PHARMACEUTICAL & BIOTECHNOLOGY

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.

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.

Capabilities of the existing manufacturing facility:

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.

KBI Biopharma’s New Biologics Manufacturing Facility, North Carolina

KBI Biopharma is building a new commercial biologics manufacturing facility in the Research Triangle Park (RTP), Durham, in North Carolina, US.

The company is co-investing approximately $150m in the facility with an undisclosed pharmaceutical investor to facilitate the manufacturing of the client’s therapeutic protein programs. The facility will also serve as a commercialization option for the existing and potential future clients of the KBI.

Expected to create more than 200 operations and quality assurance technical jobs, the facility is anticipated to be operational in the first quarter of 2022.

The new site is located near KBI’s RTP mammalian drug development laboratories in Patriot Park, a new multi-phase industrial development situated in the Research Triangle area. It is built by Strategic Capital Partners, which is headquartered in Indianapolis.

The site was strategically secured in collaboration with Cushman & Wakefield due to its accessibility to the highly-skilled workforce, combining the region’s talent, technical and academic skills. It is also in proximity to the Raleigh-Durham (RDU) International Airport.

KBI Biopharma’s new biologics manufacturing facility details.

KBI’s new state-of-the-art commercial manufacturing facility will be built upon an area of 140,000 ft² and incorporate Manufacturing 4.0 principles by utilizing the latest automation and digitalization technologies to better address the needs of its clients.

The biologics manufacturing facility will be equipped with up to six 2,000l single-use bioreactors along with the related harvest and purification equipment to manufacture more than 100 commercial batches a year.

It will feature a ring corridor for access to suite and a ‘science on display’ viewing corridor to display the facility to KBI clients.

The digital facility will incorporate data collection tools, such as electronic batch reports, electronic logbooks, paperless materials management and laboratory information management systems (LIMS), to manage the quality control data.

They will allow the monitoring of product quality and processes in real-time, as well as enable to adopt artificial intelligence (AI) technologies in future.

Advanced analytical services will be employed to characterize the commercial product and release testing capabilities to facilitate the commercial launch and routine supply.

Design-build construction will use the proven single-use platform of KBI to make its supply reliable with the dispensable equipment, automation and complete utility back-up.

The design allows flexibility to house diverse manufacturing processes for mammalian-based biologics.

Marketing commentary on KBI Biopharma:

Established in 2013, KBI Biopharma, a subsidiary of JSR Life Sciences, is a biopharmaceutical development and contract manufacturing organization based in the US.

The company provides fully-integrated, accelerated drug development and bio-manufacturing services for mammalian, microbial and cell therapy programs to pharmaceutical and biotechnology companies globally.

Its capabilities and services include cell-line development, process, analytical & formulation development, clinical manufacturing, commercial manufacturing, cell therapy, and characterization & consulting. The company has partnered with more than 300 clients and employs more than 1,000 people globally.

KBI Biopharma has supported the advancement of more than 300 molecules in more than 70 indications.

In October 2020, JSR Life Sciences announced the expansion of its biologics manufacturing facilities in Geneva, Switzerland, for its subsidiaries Selexis And KBI Biopharma. The site is expected to be operational by mid-2022 and will allow KBI to deliver bulk drug production of clinical cGMP biologics to European customers.

Rocket Pharmaceuticals’ Research, Development and Manufacturing Facility

Rocket Pharmaceuticals will build a new research and development (R&D) and manufacturing facility in Cranbury, New Jersey, US to support the production of its pipeline of lentivirus and adeno-associated virus (AAV) gene therapies.

The facility will house R&D and chemistry, manufacturing and control (CMC) operations. Announced in January 2021, it will also serve as the new headquarters and accommodate 150 staff members in Cranbury, New Jersey.

Rocket Pharmaceuticals plans to begin the first current good manufacturing practice (cGMP) production at the facility in 2021.

Spanning 103,720ft², Rocket Pharmaceuticals’ new state-of-the-art facility will dedicate approximately half of the entire space to AAV cGMP production. The remaining area will house R&D laboratories to support CMC operations for process and analytics.

Furthermore, the company intends to use the facility for a phase two study to evaluate the company’s first AAV-based gene therapy, RP-A501, for the treatment of Danon disease, a heart-related disease.

The Cranbury facility will play a vital role in the company’s objective to deliver five curative gene therapies for the treatment of rare diseases by 2025. It will support the company’s pipeline of genetic therapies.

Rocket Pharmaceuticals signed a lease agreement for approximately 92,000ft² of rentable space in Cranbury to support process development, office, research and manufacturing activities.

The company’s Research and Discovery group uses 20,000ft2 of labs at the site for the development of therapeutics.

Rocket Pharmaceuticals secured approximately $300m through a public equity offering of 6,035,714 shares of its common stock in December 2020.

The company will use a portion of the funds raised through the public equity offering to build-out the new facility and develop Rocket’s gene therapies pipeline for rare diseases filing for the marketing authorization of RP-L201 in the US and Europe.

Investment banking firms, including JP Morgan, BofA Securities, Piper Sandler and SVB Leerink served as the joint book-running managers for the public offering.

Rocket reported positive interim Phase 1 clinical trial results for RP-A501 in December 2020. The gene therapy candidate expressing lysosomal associated membrane protein 2 (LAMP2B) for the treatment of Danon Disease showcased increased gene expression and positive biomarkers.

Preliminary data indicated that the low dose RP-A501 cohort remained well-tolerated and offered early evidence of clinical benefit.

Marketing commentary on Rocket Pharmaceuticals:

Rocket Pharmaceuticals is a clinical-stage biotechnology firm focused on the development of a pipeline of genetic therapies for complex and rare childhood diseases.

In March 2020, Rocket Pharmaceuticals entered a research partnership agreement with Forty Seven, a clinical-stage immuno-oncology company, for the treatment of Fanconi Anaemia, a rare pediatric genetic disorder that results in bone marrow failure.

Rocket’s genetic therapies pipeline includes both adeno-associated viral vector and lentiviral vector (LVV) approaches for the treatment of rare genetic disorders.

The company leverages LVV-based programs for the treatment of Fanconi Anemia, Leukocyte Adhesion Deficiency-I, a rare genetic disease that leads to malfunctioning of the immune system, Pyruvate Kinase Deficiency, a rare red blood cell disorder and Infantile Malignant Osteoporosis, a rare, genetic bone disorder. The company announced that its first AAV-based program targets Danon disease.

