PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Strides Acquires US Capsule Facility

Strides acquires the only FDA-approved integrated soft gel capsule manufacturing facility in the US, owned by Micelle, to support its operations in India.

Indian pharmaceutical manufacturer, Strides Pharma announced it has reached an asset purchase agreement with Micelle BioPharma, to acquire the latter’s facility in Riviera Beach, Florida, US, for $500,000 (€451.000).

Following the acquisition, with which Strides increases the number of its global formulation sites to eight, the company will proceed with a $10m investment to “build incremental capabilities and add additional dosage formats.”

According to the company, the facility is ‘one of the very few’ facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs. This means that the plant has been designed to prevent contamination and cross-contamination between the products.

Furthermore, the Florida site is the only integrated manufacturing and packaging SGC facility in the country approved by the US Food and Drug Administration (FDA), while it has undergone ‘several’ successful inspections and has no ‘outstanding’ FDA observations to address, Strides stated.

The facility is expected to boost Strides’ existing capacity in SGC manufacturing, which the company stated is an important pivot in its growth.

Strides markets 10 drug products in SGC formulation in several markets including the US, as well as 15 products for which it anticipates US FDA approval.

The news about the acquisition arrived less than two months after Strides’ facility in Puducherry, India, which manufactures drug products in SGC, amongst other formulations, received an FDA warning leading to deferrals for 10 pending ANDA approvals.

Velesco Acquires Facility

Michigan, US-based contract development and manufacturing organization (CDMO), Velesco Pharma, announced the purchase of a facility which will triple the company’s manufacturing capacity.

Velesco will triple its capacity for non-sterile clinical material manufacturing and consolidate its cGMP capabilities with the purchase of a facility in Wixom, Michigan.

The building added to Velesco’s assets features a processing suite space, which is expected to allow Velesco to provide enhanced current good manufacturing practice (cGMP) capabilities.

The building, which was previously owned by a constructions company, will include a warehouse and a materials management area, and will manufacture oral liquids, semi-solids and solid dose products used in early phase clinical trials.

The facility will be supported by the company’s existing quality check release and stability testing laboratory, also located in Wixom, while the company also plans to consolidate its manufacturing site in Kalamazoo, MI.

Dave Barnes, Velesco’s CEO, commented on the purchase, stating that it will enable the company to meet growing client demands, “while still maintaining our science-focus and flexible approach to client projects.”

The new facility is set to be fully operational by the end of this year.

Formed in 2007 by former Pfizer Michigan Research and Development (Pharmaceutical Science) colleagues, Velesco has been making steady steps building on its expansion during the past years.

In late 2018, the company announced a doubling of its analytical research and development capabilities with the acquisition of a building near its facility in Wixom, concurrently announcing an increase of its scientific team.

The company’s CEO related that this move answered increased market demands and that it would allow sponsors to advance new medicines into the clinic faster.

The expansion followed the addition of compound management services to the company’s portfolio, aiming to meet increased demand for materials management, in 2016.

Brammer Bio in Talks to Build Manufacturing Site in Massachusetts

Brammer Bio is looking to build a pharma manufacturing facility in Norton, MA. The viral vector manufacturers are attempting to finance this Massachusetts plant with tax increment financing (TIF). Brammer Bio was recently acquired by equipment manufacturer Thermo Fisher.

The US CDMO provides services for the cell and gene therapy sector and expects to employ around 300 people in the town by 2021.

Ron O’Brien, a spokesman for Thermo Fisher who purchased Brammer Bio in March, said the project is still in a preliminary stage and additional information such as size and projected cost will be released in the near future.

This is not the first major project in the area. In 2016, Alnylam Pharmaceuticals built a US$200 million, 200,000 sq. ft. facility in Norton’s industrial park near Taunton.

PTC Therapeutics Acquires Biologics Facility from Bristol-Myers Squibb

PTC Therapeutics has signed a long-term lease agreement with Bristol-Myers Squibb (BMS) to acquire BMS’ biologics facility in New Jersey, PTC announced in an Aug. 5, 2019 press release. Under the agreement, PTC will gain access to approximately 185,000 ft2 of space, including an existing state-of-the-art biologics production facility and supporting research and operations buildings on the BMS Hopewell, NJ, campus. Financial terms of the acquisition were not disclosed.

PTC plans to further develop the biologics facility to support gene therapy production and foster innovation and employment in the community. In addition, the company plans to move its research operations to a newly renovated building on the same campus. These facilities will complement and enhance existing operations at the company’s global headquarters in South Plainfield, NJ.

"The Hopewell facility is a vital part of our strategy to develop best-in-class therapeutics for patients with high unmet medical need," said Stuart W. Peltz, PhD, PTC’s CEO, in a company press release. "Obtaining this facility allows PTC to execute on our plans of rapidly advancing our gene therapy pipeline. Access to best-in-class technology and highly qualified biologics operation specialists is key for PTC to meet our goal of becoming a leader in gene therapy."

The facility is located on an existing BMS property encompassing more than a million square feet which BMS is transitioning into a multi-tenant research and development campus. PTC intends to initially dedicate the cGMP suites on the site, which were recently renovated, to produce material that will serve multiple pre-clinical and clinical programs. This will add to the current pre-clinical production capacity in Bridgewater, NJ. Together with the start-up of the gene therapy development and production operations, PTC plans to relocate and expand its global discovery and research operations to the same site in 2020.

Nephron Partners with University to Create Sterile Syringe-Filling Robots

The partnership aims to harness the power of automation to make production processes more efficient

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing in the pharmaceutical production process. This improvement will aid in keeping up with growing hospital demands for these products.

The partnership aims to harness the power of technology and automation to make production processes more efficient. To do so, Nephron is enlisting the expertise of the College of Engineering, Computing and Applied Science professor and researcher Yue "Sophie" Wang and mechanical engineering doctoral student Brandon Delspina and mechanical engineering master's student Yu "Gloria" Zhang.

Their robotics research for syringe automation will support the Nephron 503B Outsourcing Facility, a cGMP manufacturer providing sterile, pre-filled medications to address persistent drug shortages in hospitals and medical facilities across America.

"When the External Affairs' Office of Corporate Partnerships and Strategic Initiatives approached us about this project we were excited to get involved," said Wang, associate professor of mechanical engineering. "Our work in robotics can have a tremendous impact on individuals across the country and we are looking forward to working on this because of its benefits for the many patients Nephron serves."

Based in West Columbia, Nephron is a certified woman-owned business and one of the fastest-growing companies in South Carolina. This is Nephron's first partnership with the University and was developed through External Affairs' Office of Corporate Partnerships and Strategic Initiatives at Clemson University.

"Industry needs are changing at a rapid rate and Clemson is equipped to support companies like Nephron. Together, we have created a mutually beneficial project to enhance their capabilities while providing the University's students with unique, hands-on research experience," said Angie Leidinger, Vice President for External Affairs. "This partnership is a testament to the work happening at Clemson and we're looking forward to this collaboration, which will advance their business and benefit South Carolinians."

Nephron CEO, Lou Kennedy, said: "Working together with Clemson's world-class researchers and engineers, we can ensure that the pharmaceutical manufacturing process remains safe, and we can deliver life-saving drugs to patients and hospitals across the country."

Boehringer, MD Anderson Build Out 'Virtual R&D Center' for Cancer Research

German pharma Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center have joined forces to create a new “virtual” R&D hub so the pair can work on cancer drugs.

The so-called Virtual Research and Development Center will see experimental gastrointestinal and lung cancer therapies out of Boehringer’s pipeline combined with the drug-development capabilities at MD Anderson.

The collaboration will see projects at various phases, such as research, development and / or clinical stage.

MD Anderson TRACTION executive director Tim Heffernan said: “Our therapeutics discovery team is well-poised to conduct impactful translational research. This partnership will allow us to more rapidly advance much-needed new therapies to patients.”

TRACTION is a platform designed for translational research to gain better insights into the mechanism of new medicines and identify patients who will benefit the most.

The new Virtual Research and Development Center will initially work on Boehringer’s KRAS pathway inhibitors and a TRAIL-R2 antibody that is said to possess the potential to specifically induce the death of cancer cells.

Boehringer Ingelheim Medicine oncology corporate vice-president and global head Dr Victoria Zazulina said: “Together, we hope to transform the treatment landscape for these diseases by tackling their root causes and drivers, that have so far remained elusive, exploring new and smart ways of killing cancer cells.

“Our innovative oncology pipeline, coupled with strong partnerships like this, will contribute to unravelling the complexities of these diseases and bring innovative solutions to people with various types of cancers.”

Over the past months, Boehringer forged multiple partnerships to strengthen its oncology pipeline, including a deal with US-based PureTech Health in April to develop new cancer drug candidates.

In June, the company extended its alliance with the University of Dundee to develop proteolysis targeting chimera (PROTAC) based treatments for cancer.

In July, Boehringer acquired Swiss biotechnology firm AMAL Therapeutics, a developer of cancer vaccines.

To start, the center will look at KRAS pathway inhibitors and a TRAIL-R2 antibody (with the potential to selectively induce cancer cell death) from Boehringer as it looks to make deeper advances out of its pipeline.

The center will also “enable effective data sharing and analysis between the organizations,” the pair said in a statement.

“We could not have chosen a better partner with all its research, translational and clinical expertise in lung and gastrointestinal cancers. Together, we hope to transform the treatment landscape for these diseases by tackling their root causes and drivers, that have so far remained elusive, exploring new and smart ways of killing cancer cells,” explained Dr. Victoria Zazulina, corporate vice president and global head of oncology medicine at Boehringer.

“Our innovative oncology pipeline coupled with strong partnerships like this will contribute to unraveling the complexities of these diseases and bringing innovative solutions to people with various types of cancers.”

Boehringer came into the oncology game a few years back with the approval of its lung cancer med Giotrif and has since been busy penning a series of pacts inside and outside of oncology to boost work on its pipeline.

This includes recent deals with Swiss cancer vaccine biotech Amal Therapeutics, which it bought just last month, and late last year it also inked a $300 million deal with Epizyme for research into two previously unaddressed regulators of genes linked to cancer.

“Within MD Anderson, we are committed to a singular goal of ending cancer,” added Tim Heffernan, Ph.D., executive director of TRACTION at MD Anderson. “We look forward to working with Boehringer Ingelheim to advance their innovative pipeline of cancer medicines. Our Therapeutics Discovery team is well-poised to conduct impactful translational research, and this partnership will allow us to more rapidly advance much-needed new therapies to patients.”

Reed-Lane Opens Cold Chain Room for Vial and Ampoule Kitting

New facilities are located adjacent to existing cold chain infrastructure for limited intra-facility travel and product excursion

Reed-Lane, the pharmaceutical contract packaging company based in Wayne, New Jersey, has added a dedicated room for vial and ampule kitting to its cold chain capabilities. Located adjacent to its existing cold chain infrastructure for limited intra-facility travel and product excursion, the space is capable of labelling vials and ampules, then kitting them with other components such as printed literature.

Once products are kitted they are brought to Reed-Lane’s carton serialization suite, which can handle serialization from unit-level coding to full-pallet aggregation.

Among other benefits, the additional cold chain environment makes Reed-Lane a more viable player in the packaging of biopharmaceuticals, a burgeoning pharma industry niche. Among the New Jersey-based contract packager’s reasons for entering the cold chain market is the strong growth of the biologics industry, whose high-value products often place added emphasis on proper, tightly controlled storage temperatures.

Maintaining a secure cold chain through the storage, handling and transportation of temperature-sensitive drugs assures product quality and integrity, benefitting patients and keeping manufacturers, hospitals and pharmacists in compliance with various laws, regulations, guidelines and codes.

“The new dedicated environment for vial and ampoule kitting showcases Reed-Lane’s commitment to steadily growing our cold chain capabilities,” said Patricia Elvin, President of Reed-Lane. “In combination with our ahead-of-schedule ability to achieve full aggregation for serialized products, this latest infrastructure makes us even more attractive to biopharma companies as well as an expanding set of traditional pharma manufacturers.”

Plans for Kite Pharma’s Viral Vector Manufacturing Facility

Kite Pharma, a subsidiary of Gilead Company, announced plans to build a new viral vector manufacturing facility in Oceanside, California, US, on July 2019.

The facility will be used for manufacturing viral vectors for production of cell therapy as well as the company’s first commercially available chimeric antigen receptor T (CAR T) cell therapy known as Yescarta®.

The new facility will improve development, manufacturing, and supply capabilities of the existing CAR T-cell therapies and future pipeline products.

The viral vector manufacturing facility will be developed within Gilead’s existing biologics operation facility in 4049 Avenida de la Plata, Oceanside. The facility was purchased from Genentech in August 2011.

A new state-of-the-art 67,000ft² building will be constructed inside Gilead’s existing facility.

The new facility will be dedicated to the manufacture of viral vectors such as replication-deficient gamma-retroviral vector PG13-CD19-H3 and replication-deficient lentiviral vector.

PG13-CD19-H3 is the important starting material used for production of Yescarta. It was the company’s first CAR T-cell therapy that was approved by the US Food and Drug Administration (FDA) in 2017 and is used for treatment of large B-cell lymphoma in adult patients.

Yescarta is developed from patient’s own white blood cells (WBCs). T-cells from the WBCs are extracted, modified and re-infused into the patients to identify and kill cancer cells.

The retroviral vector PG13-CD19-H3 is also used for development of other investigational therapies candidates such as KTE-X19 for acute lymphocytic leukemia and mantle cell lymphoma.

The facility will develop replication-deficient lentiviral vector, which is used to produce an investigational biologic candidate KITE-585. It will also support production of KITE-718 therapy.

It will be an addition to Gilead’s existing network of manufacturing sites in California, Maryland and the Netherlands in Europe.

Gilead’s existing facility in Oceanside is a 70,000ft² building with the related process development resources.

The facility was designed and equipped for production of biologics candidates. It is currently used for clinical manufacturing and process development of biologic compounds for pre-clinical or early-stage clinical trials.

Kite Pharma develops T-cell-based cancer immunotherapies for oncology by using CAR or a T-cell receptor (TCR), based on the type of cancer.

"The retroviral vector PG13-CD19-H3 is also used for development of other investigational therapies candidates such as KTE-X19 for acute lymphocytic leukemia and mantle cell lymphoma.”

CARs are engineered proteins that contain an antibody or target-binding component to identify the specific antigen expressed by the tumor cells and other signal-activating component for T-cells to kill tumor cells.

TCRs are specifically modified proteins for a particular type of cancer, which enables T-cells to recognize and kill antigens expressed by the tumor cells.

Marketing commentary on Kite Pharma:

Based in California, US, Kite Pharma is a pharmaceutical company focused on development and manufacture of immune-based cell therapies for cancer treatment. US-based biotechnology company Gilead Sciences acquired Kite Pharma for $11.9bn in October 2017. Kite’s CAR and TCR platforms and more than 700 employees of Kite became part of Gilead’s portfolio following the acquisition.

