PHARMACEUTICAL & BIOTECHNOLOGY

Level 10 Construction has completed a project for TriLink Biotechnologies including GMP and non-GMP manufacturing spaces for vaccine and diagnostic test kit components.

Level 10 Construction has completed a cGMP space for TriLink Biotechnologies, which has fueled the development of COVID-19 diagnostic test kits and vaccines by providing high-quality and efficient delivery of mRNA, capping reagents, oligonucleotides, and NTPs.

This will be the second construction that Level 10 Construction has completed for TriLink Biotechnologies including GMP and non-GMP Manufacturing spaces, as well as an expanded shipping and receiving area.

"The design and construction teams worked side by side day and night overcoming several obstacles to deliver the facility ready for validation in a very short time frame. And because of this, we knocked this project out of the park by completing a cGMP space in 4-1/2 months to deliver an important component of the COVID vaccine," said Jerry Kirkland, Project Executive of Level 10 Construction. "Thanks to all the project team members including McFarlane Architects among many others."

Level 10 Construction worked directly with Christine Perez, Sr Director, Project Management at TriLink BioTechnologies, part of Maravai LifeSciences.

Perez added: "Throughout the construction process, Level 10 stayed on schedule to meet the deadlines they promised. Level 10 worked very collaboratively keeping us informed through the entire process including budget review, critical timelines and long lead item material planning. It is important to mention that both critical projects were in support of COVID 19 efforts and had very aggressive timelines. Level 10 worked through essential business operations, supply chain constraints and all the while maintained a safe operating environment."

Taysha’s Gene Therapy Manufacturing Facility, Durham, North Carolina

Taysha Gene Therapies will build a new current Good Manufacturing Practices (cGMP) gene therapy manufacturing facility in Durham, North Carolina, US to support preclinical, clinical and commercial cGMP production of its broad gene therapy pipeline drugs.

The facility is expected to begin production in 2023, creating approximately 200 jobs over a 30-month period.

The site for the manufacturing facility was finalized in North Carolina as the location has a thriving gene therapy ecosystem with a talented workforce and extensive expertise in gene therapy manufacturing.

Taysha’s decision to expand to Durham will enhance the city’s reputation as a leading center for technology, innovation and life sciences.

The new commercial-scale gene therapy manufacturing facility will be developed in a leased cGMP facility built upon an area of 187,000ft2. It will feature several production suites with a total capacity of 2,000l that will allow production in compliance with the US Food and Drug Administration (FDA) guidelines.

Taysha’s state-of-the-art facility will be designed to support scalable production of comprehensive gene therapy material for the company’s pipeline and to satisfy the potential clinical and commercial demand. It will also improve the manufacturing capacity from the company’s existing manufacturing partnerships with UT Southwestern’s Gene Therapy Program and Catalent.

The manufacturing facility will complement the existing capabilities and secure a long-term supply chain that is well aligned with the strategic objectives. It will allow rapid and efficient delivery of potentially transformative therapies for patients with monogenic central nervous system (CNS) diseases.

The company will invest $75m for the development of the manufacturing facility and will receive up to $9.4m in state and local incentives for the expansion. Up to $4.8m of funding will be received as a Job Development Investment Grant (JDIG) by the state’s Economic Investment Committee over 12 years, while a local incentive investment of up to $4.6m will be received over four years.

“The facility is expected to begin production in 2023, creating approximately 200 jobs over a 30-month period.”

During the 12-year term of JDIG, the project is expected to increase the economy of the state by $772m and will have an annual payroll impact of more than $22m in the region after the commencement of the production.

The investment in the facility is part of the company’s comprehensive three-pillar production strategy to satisfy the supply needs of several concurrent clinical programs emerging from the gene therapy pipeline as the company plans to file four open investigational new drug (IND) applications in 2021.

Marketing commentary on Taysha Gene Therapies:

Taysha Gene Therapies is a gene therapy developing company established in partnership with the University of Texas Southwestern Medical Centre (UT Southwestern) to develop and commercialize transformative gene therapy treatments.

The company focuses on the discovery, development, and commercialization of gene therapies for the treatment of CNS monogenic disorders, both in rare and large patient populations.

Through the collaboration, the company can harness the collective resources of UT Southwestern researchers, clinicians, and investigators with decades of experience in cutting-edge research and offering clinical treatment.

Taysha has access to the UT Southwestern faculty, the GMP viral vector production facility, and the integrated research and clinical treatment approach.

The company leverages the recent successes in the production and commercialization of gene therapy, including adeno-associated virus serotype 9 (AAV9) capsid, intrathecal delivery and an efficient manufacturing process in its approach.

Aphena’s Expansion Nears Completion in Tennessee

Bottle packaging capacity has been expanded with the installation of 10 high-speed bottling lines to start.

Aphena Pharma Solutions’ ongoing $21 million expansion of its Solid Dose Division in Cookeville, TN, is on schedule with a planned completion date of April 1.

The expansion, announced in September 2020, includes the acquisition of a 500,000-sq.-ft. property purpose-built for FDA manufacturing and packaging operations and represents Aphena’s expansion into biologics, cold chain storage and third-party logistics distribution.

The company’s bottle packaging capacity has been expanded with the installation of 10 high-speed bottling lines to start, for solid-based products including tablets, capsules, caplets, soft gels and gel caps. Aphena plans to install 30 more high-speed lines in the new facility, bringing monthly capacity to over 80 million bottles.

Aphena’s bottling services include purchasing all of the primary and secondary packaging materials, including pharmaceutical bottle labeling with serialization support. Various configurations and sizes are available, including square bottles, and Aphena has the ability to run batches from 1,000 to 10 million bottles under cGMP quality systems.

“This new facility and bottling lines set the foundation for Aphena’s solid dose packaging future, allowing us to maintain a 50% capacity level for any new projects or surge capacity requirements so that we can continue to stay ahead of our current and future customers’ needs,” said Eric Allen, Aphena’s EVP of Sales and Marketing.

CDMO Northway Biotech Expands in U.S.

Opens new biopharmaceutical manufacturing site in greater Boston area.

Northway Biotech's new facility will provide end-to-end services for biologics microbial and mammalian-based biologics.

Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art, cGMP manufacturing site in Europe, has opened its new 30,000-square-foot process development and cGMP manufacturing site in Waltham, MA.

From cell line development to cGMP DS manufacturing and aseptic filling, the state-of-the-art facility, in the booming biotech hub in the Greater Boston area, will provide end-to-end services for biologics microbial and mammalian-based biologics. Currently, the new site has fully established process, analytical method development, and quality control labs supporting local and international customer projects since summer 2020. The cGMP biomanufacturing suite will house 500 L microbial and 2,000 L mammalian bioreactors and be operational in Q4 2021, representing a capital investment program worth $40 million.

"Northway Biotech reaches an important strategic milestone to further strengthen its leadership by opening a second biomanufacturing facility and its first in the U.S,” said Vladas Algirdas Bumelis, chief executive officer, Northway Biotech. “We are very excited about this expansion and are poised to support our next-door partners in the Boston biotech hub, as well as other domestically or internationally located companies, by enabling accelerated development and manufacturing of their novel, life-saving biopharmaceuticals for clinical or commercial needs.”

Earlier last month, the company announced that it is changing its brand name from Northway Biotechpharma to Northway Biotech to harmonize its brand name across EU and U.S.-located sites.

Cytiva’s New Manufacturing Facility, Shrewsbury, Massachusetts, USA

Cytiva opened a new facility for manufacturing Xcellerex XDR bioreactors in Shrewsbury, Massachusetts, US, in December 2020.

The new manufacturing facility has been developed as a part of the company’s five-year plan to expand its global manufacturing capacity with a total investment of $500m to tap the rising demand for its technologies and solutions and new market opportunities.