Columbus Innovation District, Ohio State University

The Columbus Innovation District is a proposed healthcare and technology hub within the Ohio State University in the state of Ohio, US.

It will act as a hub to drive innovation and growth in the state while increasing educational opportunities for the science, technology, engineering and math (STEM) academic discipline.

Unveiled in February 2021, the technology hub will bring together global education and healthcare research institutions, attracting researchers to initiate, develop and share ideas. It is being developed by JobsOhio, Ohio State University, and Nationwide Children’s Hospital.

Expected to be completed in 2023, the Columbus Innovation District is expected to create up to 20,000 new jobs over the next decade, including 10,000 STEM-related jobs across technology and healthcare industries and 10,000 indirect jobs. It is estimated to contribute $3bn to the economy of Columbus and Ohio over the coming ten years.

To be located at Ohio State University’s West Campus, the new innovation district will allow academic researchers, students, Fortune 500 companies and start-ups to share and develop ideas. It will be the third innovation district in the state of Ohio, after Cincinnati and Cleveland.

The innovation hub will feature an interdisciplinary research facility, a gene therapy manufacturing facility, an energy advancement and innovation Center, and an outpatient cancer center. The buildings will take up approximately 750,000ft².

The interdisciplinary research facility is being developed as a 305,000ft², five-story laboratory building with a budget of $237.5m. The site is located to the west of Kenny Road and south of Lane Avenue.

The university sought approval from its board of trustees for the construction and the remaining balance of design services for the research facility in February 2020. Construction of the facility began during at the end of 2020 is anticipated to be completed by mid-2023.

The facility will support a multitude of research disciplines such as biomedical, life sciences, engineering, and environmental sciences.

Nationwide Children’s Hospital Starts Construction

Nationwide Children’s Hospital, through its affiliate Andelyn Biosciences, started the construction of a new gene therapy manufacturing facility at 1250 Arthur E Adams Drive in the innovation hub in November 2020.

Expected to be opened in 2022, the 185,000ft² production facility will be central Ohio’s first commercial-scale current good manufacturing practices (cGMP) production facility and is expected to create more than 200 jobs.

Andelyn is investing more than $100m in gene therapy contract development and manufacturing organization.

Outpatient Cancer Facility at Columbus Innovation District

The outpatient cancer facility at the university, also known as Wexner Medical Center Outpatient Care West Campus, is being built south of the intersection of the Kenny and Carmack roads. The 385,000ft², five-story, cancer-focused center will house the first proton therapy treatment facility in central Ohio.

Being constructed by the Ohio State University in partnership with Nationwide Children’s Hospital, the building will include outpatient operating rooms, pre-anesthesia center, interventional radiology rooms, extended recovery unit, a diagnostic imaging center, hematology clinic, genitourinary (GU) clinic, retail pharmacy, infusion and medical office spaces.

Construction started in July 2020 and the facility is expected to be inaugurated in mid-2023, while the proton center is scheduled for opening by the end of 2023.

Energy Advancement and Innovation Centre

The 52,600ft² energy advancement and innovation center will support the next generation smart energy systems, renewable energy and green mobility solutions. It will facilitate collaboration between the university’s faculty members, students, alumni, researchers of Engie Buckeye Operations, as well as entrepreneurs and industry experts.

The design of the facility started in September 2019 and is expected to continue until March 2021. Construction is expected to begin in June 2021, subject to approval by the Board of Trustees, with completion anticipated by May 2023.

Financing for Columbus Innovation District:

The innovation hub secured financial commitments totaling $1.1bn from the developers in February 2021. While JobsOhio pledged to invest up to $100m, the Ohio State University agreed to invest $647m to build infrastructure on a 109.26ha university-owned land.

Contractors:

Andelyn signed the land lease agreement for the new gene therapy manufacturing center with SciTech.

CE&IC was selected as the architect for the gene therapy production facility while Gilbane was appointed as the project’s main contractor.

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.

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.

Vacaville Unveils California Biomanufacturing Center

City of Vacaville officials say they have started the next-generation development of its biomanufacturing cluster by announcing plans to expand it on approximately 300 acres adjacent to existing facilities and to name the entire zone the California Biomanufacturing Center.

At the same time, the city announced the creation of the California Biomanufacturing Center, Inc., a nonprofit that will work to accelerate the growth of the sector in Vacaville by working with industry and academic partners.

Vacaville Mayor Ron Rowlett pointed to the establishment of the California Biomanufacturing Center as a reflection of the city’s commitment to the sector and said it will help to guide the continuing growth of the industry in Vacaville.

The city expects that this expansion will lead to more than $2 billion in industrial development, 3.5 million square feet of commercial real estate, and the addition of 10,000 jobs with a payroll of more than $1 billion a year.

Also, The California Biomanufacturing Center, Inc. and Solano Community College signed a memorandum of understanding to guide ongoing collaboration between the two. To support future development of the city’s biomanufacturing cluster, the new nonprofit will work with industry and its partner Solano Community College to address the workforce training needs of local industry and workforce development opportunities. Solano Community College has offered a Bachelor of Science degree in biomanufacturing since August 2017.

“Building on the college’s existing program, our collaboration with the city, and our partnership with the California Biomanufacturing Center, we will not only help meet the workforce demands of biomanufacturers today, but well into the future,” Celia Esposito-Noy, superintendent/president, Solano Community College District. “Our program was the first program of its kind to teach students the skills and knowledge required to enter biomanufacturing jobs and has served as a model for producing graduates with ready expertise to meet the strenuous demands of industry.”

A medical school in the U.S. has built a large-scale manufacturing facility to overcome bottlenecks in adeno-associated virus (AAV) production.

University of Massachusetts (UMass) Medical School Opened Large-Scale Manufacturing Facility

The AAV large-scale manufacturing facility, which opened in June at the University of Massachusetts (UMass) Medical School in Worcester, aims to help address a shortage of viral vectors for preclinical research.

“There’s a bottleneck in availability of these products,” says Sylvain Cecchini, PhD, an associate professor of microbiology and physiological systems at UMass Medical School and the facility’s director. “If you’re doing research in a lab, you’re fine, but the purpose of biotechs is to bring research to commercialization.”

