PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Ransom Everglades School’s New STEM Facility

Ransom Everglades School’s new 45,000 sq. ft., three-story STEM facility will be a flexible space with the ability to adapt to a variety of learning needs, according to new details released by Perkins+Will, the project’s architect. The STEM facility is part of the larger master plan for the school’s Coconut Grove campus.

The building will feature 10 classrooms with movable walls and furniture, maker and fabrication labs, an outdoor rooftop lab, rooftop solar panels, a multi-purpose conference room, and a 200 person auditorium. The facility will include laboratories for earth sciences, biology, chemistry, and physics.

“It will be flexible, adaptable, collaborative; a think-tank type space,” said Pat Bosch, Design Director for Perkins+Will’s Miami office, while speaking to Ransom Everglades parents at a preview for the new building. “This is not a static building.”

The collaboration will pour out of the building and spill into the surrounding landscape as well. The project will create new outdoor breakout areas adjacent to the STEM building and a new quad. This connection between indoor and outdoor learning spaces is an important aspect of the new facility, which is slated to be ready for occupancy by early 2020.

Aphena Pharma Solutions Invests for Expansion

Aphena Pharma Solutions is investing in a $7 million company-wide expansion for future growth opportunities to be completed by the end of 2019. Targeted expansion areas include additional manufacturing space, custom blending suites, new liquid blending vessels and an additional high-speed bottling line.

“As Aphena continues our path towards healthcare contract service excellence and innovation, we are committed to investing in our customers’ future and earning our place as their preferred and trusted partner,” said Aphena chief executive officer, Shawn Reilley.

The expansion includes: two additional large pharmaceutical blending suites with separate air handling systems in the company’s manufacturing facility in Maryland; two tri-mix blending tanks with counter-rotating sweep and high-shear mixing with vacuum to handle small and large batching for specialty creams, gels and topical products; a 30,000-sq.-ft. expansion of the Tennessee facility; and an additional high-speed, fully-automated bottling line with serialization in the company’s Tennessee facility to support both over-the-counter (OTC) and prescription products.

“These planned expansions at our Maryland and Tennessee facilities will position Aphena to support significant future growth,” said Aphena chief operating officer, Bob Scott. “We are committed to investing aggressively as needed to ensure that Aphena remains an industry leader in terms of innovation and turnaround time.”

Aphena provides contract packaging and manufacturing services for the pharmaceutical, consumer health and medical device markets.

REGENXBIO Building Plant to Support Gene Therapies

REGENXBIO will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into REGENXBIO’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

“The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently advance our development programs from research stage to the clinic and ultimately to patients, while ensuring manufacturing capacity availability,” chief technology officer Curran Simpson said in a statement.

The plant will support the firm’s multiple gene-therapy programs through the production of REGENXBIO’s NAV Technology-based vectors at scales up to 2,000 liters.

“REGENXBIO’s novel and unique approach to gene therapy focuses on enabling cells in the body to produce therapeutic proteins or antibodies and targeting and correcting genetic defects,” Kenneth Mills, CEO of REGENXBIO, said earlier during a financial conference call.

“Our NAV Technology serves as a backbone gene therapy research and is widely utilized gene therapy platform across diverse disease applications.”

The technology consists of over 100 adeno-associated viral (AAV) vectors including AAV7, AAV8, AAV9 and AAVrh10, which deliver engineered genes to cells. It has so far been used to treat over 200 patients in clinical trials for REGENXBIO and its licensee partners.

The firm has also recently produced its first GMP pulp drug substance based on a new suspension cell culture platform process. “This bioreactor based process enables us to reach manufacturing scale suitable for future commercial production,” chief medical officer Steve Pakola added on the call.

REGENXBIO has several gene therapy candidates in early-phase clinical trials, including RGX-314 for wet AMD, RGX-111 for Mucopolysaccharidosis Type I (MPS I), RGX-121 for Mucopolysaccharidosis Type II (MPS II), and RGX-501 for homozygous familial hypercholesterolemia (HoFH).

Xellia Moves Production from North Carolina to Ohio

Xellia will move US production from its North Carolina manufacturing facility to its site in Ohio to bolster workforce and manufacture generic IV antibiotics.

Xellia Pharmaceuticals specializes in the production of anti-infective drugs for the treatment of life-threatening bacterial and fungal infections. The Copenhagen-based pharmaceutical company will produce its anti-infective drugs at the former Ben Venue Laboratories in Bedford, Ohio.

Ben Venue Laboratories was previously operated by Boehringer Ingelheim until 2013, when drug production at the site ceased after quality control issues.

In 2015, Xellia took over the facility under Ohio‘s Job Creation Tax Credit program and expanded its North American footprint. After taking it over Xellia only used the facility as a packaging and distribution hub.

The company stated that the site is expected to continue to grow and enabling it to expand production capabilities to match its portfolio of products.

The Bedford site currently has around 200 employees but, after this move, the site is expected to grow in headcount. The company will also add employees in multiple areas including manufacturing, maintenance mechanics, supply chain, distribution, quality and engineering.

The Bedford site will produce two intravenous antibiotics, Vancomycin and Daptomycin. Xellia partnered with Civica through its manufacturing agreement, to distribute the two generic antibiotics.

Civica and Xellia entered a manufacturing agreement in May 2019 to ensure the availability of generics in short supply, including Vancomycin and Daptomycin. Per the agreement, Xellia will produce generic medicines for Civica to streamline the generic supply chain.

Upon final approval from the US Food and Drug Administration, full-scale commercial production will begin in 2020.

Goodwin Biotechnology Expands Capacity

Goodwin Biotechnology has recently purchased the two-acre site where the company has operated for over 26 years in order to expand its capacity to meet the needs of its long-term clients. The company is a U.S.-based, FDA-registered, uniquely qualified and flexible full GMP biopharmaceutical contract development and manufacturing organization (CDMO) that offers a fully integrated Single Source Solution from cell line development, process development including bioconjugation, scale-up, cGMP contract manufacturing, and aseptic fill/finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and antibody dug conjugates (ADCs).

“The Goodwin team is really excited about this next chapter in our business story,” said Karl Pinto, chief executive officer, Goodwin Biotechnology. “Based on the success of biopharmaceutical candidates that we have helped successfully navigate through their early- and late-stage clinical trials, we have strategically aligned ourselves to invest in doubling our cGMP manufacturing capacity and enhancing our regulatory compliance to support commercial manufacturing. This is a testament to the dedication, commitment and the vast experience of the highly skilled scientists who make up the Goodwin Biotechnology family, as well as the strong, successful client relationships that we have built over the years.”

The first phase of Goodwin’s expansion was to increase process development capabilities by more than doubling its development bioreactor. The laboratory scale bioreactor is where it performs multiple small-scale bioreactor runs in parallel as it optimizes and validates the cell culture process to develop reproducible and scalable bioreactor processes for GMP manufacturing for clients.

