PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

CRMC Board Oks Budget for Drug Room

Cookeville Regional Medical Center's Board of Trustees officially voted to build a new room for toxic drugs.

It's part of an overall plan to upgrade the hospital's pharmacy and build a USP800 cleanroom.

The room will cost $1,138,397 to buy and equip. The cost includes a buffer room, anteroom, storage room, mechanical work, exterior exhaust, bio-safety cabinets, pass-through cabinets and pharmacy refrigeration.

Hospital Director of Pharmacy Casey White said the USP800 regulation is a change that requires health care facilities to have a cleanroom set up to handle hazardous materials. The cleanroom would make it safer for employees who deal with those types of materials, like chemotherapy drugs. If CRMC wants to continue offering cancer treatments, they have to install the room. All the work must be done before the end of this year.

CEO Paul Korth said they expect to have the room completed and inspected in time to meet the December 2019 deadline.

In order to make space for the USP800 cleanroom, CRMC's pharmacy robot is being moved and upgraded to an Omnicell system. Construction on the Omnicell portion should begin on March 11, White said. The Omnicell system will replace the cabinets that hold drugs at the nursing stations, White said. Omnicell also has the ability to track drug use and delivery in real time. The system uses biometric scanning to open the drawers, increasing safety.

The CRMC board approved both projects last August.

The Omnicell portion of the project cost $2.5 million, bringing the total cost of the project to more than $3.6 million.

Rubius Therapeutics’ Pharma Manufacturing Facility, Rhode Island

Rubius Therapeutics is constructing a pharmaceutical manufacturing facility in Smithfield, Rhode Island, US.

The plant will use Rubius Therapeutics’ erythrocyte design platform RED to scale-up the manufacturing of Red Cell Therapeutic™ (RCT) product candidates.

The lentiviral vectors, which encode biotherapeutic proteins in the RCT™, will also be developed in the facility.

The company intends to invest up to $95m on the facility by 2020.

An official ground-breaking ceremony for the project was held in September 2018 and the first phase of construction is expected to be completed by 2020. The project will create approximately 160 new jobs in Smithfield.

In July 2018, Rubius purchased an existing 135,000ft² building from Alexion Pharmaceuticals for the project.

Located at 100 Technology Way and 30 Hanton City Road in Smithfield, the building will be renovated to be used as the company’s new pharmaceutical manufacturing facility.

Rhode Island has emerged as a favorable location for various companies due to the incentives offered by the Qualified Jobs Tax Credit Program.

The customized facility will be equipped with multiple current good manufacturing practices (CGMP) compliant manufacturing suites for clinical supply.

The Red platform will be used to generate genetically engineered RCT product candidates at the facility.

RCT can be used for the development of potent and allogeneic cellular medicines that can potentially treat a number of patients from a single universal donor. It can develop medicines for a wide range of diseases such as phenylketonuria, refractory gout, homocystinuria, hyperoxaluria, solid tumors, pemphigus vulgaris, and type-1 diabetes.

The facility will also be utilized for the commercial supply of the RCT product candidates after approval. It will enable the company to ensure the availability of medicines for patients as soon as they are required. The lentiviral vectors required to code biotherapeutic proteins in the RCT will also be developed in the facility.

Gina Raimondo, the Governor of Rhode Island, and the Rhode Island Commerce Corporation worked closely with the company to provide incentives for the project.

The Board of the Rhode Island Commerce Corporation approved tax credits valued at approximately $2.75m through the Rebuild Rhode Island Tax Credit Program and the Qualified Jobs Incentive Act.

Qualified Jobs tax credits worth approximately $370,000 a year will be provided over ten years. A total of $9.345m-worth credits over the ten-year period are expected to be provided.

Rubius is also eligible to obtain sales tax rebate on the construction materials utilized in the project.

A/Z Corporation has been appointed to design and develop the new facility. It will collaborate with other design partners to draft the required renovations to develop the facility.

Marketing Commentary on Rubius Therapeutics:

Rubius Therapeutics was founded in 2013 by Flagship Labs, a life science innovation enterprise founded by venture capital firm Flagship Pioneering.

The company was established on the discoveries of the scientists of Whitehead Institute for Biomedical Research at MIT and research findings of Flagship Pioneering’s VentureLabs.

Rubius focuses on the advancement of the RCT product candidates by utilizing three types of therapeutic modes, which include cellular shielding, cell-cell interaction, and tolerance induction.

AveXis Gene Therapy Manufacturing Facility, North Carolina, US

AveXis is investing an additional $60m in its new gene therapy manufacturing facility in Durham County, North Carolina, US.

The facility was first announced in May 2018 and was estimated to cost $55m. The center will enable the company to scale-up production of transformational therapies for rare neurological genetic diseases.

The project is expected to create 200 new jobs with an average payroll of $104,000. With positions including engineering, manufacturing, quality control and supply chain roles, the number of jobs is expected to reach 400 by the end of 2020.

AveXis’s continued investment in North Carolina will boost the state’s biotechnology industry.

AveXis’s new gene therapy manufacturing plant is located in a leased property at 2500 South Tri-Center Boulevard in Durham.

The Research Tri Center South warehouse is located within the Research Triangle Park region, which is close to the Raleigh-Durham International Airport. The site is well connected to North Carolina Highway 147 and interstates 40 and 85. It provides access to Raleigh, Durham, Chapel Hill, and Cary in North Carolina.

The new facility will manufacture AveXis’s initial product candidate ZOLGENSMA©, which was formerly known as AVXS-101.

The ZOLGENSMA gene therapy product candidate treats three types of spinal muscular atrophy (SMA), a rare neuromuscular disease and one of the most common genetic causes of infant death. It addresses the main cause of Type 1 SMA, which has very few treatment options.

AveXis submitted the biologics license application (BLA) for ZOLGENSMA to the Food and Drug Administration (FDA) in December 2018. The drug has received breakthrough therapy designation and has been granted priority review status by the FDA, while regulatory action is anticipated in May 2019.

Regulatory applications for the drug have also been submitted in Europe and Japan.

In addition to ZOLGENSMA, AveXis plans to develop new drugs for the treatment of rare neurological diseases such as Rett syndrome and amyotrophic lateral sclerosis.

AveXis’s Durham manufacturing facility is supported by the North Carolina Department of Commerce and the Economic Development Partnership of North Carolina (EDPNC) in partnership with the North Carolina Biotechnology Center, the North Carolina General Assembly and the North Carolina Community College System, as well as the Greater Durham Chamber of Commerce and Durham County.

The North Carolina Economic Investment Committee agreed to provide $1.44m under the Job Development Investment Grant (JDIG) in May 2018 to support the facility for 12 years. The company will repay the funds along with tax revenues generated by the new jobs over the 12-year term.

The facility will contribute an estimated $1.3bn to North Carolina’s economy during the period. It will also provide up to $483,000 to the state’s Industrial Development Fund – Utility Account, according to the JDIG deal.

Marketing commentary on AveXis:

Headquartered in Bannockburn, Illinois, AveXis develops and commercializes gene therapies to treat rare and fatal neurological genetic diseases. It was acquired by Switzerland-based pharmaceutical firm Novartis for $8.7bn in May 2018.

AveXis operates a state-of-the-art manufacturing site in the Chicagoland area in Illinois, US.

Amicus Therapeutics’ Global Research and Gene Therapy Centre, Philadelphia

Amicus Therapeutics is building a global research and gene therapy center of excellence in Philadelphia, Pennsylvania, US.

The facility will be developed to serve as the headquarters of the company’s science organization and to host the leadership team working on gene therapy.

The new facility was announced in February 2019 and is expected to be completed in the second half of 2019. It will provide approximately 200 new jobs and allow the company to advance its pipeline of medicines for patients with rare metabolic diseases by bolstering its gene therapy research capabilities.

The new research and gene therapy center is located in a 14-storey 3675 Market Street building, spread across 345,000ft², in the uCity Square mixed-use community in Philadelphia.

The 6.5 million square feet uCity Square community houses offices, residential, retail, clinical, and office spaces as well as laboratories.

Philadelphia, which is emerging as a biotechnology and gene therapy research hub, will help advance the company’s gene therapy activities. The city’s close proximity to the company’s global headquarters in Cranbury, New Jersey, US, will further strengthen external collaborations to deliver high-quality medicines.

The site also offers easy reach to the University of Pennsylvania and Penn Medicine, which host some top gene therapy researchers, and hospitals in Philadelphia. Amicus also intends to extend its collaboration to other institutions such as Drexel University.

Amicus’ new facility will occupy 75,000ft² of office and laboratory space across the top three floors of the 3675 Market Street building, which was developed by Wexford Science & Technology in collaboration with the University City Science Center and Ventas.

The building currently houses a number of innovation centers, including CIC Philadelphia, BioLabs@CIC Philadelphia, Quorum, Venture Café Philadelphia, FirstHand, and other science center commercialization programs.

A team of Amicus’ researchers is currently based in a temporary space in the building as a client of BioLabs@CIC Philadelphia, a co-working space with a wet laboratory and office facility. Researchers will be moved to the new facility once it is completed.

The new facility will be used for research and development of biotechnology and gene therapy to treat rare metabolic diseases.

Amicus collaborated with the Perelman School of Medicine at the University of Pennsylvania on Gene Therapy Program in October 2018.

Partners will carry out research and development work to innovate gene therapies for the treatment of Pompe disease, Fabry disease, CDKL5 deficiency and other rare metabolic disorders.

The collaboration will develop AAV gene therapies using the University of Pennsylvania’s adeno associated virus (AAV) gene transfer technologies and the company’s protein engineering expertise.

Amicus acquired ten pre-clinical and clinical stage gene therapy programs developed at the Center for Gene Therapy at the Research Institute at Nationwide Children’s Hospital and the Ohio State University for the treatment of lysosomal storage disorders in children.

Marketing commentary on Amicus Therapeutics:

Amicus is a biopharmaceutical company focused on the discovery and development of high-quality medicines for the treatment of rare metabolic diseases.

The company developed certain technologies, including a pharmacological chaperone technology, enzyme-targeting technology, and proprietary Chaperone-Advanced Replacement Therapy (CHART®) technology to develop novel gene therapies for lysosomal storage disorders.

It has one FDA-approved drug in its portfolio, Galafold, which is indicated for the treatment of Fabry disease. The lead product candidate in the company’s pipeline is AT-GAA, which is being investigated to treat Pompe disease.

bluebird bio Opens Gene and Cell Therapy Mfg. Facility

bluebird bio has opened its first wholly owned manufacturing facility in Durham, NC that will produce lentiviral vector for the company’s investigational gene and cell therapies, including: bb2121 and bb21217 for the treatment of multiple myeloma and potentially LentiGlobin for the treatment of transfusion-dependent β-thalassemia (TDT) and sickle cell disease.

Gov. Roy Cooper, Secretary of Commerce Tony Copeland and local patient advocates will join chief bluebird Nick Leschly in a ribbon cutting ceremony at the 125,000-square-foot facility. Currently, bluebird employs approximately 50 scientists, engineers, manufacturing and operations personnel at the facility and is on track to grow to approximately 70 employees by the end of 2019.

“At bluebird bio, we view every aspect of our path to helping patients as both a privilege and a responsibility. This includes the expertise that we’ve poured into the construction and operation of our manufacturing facility, because it is a crucial step toward our mission of bringing a new generation of treatments to people living with severe genetic diseases and cancer,” said Mr. Leschly. “Our teams in North Carolina and across the globe are working to deliver treatments that will make a big difference for a lot of patients and families. This is what drives our ambition to bring four gene therapies forward in the next few years.”