Researchers conducting large animal studies before moving into Phase I trials need large amounts of AVV vectors, he argues, but few companies are currently producing vectors at a sufficiently large scale.

“People initially didn’t realize vectors for research could be a bottleneck,” he explains. “The situation is getting better, but the prime CMOs [contract manufacturing organizations] are saturated [with customers].” As a result, researchers often wait 12 to 24 months to obtain enough AAV for their studies, he says.

The new UMass Medical School facility, which is part of the medical school’s Horae Gene Therapy Center, uses a Sf9 baculovirus expression system for high-quality, research-grade AAV production. According to Cecchini, this system produces higher product volumes than more traditional mammalian systems for AAV production and the process is portable to CMO and GMP facility.

In addition, the Sf9 insect cells can be grown in suspension, which he argues, makes the production volumes easier to scale up. The facility currently has a 200 L production capacity with an aim to increase to 500 L.

The facility also plans to offer a wider variety of capsids to potential clients. “At the moment, we’ve just opened our facility, so we’re still making plans for this year and starting to talk to clients,” he says.

The facility is open to academic and industry clients. Cecchini recommends that potential customers visit the facility’s website and use the contact form to get in touch.

Sandoz Incorporates RFID Technology on Injectables

The generic drug manufacturer is working with Kit Check to incorporate the company's drug supply-chain management technology into two of its products.

Sandoz, a division of Novartis specializing in production of generic pharmaceuticals and biosimilars, has partnered with Kit Check (a company offering artificial intelligence and radio-frequency identification medication management technology). Starting this month, two RFID-tagged injectable Sandoz products will be available in US hospitals.

Outsourcing-Pharma spoke about the RFID management technology with Robert Spina (RS), vice president of key accounts and sales with Sandoz; and Kevin MacDonald (KM), Kit Check CEO and co-founder. The two explained how the technology helps medical professionals manage inventory, save time, conserve costs and improve patient safety.

OSP: Could you please tell us about Sandoz?

RS: Our ambition is to make Sandoz the world’s leading and most valued generics company; to realize that ambition, we have a clear plan to focus on specific segments of the off-patent market such as biosimilars, generic injectables and opthalmics, where we can do the most to pioneer access for patients. We have a broad global portfolio of high-quality medicines that covers all major therapeutic areas, and includes leading positions in biosimilars, anti-infectives and oncology.

Globally, Sandoz is a leader in generic oncology medicines, which complements our leading positions in generic anti-infectives and biosimilars. Our oncology portfolio of more than 50 products reaches patients in nearly 100 countries and spans the full range from chemotherapy via hormones and supportive care, to more targeted biologics; furthermore, our oncology offering also complements the leading innovative presence of Novartis Oncology.

OSP: Could you please talk a little bit about the evolution of RFID technology in this space?

KM: We have seen RFID revolutionize retail, aerospace, and other industrial supply chains. This technology allows detailed and interoperable item-level data that can be scanned and updated without line of sight means.

Since 2012, Kit Check has led the US hospital market in RFID adoption for medication inventory management. Historically, clinicians needed to affix RFID labels on vials and syringes of medication to be scanned in Kit Check’s proprietary scanning stations.

With the launch of Sandoz pre-tagged medications, vials will arrive at hospitals with the RFID label embedded in the dose packaging right off the manufacturing line. This provides an additional level of cost and time savings for clinicians.

OSP: How has RFID benefited pharma manufacturers, clinical trial teams, healthcare providers, patients and others? Please feel free to talk about safety, inventory management, thwarting counterfeiters or anything else.

RS, KM: Through its collaboration with Kit Check, Sandoz will help hospital pharmacies improve efficiency, reduce risk and better support patient treatment in hospitals by providing real-time inventory reports and timely tracking of expiration of products and recalls. This will aid in automatic replenishment of supplies long-term.

Especially during a pandemic, ensuring medicines are readily available, in addition to keeping prices stable, is paramount to patient care when healthcare systems are already being challenged and overwhelmed. Both Sandoz and Kit Check are members of the newly formed industry consortium DoseID, launched in August 2020 to ensure standardization and interoperability of RFID in the pharmaceutical supply chain.

Kit Check is a leader in RFID-based medication inventory tracking and automated tray processing in use at more than 500 hospitals in the US and Canada. RFID tags are applied to vials, syringes, bags, and other medication packages and supplies in trays and kits and used to track each medication that passes through the hospital pharmacies.

Scanners will automatically identify the products in terms of NDC, lot number, and expiration date, saving time for hospital staff and reducing the risk of medical error. As a result, the pharmacy can see the product’s journey from the plant to the point of administration in real time.

OSP: Please tell us a little more about Kit Check.

KM: Kit Check is the leading provider of automated medication tracking solutions for hospital pharmacies in the US, bringing visibility, simplicity, and predictability to the complex world of medication supply management. Our groundbreaking medication intelligence platforms provide item level visibility, workflow simplicity and actionable analytics, empowering stakeholders to deliver the right medicine to the right patient at the right time, every time.

The flagship Kit Check product is an RFID-based automated medication tray management system, designed to help hospital pharmacies gain better visibility into medication usage and lifespan, increase efficiencies, and free up staff to focus on patient care. Kit Check is live in over 500 hospitals and there are medications available pre-tagged with RFID from every major 503b outsourcing facility and, launching in October 2020, generic manufacturer Sandoz.

OSP: How did your two companies come to work together?

KM, RS: This is a real testament to Sandoz and Kit Check’s exceptionally close relationships with customers. One of our mutual customers reached out to Sandoz to see if they could partner with Kit Check to make manually tagging medications a thing of the past. A short time later, here we are, with the first of its kind RFID tagged medication from a cGMP facility.

OSP: When should pharma companies and their production/design partners start thinking about integrating RFID solutions?

RS: While this technology is not new and is used for so many other processes requiring automation, it is new to the pharmaceutical industry and has been a learning curve for all of us to integrate this technology into our manufacturing process. We look forward to broader use of RFID as we begin to realize the benefits of it for timely reporting, transparency of stockouts or notification of re-orders, and to facilitate recalls and identification of expiration dates.

OSP: You refer to how RFID technology might help the “strained” supply chain. Could you please elaborate?

