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Pre-filled syringe maker ApiJect Systems Corp said it has been approved by the U.S. government for a $590-million loan to make single-dose injectors that are capable of delivering nearly all leading COVID-19 vaccine candidates.

The loan is part of the Trump administration’s initiatives to bolster the country’s ability to produce drugs and pharmaceutical raw materials.

The privately held company said it would build a facility capable of producing up to 3 billion single-dose prefilled injectors annually.

The facility will support vaccine candidates that require standard cold storage or ultra-cold storage down to minus 70 degrees Celsius, it said.

The loan from the U.S. International Development Finance Corporation will finance 75% of the project’s capital costs, with the remaining coming from a capital raise led by U.S. investment bank Jefferies Financial Group.

Earlier this month, drug companies Pfizer Inc, BioNTech and Moderna Inc reported data from late-stage COVID-19 vaccine trials that showed more than 90% efficacy. Pfizer and partner BioNTech could secure emergency U.S. authorization for their COVID-19 vaccine next month.

New VA Care Center

The 160,000-sf, three-story VA Ambulatory Care Center opened in Omaha, Neb., on August 3. This is the first of five pilot projects authorized to be built under the Communities Helping Invest through Property and Improvements Needed for Veterans Act, otherwise known as CHIP IN, which became law in 2016 and allows the cash-strapped U.S. Department of Veterans Affairs to use private investments to fund construction and real estate purchases.

The Omaha facility’s $86 million price tag was defrayed by $30 million in private contributions funneled through the nonprofit Heritage Services, the project’s construction manager, which donated its services and the building to the VA. This funding mechanism created efficiencies that shortened construction time and aligned design specifications with those used in private healthcare projects.

The new center has the capacity to provide healthcare services to about 400 patients per day.

LEO A DALY provided the architectural, engineering, and interior design services on this project, for which McCarthy Building Companies was the GC. The Ambulatory Care Center has eight primary care clinics, including one for women vets (a first in VA’s healthcare network), and a care clinic that is shared by orthopedics, cardiology, and other specialty medical practices.

All clinics employ Patient Aligned Care Team (PACT) programming to enhance patient privacy and navigation. By centralizing clinical staff and resources, the PACT model also promotes collaboration. A new outpatient surgery center occupies the third floor, along with radiology. On the first level, a new connector building provides direct indoor access to the existing hospital and its services.

Sophisticated structural and architectural coordination created the folded glass form of the building’s “flag wall.” Against the western façade, alternating colors symbolize the “colored bars” earned by military servicemen and women for acts of gallantry and heroism. Both walls use transparent glazing to stream abundant daylighting into the interior spaces.

A sense of refuge, comfort, and reflection are reinforced by amenities that include an outdoor healing garden and commissioned artwork (some of it created by veteran-artists) installed in the facility’s public spaces.

The new Ambulatory Care Center replaces a crumbling hospital built in the 1940s and had long been on the VA’s list of replacement priorities.

A Hospital Addition in Maryland Was Designed and Built in 120 Days

Lean practices, and early engagement with the county’s permitting department, moved this project forward quickly.

A 12,560-sf addition to Meritus Health Center in Maryland went from concept to completion in four months. Design-to-permit alone took less than six weeks.

On March 20, Meritus Health Center in Hagerstown, Md., submitted an emergency certificate of need to the state of Maryland’s Healthcare Commission, which one day later approved the hospital’s plan for its permanent 2 South Regional Infection Containment Wing to support COVID-19 infected patients.

Two days after that approval, Gilbane Building Company and Matthei & Colin Associates started assembling a building team to design and build this new facility. (A decade earlier, this same team built the 510,000-sf, 267-bed Meritus Medical Center in what at that time was a record 30 months.)

“Eight days after our initial call, our team was moving soil and digging foundations,” says Gary Orton, vice president and director of healthcare for Gilbane’s Mid-Atlantic division. “A project like this would typically take more than a year to conceptualize, design and build, but we didn’t have that kind of time.”

The steel framing was erected in six weeks and the building was airtight in two months. Streamlining was evident in the reduction of the construction punch list to seven open items, from 73.

The 12,560-sf addition was completed on July 31; the time between the start of designing this wing and its receipt of a temporary certificate of occupancy was only 120 days. The addition was accepting patients by early August.

As this project proceeded, the first critical steps, according to Matthei & Colin, were defined as: identifying long lead materials/systems and get them ordered as the building was being designed; engaging County and State officials to develop a plan to streamline the permit processes, while ensuring quality and safety of the final product; and developing a schedule with major milestones identified along the critical path.

“We reinvented decision making and certification processes to recognize the realities of working remotely and serving the schedule to bring the facility online as quickly as possible for the community,” says William Heun, lead architect for the project and partner with Matthei & Colin Associates.

According to Gilbane, the fast-track schedule was abetted by bringing the Washington County (Md.) permit and inspections department into daily meetings with the Building Team, to identify areas of improvement and to minimize delays in the permitting and life safety processes.

Gilbane adds that the design-to-permit time for the addition, which normally would take six to nine months for a building this size, was whittled down to less than six weeks.

The team exercised Lean practices to coordinate and streamline processes, expedite permitting, and procurement, design, and construction.

Exterior metal stud wall framing was fabricated on the ground and lifted into place when the structural steel frame was erected. Millwork and casework were assembled in the largest and most complete units possible. Headwalls were prefabricated with all power, gases, outlets and light controls in place, reducing installation time and providing a single point of connection above the ceiling. Door hardware was installed on doors off site, to minimize carpenters’ time in the project area.

Among the project's time-saving measures was prefabricating the patient room headwalls.

CM Cost Plus Fee was the delivery method deployed for this $12.5 million addition, which is the first of its kind in the region, with 20 ventilator-capable negative pressure isolation rooms designed and built to contain any type of infectious disease. A sophisticated nurse call system enhances connectivity between patients and the nursing staff. Eight of the wing’s rooms have corridor windows with integrated blinds.

The Building Team included Frederick, Seibert & Associates (CE, land surveying, and landscape architecture), Leach Wallace Associates (MEP engineer), and GRAEF-USA (SE). Other suppliers and subcontractors listed are Heffron, Cindell Construction, Davenport Commercial, Ellsworth Electric, Emmitsburg Glass, Johnson Controls, Kalkreuth Roofing and Sheet Metal, KBK Builders, Kinsley Manufacturing, Modular Services, PAINTech, Ruppert Landscape, Robert W. Sheckles, Siemens, Swisslog Healthcare Solutions, Triad Engineering, and Virginia Sprinkler.

HOK Designs New Cancer Pavilion For Rutgers Cancer Institute of New Jersey

The project will be New Jersey’s first comprehensive cancer center.

HOK has unveiled the design for the new RWJBarnabas Health and Rutgers Cancer Institute of New Jersey cancer pavilion.

The new 510,000-sf cancer treatment and research facility will include laboratory services, an outpatient clinic, an infusion and chemotherapy suite, radiation oncology, imaging, and interventional radiology. The facility will expand service offerings to people living in a state with one of the highest rates of cancer in the country.

Designed to respond in scale and character of the existing RWJBarnabas campus, the facility is organized into three primary components:

– Outpatient care: 84 infusion bays, 74 exam rooms, advanced radiology including four linear accelerators, diagnostic equipment (CT, MRI, mammogram and other equipment with core lab), pharmacy facilities, and outpatient urgent care.

– Inpatient care: 96 inpatient beds on three floors, a dedicated floor for surgical and procedure rooms (up to 11 total), a central sterile processing area, and inpatient support spaces.

– Research: Wet lab facilities and equipment to support 10 research teams, clinical trial offices, and faculty offices.

A four-story atrium lobby that spans the full depth of the building will serve as a “town square.” The atrium was designed as a biophilic, healing environment with natural light and lush plantings to enhance the well-being of patients, visitors, clinicians, students, and staff.

“The new facility places the patient first and improves the patient’s experience at every stage of treatment,” said Kenneth Drucker, FAIA, LEED AP, Design Principal for HOK’s New York studio. “The design features a bridge connecting the cancer pavilion to the existing Cancer Institute and Robert Wood Johnson University Hospital, facilitating access for both patients and staff.”

When complete, the pavilion will provide 500-600 permanent healthcare positions.

Lykan Bioscience’s SMART Manufacturing Facility, Hopkinton, Massachusetts

Lykan Bioscience opened a purpose-built SMART Manufacturing™ facility for developing cell-based therapies in Hopkinton, Massachusetts, US, in September 2020.

The first-of-its-kind, multi-product current good manufacturing practices (cGMP) manufacturing facility is integrated with advanced software solutions to provide innovative medicines to patients with unmet needs in the fields of oncology, immunology, hematology and other diseases of genetic origin.

Built with an estimated investment of $12m, the facility will create 125 new jobs for the local community of Hopkinton.

Lykan Bioscience collaborated with Windrose Health, a medical investment firm, to complete the construction of the facility and business expansion, in June 2019.

Details of Lykan Bioscience’s SMART manufacturing facility:

Spanning an area of 64,000ft2, the facility contains a 17,000ft2 modular cleanroom space with multiple fully separated processing suites. The facility is installed with an operations control center that is monitored round the clock by Lykan.

The smart manufacturing facility is incorporated with a proprietary electronic data management system (EDMS) that enables real-time collection and integration of manufacturing process data including testing, equipment, facilities, and inventory. EDMS allows rapid analysis of data and lot release in real-time.

Advanced data processing systems and other features allow high throughput and flexibility through customized operational logic to further improve patient access effectively and cost-efficiently.

The new manufacturing facility provides consumers with direct, safe online visibility of product and process data including scheduling, testing data, processing status, process data and logistics.

Lykans Bioscience’s SMART manufacturing facility benefits:

Computer-aided manufacturing facility optimizes process flows and assures the integrity of the product from the receipt of a donor or patient material into processing, storage in the company’s cell pharmacy, shipping and back to the healthcare providers (HCP).

SMART manufacturing facility’s quality management system (QMS) supports the entire product life cycle from clinical-stage to commercial production, including QMS paperless operations for reducing the risk of human errors. Clients can avoid the time, cost and risk of a second transfer and comparability testing.

Lykan Bioscience offers process development and CGMP manufacturing for autologous and allogeneic cell- and gene-mediated cell-based therapies in combination with strategic quality control, serving the entire product life-cycle.

It can address any immediate requirement by availing production capacity and also provide a long-term vision for scalability, validation, and high-throughput commercial development of cell-based therapies, such as CAR-T, TCR, TIL, iPSC or other platforms.

Other services include technology transfer and gap assessment, method and process development, on-site quality control and assurance, cGMP stability, client dashboard visibility, full analytical services, method and process validation and regulatory support for filings and inspections, ordering and scheduling, client dashboard visibility and long-term storage in company’s cell pharmacy.

