystem which is favorable for the growth of companies moving towards clinical adoption. Autolus are expanding within the facility to utilize additional cleanroom space in the newly operational modules, supporting the manufacture of materials for their pipeline products.

“We are proud to undertake this collaboration with Autolus, a pioneering company that has been showing tremendous progress with their pipeline products for oncology. We look forward to working with Autolus to meet all of the standards required for commercial CAR-T cell therapy manufacturing,” Matthew Durdy, CEO, Cell and Gene Therapy Catapult said. “With its unique operating model, the Manufacturing Centre is well suited as an international base for manufacturing innovation at scale and, having recently expanded, has the capacity to support new and existing collaborating companies as they grow.”

Seqens Inaugurates New HPAPI Unit at French Site

The new unit is a result of a $35 million investment in one of the three leading technologies in pharmaceutical synthesis

Seqens, a pharmaceutical synthesis and specialty ingredients provider, has inaugurated its new innovative HPAPI unit for the production of highly active ingredients at its Villeneuve-La-Garenne site, in the presence of French President Emmanuel Macron.

This investment of $35 million in one of the three leading technologies in pharmaceutical synthesis, demonstrates the Seqens group's ability to design, develop and industrialize the most complex molecules while maintaining a high level of performance in terms of quality, safety and respect for the environment.

This project, called UPP30, has been carried out in partnership with the Belgian biotech company Mithra for the production of a fifth-generation contraceptive molecule with a superior safety profile for women and with a very high level of biodegradability, giving it a major environmental interest. It demonstrates the interest for both major pharmaceutical laboratories and biotech companies to rely on local and perennial skills for the development and industrialization of their molecules.

"Today, I am proud and happy to inaugurate the fruit of many years of work and to see that the Seqens group continues to invest massively in the latest cutting-edge technologies to maintain and develop more than a hundred years of know-how and skills and thus continue to maintain in France real competences in pharmaceutical synthesis. It is the key to keep our health sovereignty over the long term," said JeanPhilippe Aubert, Seqens' UPP30 project director.

As an integrated player in the drug production chain, from the production of intermediates to the production of active pharmaceutical ingredients and from research and development to industrialization, Seqens has the technical and industrial capacities to relocate and increase the production capacity of essential and critical molecules.

For Seqens, revitalizing its industrial footprint will be based on three pillars:

The development of skills. Seqens is committed to doubling the number of its work-study students and apprentices, particularly in technical fields, and achieved that by early 2020. In 2021, more than 150 young people will be welcomed to our sites to learn our businesses. Similarly, Seqens has set up a training program to offer a qualifying career path and radical career changes to people who want to discover the world of industry.

Innovation and R&D. Seqens has been able to withstand the waves of relocation by relying on its know-how and its ability to innovate. 10% of the group's employees work on the development of new products and innovative processes, always more efficient and respectful of the environment. The Seqens' Lab in Porcheville, inaugurated in June 2019 by Agnès Pannier-Runacher, Minister of Industry, is a world-class R&D campus that supports our customers in the development of their molecules from the pre-clinical phases through to industrialization.

The quality and performance of productions. Seqens is above all an industrial group that relies on the high skills of its employees throughout its 24 production sites. It is an industrial culture of performance, rigor and continuous improvement that allows us to continue to offer our customers quality products in compliance with the strictest quality, environmental and safety standards.

"Our sustainability will depend on the ability of our companies to innovate and boost productive investment in our territories. Seqens is ready to take up the challenge by relying on innovation, R&D and the skills of our teams on our production sites!" said Pierre Luzeau, CEO of Seqens.

Mecart Supplies Modular Isolation Units to Montreal Hospital

The new units will be integrated to a new structure adjacent to the Maisonneuve-Rosemont Hospital.

Quebec-based Mecart has started shipping modular isolation rooms for COVID-19 patients to a major Montreal hospital.

Fully assembled at the Mecart plant, the units will be integrated to a new structure adjacent to the Maisonneuve-Rosemont Hospital, built by well-known general contractor Pomerleau.

Mecart President Benoît Poupart and VP and general manager, Patrice Genois, said they were "proud that, with its expertise and capabilities, Mecart was in a position to contribute in a significant way to the fight against COVID-19". The isolation chambers provided by Mecart will be used for COVID-19 patients and subsequently for immunosuppressed patients in oncology, allowing long-term use of the investment after the pandemic.