SooYoung Lee, chief operating officer, Goodwin Biotechnology, said, “We’ve also expanded our purification and bioconjugation development capabilities as well as our method development groups and infrastructure to enable us to characterize in-process samples, develop analytical methods, and to provide analytical services so that we are able to characterize upstream and downstream processes in real time, thus ensuring that we can successfully complete our clients’ campaigns on time and on budget. Now that we have purchased the entire site from which we currently operate, we have access to significantly more space as we prepare for the second phase of the expansion which will feature an increased scale in our cGMP manufacturing capacity in order to support the commercial production needs of our clients’ biopharmaceutical products.”

“These strategic investments and clear growth roadmap demonstrate our commitment to support our clients through all stages of their product development cycle, including continuous commercial production,” said Mr. Pinto. “Goodwin helps fill a niche in the industry as a unique and viable manufacturing partner built to efficiently handle small to mid-volume product needs, which we increasingly see as the future of biopharmaceutical manufacturing.”

NJII and Pall form Agreement to Advance Cell and Gene Therapy Manufacturing

New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology (NJIT) Corporation, has signed an Industry Participation Agreement with Pall Corporation to support the development of its BioPharmaceutical Innovation iLab.

The partnership will support two key centers at NJII that will advance the manufacturing of new cell and gene therapies: the Cell and Gene Therapy Development Center and the Center of Advanced Biologic Manufacturing.

"We are excited to work with Pall Corporation, a world leader in high-tech filtration, separation and purification, to advance manufacturing of new cell and gene therapies,” said Haro Hartounian, senior executive director, biotechnology and pharmaceutical innovation, NJII. “These therapies represent a new era in the treatment of cancer and other major diseases and hold great promise in achieving successful patient outcomes.”

The NJII Cell and Gene Therapy Development Center will focus on addressing manufacturing process technologies and workforce development challenges faced by the industry. This center will serve as a dedicated platform where the industry can access shared resources including equipment, expertise and project work to find innovative solutions to manufacturing needs for biologic medicines, such as cell-based immunotherapies.

The NJII Center of Advanced Biologic Manufacturing, meanwhile, will address challenges of mass production through continuous processing and viral vector manufacturing. This center will bring big pharma, emerging biotechnology companies, technology developers and instrumentation companies together with regulatory agencies to pioneer new techniques and train those who will take the technology into commercial practice at an industrial scale.

A leader in continuous bioprocessing, Pall is at the forefront of research and development in the industrialization of gene therapy manufacture and brings new resources to both projects. State-of-the-art bioreactors, continuous chromatography units, and an acoustic wave separator have been provided by Pall to both NJII Centers as part of the Industry Participation Agreement. Pall experts will also be deployed to support the experimental program and provide training on the new equipment.

Peter Levison, executive director business development, Pall, said, "Scaling up the manufacture of gene therapies and gene-modified cell therapies to industrial levels is one of the biggest challenges in modern medicine manufacture. If we're going to tackle the industry's productivity challenges, we need to think smart and invest in finding innovative manufacturing solutions, for example through continuous bioprocessing. NJII is doing remarkable work in this area and we're very excited to partner with them on this innovative program.”

Iovance Builds Gene Therapy Manufacturing Facility in Philadelphia

Iovance ramps up clinical and commercial immunotherapy production with a $75m (€67.3m), 136,000 square-foot build in Philadelphia’s Navy Yard.

The late-stage biotech will increase its production capacity for its tumor-infiltrating lymphocyte (TIL) technology-based therapeutics with the Philadelphia site. Iovance, headquartered in the San Francisco Bay Area, has research facilities in Florida and New York, but this will be its first manufacturing facility.

Iovance’s new facility will enable the company to produce its TIL products and its lead drug candidate lifileucel – which is in Phase II studies for the treatment of advanced melanoma – through scalable processes.

TIL therapy uses treats a patient with their own immune cells and involves the collection of a patient’s tissue sample that is then shipped to a manufacturing facility for processing. For Iovance, this supply chain requires the cells to be cryopressed after processing and shipped back to the patient for infusion.

A spokesperson for Iovance said that the company chose to build in the city’s centrally-located Navy Yard as it is close to the airport and has efficient access to transportation, which he said are key factors for a cell therapy where a rapid turnaround is imperative for accessibility.

Maria Fardis, president and CEO of Iovance said in a statement, “Building our own internal production capabilities will help us reduce the cost of operations which is necessary for offering broad access to TIL therapy.”

According to the company, the site will be designed to manufacture enough products for thousands of patients annually in both a clinical and commercial capacity.

The facility is expected to be complete in 2021.

AMPAC Re-Opens API Facility in Virginia

After being acquired by SK Holdings, AMPAC re-opens its API manufacturing facility in Virginia as part of a growing investment in its US capabilities.

AMPAC Fine Chemicals (AFC) re-opened its manufacturing operations at its active pharmaceutical ingredient (API) facility in Petersburg, US, after the site saw infrastructure refurbishment.

According to AFC, the pharmaceutical ingredients manufactured at the plant will be for pharmaceutical companies across the US and will be used in the production of treatments for central nervous system deficiencies, cancer, and epilepsy.

The expansion of the US-based company’s operations comes shortly after it was acquired as a portfolio company by SK holdings, an investment holding company of the South Korean SK Group.

The Petersburg site encompasses around 200 acres of the city’s industrial complex and has a 50,000-gallon capacity. With the re-opening, 100 jobs are expected to generate over the next few years.

AFC president and CEO, Aslam Malik, said in a statement that the re-opening of the plant demonstrates the company’s interest in employing more local residents, its growing investment in the US, and to create opportunities to develop community partnerships.

The company has operations in La Porte, Texas, Petersburg, Virginia, and both Rancho Cordova and El Dorado Hills, California. Its global offerings extend beyond technology platforms for API production including, continuous processes and industrial scale chromatographic separation, highly potent compound manufacturing, and analytical services.

Tergus to Build Commercial Manufacturing Facility

Tergus Pharma, an end-to-end service provider for topical pharmaceutical research, drug development, testing and manufacturing, has unveiled a 100,000-square-foot building for its new headquarters and plans to invest to expand into commercial manufacturing. Tergus will provide comprehensive services from development through manufacturing and will become a contract development and manufacturing organization (CDMO).

Tergus has also partnered with Great Point Partners (GPP), a Greenwich, CT based health care investment firm. GPP has provided growth equity, growth recapitalization, and management buyout financing to more than 100 growing health care companies.

Tergus provides topical formulation development, in vitro permeating testing (IVPT), in vitro release testing (IVRT), skin biology, analytical services, and clinical trial materials (CTM) manufacturing services for branded and generic dermatology products. Great Point’s investment will allow Tergus to build a state-of-the-art commercial manufacturing facility in the Raleigh-Durham, NC area and will begin construction in July 2019. The new 100,000 square foot facility will have clinical trial material (Phases I thru III) supplies and commercial manufacturing capabilities and expand current capacity by over 400%. Tergus plans to open the new facility in early 2020.

“Great Point’s expertise and successful track record growing pharmaceutical services companies was evident when they proactively approached us about a partnership,” said Vijendra Nalamothu, chief executive officer, Tergus. “For years we have discussed building a commercial facility. The equity capital from GPP will enable us to do this and we will be able to better serve our customers by offering end-to-end services including commercial manufacturing. Great Point’s experience, network, and success in current and previous outsourced pharmaceutical services investments was a true differentiator.”