The company’s capabilities also include core chemistry, analytical, and microbiological analysis such as compendial analysis, ELISA, rapid product sterility, microbial identification and spectroscopy.

Marketing commentary on Lykan Bioscience:

Established in 2019, Lykan Bioscience is a private Manufacturing Services Organization™ (MSO) headquartered in Hopkinton, US.

The company has decades of experience in the biopharmaceutical industry with expertise in cGMP facility architectural design, software, engineering, manufacturing, and quality operations. It also offers comprehensive end-to-end services including shipping and logistics for cell-based therapies.

Lykan Bioscience is a member of Massachusetts Biotechnology Council, Bioscience Association of Maine, and International Society for Pharmaceutical Engineering (ISPE).

The company is working with its clients to provide novel life-saving therapeutics to patients globally.

Berkshire Sterile Manufacturing Facility Expansion, Lee, Massachusetts

Berkshire Sterile Manufacturing (BSM) is expanding its manufacturing facility in Lee, Massachusetts (MA), US.

The company began preparations for the $20m expansion in April 2020. BSM raised a funding of $16.5m from Berkshire Bank and Lee Bank in June 2020, receiving a package of $1.5m tax increment finance for the project from the town of Lee in October 2020.

The company will add 75 new employees to its existing workforce of approximately 160 people in the next two years. The expanded facility should be fully operational by March 2022.

Details of Berkshire Sterile Manufacturing facility expansion

BSM will increase its manufacturing capabilities with the installation of a new sophisticated, state-of-the-art sterile, completely robotic manufacturing line to produce sterile drug products in vials, syringes and cartridges.

The manufacturing line will have autoclaves to sterilize equipment and a state-of-the-art system for producing water for injection (WFI) as well as a 1,500-gallon tank for storing the produced liquid.

The facility will incorporate a new pharmaceutical-grade water system, testing capabilities in microbiology and analytical laboratories.

BSM doubled the size of its cleanrooms by expanding it at the 116,000ft2 Lee Corporate Centre, a previous toy warehouse, acquired by the company in 2014. Installation and validation of a new glove integrity system will be completed by the end of 2020.

Equipment to be installed in the facility is being developed by the companies in the US and Europe, which will arrive at the facility in 2021.

The project also includes the development of new inspection and office areas, as well as the expansion of its warehouse and laboratory spaces.

In 2021, BSM will expand its filling capabilities by introducing a first-of-its-kind isolator based robotic flexible filling line. The new line will be capable of filling up to 70,000 units of the drug component.

A filling line will have pulsed light capabilities to decontaminate ready-to-use (RTU) outer packaging.

The filling line will enable the filling of larger lots of vials (RTU and bulk), cartridges, syringes and custom containers with improved quality and greater sterility assurance for aseptic products.

WFI system and filler in Fedegari (SAT, IQ / OQ) isolator will be installed and validated in January 2021.

Installation and validation of the new Depyro tunnel, Lyo and new isolator line will be completed by March 2022.

The existing manufacturing facility comprises state-of-the-art flexible filling equipment within isolators, a range of validated analytical tools to facilitate the filling of the finished products and walk-ins at different temperature and humidity points to maintain the integrity of the drug product.

It incorporates semi-automatic and manual filling lines with 100% isolator technology.

The semi-automatic filling line is fitted with a state-of-the-art flexible filler capable of filling 40,000 units of vials, cartridges or syringes.

A flexible manual fill line is configured for smaller batch fillings. The line can fill bulk or RTU vials, cartridges, syringes and custom containers.

Marketing commentary on Berkshire Sterile Manufacturing:

Established in 2014, BSM is a biotechnology company based in the US. It fills injectable drug products for various biotechnological and pharmaceutical companies to use in clinical studies or in small quantity for commercial treatments.

Key services of BSM include sterile filling, stability programs, analytical services and packaging distribution.

Arranta’s New Commercial-Ready Manufacturing Facility, Watertown, Massachusetts

Arranta Bio is constructing a new multi-product, commercial-ready manufacturing facility in Watertown, Massachusetts, US.

Watertown facility will be used for the production of live biotherapeutic products (LBPs) of superior quality to supply to the microbiome innovation companies.

The facility is a part of the company’s commitment to invest more than $100m to build its end-to-end microbiome capacity. The company also expanded its purpose-built microbiome process development laboratory at the Arranta’s Centre of Excellence in Gainesville, Florida, in May 2020.

Good manufacturing practice (GMP) suites of the commercial-ready facility were completed in September 2020. The facility will create approximately 200 new jobs.

The new current good manufacturing practice (cGMP) commercial-ready facility will expand the company’s late-stage clinical or commercial capacity for advanced biologics. Small-volume biotechnology products will be developed, manufactured and analyzed in the facility.

The facility will be equipped with laboratories, offices, and GMP suites. GMP facility has been installed with state-of-the-art equipment and processes.

A new modern two-level, 16,000ft2 office at the facility will serve as the head office of the company, which will replace the existing 5,000ft2 portion at the road front of the site.

The facility complies with the FDA Code of Federal Regulations (Part 21) and European Advanced Therapy Medicinal Products (ATMP).

CGMP facility has been developed to minimize the environmental impact. Sustainable features of the facility include solar installations, highly efficient heating, and ventilation systems, charging points for electric vehicles, connected bicycle path to the site along the Charles river and pool transit services to and from the site to the Rapid Transit system.

Arranta aims to create a highly attractive professional frontage by developing a frontage on the street with landscapes at the front and side of the building that creates a highly attractive professional workspace.

The company will clear the trash and weeds and dampen the area at the back of the premises bordering the Charles River, to provide the staff members with communal outdoor space, while operating within the Wetlands conservation restrictions. It will provide a more natural foundation for the area.

Approximately 200 companies are actively studying the link between the diseases and microbiomes including millions of bacteria, fungi, protozoa and viruses reside in and outside the human body to establish therapeutic targets.

The number of genes in the microbes that make up one person’s microbiome is at least 200 times the number in the human genome. Scientists named the microbiome the second genome.

Arranta substantially improved its scientific understanding of gut microbiota composition and functions over the past decade.

DC Beane and Associates Construction Company acted as the construction management partner for Arranta, for the project.

Multiple sub-contractors were preferred by Arranta to construct the new commercial-ready manufacturing facility.

Marketing commentary on Arranta Bio:

Established in 2019, Arranta Bio is a leading contract development and manufacturing organization (CDMO) that primarily serves companies involved in the development and marketing of human microbiome therapies.

In November 2019, Arranta Bio acquired Captozyme™ and established Arranta Bio’s Centre of Excellence in Gainesville, Florida for process and analytical development and early clinical supply to serve its microbiome clients. The company produced and manufactured more than 125 LBPs over the last decade.

The Arranta’s team will first determine the most feasible process for large-scale development, which will be produced in the company’s Watertown facility and then will be scaled down again for intensive development in the Gainesville.

Arranta aims to become the best-in-class microbiome CDMO, offering LBPs by bacterial fermentation, isolation, lyophilization and encapsulation for microbiome-related product pioneers.

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.

The facility will be equipped with a 2×2,000L single-use bioreactor train to enable the production of millions of vaccine doses as well as additional aseptic fill-finish capabilities.

It will support the manufacturing of respiratory syncytial virus (RSV), dengue and HIV vaccines, as well as Covid-19 vaccines.

The addition of a late-stage clinical and commercial facility will allow the company to easily transfer the technology of the customers’ products from the early-stage production facility in Germany to the US, providing comprehensive end-to-end solutions from pre-clinical to commercial manufacturing.

Virotherapy production is a complex, multi-stage process. The company utilizes its more than 15 years of experience with live viruses, such as herpes virus (HSV), adeno associated virus (AAV), and cytomegalovirus (CMV) for manufacturing.

The company produces viruses in various culture vessels including shake flasks, single-use suspension bioreactors, disposable iCELLis® fixed-bed bioreactors, T-flasks, roller bottles and CellSTACK®, catering to the diverse virotherapy product requirements of customers.

The Germany-based contract development and manufacturing organization (CDMO) develops and manufactures both cell-based (suspension and adherent) and egg-based viruses. It offers full upstream and downstream processing, analytical testing (including method transfer, development, and validation), and filling / finishing services, primarily developed for the manufacturing of virotherapy.

With a unique emphasis on viruses, live bacteria, and aseptic manufacturing, the company’s 50 workers operate in strict compliance with international good manufacturing practices (GMP) requirements in the state-of-the-art BSL-2, 27,000ft2 (2,500m2) plant in Cuxhaven, Germany.

Vibalogics collaborated with Janssen, a subsidiary of Johnson and Johnson, to provide additional clinical trial material for the lead Covid-19 vaccine candidate being developed by Janssen.

Janssen produces several batches of material in its GMP facility in Cuxhaven, Germany, to produce thousands of doses of a Covid-19 investigational vaccine candidate.

The facility was installed with new equipment, including a new filling line capable of filling and labelling more than 30,000 vials per batch to handle larger clinical batches.

The collaboration will boost Vibalogics’ position in the development of virotherapy worldwide while providing crucial service to its customers to combat SARS-CoV-2 virus.

Colliers International, a global commercial real estate services company, was the advisor to Vibalogics for the long-term lease transaction of the property for the new facility.

Lincoln Property Company, the building owner of the property, also worked with Vibalogics to close the deal.

Abenza Upgrades Chemistry GMP Suites

Abzena, a global partner research organization for integrated bench to market solutions for biologics and bioconjugates, has announced upgrades of its chemistry GMP suites.

The Bristol PA site manufacturing facility upgrades allow Abzena’s ADC client projects to seamlessly progress from discovery to commercial without technology transfer.

The Bristol site enhancements include two new GMP suites, one for small molecules, including high potency up to 100L scale, and one for conjugation, as well as other GMP facility upgrades.

Jonathan Goldman, CEO of Abzena said; “Customer demand for our high quality, integrated services has increased 93% since 2019. This has driven our decision to invest in our capacity for commercial GMP capacity for ADCs. We are delighted to augment our market-leading discovery, design and development capability and add to our outstanding scientific team.”

Abzena also recently announced senior leadership appointments at the Bristol site. These include Giovanni Escobar, as SVP and site head, who joined the company from a senior role at GSK and Anu Bansal, as senior director of manufacturing, formerly a leader in manufacturing at Genentech. Both leaders bring a wealth of experience in the journey from discovery to market of ADCs.

Dr. Goldman continued, “Abzena is committed to being the best-in-class provider of fully integrated drug discovery and development services of biologics and ADC, supported by unrivalled experience. We look forward to supporting our partners and the patients they serve.”