Governor Cooper said, “North Carolina is proud to bring bluebird bio’s cutting-edge work to Durham. bluebird is developing treatments for devastating diseases that could change the course of medicine. And, with the Triangle’s highly-skilled workforce, it will continue to be a leader in the biotech field.”

bluebird bio purchased the facility in November 2017. Once completed, the company will have invested more than $80 million building a world class site equipped with multiple manufacturing suites capable of producing lentiviral vector (LVV). The facility also includes warehouse and quality control testing laboratories. The facility construction is substantially complete and equipment qualification is underway. Initially, bluebird bio expects the facility to produce clinical and commercial supply of lentiviral vector, which is a critical component of the company’s gene and cell therapies. The facility is large enough to accommodate significant future expansion, including the possibility of manufacturing commercial drug product.

In addition to the Durham facility, bluebird bio also has multi-year agreements with three manufacturing partners in the United States and Europe: Brammer Bio (Cambridge, MA), Novasep (Gosselies, Belgium) and MilliporeSigma, the Life Science business of Merck KGaA (Carlsbad, CA). Each of these partners is collaborating with bluebird bio on production of lentiviral vector across all programs. bluebird bio also partners with Lonza (Houston, TX) and apceth Biopharma (Munich, Germany) to produce drug product for Lenti-D and LentiGlobin.

Riverside Research Presents The Mini-Open Innovation Center at STEM Symposium

As a not-for-profit serving the defense and intelligence communities, Riverside Research is invested in developing the next generation of great scientists and engineers. The organization is the presenting sponsor of this year's WashingtonExec's STEM Symposium, bringing several hands-on demonstrations in hopes of sparking curiosity to young students.

"The future of our nation relies on the students who are in school today," says Riverside Research President and CEO, Dr. Steve Omick. "For both our company and our nation, it's so important to nurture curiosity in STEM education at a young age."

Riverside Research operates a series of laboratories called the Open Innovation Center (OIC). Researchers within these high-tech labs perform applied research in the areas of artificial intelligence and machine learning, plasma physics, optics and photonics, and radar engineering. Recognizing the OIC as a model for how STEM education translates to careers that support our national interest, Riverside Research has developed a mini-OIC to educate students on real-world applications of the STEM topics they're learning in school. The mini-OIC is open for business at the STEM Symposium at the Nysmith School for the Gifted in Herndon, VA, on 30 March.

Within the mini-OIC, students will have the opportunity to participate in hands-on demonstrations on artificial intelligence, plasma physics, optics, and radar engineering. Students will also be able to talk one-on-one with scientists and engineers who have built careers from their STEM educations.

Hands-on demonstration topics:

Artificial intelligence: By dancing a few moves from popular kids' dances, students will learn how AI systems track and recognize movement.

Machine learning: Students will trace a digit (1-9) in the air using their hand. A machine learning algorithm will process the video and display the number drawn, demonstrating cutting-edge machine learning research.

Radar: The organization's radar engineers are bringing a working radar to demonstrate how waves are used to track an object's position and speed. Students will have the chance to move in front of the radar, which will recognize the student's movement and speed.

Optics: Using a miniature model of the earth and moon in space, students will use lasers to deliver a message from earth to a satellite and back again. This puzzle demonstrates the capabilities of optical communications.

Plasma physics: Investigating a small plasma globe, students will learn about the fourth and most prevalent state of matter. Experimenting with a disconnected fluorescent lamp, they'll learn about electromagnetics as the lamp lights up, or ionizes, within the electric field generated by the plasma globe. They will learn how plasma conducts electricity and responds to outside influence.

The mini-OIC is also supported by two non-profits. The United States Geospatial Intelligence Foundation (USGIF) joins the mini-OIC to provide a hands-on activity in which students will learn about satellites and get to build their own. The satellite they build at USGIF's station unlocks a special learning curriculum at all of the other demonstration stations in the mini-OIC, through which students will learn how artificial intelligence, machine learning, optics, and plasma all support the operation of satellites. CyberPatriot is joining the mini-OIC to teach important cyber security principles. Students who complete the CyberPatriot activities will earn their cape as a cyber hero.

The STEM Symposium is one of the National Capital Region's largest STEM events. It is open to all and is free to attend. For more information, visit STEMsymposium.com.

About Riverside Research:

Riverside Research is a not-for-profit organization chartered to advance scientific research for the benefit of the US government and in the public interest. Through the company's open innovation concept, they invest in multi-disciplinary research and development and encourage collaboration to accelerate innovation and advance science. Riverside Research conducts independent research in machine learning, trusted and resilient systems, optics and photonics, electromagnetics, plasma physics, and biomedical engineering.

Pall Agrees to Develop New Jersey Cell and Gene Therapy Sites

Pall Biotech signs an industry participation agreement with the New Jersey Innovation Institute to create two centers designed to develop and manufacture cell and gene therapies.

The New Jersey-based centers will be the Cell and Gene Therapy Development Center and the Center of Advanced Biologic Manufacturing, which will be utilized to progress the manufacture of new cell and gene therapies.

According to the New Jersey Innovation Institute (NJII), the Cell and Gene Therapy Development Center will focus on how to integrate newly created process technologies and how the workforce works with such equipment. Specifically, the center will look to find manufacturing solutions for the next generation of cell-based immunotherapies.

Complementing this approach will be the Center of Advanced Biologic Manufacturing that will be utilized to address issues of the mass production of such therapies. The center will attempt to find solutions to the ongoing viral vector shortage in the industry by developing its own solutions, as well as looking into continuous bioprocessing.

“If we're going to tackle the industry's productivity challenges, we need to think smart and invest in finding innovative manufacturing solutions, for example through continuous bioprocessing. NJII is doing remarkable work in this area and we're very excited to partner with them on this innovative program,” explained Peter Levison, Pall's executive director business development.

The state of New Jersey has seen increased investment from the biopharma industry during recent years. Notably, Teva decided to relocate its US headquarters to the state, after New Jersey’s economic development authority offered tax savings of $40m (€34m) in return.

On the biologics side of investment, a number of companies have invested in the state recently to house their manufacturing facilities; Oncobiologics constructed a commercial manufacturing site for the commercialization of monoclonal antibody biosimilars recently, and Hitachi Chemical expanded its cell therapy manufacturing site in the state.

STC Biologics’ GMP Manufacturing Facility, Massachusetts

In April 2019, STC Biologics opened a single-use mammalian good manufacturing practices (GMP) facility in Newton, Massachusetts, US.

The new facility features advanced disposable equipment.

The company has successfully completed a production run at the plant for its first master cell banking (MCB) and three GMP drug products.

Newton was chosen as a location for the facility due to its proximity to the biotechnology hub in Cambridge, Massachusetts.

This hub houses more than 400 biotechnology companies and has access to various incentives, including economic development programs, investments and tax benefits for infrastructure, construction, equipment, research and development (R&D), and workforce training.

STC Biologics’ new manufacturing facility features advanced equipment, including the Thermo Scientific’s Finesse™ bioreactor controller, the HyPerforma™ single-use bioreactor, and GE’s ÄKTA™ Ready purification system.

The facility will use the company’s Speed-To-Clinic Platform™ to produce monoclonal antibodies (mAb). The platform accelerates the procedure from royalty-free cell lines to current GMP manufacturing to patients within one year.

The Speed-To-Clinic Platform provides accelerated low-cost programs and personalized development opportunity to the company’s clients while reducing product development timelines.

The Finesse bioreactor controller combines Finesse’s hardware and software for high-configurability and scalability. It utilizes the SmartLab™ data management software to automate any generated data. The data is collected and organized at one place for better control and monitoring of the process.

The controller also harnesses TrueBio® DV software, an open, fully-configurable program that is based on the Emerson Process Management’s DeltaV® control platform. The software improves the bioreactor controls by using good automated manufacturing practice (GAMP) methods.

The migration feature of the controller allows for easy upgradation of the existing facility with the new Finesse bioreactor controller from laboratory scale to GMP settings.

The HyPerforma™ 500l is a single-use bioreactor that is expandable up to 1,000l. It features a mixed platform design for both upstream and downstream applications.

The bioreactor has non-jacket or water-jacket vessels with an external temperature control unit. The bottom of the reactor is conical in shape for improved drainage and reduced hold-up volume.

The bioreactor’s touchscreen user interface is integrated with sensor monitor, automated mixing recipes and pump controls. The open cart frame makes cleaning easier.

In addition, the bioreactor features a cable management system, adjustable powder hanger, two swivel-locking casters and lush handles.

ÄKTA™ Ready is a biocompatible liquid chromatography system belonging to GE’s ReadyToProcess platform. The system is driven by UNICORN™ software and offers easy, ready-to-use solutions for bioprocessing.

The system eliminates the need for cleaning between batches, risk of cross-contamination, and development and validation procedures for cleaning.

Marketing commentary on STC Biologics:

Founded in 2009, STC Biologics is a contract development and manufacturing organization (CDMO) based in the US. It is experienced in drug development in the fields of oncology, immune diseases and infectious diseases.

The company offers complete chemistry, manufacturing and controls (CMC) services, and consultation to clients for advanced biologics development through all stages of product development.

The company has filed eight biologics license applications (BLAs), 20 comparability protocols, and dozens of investigational new drug (IND) applications and has five approved biologics.

STC Biologics enables clients to discuss projects with scientists and view data in real-time. The company also operates a GMP testing facility, which was opened in March 2016.

Takeda Opens New Drug Research Facility in California

Takeda Pharmaceutical has built on its 14-year presence in San Diego, opening a new 165,000 soft research facility. The plant 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.

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. This new center complements the company’s global R&D center in Cambridge, Massachusetts and another global research site in Shonan, Japan. The 165,000 sq. ft. facility will play an important role in connecting research collaborators from a local to a global scale.

Steve Hitchcock, Head of Research at Takeda, said: “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.”

Hitchcock added: “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.

In the last three years, Takeda, through its venture group, has committed US$35 million to Southern California startup companies, underscoring its commitment to the active life sciences cluster in the San Diego and broader California area.

Alector Chooses Lonza Platform for Manufacturing Scale-Up

The companies have extended collaboration beyond the early phases to include using the Ibex Solutions platform for neurodegenerative disease drug candidates

Alector and Lonza have penned an agreement to secure manufacturing capacity for two of Alector’s drug candidates currently in Phase 1 development for neurodegenerative diseases. The California-based biotech has chosen the Swiss corporation’s Ibex Solutions to ensure drug supply and accelerate market-readiness.

The two companies have been working together since 2016 on the early phases of development for Alector’s lead candidates. Based on the potential product needs of these candidates, Lonza’s GS Xceed Gene Expression System was used to create high-producing cell lines.

The programs have also included clinical manufacturing of drug substance and drug product across the Lonza network. Alector is now looking to secure supply for current and future trials with the ability to scale up rapidly.

Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing at Lonza, said: "With biotech customers like Alector who want to commercialize their drug candidate, we offer a rapid and simplified path to transition from clinical to launch which allows them to focus on bringing their therapies to patients.”

The Ibex Develop offering in Visp, Switzerland helps companies rapidly transition from clinical phase II to commercialization. This was a compelling choice for Alector, who was looking for a simplified tech transfer from Lonza’s clinical assets in Slough (UK) and Hayward, CA (US) into a scalable solution with clinical and commercial production under the same roof.

Under the agreement, Alector will have the flexibility to move molecules from their pipeline in and out of production as needed, to match the pace of their clinical trials and assure the quantities required are available.