The Shrewsbury facility enabled the company to release the manufacturing capacity in the Westborough facility, Massachusetts, for the manufacturing of complementary single-use technologies. Cytiva aims to expand the Westborough facility’s capacity by the second quarter of 2021.

A technology investment agreement signed between Cytiva and the Biomedical Advanced Research and Development Authority (BARDA) in October 2020 benefitted the new manufacturing facility.

Cytiva plans to hire approximately 200 Massachusetts residents for the plant for various roles.

Cytiva’s new facility in Shrewsbury is an addition to the company’s global manufacturing and distribution network present across 13 sites in North America, Europe and Asia.

The 80,000ft2 facility is equipped with five production lines that operate 24 hours through five days a week, a new clean room and a research and development laboratory.

Automation has been increased at the facility to provide additional manufacturing capacity.

Xcellerex XDR is a single-use, cell culture bioreactor system with robust stirred tank efficiency of up to 2,000l in both cGMP (current good manufacturing practice) and non-cGMP environments.

XDR bioreactor platforms are available with operating volumes of 50l, 200l, 500l, 1,000l and 2,000l and can be operated in batch, fed-batch and perfusion bioreactor modes, depending on their development objectives.

The bioreactor vessel is made up of 304-grade stainless steel. The bioreactor bag assembly (XDA) is disposed of after the termination of culture, eliminating the costly and time-taking cleaning-in-place (CIP) and steam-in-place (SIP) functions.

“Cytiva plans to hire approximately 200 Massachusetts residents for the plant for various roles.”

Bioreactors offer versatile and scalable options for biopharmaceutical, vaccine and antibodies manufacturers. The systems deliver a seamless transition from process development to production scale, with the ease and cost-effectiveness of single-use technology.

XDR stirred tank bioreactor is proven and dependable, whether migrating from re-useable technology or opening a new facility.

The biotherapeutics sector is expected to witness double-digit growth by 2025. Approximately 85% of the biologics used in pre-commercial and clinical scale are manufactured using single-use technologies, according to BioPlan’s 2020 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

Cytiva plans to more than double its single-use products’ manufacturing capacity by installing additional equipment and infrastructure at various sites.

Its partnership with Wego, a healthcare technology supplier in China, will enable it to triple its single-use capacity in the Asia-Pacific.

Marketing commentary on Cytiva:

Formerly part of GE Healthcare Life Sciences, Cytiva is a global healthcare technologies and services provider with more than 7,000 associates in 40 countries dedicated to improving access to life-changing therapies that transform human health.

The company brings efficiency to research and manufacturing workflows, ensuring the development, production and distribution of ground-breaking medications to patients. More than 75% of the biological therapies approved by the US Food and Drug Administration (FDA) in 2019 depended on Cytiva’s manufacturing technologies.

The company also doubled its MabSelect and Capto chromatography product platforms’ manufacturing capacity through the facility modernization program at its site in Uppsala, Sweden.

Cognate Plans Manufacturing Expansion in US And Europe

Build-out of the commercial manufacturing location will begin in 2021 with the goal of coming online as quickly as possible.

Cognate BioServices, the premier commercial-ready, global CDMO in the Cell and Gene Therapy industry, has announced its plans to expand cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities, and increase office support at its facilities in the US and Europe.

The expansion activities will nearly double the capacity at Cognate's existing global manufacturing facility & headquarters, located only minutes from Memphis International Airport, the world's second-busiest cargo airport. In Memphis, Cognate will add two separate facilities - a distribution center to help manage global supply chain needs, and a third site focused on commercial manufacturing capabilities - all totaling nearly 250,000 sq. ft. of space.

Construction has already begun on Cognate's GMP distribution center and is expected to finalize in early 2021; build-out of the commercial manufacturing location will begin in 2021 with the goal of coming online as quickly as possible.

"Our expansion plans in cell and gene therapy, in the US and Europe, and the close proximity to a global shipping and logistics hubs, provide Cognate BioServices, together with Cobra Biologics, a unique competitive advantage not available to other CDMOs. This is critically important to our clients around the world who are commercializing cell and gene therapies that require rapid turn around and often utilize real-time shipping and handling," said J. Kelly Ganjei, Chairman & CEO of Cognate.

Cognate initially outlined these US expansion plans in connection with its application for a 15-year Expansion PILOT (payment-in-lieu-of-taxes) approval from the Economic Development Growth Engine (EDGE) for Memphis and Shelby County.

"As our economy continues to recover in the midst of a pandemic, Cognate BioServices' decision to expand in Memphis is great news for our state and the citizens of West Tennessee," Tennessee Governor Bill Lee said. "The creation of more than 550 high-quality jobs means new opportunities for area residents, and I appreciate Cognate BioServices for its continued investment and job creation in Tennessee."

In addition, Cobra Biologics, the gene therapy division of the Cognate BioServices' group, is undertaking a multi-phase augmentation of its plasmid DNA services as a continuation of its Gene Therapy services' expansion project for viral vectors and plasmid DNA. This includes a four-fold increase in HQ (High Quality) DNA manufacturing capacity alongside new clinical and commercial GMP DNA facilities at its European facilities. The HQ plasmid manufacturing service provides a rapid six-week delivery time for the clinical manufacture of immuno-oncology therapies, for example products utilizing AAV, lentiviral vector and CRISPR products.

After its acquisition of Cobra Biologics in January 2020, Cognate has positioned itself as a global provider of end-to-end capabilities in the development and manufacturing of cell & gene therapy products. This expansion is in direct response to the great demand of commercial capacity within the biologics industry.

LSNE Expands Fill Finish and Lyophilization Ops

New automated fill line at Bedford Campus adds ready-to-use aseptic filling and freeze-dryer capacity.

LSNE Contract Manufacturing expanded vial filling and lyophilization capacity with the addition of a new automated aseptic fill line, housed in an existing ISO-5 clean room suite at its facility in Bedford, NH. The multi-product fill line serves to increase capacity and flexibility for manufacturing high-value APIs to meet the demand in drug product manufacturing driven by the Covid-19 pandemic.

This manufacturing suite is designed to support products that require minimal process loss because of API availability or high cost. The new fill suite features in-line (non-destructive) weight checks and fully disposable formulation and manufacturing materials, minimizing line loss and conserving product for every batch. The new fill suite is scheduled to be qualified and ready for contract cGMP manufacturing in 3Q21 increasing LSNE's capacity by up to 100 additional aseptic manufacturing lots per year.

"LSNE continues to innovate and expand our global capacity and capabilities to better serve pharmaceutical companies with their ever changing clinical and commercial programs. By investing in this new GMP sterile fill finish capacity on our Bedford, New Hampshire campus, we continue to execute on our corporate growth strategy and better serve our client's needs, especially where product loss is a key consideration," said Shawn Cain, Chief Operating Officer.

Abzena Unveils New Biologics GMP Manufacturing Site

U.S.-based facility will be equipped with up to 12 X 2000L bioreactors.

Abzena, a global partner research organization for integrated bench to market solutions for biologics and bioconjugates, has added a sixth global site that will augment cGMP manufacturing capacity for mammalian biologics. This expansion is driven by an increase in customer demand for commercial scale 2000L single use bioreactors across a wide range of therapeutic areas.

The new facility will be based in the U.S. and will accommodate phase 3 and commercial manufacturing. A phased approach to construction will initially allow 4 modular suites with each suite including up to two 2000L bioreactors, followed by the addition of two further 2000L suites. Additionally, the site will be equipped to handle existing and new advances in manufacturing such as continuous manufacturing and perfusion with manufacturing commencing in mid-2022.