The company’s clinical and commercial manufacturing facilities are located in Foster City, San Dimas, La Verne, El Segundo, and Oceanside in California (US), Cork in Ireland and Edmonton in Canada.

The company contracts with third-party manufacturers for certain active pharmaceutical ingredients (APIs) and commercial products.

Bio-Techne Reagent Plant Will Support Cell & Gene Therapies

Plans for a $50 million GMP reagent facility in Minnesota are materializing at Bio-Techne as it looks to support the burgeoning cell & gene therapy sector.

In its third quarter FY2019 financial call, life sciences services and consumables firm Bio-Techne spoke of intentions to build a $40 million (€36 million) GMP facility in Minneapolis, Minnesota to produce reagent proteins for use in cell and gene therapy applications.

Three months on, the firm has said plans are now laid to invest $10 million more – $50 million – over the course of the next 12 to 18 months to feed demand from its customers as their cell and gene therapies get FDA approved and move to commercial production.

“This cost will include viral testing of our existing products to be manufactured in the new facility. It will also include upfront sales and marketing campaigns to make our customers more aware of our new strategic cell and gene therapy workflow offering, ultimately seeding our products in more clinical and preclinical trials,” Bio-Techne CFO Jim Hippel told stakeholders on a Q4 FY2019 financial call.

“This is a big investment, but with huge potential returns. We call this our internal acquisition. We see the possibility of our cell and gene therapy offering generating more than $200 million of annual revenue five years from now.”

CEO Chuck Kummeth added the company is “on the way to having a healthy cell and gene therapy business” through the addition of capacity and “hot market demand.”

He added: “This business will take a few years to grow to material level for the company, but we see explosive growth in this space and our larger biopharma customers have been asking us to invest further in this direction.”

He also spoke about the firm’s recent acquisition of B-MoGen Biotechnologies, adding gene editing and delivery tools to Bio-Techne’s arsenal.

“This technology holds the promise of being able to deliver personalized therapeutic agents that have greater target effect and less off-target side effects,” he said on the call.

“B-MoGen’s key non-viral vector technology obviate several concerns associated with the use of viral vectors, including simplification of the entire vector manufacturing process, reduced biosafety concerns related to cytotoxicity, mutagenesis or malignant transformation of target cells and greater flexibility in payload size.”

Tissue Regenix Plans Tissue Engineering Expansion in Texas

UK-based Tissue Regenix Group has signed a 10-year lease agreement on a 21,000 sq. ft. facility to expand processing capacity at its manufacturing base in San Antonio, Texas. The agreement with the tissue engineering company also includes the option to purchase the facility at a later date.

The new facility, situated on adjacent land to the Group’s current 13,700 sq. ft. facility, will be brought on stream in a phased plan to meet the growing commercial demand for the company’s novel product portfolio.

Tissue Regenix’s portfolio leverages innovative tissue engineering platform technologies to develop and commercialize acellular tissue matrices to prevent donor tissue rejection.

Phase one of the expansion will commence immediately with part of the new building being converted into office, distribution and warehouse space, allowing for additional cleanrooms to be built in the original facility, which are expected to be operational by the end of 2020.

Over time, it is planned for further processing and packaging cleanrooms to be built in the new facility, therefore, increasing the company’s ability to process more tissue and produce products.

The new facility underpins the company’s strategy of building strategic partnerships, accelerating US market penetration and pursuing geographic expansion opportunities.

Gareth Jones, Interim CEO of Tissue Regenix Group, said: “I am delighted that we have secured this additional facility to support our ambitious growth plans. The group has undertaken a number of operational initiatives in order to increase production capabilities and meet the growing market demand for our products. Having commenced a second shift at the beginning of the year in our current facility in San Antonio, the phased build-out of this new facility will allow us to meet the growing requirements of our customers well into the future.”

Aside from the direct medical applications, tissue engineering has great potential for use in clinical drug trials to bridge the gap between animal testing and human trials.

The company’s lead technology is the patented process called dCell Technology. This method is a gentle soft tissue decellularisation process, removing DNA and cellular material to reduce the risk of rejection of donor tissue.

Differentiated characteristics:

Maintaining the natural acellular scaffold of the tissue structure to allow for cellular proliferation

Supports regeneration of native tissue

Can be applied to both human and animal tissue sources, no supply issue

Favorable health economic benefits due to reduced operation time, reduction in rehab activities, no anticoagulant drugs, stored at room temperature.

Bioquell Opens Technology Centre in Pennsylvania

Bioquell, an Ecolab company and a specialist in reducing the risk biocontamination in the life science and healthcare markets, has opened a state-of-the-art technology center at its Americas headquarters located in Horsham, Pennsylvania.

The new facility showcases the company’s full range of high performance biodecontamination systems and services. The facility has been designed to highlight and train customers on new biodecontamination solutions.

“Our new technology center will provide customers with a better understanding of Bioquell’s capabilities and solutions for the life science and healthcare markets,” says Ed Striefsky, Bioquell Vice President of Business Operations for North and South America.

“The center will also serve as an incubator for product development.”

The technology center has full scale working models of Bioquell’s biodecontamination systems and service capabilities.

It has a mock cleanroom area, complete with working Bioquell equipment, and a mock hospital room which includes a Bioquell SeQure fixed wall mounted biodecontamination system and Bioquell BQ-50 mobile hydrogen peroxide vapor generator.

Berkshire Sterile Manufacturing to Add Third Isolator Line

Berkshire Sterile Manufacturing (BSM) announces its plan to add a third isolator line to expand capacity for future commercial clients. BSM is a state-of-the-art fill/finish contract manufacturer providing formulation and sterile filling services to companies producing injectable medications for pre-clinical through commercialization.

The injectable medications are produced inside isolators with robotic flexible fillers that can be modified to fill three container types: vials, syringes, and cartridges. The company currently has two isolators in operation with a fill rate of up to 1200 units/hour. The third line will contain a flex filler with the ability to fill at a rate of 3000 units/hour depending on container and fill volume. The isolator and filling line will be linked to a depyrogenation oven (sterilization by heat), allowing for bulk vial use, with a vial washer located on the loading side of the oven. A rapid decontamination chamber will be included in the isolator for the introduction of pre-sterilized containers, and a high capacity lyophilizer (capable of producing 20,000 freeze-dried vials) will be also be connected to the isolator.

The company will also add a second ventilator autoclave (sterilization by pressurized steam) and a new water for injection system (WFI; sterile water system) to the manufacturing area to provide redundancy in BSM's systems. This will ensure all necessary equipment is available if one of the systems were to be placed out of order.

Inspection will be updated with a semi-automated inspection system to handle the greater volume of product. This system will roll vials, cartridges, and syringes past inspectors and robotically spin the containers. This system will prevent loss of time due to manual inspectors having to pick up, swirl, and put down containers, and it will improve consistency in the inspection process.

The additions will be completed in 2020 to early 2021 and will offer expanded capabilities and better services to existing and future clients.

"This is a win-win-win for our clients, the company and the community,” CEO, Shawn Kinney said. “The expansion will create 60 high-salary positions in Berkshire County, Massachusetts, expand services to our current and future clients, and produce high quality medications to further clinical research.”

Orano Med Invests in Radiopharma Production in France and US

Orano Med will be investing €15 million in France and the US to accelerate the development of therapeutic solutions using the radioactive properties of lead-212 (212Pb) in the fight against cancer. These investments will allow the expansion of the technical production capacities of the two main Orano Med sites in response to needs related to preclinical and clinical development.

In practice, these investments will double the laboratory space available at the Maurice Tubiana Laboratory in Bessines-sur-Gartempe (France) in order to increase its lead-212 production capacities.

The French company will also finance the installation of a cleanroom, allowing the facility to achieve the status of "pharmaceutical establishment" as recognized by the French National Agency for the Safety of Medicines and Health Products (ANSM). This is a necessary step before clinical doses can be sent for therapeutic trials in Europe.

In the US, the capacities of the Domestic Distribution & Purification Unit (DDPU), located near Dallas, Texas, will be extended to allow several clinical trials to be performed in parallel.

New research and development laboratories and the purchase of special equipment for the development and synthesis of new molecules will also accelerate Orano Med’s preclinical research into peptides radiolabelled with lead-212.

Lead-212 is a rare isotope produced by Orano Med that is used for a series of treatments known as "targeted alpha therapy", an approach to fighting cancers with limited therapeutic options. This approach uses the properties of alpha emitters such as lead-212 to specifically target and destroy the cancer cells, while limiting the impact on healthy cells.

"We have reached a point where we are sufficiently confident in the potential of our lead-212 therapies to make these investments, which are vital to our development," explained Julien Dodet, the CEO of Orano Med, at the International Symposium on Targeted Alpha Therapy, in Ottawa.

Dodet added: "They will enable us to guarantee our supply of lead-212, and produce and ship clinical doses for forthcoming trials, as well as strengthen our potential to develop new molecules to enrich our portfolio of new therapies. The investment program will run until mid-2020."

Orano is a recent company but has existed in one form or another for a long time. The Areva Group had a corporate restructure and, in the process, separated its nuclear cycle business into a separate company, called New Areva. This later became Orano.

Pfizer Expands Manufacturing Facility

Pfizer invests half a billion dollars to expand its gene therapy manufacturing facility in North Carolina and enhance its position to compete in the booming market.

At its site in Sanford, US, Pfizer manufactures investigational gene therapies for the treatment of rare diseases, as well as components for its vaccine portfolio, including Prevnar 13, a pneumonia vaccine with nearly $6bn (€5.4bn) sales in 2018. Pfizer began working on the site's expansion in January 2019 and expects to have it completed in early 2022.

The $500m (€450m) investment follows Pfizer’s $100m investment to establish the Sanford site in 2017. Upon completion of the expansion, the facility is expected to further support Pfizer’s gene therapy R&D activity at its North Carolina sites in Chapel Hill and Kit Creek.

Additionally, with the expanded footprint in the area, Pfizer announced plans to advance its clinical and commercial scale production capabilities for one-time gene therapies that use recombinant adeno-associated virus (rAAV) vectors.

The expanded site will cover approximately 100,000 sq. ft. and will include eight single-use bioreactors of 2,000L each. Following the expansion, the facility will have the ability to "run multiple products concurrently," the spokesperson said.

Mike McDermott, president of Pfizer Global Supply, said in a statement that the investment is part of the company’s “overall plan to invest approximately $5bn in US-based capital projects over the next several years.”

The expansion is projected to add approximately 300 new employees to the 650 who are already employed at the company’s site in Sanford. Through its existing facilities in North Carolina, Pfizer employs approximately 3,600 people in the state.

The small scale facilities in Kit Creek and Chapel Hill have a capacity of 250L bioreactors each, which have been utilized to develop the process for use in larger scale manufacturing.

Pfizer has made significant investments to establish its position in the emerging gene therapy R&D space, such as with the acquisition of Vivet, an AAV gene therapy developer, for over $600m, earlier this year.

The investment in the market is rising, especially after Novartis received the green light to market its gene therapy Zolgensma (onasemnogene abeparvovec), at the price of $2.1m per patient – becoming the most expensive commercially available drug.

The Sandford facility supplies the clinical trial materials for PF-06939926, the company’s Duchenne muscular dystrophy (DMD) gene therapy candidate, which is soon to enter Phase III trials.

Mikael Dolsten, president of worldwide research and development at Pfizer, spoke about the progress of the product’s development during a conference call earlier this month.

“Our manufacturing including large-scale 2,000-liter bioprocessors are on track,” Dolsten said, adding that the company aims to continue the product development with a pivotal study in 2020, after having seen ‘sufficiently encouraging’ clinical data.

The news about the Sanford facility expansion came only two days after the FDA rejected the new drug application for Golodirsen (SRP-4053), a DMD treatment candidate rival being developed by Sarepta Therapeutics.

New Biomedical Research Center Facility at Northwestern University

Designed by Perkins+Will, Northwestern University’s 12-story Louis A. Simpson and Kimberly K. Querrey Biomedical Research Center contains spaces which are reconfigurable for different uses and which were crafted with researchers and their tasks in mind. The structure also is meant to strengthen collaboration between the education, research, and medical professional communities.

In the 12-story Louis A. Simpson and Kimberly K. Querrey Biomedical Research Center, a structure designed by Perkins+Will, contemporary design facilitates scientific research by easing the process. Research areas in the new 627,000-square-foot facility include spaces for work on diabetes, neurodegenerative disorders, cardiovascular disease, and cancer.

The structure has laboratories created with their intent in mind. Built around “research neighborhoods,” as well as connections to hospitals on campus and the Robert H. Lurie Medical Research Center of Northwestern University, the spaces engender collaboration and discovery. Through the new facility, the university now offers the flexible spaces necessary for research.

“The Simpson Querrey Biomedical Research Center is an inspired new home for discovery on Northwestern University’s Chicago medical campus,” said Dr. Eric G. Neilson, vice president for medical affairs and Lewis Landsberg Dean of Northwestern University Feinberg School of Medicine. “Inside this modern new building, scientists will pioneer discoveries that will impact the practice of medicine and transform human health. Here, we will accelerate the pace of lifesaving medical science that fuels the local and national economy, near world-class campus partners and in a global city with unrivaled opportunities for biomedical commercialization and entrepreneurship.”

Touted by the university as the largest new academic biomedical research facility in the country, the research center makes the most of limited space in a tight area. Designed with open space at the street level and a glass lobby creating an open feel, the building’s modern design echoes the state-of-art research inside.

About 1,500 researchers labor on nine laboratory floors of the new building. It’s the core a newly unified academic medical district comprising physicians and scientists from Northwestern University Feinberg School of Medicine, the McCormick School of Engineering, and the Stanley Manne Children’s Research Institute, along with clinical affiliates Northwestern Memorial Hospital, Ann and Robert H. Lurie Children’s Hospital of Chicago, and Shirley Ryan AbilityLab.

“The building was designed with elegance and transparency in mind, welcoming the public at street level and prioritizing varied space types, natural light, and extensive collaboration areas,” said Ralph Johnson, Design Director at Perkins+Will.

Twenty-three labs on each floor can be reconfigured to fit research needs. Positioned at the center of the facility, the labs are ringed by glass walls to allow natural light. Two-story collaboration spaces connect groupings of lab levels by way of a cantilevered balcony and staircase.

A multi-story atrium lobby in the building can be used for events of up to 300. The atrium, located at the base of the building’s curving glass façade, connects to the Lurie Medical Research Center and the campus bridge network.

New Student Wellness Center at the University of Chicago Begins Construction

The University of Chicago’s new Student Wellness Center at the Hyde Park, IL campus, which will create a single, integrated facility for the university’s student health, counseling, and wellness resources, is now under construction.

The 30,000 sq. ft. project includes ground floor renovation of a portion of the historic building that houses the school’s student health clinic, and the construction of a new modern glass addition infilling an existing courtyard that will accommodate student counseling and health promotion services into one location. A new dedicated student entrance is also being created.

Existing gothic stone masonry will be on display by constituting the perimeter circulation walls of the main corridors. Continuous overhead skylights will bring natural light into these passages.