Ibex Develop is based on flexible single-use technology that allows management of forecast volatility and scale-up or -out within the same facility or in the wider Lonza network.

In addition, Alector will be able to leverage Lonza’s experience in expedited regulatory pathways and in bringing biologics successfully through BLA submissions as well as the option of drug substance and drug product manufacturing under one roof.

The Visp, CH facility, from which Ibex Solutions is offered, will be operational from 2020 onward, with the planned start of operations for Alector in Q3 2020.

Neopac Opening its First US Facility

Packaging provider Hoffmann Neopac has joined the Tube Council of North America as Neopac US Inc. With a range of tube solutions, Swiss-based Neopac’s new membership comes in time with the opening of its first US facility in Wilson, North Carolina.

A formal ribbon-cutting ceremony took place in May to mark the facility’s launch; Neopac executives will be in attendance for interviews, and VIPs and media will have access to site tours.

Neopac’s 37,000 sq. ft. Wilson plant will feature a high-speed tube line and contain floor space for several additional packaging lines. In total, the facility can support the production of some 80 million tubes annually.

Such capabilities position Neopac to best serve the needs of the US market in a twofold capacity: in the small tubes niche, especially in the pharma, cosmetics and animal health sectors, and also for emerging applications such as cannabis-based creams and liquids.

A wide range of small-diameter tubes will be produced at the North Carolina plant utilizing the company’s signature Polyfoil technology. Polyfoil is a proprietary blend of materials providing advanced barrier properties for products requiring ample protection against moisture, oxygen and other potentially harmful external factors.

Products housed in Polyfoil solutions can enjoy a longer shelf life compared to those stored in conventional polyethylene (PE) or polypropylene (PP) packaging.

The Tube Council of North America is a non-profit organization dedicated to providing educational resources and networking opportunities to professionals in the tube industry.

Martina Christiansen, Head of Sales and Marketing Pharma of Hoffmann Neopac, said: “Membership on the Tube Council solidifies Neopac’s growing global presence and continued leadership as a tube manufacturer.”

Steven Canfield, Executive Secretary & Treasurer of The Tube Council of North America, said: “Considering Neopac’s exemplary reputation abroad, we’re confident that the new US facility will be a tremendous addition to the manufacturing landscape on this side of the Atlantic.”

The company has not just been active in the US, it has also recently taken a majority stake in 3D Technopack, from Mumbai, India, thereby securing its foothold in the Asian market.

Precigen Opens Cell and Gene Therapy Facility in Maryland

Precigen has officially opened its new manufacturing facility near the company's headquarters in Maryland. Precigen commenced the build-out of the nearly 5,000 sq. ft. manufacturing facility in 2018 to support gene therapy manufacturing. The GMP facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early-stage clinical trial needs.

The new facility adds to Precigen's existing footprint in Germantown, Maryland, which supports more than 95 employees. To mark the official opening, the company held a ribbon cutting ceremony attended by elected officials and local community members

Dr Schlom is the principal investigator of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute and Precigen. Under this CRADA, the National Cancer Institute and Precigen are collaborating to evaluate Precigen's proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.

"Precigen needs to be agile and cost-conscious in our early-stage clinical manufacturing. In today's drug development environment, it's important to reduce a myriad of risks that can impact manufacturing such as technology transfer risks when outsourcing to CDMOs as well as process and timing risks," said Dr Sabzevari, CEO of parent company Intrexon. "This facility puts Precigen in control of our gene therapy manufacturing needs."

The facility includes ISO 7 cleanroom suites that will be utilized to manufacture gene therapy vectors, such as adenoviral vectors, including AdenoVerse vaccines and AdenoVerse cytokine therapies, as well as cell banks for early-stage gene therapy trials.

Due to the flexible design, other types of cell-based biopharmaceutical products can also be manufactured in the facility. Additionally, the facility includes a GMP quality control laboratory that supports lot release and stability testing.

Precigen's multimodal manufacturing strategy increases patient access through shortening manufacturing times using both centralized and decentralized manufacturing processes.

This new state-of-the-art facility supports the company's centralized manufacturing capacity needs for gene therapy vector production, initially centered around viral vectors, used in early-stage clinical trials.

Precigen's decentralized manufacturing will be utilized for UltraCAR-T clinical trials and will occur at clinical centers through its non-viral gene transfer rapid manufacturing process. Rapid manufacturing of UltraCAR-T cells using proprietary non-viral gene transfer process eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to less than two days.

Catalent’s Biologics Manufacturing Facility Expansion

Catalent announced plans to expand its biologics manufacturing facility in Bloomington, Indiana, US.

With an estimated investment of more than $114m, the project is part of a $200m investment program me launched in January 2019 to expand the company’s drug substance manufacturing and product fill / finish capacity.

The $200m investment will be phased over three years and used for the expansion of Catalent’s biologics facility in Madison and the site in Bloomington, US.

The expansion will help the company meet the requirements of clinical and commercial customers, as well as gain the necessary flexibility to address future market demand.

The first project under the investment program me includes the construction of a packaging facility at the Bloomington site with an investment of $14m. It will expand Catalent’s biologics packaging capabilities and is expected to generate 36 new jobs. The company plans to generate approximately 200 new vacancies by 2024.

The construction of the packaging facility is scheduled for completion in April 2019.

Catalent’s biologics manufacturing facility is located in Bloomington city in Indiana, US.

Indiana holds the second position in life sciences products export in the US. The business-friendly environment created by the state and local government of Indiana and the availability of a skilled workforce helps biotech companies to remain competitive in the global market.

Catalent is constructing a 15,000ft² facility at the Bloomington site, which will feature five new packaging suites and a quality control laboratory.

The project will be installed with semi and fully automated top-loading cartonning machines, a combination syringe assembly line with accessories, and two semi-automatic visual inspection machines.

The new facility will enable Catalent to offer improved and automated packaging services to its customers.

The fill / finish capacity of the existing Bloomington site will be expanded by 79,000ft² to include both good manufacturing practices (GMP) and non-GMP capabilities.

The expanded facility will be equipped with a high-speed flexible vial line, which will use both ready-to-use components and bulk filling. The filling speed of the vial line will be 300 units per minute.

A high-speed flexible syringe/cartridge line and a fully-automated vial inspection machine will also be installed at the facility. The cartridge line will be capable of producing 300 units per minute.

The Indiana Economic Development Corporation (IEDC) has proposed to provide up to $2.4m to Catalent as conditional tax credits depending upon the company’s job creation strategy.

The Bloomington city may also provide additional incentives to the company based on recommendations by the Bloomington Economic Development Corporation.

Spanning 875,000ft², the existing Bloomington biologics manufacturing facility uses both stainless steel and single-use technologies.

The facility features a 50l single-use stirred, 20l-2,500l stainless-steel bioreactors and a Delta V control system. It provides a comprehensive model for process and formulation development, drug substance biomanufacturing, fill / finish, packaging, and clinical supply services. It also recently received regulatory approval for a 20th commercial product.

Marketing commentary on Catalent:

Based in the US, Catalent is a provider of advanced technologies and solutions for drugs and biologics development.

The company operates more than 30 facilities located across the Asia Pacific, Europe, Latin America and North America. It employs approximately 11,000 people, out of which 900 are employed at the Bloomington site.

Catalent Invests $40 Million at Kentucky Manufacturing Facility

Catalent announced on April 29, 2019 that it is investing up to $40 million at its manufacturing facility in Winchester, KY. The investment will include new equipment that will increase the site's formulation and controlled-release tablet and capsule manufacturing capabilities and capacity.

Other equipment included in the investment are a laser drill for osmotic drug delivery, stick-pack dosage manufacturing capabilities, and roller compaction and fluid bed capacity. Additionally, a spray dryer will be installed that will provide commercial scale-up capacity for projects starting at early stage development and will allow projects to be tech transferred from the company's development sites, including San Diego, CA, and Nottingham, United Kingdom, to client facilities. The spray dryer is used to create amorphous solid dispersions and to overcome formulation challenges posed by poorly soluble drugs.

In addition, an automated bottling line will be installed. Validations for the new equipment are expected to be completed in the coming months, according to Catalent. In 2015, the site also underwent a $35 million facility investment that doubled its footprint to 180,000 ft2.

"Our Winchester facility provides customers with a high degree of flexible manufacturing solutions and has a proven track record of success with technology transfers and product launches," commented Rick Tucker, general manager, Catalent Winchester, in a company press release. "We have a clear investment strategy at the site that is not only driven by immediate customer needs, but also looks to the future in anticipation of demand and new technologies."

This current investment is the latest in a series of recent investments by Catalent. In April 2019, the company announced a $14 million expansion to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany, and a $5-million investment to expand its OptiMelt hot melt extrusion capabilities at its Somerset, NJ, drug development center. Additionally, in March 2019, the company revealed an investment of more than $27 million to commercialize Zydis Ultra, its fast-dissolving tablet formulation technology that incorporates increased drug load with taste masking into its Zydis oral disintegrating tablet, a freeze-dried tablet that disperses in the mouth without water.

GSK To Expand Long-Term Vaccine Manufacturing Capabilities In Hamilton, MT

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.

Kite Plans for New Facility to Expand Cell Therapy Production

Kite, a Gilead Company, announced plans for a new facility in Frederick County, Maryland, which will produce innovative cell therapies for people with cancer. The 20-acre site will significantly expand Kite’s ability to manufacture a variety of chimeric antigen receptor T (CAR T) therapies, including Yescarta® (axicabtagene ciloleucel), Kite’s first commercially available CAR T cancer therapy, and investigational T cell receptor (TCR) cell therapies being evaluated in solid tumors.

“This new facility in Frederick County builds on our substantial technical capabilities and rapid progress in making personalized CAR T and TCR cell therapies for people with cancer. As we advance our industry-leading cell therapy pipeline and seek to help a growing number of people with cancer, expanding and investing in our manufacturing capabilities is essential,” said Tim Moore, Executive Vice President of Technical Operations at Kite. “With the Frederick County site, we will have the opportunity to build and design the facility tailored to our own innovative processes and with state-of-the-art features that will enable us to meet the future needs for cell therapies.”

CAR T therapies require many complex and carefully controlled, multi-step processes. The Frederick County facility will become part of Kite’s growing commercial manufacturing network that includes sites in California and the Netherlands.

About Kite:

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.

About Gilead Sciences:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Pfizer Opens New Biologics Clinical Manufacturing Facility

Pfizer Inc. announced the opening of a new 175,000 square-foot manufacturing facility in Andover, Mass. Pfizer’s Andover site houses commercial manufacturing and product development functions, with colleagues dedicated to the development and production of high-quality complex biologics and vaccines. With its modular and flexible design, the newly opened Andover Clinical Manufacturing Facility (ACMF) will expand the capacity for Pfizer’s BioTherapeutics Pharmaceutical Sciences organization to manufacture clinical supplies.

“We are excited to expand our presence in Andover with a state-of-the-art facility that is designed to provide clinical manufacturing options in a cost efficient and flexible manner to help further accelerate important treatments to patients,” said Mikael Dolsten, M.D., Ph.D., Pfizer Chief Scientific Officer and President, Worldwide Research, Development, and Medical. “We aim to increase connectivity between our research and in-house manufacturing efforts to better inform the process, ensure quality assurance, and ultimately improve patient access to potentially life-changing treatments.”