“We are delighted to support our partners and the patients they serve with this investment in cGMP biologics manufacturing,” said Jonathan Goldman, chief executive officer, Abzena. “This builds on the successful launch of our second cGMP facility in San Diego in 2020. We are pleased to provide integrated asset development with a full suite of in-house services from discovery through clinical and commercial phases without the need for technology transfer.”

Kimball Hall, president and chief operating officer, Abzena, said, “The expansion in manufacturing capacity allows us to scale with our expanding customer needs. Our team is very experienced in high quality clinical and commercial manufacturing of mammalian drug substance. We have used this experience to incorporate the most technologically advanced solutions in the design of the new site and are excited to welcome existing and new partners to work with us.”

Altasciences Doubles Size of PA CDMO Facility

The additional 35,000-sq.-ft. building in Philadelphia will include warehouse and cGMP manufacturing suites.

Altasciences, a Quebec-based early phase CRO/CDMO, began the expansion of its CDMO facility in Philadelphia, PA. The additional 35,000-sq.-ft. building directly adjoins the current location, and will be fully renovated to meet growing business needs.

The first phase of construction, including warehouse and cGMP manufacturing suites, is expected to be completed by the end of 2021. The new space will be configured to include a ~8,750-sq.-ft. warehouse, a ~8,750-sq.-ft. Grade C/D manufacturing area, and a 17,500-sq.-ft. client-dedicated cGMP manufacturing area.

“This expansion ensures that we are in an excellent position to continue to meet the needs of our clients and remain at the forefront of pharmaceutical manufacturing technology. We look forward to seeing this ambitious project come to completion in the coming months,” says Ben Reed, Vice President, Manufacturing at Altasciences.

Altasciences acquired the Philadelphia CDMO facility in February of 2020, and purchased the new building in December of 2020.

Piramal Pharma Solutions’ API Manufacturing Facility Expansion, Riverview, Michigan

Piramal Pharma Solutions (PPS) is expanding its manufacturing facility in Riverview, Michigan, with an investment of approximately $32m to develop and manufacture potent and non-potent active pharmaceutical ingredients (API).

Announced in December 2020, the expansion will incorporate innovative capabilities and increased capacity for a new laboratory and large-scale manufacturing.

The expansion should be complete for operations in June 2022. It will add approximately 20 new workers to the facility, increasing the overall number of employees to more than 180 and will support the regional economy.

PPS’ API manufacturing facility, located at Krause Street, Riverview, Michigan is well-known for high-potency active pharmaceutical ingredients (HPAPIs) manufacturing.

The facility will be expanded with the addition of more than 25,000ft2 that includes an 8,500ft2 production area to the existing facility.

It will be installed with new 4,000L reactors along with the addition of two new kilo laboratories for process development and GMP manufacturing for clinical trials up to 100L scale.

Other crucial equipment, including a 1m2 filters dryer with glove box technology, a 3KL and a 4KL mild steel glass-lined reactor, and a 3KL Hastelloy reactor will also be added to the facility. All equipment is designed to handle potent compounds with occupational exposure levels (OELs) more than 1mcg / m3.

The facility is designed with all necessary measures for safe handling of the highly-potent compounds, including controlled room pressurization and airlocks for the safe movement of both persons and goods, scrubber for any off-gassing reaction and glove box technology or contained systems for charging and discharging of the powders.

The expansion will allow the company to meet the consumers’ immediate and long-term API needs, increasing its foothold in North America. It will improve the company’s ability to timely deliver quality active ingredients around the world.

The expansion marks the company’s seventh major acquisition or expansion in North America over the past six years.

PPS’ Riverview facility is compliant with regulatory norms, including those set by the US Food and Drug Administration (FDA) and several European and Asian government agencies. It maintains a high standard in health, safety and environmental sustainability.

The state-of-the-art Riverview facility is committed to manufacturing low OEL HPAPIs.

It is equipped with 4,000L glass-lined reaction vessels which can operate in a temperature range from -70°C to 200°C, high-potency manufacturing suites with airlocks and barrier isolation systems and reactor bays for large-scale HPAPIs.

“The facility will be expanded with the addition of more than 25,000ft2 that includes an 8,500ft2 production area to the existing facility.”

The site features product insulation capabilities, including extraction, filtration, centrifugation, and distillation, as well as drying and finishing capabilities including enclosed Rosenmund glove-box filter dryers, forced air and vacuum drying ovens and class 10,000 clean suites.

Running for 12 hours a day through seven days a week and is heading towards becoming a full 24 / 7 site, the establishment holds 15 US Food and Drug Administration (FDA) approvals and has experience in breakthrough status, orphan diseases, and fast track approvals.

The site also offers featured services such as process research full-time equivalents (FTEs), optimization, commercial API and HPAPI manufacturing, safety assessments, impurity identification, characterization and synthesis, solid-state characterization, analytical method development, qualification and validation.

Rocket Pharmaceuticals’ Research and Development (R&D) 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.

Rocket Pharmaceuticals’ Research and Development and Manufacturing Facility details…

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

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.

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 Osteopetrosis, a rare, genetic bone disorder. The company announced that its first AAV-based program targets Danon disease.

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’s new state-of-the-art commercial manufacturing facility will be built upon an area of 140,000ft2 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.

“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.”

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.

Arranta Bio’s Boxborough Facility, Massachusetts

Arranta Bio, a US-based microbiome contract development and manufacturing organization (CDMO), is building a manufacturing facility in Boxborough, Massachusetts.

Arranta Bio, a US-based microbiome contract development and manufacturing organization (CDMO), is building a manufacturing facility in Boxborough, Massachusetts. The 130,000ft² facility will complement Arranta Bio’s existing facilities in Watertown, Massachusetts, and Gainesville, Florida, and will increase the company’s total manufacturing capacity to more than 230,000ft².

Construction of the facility started in March 2021 and long-lead items are currently being procured. The first phase of construction is expected to be finished by the end of 2021, with the plant expected to start operations in early 2022.

The microbiome production facility will add capacity for the supply of clinical and commercial microbiome products to customers. It will include flexible production suites that comply with good manufacturing practice (GMP) and will meet clients’ processing requirements for drug substances and finished drug products.

The plant will provide dedicated laboratory spaces to support clients’ commercial products or product pipelines. It will initially feature multi-client capacity of up to 2,000l single-use bioreactors for producing anaerobic bacteria or 1,000l scale single-use fermenters for producing aerobic bacteria.

Arranta Bio also plans to make the facility capable of fully automated manufacture of drug products, as well as having secondary packaging and labelling capacities. The firm is in discussions with microbiome innovators for commercial supply.

Arranta Bio aims to develop the Boxborough facility as a Centre of Excellence for late-stage and commercial microbiome live biotherapeutic products (LBP).

The facility will feature training capabilities to help address challenges in the microbiome sector, which will include developing a pipeline of anaerobic bacterial production expertise. It is also intended to support regulators to prepare for microbiome inspections and approvals by providing analysis and access to live biotherapeutics manufacturing and analytical capabilities.

Arranta Bio is investing more than $150m in the Boxborough facility. In October 2019, it raised $82m in a funding round that involved company founders, colleagues, Thermo Fisher Scientific and Ampersand Capital Partners. In March 2021, the company closed a Series B equity financing round to fund the Boxborough project.

Marketing commentary on Arranta Bio:

Arranta Bio is a CDMO that supports companies involved in the development and commercialization of therapies targeting human microbiome. The company was established in 2019 and is based in Watertown, Massachusetts. In November 2019, Arranta Bio acquired Captozyme, a company that provides process development and clinical contract manufacturing services to microbiome innovator companies.