Audentes' Future Manufacturing Facility

Audentes’ Sanford, NC future facility, which will manufacture the company’s portfolio of adeno-associated virus-based gene therapies aimed at targeting serious rare neuromuscular diseases, is slated to be operational next year. Donald Wuchterl, Audentes’ Senior Vice President, Technical Operations talked to me about the best practices he and his team have implemented thus far in the planning stages, equipment needs, challenges and solutions, and more.

Audentes’ Sanford, NC future facility, which will manufacture the company’s portfolio of adeno-associated virus-based gene therapies aimed at targeting serious rare neuromuscular diseases, is slated to be operational next year. What are the best practices you and your team have implemented thus far in the planning stages for the manufacturing facility?

Wuchterl: During the base building selection and design phases of the project, we focused on creating an expandable facility that can rapidly grow with and meet the needs of the Audentes / Astellas AAV product portfolio well into the future. From an execution standpoint, the site is planned as a multi-phased modular expansion that will add additional production suites without impacting the ongoing operations of previously built-out and licensed phases.

To manage budget, we negotiated a guaranteed maximum price and a shared savings agreement with the general contractor (GC). This shared agreement helps to lock in the project budget and incentivizes the GC to find savings along the way. This is a true win-win for the GC and the owner.

We have also sought ways to integrate local offerings and create mutually beneficial alliances in the area, one of which is with Duke Energy One. Duke Energy One is providing a comprehensive base and emergency power solution for the site including maintenance and operation services. This strategic relationship allows us to take advantage of Duke Energy One’s depth of knowledge and experience in the electrical field while freeing capital funds to redirect to other parts of the project.

Do not underestimate the importance of onboarding key site leadership early on in the project. We have already hired our site head and several leadership and functional roles for facilities, engineering, manufacturing, validation, and quality. This is about 12-18 months ahead of our cGMP start. This site core team will be responsible for taking the facility from construction handoff through commissioning and validation. Additionally, these leaders will be responsible for any remaining operational readiness activities including: hiring, training, and onboarding the remaining team, policy and procedure generation and approval, validation execution and oversight, process tech transfer, shakedown and engineering batches, and eventual escalation to full cGMP operations.

What challenges have you encountered, and how are you handling them?

Wuchterl: Of course, no one anticipated building out the facility in the middle of a pandemic. Our typical project team working dynamic has shifted to more remote work with tools like Zoom, Box, and MS Teams. We are pleased that we recently installed trailers at the site for our Audentes employees and contractors. So, we are slowly transitioning to the job site / office dynamic we were used to pre-pandemic, albeit under strict protocols ensure we are protecting everyone’s health.

As with any large capital project there are unforeseen site, design, and/or procurement issues that arise. To date these have all been very manageable, but the project is still in an early phase and has about another year of construction, so new issues may arise. When these happen, the best approach is strong collaboration with the architectural & engineering firm, general contractor, and / or equipment vendor to work together on solutions. The end goal is to provide a state-of-the-art facility producing high-quality gene therapies that are critical for the patients and families in need. The cross-functional team we have built, including all key vendors and contracted services working on the project all share this mission.

Is there anything you would do differently out of the gate, and if so, please explain.

Wuchterl: Although this has not impacted us significantly, I believe that we might have done a better job estimating the appropriate project contingency. A healthy contingency helps speed things up when unexpected issues arise. Without it you have to navigate the financial processes for unbudgeted scope, and that can have implications on the overall project timeline. It is always a trade-off. Determining the appropriate project contingency early on is challenging, especially when the project budget is established ahead of final drawing sets or contractor / subcontractor bid estimates.

From an equipment perspective, what challenges has Audentes faced that the company was not anticipating, and how did it overcome them?

Wuchterl: We have not had any significant equipment issues so far. I think this is because we have spent the last five years fine-tuning our process at our existing South San Francisco cGMP manufacturing facility. So, we made the decision early in the project planning that we would take most of our platform process (including equipment type and vendor) and duplicate it at our Sanford site, the only difference being a slight increase in scale.

What manufacturing equipment is essential for the company to scale?

Wuchterl: Our new Sanford manufacturing facility is designed to be built out over three phases. In the initial phase of the build out, we are adding manufacturing suites to support 4000L of bioreactor capacity (two production trains each with 2x1000L single use production scale bioreactors). To put this in perspective, our South San Francisco facility operates one 2x500L bioreactor train. We have designed the Sanford facility to support significant growth in future phases. Current design can support even larger scale bioreactors. So as demand grows, we can expand this facility to 20 times our current South San Francisco capacity.

What other information can you offer regarding best practices in equipment selection?

Wuchterl: Taking the time to properly develop user requirement documents ahead of the vendor bid process is crucial to ensuring you get what you need. All this documentation can slow things down, but a well-run project will take the time to do this. Later, these documents will serve as the basis for the validation activities. Do not underestimate the workload with these and other foundation documents. Even though we were leaning towards our current platform vendors, we still went out to bid from multiple competing vendors. This was not only a way to help drive costs down, but also to stay up to date on the current vendor offerings. There are a few examples where we deviated from our South San Francisco equipment list and went with another option because there were newer versions or additional offerings that were not available when procuring equipment for the original South San Francisco facility.

Lonza to Expand Particle Engineering and Drug Product Capabilities at its Oregon Site

Lonza announced on Nov. 30, 2020 that it is expanding its particle engineering and drug product capabilities at its Bend, OR site.

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products using spray-drying, hot-melt extrusion, and melt-spray-congeal processing and cGMP suites for early-phase cGMP manufacturing featuring added storage, gowning, and a customer in-plant viewing corridor, a company press release said.

“We continue to see increased demand for development, clinical, and commercial manufacture of particle-engineered intermediates and finished drug products,” said Paul Granberry, managing director, Lonza Bend, in the press release. “Dedicated, fit-for-purpose suites, infrastructure, and systems are critical for supporting the needs of our customers’ early-phase programs.”

“Our customers look to Lonza to rapidly advance challenging molecules and meet increasingly difficult target product profiles,” added Christian Dowdeswell, vice president and global head of Commercial Development for Small Molecules business, Lonza, in the press release. “We listened, and this new investment is aimed directly at meeting those needs.”

CordenPharma Colorado Completes Peptide Manufacturing Expansion

CordenPharma Colorado announced on Nov. 25, 2020 it has completed the expansion of its solid-phase peptide synthesis (SPPS) manufacturing capacity with the addition of an extra-large 3000-L SPPS vessel.

The expansion is part of a new expansion initiative aimed at increasing flexibility, efficiency, and cost-effective production, a company press release said.

“For the first phase of this commitment, customized automated synthesizer production lines will be installed supporting fast and efficient GMP manufacturing,” CordenPharma said in the press release. “This infrastructure will further strengthen the existing manufacturing of Peptides in the low to mid-kg scale range by complementing the current state-of-the art large-scale manufacturing capabilities at CordenPharma Colorado.”

The company will also supply peptide APIs for injectable drug products at their Italian facility, CordenPharma Caponago, as part of the initiative.

Baxter to Invest into Indiana Fill/Finish Manufacturing Facilities Expansion

Baxter announced on Nov. 24, 2020 that it is investing $50 million into the expansion of its sterile fill/finish manufacturing facilities in Bloomington, IN.

The expansion will include a new 25,000 ft-2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line, a company press release said. Construction is expected to be completed in 2021, and the new facilities will create 100 new jobs at the site.

“We pride ourselves on being a contract manufacturing partner with the specialized expertise, proven experience, and facilities to help our clients successfully achieve their sterile manufacturing objectives,” said Marie Keeley, vice-president, BioPharma Solutions, Baxter, in the press release. “Our Bloomington facility is already a global leader in sterile contract manufacturing, and this expansion will add capacity and state-of-the-art technology that will better enable us to meet the diverse needs of our clients and the patients they serve.”

Trammell Crow Company Breaks Ground on Fulton Labs Development in Chicago

Trammell Crow Company (TCC), one of the largest commercial real estate developers in the United States, broke ground on Fulton Labs, a best-in-class laboratory facility that is being developed to help solve chronic lab space shortage throughout the Chicago region. Fulton Labs is located at 400 N. Aberdeen St., in the heart of the Fulton Market District, Chicago’s fastest growing neighborhood and one of the hottest tech markets in the country.

The 423,454-square-foot facility will span 16 floors, including 12 floors of advanced wet and dry lab space. The facility is designed to offer researchers the flexibility they need with features like column-free and long-span layouts and lab space that meets VC-A vibration criteria, which is important for researchers as they strive for reproducible results.

"Illinois is home to a massive biopharma concentration, one of the largest tech talent pools in the United States, and some of the best research universities on earth," said Governor JB Pritzker. "I’m committed to building an Illinois economy that creates jobs and expands access to prosperity – and the life science industry is a critical asset to that vision. Fulton Labs brings over 400,000 square feet of best-in-class lab facilities to Illinois, and I'm proud to welcome this expansion to our biotech ecosystem in this critical moment for innovation in the life sciences and healthcare."

Chicago’s life science sector is prime for growth with its abundance of major research institutions, universities and Fortune 100 life science companies. Further, the region is home to a qualified and highly educated labor force and provides a low cost of doing business compared to other peer cities.

“We listened to the needs of the Chicago life science community when designing Fulton Labs,” said Grady Hamilton, managing director of TCC’s Midwest Business Unit. “From startups to established global companies, we wanted to create a space that provides the flexibility and room for growth that our prospective tenants need to expand their R&D capabilities.”

Fulton Labs is a great example of the collaboration between the business and life science communities to invest and build a foundation to fuel growth in Illinois. It will be a cutting-edge facility that will nurture the scientific community and provide a home to drive innovation and discovery. To facilitate this, Trammell Crow Company has partnered with Portal Innovations, a life sciences start-up incubator founded by John Flavin, to dedicate space as a launch pad for early stage companies.

“Chicago and specifically Fulton Market, has the top-tier talent, academic institutions and infrastructure to be a premier life sciences hub” said John Flavin. “Portal Innovations will assemble these components and enable start-up companies to bridge scientific ideation and entrepreneurship to deliver breakthrough biomedical technologies and improve health and wellness.”

“Chicagoland’s life sciences ecosystem has long been punching below its weight,” said Dan Lyne, Senior Vice President at CBRE and co-founder of MATTER and 1871. “With less than two percent vacant lab space, our Chicago-based clients have been forced to establish research and development operations on the coasts. But with this new facility, biotech innovators will have access to the world-class space their researchers deserve, at just a fraction of the cost of other top-tier markets.”

Vibalogics Planning New Virotherapy Facility

Vibalogics has announced it is expanding its global footprint with a late phase clinical and commercial manufacturing facility near Boston, Massachusetts, a major milestone as it looks to advance its services to drug developers across the globe.