Pfizer’s ACMF investment is over $200 million and includes five independent manufacturing suites to advance Pfizer’s robust pipeline of potential new biotherapeutics and vaccines, with more than 50 projects in development. The site will provide 75 new jobs for the Andover area economy, adding to the approximately 2,000 colleagues currently based in Massachusetts. It will bring together talent with specialized expertise to manufacture high-quality clinical supplies to support trials in disease areas including oncology, rare diseases, infectious diseases, hemophilia, and rheumatoid arthritis.

“Massachusetts is a global hub for innovation and research, and our Administration is proud to have supported the expansion of one of the world’s premier biopharmaceutical companies right here in the Commonwealth,” said Massachusetts Governor Charlie Baker. “Pfizer’s expansion in Andover, combined with current operations in Boston and Cambridge, is a testament to the strength of this important sector of the Commonwealth’s economy, and Pfizer’s commitment to Massachusetts.”

Pfizer’s Andover campus currently includes 7 buildings, which house laboratories, clinical and commercial manufacturing suites, and support areas. The new ACMF is a multiproduct manufacturing facility with a flexible design that allows clinical products to be manufactured more efficiently and fully enable next-generation manufacturing technologies.

“This new facility builds on a strong partnership between our Research and Development and Manufacturing teams, which is especially evident in Andover,” said Mike McDermott, President, Pfizer Global Supply. “By bringing together colleagues who play a critical role in every step of the process — from discovery through development and manufacture — we can help speed the availability of medicines to patients. Manufacturing medicines for clinical trials in these critical disease areas inspires and challenges us to bring our very best to our work and our patients every day.”

Sharp Facility Investment

Sharp invests $21m to meet growing demand by expanding its capacity for packaging services at its Allentown, PA campus.

Additions to the site from the investment, which included funding from an undisclosed client, will include the installation of vial labelers and vaporized hydrogen peroxide cold sterilization systems.

A spokesperson for Sharp said that the company has seen increased demand for its packaging services but noted that there has been a specific interest from the biotech sector, as it has grown in recent years.

“In expanding capacity and adding capabilities at Allentown, we are future-proofing our business in line with these [increased packaging] trends and to ensure we can meet anticipated demand in the coming years,” said the spokesperson.

Sharp’s Allentown campus opened as the company’s injectables center of excellence in April 2016. The site development doubled the site’s capacity for pre-filled syringe, autoinjector, and pen assembly, as well as its cold storage capacity.

Over recent years, the company has invested approximately $11m (€9.86m) in its clinical services center of excellence in Wales, and an additional $11m was spent on bolstering its injectable and cold chain capabilities in the US, Belgium, and the Netherlands.

It also recently refitted its facility in Bethlehem, Pennsylvania, as a result of a $23m investment.

The spokesperson said that over recent years Sharp has spent over $60m in total, globally, to increase capacity and add clinical and commercial packaging capabilities to meet demand.

“Over the same time, we've developed a deep cross-functional expertise in the challenges of packaging biotech products, notably in the design, kitting, assembly, labeling and packaging of injectables. We want our biotech center of excellence in Allentown to continue to deliver – indeed to set the standard – for these kinds of contract services,” the spokesperson added.

The company has also made changes to its operational structure by establishing four different packaging centers of excellence at the Allentown campus.

Merck Expands Virginia Site to Support HPV Vaccines

Merck & Co. will invest $1 billion over the next three years to increase production of its human papillomavirus (HPV) vaccine Gardasil at its Rockingham County site.

Charlie McCurdy, a spokesperson for Merck & Co., confirmed his firm has committed to expand the Elkton facility in Rockingham County, Virginia facility to meet global demand for its HPV vaccines Gardasil and Gardasil 9.

The $1 billion (€900 million) investment will be spread over the next three years to add an extra 120,000 square-feet of production space to the 1.1 million square-foot site. Around 100 jobs will be created.

“This record investment in Rockingham County is a symbol of Merck’s strong commitment to the Shenandoah Valley and will support further economic growth in the region,” said Ralph Northam, governor of Virginia. “Merck has long been a valued employer and important corporate steward in Virginia that continues to play a vital role in advancing the 21st-century manufacturing sector in our Commonwealth.”

Demand for Gardasil and Gardasil 9 continues to rise, with sales of the HPV vaccine jumping 31% year-on-year in the first quarter of this year, pulling in sales of $838 million.

“Ex-US demand remains particularly robust with continued strong uptake in China following the GARDASIL 9 launch last May and increased gender-neutral vaccination in Europe,” Robert Davis, Merck’s CFO, said in a conference call discussing the quarter last week. The product saw a slight decline in the US, attributed to the “timing of public sector purchases, which will more than offset underlying demand.”

The investment comes six months after the firm announced it intends to spend $16 billion across its manufacturing network through 2022.

At the time, management highlighted Gardasil as a key area for expansion, with Adam Schechter, Merck’s president of Global Human Health, telling investors: “We really are seeing unprecedented increase in worldwide demand for the HPV vaccines.”

Specifically, Schechter cited changing policies in countries supported by Gavi, an international organization aimed at improving access to new and underused vaccines for children living in the world’s poorest countries, as driving demand.

Mispro Expands Vivarium Capacity

Mispro is expanding its vivarium service network with the opening of its fifth facility, an 18,000 square foot facility in Broad Hollow Bioscience Park, NY.

The preclinical biotech services company provides vivarium operations and services through its network of facilities outside of New York, in Cambridge, MA, Research Triangle Park, NC, and Montreal, Canada – all of which Mispro said are ‘key biotech and life science clusters.’

This new facility 18,000 square foot facility in Broad Hollow Bioscience Park, NY will be the company’s second in the state after it opened a facility in Manhattan in 2010.

Providing vivarium operations, the company supports clients with access to research and animal housing space as well as animal care, regulatory, and compliance services.

Philippe Lamarre, CEO of Mispro Biotech Services, said in a statement that within 25 miles of the facility there are established biopharma organizations and incubators, as well as a growing amount of early-stage biotechs. Farmingdale, New York, home to Broad Hollow Bioscience park is around 40 miles East of Manhattan.

Lamarre said that with the new facility the company has the opportunity to provide space to the surrounding research community as well as companies headquartered in New York city that need more space or are getting priced out.

“At our very best, we are a catalyst for early-stage companies, enabling them to launch and control their own studies relative to their funding, which we believe will produce increased innovation in therapeutic drug development,” said LaMarre. He added that Mispro is currently seeing ‘tremendous potential’ in its ability to serve the industry.

The company also has plans to expand into Europe in later 2019 and early 2020.

Bayer Chooses Fluor and GE Healthcare for New Cell Culture Technology Centre

Bayer will invest US$150 million in new California facility expected to be ready for clinical production in late 2021

Bayer has announced that the company will invest US$150 million in its Berkeley pharmaceutical development and manufacturing campus in California, US. The project will see the construction of a Cell Culture Technology Center that will be used to accelerate the development of biological therapies.

Once complete, the new facility will support Bayer's growing portfolio in biologics to serve multiple patient populations.

"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.

Carius added: "We are especially proud to bring this investment to Berkeley, where Bayer has been for many years, and to the greater San Francisco Bay Area, the birthplace of biotechnology and a global epicenter of drug development innovation."

The new Cell Culture Technology Center will be built on Bayer's existing Berkeley campus, home to its recombinant Factor VIII manufacturing center that produces hemophilia A treatments for patients in nearly 80 countries around the world.

The new 40,000 sq. ft. 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.

"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."

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

"Fighting cancer on all fronts requires fast and scalable innovation, as well as solutions based on digital insights," said Emmanuel Ligner, President and CEO of GE Healthcare Life Sciences.

Ligner added: 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."

Bayer has established innovation hubs in scientific hotspots around the globe to advance its focus on excellence in research, development, and groundbreaking technologies.

One of the largest biotech employers in the Bay Area, Bayer's presence on the US West Coast includes a pharmaceutical development and manufacturing facility in Berkeley and the Innovation Center in San Francisco, home to the first CoLaborator, an incubator for life science startups.

Teva Seals Deal for NJ HQ

The Israeli drugmaker and NJ Governor Murphy formalize North America headquarters move with ceremony in Israel

Teva Pharmaceuticals executives Kåre Schultz and Brendan O’Grady, alongside State of New Jersey Governor, Phil Murphy, formalized Teva’s commitment to consolidate its North America Commercial business areas into New Jersey at the company’s global headquarters in Petach Tikva, Israel.

Announced earlier this year as part of a global restructuring process, Teva will establish its North America headquarters in Parsippany-Troy Hills, including more than 1,000 high-wage jobs and the transfer and creation of more than 800 positions. Teva accepted an offer of 10-year, $40 million tax savings incentives from the NJ Economic Development Authority to move forward with its plan to negotiate a lease for office space in the Parsippany-Troy Hills area.

“We’re entering into a new era of innovation and growth as a leading global generics and biopharmaceuticals company,” said Brendan O’Grady, executive vice president and head of North America Commercial, Teva. “New Jersey offers Teva North America a value proposition of a unique biopharma cluster of universities and life sciences organizations in which Teva can build its future in North America—and today’s event is an important recognition of this milestone.”

This ceremony marks another step forward in Teva’s global restructuring efforts to drive savings, restore financial security and stabilize its business. Reducing the number of sites is part of Teva’s strategy to unify and simplify the organization, as well as improve productivity and efficiencies.

“We’re pleased to honor Teva today in recognition of its long-time partnership and commitment to innovation in New Jersey,” said Governor Murphy. “The presence of global life sciences companies like Teva is critical to our ability to strengthen our prosperous innovation ecosystem. We’re excited to welcome Teva to the Garden State—the location to be for the world’s most competitive life sciences companies.”

Velesco Doubles cGMP Analytical Lab Space with Facility Purchase

Velesco Pharma has expanded its analytical research and development capabilities to meet a growing demand for its services after acquiring a new facility in Michigan.

With this acquisition, Velesco has doubled its formulation and analytical lab space. The development and clinical manufacturing company said the expansion will allow the company to maintain its rate of growth that it has experienced in recent years.

Gerry Cox, Velesco chief operating officer, said, “Velesco Pharma has experienced increased demand for our analytical and formulation services in recent years and the time has come to create the capacity commensurate with this demand.”

Cox said the expansion will allow sponsors to advance new medicines into the clinic faster.

“Our new building in Wixom, MI was acquired earlier this year. The fit-out is nearing completion and our laboratory staff will be relocated to the expanded space prior to the end of the year,” said Cox.

According to a statement by Velesco’s CEO Dave Barnes, the company will be increasing its scientific team after this acquisition. The expansion will allow the company to meet the growing demand for formulation and analytical services.

The company will continue to offer research and current good manufacturing practice (cGMP) services during its move to the new laboratory. These services include formulation development, analytical method development and validation, release and stability testing, and clinical manufacturing.

UCSD Jacobs Medical Center

A new version of health care is being delivered at Jacobs Medical Center, a gleaming 509,000-square-foot, 245-bed medical and surgical specialty hospital in the University of California San Diego Health System. There, patients are in control: They can securely review their treatment schedules on tablet computers, adjust the room temperature and lighting, or adjust their “smart” bed to get a better view of the surrounding hills and ocean.

This “patient first” approach was the inspiration for the hospital’s design. With an objective to establish a healing, relaxing environment, architectural firm CannonDesign specified transparent solar control low-emissivity (low-e) Solarban® 70XL glass on Starphire Ultra-Clear® glass by Vitro Glass to provide abundant natural daylight and minimize glare and outside noise.

Although it met performance requirements, the glass specification had to be adjusted to achieve another design objective. That required close collaboration between Vitro Glass and Northwestern Industries, Inc. (NWI), a Vitro Certified™ fabricator.