Arranta Bio’s team has expertise in process development and contract manufacturing from fermentation stage to lyophilization and encapsulation of live biopharmaceuticals. In May 2020, the company finished expanding its microbiome process development laboratories at its facility in Gainesville, Florida, to meet the requirements of increasing client programs. It invested more than $100m to increase the process development and early clinical GMP supply capacity at the facility. The company also established an advanced, multi-product, commercial-ready manufacturing facility in Watertown, Massachusetts, to supply LBPs to microbiome companies. The Watertown facility was completed at the end of 2020 and is designed for advanced biologics production.

The company plans to have a workforce of more than 200 by the end of 2021 and is expected to employ 500 people once the expanded capacity is commissioned.

Thermo Fisher Scientific’s Plasmid DNA Manufacturing Facility, Carlsbad, California

Thermo Fisher Scientific is developing a new current good manufacturing practice (cGMP) facility in Carlsbad, California to expand its clinical and commercial capabilities for the production of plasmid DNA for cell and gene-based therapies.

The new facility is scheduled for completion in the first half of 2021. It will add approximately 150 jobs over the next 12 months.

The 67,000ft2 plasmid DNA manufacturing facility will be located on the Carlsbad campus of Thermo Fisher, the center of excellence for life science solutions to capitalize on the company’s long-standing presence in the city and leverage its rich talent pool.

The new state-of-the-art production facility will incorporate advanced technologies, including single-use equipment with a scale of up to 1,000l, digital connectivity, and data visibility to facilitate operational efficiencies and operator training.

CGMP plasmid DNA is used as a critical raw material for the manufacturing of life-saving cancer treatments as well as mRNA vaccines. The cGMP site will be strategically equipped to offer comprehensive end-to-end cell and gene therapy capabilities and will accelerate the commercialization of plasmid-based medicines and vaccines.

The site would also be capable of developing large-scale plasmid DNA as the primary drug material for DNA therapy.

An expansion will complement the viral vector services that the company offers from its facilities in Cambridge, Lexington, Plainville, Massachusetts, and Alachua, Florida, as well as from its cell therapy manufacturing plant in Princeton, New Jersey, and a new cryocentre in Weil am Rhein, Germany.

In biotechnology, plasmids have several uses and are regularly utilized as cloning vectors in bacteria and for the production of large-scale proteins, gene therapy, mRNA therapy, vaccine development, genetic modification, and animal-disease models.

Plasmids have played a key role over the last three decades as a commonly used molecular tool in various microorganisms and animal cells for DNA alteration and gene expression.

The key step in the workflow includes robust purification of plasmid DNA, in the volume and purity needed for the downstream application of interest.

A wide variety of Thermo Scientific™ GeneJET™ and Invitrogen™ PureLink™ plasmid purification kits have been designed and developed with the customer’s experimental specifications, plasmid purity, and throughput criteria in mind.

“CGMP plasmid DNA is used as a critical raw material for the manufacturing of life-saving cancer treatments as well as mRNA vaccines.”

Thermo Scientific GeneJET Plasmid Mini Kit uses silica-based membrane technology in the shape of a convenient spin column. The kit recovers up to 20μg of high-copy plasmid DNA by isolation procedure.

Invitrogen PureLink Fast Low-Endotoxin plasmid purification kits utilize next-generation columns with advanced silica membranes to allow rapid, precipitation-free isolation of transfection-grade (<1 EU/μg) plasmid DNA.

The simple precipitation-free protocol generates high-quality plasmids and is ideal for standard transfections as well as all molecular biology applications such as cloning and sequencing.

Headquartered in Boston, US, Thermo Fisher is a major producer of scientific instrumentation, diagnostics, reagents, and other materials for academics, researchers, government, healthcare, and life sciences industry.

The company offers pharmaceutical solutions for drug development, clinical trial logistics, and commercial production to consumers of all sizes through its Patheon brand.

It provides scientific and technological excellence, including advanced skills for highly potent and controlled drugs, expertise in virus vectors, aseptic filling and lyophilization, complex formulations, enhancement of solubility and difficult active pharmaceutical ingredients (APIs) to produce.

It also offers integrated drug development services that align drug and drug product development through a coordinated drive towards proof of concept that can minimize timelines for drug development.

Fujifilm to Invest to Build Large Scale US Cell Culture Facility

Tokyo headquartered, Fujifilm Corporation, has announced a new US$2bn (£1.4bn/€1.5bn) investment to establish a new large-scale biopharma site in the US.

The facility will be operated by its subsidiary, Fujifilm Diosynth Biotechnologies, which has locations in Teesside, UK, in North Carolina and Texas in the US and in Hillerød, Denmark.

The move serves to further underline Fujiflim’s ambitions within the contract development and manufacturing (CDMO) space, following its US$928m investment, announced last year, to expand its site in Hillerød, Denmark, and the capital it is ploughing into its UK and US facilities.

This latest investment, it said, will significantly expand Fujifilm's capacity for process development and manufacturing of antibodies, recombinant proteins, gene therapies and vaccines.

“Through this large investment in the US, we are able to support the development and manufacturing of new drugs that can help fulfill unmet medical needs,” commented Kenji Sukeno, president of Fujifilm Corporation.

The idea is that the new facility will become an end-to-end single-site solution.

It will offer large-scale cell culture manufacturing of bulk drug substance with eight 20,000L bioreactors, with the potential to expand and add a further 24 bioreactors of that volume based on market demand.

In addition to drug substance manufacture, the plant will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services, said the company.

The new facility will be built within the vicinity of an existing Fujifilm site, and is not scheduled to become operational before the spring of 2025.

Fujifilm has set a target to achieve an annual revenue of US$2bn for its bio-CDMO business by March 2025.

By March 2026, the company said it expects this latest investment to boost the annual growth rate of its bio-CDMO business to 20%, greatly exceeding market projections.

Oncorus to Build GMP Viral Immunotherapy Clinical Manufacturing Facility in Massachusetts

Oncorus has signed a 15-year lease to build an 88,000 square foot Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility in Andover, Massachusetts.

Oncorus is advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple cancer indications with significant unmet needs based on its oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. The company is currently conducting a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The company anticipates reporting interim data from this Phase 1 trial in the second half of 2021 through the second half of 2022. Oncorus plans to nominate its first intravenously administered synthetic virus clinical candidates (coxsackievirus A21 and Seneca Valley Virus programs) in the first half of 2021 and its second intratumorally administered oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021.

“Last year was a year of tremendous progress for Oncorus. We initiated a first-in-human study of our lead viral immunotherapy program, ONCR-177, signed a clinical collaboration agreement and supply agreement with Merck for ONCR-177, made strides advancing multiple earlier stage programs, successfully completed an IPO, and continued to strengthen our team,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO at Oncorus. “Now we’re thrilled to announce that we’ve signed a lease for our planned manufacturing facility, which will play a central role in enabling us to advance our mission to realize the full promise of viral immunotherapy for cancer patients. Operational and manufacturing scale-up will be a strategic priority for Oncorus going forward.”

The facility is intended to provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.

“The investment in this manufacturing facility demonstrates our commitment to growth and innovation,” said Steve Harbin, Chief Operations Officer and Chief of Staff at Oncorus. “In addition to ramping up GMP activities to support our near-term development needs, we also plan to build robust process development and scale-up infrastructure, which is critical for future efforts, including potential commercial launch support. This facility will give us control over quality and output and enhanced flexibility as we develop our multiple oHSV- and synthetic virus-based viral immunotherapy programs."

Rest of World

Polyplus-Transfection Begins Construction

Strasbourg-based Polyplus-transfection started construction of Vectura, a new 43,040 sq. ft. (4,000-square-meter) facility which is being built to enable the company to continue to tap into the exponential growth in demand for raw materials for advanced therapy medicinal product (ATMP) development and manufacturing.