The new courtyard addition was designed as a single-story glass structure to maintain a low profile when viewed from the street. The entrance will be recessed behind the existing gothic cloister to avoid altering the appearance of the historic Lying-In Hospital. A small landscape courtyard will provide transition from 59th Street through the cloister to the entrance and lobby of the new facility.

“We’re updating a historic building to enable the University of Chicago to meet the comprehensive health and wellness needs of students, and we are doing so in a way that is deeply respectful of the original architecture and seamless in its integration of past and present,” said Kevin Havens, Executive Vice President, Director of Design at Wight & Company.

Wight & Company is providing design-build services for the project.

The first phase of the project is slated for completion by spring 2020.

Ibio Activates Sterile Fill-Finish Operations For Clinical Stage Biopharma

Sterile fill-finish capabilities will be available to clinical stage customers as iBio activates its operations for biopharmaceutical products after entering a supply agreement.

After signing a supply agreement with an undisclosed customer, iBio has activated its new current good manufacturing practice (cGMP) sterile fill-finish services operation at its 135,000-sq. ft. Bryan, Texas facility.

Earlier, the plant-based contract development and manufacturing organization (CDMO) introduced its cGMP sterile fill-finish capabilities for products, including monoclonal antibodies (mAbs), viral vectors, and biologics.

Per a recent supply agreement iBio entered, the company has activated its fill-finish capabilities and will formulate and fill clinical research quantities of the customer’s investigational therapies into sterile vials for use in a late-stage clinical trial.

A spokesperson for iBio said investigational therapies often have smaller fill requirements, because of the nature of the smaller disease populations.

“Increasingly there is an unmet need for high quality sterile fill-finish services in this space, and iBio’s comfort with a variety of pharmaceutical products, including gene and cell therapy, viral vectors, and mAbs makes it a natural fit for these solutions,” the spokesperson added.

iBio will focus on using the fill-finish capabilities on clients with preclinical and clinical stage programs.

The spokesperson explained that the company’s fill-finish capabilities are specifically targeted at companies with smaller fill requirements, as it is often problematic to identify available capacity for small volume filling with larger CDMOs set up to fill larger and ongoing orders.

FLAMMA Acquires Teva’s Philadelphia cGMP Facility

Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that the company has acquired the Teva’s Chemical Synthesis Center in Malvern, PA in the Philadelphia area.

“The industry knows and respects the Flamma brand, yet some customers are apprehensive when considering the placement of a project overseas. Flamma understands this and feels that this will be a good option for those wanting to initially start a project close to home,” said Kenneth Drew, Ph.D., Sr. Director of North America Sales and Business Development.

“This facility will be a welcome addition to Flamma’s current customer base as well. Having a US cGMP facility provides further flexibility and options to customers as Flamma continues to grow its R&D teams. Using our unique model of Flamma Academy, we will be able to have R&D chemists from both Italy and China to spend time in the Philly area labs and understand what customers want a first-hand. It also helps to bring the entire company together by pairing Italian, Chinese and American scientists together. Flamma is the Thinking CDMO.”

GianMarco Negrisoli, President of Flamma Innovation (the R&D unit within the Flamma Group), noted, “This is another example of the strategic vision for Flamma. The goal is to be recognized by customers as a strategic partner that is ready to invest when and where customers need us to.”

The 40,000 sq. ft. the facility is in close proximity to Boston/Cambridge (1.5 h flight) as well as the greater New York/New Jersey area (1.5 h drive). Affectionately being dubbed “Flamma-delphia” for now, this extremely well built lab and manufacturing site possesses a cGMP Pilot Plant with hydrogenation capabilities as well as wet-milling, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite with isolators that have been classified 3b (Roche) or band 4 (Safebridge), 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs. Also, the site previously handled controlled drug substances (Schedule II to IV) and Flamma looks forward to reactivating the necessary licenses.

This site will be to be initially dedicated to the development and, production of APIs ranging from pre-clinical/clinical (Phases 1 to 3) and up to commercial phase (after future FDA inspection) with the scale being dependent on the forecasted quantities. Flamma plans to grow the site to 60 employees by 2023 and looks forward to attracting talented personnel

As part of the growing demands of the industry, Flamma has carefully examined various options over the past few years for growth. Flamma felt it was best to start a laboratory operation from the ground floor than try to incorporate an already existing business. By doing this, Flamma can continue to impart its unique culture to its employees from day one and bring value to customers knowing that the same family owned and run culture permeates the new site. This site will be able to quickly accommodate fast-tracked molecules and respond to the constantly growing analytical needs of today’s projects.

This milestone complements the Flamma 2020 Plan to bring value to customers who are looking for a home for their projects and have numerous options to move it forward at the right time. These options include moving projects later on to Flamma’s cGMP facilities in Italy, its cGMP facility in Dalian, China, or taking advantage of both by back integrating the project appropriately.

This acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug manufacturing license from the Chinese FDA. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high containment lab to handle genotoxic materials. Flamma intends to invest ~$10M USD to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.

Piramal Pharma Solutions Expands High Potency API Capability

Piramal Pharma Solutions (PPS), a leading Contract Development and Manufacturing Organization (CDMO), announced the Grand Opening of a new wing at the Riverview, MI site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs). The total investment required to upgrade the site was approximately $10 million USD. This includes the new QC/analytical lab and two kilo-labs, as well as a doubling of the office space, which was needed to support the dramatic growth at the Riverview site.

To date, the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m3, at scales ranging from grams to ~250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, brings more to the table. It was designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m3 and as low as ~20ng/m3. Materials will primarily be produced in this new wing at kilo-lab scales; lots of <5 kilos can be produced in this new state-of-the-art facility.

Vivek Sharma, CEO, Piramal Pharma Solutions, said, "We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs. It's another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease."

Historically, the site operated as one shift, five days a week. Today, the site operates twelve hours a day, seven days a week, and is headed towards being a full 24/7 site. The Riverview site expansion also provides significant benefits to the local economy, including the addition of new high-tech jobs. The local staff has increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future. This includes high-tech staffing of PhD and BS degreed scientists, plus manufacturing operators and other skilled workers.

Vince Ammoscato, Vice President and Riverview Site Head, added, "This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market. We are equipped to offer ADC customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Kentucky site for sterile fill and finish."

The ability to offer a fully integrated solution for the ADC market – from proof-of-concept studies to conjugation development, clinical and commercial ADC GMP batch manufacturing and fill/finish – represents a significant strategic advantage for Piramal Pharma Solutions.

According to Mr. Ammoscato, more expansions are forthcoming. There is additional real estate available on the site for added capacity and new capability enhancements that will be designed to match the market needs of the pharmaceutical industry.

About Piramal Pharma Solutions:

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

Selkirk Pharma Plans Manufacturing Facility in Spokane

Selkirk Pharma, a contract manufacturing startup in the pharmaceutical industry, is planning to build a $30 million manufacturing facility on the West Plains, WA.

The company wants to build a 65,000-square-foot manufacturing facility at 9110 W. Granite Ave. in the Pacific Northwest Technology Park, according to an application filed with the city of Spokane.

Selkirk Pharma, which was founded in 2018 by a team of physicians and pharmaceutical leaders, manufactures and packages injectable drug products. The company has an office at 821 W. First Ave. in downtown Spokane.

Selkirk Pharma would use the VarioSys sterile filling system from Bausch and Stroebel to fill and close vials through an automated process using a Skan isolator and Skanfog decontamination technology. The company indicates initial client fills would begin by the end of 2020, according to a company news release.

The West Plains facility would house two additional manufacturing lines. Details are to be announced at a later date, according to the release.

Selkirk Pharma CEO Patrick Haffey declined to provide additional details about the project, including the number of jobs and a construction timeline.

The company is looking to fill positions in engineering, science, manufacturing, information technology and project management, according to its website.

Spokane-based Bernardo|Willis Architects is designing the project.

The manufacturing facility is the latest in a series of developments coming to the West Plains, following Amazon’s announcement to build a 640,000-square-foot fulfillment center, which is scheduled for completion this fall.

Aerospace manufacturer Exotic Metals is building a new manufacturing facility in Airway Heights, and California-based Mullen Technologies announced plans in April to build and lease a 1.3 million-square-foot manufacturing space that is expected to bring more than 860 jobs to the area relating to assembly of the Qiantu K50 electric sports car.

Catalent Breaks Ground on Drug Manufacturing Facility

Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana site to mark the start of construction on a $112-million drug product manufacturing facility, which will increase fill/finish capacity at the site by 79,000 ft2. The facility will house a high-speed vial line, using both ready-to-use components and bulk filling; a high-speed flexible syringe/cartridge line; a fully automated vial inspection machine; and all associated services and support areas. Catalent Biologics plans to create up to 200 new jobs to support the increased production. Completion of both construction and recruitment are expected by the end of 2024.

Aphena Pharma Solutions Expansion

Aphena Pharma Solutions Inc. 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. The company has two FDA- and DEA-registered sites in the U.S. that handle solid dose, liquids, gels, creams, ointments, foams, suspensions and lotions.

Thermo Fisher Scientific to Invest in Bioproduction Expansion

The expansion will increase the company’s single-use capacity to meet growing demand.

On May 20, 2019, Thermo Fisher Scientific announced that it is investing more than $50 million into its global bioproduction capabilities. The expansion will provide additional capacity for manufacturing single-use bioprocess container (BPC) systems.

In Cramlington, United Kingdom, Thermo Fisher will expand assembly capacity and add BPC systems manufacturing. The proximity of these capabilities to customers in Europe will shorten lead times and improve overall global efficiency, according to the company.

In the United States, the company will expand cleanroom space for BPC chamber and related assembly production processes at its site in Logan, UT, and further expand capacity at its site in Millersburg, PA.

Construction is expected to be completed by the end of 2020.

"The demand for our bioproduction products and services continues to outpace the market," said Cory Stevenson, president of Thermo Fisher's bioproduction business, in a company press release. "These investments will expand capabilities across our existing bioproduction network while we look to extend our footprint into new regions to meet increasing customer demand for our industry-leading single-use technologies.

Bayer Invests to Build Cell Culture Technology Center

Bayer is investing $150 million in its Berkeley, CA pharmaceutical development and manufacturing site to build a Cell Culture Technology Center for the development of biological therapies.

The new 40,000 square foot facility, which is expected to be ready for clinical production in late 2021, will support the development of emerging therapies in Bayer's portfolio with an emphasis on oncology, cardiology and additional specialty care therapeutic areas. Bayer has selected Fluor for design and construction, and GE Healthcare for the integration of its FlexFactory technology platform into the Center.

Two years ago, Bayer implemented a strategy around key specialty care therapeutic areas, and recently increased its R&D focus on open innovation. The Center is being designed to support candidates in the drug pipeline, and enable development of new assets resulting from a range of collaborations from Bayer's open innovation approach.

"Bayer is deeply committed to bringing innovative medicines to market that provide significant patient benefit. This investment allows Bayer to expand our biologics development and launch capabilities, as we advance our R&D programs internally and through strategic collaborations," said Wolfram Carius, Ph.D., executive vice president and head of Bayer Pharmaceuticals Product Supply.

"Bayer's Cell Center Technology Center will combine automation, digital capabilities and single-use bioprocessing technologies to streamline production to allow us to bring new medicines to patients faster," said Judy Chou, Ph.D., senior vice president and Global head of Bayer Biotech. "We've chosen to partner with Fluor and GE Healthcare on the Cell Culture Technology Center to leverage their expertise in designing flexible, scalable facilities for the future."

"Fighting cancer on all fronts requires fast and scalable innovation, as well as solutions based on digital insights," said Emmanuel Ligner, president and chief executive officer of GE Healthcare Life Sciences. We are delighted to work with Fluor to offer our FlexFactory platform to help Bayer quickly and easily establish development and production capacity in oncology and other therapeutics."

Sharp Invests to Expand US Packaging Capacity and Capabilities

Sharp – part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has invested $21 million in expanding capacity and capabilities at its Allentown and Conshohocken Pennsylvania facilities.

The latest expansion in the Allentown campus represents the third phase of development of its Biotechnology Center of Excellence. New equipment installations will include vial labelers as well as a cold sterilization system.

Kevin Orfan, US President of Sharp Packaging said: “We are seeing increased demand for our packaging capabilities from clients across the biotech industry, with the injectables sector growing significantly in recent years.

“We are making these capacity expansions on behalf of our clients and through our parent company UDG Healthcare. Sharp has invested continuously to keep pace with demand for our services. This expansion is intended to support that demand into the future.”

Building four in Sharp US’s Allentown Campus opened as the company’s Injectables Center of Excellence in April 2016. When the Allentown facility was built, it included an additional area of undeveloped space of approximately 21,500 square feet.

Subsequent investment doubled Pre-filled Syringe (PFS), autoinjector and pen assembly and increased cold storage capacity at the site as part of the company’s drive to meet growing demand from the injectable device and biologics markets.

The company has invested significantly in its global facilities over recent years including $11 million on its new Clinical Services Centre of Excellence in Wales, an additional $11 million on enhancing its injectable and cold chain capabilities in the US, Belgium and the Netherlands and $23m on its recently refitted state-of-the-art facility in Bethlehem, PA.

About Sharp:

Sharp, part of UDG healthcare, is a global leader in contract packaging and clinical services. Operating from eight state-of-the-art facilities across the US and Europe, Sharp has built an international reputation for delivering cost-effective blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, formulation and manufacturing services, label design and printing. We are also a world leader in ’Track and Trace’ and serialization services, with over eleven years’ experience in implementing serialized solutions for our pharma clients.

Takeda Opens New Global Research Center in San Diego

Takeda announced the opening of a new research facility in San Diego, California. Extending Takeda’s 14-year presence in San Diego, the 165,000-square-foot facility is home to more than 250 employees focused on leveraging specialized drug discovery technologies and advancing discovery research in gastroenterology and neuroscience. The facility is home to four research platform groups – structural biology, early target discovery, computational biology and biologics – that provide key capabilities to discover and advance promising molecules. The new research center in San Diego complements Takeda’s global Research & Development center in Cambridge, Massachusetts and its other global research site in Shonan, Japan.

“Our San Diego research center demonstrates an ideal balance between highly specialized internal research competencies and dedication to external partnerships both within the local community and on a global scale,” said Steve Hitchcock, Ph.D., Head of Research at Takeda. “By consulting with and leveraging our relationships with academic and industry partners and patient groups, we are able to operate nimbly and efficiently to advance early discovery research that could potentially translate into transformative, life-changing therapies for patients in need, complementing our efforts in our other global research centers in Cambridge and Shonan.”

Takeda’s R&D efforts are in four therapeutic areas – Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases – with targeted investments also committed to Plasma-Derived Therapies (PDT) and Vaccines. With a modality-diverse pipeline aligned to its therapeutic area strategies and an externally oriented mindset toward drug discovery and development, Takeda collaborates with partners around the world to unlock innovation and deliver potentially transformative therapies to patients. Today, more than 50 percent of Takeda’s research pipeline focuses on non-small molecules, including biologics, peptides, oligonucleotides, cell and gene therapy, the microbiome and other modalities. The work being done in San Diego today represents the future of Takeda’s pipeline.