It is planning to invest US$150M into the US virotherapy production site. The US location will evidently bring proximity to the US clients and will allow a seamless service from R&D and early stage clinical supply to late stage and commercial supply, the company told BioPharma-Reporter.

The global contract development and manufacturing organization (CDMO) expects the site to be operational by the second half of 2021.

In May 2019, Vibalogics was acquired by Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector; that deal is allowing the CDMO to further its growth strategy and fast-track its plans to extend its footprint in the US.

The CDMO said the expansion is informed by the high demand for biomanufacturing services and development capacity in viral vector vaccines and oncolytic viruses.

"The facility is designed to manufacture commercial volumes of viral vectors, such as oncolytic viruses, and can also produce viral vector vaccines. We will implement a 2 x 2,000 L single-use bioreactor train during the first phase, which enables us to provide millions of vaccine doses of drug substance. As long as the vaccine is constructed as a viral vector, we can support COVID-19 vaccine needs as well as RSV, Dengue, HIV, and others," the company said.

Vibalogics Germany started with oncolytic viruses around 2006 and expanded the technology towards vaccines.

Commenting on the US strategy, Vibalogics’ CEO, Tom Hochuli, said the Boxborough located facility will meet the CDMO’s current and future needs, giving it the ability to further expand to meet growing customer demand.

“The site will provide a complete suite of virotherapy services to support drug developers and their most revolutionary products. The addition of a late stage clinical and commercial facility means we can easily tech transfer our customers’ products from our early phase manufacturing facility in Germany to the US, resulting in a complete end-to-end service from pre-clinical to commercial supply.

“Boston is the largest global hub for cell and gene therapy R&D, so there is also a great pool of local talent and expertise to draw from to strengthen the Vibalogics team. The facility is expected to create 100 jobs initially, reaching 250 employees in the next four years.”

If a customer commits early to partner with Vibalogics, the company said space and particularly specific production process needs will be considered during the implementation phase. "Vibalogics will also operate an aseptic fill & finish line in Boxborough, in addition to the one already used in Germany. There is also significant expansion space in the facility to allow us to implement a large scale fill & finish line to serve customers in the vaccine arena."

Vibalogics was recently selected by Janssen Pharmaceutical Companies, a Johnson & Johnson company, as one of its manufacturing partners for its investigational COVID-19 vaccine candidate.

Cambrex Expands API Mfg. Capacity in Charles City

Will add three large-scale manufacturing work centers and one mid-scale work center to the facility increasing the site’s capacity by 30 percent.

Cambrex is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment aims to meet growing demand for small molecule drug substance development and manufacturing. It will be the sixth major investment that Cambrex has made at the site in the past eight years to support customers in mid-scale, large-scale and highly potent small molecule API manufacturing.

The expansion, which will be operational in early 2022, will add three large-scale manufacturing work centers and one mid-scale work center to the facility, increasing the site’s capacity by 30 percent. When completed, the Charles City site will employ more than 400 people.

“Small molecule manufacturing demand has been growing consistently over recent years, and this investment will enable Cambrex to continue to capitalize on this growth, further strengthening our position as a market-leading CDMO,” commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, “This expansion in the U.S. for API manufacturing capacity comes at a time when our customers increasingly require high-quality partners to ensure reliable supply chains within the pharmaceutical sector.”

Cambrex’s Charles City facility is located on a 45-acre site, and as part of the company’s Drug Substance business unit, manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.

Comar Breaks Ground in Vineland, NJ

New 159,000 square-foot site will house injection molding machines, proprietary automation, and packaging equipment.

Comar and representatives from the City of Vineland, Cumberland County and the State of New Jersey held a groundbreaking ceremony to celebrate the start of construction on the new Comar Vineland manufacturing facility. New Jersey State Senator Michael Testa Jr. participated as did Vineland Mayor Anthony Fanucci, Vineland City Council President Paul Spinelli, Freeholder Director Joseph Derella, Deputy Freeholder Director Darlene Barber, Freeholder George Castellini, Assemblyman Antwan McClellan, Assemblyman Erik Simonsen and members of the local Chamber of Commerce.

Comar, a supplier of specialty packaging solutions and custom molded medical devices and assemblies has been undergoing rapid expansion increasing its operations footprint by 40% in 2020 alone. The new 159,000 square-foot Vineland location will house injection molding machines, proprietary automation, and packaging equipment to service Comar’s customers in the medical, pharmaceutical, and consumer wellness markets. Comar is actively recruiting to fill immediate openings for skilled technicians and shift operators for the plant.

“Vineland has a special place in our hearts. My grandfather started the Comar company in Vineland on Valley Avenue in 1949 making glass syringes for the healthcare industry,” said Mike Ruggieri, chief executive officer, Comar. “The business grew rapidly over the decades and eventually relocated as we transitioned from glass into plastics molding in 2006. Now, 14 years later and seven times bigger, it is exciting to be back in Vineland where we have our roots. It is a big day for Comar and our organization. We are proud of our Comar team and appreciate the continued support of our customers, Morgan Stanley and other financial partners, local and state officials, and especially the community.”

During the ceremony, New Jersey State Senator Michael Testa Jr. congratulated Comar for its ability to thrive and create jobs despite the challenges brought about by the pandemic. He bestowed Comar with a certificate of ‘Commendations and Praises’ from the State of New Jersey Senate and General Assembly. A commemorative letter from U.S. Senator Robert Mendez acknowledged the historic occasion. Comar was also presented with a ‘Congressional

Proclamation’ from the Office of U.S. Congressman Jefferson Van Drew recognizing the company as an inspiration to all through its achievements, energy, and drive to shape the future.

At the time of this release, the foundation, walls, and roof of the Comar Vineland site have been constructed. The Vineland facility is on track for substantial completion by March 2021 with production machinery installed shortly thereafter.

Lonza Expands HPAPI Capabilities

Lonza has made additional investments in its oral drug product development and manufacturing capabilities at its Tampa, FL site. Capability for formulation development has been enhanced with the upgrade of drug product development laboratories for highly potent material handling. Dry granulation processing has been expanded and standardized with the addition of Gerteis roller compaction equipment. The new roller compactor will be equipped with high containment and adds to Lonza’s integrated highly potent API (HPAPI) value chain across drug substance, particle engineering and specialized drug product.

The containment capability of the new roller compaction unit complements Lonza’s leading capabilities in HPAPI processing across its site network in the U.S. and Europe. The Visp, Switzerland site has one of the world’s largest capacity for HPAPI development and manufacturing. Contained particle engineering, using either jet milling or spray dry processing, and specialized oral solid or parenteral drug product capabilities are also available within the network.

Lonza has invested more than $15 million to expand and upgrade the Tampa site capabilities over the last two years. The new roller compaction equipment complements previously made HPAPI processing investments inclusive of a new sampling and dispensing suite, a dedicated suite for product development, and two new product manufacturing suites.

Catalent Invests in Bloomington Facility

Catalent is investing $50 million to install an additional high-speed vial filling line at its Bloomington, IN facility. The new line is expected to be operational by April 2021 and will add capacity to support the growing pipeline of clinical programs and commercial launches at the site. It will provide sufficient capacity to produce up to 80 million vials annually under barrier isolator technology and a peristaltic pump filling mechanism, consistent with cGMP regulations.

The Bloomington site has been able to accelerate the overall project from a typical 18-month timeframe to approximately 10 months in total, including construction, procurement, installation, and cGMP qualification of the new line.

“The industry has seen an increased demand for vial filling of biologic drugs, which has been compounded by the accelerated development of vaccine and therapeutic candidates to address the COVID-19 pandemic,” commented Mike Riley, Region President, Biologics, North America. “Catalent’s continued investment in this capacity will allow us to remain flexible and continue to support the growth of our customers’ programs.”

This is the third major investment in the last two years at the Bloomington site. By the end of 2021, the site will have high-speed filling capacity across three vial lines, two syringe lines, and a flexible line capable of filling vials, syringes, or cartridges.

NJII Launches New Cell and Gene Therapy Development and Clinical Manufacturing Center

A virtual ribbon cutting, tour, and panel discussions were hosted on Oct. 29, 2020 to announce the opening of BioCentriq on the campus of the New Jersey Institute of Technology in Newark, NJ.

The New Jersey Innovation Institute (NJII) and Choose New Jersey, a nonprofit economic development company, hosted a virtual ribbon cutting, tour, and panel discussions on Oct. 29, 2020 to announce the opening of NJII’s BioCentriq, a cell and gene therapy development and clinical manufacturing center located on the campus of the New Jersey Institute of Technology (NJIT) in Newark, NJ.

The event kicked off with opening remarks from Joel Bloom, president of NJIT, Governor Phil Murphy, Robert Cohen, president, digital, robotics, and enabling technology at Stryker, and Simon Nynens, CEO of NJII, followed by industry leader recognitions and a video tour of the new facility, a press release said. The event concluded with various panel discussions featuring local leaders regarding the importance of cell and gene therapy.

“There is a massive need for what BioCentriq can provide, and our ability to fill that gap will translate into results that literally save and improve the quality of countless lives,” Bloom said in the press release. “We have the capacity to help companies develop processes, conduct clinical production trials, and train employees.”

“BioCentriq’s mission is to bring together industry, technology developers, academia, and regulatory agencies to help advance the development and manufacturing of cell and gene therapies,” added Dr. Haro Hartounian, PhD, senior vice-president and general manager of the Biopharma Division, and senior vice-president and general manager of BioCentriq, in the press release. “We are thrilled to open the doors to our center at a time when demand for process development and clinical manufacturing of cell and gene therapies exceeds capacity available from existing contract development and manufacturing organizations. Our goal is to provide a collaborative space where innovative approaches and technologies can be utilized to help make emerging therapeutics available to the patients that so desperately need them.”

Novavax to Expand its Maryland Sites to Accommodate Rapid Company Growth

In the wake of its efforts to develop a COVID-19 vaccine candidate, the company has secured two additional properties in the Gaithersburg, MD area.

Novavax announced on Nov. 2, 2020 that it is expanding its Gaithersburg, MD site to accommodate the company’s rapid growth in the wake of its efforts to develop a COVID-19 vaccine candidate.

According to a company press release, Novavax has secured two additional properties in the Gaithersburg area, a 122,000 ft2 space for manufacturing, research and development, and offices, and a 9.7-acre parcel of land for future accommodations. The company plans to invest in the buildout of the sites for use in early 2021.

Currently, Novavax is conducting a Phase III trial for its COVID-19 vaccine candidate, NVX-CoV2373, in the United Kingdom, with plans to conduct additional trials in the United States and Mexico in November, the press release said.