Rohan Saikia, managing director, Great Point Partners, said, “Tergus has differentiated itself as a leader in the complex topical dermatology development space that has been growing at approximately 15% per year. Tergus’ reputation within topical dermatology is unparalleled and we are thrilled that Tergus will now be a ‘one-stop-shop’ from clinical development to commercial manufacturing for all of their clients.”

Goodwin Biotechnology Invests in Space for cGMP Capacity

Goodwin Biotechnology, Inc. announced that it has recently purchased the two-acre site where the company has flourished for over 26 years in order to expand its capacity to meet the needs of its long-term clients. Goodwin Biotechnology is a US-based, FDA-registered, uniquely qualified and flexible full GMP biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers a fully integrated Single Source Solution™ from Cell Line Development, Process Development including Bioconjugation, Scale-Up, cGMP Contract Manufacturing, and Aseptic Fill / Finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and Antibody Dug Conjugates (ADCs).

"The Goodwin team is really excited about this next chapter in our business story," noted Karl Pinto, Chief Executive Officer at Goodwin Biotechnology. "Based on the success of biopharmaceutical candidates that we have helped successfully navigate through their early- and late-stage clinical trials, we have strategically aligned ourselves to invest in doubling our cGMP manufacturing capacity and enhancing our regulatory compliance to support commercial manufacturing. This is a testament to the dedication, commitment and the vast experience of the highly skilled scientists who make up the Goodwin Biotechnology family, as well as the strong, successful client relationships that we have built over the years."

"The first phase of our expansion was increasing the Process Development capabilities to better serve our growing customer base," noted SooYoung Lee, PhD, Chief Operating Officer at Goodwin Biotechnology. "This included a significant increase, effectively more than doubling our Development bioreactor laboratory scale where we perform multiple small-scale bioreactor runs in parallel as we optimize and validate the cell culture process to develop reproducible and scalable bioreactor processes for GMP manufacturing for our clients. We've also expanded our Purification and Bioconjugation Development capabilities as well as our Method Development groups and infrastructure to enable us to characterize in-process samples, develop analytical methods, and to provide analytical services so that we are able to characterize upstream and downstream processes in real time, thus ensuring that we can successfully complete our clients' campaigns on time and on budget. Now that we have purchased the entire site from which we currently operate, we have access to significantly more space as we prepare for the second phase of the expansion which will feature an increased scale in our cGMP manufacturing capacity in order to support the commercial production needs of our clients' biopharmaceutical products."

"These strategic investments and clear growth roadmap demonstrate our commitment to support our clients through all stages of their product development cycle, including continuous commercial production," added Mr. Pinto. "Goodwin helps fill a niche in the industry as a unique and viable manufacturing partner built to efficiently handle small to mid-volume product needs, which we increasingly see as the future of biopharmaceutical manufacturing."

About Goodwin Biotechnology, Inc.:

Goodwin Biotechnology is a uniquely qualified and flexible, US-based CDMO that offers a Single Source Solution™ for our clients from cell line development, exploratory proof-of-concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) for early- and late-stage clinical trials. By working with Goodwin Biotechnology, clients can enhance the value of their product candidates with clear development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 26 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has been awarded Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing! In addition, Goodwin Biotechnology was awarded "Best in Sector: Biopharmaceutical Contract Development & Manufacturing" at Acquisition International magazine's 2015 Sector Performance Awards. Last year, Goodwin Biotechnology received Global Health & Pharma's 2017 award for Best for BioProcess Development & cGMP Manufacturing and Best in Mammalian Cell Culture Process Development & cGMP Manufacturing. In 2018, Goodwin Biotechnology was named Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News.

Thermo Fisher Expands Pharma Services

Invests $150 million in sterile liquid and lyophilized product development and commercial manufacturing in Italy and Greenville, NC

Thermo Fisher Scientific Inc. is investing $150 million in its Pharma Services business to provide additional capacity for sterile liquid and lyophilized product development and commercial manufacturing, in Monza and Ferentino, Italy, and Greenville, NC.

The sites will be equipped with aseptic filling lines and isolator technology. Construction is expected to be completed within the next two years.

"These investments will help expand our global sterile manufacturing network and meet the increasing demand from customers that rely on our biologics development and manufacturing expertise," said Michel Lagarde, president of pharma services for Thermo Fisher Scientific. "We continue to invest to expand our capabilities and help our customers deliver the highest quality medicines to the patients who need them."

Fluor and Bayer Break Ground for New Cell Culture Technology Center

Fluor Corporation announced that a groundbreaking event was held for Bayer’s first-of-a-kind cell culture technology center in Berkeley, California. Fluor is providing a single point of responsibility for engineering, procurement, construction management and commissioning, qualification and validation of the facility that will produce oncology and other therapeutics.

“We look forward to working with Fluor on this exciting project, and benefiting from the company’s expertise in engineering, procurement, construction management and validation — all of which will allow us to have flexible and scalable facilities for the future and enable us to bring new medicines to patients faster,” said Judy Chou, Ph.D., senior vice president and global head of Bayer Biotech.

“We are delighted that Fluor’s innovative plant layout and modularized construction solution will allow Bayer’s strategically important manufacturing facility to be designed and built with capital efficiency and a focus on optimizing the project’s schedule,” said Juan G. Hernandez, president of Fluor’s Life Sciences and Advanced Manufacturing business line. “The facility’s user-friendly, reconfigurable design will facilitate increased speed to market for new life saving treatments.”

The state-of-the-art Single Use Technology (SUT) biopharmaceutical manufacturing facility will be constructed at Bayer’s Berkeley site using land from a demolished office building. In 2018, Fluor engaged in the conceptual study and front-end engineering design for the project which is due for completion in early 2021.

Bayer selected GE Healthcare to provide its FlexFactoryTM SUT platform which will be incorporated into the project through a collaborative subcontract to Fluor. GE Healthcare is supplying all major unit operations, systems and ancillary equipment and components.

Fluor’s scope also includes process integration for the entire facility and all associated utilities. Fluor’s San Francisco office will lead the project with support from the company’s offices in Greenville, South Carolina and Gliwice, Poland.

About Fluor Corporation

Founded in 1912, Fluor Corporation (NYSE: FLR) is a global engineering, procurement, fabrication, construction and maintenance company that transforms the world by building prosperity and empowering progress. Fluor serves its clients by designing, building and maintaining safe, well executed, capital-efficient projects around the world. With headquarters in Irving, Texas, Fluor ranks 153 on the Fortune 500 list with revenue of $19.2 billion in 2018 and has more than 53,000 employees worldwide.

REST OF WORLD

The Karolinska Institute’s New Laboratory Building

C.F. Møller Architects designed the building.

Biomedicum, the new laboratory building at the Karolinska Institute in Stockholm, unifies the institute’s research environments under one roof.

The nearly 700,000 sq. ft., 11-story facility will feature flexible laboratory and office space meant to be a catalyst for collaboration between the various research and study environments. It comprises four connected buildings with laboratories built around an eight-story high atrium wrapped in a transparent double-shell façade.