“The architect wanted the building to have a whitish exterior look,” explained Frank Forgione of NWI. “We worked with Vitro testing various glass samples and mock-ups that could meet this requirement and still maintain the desired performance. Ultimately, we put a customized silk-screened white frit on Starphire Ultra-Clear® glass, which we laminated on Solarban® 70XL glass.”

This configuration was used extensively, including the floor-to-ceiling windows in all patient rooms; the front-glazed, unitized curtain wall system; and spandrel shadow-box glazing. More than 100,000 square-feet of glass was installed.

To handle this high volume and facilitate the timely shipment of glass orders to ENCLOS, the glazing contractor, NWI used the Vitro Concierge Program™, which provides logistics management and customized coordination for large projects. By providing priority access to the glass, the Vitro Concierge Program™ helped to ensure the project stayed on schedule. “We worked closely with ENCLOS to meet their scheduling requirements, and worked through the Concierge Program, which allowed us to stay on top of everything,” said Forgione.

Other amenities were incorporated to ensure convenience and comfort. Patient rooms were designed as private suites furnished with smart beds oriented for panoramic views of La Jolla and equipped with tablet computers that patients can use to see their treatment schedules and medical records and control motorized solar shading, lighting and temperature.

Since starting operation in November 2016, Jacobs Medical Center has passed its check-ups with flying colors. Groundbreaking research and education, advanced surgical technologies and a patient-first ethos in an architecturally significant setting have ushered in a new era of health care.

Formulated with the industry’s most advanced triple-silver coating, Solarban® 70XL glass has visible light transmittance (VLT) of 64 percent with a solar heat gain coefficient (SHGC) of 0.27 and a light-to-solar gain (LSG) ratio of 1.85. This high performance, combined with the silk-screened white frit on Starphire Ultra-Clear® glass, helped achieve design objectives and enabled the facility to earn LEED® (Leadership in Energy and Environmental Design) certification at the Silver level.

REST OF WORLD

Medicines Manufacturing Innovation Centre, Renfrewshire

The Centre for Process Innovation (CPI), the University of Strathclyde, Scottish Enterprise, Innovate UK, AstraZeneca and GlaxoSmithKline (GSK) have partnered to open the Medicines Manufacturing Innovation Centre (MMIC) in Renfrewshire, Scotland.

Other pharmaceutical companies in the Medicines Manufacturing Industry Partnership (MMIP) are also involved in the project.

To be developed with an investment of £56m ($72.4m), the new innovation center will allow pharmaceutical companies, research scientists and manufacturing partners to develop and test drug manufacturing technologies that incorporate productive, high-quality, sustainable and cost-effective practices. It will also address the key challenges faced by the pharmaceutical industry.

The project was launched in June 2018 and is currently in its design stage. The project will be completed in three years.

The MMIC will be built in the 52ha Advanced Manufacturing Innovation District Scotland (AMIDS) business park located in Inchinnan village next to Glasgow Airport. The AMIDS facility is a center for research, innovation and advanced manufacturing.

Located adjacent to Lightweight Manufacturing Centre at Westway Business Park and the National Manufacturing Institute for Scotland (NMIS), the facility will support Scotland’s chemical and life sciences sectors.

The AMIDS center offers approximately 1,614,000 sq. ft. (150,000m²) of floor space for life sciences, advanced manufacturing, aviation services, logistics resources and manufacturing solutions.

The MMIC will be equipped with advanced technical equipment and capabilities, which will allow scientists and companies to develop and manufacture small molecule medicines, fine chemicals, drug substances, and drug products in a good manufacturing practices (GMP) environment.

The facility will enable the adoption of next-generation technologies, reduce the quantity of materials used in process development and allow companies to release drugs in real-time, while reducing costs.

The facility will incorporate an array of advanced Industry 4.0 technologies to facilitate evaluation, testing and prototyping of processes through continuous, digital and autonomous manufacturing.

The project will also use continuous manufacturing techniques developed by the Continuous Manufacturing and Crystallisation Centre (CMAC) led by the University of Strathclyde for the development of drugs.

UK Research and Innovation is investing £13m ($16.7m) in the facility through the Industrial Strategy Challenge Fund (ISCF), while Scottish Enterprise is providing £15m ($19.3m). GSK and AstraZeneca are investing £7m ($9m) each.

The remaining investment will be made through revenue generated by funding bids and commercial projects.

Design and engineering firm BakerHicks was awarded a contract by CPI in January 2019 to provide architecture, design, pharmaceutical consultancy, civil and structural, mechanical and electrical, and process engineering to RIBA Stage 3.

The MMIC is expected to create 80 high-value jobs by 2023 and employ 90 people during its design and construction phases. It will also help generate indirect jobs through start-ups, and small, medium and large enterprises.

The facility is expected to draw an investment of £80.5m ($103.8m) in research and development (R&D) by 2028. It will deliver a substantial benefit to the pharmaceutical sector, which is a major contributor to Scotland’s economy.

The center will also strengthen Scotland’s life sciences industry, which is expected to contribute up to £8bn ($10.3bn) to the Scottish economy by 2025.

Flamma Completes Successful CFDA Inspection

Flamma SpA, a contract development and manufacturing organization (CDMO) that develops, manufactures, and commercializes small molecule active pharmaceutical ingredients (APIs) for the pharmaceutical industry, said that Flamma Honkai has passed its first Chinese FDA (CFDA) inspection that took place in December 2018. Part of the Flamma Group, Flamma Honkai is a 100% owned and managed facility in Dalian, China, that is part of Flamma’s fully integrated supply chain.

Flamma Honkai opened its new cGMP workshop in June 2017 to continue to address customer desires for more options when it comes to selecting a CDMO that they can trust especially when working overseas in Asia.

This milestone is part of the Flamma 2020 Plan to bring improvement across its network of manufacturing sites. This certification of the Flamma Honkai facility adds another customer option when working with the Flamma Group.

“This is a strategic and important milestone for Flamma Honkai and Flamma,” said Gian Paolo Negrisoli, president and chief executive officer, Flamma. “The efforts made over the past several years have been exceptional.”

Kenneth Drew, senior director of North America sales and business development, Flamm, said, “Flamma has been listening to its customers and their need to have a trusted supplier in China. Flamma is unique in our industry by having the ability to provide customers manufacturing of APIs, RSMs, and advanced intermediates from both Europe and China while being led by one management team. Also, with all the consolidation of the CMO industry, being a family owned, privately held and managed company still brings significant value to our customers. Having that long-term vision continues to differentiate Flamma from other CMOs and CDMOs.”

The Flamma Honkai site comprises two production workshops, supported by a pilot plant, kilo-scale plant and development and analytical laboratories.

Stem Cell Medicine Receives Israeli Funding for Gene Therapy Facility

Stem Cell Medicine has received funding from the Israeli Ministry of the Economy to build a gene therapy facility. The new facility will enable SCM to manufacture gene therapy products for commercial launches, benefiting from the favorable global regulatory and marketing environment for its products. The first gene therapy product under development at SCM is for the treatment of neuropathic pain.

The plant will be built in Jerusalem, a Zone A region, allowing tax and grant benefits, in an investment of over 20 million NIS (approximately $5.5 million), of which 20% will be covered by the grant. The new production facility will make available production space in SCM's existing GMP approved facility for production of exosomes from stem cell for collaboration with large biopharma companies.

"We are pleased that the government of Israel recognizes our unique contribution to the development of new therapies. SCM is advancing its gene therapy portfolio at a time of major global investment and value creation in gene therapy, as evidenced by both capital investments and M&A activity,” Ehud Marom, SCM's Chairman, said. “There is, however, a global bottleneck in GMP approved labs and production facilities for gene therapy and our goal is to help address this with this new investment. The new facility will enable us to further integrate our capabilities, adding gene delivery vehicles for genetic modification for human use. SCM is currently raising $30 million in a pre-IPO round, which we expect to be followed by an IPO in the next few years. We are expecting our first cell-based product, for cosmetic uses, to be on the market this year."

Ajinomoto Bio-Pharma Services Expands

Ajinomoto Bio-Pharma Services, a global provider of bio-pharmaceutical contract development and manufacturing, is expanding its capabilities and capacities. The company has several capital projects currently underway in both the U.S. and Belgium, investing more than $100 million to further expand its offerings and capabilities. In addition to the previously announced highly potent product conjugation and fully isolated fill line, which has recently began operations in its new facility in San Diego, the company is also adding a new fully isolated, nested flexible fill line, installing automated packaging and labeling equipment, and upgrading its continuous flow and small molecule API manufacturing capabilities.

Updates include:

The Optima 7000 fill line and upgraded aseptic fill suite have been released for client aseptic filling operations (2ml to 100 ml vials).
The HPP/ADC fill line (Isolator system) is scheduled to complete its validation activities, and be released for GMP use during the first half of 2019.
A nested flexible fill line will support a broad range of drug substance APIs, increasing capacity by 50%, enabling larger batch size and a broader range of aseptic filling volumes for vials, syringes and cartridges.
The addition of the automated packaging and labeling equipment offers serialization and aggregation capabilities to support and comply with Drug Supply Chain Security Act.
Terminal Sterilization services are now offered for drug product manufacturing projects requiring this step.
Continuous flow and capability upgrades provide additional capacity and resources to support increased requests for small molecule API manufacturing.
A new Quality Control lab in Belgium will expand operational capabilities.
Reconfiguration of GMP manufacturing suites in Belgium to support increased HPAPI capacity and improve process safety with additional instrumentation.

“These investments not only increase our capabilities and capacities at our US and Belgium facilities, they represent a strong step towards achieving our Vision Statement of being a leading, trusted, innovative partner to our customers and to our people. In doing so, we can further contribute to what’s really important to us as a company, that is, improving and extending the lives of patients with the drugs we produce,” said David Enloe, president and chief executive officer of Ajinomoto Bio-Pharma Services .“These capacity expansions ensure that we have the assets and capabilities to meet current and future industry needs. They also ensure we continue to attract the best talent to add to our world class teams.”

Asymchem Announces Successful FDA Inspection of HPAPI Development, Manufacturing

Asymchem announced its Tianjin1 site, a dedicated High Potency Active Pharmaceutical Ingredients (HPAPI) development and manufacturing facility, successfully completed a U.S. Food and Drug Administration (FDA) general GMP reinspection conducted between January 14-18, 2019. No Form 483 was issued. Previous FDA inspections of Tianjin1 took place in 2014, also with no 483.

Asymchem Laboratories (Tianjin) Co., Ltd., otherwise known as Tianjin1, produces Dexmedetomidine HCl, for which Asymchem holds an active Drug Master File, as well as other development HPAPI candidates.

"I'm very pleased once again to receive a positive outcome from a USFDA inspection,” Dr. Hao Hong, Chairman and CEO of Asymchem Group said. “The result is the culmination of many years' commitment to unyielding quality standards in the manufacturing of GMP products, and highlights the robust system implemented by Asymchem' s QA team. We will continue to improve and provide only the highest standards as our customers expect moving forward."

PCI Announces Expansion of High Potent Tableting and Powder Modification Capacity

PCI Pharma Services (PCI) has announced further investment to expand its flagship manufacturing center in Tredegar, Wales.

PCI’s investment at Tredegar will double its tableting capacity and see an increase in general throughput to support recent and anticipated product launches. It is the latest investment at PCI’s core manufacturing site within its global network, made in direct response to customer needs and market growth.