Following completion of the facility, Polyplus officials say they will be able to meet the expectations of the gene and cell therapy market moving from late-stage clinical development into commercialization as well as ongoing increases in R&D and pre-clinical gene therapy development.

The facility will also house Polyplus-transfection’s head office, managing its international operations and delivery of transfection reagents to cell and gene therapy organizations around the globe.

According to a company spokesperson, the completion of the new facility will fulfil several immediate priorities for Polyplus, including doubling its headcount both in its gene and cell therapy transfection reagent manufacturing and development departments. It will also provide additional manufacturing capacity for ex vivo and in vivo therapy products. This is expected to increase Polyplus’ production capacity to manufacture and deliver transfection solutions to target a wide range of diseases globally. In the new facility, R&D and laboratory space will increase by over 300 percent.

Polyplus currently plans for the facility to be operational for its 20-year anniversary in the third quarter of 2021. The initiation of construction follows significant investment by Warburg Pincus and ArchiMed last April.

“The gene and cell therapy market continues to grow at a high rate, with more late-stage clinical trials moving towards commercialization, additionally supported by an increase in earlier stage therapies moving into the clinic. As a supplier of critical strategic materials for the sector, Polyplus-transfection will continue to invest to increase its capabilities and support its global customer base,” said Mario Philips, CEO, Polyplus-transfection. “We remain in prime position to support the maturing gene and cell therapy sector with critical materials, including innovative transfection solutions.”

NHS Wales and C2C Streamlined Sterile Manufacturing

Connect 2 Cleanrooms (C2C) expedited the design and build of a temporary medicines unit for NHS Wales’ new Central Intravenous Additive Service (CIVAS).

The new CIVAS temporary medicines unit can produce up to 2,600 syringes per week, to meet the forecasted demand during the second winter wave.

In March 2020, the UK Government increased Critical Care Unit (CCU) bed numbers by 3-4 times. However, it wasn’t possible to increase the number of critical care nurses overnight. With an urgent requirement for the nurses who have this specialist training to cover more beds than they would normally do, it explored ways in which CCUs could apply lean principles to generate efficiencies.

One of the main activities that takes critical care nurses away from patients is making up their intravenous drugs. The Welsh Government decided to create a central manufacturing capacity to make the sterile injections for critical care to support CCUs right across Wales.

The MHRA determined that this process would need to be conducted in cleanroom facilities, so NHS Wales partnered with C2C. It fast-tracked a purpose-built cleanroom facility, including GMP qualification from DQ-PQ, which was ready for MHRA inspection in just six months.

Paul Spark, Pharmacist at NHS Wales Shared Services Partnership, said: “Connect 2 Cleanrooms recognized the importance of the project and it’s been completed amazingly quickly. The company pulled out all the stops to begin with at design stage and the same urgency went right the way through the construction phase.”

The 8,608 sq. ft. (80m squared) cleanroom features integrated doors with an interlocking system to create airlocks that protect integrity and staff. The safe transfer of materials in and out of the facility is provided through diffusion pathway interlocking transfer hatches.

C2C’s ECO2 integrated monitoring and control system gives real-time visibility on the cleanroom’s performance by monitoring pressure differentials, temperature, relative humidity, particle counts and other requirements. NHS Wales can record batch ID against datasets and the 21 CFR 11 system meets audit trail requirements for traceability and protection of data.

WHP Completes New Medical Cannabis Cleanroom and Production Facilities

WHP Engineering designed the specialist areas in full compliance with MHRA regulations and conform to ISO Class 7 at rest with 20 air changes.

Multi-disciplinary engineering company WHP has been awarded the contract to design, build and validate a state-of-the-art manufacturing pharmaceutical cleanroom and food production facility.

New state of the art cleanroom and production facilities for a leading UK MHRA approved and NHS Accredited Specials Manufacturing Company will assist them in their goal of becoming a center of medical cannabis excellence for the UK.

The specialist areas were designed in full compliance with MHRA regulations and conform to ISO Class 7 at rest with 20 air changes. This includes a specially designed HVAC system with room side HEPA filtration to maintain the segregation, cleanliness, air pressures and other environmental controls.

WHP were able to offer space-saving solutions during the design phase to maximize the production and cleanroom areas. This included innovative ways of locating equipment and incorporating a steel partition wall system to provide a flexible layout to the facility.

Ian Lichfield, Chief Executive of WHP, said: "WHP's cleanroom solutions, designed and built to the highest standards, balance health and safety, process demands and energy-efficient cleanliness; helping our clients to retain their lead in growing and highly competitive sectors."

Hydroflex Progresses Well with New Headquarters Construction

Hydroflex is expanding at new location in Buseck, near Giessen, Germany.

Hydroflex has announced its expansion at new location in Buseck, near Giessen. The construction of the new Hydroflex headquarters is well advanced. It forms the basis for further expansion and the ambitious future plans of the internationally operating expert for cleanroom cleaning solutions. More than three times as much workspace is available at the new location in Buseck, near Giessen, than at the previous location. This enables 50 workplaces within a short term. Relocation to the new facility is scheduled for the second quarter of 2021.

With a clear focus on developing cleanroom compatible hygiene solutions, the brothers Terry and Edward Becker founded Hydroflex Cleanroom Hygiene in 2009, a specialization that has paid off. Today, thanks to clever solutions and highest quality, Hydroflex is internationally renowned and a leading supplier in its segment.

"Our specialized solutions engineered in Germany receive great acceptance worldwide and are able to achieve highly in international competition," said Edward Becker. This is also reflected in the company's dynamic development. Contrary to the current overall economic situation, the two founders achieved a very positive development in 2020, as also in previous years: "We were able to continue our strong double-digit growth", said Edward Becker. "And we are now setting the course for the future with our new facility," Terry Becker adds.

The modern new building will function as the global company headquarters and will have a site area of more than 11,000 sqm The administration, sales, and marketing, as well as the global quality management of the company, will be controlled from here.

The newly designed, spacious cleanroom and laboratory areas set clear focus on product development and thus ensure the company's claim to be the innovation leader in cleanroom cleaning systems. The increased production space for cleaning tools and system as well as a state-of-the-art warehouse will ensure reliable delivery to European and worldwide customers.

Despite the international orientation, the choice of the new location also means staying in the central state region of Hesse and creating new jobs there. The location in Giessen is centrally located in Germany, close to the highway and Frankfurt Airport, and offers an optimal overall infrastructure.

In addition, Hydroflex is also focused on the well-being of its employees. Great views over the forests of central Hesse, for instance from the large roof terrace as well as modern, ergonomically thought-out workplaces ensure a particularly relaxed working atmosphere. Hydroflex's customers and partners will be able to experience and test its products in the showroom and training spaces.

"Hydroflex has the claim to be a pioneer and to break new grounds in cleanroom cleaning. The distinctive dynamism of the company and its core values are reflected in the building design: dynamic, ambitious architecture, aspiring lines, contemporary design", said Terry Becker. "A consequent continuation of the corporate design - translated into the third dimension." A competence center for the development and manufacturing of innovative solutions and services for a clean future.

With a motivated and passionate team of experts, Hydroflex is ready for any challenges linked to cleanroom hygiene. By supplying technologically advanced cleaning products and hygiene solutions for research and production facilities, Hydroflex contributes to the safe production of vital pharmaceutical and medical products of its customers worldwide. True to the company claim: Pure Passion For Cleanroom Hygiene.

Samsung Bioepis Opens Korea HQ for Biologics

The building was completed in December 2020.