“The expansion of our physical footprint reflects Novavax’ significant growth as we work to both rapidly deliver a COVID-19 vaccine and progress NanoFlu, our influenza vaccine candidate, for regulatory submission and potential commercialization,” said Stanley C. Erck, president and CEO, Novavax, in the press release. “We appreciate the support, partnership, and speed of the Maryland Department of Commerce, Montgomery County, and the city of Gaithersburg, which have enabled the expansion of our operations, enhanced our ability to retain and attract highly skilled employees, and reinforced our longstanding commitment to the biotechnology sector in Maryland.”

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 I 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.

LMN Architects Completes Plant Sciences Building at Washington State University

LMN Architects is pleased to celebrate the opening of the Plant Sciences Building at Washington State University in Pullman, Washington. The latest addition to the V. Lane Rawlins Research and Education Complex, the $66 million building was funded by the Washington State Legislature.

The project is a state-of-the-art building for collaborative research and is intended to support regional and global agriculture. The 82,437-square-foot building supports Washington’s $51 billion food and agriculture industry by providing a modern research venue for faculty and students in the Institute of Biological Chemistry, WSU's Molecular Plant Science Program, and portions of the Departments of Horticulture, Plant Pathology, and Crop and Soil Sciences.

Washington State University is a preeminent agricultural research institution committed to fostering its land-grant heritage and tradition of service to society. The Plant Sciences Building integrates several disciplines from the College of Agricultural, Human, and Natural Resource Sciences (CAHNRS), and is central to fulfilling this mission. The recently completed building is a new center for interdisciplinary research and was designed and constructed by the design/build team of Skanska and LMN Architects. The project provides new infrastructure for the Institute of Biological Chemistry, as well as laboratories that integrate faculty and students in plant biochemistry, pathology, horticulture, and crop and soil sciences into a single facility.

"Because of the close collaboration between the architects at LMN and our college and university, we were able to design and build a truly modern facility for WSU plant research," said André-Denis Wright, Dean of CAHNRS.

The project drew on participation from members of the state's grain, tree fruit, wine, grape, potato, dairy, beef, and raspberry industries, as well as the Washington State Department of Agriculture and the Washington Farm Bureau, in development of the facility.

"This isn't just a building—it's a braintrust for the future of Washington agriculture," said Vicky Scharlau, Executive Director of the Washington Winegrowers Association. "By understanding basic, fundamental plant processes, people here today are creating the foundation for the agriculture of tomorrow."

The building is the fourth to be completed within the master plan for the Research and Education Complex (REC) at WSU, originally developed by LMN Architects in 2005. The master plan envisioned a series of laboratory buildings alternately flanking a glazed spine element that serves as the connective tissue for the social and research life of the complex. The new building is positioned to the south of the Biotechnology and Life Sciences building, also designed by LMN Architects, and completed in 2009. As the central element of the completed complex, the building forms a prominent primary entry point that frames a new public space along Stadium Way.

“The new Plant Sciences Building marks a significant milestone in Washington State’s commitment to sustainable agriculture and ecological stewardship,” says LMN Partner Stephen Van Dyck, AIA. “As a central element of the Research and Education Complex, the new building provides state-of-the-art research facilities that are interconnected to the culture of research on the Washington State University campus. As a central node of the interdisciplinary complex, the building is designed to nurture collaborative innovation in this critical sector.”

The plan configuration of the building allows it to fulfill the master plan while accommodating an existing utility tunnel to the south – a formal adjustment to the master plan which unlocked significant opportunities in construction cost and schedule savings. At the western entry, the building’s cantilevered composition frames a new grand entry to the whole complex, and features a two-floor cantilever facing west towards Martin Stadium. The new landscaped approach creates a multifunctional public space for the university, celebrating arrival to the complex and fostering campus-wide gatherings.

The new facility will be a social and interdisciplinary heart for the research complex. Designed for flexibility well into the future, the building hosts infrastructure for a variety of research needs beyond the College of Agricultural, Human, and Natural Resource Sciences. Upon arrival, a welcoming four-floor staircase encourages vertical circulation and provides important visual connections between floors. At every level, centralized social spaces link circulation elements with the REC’s central spine, designed to fuel spontaneous collaboration within the communal core.

The interior arrangement of laboratories is designed to support efficient and flexible research over time. The modular laboratories can be easily rearranged to respond to the changing needs of research throughout the building. To the north of the modular laboratories, offices for Principal Investigators are interspersed with open work areas for graduate researchers. To the south of the laboratories, a series of modular support spaces accommodate a variety of specialized research equipment within easy reach of the adjacent lab benches.

On the exterior, the building reimagines the red-brick campus vernacular in a new architectural approach; a high-performance precast concrete façade panel system is clad with a sculpted, red-brick veneer. The panels integrate structure, insulation, weather barrier, interior, and exterior finishes within a single prefabricated component, accelerating construction sequencing and enabling a bespoke composition of organically inspired brick surfacing. The resulting building form presents an abstract composition culminating in the integration of the building’s internal modular planning with the panelized façade components.

Jennifer Milliron, Principal, comments: “We have approached the design and delivery process for this building as an effort in applied research. Our Progressive Design-Build team partnered with WSU early in the process and prioritized innovative design and construction methods. Our partnership with Skanska allowed our team to explore integrated design and construction opportunities that prioritized high-performance systems, opening opportunities for architectural expression while simultaneously maximizing construction efficiencies.”

The building’s prefabricated façade system both enhances the speed of the construction schedule and transforms the architectural possibilities throughout the building. On the inside, the integrated concrete panels are left exposed to become the finished surface in many of the building’s workspaces. On the exterior, the undulating brick pattern—made possible through CNC-driven formwork—casts shadows which animate the façade throughout the day in a dynamic play of light that is unique to the eastern Washington Palouse landscape.

LMN Architects is a leader in the design of higher education facilities across the United States. Other completed projects include the Bill & Melinda Gates Center for Computer Science & Engineering at the University of Washington; the Voxman Music Building at the University of Iowa in Iowa City; the Anteater Learning Pavilion at the University of California, Irvine; and the Huntsman School of Business Addition at Utah State University in Logan, Utah.

About LMN Architects:

Since its founding in 1979, LMN Architects has dedicated its practice to the health and vitality of communities of all scales. Internationally recognized for the planning and design of environments that elevate the social experience, the firm works across a diversity of project typologies, including higher education facilities, science and technology, civic and cultural projects, conference and convention centers, urban mixed-use and transportation.

LMN has successfully completed over 700 projects across North America, including the Voxman Music Building at the University of Iowa in Iowa City, Iowa; Tobin Center for the Performing Arts in San Antonio, Texas; Vancouver Convention Centre West in Vancouver, Canada; Sound Transit University of Washington Station in Seattle, Washington; and the new Seattle Asian Art Museum.

Based in Seattle, Washington, LMN Architects is led by partners John Chau, Sam Miller, Walt Niehoff, Wendy Pautz, Mark Reddington, George Shaw, Stephen Van Dyck, and Rafael Viñoly-Menendez. The firm employs 165 talented professionals practicing architecture, interior design, and urban design, and the quality of the work has been recognized with nearly 300 national and international design awards, including the prestigious 2016 National Architecture Firm Award from the American Institute of Architects (AIA).

REST OF WORLD

New Foster + Partners-Designed Hospital Begins Construction in Cairo

The Magdi Yacoub Heart Centre Cairo has begun construction. The project marks the newest outpost of the Aswan Heart Centre founded by Egyptian surgeon Sir Magdi Yacoub and provides free treatment for the people of Egypt and those in sub-Saharan Africa.

The 300-bed hospital has views of the Pyramids of Giza and is set within a verdant landscape with a lake and seeks to optimize the overall patient experience and decrease recovery times. The site of the hospital borders the Zewail City of Science and Technology, forming part of an integrated health and medical research zone.

The ground floor comprises comprehensive diagnosis and treatment facilities, including an accident and emergency department, a large outpatient clinic, and rehabilitative departments. Several courtyards bring natural light into the building and aid orientation. The surgical department and intensive care units are co-located, minimizing the distance between “bed and bench” and maximizing collaboration between researchers and caregivers.

Eight intensive care units on the first floor are designed to optimize recovery. Each patient room on the ground level is oriented so the patients benefit from landscaped views and the newly formed lake on the northern edge. Prefabricated operating theaters feature carefully planned flows to ensure high clinical safety standards. The hospital will also feature support spaces for families, as well as classrooms and educational spaces for medical students. Single and shared patient rooms on the upper floors are sheltered by sculptural shell-like roof structures.

A green terrace on the second floor will provide break-out space for the staff and visitors. The open terrace is interspersed with built spaces containing a large staff canteen, children’s nurse, and other collaborative meeting spaces.

“This is a special project that focuses on giving the best care to the patients and offering them the best natural setting to recover in,” said Nigel Dancey, Head of Studio, Foster + Partners, said in a release. “It brings together the latest research on biophilia and the positive impact of nature in clinical settings with our pioneering work on collaborative working environments that allow healthcare professionals to give the best care.”

CordenPharma Expands Non-GMP Solid-Phase Peptide Synthesis Manufacturing

CordenPharma has announced the expansion of its non-GMP SPPS manufacturing capacity at its Centre of Excellence for Peptide Process Development and non-GMP manufacturing in Frankfurt, Germany.

CordenPharma has announced the expansion of its non-GMP (good manufacturing practice) solid-phase peptide synthesis (SPPS) manufacturing capacity at its Centre of Excellence for Peptide Process Development and non-GMP manufacturing in Frankfurt, Germany.

According to a Nov. 17, 2020 press release, the expansion of the non-GMP SPPS manufacturing capacity will include an increase in available lab space by 25% and the addition of a dedicated explosion proof area. The increased capacity will allow the company to accommodate recent growth in European domestic demand for non-GMP peptide development.

“With the addition of these fully automated larger lines in Frankfurt, assembly, capacity, and flexibility will be significantly increased, reinforcing our leading position in Europe while keeping a flexible and cost-effective approach,” said Dr. Matthieu Giraud, global director of CordenPharma’s Peptides, Lipids and Carbohydrates Platform, in the press release. “Special efforts will be focused on mirroring the new equipment design with that of current GMP in order to ensure smooth technical transfer when it comes to later-stage clinical support. The expanded peptide manufacturing, explosion proof area and tank farm will be available starting Q3 2021.”

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.

The purpose-built, state-of-the-art facility will be in place to develop MF59®, a proprietary supplement of Seqirus added to certain vaccines to boost immune response and to reduce the amount of required antigen in each vaccine, facilitating rapid and increased manufacturing of doses.

The products specifically essential to Australia’s public health needs, including antivenoms for Australian snakes, spiders, and aquatic species and the world’s only human vaccine for Q-fever, will also be developed in the facility.

Seqirus signed an agreement with the Australian Government to ensure the on-shore manufacturing and delivery of influenza pandemic vaccines, anti-venom and Q-fever vaccines for more than ten years. The supply contract will last until 2036.