RS: Sandoz entered into a long-term partnership with Kit Check, Inc. a leader in automated medication management solutions for hospitals, to automate the restocking of certain Sandoz products in hospitals in the US. The collaboration seeks to optimize the supply chain by providing real-time inventory reports, as well as timely tracking of recalls and product expirations.

OSP: What else would you like to talk about that we did not touch upon above?

RS: Across the industry, COVID-19 has provided an opportunity to look at how we want to connect as an organization, how we work as teams, and how we connect with our customers and suppliers to ultimately ensure patients have the medicines they need, when they need them.

TFF Pharmaceuticals Partners with Experic to Expand Manufacturing

TFF Pharmaceuticals, a clinical-stage pharmaceutical company that specializes in developing and commercializing novel drug products using its thin-film freezing (TFF) technology, has expanded its engagement with contract manufacturing organization (CMO) Experic LLC. Under the agreement, Experic will install a TFF processing line at the company’s cGMP facility located in Cranbury, New Jersey.

According to the companies, installation of the custom-engineered equipment is expected to wrap in the early second quarter of 2021. The processing equipment installation will give TFF its third cGMP manufacturing location and increase its manufacturing capacity.

The TFF platform was created to help improve the solubility and absorption of poorly water-soluble drugs; according to the company, the technology is especially suited to generate dry-powder particles with properties targeted for inhalation delivery, especially to the deep lung, for respiratory therapies. The TFF process results in a “brittle matrix particle,” which reportedly possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue.

Glenn Mattes, CEO and president of TFF Pharmaceuticals, said the expansion of manufacturing operations at Experic provides the company with the capability to develop and produce products currently in assessment with various pharma companies.

“Experic has been a terrific partner for us because of their domain expertise in dry powder inhalation products,” Mattes commented. “They also provide us with unique downstream encapsulation technology that rounds out the specialized manufacturing requirements of our dry powder inhalation therapies.”

Jeffrey P. McMullen, CEO and chair of Experic, said the company is looking forward to working with TFF and supporting product development and manufacturing.

“We share their excitement in the continued advancement and expansion of their technology and business,” he commented.

Experic offers CMO and pharma supply services across a variety of dosing and packaging formats, including capsule filling, powder and pellet dosing (such as DPI), and autoinjectors and pen assemblies.

Thermo Fisher Sketches Out Carlsbad Plasmid DNA Plant as German Cell and Gene Therapy Facility Preps for Opening

Thermo Fisher sketched out a new plasmid DNA plant in Carlsbad, California, set to boost its clinical and commercial offerings for cell and gene therapies.

Thermo Fisher Scientific is shoring up production of cell and gene therapies on both sides of the pond, a move it hopes will support the development of COVID-19 drugs and vaccines—and ensure supplies are in place should they pass muster with regulators.

The New Jersey contract manufacturer is laying out a new plasmid DNA manufacturing facility at its Carlsbad, California, campus, aiming to boost its cell and gene therapy offerings against the backdrop of a global plasmid market where demand has quickly outpaced supply, the company said.

That is on top of plans for a new cryocenter in Germany. That site, one of two new German facilities set to come online in the next few weeks, will offer cold chain support for clinical trials of cell and gene therapies, including COVID-19 vaccine hopefuls, in Europe and beyond.

The 67,000-square-foot Carlsbad facility will add some 150 jobs over the next 12 months, with construction pegged to wrap in the first half of 2021, Thermo Fisher said. The site will boost clinical and commercial output of plasmid DNA used to develop and produce cell and gene therapies for cancer, as well as mRNA vaccines. It will also be equipped to churn out large-scale plasmid DNA as a primary drug substance for DNA therapies.

The facility will be kitted out with single-use equipment capable of handling projects up to 1,000 liters and will boast digital connectivity and data visibility to smooth operations and make training employees easier, Thermo Fisher said.

Thermo Fisher is no stranger to the field, with a cell and gene therapy footprint in Massachusetts and Florida, plus a newly minted cell therapy manufacturing plant in Princeton, New Jersey—but it figures the expanded commercial and supply chain services at its Carlsbad site will smooth the wrinkles in the current plasmid market.

"The race to develop new transformative cell and gene therapies and vaccines is outpacing supply of commercial-quality plasmid DNA that can be produced at scale," said Mike Shafer, SVP and president of pharma services at Thermo Fisher.

"Our new state-of-the art site will not only tackle the supply bottleneck for our customers but also uniquely positions us to deliver robust, end-to-end cell and gene therapy capabilities.”

A day before Thermo Fisher sketched out its Carlsbad plans, the company announced a twin pharma services expansion in Europe. First up for completion in late December is an 86,000-square-foot packaging, storage, logistics and distribution center in Rheinfelden, Germany, which will serve as a strategic logistics hub for European clinical trials.

Then there’s Thermo Fisher’s 9,600-square-foot cryocenter in Weil am Rhein, Germany, set to go live in January 2021. That site, poised to support super-cold storage of experimental cell and gene therapies, including vaccines, will boast minus 112 degrees Fahrenheit freezers, liquid nitrogen storage tanks and walk-in storage as cold as minus 4 degrees Fahrenheit.

Aside from supporting trials of cell and gene therapies against COVID-19, Thermo Fisher in September teamed up with Humanigen to help the California biotech scale up production of its clinical-stage cytokine storm hopeful, lenlizumab. That deal marked Humanigen’s third tie-up for its monoclonal antibody on the heels of manufacturing pacts with Lonza and Catalent.

Elsewhere, Thermo Fisher in October drew up plans for a new, $130 million Singapore facility that will house two sterile filling lines, expected to eventually crank out 30 million drug and vaccine doses per month, the CDMO said.

Fujifilm Continues CMDO Expansions with Funding for New Boston Site

Fujifilm is laying plans for a new manufacturing facility in Watertown, Massachusetts—the second it’s announced in a little over a week.

Fujifilm and The Massachusetts Center for Advanced Biological Innovation and Manufacturing (CABIM) have ginned up $76 million in funding and signed a lease for a 40,000-square-foot site at The Arsenal on the Charles business park in Watertown. Set to kick off operations in early 2022, the manufacturing-and-innovation-center-in-waiting will support research and development in cell and gene therapy, gene editing, immunotherapy and biotechnology, Fujifilm said.

Fujifilm's latest U.S. move is just part of the Japan-based company's push toward $1.8 billion in CDMO revenues by 2024, a goal sketched out during a presentation Wednesday at the annual J.P. Morgan healthcare conference. The biggest piece of that puzzle, unveiled just last week, is a $2 billion megaplant planned for a site in the U.S.