Samsung Bioepis has announced the opening of its headquarters in Korea’s ‘Bio Cluster’ of Songdo, located in the Incheon Free Economic Zone (IFEZ), a specially designated economic zone in the city of Incheon. The site is approximately 52,000 sq.ft. and will be the hub for the company’s development of biologic medicines.

“We are very excited to be opening our new headquarters which will serve as the foundation for the company’s next stage of growth. Our colleagues who were previously stationed in two campuses in Korea will be working together at the new headquarters to accelerate our passion for health," said Christopher Hansung Ko, President and CEO of Samsung Bioepis. “With the new office equipped with the state-of-the-art laboratories, we look forward to providing our high-quality biologic medicines with more agility and with stringent quality control so that patients around the world can have access to our proven medicines more quickly and more widely available.”

The building will house approximately 1,000 employees, who will be working in the laboratory and office space. Attached to the main building is a three-story ‘welfare center’ which includes a cafeteria, a gymnasium and a fitness center for employees to enjoy. It also has an onsite childcare center to support employees with young children.

GE Healthcare to Open Biotechnology Manufacturing Centre in UK

Located at the Stevenage Bioscience Catalyst, the facility includes 3,012 sq. ft. (280sqm) of cleanroom space.

GE Healthcare has announced the opening of a biotechnology manufacturing center at the Stevenage Bioscience Catalyst (SBC) Open Innovation Campus, in Stevenage, UK. The project incorporates 3000sqft (280sqm) of cleanroom space.

In the first half of 2019, the center will start producing a fiber-based purification platform, which has the potential to significantly improve efficiency in the purification steps of manufacturing biopharmaceuticals, gene therapies and viral vectors, the company said.

The fiber-based chromatography technology developed and manufactured in Stevenage will extend GE Healthcare’s start-to-finish bioprocess purification portfolio.

Olivier Loeillot, General Manager, BioProcess at GE Healthcare Life Sciences, commented: “This technology will bring real efficiency and productivity advantages for biopharmaceutical manufacturers as they move towards integrated, connected or continuous operations."

The fiber-based purification products will be prepared in Stevenage before being further processed and finished in GE Healthcare’s existing manufacturing facility in Cardiff, Wales.

The purification technology to be produced at the new facility came to GE Healthcare as part of the acquisition of Puridify in November 2017.

Puridify was founded in 2013 as a spin-out from University College London (UCL) and was based at the bio-incubator facility at the SBC, where GE Healthcare maintains an open laboratory aimed at providing SBC tenants with affordable access to advanced protein and cell analysis technologies.

The company said the material that makes the fiber-based purification platform boasts a unique proprietary structure, which offers the potential to significantly improve process speed, flexibility and robustness during purification, a key step in the manufacturing of biopharmaceuticals.

Additional products will also be produced at the center to serve both laboratory and clinical applications.

Biopharmaceuticals, such as monoclonal antibodies are the world’s fastest-growing class of medicine. The global market for biopharmaceuticals is estimated at more than US$200 billion, and the market is growing around 8% annually.

Bouygues Wins COVID-19 Vaccine Build for Valneva

Bouygues Energies & Services has been selected by Valneva for the turnkey design and build of their manufacturing facility.

Bouygues Energies & Services, a subsidiary of Bouygues Construction, has been selected by Valneva, a specialty vaccine company, for the turnkey design and build of their manufacturing facility, located in Livingston, Scotland.

A new Multi Vaccine Facility (MVF), adjacent to the existing vaccine facility, which will be designed to EU GMP Grade A to D cleanroom standards. The facility will house two manufacturing streams and QC testing laboratories uninterruptedly working to produce Valneva's inactivated whole-virus COVID-19 vaccine. All areas where the live virus will be handled will be designed to meet the requirements of ACDP containment level 3 as agreed with the Health and Safety Executive.

A new warehouse facility that will consist of temperature-controlled storage areas along with goods in and off-loading bays.

An energy center that will shelter all essential plant services to serve the main manufacturing facility and associated labs.

Shared hub facilities that will comprise the main site entrance, offices, employee's welfare areas as well as the staff car park and the access road for the delivery.

Bouygues, as the main design and build partner, will be responsible for the industrial park development, as a turnkey design and build solution.

The facility will be designed to EU GMP Grade A to D cleanroom standards.

This project started with a site master planning and detailed design now progressing to engineering, build, commissioning and validation of the new facilities which will be delivered on a phased basis. The master planning of the industrial park has started in July 2020, and the production of vaccines will commence in the first half of 2021.

Managing Director and CEO of Bouygues, Steven Weir, said: "We have an excellent track record working with Valneva and are extremely proud to continue with them on this landmark project. We hope that in doing so we can play our small part in the production of this very important vaccine."

Bouygues is committed to supporting Valneva to scale up its manufacturing capacity to be able to produce required doses of the COVID-19 vaccine. The facility will also ensure the readiness for future vaccine development and manufacturing.

David Lawrence, Acting CFO of Valneva added: "Our partnership with the UK Government will ensure that our Livingston facility is well prepared to deliver a COVID-19 vaccine during 2021 and beyond. Bouygues Energies & Services is a tried and tested partner, we're working closely with them to ensure that the project is delivered as quickly as possible."

With 50 years of experience in controlled critical environments, Bouygues Energies & Services offers a high-level of expertise delivering state-of-art cleanroom, laboratory and manufacturing facilities.

Cognate Plans Manufacturing Expansion in US And Europe

Build-out of the commercial manufacturing location will begin in 2021 with the goal of coming online as quickly as possible.

Cytiva Delivers Modular Biologics Factory to Lonza in China

Site to become a strategic base in China for Lonza to provide CDMO services throughout Asia Pacific region.

Cytiva has successfully completed a KUBio installation to Lonza in Guangzhou Biopark, China. The high throughput modular biomanufacturing facility will offer process development and manufacturing for Chinese companies developing innovative medicines, as well as multinationals with manufacturing requirements in China.

The 17,000-square-meter site includes 6,500 square meters of lab space and one KUBio modular facility, and will enable quick ramp-up of antibody development services and manufacturing, which are urgently needed to respond to market needs for biologics, including mAbs and other complex proteins, in and for China, and the rest of the world.

Stefan Stoffel, Chief Operating Officer, Lonza, said, "The Cytiva team showed great agility and speed in delivering this important site. With the KUBio and FlexFactory single-use platform now ready for business, Lonza will be able to respond to the great demand for innovative therapies in the current environment, now and in the future."

Olivier Loeillot, Vice President, Cytiva, said, "In a rapidly-growing industry with increasing needs for mAbs and other key biopharmaceuticals, this facility demonstrates the strength of combining modular manufacturing with single-use technologies. Together, the KUBio and FlexFactory speed up delivery of innovative therapeutics to patients who need them."

This is Lonza's first manufacturing site for biologics in China. Lonza will combine Cytiva's KUBio modular facility and single-use equipment to support its GMP manufacturing integrated with its own platforms and expertise in development, including cell line construction and process development. Scaling up production will be streamlined when needed thanks to the flexibility in the design.

Lonza’s Bioconjugation Facility Expansion, Visp

Lonza announced the expansion of its bioconjugation facility at its Visp site in Switzerland in December 2020.

The expansion will improve the facility’s bioconjugation capabilities with the addition of development and production capacity for pre-clinical to commercial scale supply.

The manufacturing facility expansion will enable the company to provide highly flexible solutions to a wide range of clients and will complement Lonza’s recent expansion of customer-dedicated suites, which is a part of Ibex® Dedicate model. Ibex® Dedicate is a technology-agnostic supply approach that helps minimize time to market and monitor investment risk.

Clients will benefit from the company’s experience and in-house supply of integrated offering encompassing protein, linker, payload and conjugation, thus reducing supply chain risks and accelerating the path to commercialization.