The building, located within the campus park, also brings the park inside its walls with a glass-covered green atrium. The atrium roof is a suspended ceiling with large dome-shaped lanterns that let in daylight. Above is a fully glazed roof that is easy to maintain and can be reached from a suspended ceiling.

The transparent ground floor offers access to the atrium, a cafe, conference rooms, and a public exhibition space. The ground floor also forms new connections through the park to open up the Karolinska Institute towards both the city and the planned university hospital.

Biomedicum accommodates 1,600 researchers and staff and house the following departments:

– The Department of Cell and Molecular Biology

– The Department of Physiology and Pharmacology

– The Department of Microbiology, Tumor and Cell Biology

– The Department of Medical Biochemistry and Biophysics

– The Department of Neuroscience

SGS Celebrates Opening of the Biologics Testing Facility Expansion

Facility in Glasgow now boasts 25,824 sq. ft. (2,400 sq.meter) floor space and additional capabilities for testing cell banks and routine bulk harvest

The newly extended state-of-the-art facility now doubles the total floor space from 1,200 sqm to 2,400 sqm

The greater laboratory space provides SGS with additional capabilities for testing cell banks and routine bulk harvest for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines and will increase the capacity of all existing biosafety services and enhanced real-time polymerase chain reaction (PCR) platforms.

Ivan McKee Minister for Trade, Investment and Innovation commented on the expansion project: “Innovative and ambitious companies like SGS Vitrology are vital to the Scottish economy. This Scottish Enterprise grant of GBP 1.7 million, as a contribution towards the company’s GBP 7.6 million investment, will help create high-value jobs in Glasgow and help support the company realize their ambitious growth plans in Scotland.

“Scotland is the UK’s leading destination for foreign direct investments outside of London and the best in the UK for attracting high value R&D projects. The Scottish Government has set an ambitious target to double Business Expenditure Research and Development to £1.75 billion by 2025 and have boosted existing R&D grant funding by £45 million between 2018 and 2021- an increase of almost 70%.

Boehringer Investment to Expand Oral Solid Dosage Production in Mexico

German pharmaceutical company Boehringer Ingelheim has announced a multimillion-dollar investment that will see the expansion of its manufacturing capacity in Mexico over the next two years. Miguel Salazar, president and CEO of the company for Mexico, Central America and the Caribbean, made the announcement.

Located in Xochimilco, just over a one-hour drive from the capital city to the south, Boehringer Ingelheim's plant specializes in oral dosage anti-diabetic drugs. The company said the investment plant will take at least one billion Mexican pesos (US$52 million).

The Xochimilco plant is one of three sites that Boehringer has in Mexico, and the capital injection will be destined to increase the production capacity by at least 50%.

Currently, the Xochimilco plant generates 1,600 tablets, 50 million units of product, and it's expected that it will generate 2,500 million tablets and 80 million units by in 2028.

The plant expansion will allow Boehringer to increase export capacity to the US, Argentina, Colombia and Brazil.

Speaking to the Mexican press, Salazar explained that the demand for medicines for the control of diabetes is growing at a rate of 45% per year in Mexico.

The country has the highest prevalence of diabetes among the 35 countries in the Organization for Economic Co-operation and Development (OECD) countries, with an impact of 15.8% of adults, more than twice the average of 7%, according to the organization.

The market demand in Canada and the US, the destination of 30% of Boehringer's exports, is estimated to rocket in the next four years by up to 80%.

The project for the Xochimilco plant is part of an investment plan that will see the German company invest a total of MXN$1,600 million ($84m) by 2023 to boost production.

Salazar said the business recorded MXN$6.800 ($357m) in global sales in 2018, up 8.3% compared to the previous year.

The Mexican executive said Boehringer expects to reach $445m in sales by 2023, hence the company seeks to grow at rates of more than 10% per year.

ILC Dover’s New Cork Manufacturing Plant Includes 10,500 sq. ft. of Cleanroom Capability

MEP Deirdre Clune officially opened the new ILC Dover manufacturing facility in Blarney Business Park, Cork alongside ILC Dover CEO and President Fran DiNuzzo.

The state-of-the-art manufacturing facility equipped with 10,500 sq. ft. of cleanroom capability will enable the global leader in flexible containment solutions for the pharma industry to meet sustained market demand for their packaging solutions.

The expansion to the new facility has created 70 new jobs, with 35 of these roles already filled in the last three months.

Speaking at the official opening, MEP Deirdre Clune said: “Innovation is in the DNA of ILC Dover which operates across a number of market sectors; from developing the spacesuits that enabled Neil Armstrong and Buzz Aldrin to walk on the moon to highly effective containment solutions for the pharmaceutical sector, the company has always driven breakthrough solutions. I am delighted to officially open the new manufacturing facility in Cork, and welcome the continued investment by ILC Dover in Cork.”

ILC Dover has been operational in Cork since 2007. The company employs 22 in Little Island and Blarney, with recruitment well underway to fill the 60-70 new jobs created in their new manufacturing facility.

ILC Dover president and CEO Fran DiNuzzo said: “For more than a decade, ILC Dover has been based in Cork and our positive experience and engagement here has led to this new investment and our continued confidence in the Irish labor market. In manufacturing terms, we can source the best talent that operate to high quality standards and are a great fit with the innovative culture of ILC Dover. Today’s official opening of the new Cork facility is an important next step in our commitment to Ireland and to our pharmaceutical clients in Europe and beyond.”

Already 9 roles of the 60-70 new jobs have been filled in the last 3 months, with the remainder expected to come on stream in the coming months. As well as Production and Quality roles, ILC Dover are also recruiting those with Engineering qualifications, experience with cleanroom environments, Accountancy experience and Materials Management.

Chugai Pharmaceutical to Build Research Lab in Japan

Chugai Pharmaceutical has revealed plans to establish a core research laboratory at its business site in Yokohama, Kanagawa Prefecture, Japan.

Named Chugai Life Science Park Yokohama, the new facility will focus on the development of drugs, working with researchers from international markets. The firm will make a JPY127.3bn ($1.15bn) investment in the project, which is expected to be completed in August 2022 and begin operations in January 2023.

The company’s Fuji Gotemba Research Laboratories and Kamakura Research Laboratories will be consolidated to the new facility. These research centers have been engaged in the development of antibody technology, middle molecule drug discovery technology and also new drug discovery research.

The consolidation of these functions is meant to promote drug discovery, allow efficient multifaceted assessment and maximize the company’s research and development activities.

Chugai noted that the building was designed to save energy and reduce CO2 emissions.

The company estimates that this investment will have minimal impact on its consolidated forecasts for the fiscal year ending December 2019 announced on 31 January 2019.

A statement from the company read: “At the newly constructed Yokohama Research Laboratories, we aim to accelerate drug discovery and deliver innovative new drugs to patients around the world at an extraordinary speed, by bringing together the individual strengths of Fuji Gotemba and Kamakura Research Laboratories that have been honed over the years, and leading from further deepening of knowledge on the disease pathology to creative target identification, in addition to strengthening the core drug discovery technology.”

Based in Japan, Chugai Pharmaceutical focuses on research, development, manufacturing, sales and pharmaceutical import and export.