In addition to the internal research conducted on site, the San Diego research center plays an important role in connecting local collaborators with Takeda’s global network of more than 200 research partners. Additionally, in the last three years, Takeda, through its venture group, has committed $35 million to Southern California startup companies, underscoring its commitment to the active life sciences cluster in the San Diego and broader California area. The company supports the local community through continued engagement in patient advocacy and disease awareness, children & STEM education and the environment. For example, since 2005, Takeda has partnered with the San Diego Center for Children – the region’s oldest children’s non-profit, to support children with mental, emotional and behavioral health challenges. In addition, Takeda provides over 25 paid college-level student internships in the sciences each year.

About Takeda Pharmaceutical Company Limited:

Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

GSK Invests to Expand Vaccine Manufacturing Capabilities

GSK announced $100 million of new investment in its manufacturing site in Hamilton, Montana to expand the production capacity of key components of the adjuvant system used in several of GSK’s vaccines, including SHINGRIX, which was approved by the US Food and Drug Administration in October 2017.

For more than 20 years, GSK has been innovating in adjuvant systems and has developed vaccines to help prevent malaria and shingles that utilize adjuvant systems to help achieve a stronger immune response.

The Hamilton vaccines facility currently manufactures components of GSK’s essential adjuvant technologies, which this investment will expand further.

“For more than a decade, our Hamilton facility has supported GSK’s adjuvant system development program,” said Jack Bailey, President, US Pharmaceuticals, GSK. “By expanding the adjuvant system production capabilities in Hamilton, we will continue to deliver long-term and sustainable supply for key vaccines, including SHINGRIX.”

GSK is dedicated to investing in and supporting communities by creating high-quality jobs in areas like R&D and manufacturing. Over the next few years, the Hamilton site expansion is expected to add a combination of temporary construction and contracting jobs, as well as new permanent positions, including scientists, engineers and manufacturing and quality professionals.

“Thanks to the bi-partisan support of Governor Steve Bullock and the congressional delegation – Sens. Jon Tester and Steve Daines and Rep. Greg Gianforte – Montana is emerging as a hub for the biotechnology industry,” said Bailey. “GSK is grateful for their leadership and the opportunity they have given us to create new jobs and expand our footprint in the state.”

Hamilton is one of nine GSK manufacturing sites in the United States, and 86 sites globally, that produce a variety of prescription medicines, vaccines and consumer healthcare products.

ATUM Completes 100% Renewable Electricity for State-of-the-Art Bioproduction Facility

ATUM, a Newark, California-based leader in bioengineering and bioproduction, announced the completion of a $1.5 million 26,000 sq. ft solar panel installation at its corporate headquarters and manufacturing site. The panel will generate enough electricity to satisfy all of ATUM’s electricity needs, making it one of just a handful of biotech firms fueled entirely by renewable energy.

“Delivering ATUM's products and services requires a lot of electricity: from air conditioning the building to running the incubators, freezers, robots, and servers that power our business,” said Jeremy Minshull, PhD., CEO of ATUM. “Our new solar panel array, with an annual capacity of nearly 1 MWH, enables us to generate all of our electricity from the sun.”

A series of panels installed at three carports adjacent to the ATUM headquarters by Pleasanton, California-based Cool Earth Solar provides the majority of the new capacity, adding to an earlier roof installation.

The solar project is just the latest in a series of green initiatives at ATUM, which aims to achieve the highest standards of energy efficiency and environmental sustainability in all areas of its business, including manufacturing, architecture, human resources and portfolio management. The company’s efforts to reduce its carbon footprint and make a positive contribution towards combating climate change started with the purchase and retrofit of their current bioproduction facility in 2015.

In addition to the recently completed solar array, the site features LED lighting throughout, energy efficient elastomeric acrylic roofing, and a water recycling system. ATUM also participates in a cost-neutral waste to energy program and a composting program. Employees have access to free solar-powered car charging stations, as well as carpool and other shared transportation incentives.

The new ATUM state-of-the-art bioproduction facility supports customers in the fields of protein pharmaceuticals to engineer new biological drugs to cure diseases, industrial biocatalysis to replace toxic chemical processes with biofriendly methods, and food industry to make better nourishment for customers across the globe.

For the founders of ATUM, sustainability is more than a corporate slogan. It’s a personal ethos and a long-term commitment. “Climate change is the biggest challenge facing us today,” said Minshull. “Every year we watch California's wildfires grow bigger and more destructive and wonder what kind of world we are making for our children. ATUM's solar power project is an investment in the future - for all of us.”

About ATUM:

ATUM offers an integrated pipeline of tools including gene design, optimization and synthesis, expression vectors, and platforms for protein and cellular engineering and production. The company exploits the dependence of biological activity on well-designed sequences. ATUM’s tools and solutions are fueling the transformation of biology from a discovery science to an engineering discipline. By collaborating with our clients, ATUM accelerates breakthroughs and moves research further faster. For more information please visit: https://www.atum.bio.

Vetter's Skokie Facility Expansion Nears Completion

Vetter, a global operating Contract Development and Manufacturing Organization (CDMO) announced that a significant level of expansion activities are nearing completion at its US clinical manufacturing facility located at the Illinois Science & Technology Park in suburban Chicago. The ongoing growth of the facility will help satisfy existing and ever-increasing future customer requirements as well enable meet the complex needs of newer drug molecules like peptides or antibodies, many which need refrigeration or freezing. New offices with 45 workstations, conference rooms and an archive room are also included. To support the increase in customer projects, a permanent second work shift will be added in Visual Inspection over the next months. A second shift in Quality Oversight is also planned.

“This variety of activities is a further proof point of Vetter’s consistent strategic approach to stay ahead of the market by focusing on the important service needs of our customers during their drug development journey; promptness; flexibility; high yield of their valuable API and, of course high quality,” explains Dr. Claus Feussner, Senior Vice President of Vetter Development Service.

Since beginning full operations in late 2011, Vetter’s US early-stage development site has been expanding to help meet growing customer demands. As recently as 2016, the site expanded its storage capacity by 150 percent to 3,700 sq. ft. With the new additions, most of which are expected to be completed by April, the site will increase its storage space by an additional 3,100 sq. ft. The new storage includes a 2,500 sq. ft. freezer farm as well as a planned 600 sq. ft. walk-in refrigerator. In total, 6,800 sq. ft. of storage space will result. A second extension, now in the final planning stage, will include an additional 1,500 sq. ft. of room temperature and freezer space. “When completed, the facility will have more than double the overall storage space we have currently available. This extensive expansion of freezer and refrigeration storage space represents the ongoing evolution in our Chicago business,” summarizes Dr. Susanne Lemaine, Vice President Vetter Development Service Chicago.

About Vetter:

Headquartered in Ravensburg, Germany, Vetter is a global leading contract development and manufacturing organization (CDMO) with production facilities in Germany and the United States. Currently employing 4,500 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility including environmental protection and sustainability.

STC Biologics Completes New GMP Mfg. Facility

STC Biologics has completed construction of a single-use mammalian GMP manufacturing facility in Newton, MA, and has successfully conducted its first MCB and three GMP drug substance production runs. This facility includes state-of-the-art, fully disposable equipment, such as a Finesse controller, a Thermo Scientific HyPerforma 500L Single-Use Bioreactor (expandable to 1000L), and GE ÄKTA Ready purification skids.

"We selected Newton, MA for our manufacturing site because of its proximity to the hub of biotechnology. We have an open door policy, where clients can drop by to discuss their projects with our scientists and see their data in real time," said Magdalena Leszczyniecka, Ph.D., president and chief executive officer of STC Biologics.

STC Biologics introduced the Speed-To-Clinic Platform for MAbs to go from royalty-free cell line development directly to cGMP manufacturing with released drug substance in twelve months.

"Our Regulatory Science expertise brings a unique value to clients, from devising efficient CMC strategy to providing submission-ready documents," said Zahra Shahrokh, PhD, chief development officer at STC. "Our expertise in drug product pharmaceutical development facilitates seamless tech transfer to a drug product CMO for speedy timelines from cell line to IND. We have a proven track record of developing commercialized protein formulations, complete biophysical and biochemical product characterization, and rapid delivery of BLA-enabling services such as process characterization, assay validation, in-use studies for IV, subcutaneous and CNS administration."

Cambrex Completes Highly Potent API Manufacturing Facility

Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, announced that it had completed the construction of a $24 million highly potent API (HPAPI) manufacturing facility at its site in Charles City, IA. The 6,000 sq. ft. facility is currently undergoing validation and will be ready to commence customer projects in mid-2019.

The production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3 and contain 4 reactors ranging from 200 to 1,000 gallon capacity enabling manufacturing campaigns of batch sizes up to 300 kg. With the completion of this new facility, the Charles City site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full OEL band spectrum.

“Across our sites, Cambrex has a strong reputation in the handling and supply of potent molecules, and this investment allows us to increase the capacity we can offer our customers,” commented John Andrews, VP, Operations & Site Director, Cambrex Charles City. “We have seen an increased number of molecules in the clinical pipeline being designated as potent and highly potent, so having the flexibility within our manufacturing network to scale up with existing customers as projects progress, as well as accommodate new projects, is crucial to meet those market needs.”

Cambrex’s Charles City, Iowa facility employs over 370 people and is located on a 45-acre site. The site is part of the company’s Drug Substance business unit and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.

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 a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

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

Paragon to Build Second GMP Mfg. Facility

On the heels of its acquisition by Catalent, Paragon Bioservices, the biologics contract development and manufacturing organization (CDMO), is forming a wide-ranging partnership in gene therapy manufacturing with Sarepta Therapeutics. The two companies will seek to establish additional dedicated facilities for manufacturing Sarepta's gene therapy candidates.

Prior to the news, Catalent unveiled its intent to acquire Paragon for $1.2 billion. With the future support of Catalent and the opening of its new, state-of-the-art commercial manufacturing center near the Baltimore-Washington International Airport, Paragon is positioned to advance gene therapy products including Sarepta's Duchenne muscular dystrophy (DMD) gene therapy candidate. The new large-scale production campus—now combined with a recently leased second building which will be built out for commercial GMP manufacturing—has the potential for more than 425,000 square feet of manufacturing space upon completion of construction. The facility will offer individualized manufacturing suites specially designed to handle the needs of gene therapy products.

Sarepta has developed proprietary manufacturing capabilities for the development, scale-up and purification of its gene therapy candidates for clinical development and commercialization.

"With the recent grand opening of our new manufacturing facility, the expansion of our relationship with Sarepta, and the anticipated transaction with Catalent, Paragon is positioned to be the premier leader in gene therapy manufacturing," said Pete Buzy, president and chief executive officer, Paragon. "Paragon's level of expertise and experience in this area is unparalleled. That together with our high caliber partners and customers will allow us to meet the manufacturing demands of the double-digit growth in the gene therapy market."

Paragon and Sarepta will use their respective strengths in gene therapy manufacturing, as well as the related development techniques including bioanalytics, to take viral vector manufacturing to the next level. The partners will explore the potential for a joint venture in manufacturing new gene therapy candidates in a dedicated facility.

Douglas S. Ingram, president and chief executive officer, Sarepta, said, "We are excited to begin work on this new venture with Paragon and ultimately Catalent. Sarepta has had a long and fruitful relationship with both Paragon and Catalent, one of Sarepta's current PMO drug manufacturers, and we are particularly pleased to expand our relationship with both companies. Catalent is a well-resourced innovator with an outstanding reputation for operational excellence, product quality, and reliable supply. By making our expertise available to Paragon and Catalent, we can ensure the success of our own manufacturing programs and explore potentially new and enhanced techniques to drive innovation in gene therapy manufacturing."

"The unmatched expertise of both Paragon and Sarepta in developing and overseeing the manufacture of potentially transformative gene therapy technologies will be a tremendous asset to Catalent," said John Chiminski, chief executive officer, Catalent. "We are delighted to have this opportunity to work together with Sarepta in this high-growth and life-saving field of medicine."

REST OF WORLD

Mapi Pharma’s Sterile Injectable Production Plant in Jerusalem

Israel-based clinical-stage pharmaceutical company Mapi Pharma has announced the development of a new sterile injectable production plant in Jerusalem.

Announced in July 2019, the plant will be used for the commercial-scale production of the company’s glatiramer acetate (GA) injectable products. It will be an addition to Mapi Pharma’s existing production network in Israel, which includes an active pharmaceutical ingredient (API) facility in Neot Hovav and a quality assurance (QA) laboratory in Ness Ziona.

The facility is being developed with an investment of NIS46m ($13m). It will support the company’s future growth plans of becoming an integrated biopharmaceutical company with research and development, production and commercialization capabilities. The company will hire 30 new employees at the new facility.

The new facility will be located in the Har-Hotzvim Hi-Tech Park, Israel, on a site leased for long-term.

The company’s existing facility, which is compliant with good manufacturing practices (GMP) as per the Israeli Ministry of Health (MOH) guidelines, will also be scaled-up as part of the project. The existing facility supplies products to mid to late-stage clinical trials.

Har-Hotzvim Hi-Tech Park is one of the biggest high-technology centers in Israel. It features spacious areas, parking and a comfortable work environment. It is also well connected to Jerusalem, Modi’in and Tel Aviv.

The park is currently under development and houses several Israeli and international companies, including Intel, Omrix, and Cisco. It employs more than 9,500 people.

The new facility will be a 50,000ft² plant, which was previously an FDA-approved facility operated by Omrix Biopharmaceuticals, a Johnson & Johnson company.

It will be GMP-compliant and will be equipped with a high-standard cleanroom. The products developed at the facility are planned to be exported.

Israeli Ministry of Economy granted more than NIS9m (approximately $2.5m) for the development of the facility in March. The grant is a part of the $13m investment provided by the Israeli Ministry of Economy to Mapi Pharma for the installation of equipment.

The location of the facility in the Zone A region enables Mapi Pharma to take advantage of the tax and grants.

The company’s lead investigational product candidate GA Depot will be manufactured at the facility. Mapi is developing the product in partnership with Mylan.

GA Depot is a once-monthly injection of long-acting glatiramer acetate (Copaxone®) intended for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company has completed a phase two clinical trial and plans to initiate phase three clinical trial to support the submission of a marketing application to the US Food and Drug Administration (FDA).

Marketing commentary on Mapi Pharma:

Mapi Pharma is focused on the development of lifecycle management (LCM) products, which include complex APIs and formulations.

The company is developing various LCM products such as Pregabalin ER, which is an oral form of Lyrica®; Risperidone LAI+ and Buspirone ER. The company holds intellectual property (IP) rights and has filed a number of patent applications for the APIs and formulations.

Mapi has a GMP-approved API manufacturing facility in the Neot Hovav industrial park, Israel. The facility is designed for the synthesis of APIs and intermediates. It is equipped with industrial production reactors, ranging up to 4,000l and also features facilities for small-scale production, supporting initial scale-up and sales.