The long-term partnership of Lonza with a multinational biopharmaceutical company will create approximately 200 new jobs in the Visp biopark. The new facility is scheduled to commence operations in the first half of 2022.

The bioconjugation facility will be expanded with the addition of 1500m2 manufacturing space, which will add approximately 30% capacity to the facility for clinical and commercial supply.

Extended manufacturing space will be equipped with two bioconjugation manufacturing suites with the required infrastructure related to manufacturing. Suites will be constructed within a pre-existing shell and will be benefited by the existing quality control (QC) laboratories, logistics and other central services, enabling rapid ramp-up, superior performance and timely delivery.

The highly flexible system will utilize single-use, stainless-steel and hybrid concepts for bioconjugation operations.

High throughput bioconjugation suites will be capable of managing highly-potent substances for cancer drugs and will initially produce two therapies for cancer treatment.

The two new suites will provide high-performance conjugation for the commercialization of antibody-drug conjugates (ADCs) in Lonza’s Ibex® Dedicate model.

The expansion will also involve the addition of a 5000m2 support building, which will provide space for logistics, storage and other related infrastructure for an optimized workflow. The laboratory space in the facility will also be extended, doubling the analytical and process development capacity.

Additionally, the opening of the first manufacturing suite for antibody-drug conjugate (ADC) payload manufacturing at Visp (CH) site in November 2020 and acquisition of Novartis’ sterile fill-finish facility will support the rising development and manufacturing requirements for bioconjugates.

“The two new suites will provide high-performance conjugation for the commercialization of antibody-drug conjugates (ADCs) in Lonza’s Ibex® Dedicate model.”

Visp is the largest and one of the most important sites for research and development (R&D) and manufacturing. It houses advanced facilities specialized in the development and production of pharmaceutical products including mammalian and microbial biopharmaceuticals, small molecules, highly potent active pharmaceutical ingredients (APIs), peptides and bioconjugates including ADCs.

Visp also accommodates the Lonza’s pioneering services, Ibex Solutions. Ibex provides end-to-end biopharmaceutical solutions, including preclinical to commercial processes and drug substance to the drug product, all in one location.

The recently opened first manufacturing suite at the Visp (CH) site is dedicated to the manufacturing of ADC drug-linker and complements the full-service capability for highly active product ingredients (HAPI) from a bench-scale through a 10m3 scale.

The Visp site offers customized development, cGMP clinical and commercial manufacturing services for APIs and their intermediates.

The Microbial site in Visp (CH) houses a range of multi-product cGMP manufacturing and development suites for microbial-derived biotherapeutics production.

Its location also operates as the center of excellence for the development and manufacturing of highly potent API (HPAPI), comprising facilities for small-scale to commercial-scale production and high containment trains.

Lonza’s microbial center of excellence supports services for several types of molecules, including emerging molecular formats such as antibody fragments, mimetics and novel scaffolds.

The cGMP site accommodates cell banking, production, fermentation, purification and quality control and process development labs and manufacturing assets, including 70l, 1,000l and two 15,000l stainless steel reactors, as well as 50l, 200l and 1000l single-use reactors.

Visp functions within a global quality management system that complies with internal guidelines, as well as national and international standards and regulations.

AmbioPharm Opens New Shanghai Campus

AmbioPharm Inc., a provider of peptide API CDMO services, has recently opened its new Shanghai campus. The new campus adds nearly 50,000 square meters of manufacturing, quality control and administrative space.

“We have added 4 new buildings which add to our solid-phase and liquid-phase peptide facilities at our Shanghai production site positioning AmbioPharm as the go-to source for all peptide API needs that our partners have. This is in addition to the manufacturing expansion which was completed at our U.S. headquarters in mid-2020,” said Chris Bai, chief executive officer and co-founder, AmbioPharm.

Additionally, AmbioPharm has established a new office in Zurich, Switzerland which is headed by Kathleen Noack, vice president of European sales and marketing. Additionally, Michael Postlethwaite, sales director, has joined the AmbioPharm Europe team also working from this new office.

“We are delighted to add two highly experienced seasoned professionals to our European team. Both Ms. Noack and Dr. Postlethwaite come with a wealth of peptide API development knowledge to establish and extend our European partnerships,” said Jim Hampton, executive VP of GMP Sales and co-founder.

AmbioPharm is a leading and innovation-driven company specializing in the development and manufacture of peptides and peptide-related products. With a comprehensive range of services, AmbioPharm produces custom products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide. Headquartered in the United States of America and with locations in Europe, the USA and Asia, AmbioPharm operates internationally with over 14 years of experience and expertise.

Gerresheimer Builds India Production Plant for Plastic Containers

Gerresheimer has already been well-positioned in India for several years with Triveni Polymers Pvt Ltd in Kundli. A second production plant in Kosamba (Gujarat) is to strengthen the production capacity for Triveni plastic containers, which are in strong demand worldwide. With a festive land worship ceremony in accordance with traditional Indian custom, the construction of a building measuring several thousand square meters a new plastic packaging production with clean-room environment began in December. Gerresheimer is thus concentrating its production of pharmaceutical primary packaging made of molded glass, tubular glass and plastic at the Kosamba plant near Mumbai. Together with the Triveni plant in Kundli, the four highly specialized Indian plants belong to the Gerresheimer Group’s worldwide production network.

“That we were able to achieve this goal in these difficult times of the pandemic is the result of good and intensive cooperation. The team had a vision and a goal in mind, which they achieved in an impressive way. We are all very proud and happy about this. We are particularly grateful to our colleagues from Gerresheimer Primary Packaging Glass who helped us to be able to hold the important traditional ceremony of land worship under appropriate hygienic safety precautions,” says Managing Director Prakash Dhameja.

“The fact that we are working side by side with our glass production colleagues here in Kosamba is very beneficial and sustainable for our customers and once again proves Gerresheimer’s leading global role in Pharma Primary Packaging in terms of glass and plastic,” says Jari Tevajarvi, Vice President Asia Plastic Packaging.

Since Gerresheimer acquired Primary Packaging Plastic Triveni Polymers Ltd. based in Kundli, India, eight years ago, the company has almost doubled its capacity. The new production building in Kosamba is designed to help meet the growing demand. The portfolio includes plastic containers for medicines in many formats and designs. The production of child-resistant closures is also particularly important.

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 purest 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.

Minaris Invests $64.5M to Expand Cell and Gene Mfg. Facilities

New buildings near Munich, Germany and Yokohama, Japan will more than double capacity for commercial manufacturing of regenerative medicines.

Minaris Regenerative Medicine, a global contract development and manufacturing organization for cell and gene therapies, is investing $64.5 million to significantly expand its facilities in Europe and Asia.

A new state-of-the-art facility will be built near its existing site in Ottobrunn near Munich, Germany with a total investment of $40.7 million. 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 6,650 square meter building will initially more than double Minaris’ existing capacity in Europe by providing additional clean rooms, quality control labs, warehousing, cryo-storage and office space.

The new facility is expected to be operational early 2023 and will allow for additional expansion of clean rooms 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 Regenerative Medicine GmbH.

Also, a new facility will be established adjacent to the existing facility in Yokohama, Japan allowing for an additional 4,000 square meters, which will double the capacity for commercial manufacturing of regenerative medicine. The new facility is scheduled to start operations in October 2022. The $23.8 million investment 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, NJ announced in January this year.

“Our investment in the facility expansions of all our three regional sites confirms our commitment to contract development and manufacturing for the cell and gene therapy industry,” said Kazuchika Furuishi, PhD, Corporate Officer and General Manager, Regenerative Medicine Business Sector of Showa Denko Materials Co., Ltd. “Our global offering to our clients with sites in USA, Germany and Japan enables us to advance our clients’ life-saving therapeutics to patients in need around the world.”