The CABIM-partnered facility in Watertown, which will open with 40 full-time staffers, is expected to house eight clean rooms for production of cell and viral vector products, as well as quality control, lab, office and conference space. Fujifilm Diosynth, the Japanese company’s bio CDMO arm, will carry out process development and manufacturing work at the plant.

Working with CABIM, an R&D consortium that Fujifilm had a hand in establishing, the company aims to tap into the Greater Boston Area’s bustling life sciences ecosystem, with a view to training up emerging manufacturing talent.

“Fujifilm is pleased to partner with leading academia, industry, and teaching hospitals, to explore the application of genetically modified cell therapies, and bring new treatment options to the market,” Takatoshi Ishikawa, senior EVP and chief life science officer at Fujifilm, said in a release.

CABIM has a slate of collaborators lined up, including Brigham and Women’s Hospital, Dana-Farber Cancer Institute and the MilliporeSigma unit of Germany’s Merck KGaA. The consortium uncloaked in 2019 and is backed by equal investments from Fujifilm, Harvard University, Massachusetts Institute of Technology, Cytiva and Alexandria Real Estate Equities.

The new site should not be confused with a $40 million viral vector plant that Fujifilm sketched out on Jan. 5. That facility, also in Watertown, was set to become the company’s third viral-vector manufacturing site; the latest plant will make four. The first Watertown facility will start process development this fall, Fujifilm said.

Meanwhile, Fujifilm is also plowing an eye-popping $2 billion into a large cell culture production site in the U.S., which will boast eight 20,000-liter bioreactors and have the potential for 24 more. Fujifilm Diosynth will operate the facility, which will be built out of an existing location in the U.S. The company will offer drug substance manufacturing and fill-finish services, as well as packaging and labeling, and expects the site to be up and running in the spring of 2025.

Fujifilm is on a mission to hit ¥1 trillion in healthcare revenue by the middle of the decade, COO Kenji Sukeno said during his JPM presentation this week. To get there, it is largely banking on sales growth from its fast-growing medical systems and CDMO business, Sukeno said.

The company is gunning for ¥500 billion ($4.6 billion) in medical systems sales in 2021, which hinges on the close of Fujifilm’s $1.7 billion buyout of Hitachi’s diagnostic imaging-related business. Meanwhile, Fujifilm hopes to grow CDMO revenue to ¥200 billion ($1.8 billion) by 2024—and the company’s cash infusion spree will help it meet that goal, Sukeno said.

Charles River Enters Cell and Gene Therapy Manufacturing With Cognate Buy

Charles River jumps into cell and gene therapy manufacturing with $875M Cognate buy.

Cognate's buyout-to-be comes shortly after the company plotted cell and gene therapy manufacturing expansions in Europe and the U.S. (Cognate BioServices)

Just a few weeks after Cognate BioServices moved to beef up its cell and gene therapy manufacturing, the company has attracted a buyer eager to tap that expertise.

Charles River Laboratories agreed to throw down $875 million cash for Cognate in a deal designed to create a one-stop-shop in cell and gene therapies. Cognate's production muscle will complement Charles River's own work in the field to bring development, testing and manufacturing under one umbrella, the companies said Wednesday.

The move comes shortly after Cognate laid out plans to upgrade manufacturing in Europe and the U.S. And with a slew of drugmakers advancing cell and gene therapies, Charles River figures demand for the CDMO’s services will only grow with time.

Charles River estimates the current market for Cognate’s manufacturing operations—mainly in cell therapy and plasmid production—is somewhere in the vicinity of $1.5 billion now and could grow at least 25% annually for the next five years.

Meanwhile, Cognate is expected to pull annual revenue of about $140 million this year and is on track to grow 25% per year over the next half-decade, Charles River said. If the deal closes in the first quarter as planned, it could boost Charles River’s 2021 revenue by $110 million, the company said.

The takeover will help Charles River offer clients "a single scientific partner" to speed cell and gene therapy work from discovery all the way to market, CEO James Foster said in a release.

Memphis, Tennessee-based Cognate boasts production know-how for various cell types and technologies used in immunotherapy, immuno-oncology, regenerative medicine and advanced cell therapy, the company said. Its dedicated gene therapy unit, Cobra Biologics, operates a DNA, microbiota and fill-finish facility in Matfors, Sweden, and it cranks out DNA and viral vectors at its Centre of Excellence for Advanced Therapies in Keele, England.

Charles River is snapping up Cognate shortly after the CDMO plotted its own cell and gene therapy expansion. In January, Cognate unveiled plans to expand its global manufacturing facility and headquarters in Memphis, teeing up 500 new hires over the next four years, a Cognate spokesperson said at the time.

The upgrade will add a new cellular- and advanced-therapy-focused commercial manufacturing plant at the site as well as a new distribution center.

At the same time, Cognate’s gene therapy unit Cobra charted its own multiphase upgrade of its plasmid DNA services, with plans to add new clinical and commercial DNA facilities at its existing European sites.

REST OF WORLD

Wiskind Assists Moscow R-Pharm to Build Covid-19 Vaccine Plant

Moscow-based "R-Pharm" will become a leading manufacturer of Russia's Sputnik V covid-19 vaccine.

On December 11, 2020, Moscow Mayor Sergei Sobyanin and R-Pharm Chairman Alexey Repik checked the progress of the production of the vaccine against Covid-19 in the Moscow plant. The project is being developed by R-Pharm. Wiskind provided more than 430,400 sq. ft. (40,000 square meters) of rock wool cleanroom panels, cleanroom doors and other cleanroom enclosure products for the project.

The production base will produce the flagship home vaccine "Sputnik V" developed by the Epidemiology and Microbiology Centre. According to this project, when the factory reaches full capacity, it will produce up to 20 million doses of vaccine every month. The total investment in the project amounts to 8.6 billion rubles.

The R-Pharm enterprise plans to start at the end of December 2020, and the first batch of Sputnik V vaccines are planned to be produced in Moscow Technopolis in January 2021. The construction of the complex located on the territory of the special economic zone "Technopolis "Moscow" took place in record time, which is necessary for the implementation of national and urban vaccination programs. The area of the new factory will exceed 215,200 sq. ft. (20,000 sqm.)