Seqirus’ research and development (R&D) produces improved influenza vaccines based on proprietary cell culture and adjuvant technology.

The cell-based technology platform provides a number of advantages over the traditional egg-based manufacturing, including improved scalability, high efficiency, and rapid production of vaccines.

The company introduced the influenza vaccine modernization with the development of FLUCELVAX® QUADRIVALENT, a four-strain formulation where the vaccine components are grown in state-of-the-art cell-culture bioreactors at its Holly Springs facility. The strategy has several potential benefits, including better manufacturing efficiency and better matching of circulating virus infecting individuals with the virus strains used in the vaccine.

Marketing commentary on Seqirus:

Established in 2015, Seqirus is an influenza vaccine company with state-of-the-art production facilities and R&D hubs in the US, UK and Australia. The company boasts of an internationally integrated supply chain and marketing footprint in more than 20 countries.

In September 2020, the company partnered with the Australian Government to supply 51 million doses of V451, the Covid-19 vaccine candidate of University of Queensland, and approximately 30 million doses of AZD1222, AstraZeneca’s COVID-19 vaccine candidate, upon successful clinical trials from 2021.

Polpharma Invests in Expanding Its Production Capabilities

Over the last 4 years, Polpharma Group has invested in a new facility for the production of non-sterile liquid formulations, a new warehouse and a new R&D laboratory for difficult development projects on inhaled medicines.

CureVac and Wacker Sign Contract for Manufacturing of Covid-19 Vaccine Candidate

Manufacturing at Wacker’s biotech site in Amsterdam is scheduled to start in the first half of 2021.

CureVac N.V., a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Wacker Chemie AG have signed a contract for the manufacturing of CureVac’s COVID-19 vaccine candidate CVnCoV.

Under the terms of the initial agreement, Wacker will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021. Preparations for the start of production, technology transfers and test runs are already underway. It is planned to produce more than 100 million doses of the CureVac vaccine per year at Wacker’s Amsterdam site. There is also further potential for expansion at the site in order to meet rising demand in the future.

Wacker’s CEO Rudolf Staudigl said, “We are proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.”

As a CDMO, Wacker Biotech bundles Wacker Group’s biopharmaceutical activities. Its Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. The portfolio ranges from conventional live and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, Wacker has invested in the site to extend production to include mRNA-based vaccines. This new class of vaccines expands the broad vaccine portfolio Wacker Biotech offers to its customers.

Dr. Florian von der Mülbe, chief production officer of CureVac, added, “With Wacker, we have found a committed and highly experienced partner for the production of our vaccine candidate in the Netherlands.”

CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company hopes to significantly increase the manufacturing capacity already existing within CureVac for CVnCoV up to several hundred million doses per year and will manage potential supply chain risks by working with several partners for each of the key manufacturing process steps.

Stelis Continues Expansion

Contract development and manufacturing organization (CDMO), Stelis BioSource, a division of Stelis Biopharma Pvt. Ltd., has started the next phase of its continued investment program after having already invested well over $100 million into its facilities in Bangalore, India.

The latest phase will see the company, which offers end-to-end development and manufacturing services for biologics and biosimilars companies, start work on installing two 2,000L single-use bioreactor trains in its mammalian CGMP facility.

The bioreactor trains will be added to the company’s 200,000 square feet state-of-the-art manufacturing facility which became fully operational earlier this year. The new manufacturing facility, which caters for drug product and drug substance manufacture, allows Stelis BioSource to offer fully integrated services from early phase development through to commercial manufacture and fill-finish.

In addition to the drug substance and drug product capabilities, which cover process scale-up and CGMP manufacturing to commercial scales, the facility offers the latest analytical methodologies and equipment and operates under Stelis’ fully compliant quality management system.

“Our CDMO facility in Bangalore is already fully operational working on both new and existing customer projects,” said Roger Lias, chief executive officer, Stelis Biopharma. “The investment has been driven by both strong market demand and multiple opportunities to develop an offering for the delivery of affordable outsourced capabilities for biologics.

“At Stelis we are committed to providing fully compliant, affordable biologics services to facilitate patient access to vital medications. Our experienced team and globally compliant facilities are capable of handling even the most complex projects. Our integrated offering means we can deliver robust and cost-effective processes and seamless manufacturing, allowing customer products to progress to market as efficiently as possible.”

The company, which is dedicated to driving down the cost of biologics, also has plans to develop the site further. The company continues to evaluate further investments into both capabilities and capacity to meet customer demand, including for those driven by the current Covid-19 pandemic.

Stelis’ drug product facility caters for formulation and fill-finish of all injectable formats using isolator-based filling lines for enhanced bioburden control. In addition, it has a fully automated packaging line with a labeler, device assembly system and blistering and carton machines. The facility is also fully equipped to handle products requiring lyophilization.

The site utilizes both conventional and single-use systems to enable multi-product CGMP manufacturing and facilitate flexible project solutions in line with customer requirements.

Stelis also operates a recently expanded 30,000 sq. ft. research and development facility which is also located in Bangalore.

Samsung Biologics Breaks Ground on 'Super Plant'

When completed, the CDMO says it will be the world's largest bio-manufacturing facility.

Samsung Biologics officially began construction of its Plant 4 in Incheon, South Korea. Dubbed the "Super Plant," the new, multi-story 2,560,880 sq. ft. (238,000-square-meter) construction will be the world's largest biopharmaceutical manufacturing facility of its kind boasting 256,000 liters total manufacturing capacity, according to the company.

In a joint event with the Korean government and the Incheon City, Samsung Biologics showcased a virtual groundbreaking ceremony in light of COVID-19 protocols and announced an investment plan to build the "Future of Biopharma."

Upon completion of Plant 4, Samsung Biologics is expected to be accountable for a third of the total global bio-CMO manufacturing capacity, offering a combined sum of 620,000 liters from a single site. Plant 4 also features a modular design that will allow flexibility for certain parts of the plant to begin manufacturing activities by the end of 2022, with the goal to commence full operations in 2023.

To ensure client confidentiality and security, equipment and instruments will be fully implemented with data integrity and cybersecurity to reduce risk and offer greater client satisfaction by allowing real-time, secure access to information.

Designed to scale to the varying needs of clients from large-scale commercial manufacturing to small-scale CMO, Plant 4 will be the most flexible facility to date with a diverse line-up of bioreactors ranging from 2,000-liters, 10,000-liters, and 15,000-liters. The Super Plant will also provide a full range of CDO, CMO, and CRO processes to offer a complete one-stop service, including early-stage development capabilities and large-scale commercial manufacturing with integrated aseptic fill/finish capabilities and a full QC Lab for testing services.

"We are committed to bringing client satisfaction to the next level. Plant 4 will add unbeatable value to our capabilities to develop and manufacture bio-medicines with the highest quality and innovative technology," said Dr. Tae Han Kim, CEO of Samsung Biologics. "We will continue to invest, create jobs, and serve our valued clients as CMO, CDO, and CRO Champion in making life-saving drugs more accessible for all."

Samsung Biologics also plans to unveil a dedicated Plant 4 virtual showroom online early next month to provide more detailed information and ongoing construction updates of its new facility as part of the company's enhanced digital transformation efforts. Learn more at www.samsungbiologics.com/plant4.

Nanoform Launches Technology for Biologics

The technology is in its early stages of development and a patent application has recently been filed with the US Patent Office for the technology

Nanoform has announced a proprietary technology to form biological nanoparticles as small as 50 nm and announced a near-term business target for 2021 to deliver its first biologics proof of concept project for the technology with a pharmaceutical or biotech partner.

As of today, Nanoform has two non-GMP lines on the biologics side in addition to the eight CESS small molecule nanoparticle technology non-GMP lines.

Prof Edward Haeggstrom, Nanoform CEO said: “Small is powerful, also in Bio! We are committed to improving patients’ lives and supporting our pharmaceutical partners in developing the best medicines possible. Having established our CESS small molecule nanoparticle technology to GMP, we continue to focus on delivering value for our partners and now we can extend our partnerships into supporting their biological programs. There are significant challenges in drug development in this space and we look forward to working closely with pharma and biotech partners to discover how we can add value to their programs, provide patient benefit and competitive product differentiation.”

Prof. Niklas Sandler, Nanoform CTO said: “We have for several years been developing this new exciting technology for Biologics, side by side with our CESS® small molecule nanoparticle technology, and it is with great excitement we now start to introduce it to our pharma partners. Potential applications could be in improving delivery route, uptake, and drug loading capacity in formulations and in enabling new drug combinations, tailoring of release profiles and implementing lighter infrastructure for drug logistics.”

Christian Jones, Nanoform CCO said: “It is rare for any company to bring to market two groundbreaking platform technologies that could open up significant opportunities for the global pharma industry. I am delighted we are introducing this early development nanoparticle technology in the field of biologics as there are so many areas where nanoparticles can add value in this hugely promising but significantly challenging space. We look forward to exploring the potential advantages with our Pharma and Biotech partners in the hope we can together make better medicines for patients.”

Syntegon Opens New OSD Customer Center

After a one-year construction phase, Syntegon Technology inaugurated its new OSD Customer Center in Waiblingen, Germany. The 6,500 sq. ft. (600 square meter) building includes everything customers from Syntegon need for the formulation, development and production of their oral solid dosage (OSD) forms – from cleanrooms and assembly areas to offices, meeting and training rooms.

“With this infrastructure and our team of experts, we offer our customers exactly the innovative power they expect from a reliable and future-oriented partner,” said Dr. Thomas Brinz, head of the new OSD Customer Center.

Syntegon has increased the cleanroom capacity at its site in Waiblingen sixfold. From laboratory equipment to production scale machines, TPR tablet presses for mono and bilayer tablets as well as GKF capsule filling machines are available for all formats and products in different cleanroom classes – up to the highest containment level OEB5.

“From the development of active ingredients or formulations to process optimization or machine operator training – we bridge the gap between all these disciplines,” said Brinz. Since Syntegon's customers do not just want to test their filling parameters on production equipment, “we also offer them the process analysis of active ingredients and formulations, as well as the diagnosis of existing processes. Especially for powders, we can now offer more comprehensive services.”

To develop optimum parameters, Syntegon uses the newly developed “Automated Process Development” (APD) tool, which is also suited for active ingredients or formulations that have not yet been approved.

The OSD Customer Center in Waiblingen complements the range of specialized laboratories and customer centers at Syntegon. Waiblingen is the third facility for solid oral dosage forms next to Schopfheim in Germany and Hangzhou in China. In addition, five partner laboratories provide optimum advice to pharmaceutical developers and manufacturers around the world.

“The OSD Customer Center in Waiblingen is the logical next step towards even stronger customer orientation and flexible services,” said Brinz.