“We are delighted to announce these most recent investments as part of both our business continuity and growth strategies. This additional capacity will provide greater security to our customers, supporting important clinical programs and new product or market launches,” PCI’s Richard Yarwood, Senior Vice President, said.

Since opening its dedicated contained manufacturing facility in 2013, PCI Tredegar has processed more than 60 highly potent products within the unit. The purpose-built, state-of-the-art facility enables PCI to offer a market-leading service; with design for manufacture principles and geometric scale-up delivering seamless development to commercial launch services and speed to market for PCI’s international customer base.

Additional investments made at PCI Tredegar since 2013 have further enhanced the facility, complementing the initial build. These include fully contained roller compaction for the processing of molecules sensitive to heat and/or moisture, as well as contained Xcelodose® technology delivering drug in capsule solutions for early stage clinical development programs, delivering cost and time efficiencies for customers. In addition to these solid oral dose processing capabilities, further investments in technologies to support the processing of highly potent liquids and semi-solids complete PCI’s full service offering for multiple dosage forms.

In 2018, PCI extended the capacity of its analytical laboratory in support of growth in the potent market. The laboratory project increased analytical capacity to support development and commercial raw material, in-process and finished product testing. The layout design incorporated lean philosophies and optimized safety with the installation of specific, high potent drug containment enclosures.

“We have developed the PCI Tredegar site in direct response to growing customer demand for the development and commercial supply of potent drug products. We are proud to be a trusted partner to more than half of the top 20 pharmaceutical companies globally and our investments have been carefully considered to ensure we keep pace with customer needs, today and in the future,” Yarwood said. “PCI has built significant experience in the effective processing of these often challenging highly potent molecules. Our customers value us for our ongoing investment in leading-edge technology, combined with the commitment of our highly skilled scientists and trained.”

ACG Expands in Latin America with Brazilian Capsule Plant

ACG announces plans to grow its Latin American presence with its newest capsule production plant in Brazil, as it continues to expand its facilities in Asia-Pacific and Europe.

End-to-end manufacturing solutions provider ACG, announces the opening of its capsule production plant in Pouso Alegre-Minas Gerais, Brazil, in addition to expansions to its factories in Croatia and India.

ACG made an investment of R$350m Brazilian ($98m) into the Brazilian facility, which spans 160,640 sq. ft. (14,000m2). It will become the company’s second facility in the country after the group acquired Nova Nordeplast in 2017.

Both the new facility and the Nova Nordeplast plant in Sao Paulo will serve the entire Latin American region.

Senior VP of ACG Capsules, Kamlesh Oza will speak on behalf of the expanding facilities in India and Croatia which both specialize in hard capsules made with non-animal sourced gelatin and hydroxypropyl methylcellulose (HPMC), during DCAT week in New York.

“We are now keen to accelerate our growth, and to build long-term relations to serve our customers better,” a spokesperson for AGC said, regarding the company’s mission for growth.

“Establishing and expanding facilities around the world better positions ACG to accommodate a growing roster of clients within the industry,” added the spokesperson.

ACG’s Brazilian facility has met the standards set by the Brazilian Health Regulatory Agency (ANVISA), as well as passing good manufacturing practice (GMP) inspection by regulatory bodies.

Expansion of Cambrex’s Milan Site

Cambrex completes expansion of its R&D laboratory at its Milan site and adds a 12,000-liter reactor to its manufacturing facility during a $3m investment.

The analytical services provider, Cambrex Corporation, completed the expansion of its site in Milan, Italy. The site now holds a new 1,614 sq. ft. (150m2) R&D laboratory.

Cambrex’s expanded R&D laboratory has both chemistry and analytical development capabilities, after the installation of semi-automated glass-line reactors, multiple high and ultra-performance liquid chromatography, and gas chromatography systems.

A spokesperson for Cambrex told us the expansion enables the company to work on new projects at the site and expand its active pharmaceutical ingredients (APIs) portfolio.

“The patents of many important drugs are coming to an end; therefore, the site is working on new generic products. The investments that have been made in R&D at the site over the last two years have increased the capabilities in development, including the installation of containment facilities at a small scale to allow for the development of potent and highly potent APIs,” the Cambrex spokesperson said.

The new laboratory also holds a flow chemistry system for continuous manufacturing development, which the spokesperson said will enable researchers to “look at efficient synthetic routes for APIs and intermediates to generic APIs, where appropriate,” added the spokesperson.

Cambrex’s generic API portfolio covers drugs across therapeutic areas including analgesics, anesthesia, and central nervous system disorders.

Additionally, the company installed a 12,000-liter reactor to a current good manufacturing practice (cGMP) manufacturing facility at the Milan location.

The installation of the 12,000-liter reactor, among other updates, was part of a $3m (€2.65m) investment by the company to bolster the intermediates and generic APIs efficiency.

Merck’s Biotech Manufacturing Facility Expansion, Aubonne, Switzerland

In March 2019, Merck announced plans to expand its biotech manufacturing facility in Aubonne, Switzerland.

The expansion includes a biotechnology development and manufacturing facility, which will cost an estimated $165.85m over a period of five years.

The plant will help the company meet the growing global demand for biotechnology drugs and support its portfolio of biotech medicines.

The latest expansion is part of a CHF1bn ($1bn) investment program initiated by the company in Switzerland in the last decade. Construction is scheduled for completion in 2020.

Merck’s biotech manufacturing facility is located in Aubonne in the Morges district of the Canton de Vaud region. The 360 companies and 400 laboratories in this area provide employment to approximately 20,000 people.

Aubonne is one of two significant sites that manufacture the company’s biotech medicines. The site hosts offices and laboratories for global functions, including manufacturing, supply and quality control.

The new building will feature aseptic filling and quality control laboratories with novel design and state-of-the-art technologies. The facility will adopt a flexible operations model to increase productivity on demand. The new quality control laboratory is expected to be operational in 2021.

Aseptic filling lines will be equipped with isolator technology to avoid contamination hazards. The technology utilizes good practice in aseptic filling to ensure the safety of injectable drugs.

One of these lines will be utilized for freeze-dried formulations, while the other will process liquid formulations. They are expected to be operational in 2023 after validation from relevant regulatory authorities.

The set up will replace the existing infrastructure and undergo technology and capacity upgradation, enabling the production of up to 27 million vials a year.

Approved medicines such as Gonal-f® (follitropin alfa for injection) and Bavencio® (avelumab) will be manufactured in the new building.

Gonal-f is a human follicle stimulating hormone used to regulate reproductive processes in the body, while Bavencio is a fully human monoclonal antibody (mAb) approved for the treatment of Merkel cell carcinoma.

Products such as investigational cancer candidate M7824 (bintrafusp alfa) will also be developed in the facility. M7824 is being investigated for the treatment of multiple difficult-to-treat cancers such as non-small cell lung and biliary tract cancers.

Established in 1984, the existing manufacturing facility in Aubonne is capable of performing the entire biotech manufacturing cycle, including small-scale process development of drug substances, commercial production of biological drug substances, fill/finish and packaging activities.

The site was expanded with the addition of a new state-of-the-art packaging building in 2017. This facility was developed for visual inspection, secondary packaging and shipping of biotech medicines.

Marketing commentary on Merck:

Merck is a US-based biopharmaceutical company operating in segments such as healthcare, life science and performance materials.

The company has an 18-site network globally for the production of the company’s biotech and pharmaceutical medicines.

The company is present in 11 locations in Switzerland, where it employs 2,300 people. It has approximately 52,000 employees in 66 countries worldwide.

The Centre for Cancer Immunology, University of Southampton

The University of Southampton’s Centre of Cancer Immunology is situated at Southampton General Hospital.

Built adjacent to the Somers Building, the center was developed by the University Hospital Southampton NHS Foundation Trust (UHS) and Southampton City Council.

The center’s research facilities include a clinical trials unit, a suite of molecular biology laboratories and a pre-clinical immunology lab to support the development of new cancer immunotherapies.

Construction began in 2016 and was completed with an estimated investment of £25m ($32.46m) in April 2018.

The University of Southampton launched a campaign in 2015 to raise £25m ($32.46m) for the center. It received donations from the Wolfson Foundation, Matthew Hodgson of Warwick Capital Partners and rock band Coldplay.

Solent LEP contributed £4.5m ($5.84m) for the construction of the center, which was carried out as part of the 21+ NHS procurement framework.

A planning application for the center was approved by Southampton City Council in February 2016. A topping out ceremony was held in October of the same year.

The Centre for Cancer Immunology is situated in a four-story building, which has a total floor space of 43,040 sq. ft. (4,000m²). The upper two floors have space dedicated for research and administration, while the lower two floors feature laboratories.

The ground floor of the building includes an atrium, space for meeting rooms and a clinical trials unit, as well as an open-plan office space.

The first floor includes work spaces and meeting rooms for researchers, PhD and undergraduate students, senior academics and clinicians in cancer immunology.

The second floor of the building serves as a hub for laboratory research. It has study and work areas for students and staff.

The Centre for Cancer Immunology accommodates immunotherapy scientists, clinicians and technical experts.

It includes sophisticated research equipment and acts as a hub for academic and industry partners worldwide. It supports clinical trials for the development of lifesaving drugs for cancer.

The building features a clinical trials unit, a suite of molecular biology laboratories and a pre-clinical immunology lab. It significantly enhances the number of staff working on cancer immunology and patient clinical trials.

The new facility attracts leading scientists from all over the world in the development of immunotherapy treatments and partners with Francis Crick Centre in London. It supports research in multiple cancer forms such as lung, skin, pancreatic and neuroblastoma cancer.

PM Devereux was awarded a contract to design the Centre for Cancer Immunology, while Kier Construction Southern was contracted to provide general construction services for the project.

BuroHappold Engineering was involved in developing solutions for mechanical, electrical and plumbing (MEP) work, as well as structural, energy and sustainability aspects. The University of Southampton appointed Cliftons Projects as the client’s representative for the construction management.

Other contractors and suppliers involved in the project were 4Energy Group, Rekam (client’s adviser to the design team), and BOF (approved furniture supplier).

BioVectra’s Biologics Manufacturing Facility Expansion, Canada

In March 2019, BioVectra announced plans to expand its biologics manufacturing facility in Windsor, Nova Scotia, Canada.

The project is part of a five-year C$144.6m ($86.1m) expansion program that includes the company’s Windsor, Charlottetown and Prince Edward Island facilities.

The investment will support the company’s collaborations with various Canadian universities and research institutes, as well as create jobs in the Canadian pharmaceutical industry.

BioVectra’s 50,000ft² facility in Windsor will be expanded with the addition of a new mammalian cell-culture facility. The project includes renovations and installation of new equipment, as well as expanded microbial fermentation capabilities.

The expansion will enable the facility to develop and manufacture biologic drug substances to be used in developing treatments for cancer, autoimmune diseases and diabetes.

Zero-emission materials will be used to construct the facility and reduce the building’s environmental impact.

The Government of Canada provided C$37.5m ($28.2m) through the Strategic Innovation Fund (SIF) for the project. It is one of the biggest social investment fund (SIF) projects in the Atlantic Canada region. SIF aims to increase business investments in various sectors to improve the region’s economy.

“The project includes renovations and installation of new equipment, as well as expanded microbial fermentation capabilities.”

The Government of Canada previously invested C$5m ($3.74m) through the Atlantic Canada Opportunities Agency’s (ACOA) Business Development Program for the expansion of the Windsor facility in April 2018. The ACOA works to create economic growth opportunities for the Atlantic Canadian people.

The existing investment is expected to support on-the-job training and provide internship opportunities to more than 25 students a year to generate a future workforce.