Founded in 1974 and under the current ownership since 2012, Mecart specializes in controlled environments, such as cleanrooms and laboratories which it engineers, manufactures and installs globally.

Mecart custom modular cleanrooms can be found in many fields, from health-related applications such as pharmaceuticals, hazardous pharmacy compounding, research and clinical trials to industrial sectors such as electronics, aerospace and nanofabrication. This same technology and expertise allow the company to supply much-needed medical isolation rooms to hospitals and healthcare facilities with short lead-times.

GEA Builds Process Plant for the Production of Immunoglobulin

The CSL Behring facility in Bern has been improved on previous modules with a purely manual switchover panel could be replaced by a complex valve combination in the cleanroom

PROTINUS is the name of the project with which the biopharmaceutical company CSL Behring will significantly increase the production capacity of immunoglobulin at its site. GEA received the order for the process plant, the heart of the facility.

The two additional production lines will enable a further 90,000 patients per year to be supplied with life-saving drugs. Thanks to the good cooperation of all parties involved in the project, it was possible to continue the project on schedule despite the global corona pandemic.

Following the successful commissioning of the modules I and II also in Berne, Switzerland (2007 and 2009) and modules III and IV at CSL Behring's Melbourne, Australia site (2013 and 2017), this is now the third GEA process plant at CSL Behring to be commissioned with modules V and VI.

CSL Behring relied on GEA not only because of the good experience with the previous projects in Berne and Melbourne. As a supplier of sterile process plants with many years of experience, GEA can draw on the extensive theoretical knowledge and professional competence of its engineers to provide modern, customized and cost-efficient process lines for the production of new drugs in accordance with the current requirements of the global drug regulatory authorities.

The technological competence for the biotechnology industry includes cultivation, fermentation, separation, homogenization, crystallization, concentration, freeze drying and fractionation, complemented by a comprehensive range of bioreactors, fermenters, vessels and high-quality components. GEA plants are also characterized by high availability and economical operation.

This is backed up by a long history, combined with a great deal of competence and experience in this field. In fact, the first pharmaceutical built back in the 1970s. Since the 1980s the company has strategically focused on biopharmaceutical applications.

The PROTINUS project in Berne had other success factors. For example, GEA was able to build on the many years of experience gained with the running plants in Berne and Melbourne. This was another reason why GEA was involved in the engineering process from the very beginning. Together with CSL Behring, GEA continued to work on the degree of automation and took it to new levels.

Significant progress was made in the areas of "increased availability", "operability" and "safety". A concrete example: As an improvement on the previous modules, a purely manual switchover panel could be replaced by a complex valve combination in the cleanroom.

This allows CIP cleaning and product transfer without risk of contamination in parallel and without manual operator actions.

"Our greatest incentive in this project is that the additional production capacity will enable around 90,000 people per year to lead a normal life," said Pierre Caloz, Head of Manufacturing EU & APAC, CSL Behring. CSL Behring has therefore invested 250 million Swiss francs in the project, creating 50 new jobs.

Immunoglobulins are proteins of the globulin class. They are used to defend the human organism against foreign substances that have entered the body. They therefore play a central role in the immune defense. They are used in autoimmune diseases as well as in passive immunization against certain pathogens and in cancer therapy.

Wacker Invests in Amsterdam Biotech Site

Munich-based Wacker reports that it is investing in its production facilities for live microbial products and vaccines at its Amsterdam site. The projects include the construction of a new fermentation line with a volume of 1,500 liters as well as creating new cleanroom structures in the 270-liter fermentation line. The investment price is a mid-double-digit million-euro amount, according to the company.

“By investing in new plants and production equipment, we are continuing to upgrade the Amsterdam site two years after Wacker took it over, and are making our company fit for the future,” explained Jörg Lindemann, PhD, managing director of the Wacker subsidiary Wacker Biotech.

The new construction projects will contribute to preparing the plant to produce new classes of pDNA and mRNA-based vaccines, added Lindemann. These nucleic acid-based actives are currently playing a role, for example, in the search for a vaccine against the new SARS-CoV-2 coronavirus.

As a CDMO, Wacker Biotech combines the Wacker Group’s biopharmaceutical activities. Wacker took over the Amsterdam site in 2018, doubling the company’s biologics capacity. Services also are provided by a fill-and-finish facility for filling and lyophilization, which enables the complete manufacture of pharmaceuticals from the active agent to the filled product, continued Lindemann.