Avantor Opens New Biorepository Facility

Avantor^® opened its new biorepository and sample archiving facility in Europe. Located near the international airport in Frankfurt, Germany, the new facility enables researchers to have access to their samples for future research and analysis, or study validation, within 24 hours.

"The number of clinical trials to support research and development (R&D) of therapeutic modalities continues to grow rapidly across the globe. The associated samples and research materials require meticulous care and processing to ensure the validity of the clinical trial," said Christophe Couturier, Executive Vice President, Services at Avantor. "This critical need for speed and agility is only reinforced by the COVID-19 pandemic and the race to ensure safe and efficacious therapies – whether by testing previous discoveries or innovating new ones. Avantor can store samples at the end of a trial, and as vaccine production ramps up, we will be able to support manufacturers with their Bulk Drug Substance storage.

Avantor's new biorepository and archiving facility in Germany has earned the internationally recognized DGNB "Gold" certification for sustainable construction, which helps to reduce cost intensive risks, while focusing on ecology, economy and sociocultural issues. This new facility complements the Company's U.S. landmark campus located in Leesburg, Va. and its other campus near Nice, France.

Onyx Scientific Invests in New Facility

Onyx Scientific is investing in a new facility at its UK site in order to prepare for the approval of a commercial API license.

The new facility, which represents a £3 million ($4 million) investment, is currently in the design phase and the building work will begin at the start of 2021, in preparation for the license approval. It will enable the CDMO to meet demand for flexible, small-scale drug substance manufacture, supporting customers from the moment a lead molecule is identified, into Phase I studies and through to commercial manufacture.

The facility is expected to be approximately 30,000 square feet and will be used for non-GMP & GMP Phase I – III and commercial API manufacturing.

Following the license approval, the UK facility will have the capacity to manufacture low volumes of drug substance for the commercial market. This new service will complement Onyx’s facility in North Carolina, U.S, which offers larger scale manufacturing capability.

Denise Bowser, commercial director at Onyx Scientific, commented, “The growth of our UK facility is an important milestone for Onyx and means we can help fill the gap in the market for small-scale commercial API requirements. Here at Onyx, we truly care about our customers and their chemistry, treating every molecule as if it were our own. We are excited that following license approval, our team in the UK will be able to guide our customers through the complete journey to market.”

In addition to the facility investment, Onyx is currently working on a process validation campaign that will be used to support the commercial API license.

Evotec SE Expands UK Campus

Evotec SE has expanded its existing campus based at Milton Park in Abingdon, Oxfordshire, UK, into a major, fully-integrated, co-located discovery and development center to be named Dorothy Crowfoot Hodgkin Campus. Adding a new building, which will house up to 100 biologists by the end of the year, will bring together all the key functions for high-performance small molecule discovery and up to commercial development.

The Dorothy Crowfoot Hodgkin Campus will boast the co-location of in vitro pharmacology and protein sciences, structural biology, drug metabolism and pharmacokinetics, computational, synthetic, and medicinal chemistry, formulation sciences, development chemistry and API manufacture. The co-location of these scientific functions enables communication and rapid and inventive problem-solving at the interfaces of disciplines as well as accelerating the speed of iterative cycles in the drug discovery and development processes, turning the site into a fully integrated R&D center.

Evotec's campus at Milton Park already benefits from the relationships and proximity with the Diamond Light Source at Harwell, making it a center of excellence in structure-based drug design. The location also facilitates partnership opportunities in the Oxford and UK-wide academic and biotech scene.

With over 600 employees on site, Evotec's Dorothy Crowfoot Hodgkin Campus now joins Evotec's sites in Toulouse and Verona as one of three fully integrated powerhouses of capacity, capabilities and know-how in integrated R&D for the benefit of its partners.

Dr Craig Johnstone, Chief Operating Officer of Evotec, said, "Successful, fully-integrated drug discovery and development requires know-how and expertise as well as cutting-edge technologies and capabilities. We are delighted to extend our breadth of fully-integrated R&D sites with this extension to our capabilities at our Abingdon site, which we are proud to name after the X-ray crystallography technology leader and Nobel laureate: Dorothy Crowfoot Hodgkin Campus."

CCRM, MIP Partner to Build Biomanufacturing Campus

Aims to establish CDMO ops focused on regenerative medicine-based technologies and cell and gene therapies.

CCRM, a company developing and commercializing regenerative medicine-based technologies and cell and gene therapies, and McMaster Innovation Park (MIP) in Canada, have signed a Letter of Intent (LOI) to partner in the development of a biomanufacturing campus at MIP focused on regenerative medicine-based technologies and cell and gene therapies.

The LOI expands a months-long relationship between CCRM and MIP, and formalizes their intent to co-develop a business around the construction and operation of one of Canada's largest and most advanced Contract Development and Manufacturing Organization (CDMO). The envisioned facility will enable CCRM to scale its operations and provide critical space, services and support to cell and gene therapy focused ventures from across Canada and the world.

The agreement, which is focused on an initial CDMO facility to produce cells and viral vectors for Phase III trials and commercial-scale manufacturing, represents the first phase to develop a biomanufacturing campus at the innovation park. The short-term priority is to develop a facility design and an investment thesis that the parties will use to secure industry, regulatory and government support, along with the funding necessary for its construction and operation.

"Our partnership with MIP is about more than building a facility," said Dr. Michael May, President and CEO, CCRM. "This is about building domestic manufacturing capacity within the region for the next generation of medical advances. Our expectation is that the biomanufacturing campus within MIP, and the CDMO, will result in jobs, economic stimulus for the region and, most importantly, life-saving products for patients."

Ty Shattuck, CEO of McMaster Innovation Park, said, "The introduction of CCRM to MIP's innovation ecosystem is in the context of MIP's 2.8 million sq. ft. Life Sciences 'MegaHub', announced earlier this year. CCRM will be an anchor within the MIP, and because they will retain their research facilities within MaRS, it will act as an ongoing and active connection between two of the most advanced life science ecosystems within Canada."

Watson-Marlow to Open ISO 14644-1 Class 7 Cleanroom

The facility at the site in Cork is currently in development and will be validated to ISO 9001 Quality Management System standards in Q1 2021.

Watson-Marlow Limited Ireland, the specialist in fluid management technology, has announced it will open a state-of-the-art facility in Cork, Ireland.

The new ISO 14644-1 Class 7 cleanroom will be added to the company's existing Cork site and will be certified to meet the demands of the highly regulated pharmaceutical and biopharmaceutical manufacturing sector in Ireland.

The expansion of Watson-Marlow's Cork facility will provide global expertise within Ireland, offering a high quality and reliable supply allied with customer service and local support.

Watson-Marlow's Ireland-based customers will be able to locally access essential bioprocess single-use assemblies for biopharmaceutical production.

The facility is currently in development and will be validated to ISO 9001 Quality Management System standards in Q1 2021.

It will create new employment opportunities in Cork and provide a robust supply of puresu single-use assemblies. These will be manufactured in the new ISO Class 7 cleanroom and validated to biopharmaceutical industry standards.

Denis Coll, Biopharm Sector Manager for Ireland, said: "We're delighted to build on our presence in Cork, reflecting the wealth of talent and opportunity available and the importance of Ireland in the growth of the global biopharmaceutical industry."

"The new ISO accredited facility offers a sustainable, Ireland-based supply chain that reflects Watson-Marlow's commitment to engineering a sustainable future," Coll 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.”

Lonza Inaugurates New Facility for ADC Payload Manufacturing

Lonza has inaugurated its first ADC payload manufacturing suite at the Visp, Switzerland site.

Lonza has revealed, in a Nov. 5, 2020 press release, that the first manufacturing suite at the company’s Visp, Switzerland site dedicated to the manufacture of antibody-drug conjugate (ADC) drug-linker (payload) is open.

The new highly-potent API suite has been in operation since March 2020. Dedicated to the manufacturing platform for ADC drug-linkers, the first suite handles compounds with occupational exposure levels down to 1 ng/m3. Lonza has reported that a second suite for similar development and manufacturing programs will be available to customers early in 2021.

“Supply from the facility is critical, and by supporting one of our global partners in the oncology field, we are enabling the treatment of many cancer patients,” said Maurits Janssen, strategic business development Small Molecules, Lonza, in the press release. “Oncology continues to be the leading indication in biopharma and a key driver for highly potent ingredients such as antibody-drug conjugates. We continue to add capabilities and capacity to meet the development and manufacturing needs of our partners in this field to answer to their increasing demand.”

“This partnership is a great example of how we can support both early and commercial-stage biopharmaceutical companies through innovation in manufacturing technology and flexible business models,” added Gordon Bates, president Small Molecules, Lonza, in the press release. “Our customers developing highly potent and increasingly complex medicines need a partner whom they can trust to handle these toxic substances throughout their lifecycle and to deliver in sync with their needs, whether for clinical or for commercial supply. Our partner has recognized the value in combining expertise in biologics and chemistry on one site and this investment has expanded our collaboration.”

Novasep to Expand Capacity, Increase Flexibility in API Manufacturing Facility

Novasep is investing €6.5 million to expand capacity & increase flexibility in an API manufacturing workshop at its Chasse-sur-Rhône site (69 - France).

The revamping of this workshop and installation of two new synthesis reactors (4000L Hastelloy & 1600L glass lined) is intended to increase the plant flexibility and its capacity for low to medium volume APIs, addressing the growing needs of the industry for targeted therapies. The two new reactors are equipped with a high-performance thermal system & benefit from a high level of automation. The project also involves repositioning the high-pressure hydrogenation reactor, (1500L,15bar), currently located in the workshop, in a new dedicated area.

Work has already started, and the construction of the utilities building is nearing completion. This investment will be fully operational by the end of 2021.

"Upgrading this workshop with the addition of two new reactors will enable us to continue modernizing our Chasse-sur-Rhône site's API manufacturing facilities, whilst improving flexibility and productivity,” said Jean Bléhaut, president of the Synthesis Solutions Business Unit of Novasep. "These investments will also reduce our environmental impact by optimizing energy consumption. This is an opportunity for us to respond to social and environmental challenges using technological advances.”

"The modernization of our equipment is critical to meeting the demands of our customers while ensuring both the safety of our employees and the minimization of our environmental impact. All of this contributes to our Rise-2 growth strategy." said Dr. Michel Spagnol, President and CEO of Novasep.

This is the latest in a series of investments at the Chasse sur Rhone site in response to increased customer demand for Novasep’s API manufacturing services. In 2018 a new 5000L cryogenic Hastelloy reactor was added. Containment capabilities have been reinforced with a new 1.5m² Hastelloy filter drier equipped with isolator for handling highly potent compounds. The pilot plant has been extended with a third cleanroom and a new Hastelloy filter drier. Finally, the analytical laboratories have been extended & additional equipment installed (LC-MS GC-MS).