Sekisui Diagnostics Invests in Microbial Biopharma CDMO Business

Sekisui Diagnostics Enzyme business announces the completion of a new BioProcess Innovation Centre at the site in Maidstone, Kent by the end of 2019, following a $1.9 million investment. This investment is part of a long-term investment strategy to grow its share of the Microbial Biopharma CDMO market, with future investment expected to focus on expanding cGMP manufacturing capabilities.

Previously part of Genzyme Diagnostics, Sekisui Diagnostics' Enzyme business launched its Microbial Biopharma CDMO service offering, BioProduction by Sekisui, in 2017, building on over 40 years' experience in this field. The new BioProcess Innovation Centre will more than double its development laboratory space to facilitate Process Transfer and Development. Specialized in expression and purification from microbial fermentation, the group has wide experience, including but not limited to recombinant systems such as E. coli and Pichia pastoris, with associated purification and analytical technologies. Its main expertise lies in the production of enzymes, however its capabilities are also suitable for plasmids, antibody fragments, and other protein production. With production capabilities from 20L to 5,000L, Sekisui handles projects from pre-clinical through to commercialization.

"Over many years we have built both a technical and operational competency and expertise in enzyme production and microbial fermentation," said Robert Schruender, President & CEO of Sekisui Diagnostics and Sekisui Medical Board Member. "As the Biopharma CDMO market grows, we aim to further leverage this capability to grow our share in this market. This investment represents our commitment to serve our customers with innovative process development solutions."

Jacobs in Ireland

WuXi Biologics announced last year that its first manufacturing site outside of China would be in County Louth, Ireland, and now the firm has announced it has contracted construction management services firm Jacobs to make the facility a reality.

The €325 million ($394 million) facility will boast a total of 48,000 L fed-batch and 6,000 L perfusion in bioreactor capacity. Around 400 jobs will be created.

“WuXi has given us the opportunity to deliver a state-of-the art project to help them serve a global patient population, while furthering the ambition to make Ireland a global center of excellence in biologics, driving investment in Co. Louth and creating highly skilled jobs,” said Jacobs Buildings, Infrastructure and Advanced Facilities SVP Ken Gilmartin.

WHP Wins Design Contract for Vaccines Manufacturing Innovation Centre in UK

Project will see the engineering company design new cGMP suites and filling rooms for the UK's innovative vaccines manufacturing center in Oxford.

Contract covers the design of an array of laboratory and production facilities including the cleanroom architecture, M&E components, and process and critical utilities systems.

British engineering company WHP has been awarded a design contract for the Vaccines Manufacturing Innovation Centre (VMIC), which is set for construction in Oxford. The contract will see WHP design an advanced array of laboratory and production facilities within a ‘cleanroom wrap’ environment.

The contract was awarded to WHP as part of plans for the specification of versatile new cGMP suites and filling rooms for the VMIC.

These units will have the capacity to meet the Department of Health and Social Care requirements concerning the provision of vaccines in an infectious disease emergency.

The center, which has secured £66m of funding from UK Research and Innovation, is being developed through the UK Government’s Industrial Strategy Challenge Fund (ISCF) Medicines Manufacturing Challenge and is scheduled to open in 2022.

WHP, which has already completed RIBA Plan of Work 2 covering conceptual design, is utilizing 3D BIM modeling to finalize the cleanroom architecture, M&E components and process and critical utility systems for a facility that is set to become a national Centre of Excellence.

The project also features complex zoned HVAC systems to maintain segregation, cleanliness, air pressures and other environmental controls, the new laboratory and production facilities will be developed in compliance with MHRA regulations.

WHP won the contract on the back of its extensive experience and track record in designing, engineering and constructing complex viral vector and vaccine facilities. This includes an in-house design team with the expertise in working with alliance partners to develop comprehensive process engineered design solutions.

The WHP team working on the VMIC project will be leading the design process through to completion, which has included the selection and appointment of project architects Derell Consultants, as well as managing the complete project design and build package.

David Weir, lead designer on the VMIC project at WHP, said: “VMIC is another major contract success for us. It’s testament to the experience, competence and added value that we bring to multi-million-pound projects across the sector.

“Our process and 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.”

VMIC will be utilized by the UK authorities to manufacture vaccines rapidly in the event of a pandemic hitting the UK. It will also support rapid global responses to emerging, highly-infectious epidemic pathogens, such as Ebola and Zika, as well as develop new technologies, including the manufacture of personalized cancer vaccines and vectors for gene therapy.

National Healthcare Photonics Centre Opens in UK

The Centre for Process Innovation (CPI) in the U.K. has officially opened its state-of-the-art facility that will help develop next-generation light-based health care treatments.

Based at NETPark in Sedgefield, England, the National Healthcare Photonics Centre will support the advancement and commercialization of MedTech products and provide a hub for businesses and academic partners to work on imaging systems, innovative methods of diagnosing disease, and light-based treatment.

The two-story building encompasses more than 6500 sq. ft. and includes a suite of specialist laboratories for optical system development and testing. The facility also includes space for laser system applications development, biomaterials handling and testing, ionizing radiation imaging and testing, 3D printing, and electronics development and pilot manufacturing work.

In addition, the center features client office space to enable companies to locate onsite and work on projects alongside CPI staff. The infrastructure was created to enable businesses to drive forward innovative products and services at reduced risk and with increased capital efficiencies, and to encourage large companies to undertake more disruptive innovation in the health care market.

According to CPI, the National Healthcare Photonics Centre will provide facilities and expertise to help companies of all sizes develop their photonics-based technologies for health care, with an infrastructure to deliver prototyping, scale-up, and validation of medical devices at the required quality and consistency to feed into clinical validation studies.

The project officially broke ground on Nov. 10, 2017. The new center received initial funding from the North East Local Enterprise Partnership as part of the North East Growth Deal from the government.

Flamma Opens New cGMP Kilo Lab in Italy

Flamma SpA, a CDMO that develops, manufactures, and commercializes small molecule APIs for the pharmaceutical industry, has completed the construction of its first cGMP Kilo Lab at its Chignolo D’Isola headquarters in Italy.

The cGMP Kilo Lab is currently being used for an internal Flamma project in conjunction with its Flow Chemistry Pilot Unit. Customers with projects are reserving production slots for later in 2019.

This investment is part of the Flamma 2020 Plan to bring improvement across its network of manufacturing sites. This Chignolo site adds another option when working with Flamma’s API site.

GianMarco Negrisoli, corporate development manager at Flamma and chief executive officer of Flamma Innovation, said, “The opening of a cGMP kilo lab not only increases capabilities of our facility but also allows our customers greater flexibility in working with Flamma. The ability to place projects in Italy or China and knowing that Flamma is actively managing all our sites is comforting to our customer base.”

Flamma will also begin construction of its new R&D building at our headquarters in Chignolo later this year. “This will quadruple our R&D space thus allowing to continue to grow our staff of researchers to serve the pharma industry and the demands of our current customers as well as future customers,” noted Kenneth Drew, Ph.D., Sr. Director North America Sales and Business Development. “The additional benefit of this addition is the ability to have a fully dedicated analytical building for our growing quality team.”