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."

Syntegon Opens OSD Centre that Increases Cleanroom Space Sixfold

After a one-year construction phase, Syntegon Technology has inaugurated its new OSD Customer Center in Germany. The 600 sqm building includes everything from cleanrooms and assembly areas to offices, meeting and training rooms.

After a one-year construction phase, Syntegon Technology has inaugurated its new OSD Customer Center in Waiblingen, Germany. The 600 sqm 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.

In the new OSD Customer Center, Syntegon's clients will meet with experts who take care of problem solving, as well as optimizing and developing their processes and providing seminars and training.

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.

The new OSD Customer Center offers pharmaceutical developers and manufacturers an ideal location to test future formulations or existing products on real machines. "From the development of active ingredients or formulations to process optimization or machine operator training – we bridge the gap between all these disciplines," says Brinz.

Since Syntegon's customers don't 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," as Brinz explains.

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. "Manual evaluations of process parameters can take days or even weeks," Brinz explains. "The APD tool achieves not only faster, but also more precise results." By determining the interactions between material, quality and process-critical parameters, the tool ensures an improved understanding of the process, which in turn has positive effects on the quality of the end product.

Apart from the GKF 720 HiProTect, the OSD Customer Center in Waiblingen offers many further machines to customers for all formats and products in different cleanroom classes – up to OEB5.

The OSD Customer Center provides customers with a ten-strong core team of pharmacists, chemists, process specialists, engineers, trainers and service technicians. "Depending on the customer project, we can flexibly call in additional specialists from different areas," says Brinz. "This way, we help our customers to design their capsule filling and tablet pressing processes much more efficiently, and to increase their overall plant effectiveness. In addition, we are now also able to expand our range of training courses and seminars."

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," says Brinz.

Calysseo Appoints Black & Veatch and Shanghai LBT Engineering & Technology as EPC Contractors for its First Commercial-Scale Animal Feed Production Facility

Asia is actively investing in biotechnology innovations to meet the needs of its rapidly growing population.

Calysseo’s FeedKind® single-cell protein project is one such biotechnology innovation that will enhance regional food safety and sustainability.

FeedKind® is an alternative bio-protein feed ingredient for the aquaculture industry. It is made by fermenting natural gas to create a safe, nutritious, traceable and affordable protein.

Calysseo has appointed the consortium of Black & Veatch and Shanghai LBT Engineering & Technology Co. Ltd to execute the full Engineering, Procurement and Construction (EPC) scope for its first commercial FeedKind® production facility.

Calysseo is a joint venture established by alternative protein producer Calysta and animal nutrition company Adisseo.

"Food security remains a priority in regions with growing populations like Asia. Alternative proteins, like FeedKind®, will contribute to building a more sustainable and resilient food system. We are excited to draw on our extensive experience in processing, handling and treating natural gas and our deep consulting, engineering and construction expertise to deliver the project execution certainty required by biotechnology leaders, like Calysseo,” said Jim Schnieders, Executive Vice President and Managing Director Floating Oil & Gas Solutions and Emerging Markets, Oil & Gas, Black & Veatch.

“Through strong and seamless cooperation with Black & Veatch, we will provide the best local content with design, fabrication and construction services for the first commercial project of Calysseo in China. This consortium teaming also provides a new EPC execution model that extends LBT’s full engineering value chain to global customers,” said Binqiang Shen, Chairman of Shanghai LBT Engineering & Technology Co. Ltd.

Located in Chongqing in southwest China, the biotechnology facility is projected to produce 20,000 tons per annum of FeedKind® by 2022.

As the consortium leader, Black & Veatch will provide project management, process design and global procurement expertise. Shanghai LBT Engineering and Technology Co. Ltd will provide local engineering design, permitting and construction expertise.

Black & Veatch provides innovative and cost-effective solutions on Liquefied Natural Gas (LNG), Floating LNG (FLNG), sulfur recovery, gas processing, gasification, and ammonia/fertilizer projects. It supports industries like biotechnology and food processing with a full range of services and engineering from consulting to design; to full engineering, procurement, construction (EPC) and start-up for projects.

Biotechnology is the use of living systems and organisms to develop products.

The United Nations (UN) estimates that Asia’s current population of 4.6 billion is equivalent to almost 60 percent of the total world population. The UN forecasts that by 2050, Asia will have a population of 5.2 billion.

In 2019, Black & Veatch was awarded the Front-End Engineering Design (FEED) for the FeedKind® aquafeed project by Calysseo. After the FEED was completed, Black & Veatch developed an execution strategy for a full-scope EPC solution.

In 2017, Black & Veatch supported the joint venture of Calysta and Cargill on a similar biotechnology project planned for Memphis, Tennessee, United States.

About Black & Veatch:

Black & Veatch is an employee-owned engineering, procurement, consulting and construction company with a more than 100-year track record of innovation in sustainable infrastructure. Since 1915, we have helped our clients improve the lives of people in over 100 countries by addressing the resilience and reliability of our world's most important infrastructure assets. Our revenues in 2019 were US$3.7 billion. Follow us on www.bv.com and on social media.

Cleanroom Specialist Completes Two Major UK Projects

Cleanroom design and build specialist, Connect 2 Cleanrooms, has announced the completion of two major life science and healthcare cleanroom projects within the UK.

The first project was a 250m² purpose-built laboratory facility. This included two cleanrooms: One for diagnostics testing, and the second - a 400m² ESD cleanroom that will form a crucial part of a seven-year expansion plan for a global leader in advanced wound care.

The second project was initiated following qualification being achieved within the above facilities. A 115m² cleanroom facility was built on a university campus, for the development, clinical production, and commercialization of new medical technologies.

This news was released at the same time as the appointment of Joan Benson as regulatory governance and assurance manager. Talking about her appointment, Benson commented: “I am very excited to be joining Connect 2 Cleanrooms in the new role of regulatory governance and assurance manager, and to have the opportunity to add to the company’s existing regulatory competence. I feel privileged to take on this role in Connect 2 Cleanrooms, an industry leader with outstanding culture, vision and values.”

Validair Diamond Scientific Supports Royal Marsden Hospital with Validation

The company delivered a comprehensive package of support to make the regional QA Audit a success that resulted in operational approval being granted.

The Royal Marsden NHS Foundation Trust hospital in Chelsea has received approval to open its new chemotherapy and gene therapy cleanroom suites, thanks to valuable assistance at all project stages from Validair Diamond Scientific (VDS).

The company delivered a comprehensive package of support to make the regional QA Audit a success that resulted in operational approval being granted.

Key members of the Royal Marsden clinical team acknowledged the role of Validair, singling out the support of Steve Ward, VDS Managing Director, for special praise. Ward points out that the validation project was a ‘cradle to grave’ initiative supported by a team from Validair, starting with assistance on the User Requirement Specifications preparation, and moving on to the delivery of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). But additional support was needed suddenly.

“I received an urgent phone call from the Royal Marsden during the day of the audit,” explains Ward. “I was asked to hurriedly join an online meeting as my expertise was required to clarify some technical aspects of the qualification process and cleanroom design philosophy to the auditors. The Royal Marsden team had been explaining the benefits of turbulent flow to reduce the chance of dead spaces in a cleanroom, the auditors were unclear and remained unconvinced. Fortunately, I was able to put that right.”

Senior managers at the Royal Marsden have since written to Validair expressing their gratitude for Steve Ward’s timely intervention. They explained that the Hospital’s in-house team learnt a lot from his expertise while the auditor’s confidence had been restored, resulting in the green light. The new cleanroom suites are now operational.

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