Catalent Adds Potent Manufacturing Capabilities At Its Buenos Aires Site

Catalent is set to expand its Argentinian site in Loma Hermosa, Buenos Aires, Argentina. The expansion, which will add more than 11,000 square feet of production space at the facility, will be segregated and designed to handle cytotoxic and highly active products for prescription softgel manufacturing.

The new facilities, which are due to be completed in December 2021, will include two new manufacturing vessels of 40 and 300 liters, which include an automatic cleaning system and an innovative mixing device suitable for very high viscosity formulations, a capsule filling line and six drying tunnels. This will add a capacity of more than 10 million doses per annum to the site, which supplies products to the Latin American, US and European markets.

“This investment will allow the site to grow and handle a wider range of projects, reacting to the increased demands of the industry for high potency treatments in areas such as oncology,” commented Sergio Alter, Vice President & General Manager Softgel Technologies, Latin America. He added, “Not only will this increase the capacity of the site, but the design of the new facility will see it meet the highest standards of environmental and energy efficiency.”

Catalent’s 265,000 square-foot-facility in Buenos Aires currently houses softgel manufacturing operations, providing customers with a full range of development services, from formulation to packaging.

Colorcon Opens Technical Centre In Melbourne, Australia

Colorcon, a world leader in the development and supply of film coating systems and excipients, announces the opening of a new technical center in Melbourne, Australia

The facility provides customers in Australasia access to pharmaceutical class development services such as tablet formulation and coating as the region seeks to shorten supply chains and increase the capacity of its pharmaceutical sector.

The new center is in the award-winning and prestigious Caribbean Business Park.

Even before COVID-19, the pharmaceutical and wellness markets in Australasia were expanding led by a steady increase in the older population and strong demand for the nutritional domestic and export markets.

Mr. David Wei, General Manager, Colorcon South East Asia, states: “Opening this facility demonstrates Colorcon’s continued commitment to supporting the growing pharmaceutical and nutritional markets in Australia, reducing our customer’s time to market during product development. The investment reflects Colorcon’s dedication to providing best-in-class products and services.”

Tim Horwood, Business Development Manager in Australia, explains the importance of the facility: “The new technical service center will provide both large and small customers the opportunity to work directly with Colorcon and for the first time in Australia to conduct laboratory-scale compression and coating trials, using automated coating equipment, saving valuable development time and cost."

Glenn Russell, Technical Director, adds: “The facility will also provide the opportunity to extend the educational events offered through the Colorcon Academy to our customers, with resources to conduct training programs to expand their knowledge in formulation and coating — benefiting both companies and individuals."

"Colorcon’s continuous investment in customer support is unmatched in the industry; this additional facility brings the total number of Technical Service Laboratories around the world to 22 and is the seventh within Southeast Asia.”

Catalent to Expand Argentinian Site in Buenos Aires

Adding 11,000 sq.-ft. of production space segregated and designed to handle cytotoxic and highly active products for prescription softgel manufacturing.

Catalent is expanding its Argentinian site in Loma Hermosa, Buenos Aires, adding more than 11,000 square feet of production space and will be segregated and designed to handle cytotoxic and highly active products for prescription softgel manufacturing.

The new facilities, scheduled to be completed in December 2021, will include two new manufacturing vessels of 40 and 300 liters, which include an automatic cleaning system and an innovative mixing device suitable for very high viscosity formulations, a capsule filling line and six drying tunnels. This will add a capacity of over 10 million doses per year to the site, which supplies products to the Latin American, U.S. and European markets.

Catalent’s 265,000 square-foot-facility in Buenos Aires currently houses softgel manufacturing operations, providing development services from formulation to packaging.

MilliporeSigma’s M Lab Collaboration Center, Shanghai

MilliporeSigma opened its new M LabTM Collaboration Center in Shanghai in July 2020. The Shanghai center is the latest addition to MilliporeSigma’s global network of nine M LabTM Collaboration Centers and is the company’s largest such center.

It will provide customized solutions to the life sciences community in China to further advance drug development.

MilliporeSigma aims to leverage the new facility to work with regional customers to improve the quality and safety of drugs.

MilliporeSigma’s latest M LabTM Collaboration Center is located in Pudong, at the heart of the Shanghai’s biomedical sciences and research community.

The overall laboratory size of the M Lab Collaboration Center is approximately 107,600 sq. ft. (10,000m2).

The M LabTM Collaboration Center provides customized solutions and services to support biopharmaceutical and biologics firms to strengthen their drug discovery, development, and manufacturing.