Sheba, Lonza Collaborate on Cell Therapy Manufacturing

Sheba Medical Center at Tel Hashomer, Israel and Lonza have entered a collaboration to develop point-of-care cell-therapy manufacturing using the Cocoon manufacturing platform. The partnership will enable Sheba to streamline its in-house cell manufacturing process and produce genetically engineered human CAR-T cells for applications in treating critically ill oncology patients.

This collaborative agreement brings together a leading academic clinical center and an established development and manufacturing partner with the goal of delivering potentially curative therapies to a greater number of patients with advanced hematological malignancies. Sheba Medical Center treats oncology patients using novel immunotherapy treatments such as CAR-T, and Lonza will leverage its expertise in autologous cell-therapy process development to transfer Sheba’s current open, manual protocols into Lonza’s closed, automated Cocoon platform.

Eytan Abraham, head of Personalized Medicine, Lonza Pharma Biotech & Nutrition said, “This collaboration with Sheba Medical Center, a proven leader in point-of-care manufacturing and treatment of patients with novel immunotherapies, is a key part of the development program for the Cocoon TM platform. We aim to confirm the benefits of using our closed, automated GMP-in-a-box concept to more efficiently manufacture personalized cell therapies right where the patients are, enabling treatment of a larger patient population.”

MilliporeSigma Opens New Collaboration Center in France

MilliporeSigma has opened its new M Lab Collaboration Center in Molsheim, France. The center is MilliporeSigma's first in Europe and ninth worldwide, providing biopharmaceutical manufacturers with a shared, exploratory environment where they can collaborate with company scientists and engineers to help solve their challenges and accelerate development and production of new therapies.

"With the rapidly growing biopharma industry in Europe and demand for cost-effective therapies worldwide, customers will benefit from our expertise to develop processes for manufacturing drugs faster, safer and more effectively," said Udit Batra, chief executive officer, MilliporeSigma. "Our investment will accelerate the future growth of EMEA's biopharmaceutical industry."

The company invested $11 million in the 43,000 sq. ft. M Lab Collaboration Center to provide customers with a fully equipped, non-GMP pilot and bench scale lab and meeting center to help address processing development challenges without impacting their production line.

The company also has M Lab Collaboration Centers in the U.S., Brazil, China, South Korea, Singapore, Japan and India.

About the Life Science Business of Merck KGaA, Darmstadt, Germany

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has some 21,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Udit Batra is the global chief executive officer of MilliporeSigma.

Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck KGaA, Darmstadt, Germany, generated sales of €14.8 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Thermo Fisher Expands Pharma Services Business

The sites will be equipped with aseptic filling lines and isolator technology. Construction is expected to be completed within the next two years.

EV Group Invests for Capacity Expansion in Austria

EV Group (EVG) says it has started construction on another extensive building project at its corporate headquarters in St. Florian am Inn, Austria.

With an investment of EUR 30 million, the new Cleanroom V building will create additional capacity for product and process development, equipment demonstrations for existing and potential customers, feasibility studies as well as prototyping and pilot production.

The groundwork for the new building was recently finished and includes footings that reach up to 14 meters deep into the ground. Once the new cleanroom is completed, it will host precision equipment, such as EVG’s lithography systems, wafer bonders and metrology systems, which operate with micro- and nanometer accuracies. The contaminant-free conditions of EVG’s cleanrooms at its headquarters, as well as its subsidiaries in America and Asia, is said to be comparable to those in the fabs of EVG’s high-tech industry customers.

“Just this past April, EV Group celebrated the opening of our new Manufacturing III facility with our employees, which itself provides 19,368 sq. ft. (1,800 square meters) of additional production floor space for the final assembly of our equipment,” says Dr. Werner Thallner, executive operations and financial director at EV Group, in a press release. “In the meantime, the construction crews already started to work at the other end of our campus on this new building, which will add even more capacity to support our business growth. With the investment in expanding our cleanroom capacity, we continue to demonstrate our local commitment to Austria, as well as our global commitment to our worldwide customers.”

The new Cleanroom V building will provide approximately 620 square meters of additional cleanroom floor space – nearly doubling the cleanroom capacity at EVG’s headquarters. In total, the new building will encompass a floor space of about 4'400 square meters. The construction work is set to be completed by mid 2020.

Univercells Vaccine Production Line to Be Adapted

After a grant from the Bill & Melinda Gates Foundation, Univercells will adapt its low-footprint, cabinet-contained vaccine production line to create affordable measles and rubella vaccinations.

The NevoLine, Univercells’ proprietary platform for manufacturing affordable vaccines, will be used to produce measles and rubella (M&R) vaccines.

A $14.3m (€12.76) grant from the Bill & Melinda Gates Foundation will be put towards increasing production of the M&R vaccine production platform to provide greater availability in low- to middle- income countries.

According to Univercells, conventional vaccine manufacturing often requires high capital and operating costs and may not provide a sustainable or cost-effective solution. However, the company’s bioproduction platform uses less equipment and lower utilities, therefore, allowing for a smaller operating facility, which enables lower capital investment and operating costs.

A spokesperson for Univercells said that the platform combines an intensified fixed-bed bioreactor chained with in-line product concentration, enabling the equipment used to be effectively miniaturized.

“This intensified upstream processing can be integrated with downstream technologies to deliver an end-to-end manufacturing process. Benefitting from a very low footprint, the entire process can be contained in a series of cabinets – biosafety cabinets or isolators – leading to a low-footprint integrated and automated production system,” the spokesperson added.

The company will adapt the NevoLine platform for M&R processes and initiate clinical validation, to do so Univercells will work with its existing partner, Batavia Biosciences.

Measles and rubella are two viral infectious diseases that affect a significant amount of the world, despite being preventable by vaccination. Accessibility to vaccines pose a challenge, as effective vaccinations cannot often be produced for programs affordably

“Currently 85% of children globally receive the first dose of measles and rubella vaccine, while only 60% receive the required second dose. Closing the gap will require a sustainable supply of affordable measles and rubella vaccines,” the Univercells spokesperson explained.

Univercells will also work to discover other vaccine delivery technologies under evaluation of the Bill & Melinda Gates Foundation to further reduce costs and create immunization campaigns to improve accessibility.

“Novel vaccine delivery technologies will also be evaluated in combination with the development of this measles and rubella production platform. The novel administration technologies aim at facilitating the execution of immunization campaigns and increasing vaccination coverage, to eventually reach and maintain eradication of the diseases,” said the spokesperson.

Univercells’ NevoLine has been previously used to produce Sabin inactivated polio vaccine (sIPV), after a different grant awarded to the company by the Bill & Melinda Gates Foundation.

Sartorius’ Puerto Rico Expansion

Sartorius’ investment in Puerto Rico site doubles production capacity of manufacturing equipment for the biopharmaceutical industry.

The $100m (€89.2m) investment at the Yauco, Puerto Rico, facility doubled the production capacity of membrane filters and single-use bags for biopharmaceutical manufacture, most of which are supplied to the US.

Joachim Kreuzburg, CEO and executive board chairman of Sartorius, said in a statement, “Operationally and strategically, this expansion is an important investment for us. The considerably higher production capacities created as a result now give us leeway to deliver an even wider product array directly from the region to our American customers and to implement our ambitious growth plans in the Americas.”