Centerpiece to Open North American ETO Sterilization Facility

The company will launch the new ethylene-oxide sterilization facility in Tijuana, Mexico early next year.

Centerpiece, a medical device contract manufacturing and sterilization company, has announced it will be launching a new ethylene-oxide sterilization facility in Tijuana, Mexico early next year. The facility will add both high and low volume processing to a region that employs over 70,000 people dedicated to the medical device industry.

“Tijuana is the leading medical device manufacturing hub in North America and is a strategic production center for US markets. Our downstream investment into ethylene-oxide processing will streamline supply chains and provide much needed sterilization capacity for a wide array of product portfolios,” commented Matt Jordan, Centerpiece’s CEO.

The 140,000 ft2 facility is equipped with state-of-the-art processing and emissions control equipment. Its sterilization chamber configuration also leverages chamber-specific preconditioning and aeration cells, moving product throughout the process via auto-pallet transfer systems.

Additionally, Centerpiece’s sterilization offering compliments its own contract manufacturing capabilities. OEM’s looking for a total supply chain solution, rather than just a contract manufacturer, now have an end-to-end offering.

“We’ve assessed the complete ecosystem of our industry and subsequently invested accordingly,” concluded Matt Jordan.

Onyx Scientific Makes UK Facility Investment

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

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

The facility, which represents a $3.96m 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.

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

Denise Bowser, Commercial Director at Onyx Scientific, commented: “At Onyx, our chemists are at the heart of everything we do, and we have built a strong reputation for assisting drug developers with complex chemistry.

“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.

The 70-strong team plans to add at least 30 extra people to its workforce in the next five years to support its clinical and commercial API manufacturing capabilities.

Stelis Starts Next Phase Of Facility Investment

This phase will see the company start work on installing two 2,000L single-use bioreactor trains in its mammalian CGMP facility.

Stelis BioSource has started the next phase of its investment program, having already invested over $100m into its facilities in Bangalore, India.

Two 2,000L single-use bioreactor trains will be added to the company’s 200,000 sq. ft. manufacturing facility which became operational earlier this year. The facility, which caters for drug product and drug substance manufacture, allows Stelis to offer 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 analytical methodologies and equipment and operates under the company’s quality management system.

Dr Roger Lias, CEO at Stelis Biopharma said: “Our CDMO facility in Bangalore is already fully operational working on both new and existing customer projects. 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’re 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 has plans to develop the site further.

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.

ISO Class 8 Mask Production Facility Built in Wales by Cleanroom Solutions

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

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

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

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

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

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

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

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

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

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

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

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

Construction Starts on the Medicines Manufacturing Innovation Centre

The technology and innovation center is designed to support small molecule and pharmaceutical manufacturing.

CPI has announced the start of construction at the Medicines Manufacturing Innovation Centre in Renfrewshire, Scotland.

It is planned to accelerate the development and industrialization of next-generation medicines manufacturing innovations and maximize technology opportunities within the medicines supply chain. Industry, academia, healthcare providers and regulators will work collaboratively within a GMP environment to address industry challenges and de-risk new technologies.

The Medicines Manufacturing Innovation Centre is a collaboration between CPI, the University of Strathclyde and founding industry partners, GSK and AstraZeneca with funding provided by Scottish Enterprise and UK Research and Innovation. The center has recently agreed partnerships with four technology companies to further strengthen the collaboration’s range of expertise.

The facility will translate, at industrial and commercial scale, novel techniques for producing patient-centric medicines, including real-time release of drugs, and integrated process analytics to drive the transformation of medicines manufacturing.

Companies will be able to use the facility to evaluate, test and prototype processes using Industry 4.0 manufacturing technologies, including continuous, digital and autonomous manufacturing.

The facility is due for completion late 2021 and will be operational in early 2022. It is expected to eventually house over 80 staff in both technical and non-technical roles.

Nadhim Zahawi, Life Sciences Minister, said: “Backed with £13 million of government funding, this center is the first of its kind and will significantly boost our domestic medicines manufacturing capability to ensure we are prepared for any future health crises. Complementing our state of the art Vaccines Manufacturing Innovation Centre in Oxfordshire, it will ensure we are at the forefront of transformational technologies, attracting tens-of-millions-of-pounds of investment to the UK and creating new highly-skilled jobs in the Renfrewshire area – a great example of how we are working to build back better.”

Frank Millar, CEO at CPI, said: “Aging populations, the increasing cost of drug development, and resource constraints impeding the adoption of emergent technologies are just some of the challenges facing the pharmaceutical industry today. The increasing financial burden on the healthcare system as a whole has led to a pressing need for more cost-effective medication. By connecting the dots between academia, government, industry and healthcare providers within this state-of-the-art center, we can address these issues and transform the pharmaceutical supply chain for the future.”

Dara and Telstar Cooperate on Vial Filling Line

A turnkey vial filling line integrating a freeze dryer with automatic loading & unloading system under isolation technology designed for the production of drugs for cancer treatment has been completed for the production facility of the South Korean pharmaceutical company Boryung Pharmaceutical in Yesan, South Chungcheong Province.

The integrated system, in which different technologies have been assembled to cover different phases of the manufacturing process of drugs, encompasses all stages of the manufacturing from washing, depyrogenation, through filling and lyophilization with automatic loading & unloading systems, to capping, and barrier system providing both, product protection and containment.

The development of this complex system relied on the cooperation between Telstar and Dara, who have collaborated on this project with their joint specialized technologies. Telstar, which has led this project under a contract holder agreement, has provided the GMP freeze-drying with row by row automatic loading & unloading system, as well as an aseptic isolator system made up of 8 modules. Dara supplied the filling machine, together with a washing machine, depyrogenation tunnel, capping machine, external vial washing machine and a tray loader.

The system has been installed in the Yesan production site. Besides the production of drugs for cancer treatment, the facility is also intended to produce the Boryung Pharmaceutical’s anti-hypertension drug Kanarb, drugs and complexes that include substances used for treating hyper blood pressure and hyperlipidemia.

Sai Life Sciences’ Process Chemistry R&D Laboratory Expansion, Manchester

Sai Life Sciences announced the expansion of its process chemistry R&D laboratory at Alderley Park, Manchester, UK in January 2021.

The expansion will double the number of scientists and enhance its technical capabilities of the Manchester site.