Thermo Fisher’s Biologics and Sterile Drug Manufacturing Facility, Hangzhou

Thermo Fisher Scientific (Thermo Fisher) will establish a new pharmaceutical services facility for integrated biologics and sterile drug development and manufacturing in Hangzhou, China.

The new good manufacturing practices (GMP)-compliant facility will be a part of Thermo Fisher’s extensive global pharmaceutical services network. It will expand the company’s existing network and enable it to provide drug development and manufacturing services to clients in China and beyond, who require the services in the region.

Thermo Fisher signed a joint venture (JV) agreement with China-based bio-innovation firm Innoforce P-harmaceuticals to establish the new facility in Hangzhou in November 2020. Innoforce will support Thermo Fisher to meet the high biologics demand in China.

The collaboration will support the bio-economy development in Xiaoshan district and Hangzhou. The drug manufacturing facility is scheduled to be completed by 2022.

The new state-of-the-art facility will include strict quality management procedures that either meet or exceed the regulatory guidelines defined by the China National Medical Products Administration (NMPA), the US Food and Drug Administration (FDA), and European Medicines Agency (EMEA).

Thermo Fisher’s new and existing clients can utilize the company’s global network of biologics and steriles in the US, Europe, and Asia-Pacific, until the completion of the new Hangzhou facility. The clients will be smoothly transitioned to the new facility after its completion.

Thermo Fisher Scientific offers more than 1,000 small and large-molecule pharmaceuticals for marketing in more than 70 countries with a full range of development, manufacturing, and clinical trial services.

The services include the development of an appropriate formulation and manufacturing method for active pharmaceutical ingredient (API) or biologics, technology transfer to scale-up clinical trial manufacturing, labelling, packaging, delivery and logistics, and manufacturing and packaging on a commercial scale.

Other key services include drug substances, drug products, viral vector, and clinical trial services.

The company provides a wide variety of specialized formulation, manufacturing, and technical services, as well as scientific expertise and solutions from early stages of product development to regulatory authorization and commercial-scale production.

The scope of the vector network encompasses the five most frequently used types of viruses, offering broad coverage across the landscape of gene and cell therapy.

Marketing commentary on Thermo Fisher Scientific:

Based in the US, Thermo Fisher Scientific serves more than 400,000 clients in the pharmaceutical and biotechnology industry, hospitals, clinical diagnostic centers, institutions, research institutes, and government departments, as well as in environmental, manufacturing safety, and process management settings.

The company deals in four segments broadly, including life sciences solutions, analytical instruments, specialty diagnostics, and laboratory products and services. It has a global workforce of more than 75,000 employees.

The company’s leading brands are Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon that offer a unique amalgamation of innovative technologies, accessibility, and pharmaceutical services.

Thermo Fisher made two strategic acquisitions to expand its global services network in 2019. One of them was that of a GlaxoSmithKline’s API manufacturing facility in Cork, Ireland, while the other was that of Brammer Bio, a US-based viral vector manufacturing company.

The objective of Thermo Fisher Scientific is to make consumers more efficient in an intensely challenging business environment and help them overcome their problems.

Thermo Fisher Scientific, Innoforce Partner to Establish Facility in China

Thermo Fisher Scientific and Innoforce have signed a joint venture agreement to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing. The new facility is expected to be completed in 2022.

The new state-of-the-art Good Manufacturing Practices (GMP) facility will become part of Thermo Fisher's extensive global pharma services network, which includes leading capabilities for drug product development, biologics manufacturing, sterile fill-finish, clinical trials packaging and logistics. The Hangzhou site will also incorporate stringent quality control processes that meet or exceed regulatory guidelines established by the China National Medical Products Administration (NMPA), the U.S. FDA and appropriate EMEA authorities.

"Our agreement with Innoforce will provide critical support in helping to meet the high demand for biologics in China," said Michel Lagarde, executive vice president, Thermo Fisher Scientific. "The addition of the Hangzhou site will expand our existing global network and provide drug development and manufacturing services for customers in China, as well as for global customers seeking capabilities in the region."

"To successfully bring novel therapies to market domestically and internationally, emerging biotech companies increasingly need partners with expertise in development and manufacturing and deep global regulatory knowledge. Through our partnership with Thermo Fisher, we can offer an accelerated pathway for biopharmaceutical manufacturers in China – and outside as well – to bring innovative therapies to the world," Innoforce CEO Yuling Li said.

Until the site is operational, new and existing customers can access Thermo Fisher's global biologics and steriles network, which includes sites across the U.S., Europe and Asia-Pacific, and then seamlessly transition to the new Hangzhou site after completion.

Novartis Expands with Kymriah Manufacturing Site in Asia

Novartis announced the receipt of marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe (FBRI) to manufacture and supply commercial Kymriah® (tisagenlecleucel) for patients in Japan. This approval makes FBRI the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia.

“Behind our efforts to reimagine medicine with CAR-T cell therapy lies a commitment to build a manufacturing network that brings treatment closer to patients,” Steffen Lang, Global Head of Novartis Technical Operations said. “The expertise and infrastructure of FBRI, a world-leading manufacturing organization, allows us to bring CAR-T manufacturing to Asia. With the Japan MHLW commercial manufacturing approval, the recent capacity expansion in the US and our ongoing efforts to optimize and evolve our processes, we are well-positioned to deliver this potentially curative treatment option to more patients around the world.”

Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) recently approved a further increase in manufacturing capacity.

Kymriah is a one-time treatment designed to empower patients’ immune systems to fight their cancer. It is also currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania.

Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Minaris Expands Manufacturing Cleanrooms in Japan And Germany

Cell and gene therapy CDMO Minaris Regenerative Medicine has announced a $64.5m to significantly expand its facilities in Europe and Asia.

European facility expansion: A new facility will be built in the proximity of the existing site in Ottobrunn near Munich, Germany with a total investment of $40.7m. The new facility will operate according to GMP standards (FDA and EMA) and be dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies.

The multi-story building with a total of 71,554 sq. ft. (6,650 sq. meters) will initially more than double Minaris existing capacity in Europe by providing additional cleanrooms, quality control laboratories, warehousing, cryo-storage and office space.

It will have a modular design with the possibilities to go from single room to ball room design and to flexibly change between grade B and grade C configuration.

The new facility is expected to be operational early 2023 and will allow for additional expansion of cleanrooms according to client demand and specifications, thus more than tripling the current cleanroom capacity.

"We are very pleased to expand our capacity to support the growing demand of clients who continue to care for an increasing number of patients in the future", said Dusan Kosijer, Managing Director of Minaris.

Asian site expansion: A new facility will also be established adjacent to the existing facility in Yokohama, Japan allowing for an additional 4,000 sqm which will double the capacity for commercial manufacturing of regenerative medicine.

The new facility is scheduled to start operations in October 2022. The investment of $23.8m is part of a strategy to establish a center for cancer immunotherapy and somatic stem cells.

The European and Asian expansions complement the opening of the new commercial facility in Allendale, New Jersey, USA announced in January this year.

Collaboration Delivers Biosecurity Plant to New Animal Quarantine Centre

The wastewater decontamination specialist has teamed up with its Australia agent, Fineweld Stainless Steel, to supply, manufacture, and install a wastewater decontamination plant and connecting containment pipework

Suncombe, based in London, has teamed up with its Australia agent Fineweld Stainless Steel to supply, manufacture, and install a wastewater decontamination plant and connecting containment pipework for the state-of-the-art Post Entry Quarantine (PEQ) facility for animals, birds and insects in northern Melbourne. The plant treats Quarantine Containment (QC3) biowaste products in the avian compound.

Safeguarding Australia's environmental biosecurity is critical in preventing the introduction and spread of pests and diseases, and the new, flagship PEQ facility in Mickelham is setting the benchmark in international best practice with the use of stainless steel, say the companies. The facility consolidates and streamlines the country's quarantine services which were previously based in five separate locations across the country.

The complex and demanding brief for the avian compound included the delivery of five high-criticality biocontainment units under QC3 requirements, one of the highest levels of biosecurity containment.

The main contractor, Geschke Plumbing, was keen to use local expertise to provide major elements of the contract.

Fineweld fabricated a 12,500L collection vessel from 316 grade stainless steel and a 1,750L heat treatment vessel from 2205 duplex stainless steel, with a 0.6μm surface finish, at the company's Carrum Downs workshop. Then they were packed and shipped across the world to Suncombe. In London they were incorporated into the wastewater decontamination plant and underwent a complete Factory Acceptance Test (FAT) at Suncombe to validate the operation prior to delivery to ensure a simple "plug 'n' play" start-up on site.

The finished plant was then transported to Australia for final inspection and then installed on site. The installation took place two stories underground, therefore manufacturing and pre-spooling had no margin of error, says Fineweld. Extensive logistical challenges had to be managed and in collaboration with Suncombe and main contractor Geschke Plumbing, the project was delivered on time and on budget.

Steve Overton, Technical Director of Suncombe said: "We were delighted to be part of this project. The team at Fineweld in Australia and our own here in London worked very well together."

"Despite the different time zones, and having to transport these vessels over 20,000 miles in total, everything ran smoothly and professionally," Overton added. "It is a vital facility for Australia's biosecurity and very important that it was delivered on time and to the performance level required."

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 sq. meters) 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 sq. meter) cleanroom.

The extreme urgency of the build and difficulties getting construction materials at short notice 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. Labor 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."

Sulzer Completes Work on Pla Bioplastics Site in China

Sulzer Chemtech (Winterthur, Switzerland) has supported B&F PLA in the development of China’s first fully-integrated sugar-to-PLA (polylactic acid) plant located in Bengbu, Anhui Province. The facility utilizes Sulzer’s distillation, crystallization and polymerization technologies to produce 30,000 metric tons per year (m.t./yr) of PLA.

The new facility uses glucose from locally sourced corn to produce lactic acid and PLA of different grades, allowing B&F PLA to support the growing bioplastic market. More precisely, the manufacturer is now able to deliver plant-based polymers with different molecular weights and L(+)/D(-) ratios to provide suitable materials for a wide variety of applications.

Sulzer, the leader in separation and mixing technologies, played a crucial role in the construction of the plant, which was completed in record time. The company designed, engineered and supplied customized mass transfer equipment for the purification of lactide and polymerization processes. Extensive remote assistance during pre-commissioning, commissioning and start-up was also provided to help B&F PLA begin its operations quickly and smoothly.

The successful completion of this project was enabled by Sulzer’s extensive experience in delivering customized equipment and key processing units for bioplastic manufacturing. In particular, the company develops specialized falling film and static crystallizers, loop and plug-flow reactors, mixers as well as distillation and devolatilization technologies for plants involved in any stage of sugar-to-PLA processing.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com