After three years of construction, the factory site is 2m-square-feet and is designed to enable additional growth in the long-term, as Sartorius can double its manufacturing capabilities once more if needed.

Sartorius opened its facility in Yauco and has been manufacturing filter membranes there since 1982, adding the production of sterile single-use bags in 2012. The facility currently employees more than 500 people.

According to this was the first time Sartorius added production capacity for manufacturing filter membranes outside of its headquarters in Göttingen, Germany.

The company currently has 60 manufacturing and sales sites across the globe, employing 8,500 people. Sartorius reported global revenue of $1.68bn in FY18 results.

In March 2019, Sartorius and Novasep collaborated to introduce new membrane technology and single -use solutions into the company’s applications. In doing so, the partnership saw Sartorius supply products for both upstream and downstream processing equipment.

Lonza’s Swiss Site Adds HPAPI Manufacturing Capacity After AZ Deal

Lonza expands its HPAPI production capacity at its Switzerland facility after entering an agreement with AstraZeneca, and invests in manufacturing to establish efficiency.

The contract development and manufacturing organization (CDMO) invested in its highly potent active pharmaceutical ingredient (HPAPI) manufacturing capacity with two additional four cubic meter scale multi-purpose production lines added to its Visp, Switzerland facility to be online by 2020.

The added space will support Lonza after it entered into a long-term manufacturing agreement with AstraZeneca. The expanded facility will support the delivery of products across its portfolio to AZ, while the remaining capacity will enable Lonza to expand its offerings to other clients.

This facility expansion also represents a continuing investment in HPAPI manufacturing.

Lonza’s large-scale manufacturing site in Visp will see greater flexibility in production lines to enable the CDMO to support shorter time-to-market and efficient approval timelines with the additional space.

Lee Newton, VP and head of the API business unit at Lonza Pharma & Biotech, said that demand for HPAPI manufacturing is on the rise.

He explained, “We are witnessing a rise in the importance of drugs that include one or more HPAPI component. These molecules are useful in treating cancer, diabetes, autoimmune diseases, and other indications, and pharma and biotech companies are taking notice and incorporating these powerful molecules into innovative medicines.”

Lonza will also provide particle engineering and finished drug products for oral and parenteral delivery applications to industry members as well.

According to Newton, many of its clients are working to develop HPAPI products for small or emerging biotech companies. He said that many of its clients have ‘developed a great product’ but do not have in-house production capabilities.

“What they value is access to flexible and scalable manufacturing assets that can serve their specific needs – and hopefully grow with them as there is increased demand for their product,” said in regard to its clientele.

Boehringer Opens Facility to Meet Demand for Respimat

Boehringer’s plant opens in Barcelona and will produce 25m units per year of Respimat to be distributed to more than 100 countries.

Boehringer Ingelheim invested €120m ($134m) in the construction of the plant, which was begun in 2017 and was constructed in only two years through ‘fast track’ planning. This will see the plant become fully operational at the end of this year.

According to the company, 300 people were involved in the planning process and 25 different suppliers participated, enabling construction to be completed rapidly.

The 183,000-square-foot facility will create 200 new jobs in the Sant Cugat del Vallés, a town located outside of Barcelona, Spain.

The site is separated into production facilities, laboratories, warehouse space, offices and technical areas.

Boehringer will produce Respimat (tiotropium bromide) at the plant, with the space able to meet demand for more than half of the annual sales of the product, at 25 million units per year.

Respimat is an inhaler product that is used for the management of chronic obstructive pulmonary disease (COPD) and asthma.

Prior to this investment, Boehringer had primarily produced the product in Germany, where the company had previously concentrated its spending.

Peter Ploeger, CEO of Boehringer Ingelheim Spain, said in a statement that the facility is a ‘world benchmark’, in terms of the capabilities, and will function as one of the company’s ‘innovation hubs’.

The facility will utilize Industry 4.0 technology, which sees the facility be fitted with serialization processes, automation, and robotics.

Reyes Maroto, acting Minister of Industry of Industry, Trade and Tourism for Spain, welcomed the ‘demonstration of confidence’ in the country and its workforce to staff the facility. In addition, Boehringer stated that it had made an R&D investment of €86.1m Spain during the course of 2018.

The move stands in contrast to the news last year that Boehringer would reduce headcount in neighboring France, where 327 positions were cut.

Seqens Opens Collaborative R&D Space

Seqens opens new center of excellence that houses R&D capabilities, onsite consulting, and space for coworking and collaboration in Porcheville, France.

Seqens opened a 366,00 sq. ft. facility in Porcheville, France to serve as the company’s center of excellence. The facility, in close proximity to Paris, will provide R&D services to clinical research in the area and customers of Seqens North America, formerly known as PCI Synthesis.

The Procheville facility will be known as Seqens’Lab will offer expanded capabilities and include a coworking space for collaborative research.

Christophe Eychenne-Baron, group R&D director at Seqens in Paris, said that the company wanted to bring a new approach to finding ways to accelerate internal and customer projects that gathered its commercial team, R&D direction, and project management in one place.

According to the company, it is not just a shared laboratory and R&D hub but a ‘development accelerator.’

Eychenne-Baron explained, “We came to the epiphany that we could achieve our goals by gathering into one working area all the key internal function needed to deliver on-time projects.”

He added, “We intend to learn from our new practice here and look to roll out lessons learned and best practices to the rest of Seqens’ facilities around the world.”

Seqens’Lab will provide services in its ‘recognized areas of excellence’, including: organic chemistry development, reference to two laboratories in physics and solid-state chemistry and process safety, kinetic and thermodynamic simulation tools, and large batch manufacturing capabilities for preclinical and clinical studies.

OGT Opens New Cambridge R&D Site

Oxford Gene Technology (OGT), A Sysmex Group Company, has opened its new facility in Cambridge, UK, in the Cambridge Science Park. The new facility has state-of-the-art refitted laboratories and is approximately three times the size of the company’s previous site.

OGT acquired fluorescence in situ hybridisation (FISH) probe manufacturer Cytocell in February 2014. Since then the company has grown its portfolio, including launching the FDA-cleared in vitro diagnostic (IVD) FISH probe range for AML (Acute myeloid Leukaemia) and MDS (Myelodysplastic syndromes). The number of employees based in Cambridge has increased from 30 to 53 and continues to grow. The expanded operations will support increased volume of product manufacture and shipment. In addition, OGT plans to create a training and demonstration facility where customers can benefit from the company’s FISH expertise.

John Anson, chief executive officer of OGT said, “We are thrilled to celebrate the opening of our state-of-the-art facility in the heart of the Cambridge life science hub. OGT continues to perform well with sustained growth and this investment by Sysmex will accelerate our next phase of product development and global expansion.”

Also, Sysmex plans to set up a global R&D facility within the OGT laboratories - similar to other sites in Hamburg and Chicago. This facility will evaluate new technologies in the life sciences field and pursue collaborations with key opinion leaders, in an effort to bring innovative new products to the market. The facility will also be a hub for networking within the life sciences community, Cambridge University and global healthcare companies.