The company also operates a research and development facility in Nanjing, China.

Vaccines Manufacturing Innovation Centre, Oxfordshire

Vaccine Manufacturing Innovation Centre (VMIC) in Oxfordshire will become the first-ever facility dedicated for the development and manufacturing of vaccines in the UK, upon its completion.

VMIC will be used to develop vaccines against serious infectious diseases such as influenza, Ebola, Zika and Lassa fever.

The center is a joint development of three academic institutions, namely the University of Oxford, Imperial College London and the London School of Hygiene and Tropical Medicine.

It is also supported by leading pharmaceutical and healthcare companies such as Merck Sharp and Dohme, Johnson and Johnson and GE Healthcare.

The center was announced in December 2018 and its design work is currently underway. It will be fully operational by 2022, with first vaccines available for use later that year.

The purpose-built facility will require an investment of £77m ($98.1m) and is expected to generate up to 50 jobs for locals.

VMIC will be located within Harwell Science and Innovation Campus in the Oxford Science Park, Oxfordshire. It will form a part of the Harwell HealthTec Cluster, which comprises 1,000 people across 40 organizations.

Harwell Science and Innovation Campus is a science and technology campus spread across more than 710 acres, with the Science and Technology Facilities Council’s Rutherford Appleton Laboratory and more than 225 organizations present in it.

The campus is the UK’s biggest innovation hub and houses world-leading research infrastructure worth more than £2bn ($2.4bn). The site is well connected to Oxford and London, enabling the campus to partner with various leading universities.

VMIC will be a state-of-the-art facility, which will include several advanced laboratories and production facilities with cleanroom environment designed in compliance with Medicines and Healthcare products Regulatory Agency (MHRA) regulations.

Suites and filling rooms in the facility will be developed to be compliant with the latest current good manufacturing practices (cGMP).

HVAC zoning systems will be installed for controlling the environment, cleanliness and air pressure of the facility.

The 3D model-based building information modelling (BIM) process will be utilized for cleanroom designing, mechanical and electrical and process utility systems.

VMIC will accelerate the early-stage clinical development of the vaccine, while delivering the affordable, high-quality vaccine to patients. It will improve the development, manufacturing and application of novel preventive, as well as therapeutic vaccines and medicines against deadly infectious diseases, using mammalian cell culture.

The center will also offer the infrastructure required for the development of vaccine manufacturing processes of technology readiness level (TRL5-9+) scale. The processes will be developed based on the existing work at TRL2-4 and will be funded by the Medical Research Council and Biotechnology and Biological Sciences Research Council.

Additional capabilities for the large-scale commercial production of vaccines and emergency response to any threat, including epidemics or release of any biological agent, will also be present in the facility.

The center will also be used for the development of personalized gene therapies and oncology products, as well as to provide training to develop GMP-level vaccines.

UK Research and Innovation granted £67m ($81.3m) for the development of the facility under the UK government’s Industrial Strategy Challenge Fund (ISCF). The industrial partners will provide the remaining £10m ($12.1m).

WHP Engineering is providing design and development services for the facility. Derell Consultants, a consultancy services provider based in the UK, was subcontracted by WHP Engineering for the facility’s development.

Currie & Brown will provide project management and project control services for the facility.

GE Healthcare will provide bioprocessing expertise and training for the facility.

B.Braun Medical Compounding Aseptic Production Unit

Paul Bradley reviews the 24-month design, build and validation process that led the company to expand its Sheffield facility with two new Grade B production rooms increasing capacity by 70%

When predictions forecasted that a Compounding Aseptic Production (CAPS) facility in Sheffield would reach production capacity by late 2018, B.Braun Medical undertook a major expansion project. The initial facility had been operational since 2010, and it took expert considerations to make the capacity increase as efficient as possible.

Headquartered in Sheffield, South Yorkshire in the UK, B.Braun Medical specializes in aseptic, patient-specific parenteral nutrition products. The company also manufactures a range of other items, and all its portfolio is under an MHRA Manufacturing Specials license. The expansion to the existing cleanroom suite was essential to meet the growing demands for parenteral nutrition.

Initial considerations for the expansion project included a new geographically separate facility, but the opportunity to use a 500 sqm patch of land adjacent to the existing site over car parking areas presented and the company moved forward with that option.

Eight years of operation enabled B.Braun to identify opportunities to improve the efficiency and quality of the new facility

The decision proved to be the better option as it had several operational as well as financial benefits. The major advantage being the speed of utilization of the new capacity with the ability to concurrently recruit and train an expanded team of specialists during the build process. This team could then transition easily to the expansion on completion. Plus, expertise onsite in Sheffield could be called upon daily, negating the requirement to have a separate offsite project and management team.

The original production facility built in 2009 comprised of three independent Grade B cleanrooms of varying sizes, hosting a total of 11 Grade A Horizontal Laminar Flow (HLAF) booths. The Grade B production rooms were within an outer Grade D area with supporting areas including goods in-store, goods out and dispatch area as well as a quality control suite, offices and staff welfare facilities. Counting these areas, the total facility had a footprint of 1,050 sqm.

After eight years of continuous operation, the Production and Quality team at B.Braun were able to use training in lean production principles to identify opportunities to improve the efficiency and quality of the new facility design. The healthcare company opted to maintain and improve upon their existing disinfection methodology for the transfer of materials into the suite employing a compliant manual three-stage process of sporicidal and alcohol wipe and spray disinfection steps.

The conceptual design supported this by almost entirely removing the movement of materials between part 1 and part 2 disinfection stages and operator manual handling.

An operational User Requirement Specification (URS) and proposed cleanroom design were provided to several UK companies at a tender stage in 2017. The bid from Bassaire Cleanrooms was chosen to deliver the initial design concept.

The general requirements:

Provision of two additional Grade B clean production rooms increasing capacity by 70%

Reduced manual handling of materials

Integration of the new cleanroom suite to the existing cleanroom

Upgrade and expansion of the existing Validair FMS monitoring system

CCTV in all production process rooms

WIFI in all production process rooms

A Grade D classified cold room airlock

Access to allow the removal of HLAF requiring maintenance rapidly from the facility

A full walk-on ceiling allowing maintenance access

Improved temperature controls between Grade B and other classified areas

A wall of 10 individual Grade D airlocks with full trolley height (1.8m) and timed magnetic locks

Managing construction

Paul Bradley, General Manager

BBCAPS Aseptic Unit, B.Braun Medical

The build itself would not come without inherent operational challenges. Aseptic production within an active construction site would understandably cause nervousness amongst even the most steadfast of Quality Managers.

Staff moving out of the existing build would be entering a construction site and would be required to adhere to the contractors' Health and Safety regulations, including wearing standard hard hat, hi-vis jackets and boots.

A single road in and out of the site required daily communication with site supervisors to manage heavy plant traffic to the site as well as continued deliveries and dispatch of products to and from the existing facility.

Additional measures and vigilance resulted in historical lows of recorded microbiological excursions. This is a testament to the detailed planning and risk assessment before commencement.

A final detailed URS was co-developed between Bassaire and B.Braun with detailed designs and piping and instrumentation diagram (P&ID) provided by the end of 2017. In February 2018, both companies met with the MHRA who provided commentary on regulatory expectations and further considerations to the design.

On the civil engineering front, the project commenced with a new three-floor extension adjoining the existing facility in November of 2017. The contract for the civil phase of the project was awarded to Triton Construction. Cooperating closely with Bassaire and B.Braun, the three parties' work enabled cleanroom construction to commence on the ground floor by April 2018.

The second floor houses the cleanroom HVAC, BMS, servers and separate office, warehouse, and air handling unit (AHU). The third floor is furnished with a new staff canteen, locker room, toilets, training and meeting rooms, and offices. Additional warehousing, cold room and pharmacy were also provided. The overall floor space expanded to 2,700 sqm.

In discussion with B.Braun, it was decided to use the Kingspan UltraTech Precision panels—a fully flush modular system for specialist cleanroom applications—in the Grade B areas, and Kingspan Versatile panels elsewhere. The Precision panels allowed for HVAC exhaust and utility ducting to be embedded within the wall’s panels with flush windows, doors, PBSC transfer hatches and electrical sockets. They also allowed for the vinyl floor to be coved to the wall without visible seams.

Bassaire and Envair performed Installation and Operational Qualification (IOQ) of the cleanroom suite and HLAF cabinets, respectively, using B.Braun approved documents under the company supervision. A separate Factory Acceptance Test (FAT) of the HLAF was performed at Envair on a single HLAF before shipment and IOQ.

Performance Qualification (PQ) of the cleanroom suite, cold rooms and HLAF was performed by B.Braun, including three process simulation media fills. As part of the PQ, Validair performed a full cleanroom qualification including pressure differentials, room air change rates, HEPA filter integrity tests and smoke visualization test. These were needed to demonstrate that no critical quality parameters had changed between completion of Bassaires' work in November 2018 to completion of media fills in February 2019.

Continuity of supply in a patient-specific aseptic production facility is critical for products that can be ordered, produced from scratch, inspected and released for dispatch in a matter of hours. So, a key aspect of the design consideration was building in operational resilience.

A novel approach to the design was to utilize an existing waste lobby and cleaners’ cupboards and convert them into airlocks between two cleanroom suites. Both Grade D areas were designed to be over pressured relative to the two new airlocks by a minimum of 15 Pa. Maintaining the airlocks at Grade D enables staff to walk and transfer materials between both cleanroom suites as if one consolidated cleanroom suite.

As a contingency, each cleanroom suite can be operated independently from the other by closure of the airlock in a matter of minutes. Each suite also has separate materials and personnel entry, cold rooms and waste out. Pressure differential checks and smoke visualization were performed during qualification to demonstrate the effectiveness of these airlocks. The same airlock design principle was used during the build process to maintain segregation of the existing and new suites.

A specific design criterion was the ability to remove the newly supplied Envair 2-metre-length HLAF cabinets from the Grade B area to an unclassified hygienically clean area to enable maintenance, filter changes and testing to be performed without hindering the operation of the Grade B cleanroom.

The two new Grade B production rooms are separated by a shared Grade B "lobby" area. This area has been designed to accommodate a full HLAF cabinet that can be moved to a Grade D corridor by opening oversized doors in the wall of the lobby. Under normal circumstances, the oversized doors act as a fire escape route for Grade B production staff with sirens notifying inadvertent opening.

In the Grade D corridor, the cabinet can be further moved to an outer material airlock enabling repairs and filter integrity testing to be performed without the risk of cross-contamination of the Grade B cleanroom. The cabinet can then be returned to the production Grade B room with sequential disinfection steps from Grade D to Grade B lobby and room. The cabinet can be removed in a matter of minutes enabling production in the remaining cabinets to continue after a standard end of session clean down.

The cleanroom HVAC fan supply system incorporates six EC supply fans, unlike the existing suites' single supply fan and fan belts. The new fans operate with redundancy built-in so that in the event of a single failure, five fans can maintain the required volume of airflow. Any failed EC fan can be swapped out with minimal disruption to production.

As a nod to the past, a bank of magnehelic gauges were mounted in the entry to the cleanroom suite with HVAC supply indicator lights. Although both suites are fitted with the most up to date Validair Monitoring FMS system with a back-up mirror system and server, the gauges provide a simple, low-tech method of monitoring and recording pressure differentials. True to the design principles, the gauges can be maintained and calibrated from the unclassified support areas. The entire facility is supported by a diesel generator and uninterrupted power supply, providing 100% of electrical requirements in the event of a site mains failure.

Several innovative solutions were developed and incorporated in the suite. For example, chilling aseptically made products as soon as possible is recommended. Typically, movement of finished products to the final cold room would be via an airlock at ambient temperature. This introduces a delay and additional manual handling. Working with Bassaire, the B.Braun suite incorporates a Grade D classified double-door entry airlock cold room. This allows the finished product to be placed into the cold room directly after inspection.

Several other challenges were overcome in the design, including the use of PTFE HEPA filters that could withstand the air temperatures and humidity levels, and an air recirculation system that would allow pressurization of the sealed cold room relative to the outer unclassified area.

Continuous monitoring of non-viable particles was overcome with a system that could sample particles immediately below the highest risk filling point without the interference of the process

Custom-built HLAF cabinets were supplied by Envair, and working closely with B.Braun, cabinets were designed specifically for the compounding process. Additional depth and length of the internal work surface allowed specialist filling equipment to be accommodated.

The requirement to continuously monitor non-viable particles was overcome by designing a system that could sample particles immediately below the highest risk filling point without the interference of the process. Fragile cabinet HEPA filters are protected with Pure Laminar Flow (PLF) screens, and HEPA filter replacement can be achieved in a fraction of the time by having filters changeable from the reverse of the cabinet.

Using technology developed in conjunction with B.Braun, UVC germicidal technology was also incorporated into the cabinets to complement the standard manual disinfection. The UVC lights automatically illuminate when the cleanroom is not in operation, providing an additional log4 reduction (EN13697) in 60 minutes of viable organisms with zero cleaning residues.

Working carefully with innovative design solutions, the construction partners delivered an expanded facility that will allow B.Braun to continue to grow, providing aseptic products across the UK.

Sartorius Launches New Mammalian Cell Bank Manufacturing Services

Sartorius Stedim Biotech (SSB) launched new services for mammalian cell bank manufacture under GMP conditions. These services are offered by its subsidiary, Sartorius Stedim BioOutsource, based in Glasgow, U.K., and Cambridge, MA.

Based on these new services, SSB now offers the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells. This activity will be conducted in a custom-designed 260 m2 GMP cleanroom facility that has been audited and approved in 2018 by the Medicine and Healthcare Products Regulatory Agency (MHRA) according to the latest guidelines, noted a Sartorius spokesperson.

Exclusively dedicated to mammalian suspension cell lines, the facility reportedly uses selected equipment that enables closed-system manufacture of GMP-compliant cell banks, from vial thaw to automated filling. For maximum process reliability and assurance of sterility, this entire manufacturing service is offered as a fully qualified broth technology platform, explained Lucia Rieger, product manager for protein expression systems.

SSB’s cell bank manufacturing is offered in a package along with cell bank characterization services that the company has been providing for more than ten years. The combination of its new manufacturing services and its established characterization service for mammalian cell banks allows clients to work with SSB as a single-source provider from vial thaw to released cell banks.

Up to 500 cell bank vials are produced during a manufacturing run, followed by full characterization, genetic stability assessment in compliance with EU and FDA guidelines, and release by the respective qualified person. The cell bank vials produced are then shipped to the client or transferred to a long-term storage facility. In addition, these cell bank manufacturing and characterization services are a “perfect match” for the cell line development services based on Sartorius Stedim Cellca’s CHO expression platform, said Rieger.

“We’re really proud that we now offer even more comprehensive services that can be easily combined with those for CHO cell line development and biosafety. As a result, we provide our clients with an integrated package that saves considerable time and minimizes risks. Furthermore, they will benefit from client-focused customer service with a single point of contact throughout their entire development and manufacturing projects,” added Rieger.