The project will support the manufacturing capacity of the company and improve the research and development (R&D) capabilities of advanced pharmaceutical products that are not currently manufactured in Canada.

The expansion will create approximately 110 new jobs in the Windsor facility, while a total of 150 jobs will be generated across both the facilities adding to the existing workforce of 300 people.

Jobs will be generated across the rural Annapolis Valley communities present in the western region of Nova Scotia.

Opened in 2017, the Windsor facility is the company’s fourth current good manufacturing practice (cGMP) site in its microbial fermentation and complex chemistries business. Development of the site increased the company’s total manufacturing capacity by 40%.

The facility is equipped with 40,000l of fermentation bioreactor capacity and downstream processing equipment. It also features suites for pre-clinical fermentation and potent chemistry.

The company has been investing approximately $25m ($18.7m) a year for the expansion since 2015. Being located close to the north-eastern US, the facility provides services to development bodies in the region.

Marketing commentary on BioVectra:

Based in Canada, BioVectra is a subsidiary of Mallinckrodt Pharmaceuticals. This contract development and manufacturing organization (CDMO) meets the requirements of biotechnology and pharmaceutical companies worldwide.

The company has experience in microbial fermentation, complex chemistry, high-potency active pharmaceutical ingredients (API), process and analytical development, as well as biologics and drug development.

The company has four facilities, three in Charlottetown and one in Windsor. The facilities feature 50,000l of chemical reactor space, 64,000l of fermentation bioreactor capacity, US Pharmacopoeia (USP) purified water system, downstream purification capabilities, cGMP and non-cGMP manufacturing, and other capabilities for drying, milling, blending and lyophilization.

Dalton Pharma Services Completes PAI Inspection

The U.S. FDA completed a PAI inspection of Dalton Pharma Services’ Health-Canada licensed manufacturing facility in Canada, in January 2019. This inspection paves way for Dalton to manufacture commercial API products for U.S. distribution.

The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by the FDA. No FDA 483 inspectional observations were issued. This inspection means that the company has successfully demonstrated these activities are in compliance with the high standards of the Food and Drugs Act and its associated regulations.

Natalie Lazarowych, director of Quality, said, “This successful inspection is a critical breakthrough for Dalton as it is the first ever PAI at our facility. The successful FDA inspection with no 483s demonstrates our commitment to meeting all applicable regulatory standards for commercial manufacture, packaging and testing.”

“I am proud of my team and their efforts in accomplishing this organizational milestone. Our hardworking, dedicated and exceptional employees are our greatest asset. This successful inspection exemplifies Dalton’s commitment to being a compliant cGMP API manufacturer for all our client`s drug candidates,” said Peter Pekos, chief executive officer.

Novartis Signs Manufacturing Memorandum in Saudi Arabia

Sudair Pharmaceuticals will work with the Swiss company on oncology drugs, which are in high demand as the country’s cancer rate soars

Dr Othman Fahad Al-Mutlaq, general manager of Novartis, and Dr Yasser Ibrahim Al-Obaida, CEO of Sudair Pharmaceuticals Company, were at the signing.

Novartis International and Sudair Pharmaceuticals have signed a memorandum of understanding for the manufacture of oncology drugs in the Kingdom of Saudi Arabia, as reported in Arab News.

Under the patronage of the President of the KSA FDA, the Swiss pharma company will provide Riyadh-based Sudair with all the information needed for the technology and quality standards in the creation of the range of cancer drugs.

Speaking to the news outlet, Novartis said: “Novartis has decided to strategically drive a long-term localization plan, which includes the transfer of technology, co-manufacturing agreements with local pharma manufacturers, building capacities and strengthening its clinical research programs.”

Sudair Pharma is a Saudi-based company, which builds and operates a pharmaceutical manufacturing complex to combat chronic and life-threatening diseases.

With the WHO revealing an increasing cancer incidence rate in the Middle East this localization may help to address a growing problem in the Kingdom.

Lilly Sells Manufacturing Facility in China

Eli Lilly and Company announced that it has entered into an agreement to sell the rights in China for two legacy Lilly antibiotic medicines, Ceclor® and Vancocin®, as well as a manufacturing facility in Suzhou, China that produces Ceclor, to Eddingpharm, a China-based specialty pharmaceutical company.

Under the terms of the agreement, Lilly will receive a deposit of $75 million, followed by a payment of $300 million upon successful closing of the transaction. As part of the transaction, all employees at the Ceclor manufacturing facility and certain employees from shared functions will be offered the opportunity to remain at the facility and continue to work with Eddingpharm. Lilly will provide ongoing services to Eddingpharm for a period of time to ensure continuity of product supply and support the smooth transition of the facility.

"Lilly remains committed to improving the health of people in China," said Julio Gay-Ger, President and General Manager of Lilly China. "This transaction will enable Lilly China to better focus our resources on the exciting new therapies that we are launching in our core therapeutic areas, so that we can bring more life-changing medicines to patients in China."

Mr. Xin Ni, CEO of Eddingpharm, said: "Ceclor and Vancocin have been on the Chinese market for more than two decades, treating numerous patients and earning the trust of patients and physicians alike. We are very proud to acquire these two brands and to carry on their legacy. We look forward to maintaining high standards of operation, supplying products with the best quality, and serving more patients in need in China."

The transaction is expected to close in either the latter part of 2019 or early 2020, subject to customary closing conditions and regulatory approval. The transaction will not be reflected in Lilly's reported results and financial guidance until closing.

About Eli Lilly and Company :

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

CPI Builds Open Innovation Facility for Continuous Wet Granulation

The UK’s Centre for Process Innovation (CPI) is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals. The new facility, built as part of a project called PROSPECT CP, will include blending and feeding of raw materials, twin screw wet granulation, drying, and ultimately tableting. Importantly, the facility is designed to include integrated in-line process analytical technologies (PAT). This suite of analytical sensors is placed at the end of the granulator to monitor important in-process product attributes in real time. Data from the in-line sensors will be used to build models, which will predict finished product attributes from the in-process measurements, enabling robust control of product quality to be achieved. A prototype of the facility has been constructed, and work is continuing on the integration of sensors and controls with the manufacturing equipment.

CPI is working closely with a number of suppliers including GEA Group, Perceptive Engineering Ltd, Siemens Plc, Innopharma Labs Ltd, and Kaiser Optical Systems Inc to create the facility, which will be based at CPI’s existing facilities at NETPark, Co. Durham. The resource will be capable of handling a wide range of active pharmaceutical ingredients and will include equipment relevant to established continuous manufacturing technologies.

Once complete, the capability will be available as an in-line, PAT-enabled, open-innovation facility to support the UK pharmaceutical industry and potentially other industries where the development of controlled complex solid forms is critical. It will be ideally suited to the rapid development of robust processes enabling reduced development timelines. However, it could also be used in the future to aid real-time monitoring and control of product quality. The longer-term ambition is to reduce or remove the need for labor-intensive testing of products at the end of manufacture and decreasing drug release timeframes.

“We are delighted that CPI has been able to support this massive step forward in the understanding of complex particles. Creating the infrastructure needed to develop UK-led fundamental learning in this high value area will enable us to drive innovation forward in the pharmaceutical sector, as well as many others,” said Graeme Cruickshank, director of formulation at CPI, in an April 8, 2019 press release.

“The work progressed on PROSPECT CP over the next two years will provide a much-needed springboard to accelerate incubation and translation of emerging process analytical technologies to the pharma business,” said Jason Crooks, director, Drug Product Design and Development at GSK, in the press release.

Kevin Sutcliffe, principal scientist, Global Product Development at AstraZeneca, said in the press release: “Creating the PAT test bed on the PROSPECT CP platform will enable industry to acquire process data using new and existing analytical technologies. Our collaboration with CPI will complement our own work in AstraZeneca on building models that show the relevance of raw material characteristics and process measurements to product quality.”

The PROSPECT CP project builds on and complements CPI’s existing capability to study mixing and scale-up in complex liquid formulations. This project follows on from the completion of another strategic project aiming to support the better implementation of computer models across manufacturing processes.

These activities are funded by the Innovate UK grant to establish the National Formulation Centre and support the center’s strategic themes of predictive design and manufacturability, incorporating aspects of advanced modeling and PAT-enabled, model-based process control to facilitate the adoption of digital manufacturing technologies across the formulation industry.

Catalent Invests at its Eberbach, Germany Softgel Facility

Catalent, the leading global diversified provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany.

The $14 million expansion, which is scheduled to be completed by mid-2020, includes two new softgel encapsulation lines dedicated to Catalent’s proprietary Vegicaps® technology. This addition is driven by the increased global demand for animal-free consumer health products, and these new lines will be completed by September 2019. The investment also includes new printing technology, a state-of-the-art vision inspection system, expansion of the facility’s softgel coating capabilities, and the addition of further packaging capacity.

“The Eberbach facility is our biggest softgel development and manufacturing facility in Europe with a capacity of more than 10 billion softgel capsules per year,” commented Raoul Bernhardt, General Manager of the Eberbach facility. “This investment reflects the importance of the site and will enable us to better serve our customers with increased volumes and turnkey services.”

In addition to these capital investments, the site is increasing its total production output by growing the workforce by more than 10% across Operations, Quality Control and related supporting functions.

The 360,000 square-feet facility offers integrated softgel manufacturing services which simplify supply chain management and deliver products faster to market. In addition to handling prescription pharmaceuticals, over-the counter pharmaceuticals, nutritional supplements, medical devices and animal health products, the facility also specializes in handling highly potent and cytotoxic compounds within an isolated, self-contained cytotoxic suite. This is the latest expansion at the facility with the most recent one dating to early 2015 when it was expanded to include additional softgel coating and blister packaging equipment.

About Catalent :

Catalent is the leading global diversified provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With more than 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable 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 approximately $2.5 billion in annual revenue.

Freeline Installs Pall System at Gene Therapy Facility

On April 29, 2019, Pall Corporation, a manufacturer of biopharmaceutical processing technology, and Freeline, a biotech company focused on developing gene therapies for chronic systemic diseases, announced the completion of the first full-scale run in Freeline’s newly commissioned GMP facility located at the Cell and Gene Therapy Catapult facility in Stevenage, UK. The Freeline proprietary adeno-associated virus (AAV) manufacturing platform uses Pall’s iCELLis bioreactor system to produce AAV gene therapy vectors. The two companies will extend their partnership to accelerate in-house production of Freeline products.

With the scale and automation provided by the iCELLis bioreactor, the adherent cell culture format used in the new system allows for the production of the AAV virus in a way that maximizes quality and yield, Pall reports. The manufacturing process at the Freeline facility at Catapult was achieved in collaboration with Pall through integrated modeling processes and design features. The platform is used at three locations as Freeline continues to expand its manufacturing capabilities.

“This is an important step forward for Freeline as we look to manufacture product for clinical trials with a commercially ready manufacturing platform in order to ensure the fastest possible development towards licensure,” said Jan Thirkettle, chief development officer of Freeline, in a company press release. “Our collaboration with Pall has been critical to our progress and we are excited to be working with them as we prepare for commercial supply and further development of our proprietary AAV manufacturing technology.”

“The iCELLis bioreactor system, coupled with Pall’s Accelerator process development services, helped deliver a robust and scalable process for Freeline to reduce time to market. We are proud that our iCELLis technology now enables the development of Freeline’s life-changing therapies,” said Roel Gordijn, vice-president, integrated solutions at Pall, in the release. “Pall continues to invest in its iCELLis technology, ensuring that it is available to the rapidly growing gene therapy industry.”