Fujifilm Investment for Continuous Bioprocessing Facility

Utilizing single-use flow paths, Fujifilm will create a continuous bioprocessing manufacturing facility after three years of in-house development.

Fujifilm Diosynth Biotechnologies will locate the facility in Billingham, UK, which will feature proprietary process controls that provide automatic feedback control for cell density and nutrient addition.

The perfusion facility will involve the constant supply of fresh media and processing of harvested media over a period of weeks. In addition, the company noted that it has designed ‘disruptive’ downstream bioprocessing technology for the facility.

Andy Topping, CSO of Fujifilm Diosynth Biotechnologies, explained.

Topping said, “One of the challenges with using commercially available equipment from a number of vendors has been the difficultly in connecting the pieces of equipment together, plus the challenges with ensuring that operators are familiar with multiple pieces of hardware and software interfaces. In addition, a continuous process requires all unit operations to be running simultaneously, which causes huge buffer demands.

“We have developed a single piece of equipment which is able to operate each of the required process steps and can be linked together to run the full process plus mix buffers from concentrated stocks at the point of use.”

What this means in practice is that the unit’s operations can include chromatography, ultra and dia-filtration, single pass tangential flow, viral inactivation and filtration and point of use in-line preparation buffers within a common single-use flow pathway.

The facility will include a 500L single-use perfusion bioreactor and seven downstream processing units. It is expected to yield greater than 15kg of antibody from a four-week batch at 500L scale.

When asked about the advantages of the single-use system, Topping outlined, “Building a continuous system in stainless steel is possible currently but gives a fixed process flow. The use of individual systems that can be connected and reconfigured to a variety of process flows is much more useful, particularly for clinical supply when the commercial process may not be finalized.”

“Fully single-use systems ensure rapid changeover and reconfiguration without issues of cleaning validation, verification or potential product carryover,” he emphasized.

According to the company, the continuous system offers a cost-effective alternative to traditional fed batch cell cultures processes and its process mitigates some of the challenges previously met in purifying the culture downstream.

“Continuous production is inherently more efficient as it reduces downtime required to clean and restart equipment. In the real world, this equates to being able to reduce the size of equipment required or produce more product from established facilities,” Topping said.

He added that the steady state of the continuous process also produces a higher level of product quality compared to batch production.

Fujifilm Diosynth Biotechnologies will make the system available for non-good manufacturing practice (GMP) process development services in autumn of 2019.

Cambrex Completes Labs and Logistics Center Expansion in Sweden

Cambrex announces the completion of a 6,456 sq. ft. (600-square-meter) facility in Karlskoga, Sweden, alongside a 32,280 sq. ft. (3,000-square-meter) warehouse.

The US-headquartered company, which recently became an integrated contract development and manufacturing organization (CDMO) by acquiring Avista, continued a series of investments at its Swedish site.

The three-story building includes process technology, QC and analytical development laboratories and is expected to house the R&D and production teams.

This investment of $5m (€4.42m), which was announced in 2018, is expected to employ computer modeling to optimize reactor set ups and plant conditions to improve technology transfer between the teams.

According to the company, the laboratory also includes high pressure reaction vessels and crystallization equipment for drug substance manufacturing, extending the capabilities for handling in-process and raw material analysis.

The equipment is also expected to expand the temperature range at which reactions can be carried out, with vessels capable of managing conditions from cryogenic levels to nearly 200°C.

“The new technical laboratory will act as a hub for the company’s engineers, operators and chemists to ensure smooth scale up and handover of processes from development sites across our global network,” said Bjarne Sandberg, managing director at Cambrex.

In order to support the site’s growth, which has included the expansion of large scale manufacturing capacity, Cambrex also opened a $6m, 32,280 sq. ft. (3,000-square-meter) logistics center.

The warehouse is current good manufacturing practice (cGMP)-compliant, with integral temperature monitoring and control, and has the capacity for 4,500 pallets.

Cambrex Completes Expansion and Upgrades in Milan

Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced that it has completed the expansion of a new 1,614 sq. ft. (150m2) research and development laboratory at its site in Paullo, Milan, Italy. In addition, Cambrex has installed a new 12,000 liter reactor into one of its cGMP manufacturing facilities at the site.

The R&D laboratory includes both chemistry and analytical development capabilities, with the installation of semi-automated glass lined reactors, as well as analytical instruments including multiple high and ultra-performance liquid chromatography, and gas chromatography systems, which have now been qualified and validated. To complement investments at other Cambrex sites, the new laboratory has also installed a flow chemistry system to allow for continuous manufacturing development.

The installation of the 12,000 liter reactor, along with the replacement of centrifuges with new, more efficient equipment in one of the site’s seven production departments, was part of a $3 million investment to upgrade and improve the efficiency of the plant which manufactures intermediates and generic APIs under GMP conditions.

“This investment is part of our ongoing strategy to ensure that the site can adapt to the growing and evolving needs of the generic API industry,” commented Aldo Magnini, Managing Director, Cambrex Milan. “Investing in key technologies such as continuous flow will allow us to look at new opportunities for the site to expand our portfolio of generic products, in a similar manner to the investment in highly potent API containment that we undertook in 2017, which allowed us to increase the number of new highly-potent oncology products in development.”

Cambrex manufactures over 70 generic APIs which are produced to cGMP standards at the Milan site, where the seven production departments are supported by a pilot plant, kilo-scale plant and development and analytical laboratories.

About Cambrex:

Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is your trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Cambrex offers a range of specialist drug substance technologies including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including solids, semi-solids and liquids and also has the capability to manufacture specialist dosage forms such as solid dose, fixed dose, pediatric, bi-layer, stick packs, topicals, controlled substances, sterile and non-sterile dose forms.

Thermo Fisher Expands Pharma Services in Italy

Invests $150 million in sterile liquid and lyophilized product development and commercial manufacturing in Italy and Greenville, NC

The sites will be equipped with aseptic filling lines and isolator technology. Construction is expected to be completed within the next two years.

WuXi Biologics to Build New Manufacturing Site in Central China

On May 16, 2019, WuXi Biologics, a provider of end-to-end solutions for biologics discovery, development, and manufacturing, announced the construction of a new 1.3 million-ft2 integrated biologics manufacturing center in Chengdu, China.

The manufacturing center will include drug development and commercial manufacturing facilities with an initial bioreactor capacity of 48,000 L. As the company’s 12th drug substances manufacturing facility, the new site is expected to enable more global partners, create more jobs for local talent, stimulate growth of the biologics industry in Chengdu, as well as accelerate the biologics ecosystem in Southwest China, according to the company.

“We are quite excited to commence this new integrated manufacturing center, the largest biologics manufacturing facility in Southwest China,” said Dr. Chris Chen, CEO of WuXi Biologics, in a company press release. “Supported by 205 ongoing biologics projects using WuXi Biologics’ open-access and proprietary platforms as well as our unique manufacturing paradigm of ‘Global Dual Sourcing within WuXi Bio’, we will continue to expand manufacturing capacity, based on our portfolio needs, to provide a robust and premier global supply chain that can enable our partners and benefit patie

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