The site operates as a center of excellence for API process and analytical development and the proposed expansion will expand Sai’s capabilities to support its customers’ new chemical entity (NCE) development programs.

Fully operational since August 2020, the Manchester facility has 24 staff members and accomplished multiple projects involving complex chemistry.

The center of excellence for small molecule API process development is located in the center of the Alderley Park biotech and life-sciences ecosystem, a hub dedicated to the advancement of research and innovation.

A part of the Bruntwood SciTech network, Alderley Park has access to a range of companies across the pharmaceutical sector. It houses more than 60 established and 150 pre-established companies.

Amenities at the cluster include a conference center with a 232-seat auditorium and meeting space, a restaurant, a gym and outdoor sports facilities.

Sai Life Sciences’ Process Chemistry R&D laboratory expansion details:

The expansion will increase the site’s capacity from 20 to 75 fume hoods and bring the number of scientists to more than 50. It will help the company to meet the increasing demand from clients across the UK, other parts of Europe, and the US. The latest expansion will expand the company’s suite through the addition of new capabilities in the areas of process analytical technology (PAT), crystallization development, and analysis of physical properties.

Sai Life Sciences has recently started recruiting for numerous positions across the API process R&D, analytical R&D and particle sciences and engineering.

The Manchester site will undergo further expansion which will involve the addition of another GMP Kilo laboratory in 2021.

Details of the existing Manchester site:

Sai Life Sciences’ facility at the Alderley Park site is its first location in Europe. The lab acts as a vital link to the company’s Indian manufacturing sites while facilitating smooth integration with its service portfolio across the US and India. The services cover areas such as drug discovery and development through to commercial-scale production.

With 5,300ft² of process chemistry and R&D laboratory space, the site offers route scouting, control strategy definition, good laboratory practices (GLP) toxicology material preparation, and consultancy services for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7, and chemistry, manufacturing and controls (CMC) regulatory affairs.

It is installed with a variety of instruments and capabilities including Buchi Versoclave, Kiloclave pressure systems, Radley’s reaction station, Amigochem Integrity 10 parallel reaction block, HEL ChemSCAN II, and Teledyne CombiFlash Torrent. The facility allows pharmaceutical and biotech companies in the UK and European Union (EU) to have face-to-face collaboration with its scientists and encourage interactions with US-based customers.

It is expected to provide world-class development, scale-up, and technology transfer to the company’s facilities in India.

Marketing commentary:

Sai Life Sciences is among the fastest-growing contract development and manufacturing organizations (CDMO) in India. It is the first Indian company to establish a facility at Alderley Park.

The company is working with global biotech and pharmaceutical firms to support the discovery, development, and production of complex small molecules and facilitate the introduction of 25 new medicines by 2025.

Sai Life Sciences plans to invest $150m between 2019 and 2023 in people and culture, processes and automation, and infrastructure and scientific capabilities.

BioNTech’s COVID-19 Vaccine Manufacturing Facility

BioNTech’s manufacturing site in Marburg, Germany, will be used for the production of its Covid-19 vaccine candidate, BNT162.

Based on BioNTech’s proprietary mRNA technology, the BNT162 vaccine was developed by the company in partnership with Pfizer.

The manufacturing site was acquired by BioNTech from Swiss pharma company Novartis in September 2020 to expand its production capacity to produce a potential vaccine for the treatment of the novel coronavirus.

The company pursued the acquisition to accelerate its efforts to expand the commercial production capacity of the BNT162 mRNA Covid-19 vaccine candidate.

The site will be among the largest mRNA manufacturing facilities worldwide. Expected to produce up to 750 million doses of the Covid-19 vaccine, it started production in February 2021.

BioNTech plans to manufacture up to 250 million BNT162b2 doses in the first half of 2021. The first batch of vaccines produced at the Marburg site is expected to be delivered in April 2021.

The Covid-19 vaccine manufacturing facility is located in a life science industry park, which houses more than ten companies with a total workforce of 6,000 employees.

The industrial park is one hour away from Frankfurt Airport and 90 minutes from the headquarters of BioNTech in Mainz, Germany.

The Marburg facility has a long legacy of research and development. Previously known as Behringwerke, the site was established in 1904 by German physiologist Emil von Behring, who developed anti-toxins for diphtheria and tetanus.

The site has been involved in pharmaceutical and biologic research, including vaccine manufacturing.

Covid-19 vaccine manufacturing facility details:

BioNTech’s Marburg site is a multi-platform good manufacturing practice (GMP) accredited manufacturing facility. It has approximately 300 employees.

Manufacturing of vaccines in compliance with the GMP specifications is a requirement for the validity of the manufacturing processes by the European Medicines Agency (EMA).

The facility can develop recombinant proteins, as well as cell and gene therapies. It is equipped with cell culture laboratories and viral vector production capabilities, with scope for expansion in the future.

The company is planning to produce other mRNAs, antibodies, and cell and gene therapy vaccines at the Marburg facility to facilitate the development of its cancer and infectious disease drug pipeline.

It will use the site to meet the global demand for Covid-19 vaccines. The new site will provide BioNTech with in-house manufacturing capability for mRNA development and vaccine formulation.

The manufacturing process involves a series of steps, with the first step beginning in February 2021. The first step involves the manufacture of mRNA, the active pharmaceutical ingredient (API) of the BNT162 Covid-19 vaccine.

A sole mRNA batch of the current scale can be used to manufacture approximately eight million doses of the vaccine.

BioNTech received a manufacturing license from the Darmstadt Regional Administrative Council for the amended Marburg site.

The mRNA will be purified and concentrated after initial production. The next stage after the completion of mRNA production is the production of lipid nanoparticles (LNP) by mixing mRNA with different lipids.

The drug product will undergo further purification before it is shipped to a partner site for filling and finishing under sterile conditions.

It will be subjected to quality checks to verify its quality before the release. The finished product’s quality analysis is conducted at BioNTech’s Idar-Oberstein quality control laboratory and the official medicinal batch laboratory (Paul-Ehrlich-Institute in Germany). The manufacturing processes must be approved based on a review of quality and validation data by the EMA to enable the delivery of drug products from the site.