Vibalogics Expansion for Viral Products

CDMO Vibalogics has increased its single-use bioreactor and purification capacity at its site in northern Germany on the back of growing demand for oncolytic virus and viral vector production.

The German contract development and manufacturing organization (CDMO) has added a new manufacturing line consisting of a 50 L and 200 L single-use bioreactors and a Siemens process control system at its site in Cuxhaven.

The expansion represents an investment of €1.2 million ($1.35 million), Vibalogics told Bioprocess Insider, and also includes an Äkta-ready chromatography system for downstream processing and liquid handling equipment to deal with the increased volumes involved in this scale of operation.

While the firm did not reveal its total capacity for viral vectors, it said its capacity for live virus manufacturing is available for suspension cell, adherent cell and egg-based virus manufacturing.

According to the firm, “the industry is booming” and this expansion will help respond to the high clinical demand for viral vectors. Furthermore, the CDMO says it will look to further expansions going forward.

The news comes following a recent expansion at the site adding an automatic filling line to extend its aseptic fill and finish capability and reinforce its ability to support early phase biologic supply needs for Phase I and II clinical trials.

SEA Vision Group Begins Construction of New Italian Headquarters

Providing visions system services to pharma and packaging machine manufacturers, the new building will include 43,040 sq. ft. (4,000 sqm) of offices, software development, R&D and production

The first stone of the new SEA Vision Group headquarters was laid in Pavia, an hour south of Milan. The new office and production space is a necessary step given that the business is in constant development, and will guarantee appropriate workspace to the more than 175 Italian employees.

The Italian-based company provides vision system solutions to pharmaceutical companies and packaging machine manufacturers.

The new 3-storey building will be built on a plot of land of about 64,560 sq. ft (6,000 sqm), and includes 43,040 sq. ft. (4,000 sqm) of offices, software development, R&D and production.

The overall investment of about €8 million (US$1.13 million) confirms the growth trend of the company, which was born out of a university spin-off in 1995. Next year, it will celebrate 25 years in business and mark the completion of the expansion.

The construction, based on innovation and modern concepts, has been conceived with a changeable way of working in mind, with outward open spaces and flexible subdivisions that satisfies the continuous changes typical of the business.

This is the reason for the presence of green areas and recreational surroundings to give a pleasant and harmonious working environment for a corporate population with an average age of just 27, and with a close partnership with universities, from which the idea of an inner court took its inspiration.

Particular attention to the environment characterizes the project, designed by Architects Bertoletti+Greco, thanks to the use of new technologies with zero emissions, which make it a sustainable building.

In their speech at the stone-laying, Luigi Carrioli and Michele Cei, President and CEO of the group respectively, underlined the focus of the construction.

Cei said: “We are very pleased to celebrate this moment of rapid growth for our company and we are sure that our business will be further boosted thanks to this important investment.”

Carrioli added: “The construction of the headquarters- as well as enabling appropriate staff organization and therefore the capacity for production expansion - lays the foundations for a further increase in R&D investments in the field of industrial vision, 4.0 technologies, artificial intelligence and Machine Learning. Not only will the new building allow our staff to have functional environments dedicated to team activities and to have innovative laboratories for research, but it will also have recreational areas dedicated to company welfare.”

The Marchesini Group, global manufacturing machines and lines for the packaging process for the pharmaceutical industry, acquired a 48% share of SEA Vision last year. Both the CEO and President of the group were in attendance at the event.

GSK Increases API Manufacturing in Scotland

GSK has opened a manufacturing plant in Montrose, Scotland, where the firm will make APIs for its Ellipta respiratory medicines.

Alongside the firm’s site in Singapore, the £54m ($69.8m) Montrose facility will support the manufacture of active pharmaceutical ingredients (APIs) for a range of respiratory drugs; this includes combination asthma and chronic obstructive pulmonary disease (COPD) drug Relvar Ellipta (fluticasone furoate/vilanterol), also known as Breo Ellipta in the US.

Unlike GSK’s diskus inhaler system, which is used to deliver blockbuster asthma and COPD medicine Advair (fluticasone propionate/salmeterol), Ellipta can hold one or two blister strips, and as such, can be used to deliver drugs containing one or two APIs.

It is not expected that the highly-automated facility will significantly impact headcount. GSK employs around 1,000 people in Scotland, and 17,000 across the UK.

GSK has made a number of investments in Ellipta production since the inhaler received European marketing approval in 2013, including the construction of a £56m manufacturing site in Hertfordshire, UK, which opened in 2016.

According to Steve Dunlop, Scottish Enterprise CEO, the opening is a “fantastic endorsement” of Scotland as a location for business investment.

“Global companies like GSK choose to invest here because we have unrivalled talent to research, develop and manufacture innovative medicines that positively impact lives all over the world.

“We’ll continue to help GSK grow its business locally and nationally to create sustainable and inclusive jobs, and recognize its significant contribution to Scotland’s thriving life sciences sector,” he added.

The news comes weeks after GSK announced plans to reduce headcount at an API manufacturing plant in Ulverston, UK.

According to the firm, a review of the facility prompted its decision to “phase out” the manufacturing of active ingredients for sterile injections at the site – downsizing staff numbers by approximately 200.

Chi-Med to Take Advantage of Chinese Growth

After operating out of China for 19 years, Chi-Med’s CEO explains how the market has grown ‘very rapidly’ in the last four years.

The Chinese market has experienced strong growth in the last few years, as regulations have eased foreign investment into the country, and its internal pharma industry becomes increasingly productive.

This expansion has led some in the industry to remind those in the West that the speed of this transformation is not fully recognized by industry.

One company well placed to speak on the changes in the country is Chi-Med, which has operated out of the country for 19 years and became the first company in the country to bring through a ‘home-grown’ medicine.

On the release of its full year financials for 2018, in-PharmaTechnologist (IPT) spoke to Christian Hogg (CH) about the company’s plans for expansion and how it is producing one drug candidate each year, with the aid of its R&D engine.

IPT: Could you give me an overview of the financials Chi-Med just released?

Christian Hogg, CEO of Chi-Med

CH: The results we've just announced for 2018 are in line with the guidance that we put out last year. So, no real surprises.

We have two core platforms. We have an innovation platform and we have a commercial platform. The innovation platform is one in which we are investing in to develop our portfolio of small molecule targeted therapies around the world. The total net loss on the innovation platform was $102m on R&D spending of around $144m. We offset some of that spending with revenues that we generate from our partners, AstraZeneca and Eli Lilly, and various other collaborations.

On the commercial side, net profit was $41.4m, which was up 10% compared to 2017 – we had a good year on the commercial side in China. So, everything is on track, increasing investments on the innovation side and continued solid progress in net income growth on our commercial side.

IPT: On the R&D side, Chi-Med has a broad portfolio. Why has the company chosen to pursue several candidates that go against a ‘biotech-approach’?

CH: We're not a small, binary biotech company. We've been operating now for 19 years, building up gradually through those years, and our market capitalization is about $3.5bn. We've built a large platform of assets that are in clinical development, and we have a scientific team of over 420 people in China. This covers discovery all the way through to clinical research, as well as regulatory aspects and manufacturing.

We have two large-scale factories, with well over 1,000 people in them. We've also built up a large platform that's really a discovery engine. We're producing probably one novel drug candidate a year out of this system – which is why we tend to have a pretty broad portfolio. We became, just last year, the first Chinese company ever to bring a home-grown innovation from discovery all the way through to NMPA [National Medical Products Administration of China] approval and the launch of a synthetic oncology drug.

IPT: In the financials, it was announced that you'd invested in small molecule manufacturing in China, could you outline what work has been done?

CH: When we got our drug, Elunate (fruquintinib) approved last year, under the new priority review process that the Chinese regulatory authorities have put in place, there was a need to manufacture the drug. We chose to do that ourselves under the new regulatory regime, which has been reformed over the last five or six years, so the speed at which companies can bring innovation to market has improved dramatically. We received good manufacturing practice (GMP) certification last year and now we're producing fruquintinib from our own in-house capabilities

IPT: Why did you decide to build in-house manufacturing rather than work with a CMO?

CH: Under the market authorization holder policy in China, innovators can use contract manufacturing organizations (CMOs) to produce their drug if they want but we have a portfolio of drug candidates all going through clinical trials, we just thought it was better from two standpoints to build our own in-house capabilities on the manufacturing side.

Number one is quality control. We felt that the building our own manufacturing operation would allow us to maintain the standards of quality control we felt was necessary. We're producing fruquintinib for the Chinese market, but we're also developing it globally, so we wanted to build a facility in China that could be used to produce the treatment for the global market. So, we had to establish a standard of quality that is global.

The second is cost. I think when you've got one drug candidate or one drug then maybe it's more efficient to use CMOs than to build your own factory. However, we have eight candidates and for the next two, we hope that we will be submitting new drug applications (NDAs) over the next couple of years. And so, with that portfolio of drug candidates coming through to, hopefully, NDA and launch – it just made sense to us to have our own manufacturing facility because cost-wise and energy-wise, the synergies would be immediate.

IPT: What are your global plans, on a broader scale?

CH: Of the drug candidates, we have in clinical trials in China today, we have decided to start global development outside of China – in the US and Europe on five of them.

That's why we've built a clinical regulatory team in New Jersey, US, to guide and to manage clinical development of those five assets outside of China, in the US and Europe. You need people on the ground in the US if you're really going to do a lot of clinical development, and that team is building very rapidly. Our investment, right now, is more on the clinical regulatory side, with regards to the US; we'll cross the bridge later in the context of building out other functional capabilities, such as manufacturing and commercial.

IPT: At the end of last year, you announced changes to the partnership agreement with Lilly – could you explain the rationale behind this decision?

CH: It was a big transaction and big amendment to our agreement with Lilly. Lilly has been a great partner, they work very closely with us now in the commercialization of fruquintinib in China, as well as all aspects of developing the treatment over the past few years. It's our first approved drug and our most important asset in China today.

What's important for us, is to ensure that we're able to expand development into multiple lifecycle indications. Fruquintinib is a VEGFR inhibitor and similar inhibitors are approved in as many as 30 solid tumor settings around the world – so, there's a lot of expansion potential for the treatment. One of the reasons that we renegotiated our deal with Lilly was to allow us to be more aggressive in investing in developing fruquintinib in more indications in more areas. Of course, Lilly has financial resources well, but they also have a lot of other priorities.

For us, we wanted to ensure that we didn't hold fruquintinib back in any way – that we were able to bring our resources to expand development. You know, if we're putting in more money to do that then we needed to get a greater share of the economics. So, Lilly agreed to expand our milestones, to expand our royalty rate in China, and also agreed to carving off 30-40% of China for us to take over commercial rights on.

IPT: How is the Chinese market at present? How has it been developing since the Chi-Med's entered the market?

CH: I think the last few years has seen very rapid growth in China, as well as very rapid increase in both investor interest in China and the flow of money coming into the industry. There are three or four companies that have that have created a lot of value in the last four years, and that's attracting a lot of interest among the global investor universe.

That's happened while the Chinese government has really been reforming the regulatory system in China, making it much more transparent and streamlined. As a result, you've just had, in the four or five years, a real shift in activity, interest and investment into China pharma – we are fortunate to be in prime position to take advantage of this situation.

Christian Hogg has been the CEO of Chi-Med since 2006 and is also a member of the technical committee. He joined the business in 2000, as its first employee, and has since led all aspects of the creation, implementation and management of the Company’s strategy, business and listings.

McIlvaine Company

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