Olon Begins Construction on New GMP API Facility in Italy

Olon has begun construction of a new GMP manufacturing facility at its microbial CDMO facility in Capua, Italy. The Active Pharmaceutical Ingredients (API) CDMO and generics supplier has 11 manufacturing facilities spread over Europe (Italy and Spain), the US (Concord OH) and India (Mahad).

The construction of this new GMP facility is associated with a long-term strategic partnership with a large pharmaceutical company.

The engineering project is designed to support the manufacture of multiple products, up to commercial scale. This project comes after Olon's recent undertakings in the development and execution of GMP as well as food-grade engineering projects; from first concept to final commissioning, based on green-field and brown-field, under challenged timelines.

Paolo Tubertini, CEO of Italy-based Olon, said: "I am pleased to announce the start of this GMP capacity expansion just 6 months after the acquisition of Capua BioServices. This truly confirms the real opportunity to accelerate growth in Olon's CDMO service positioning and to be recognized as European Leader in the CDMO of microbial fermentation."

Mezzan Holdings Acquires Only Pharma Manufacturer in Kuwait

Mezzan Holding has acquired a 67% stake in Kuwait Saudi Pharmaceutical Industries Company KSCC (KSPICO). This company is Kuwait’s only manufacturer of pharmaceutical products.

The acquisition will grant Mezzan majority board seats and effective control of KSPICO and will enable Mezzan to bolster its capabilities and offerings.

The deal was valued at around 21 million Kuwaiti Dinar (US$69m).

Mezzan Holding is a manufacturer and distributor of food, beverage, FMCG and healthcare products in the Gulf region. KSPICO manufactures generic and branded drugs, fitting into the ambition of Mezzan.

Executive Vice Chairman, Mohammed Jassim Al Wazzan, said: “KSPICO is one of Kuwait’s untold success stories. The company has a great track record and a unique market position that complements Mezzan’s business. This acquisition will mark a turning point in our healthcare businesses, transforming it into a manufacturing and distribution business with a wide array of product lines, customers, and regulatory certifications.”

Mezzan CEO, Garrett Walsh, added: “This acquisition marks a significant addition to Mezzan’s core consumer-driven healthcare business and expands its access to the local and regional consumer spending. In the coming few months, Mezzan will focus its efforts on further growing KSPICO’s market share locally and regionally, growing utilization of manufacturing and entering contract manufacturing as well as bring the Mezzan discipline and balance sheet management into KSPICO to help drive growth and profitability.”

The acquisition comes on the heels of Mezzan’s recent expansion into the healthcare space as it became the distributor of Medtronic’s and Covidein products in Kuwait through a joint venture.

JW Pharmaceutical Acquires Largest Drug Manufacturing Plant In Vietnam

The South Korea company has acquired Euvipharm and its facility in Long An, planning to launch a CMO as part of its strategy to target emerging Asian pharmaceutical markets

JW Pharmaceutical (JWP) has acquired a Vietnamese pharmaceutical company in an attempt to intensify its efforts to approach emerging pharmaceutical markets. JWP has signed a contract to take over 100% shares of Euvipharm, a manufacturer of pharmaceutical ingredients and finished products in Long An, Vietnam. The takeover cost has been kept undisclosed under mutual agreement between the two companies.

Euvipharm, founded in 2005, was acquired by Canada’s largest drugmaker Valeant (currently Bausch Health Companies) in 2013 and operates a pharmaceutical plant with the most modern manufacturing facilities in Vietnam. In particular, the plant with a total floor area of 376,600 sq. ft. (35,000 sqm) is a GMP compliant certified by the World Health Organization (WHO) and has a capacity to produce 1.9 billion pharmaceutical products a year, the largest capacity in Vietnam.

A few Korean companies have acquired part of Vietnamese drugmaker's shares or built plants in the country but JWP said it is the first Korean company to take over entire shares of a Vietnamese company and operate it directly.

The acquisition was succeeded with support from the Korea Trade-Investment Promotion Agency (KOTRA). JWP, while participating in KOTRA's project for M&A of overseas companies, identified the investment destination in last April and KOTRA's M&A investment team and Ho Chi Minh Office throughout the entire provided support to the company throughout the contract-signing process.

Though Vietnamese and other Southeast Asian pharmaceutical markets are growing rapidly, pharmaceutical-grade systems, price competitiveness and other roadblocks have been in the way for pharmaceuticals made in Korea to enter those markets.

By acquiring Euvipharm, JWP's strategy is to make a full-scale entry into the pharmerging market of Vietnam and other ASEAN countries with locally manufactured products. For that, the company will sequentially transfer its manufacturing and quality control technologies, including differentiated R&D capabilities for formulations and pursue a Pharmaceutical Inspection Co-operation Scheme (PIC/C) certification at the same. It will also launch a Contract Manufacturing Organisation (CMO).

JWP's acquisition of a Vietnamese drugmaker indicates that JW Group, which has focused on innovative new drugs and nutritional solutions, has set its strategic direction toward the pharmerging market this time. JWP transferred its novel atopic dermatitis drug technology to LEO Pharma in 2018 and launched a Total Parenteral Nutrition (TPN) product in the European market recently for the first time as an Asian drugmaker.

“With the acquisition of Euvipharm, now we have secured a large-scale plant with advanced technology and modernized equipment in Vietnam, an emerging manufacturing powerhouse,” says JWP's CEO Yeong-seop Shin. “Beginning with Vietnam as our outpost, we will continue to expand JW brand in the global market.”

Parker Bioscience Filtration Expands Single-Use System Facility in UK

Parker Bioscience Filtration, which supplies automated single-use solutions that include filtration, single-use fluid-handling systems, and sensors, opened expanded facilities at its Birtley, United Kingdom site, including new cleanroom, manufacturing, and testing facilities, the company announced in a Aug. 15, 2019 press release. The SciLog Suite supports process development by providing a facility to test and optimize unit operations within a production process. The facility includes the SciLog FD for bulk drug filtration and dispense, the SciLog TFF for tangential flow filtration operations, and the SciLog NFF for normal flow filtration operations. The facility can accommodate more than 20 people.

Earlier this year, as part of the same investment program, the company announced the opening of a new cleanroom facility at the site that is dedicated to the manufacture of single-use assemblies.

“It’s hugely exciting to have opened the doors to our extended and refurbished site in Birtley. The investment in these facilities demonstrates Parker Hannifin’s commitment to our European customer base and through this, we have strengthened the level of technical support and service that we can offer across biopharmaceutical manufacturing. We have shortened the supply chain for our European customers and made it easier for customers to access filtration solutions and automated systems,” said Kris Holmes, general manager of Parker Bioscience Filtration, in the press release. “In addition, we have also provided a greatly enhanced working environment for Parker Bioscience Filtration’s specialist workforce. The overall investment in our laboratory, cleanroom, manufacturing, office, and warehouse facilities has made our Birtley premises one of the most modern manufacturing sites for integrated bioprocessing solutions in EMEA.”

Optima Pharma Inaugurates Center for Building Turnkey Plants

Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities, the company announced in a July 2019 press release.

Optima has invested a double-digit million sum in the new 49,496 sq. ft. (4600-m2) building in Schwaebisch Hall's Solpark Industrial Estate in Germany. Construction for the building was originally scheduled to start in 2021, but it was accelerated due to demand. Construction began in October 2018, and the building was completed in April 2019.

In the past year, Optima Pharma introduced the comprehensive scientific process engineering (CSPE) approach, which is a technical and scientific approach that significantly shortens the delivery and commissioning times of complex turnkey plants. “As a result of the new infrastructure, ‘integrated acceptances’ are now possible,” said the company in the press release. The entire system, consisting of isolator and filling and closing machine, has been fully tested and approved on site.

MAT Constructs Purpose-Built Research Suite For LSHTM

When the London School of Hygiene & Tropical Medicine (LSHTM) needed a new purpose-built suite of microbiology containment laboratories for Dr. Serge Mostowy, Professor of Cellular Microbiology, to continue research into controlling infection, Medical Air Technology (MAT) was selected as the construction partner.

The completed suite is made up of two Category or Containment Level (CL) 2 laboratories and three CL3 laboratories. The containment level relates to the equivalent biological agent hazard group as defined by the Control of Substances Hazardous to Health (COSHH) Regulations and categorized by the Advisory Committee on Dangerous Pathogens (ACDP).

With Dr. Mostowy preparing to join LSHTM, building his laboratory was a priority. LSHTM knew of MAT’s experience in this highly specialized arena, and approached the company to build the Mostowy Lab, as it is now called. A project of this size can take years to develop, with several months being spent on design alone. However, if the lab was to be ready for Dr. Mostowy’s arrival, the team from MAT had just 30 weeks for design development, installation and commissioning. This was only made possible by close collaboration between MAT and LSHTM, and an absolute commitment from all involved to have the lab ready in time.

LSHTM stripped out the floor area in preparation for the new suite, with MAT designing the layout as well as the critical ventilation system. Special considerations included extra ventilation and cooling for a high-powered laser confocal microscope. LSHTM had confidence in MAT to interpret what was needed, working with its own project manager and safety team. Work progressed very smoothly, with decisions made quickly and efficiently as needed.

The Mostowy Lab would be investigating Shigella, estimated to be responsible for 125 million cases of diarrhea annually and around 160,00 deaths, a third of which are young children

The major redevelopment of an adjacent LSHTM site was being carried out at the same time, so it was vital to co-ordinate works to ensure everything ran to plan. Working on a Central London site presented additional challenges around congestion and delivery. This was addressed through phased and out-of-hours deliveries, with everyone involved pulling together to ensure progress on both projects was unhindered.

The Mostowy Lab would be investigating Shigella, estimated to be responsible for 125 million cases of diarrhea annually and around 160,00 deaths, a third of which are young children. Shigella flexneri is a Schedule 5 bacteria, as defined by the Biological Security for Pathogens and Toxins guidelines, and as such requires particular security measures, outlined in the Anti-terrorism, Crime and Security Act 2001. All areas in the new laboratory suite are SR4 security rated, as detailed in LPS 1175 Security Ratings, which relates to the physical security of intruder-resistant building components.

MAT has worked on many Schedule 5 laboratories, and was able to ensure that all necessary actions, checks and precautions were taken, demonstrating the importance of working with a specialist contractor on complex projects such as this.

The use of zebrafish is an emerging approach to studying infection, and one Dr Mostowy has helped to pioneer. In its first days of life, the tiny embryo zebrafish is completely translucent. This means scientists can examine what happens at a biological level when bacterial infection, such as Shigella, is introduced into its body via a microinjector – a microscope with an incorporated micromanipulator for precise needle positioning.

Anyone visiting the technologically advanced new lab, well equipped with a multitude of microinjectors and microscopes, will see scientists examining petri dishes containing the infected zebrafish embryos, using high resolution microscopy to observe incredibly clear images of the bacteria spreading and the immune system responding. It is hoped that understanding the mechanisms different infections use to attack cells and multiply will ultimately lead to the development of targeted ways to stop them.

Antimicrobial resistance (AMR) is considered by the World Health Organization to be one of the biggest threats to global health. MAT, along with everyone involved in the design and construction of the Mostowy Lab, was honored to have the opportunity to play a role in something that could lead to the development of new ways to fight infection.

Halix Begins Viral Vector Production At New Dutch GMP Facility

Halix is building a viral vector and viral vaccine manufacturing facility in the Netherlands. The CDMO of clinical and commercial proteins and viral products has announced that they have met their major milestone with the interim delivery of their new 72,092 sq. ft. (6,700 sqm) cGMP facility in Leiden Bio Science Park just north of Rotterdam.

According to Alex Huybens, Halix COO, after a construction time of just 12 months, the company can now begin production of viral products, and protein production will follow soon. He explained that the aggressive timeline in order to meet market demands.

Now one year into construction, Halix has completed its new state-of-the-art cGMP facility for the development and production of biopharmaceutical drug substances.

The new five-level production facility contains a state-of-the-art manufacturing line for viral vaccines and viral vectors and a separate protein manufacturing area with a capacity up to 1,000 Liter single-use bioreactors.

In addition, lab space is available for process development, analytical development and quality control.

All cleanroom areas have a unidirectional process flow and are designed to allow commercial manufacturing of biopharmaceuticals products.

Roland Hecht, HALIX Chief Customer Officer said: “This new facility offers our current and future clients capacity and flexibility for future expansion and will allow for cGMP manufacturing solutions for viral products, proteins, gene therapy and client-specific new technologies.”

Eli Lilly’s New Bio Manufacturing Plant, Cork

Located at the company’s campus in Kinsale, Cork, the facility is the company’s second commercialization and manufacturing facility at the Kinsale site.

Previously, Eli Lilly broke ground for a biopharmaceutical development and manufacturing facility at Kinsale in 2006. The facility was inaugurated in 2010 and began full-scale commercial production in 2013.

Construction of the new facility began in 2012 and the facility was opened in 2017.

The new facility created approximately 300 jobs during the onsite building works and employed 200 pharmaceutical professionals upon commencement of operations.

“IDA Ireland, the organization responsible for bringing foreign direct investments to Ireland, has worked closely with Eli Lilly to attract investment.”

The project was undertaken as part of Eli Lilly’s planned growth strategy in the biopharmaceutical business.

IDA Ireland, the organization that is responsible for bringing foreign direct investments to Ireland, has worked closely with Eli Lilly to attract the company’s further investment into the republic to foster employment and industrial growth.

The Action Plan for Jobs, announced by the Irish Government, included the measures regarding the creation of new jobs in the country in 2012.

It was principally targeted at attracting investments by multinational companies operating in high-end manufacturing and health/life sciences sectors such as Eli Lilly.

IDA Ireland achieved a significant start-up to achieving the targets of the Action Plan by encouraging Eli Lilly’s expansion in the country.

The New facility at Kinsale, Cork

The new biopharmaceutical commercialization and manufacturing facility was built over an area of 240,000 sq. ft. near the existing facility at the Kinsale site. It features a new IE28 laboratory, which consists of biotech laboratories, quality assurance (QA) and quality control (QC) laboratories.

The biotech laboratories spanning approximately 18,292 sq. ft. (1,700m²) are equipped with several equipment and utilities including bioreactors, autoclaves, biosafety cabinets, fume hoods and cooling systems.

The QA and QC laboratories cover approximately 24,748 sq. ft. (2,300m²) space, comprising a microbiology laboratory and a kilo laboratory.

Announcement of the new manufacturing plant was Eli Lilly’s second big investment at Kinsale. The company announced the first investment of €300m ($400m) at the location in 2006.

The total investment made by the company in the Kinsale facility reached more than €1bn by 2012. Further, the company invested €35m ($39.8m) in 2016 to improve the permanent manufacturing facility at the site.

The main focus areas for the new plant are cancer and diabetes drugs. The drugs are manufactured in final dosage form that is shipped to finishing plants of the company located in different parts of the world. The finishing plants convert them to tablets, capsules or injectables, depending on the drug’s approved dosage form.