It incorporates pilot-scale and process development support laboratories providing non-GMP (Good Manufacturing Practice) laboratory space to enable exploration of new ideas and learning innovative methods.

The center offers a laboratory integrated with customized approaches, validation services, training, and hands-on applications to support drug development.

Sorrel Medical’s New Manufacturing Facility, Netanya

Wearable drug delivery devices manufacturer Sorrel Medical opened a new manufacturing facility in Israel in July 2020.

The facility will develop and manufacture a range of wearable drug delivery devices to boost clinical and commercial supply capabilities. The company is looking to ramp up production of the wearable devices as it prepares for upcoming clinical trials.

The manufacturing plant can assist Sorrel’s partners in the pharmaceutical and biotechnology industry to bring advanced drug delivery solutions to the market.

Increased production scale-up capability is expected to support the needs of patients suffering from severe, high-burden illnesses.

The new facility for the manufacturing and commercialization of wearable drug delivery devices is located in the city of Netanya in Israel.

It includes an advanced production cleanroom to enable the production of scalability of wearable drug delivery devices.

The 861 sq. ft. (80m²) cleanroom conforms to the ISO class 7 environment standard, designed to minimize particulate pollution in accordance with the standards of ISO 14664-1:2015 and EU GMP Annex 1 and regulate other environmental variables including pressure, temperature and humidity.

The company will leverage the Netanya site to switch from initial design and development, with low-volume production, to scalable high-quality production.

Case Study: ISO Class 8 Mask Production Facility

The urgency of pandemic builds means extremely tight turnaround demands for design and build providers. An example of this is the new 4,573 sq. ft. (425 sqm) cleanroom in Wales that aimed to produce high grade face coverings and masks for front line workers

The COVID-19 pandemic and the new government advice/rules on mandatory face coverings has seen a huge rise in demand for face masks. But how can the UK government satisfy such a large and sustained increase in demand without impacting on the supply of face masks for the countries front-line National Health Service (NHS) staff? The answer: build new state of the art facilities in accelerated time frames.

One such facility is located at British Rototherm, in Port Talbot, Wales. Cleanroom Solutions was tasked with the design and build of the brand new, 4,573 sq. ft. (425 sqm) cleanroom.

The extreme urgency of the build and difficulties getting construction materials at short notice meant the build program had to be modified

The facility was designed in a matter of days, built in 4 weeks, with production equipment installed at the end of week 4. This proved to be an immense challenge and an even greater achievement, testament to the national effort we have seen throughout this pandemic.

The facility is an ISO Class 8 cleanroom to ISO 14644-1, which is required for production of high grade face coverings and masks for front line NHS workers. The cleanroom included changing room and goods in/out airlock for production materials. The facility was fully air-conditioned for comfort conditions.

Due to the extreme urgency of the build and difficulties getting construction materials at short notice, the build program had to be modified. The walls were erected before the steelwork and temporally supported until the steelwork was delivered and constructed.

The walls were then connected to the steelwork, and this was followed by the suspended ceiling. As soon as a section of ceiling was in place, a second team began working on fitting the fan filter units (FFUs) and lights. Finally, the vinyl floor was laid, enabling the client to start to move their production equipment in. Whilst the equipment was being installed the ceilings were sealed and the room tested and validated.

From planning to completion, the project was closely followed by national UK news outlets, such as The BBC and ITV news. Labour MP Stephen Kinnock visited the site as the project was nearing its end and was immensely impressed by the effort and workmanship involved with the facility, especially in keeping within such challenging time frames.

Upon completion, the Secretary of state for Wales The Rt Hon. Simon Hart visited the site to meet the team and highlighted how great it was to see British companies successfully working under extreme time pressures to manufacture high-quality PPE to protect our front line workers and the wider community against COVID-19.

Cleanroom Solutions Site Director, Sean Gaylard, said: "This has to be one of the most challenging cleanroom installations that I can recall us taking on and completing. In light of the current world pandemic with many manufacturers and suppliers still on furlough, we managed to have the cleanroom ready for the production equipment within 4 weeks. A great team effort."

British Rototherm Managing Director, Oliver Conger, added: "The commitment to meeting and achieving a very tight project schedule was tremendous and the quality of the build was first class. The team worked very well with our own operations team and this made it a real pleasure and we built up a very good working relationship with them and a high level of trust. We would highly recommend Cleanroom Solutions to anyone looking to build a cleanroom, particularly if you are under any time pressures such as ourselves."

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com