Data from the initial batches of production will be analyzed using a centralized variation procedure coordinated by the EMA. The validation and data submission will be completed by March 2021. The first batches of the vaccine will then be transported to the partner sites to implement sterile fill and finish operations, subject to the receipt of approval from the EMA. The vaccines will then be delivered to the vaccination sites for supply to various governments.

Samsung Biologics’ P4 Super Plant, Songdo

Samsung Biologics is planning to expand its manufacturing facilities with the construction of its fourth biopharmaceutical manufacturing plant, P4-Super Plant, in Songdo, South Korea.

The plant is a part of the company’s long-term strategy to improve its operational efficiency and to scale up its development and production capabilities in wake of rising biomanufacturing demands.

Additionally, Samsung Biologics launched a new cell line technology to boost its cell culture services in August 2020. The company is also in talks with the Incheon Free Economic Zone (IFEZ) authorities to acquire additional land for the development of its second bio complex.

Both facilities could cost more than KRW2tn (approximately $2bn), which will be more than the company’s combined investment in its existing three plants in the last nine years.

The manufacturing activities in P4-Super Plant should begin in the second half of 2022.

P4 Super biologic plant will be located at the company’s existing site in the Songdo district of Incheon in South Korea. The total floor area of the Super Plant will be 2,560,880 sq. ft. (238,000m2), which is equivalent to the combined floor area of the existing three plants.

With the area of approximately 3,550,800 sq. ft. (330,000m²), the proposed land for the second bio complex lies close to the existing complex of the company.

The land will be utilized to create an Open Innovation center to nurture biotech companies and develop a global R&D facility while accommodating the company’s potential future plants.

P4 Super Plant will add 256KL bioreactor capacity to the company’s existing 364KL capacity at the Incheon site.

The plant will allow Samsung Biologics to operate the world’s largest manufacturing facility at a single site with the total capacity of 620KL upon completion, designed to integrate all the special features from the three existing plants, facilitating multi-scale manufacturing services at the site. The services will satisfy the diverse demands of current and new customers.

The company will implement automation and latest biomanufacturing technologies to simulate real-time production schedule. It will optimize utility supply based on the data gathered from the existing plants.

Samsung Biologics is also investing generously to minimize the environmental impact of its facilities. The newly emerging technologies such as streamlined application, efficient disposal of high-concentration wastewater, and improvement of nitric acid emissions will improve the workplace and community environment.

Marketing Commentary on Samsung Biologics:

Established in April 2011, Samsung Biologics is a fully integrated contract development and manufacturing organization (CDMO) based in Seoul, South Korea. The company offers a range of global services beyond contract manufacturing, development and research at every stage of a biopharmaceutical product, addressing the emerging needs of the global healthcare industry.

The company employs more than 2,590 people and serves more than 30 global customers. It received a total of 64 global approvals, as of 2020.

Samsung Biologics has signed orders worth more than KRW1.8tn in the first half of 2020, attributed to its cost competitiveness, state-of-the-art technologies, and prompt response to demand for outsourced manufacturing of products such as Covid-19 treatment candidates. The total value of the orders is approximately 2.5 times the overall sales of the company in 2019.

Valmet to Invest in Filter Fabric Manufacturing in India

New equipment will start operation in the second quarter of 2021.

Valmet has decided to invest in filter fabric manufacturing in Pune, India, in order to better serve its customers and improve delivery times of filter fabrics to the Asia Pacific and Middle East areas.

The investment includes manufacturing equipment for filter fabric production. The new unit will start operation in the second quarter of 2021.

“This investment gives us the necessary assets to further develop our services close to customers and strengthen our position in the market. It also ensures our capacity for the coming years to deliver filter fabrics that respond to customer needs for maximized reliability and optimized performance of their production process,” says Tero Kokko, vice president, Fabrics Business Unit, Valmet.

Valmet is one of the leading suppliers of filter fabrics and industrial textiles globally. Valmet’s filtration offering covers filter fabrics and felts for the mining and chemical, pulp and paper, dry filtration and laundry industries.

Thermo Fisher Continues Global Expansion

Thermo Fisher late last year put $24 million into its biologics facility in Ireland.

Thermo Fisher Scientific has aggressively expanded its biologics manufacturing capacity in recent months, putting millions into capital spending.

Now, in another deal that will keep its supply chain growing, Thermo Fisher has inked a long-term tie-up at CSL Behring's Lengnau, Switzerland, facility to boost its biologics manufacturing capacity, the companies said.

As part of the deal, Thermo Fisher will take over operations of CSL's "state-of-the-art" biologics facility once it comes online in mid-2021. In return, Thermo Fisher will streamline discovery and manufacturing for CSL's drug portfolio, including producing hemophilia B therapy Idelvion at the Lengnau site.

According to CSL's website, the drugmaker broke ground on the $413 million Lengnau plant in June 2015. The company planned the site to employ 300 once it was fully operational.

Thermo Fisher intends to continue to expand the Lengnau site to "support additional biopharma customers," the company said.

"We continue to invest to meet the growing need for flexible biologics capacity, and Lengnau will significantly expand our pharma services capacity and capabilities," Thermo Fisher Executive Vice President Michel Lagarde said in a release.

Thermo Fisher's newest lease agreement follows a rich year for the Massachusetts-based CDMO, which has been aggressively expanding its global capacity.

In November, the company said it would invest nearly $24 million in its biologics site at Inchinnan, Scotland, to boost its ability to manufacture cell culture media. It said it expects to complete the work in 2021.

The month before, Thermo Fisher said its 2019 capital expenditures would reach $270 million with investments in its fill-finish operations, distribution in Asia, South America and India, and a virtual reality training center in Greenville, North Carolina.

The company in 2019 also paid $110 million for a GlaxoSmithKline API plant in Ireland, and the CDMO unit planned to open a viral vector facility in Lexington, Massachusetts, later in the year.

That facility was part of a $1.7 billion cash deal Thermo Fisher pulled off earlier this year for Brammer Bio, which allowed Thermo Fisher to play in the growing field of gene-modified cell therapies and in vivo gene therapies. The 50,000-square-foot plant will have 200 employees, the company said.

More Thermo Fisher

Also, a day before Thermo Fisher sketched out its Carlsbad plans, the company announced a twin pharma services expansion in Europe. First up for completion in late December is an 86,000-square-foot packaging, storage, logistics and distribution center in Rheinfelden, Germany, which will serve as a strategic logistics hub for European clinical trials.

McIlvaine Company

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

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