Eli Lilly’s manufacturing history in Ireland dates back to 1981, when the company established its first manufacturing facility in the republic.

“The manufacturing plant is Eli Lilly’s second big investment at Kinsale. The company announced the first of €300m ($400m) in 2006.”

Eli Lilly is headquartered in Indianapolis, US. The Irish branch of the company is located in Dunderrow, Kinsale.

The company currently has four manufacturing sites in the country, including Kinsale, Cork City, Sligo and Dublin.

These production facilities manufacture bulk quantities of active pharmaceutical ingredients (API), biopharmaceutical products and animal vaccines.

Some of the drugs manufactured by these sites include Alimta, Evista, Strattera and Zyprexa.

The existing facility at Kinsale is involved in development and commercialization of new products.

Contractors involved

Arup provided the architectural and engineering services for the development of the facility.

Marketing commentary for the pharmaceutical giant

The pharmaceutical sector plays a key role in the Irish industrial and economic growth as the industry is the second largest in Ireland. The republic has witnessed more than €7bn investment in pharmaceuticals in the last decade.

It has eventually grown to become the world’s biggest net exporter of pharmaceuticals.

Eli Lilly has attracted and invested significantly in a skilled workforce at the existing Kinsale manufacturing facility, therefore, expanding the site will provide synergistic benefits.

Eisai’s New Oral Solid Dose Production Facility, Suzhou

Eisai China has built a new oral solid dose (OSD) production facility at its new Suzhou plant in China.

The new OSD production facility replaces an existing building at the Suzhou site.

A ground-breaking ceremony for the project took place in May 2016 while construction was completed in January 2018. The full-scale operation of the new facility started in November 2018.

The new facility enables Eisai to strengthen its in-house domestic production system in China.

The new OSD facility is located near the 168 Xingpu Road within the Suzhou Industrial Park, which is situated in the Chinese coastal province of Jiangsu, Suzhou.

The Suzhou Industrial Park is an economic co-operation project between China and Singapore. It covers a 288km² area and provides easy access to various rail and motorway networks.

The new OSD production facility is five times bigger than the existing plant. It includes three floors with a total floor space of 217,782 sq. ft. (20,240m²).

The plant is designed and built according to Chinese good manufacturing practices (GMP) and international GMP standards. It also includes energy-saving features.

It supplies Eisai China’s high-quality products to the Chinese market and other Asian countries in the future.

Other facilities at the new Suzhou plant:

Eisai’s new Suzhou plant is built on a total site area of 1,441,840 sq. ft. (134,000m²). It comprises the OSD facility, an administration building and a parenteral production facility.

Construction of the parenteral production facility was completed in November 2014. The two-story facility covers an area of 61,224 SQ. FT. (5,690m²) and manufactures the injection formulation Methycobal®.

The administration building is a two-story facility with a floor space of 23,994 SQ. FT. (2,230m²). It features offices, meeting rooms and a cafeteria. The distribution warehouse, featuring a single floor, covers a total floor space of approximately 84,057 sq. ft. (7,812m2).

The new OSD facility is expected to serve as a global innovation center for Eisai in the future.

The new oral solid dose facility is capable of handling the formulation and packaging of OSD products such as Methycobal®, Aricept® and Pariet® for the Chinese market. It is also involved in the packaging of imported products.

The production capacity of the facility is more than double that of the existing plant in Suzhou. The new facility has an annual production capacity of three billion formulated tablets and packaging capacity of five billion tablets.

Marketing commentary on Eisai China:

Founded in 1996, Eisai China is a pharmaceutical materials manufacturing company and a wholly owned subsidiary of Eisai Co, which is based in Tokyo, Japan.

Eisai began expanding to China with the establishment of Shenyang Eisai Pharmaceutical. This was followed by Eisai Suzhou Pharmaceutical in Suzhou Industrial Park, which is now named Eisai China.

Eisai China promotes more than ten medicines in China, covering the central nervous system (CNS), the digestive system and the endocrine and orthopedics systems.

The new OSD facility enables the company to meet the growing demand for its OSD products while improving production efficiency and expanding its pharmaceutical supply chain.

Grifols Expands in Africa with Manufacturing Facility

Grifols builds its first plant in Northern Africa for Morocco-based Soludia Maghreb, which will be used in the production of intravenous solutions bags.

The plasma-derived medicines manufacturer announced an agreement to build a manufacturing plant in northern Africa for Soludia Maghreb, a provider of hemodialysis solutions, headquartered in Morocco.

Under the agreement, Grifols will develop, build and automate the main process equipment for Soludia’s manufacturing line that will produce intravenous solutions bags.

Grifols' co-CEOs, Victor Grifols Deu and Raimon Grifols suggested the agreement was a ‘milestone’ for business growth, while the CEO of Soludia Maghreb, Abdelaziz Rezkaoui, said that “This partnership is only the start of a long-term collaboration in Morocco and Africa.”

The plant is expected to begin operations next year.

Last year, Grifols purchased Biotest US, a geographical unit of the German-based Biotech AG in an $286m (€247m) deal, gaining access to more than 20 plasma collection facilities and establishing its presence in North America.

Grifols is looking to further invest in reinforcing its growth, with plans for €1.4bn ($1.57bn) worth of capital investments over the 2018-2022 period, in order to meet the growing demand for plasma-derived medicines.

The company made the above announcement along with that of the approval it received from the US Food and Drug Administration for Xembify (immune globulin subcutaneous, human- klhw), a treatment for primary immunodeficiencies.

Xembify will be launched in the US in the last quarter of 2019 while the company also awaits approvals from regulators in Canada, Europe and other markets.

In addition to that, the company announced an investment of €140m for a purification and sterile filling plant of immunoglobulins in flexible packaging in North Carolina, US. The plant is expected to be operational by 2022.

Orano Med Invests in Radiopharma Production in France and US

Investments will double lab space and finance the installation of a cleanroom

In practice, these investments will double the laboratory space available at the Maurice Tubiana Laboratory in Bessines-sur-Gartempe (France) in order to increase its lead-212 production capacities.

In the US, the capacities of the Domestic Distribution & Purification Unit (DDPU), located near Dallas, Texas, will be extended to allow several clinical trials to be performed in parallel.

Orano is a recent company but has existed in one form or another for a long time. The Areva Group had a corporate restructure and in the process separated its nuclear cycle business into a separate company, called New Areva. This later became Orano.

Concept Life Sciences Opens API Facility

Concept Life Sciences has unveiled a new clinical niche commercial facility. The facility has been designed to support pharma and biotech companies throughout the development and manufacture of active pharmaceutical ingredients (API).

Located at Discovery Park in Sandwich, UK, the purpose-built facility offers a comprehensive range of services designed to allow partner organizations to take drug candidates through discovery, scale up and into cGMP-compliant production.

Dr Paul Doyle, Chief Scientific Officer at Concept Life Sciences said: “Pharmaceutical and biotech companies of all sizes are demanding high-quality, early-stage manufacturing capabilities that can readily scale up target molecules from grams to kilograms, and then into cGMP-compliant API manufacture all while mitigating the risk typically associated with moving between different stages of the drug development process."

Doyle continued to say that the new specialist facility will strengthen support services to enable a boost in productivity and faster time to market.

With the new facility joining the company’s growing network of sites across the UK, Concept Life Sciences’ pharmaceutical manufacturing support services now comprise:

API process research and development, and cGMP – both small- and larger-scale plants, including the capability to provide demonstration, toxicology and clinical batches

Quality control release testing – a unique blend of high-end characterization techniques and standard chromatographic methods for raw material and finished product release in compliance with cGMP requirements

Stability studies – in line with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Out-of-specification investigations – identification of contaminants and impurities, materials characterization and responsiveness in emergencies to minimize production downtime

Extractables, leachables and sorption studies – testing of packaging to support regulatory submissions and packaging changes

Cleaning verification and validation – full cGMP-compliant capabilities to ensure optimal product protection

Occupational hygiene – sensitive surrogate testing using low-hazard compounds, air quality monitoring and safe handling of biological samples, as well as development, validation and analysis of air filter and swab samples

Environmental monitoring – effluent analysis, land contamination testing and emissions control

WuXi Biologics to Expand Integrated Biologics Conjugation Solution Center

WUXI, China, June 21, 2019 –access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced that it planned to expand the new state-of-the-art integrated biologics conjugation solution center to include commercial manufacturing in Wuxi city, China.

Bioconjugates such as Antibody-Drug Conjugates (ADCs) present new and exciting opportunities in treating various cancers. Last June, WuXi Biologics announced the building of an integrated biologics conjugation solution center, including process development and clinical manufacturing for ADCs drug substance and drug product. This center is expected to initiate GMP manufacturing later this year. The new 5.5-acre expansion will enable cGMP commercial manufacturing for ADCs drug substance and drug product.

“We are quite excited to expand construction of this new integrated biologics conjugation solution center, which will further enhance our technical capabilities and manufacturing capacities in the fast-growing bioconjugation field,” said Dr. Chris Chen, CEO of WuXi Biologics. “With the strength of our ONE-stop service platform covering antibody, bioconjugation drug substance and drug product, WuXi Biologics will continue enabling our global partners to develop exciting ADCs to benefit cancer patients worldwide.”

There are currently more than 20 ADCs being developed at WuXi Biologics. So far, WuXi Biologics has successfully advanced 11 ADCs projects to Investigational New Drug (IND) filing.

About WuXi Biologics:

WuXi Biologics, a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network.

Lonza to Acquire Sterile Fill and Finish Facility from Novartis

Quote from Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech:

“The intended acquisition of the sterile drug product fill and finish facility in Stein will be the latest phase in our step-wise expansion of parenteral drug product services. Combined with our development services, this manufacturing facility will provide our customers with shorter timelines to the clinic and best-in-class quality for parenteral product development through commercialization.”

Quote from Hanns-Christian Mahler, Head of Drug Products Services, Lonza Pharma & Biotech:

“Launched just three years ago with a core team of experts, Lonza DPS has since expanded in line with customer demand. Upon closing, the new manufacturing facility in Stein will be our first sterile drug product fill and finish facility and will work in close synergy with our existing facility in the Stücki Park in Basel. We will continue to provide best-in-class development and commercialization options for our customers, using our scientific approach together with our regulatory and industrial experience and to deliver with the highest quality standards.”

Basel, Switzerland, 1 July 2019 – Lonza announced its entry into a binding contractual commitment for the purchase of a sterile drug product fill & finish facility from Novartis. The closing is expected to take place within the coming months. The new facility, in Stein (CH) will enable Lonza Pharma & Biotech to build on existing parenteral drug product development and testing capabilities and offer an end-to-end service to its customers for clinical supply and launch. It will be the first sterile drug product fill and finish facility in Lonza’s network.

The sterile, multi-product facility currently serves as the Novartis Center of Excellence for sterile clinical (phases 1 to 3) drug product manufacture. The facility has an excellent quality and safety track record and is cGMP approved. Following closing, Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers.

Operational since 2009 the facility includes classified cleanroom areas for cGMP manufacture as well as office, lab space, utilities and storage. The facility will continue to perform sterile manufacturing including liquid and lyophilized dosage forms for up to 200L bulk volumes for clinical supply and commercial launch. Lonza will continue to employ the highly experienced team at the facility.

Since entering the field of drug product development services at the end of 2016, Lonza Pharma & Biotech has met considerable demand from the market and has already announced expansions at its sites in Basel and Visp (CH). From 2020 the group will expand development and testing labs into a larger building in Basel and expects its IbexTM Solutions fill and finish facility in Visp to be operational on-track from mid-2021. The new facility in Stein will be fully incorporated into Lonza’s offering and will give pharma and biotech customers immediate access to the full range of development, testing and manufacturing services for parenterally administered medicines.

Cambrex Opens QC Lab in Italy

Cambrex Corporation has opened a new 1,291 sq. ft. (120 square meter) quality control (QC) laboratory at its site in Paullo, Milan, Italy. The laboratory expands on the current QC facilities that analyze and test its generic API portfolio of products during development and manufacturing. The QC laboratory is now fully operational, having been authorized by the Agenzia Italiana Del Farmaco (AIFA).

The additional laboratory space will increase the efficiency of the QC department as the site expands the number of generic APIs in development. New instruments, including a polarimeter and infrared spectrometer, have been added, with the systems linked to secure, electronic data capturing software to allow full traceability in line with regulatory requirements.

“Our facility in Milan is the center of the Cambrex’s generic API business, and this investment is the latest in a number of steps we have taken at the site to increase its efficiency and flexibility as we look to grow the portfolio of products that we offer,” said Aldo Magnini, managing director, Cambrex Milan. “In the last year the company has made strategic investments to expand its capabilities in research and development, manufacturing, and now QC capabilities, as we look to take advantage of the opportunities that are arising in the generic market.”

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

FUJIFILM Irvine Scientific Plans Another Cell Culture Media Manufacturing Site

FUJIFILM Irvine Scientific, Inc., a global leader in the innovation, development, and manufacture of cell culture media, announced plans to open a third manufacturing facility located in Tilburg, Netherlands. The company currently has sites in the United States and Japan. Fujifilm’s investment in this project demonstrates its commitment to accelerate development in bioproduction, and cell and gene therapy markets.

The facility will occupy a 250,000 square foot building within FUJIFILM Manufacturing Europe B.V., one of the largest Fujifilm production centers outside of Japan. The space will support cGMP manufacturing of animal component-free, dry powder media, liquid media, and downstream bioprocessing liquids, thereby adding additional production capacity for FUJIFILM Irvine Scientific of 320,000 Kg/year for dry powder, and 470,000 L/year for liquids. Water for Injection (WFI) will also be manufactured on the premises.

"The biopharmaceutical market is growing at a high rate, and cell therapies are moving into clinical trials and commercialization at fast pace. The company's current capacity is >1,000,000 Kg/year of dry powder, but it is imperative that we exceed production requirements of customers worldwide, as well as meet our European customer demand for regional support," said Yutaka Yamaguchi, CEO, FUJIFILM Irvine Scientific. "Building a third, world-class cGMP manufacturing facility to serve as a European hub will enable us to better provide customers with rapid, reliable supply of products."

Work on the new manufacturing site has begun and it is expected to be commissioned in the second half of 2021.

About FUJIFILM:

FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 45 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2019, the company had global revenues of $22 billion, at an exchange rate of 111 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship.

Pall Chosen by Servier for Biomanufacturing Facility

Pall Corporation, a global leader in filtration, separation and purification, has been chosen by Servier, an independent international pharmaceutical company, as an exclusive technology and services provider for their Gidy, France biomanufacturing facility.

End-to-end solutions from Pall Biotech will be implemented for the development and manufacturing of monoclonal antibodies (mAbs) and recombinant proteins, resulting in increased speed to market and reduced customer costs. The facility is part of the Bio-S project at Servier focused on delivering best-in-class support for oncology drug production from research and development (R&D) to clinical scale.

The Bio-S project at the Gidy facility includes production lines to support internal production needs with up to 2,000L bioreactor capacity that can be run in a parallel format. The Bio-S unit aligns various activities, including a development workshop dedicated to monoclonal antibody processes (Bio-engineering) which will be operational by 2019. The rest of the unit grouping all of the steps to deliver an injectable product to humans will be operational in 2020.

"Pall was chosen as a single vendor for our unique ability to offer integrated solutions that help to guarantee supply chain security for customers and patients, while allowing data to be collected and organized efficiently. We are honored to have been chosen and look forward to delivering comprehensive and scalable biomanufacturing solutions from upstream to downstream and through to fill and finish, as well as process development service expertise," said Ed Hoare, Vice President & General Manager at Pall Biotech. "We have dedicated a great deal of resources to become more than just a supplier and will act as a co-development partner for all customer production steps."

"The Bio-S project in Gidy is the beginning of an industrial solution for biomanufacturing in France, offering an innovative path for critical oncology therapies, one of the main strategic priorities for Servier," said Renaud Bessière, Director of the Bio-S Project at Servier. "We selected Pall Biotech as our single supplier because of their capacity to deliver the complete suite of development and manufacturing equipment, including an automation package, assurance of consumables supply and technical support under a well-defined project execution plan."

Through the Bio-S project Servier is building infrastructure that enables the company to be a key partner in the development of new therapeutics in oncology, offering customer support from R&D through to manufacture and packaging of monoclonal antibodies, initially in the form of preclinical batches, then clinical batches.

About Pall Corporation:

Pall Corporation is a filtration, separation and purification leader, providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The company's engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.

GSK Completes Continuous Manufacturing Facility in Singapore

GSK opens two continuous manufacturing facilities and expands an existing production building to shorten timelines in the production of daprodustat.

The manufacturing facilities were opened in Jurong, Singapore, after an investment of S$130m ($95.6m) as part of the company’s 10-year strategic investment plan in Singapore.

GSK-EDB 10-year Singapore Manufacturing Roadmap was agreed in 2012 to “ensure manufacturing remains a competitive edge for GSK and Singapore,” with the Economic Development Board (EDB) for Singapore representing the national government in discussions.

According to GSK, Singapore has been a ‘testbed’ for its advanced manufacturing technology, with the products produced at the site shipped globally.

Regis Simard, president of GSK’s pharmaceutical supply chain, said, “Innovation is at the heart of GSK, we are glad to invest in scientific and technical excellence in Singapore to develop and launch the next generation of products which meet the needs of patients, payers and consumers.”

Daprodustat is a new chemical entity (NCE) that will be produced at the additional facility and the company expects the use of continuous manufacturing to reduce the production time.

The drug is currently in Phase III clinical trials for the treatment of anemia associated with chronic kidney disease.

One of the continuous manufacturing facilities will be used as part of an R&D Pilot Plant and will manufacture active pharmaceutical ingredients (APIs) for clinical trials.

An expansion of the existing production facility will be used to create APIs for dolutegravir used in Dovato (dolutegravir and lamivudine). The HIV therapy was recently approved by the US Food and Drug Administration as the first two-drug, fixed-dose, complete regimen.

In addition, the investment for the facility expansion has also enabled GSK to ‘test and develop digital technologies’ in the manufacturing process.

GSK’s interest in developing its continuous manufacturing technology and set up such a facility in Singapore in 2013.

More recently, the company has collaborated with the UK’s CPI, alongside AstraZeneca, to build a continuous wet granulation manufacturing facility for oral solid dosage drugs.

Thermo Fisher Buys GSK API Site

Thermo Fisher Scientific has entered into a definitive agreement to acquire a drug substance manufacturing site in Cork, Ireland, from GlaxoSmithKline for approximately $100 million (~€90mn). The Cork site will expand capacity to meet customer demand for the development and commercial manufacturing of complex active pharmaceutical ingredients (APIs).

With more than 400 employees, the site produces highly specialized APIs for treating diseases including childhood cancer, depression and Parkinson's. Thermo Fisher will continue to produce APIs for GSK under a multi-year supply agreement and plans to expand use of the site to develop and produce complex APIs for other customers as well. The site contains 270 cubic meters of reactor capacity, 10 production buildings, an R&D pilot plant and lab infrastructure to support process development, scale-up and physical characterization of APIs.

"The GSK Cork site will enhance our API offering by expanding our development and commercial capabilities to provide much-needed capacity for APIs currently in development," said Michel Lagarde, senior vice president and president of Pharma Services for Thermo Fisher Scientific. "This transaction is another great example of our strategy to build on our strong foundation by adding capacity and capabilities to our pharma services offering through a combination of capital investments and M&A."

This announcement follows the recently completed acquisition of Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies. Thermo Fisher is also investing $150 million to expand its sterile fill-finish sites in Monza and Ferentino, Italy, and Greenville, NC, and plans to complete the previously announced $50 million expansion of its St. Louis, MO, biologics facility later this year.

The GSK transaction, which is expected to be completed by the end of 2019, is subject to customary closing conditions, including regulatory approvals. Upon completion, the site will become part of Thermo Fisher's Pharma Services business within its Laboratory Products and Services Segment.

FUJIFILM Announces Expansion of Cell Culture Process Development Labs

The BioCampus will be partly supported by the Tees Valley Combined Authority.

FUJIFILM Diosynth Biotechnologies (FDB), a leading global biologics Contract Development and Manufacturing Organization (CDMO), has announced an expansion to its United Kingdom location through the creation of a new BioCampus. This expansion will be partly supported by the Tess Valley Combined Authority (TVCA) through a grant funding up to £3.625M. These funds will help to kick start the first stage of the BioCampus while at the same time enabling subsequent phases of investment and development planned by FDB. The total cost of the BioCampus project is estimated to be £12.6M.

The initial phase of this project will involve a new purpose built facility. This will consist of approximately 42,000 square feet of space and will house circa 250 of FDB’s existing staff and the addition of approximately 50 new high value jobs. It is expected that the new jobs will be filled within the span of two years. This announcement is the latest on a series of investments made by FUJIFILM Corporation to grow FDB and the CDMO business.

This latest investment is part of a major strategic growth plan. In September 2017 FDB announced the opening of the 10,000 square foot, state-of-the-art cell culture Process Development Laboratories in Wilton Centre, Teesside. In January 2019, the Wilton Laboratories were further expanded with the addition of 7,000 square feet of laboratory space increasing FDB’s cell culture process development capacity. The new space will also support dedicated process characterization activities.

“We continue to focus our growth here in the North East of England,” said Paul Found, chief operating officer of FUJIFILM Diosynth Biotechnologies in the United Kingdom. “We are proud of the part FUJIFILM Diosynth Biotechnologies is playing in growing the North East’s biotechnology industry and being a player in the creation of highly specialized jobs.”

Under its bio CDMO business newly established in March 2017, Fujifilm seeks to maintain an aggressive capital investment strategy in combination with the development of highly efficient and highly productive technologies. The company also seeks to contribute to the further advancement of the pharmaceutical industry through the stable supply of high quality pharmaceutical products.

About Fujifilm:

FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham and Redcar, UK, RTP, North Carolina and College Station, Texas. FUJIFILM Diosynth has over twenty five years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.

FUJIFILM Holdings Corporation, Tokyo, Japan brings cutting-edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2018, the company had global revenues of $23.0 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship.

SGS Opens Biologics Testing Facility in UK

Receives Scottish Enterprise grant of £1.7 million, as a contribution towards the company’s £7.6 million investment

SGS celebrated the official opening of the Biologics, Viral Vaccine, Gene and Cell Therapy Testing facility expansion in Glasgow, UK earlier this month. The newly extended state-of-the-art facility now doubles the total floor space from 12,912 sq. ft. (1,200 square meters) to 25,824 sq. ft. (2,400 square meters).

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.

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

He continued, “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%.

“The Scottish Government and our skills and enterprise agencies look forward to working with SGS Vitrology to deliver their ambitious plans for their Glasgow operation.”

Archie Lovatt, scientific director, SGS, said, “Large molecule biologics, vaccines, gene and cell therapies are a rapidly expanding field within the pharmaceutical industry. Our investment ensures we will remain at the forefront of this growth by delivering the highly specialized testing expertise necessary to establish and ensure the safety of novel human therapies and vaccines.”

Thermo Fisher Scientific to Invest in Bioproduction Expansion

The expansion will increase the company’s single-use capacity to meet growing demand.

Construction is expected to be completed by the end of 2020.

Catalent to Purchase Bristol-Myers Squibb Manufacturing Facility in Anagni, Italy

Bristol-Myers Squibb Company and Catalent, Inc., announced that Catalent has agreed to purchase Bristol-Myers Squibb’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy. Catalent is the leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The companies anticipate completing the transaction by the end of 2019, subject to regulatory approvals, the information and consultation procedure with the unions, and the satisfaction of certain other customary closing conditions.

Through the years, the Anagni plant has served as one of the primary launch facilities for new medicines from Bristol-Myers Squibb that have helped millions of people in the fight against serious diseases such as cancer and cardiovascular disease. Upon closing, Catalent will continue to manufacture Bristol-Myers Squibb’s current product portfolio at the site.

By enhancing its own global network with the Anagni plant, Catalent will bring potential new customers to the site for both biologics and oral solid dose manufacturing and packaging. In particular, this facility will provide Catalent biologics customers with access to an advanced sterile drug product fill/finish and packaging capacity in Europe to complement its existing sterile fill/finish capabilities in Belgium and its drug substance, analytical and fill/finish capabilities in North America.

“We believe that the sale to Catalent will continue the vital role the Anagni facility plays for its workforce, the community and patients,” said Lou Schmukler, President, Global Product Development and Supply, Bristol-Myers Squibb. “This marks an important step in the ongoing evolution of our manufacturing network to support the company’s innovative product portfolio. Bristol-Myers Squibb has a long history in Italy, and we intend to maintain a continued strategic presence in Italy, which is critical for our ability to deliver transformational medicines to patients.”

Alessandro Maselli, Catalent’s President and Chief Operating Officer, commented, “The addition of the Anagni facility provides our European customers with great biologics and oral dose capabilities to accelerate their development programs and improve commercial supply.” He added, “Bristol-Myers Squibb has invested in the facility to create a center of excellence for new product launches with a robust quality and delivery record, and an employee base who shares Catalent’s operational excellence and patient focus.”

William Blair & Company served as financial advisor to Bristol-Myers Squibb.

ABOUT THE ANAGNI FACILITY

The Bristol-Myers Squibb Anagni facility is a pharmaceutical manufacturing plant, situated in an industrial area one hundred kilometers southeast of Rome. The site opened in 1966. The facility floor space is approximately 19,300 square meters on a site of 34 hectares. The Anagni facility manufactures and packages cardiovascular, neuroleptics, anticancer, metabolic and anti-inflammatory medicines as well as non-penicillin-based antibiotics, antivirals, analgesics as injectables and biologics.

ABOUT BRISTOL-MYERS SQUIBB

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

ABOUT CATALENT

Catalent is the leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.

Catalent Inaugurates Second Shanghai Facility

Catalent has completed its new, 30,000-square-foot clinical supply facility in Shanghai, China. The event was marked with an official opening ceremony at the site on April 10.

The facility, located outside of the free trade zone (FTZ) in Tangzhen, is near to both Catalent’s existing Waigaoqiao FTZ site and China’s Zhangjiang Pharma Valley area. Together, Catalent’s two Shanghai locations will provide sponsors with an optimized supply solution for studies being undertaken in China, the Asia-Pacific region and globally. It is expected to employ up to 100 people and offers comprehensive clinical supply services including FastChain demand-led supply, secondary packaging, clinical storage and local distribution, as well as clinical returns and destruction services.

At the ribbon-cutting ceremony to officially open the site, Catalent executives welcomed local government officials and local and international pharma customers. Guests were accompanied on a site tour, and the opening ceremony also featured a traditional Chinese lion dance and a symbolic light display to reflect the bright future of the site’s foundations.

“We are delighted to have already engaged customers for services in Tangzhen,” said Roel de Nobel, vice president, global operations, Catalent Clinical Supply Services. “Having facilities both inside and outside the FTZ in China affords customers flexibility, convenience and streamlined logistics in support of the growing number of trials being conducted in the region.”

The Tangzhen opening follows recent investments in Singapore and Japan, strengthening Catalent’s capabilities to support clinical trials in Asia and beyond.

With sites in the U.S., UK, Germany, Singapore, Japan and China, and an extended network of over 50 depots, Catalent’s clinical supply services can handle a broad range of international compliance and distribution requirements to support global clinical trials.

Sharp Gets MHRA Approval for Clinical Services

Sharp, a global provider of contract packaging and clinical supply services, has received approval from the Medicines and Healthcare Product Regulatory Agency (MHRA) to begin production at its Clinical Services Center of Excellence in Rhymney, Wales.

Following a successful inspection by the MHRA, Sharp can now offer a range of clinical trial and commercial services from the £9.5 million (~$12mn) facility including primary and secondary packaging with low humidity control, labelling, storage and distribution, QP services as well as controlled drug storage.

The center also enables Sharp to offer a broader range of integrated services including serialization and Interactive Response Technology (IRT) solutions for clinical trial management.

“The Clinical Services Center of Excellence in Rhymney has tripled Sharp’s clinical service capacity for the pharmaceutical, biotech and clinical research sectors,” said Frank Lis, president, Sharp Clinical Services. “With the integrated capabilities on offer, the facility also better enables us to offer full-service support and meet the increased global demand for Phase III clinical trials and commercial pharmaceutical services. We are dedicated to supporting our customers for years to come and the Rhymney site is a sign of that commitment.”

The MHRA approval comes as Sharp celebrates its 30th year of clinical operations in the UK. Sharp has also invested in a solar panel system at the site that will generate approximately 20% of Sharp Clinical Services’ total annual electricity requirements, further reducing the company’s carbon footprint and increasing environmental performance.

Biotechpharma Expands Manufacturing Capacity

Biotechpharma UAB, a biopharmaceutical CDMO, has invested more than €50 million to further expand its fermentation capacity to 5,000 L, along with a new process development lab.

Dr. Vladas Bumelis, chairman of the board, said, “The expansion comes amid growing global demand for flexible and responsive outsourcing partners that are able to support the full product lifecycle, from upstream and downstream process development and optimization to GMP manufacturing of drug substance and formulated drug product.”

“We are thrilled to announce this latest expansion of our infrastructure, as it will allow us to better support our customers’ biological development programs with quality, speed and flexibility of service,” said Giedrius Žunda, chief executive officer of Biotechpharma.

The new plant located at the company’s site in Vilnius, Lithuania, will contain a new line of bioreactors for microbial fermentation at 5,000 L scale and the necessary equipment for downstream processing operations. The flexible facility design will also allow for increased mammalian cell culture production capacities in addition to the existing two lines of 1000-L and 2000-L scale for mammalian cell production, both equipped with single-use bioreactors. Completion of the plant, which should be operational in 4Q20, will result in an increase in volume capacity by nearly double.

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