PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

CordenPharma Increases API Capacity at ex-Roche Site

CordenPharma has expanded its oligonucleotide active pharmaceutical ingredient manufacturing capacity in Colorado, US.

The contract development and manufacturing organization (CDMO) has increased commercial capacity to 500kg per year at the Boulder facility, which it purchased from Roche in 2011.

Oligonucleotides are chemically synthesized short nucleic acid polymers designed to fuse with DNA or ribonucleic acid (RNA) sequences. They can be used to treat infectious, and genetic diseases, as well as some cancers.

The CDMO’s capacity expansion – which was completed in Q1, 2018 – “primarily relates to the synthesis, but also includes purification and concentration,” explained CEO of CordenPharma Boulder and Colorado Brian McCudden.

The investment “will not only provide our customers timely and much needed oligonucleotide active pharmaceutical ingredient (API) manufacturing services to advance their drug development programs in clinical trials as planned, but also allow them to leverage our regulatory expertise for scale-up and manufacture of commercial products,” said Dr. Matthieu Giraud, director, global peptides, oligonucleotides, lipids and carbohydrates platform.

McCudden added that the firm has observed growing demand for oligonucleotide APIs in the clinical space – both in early and late phase development.

The increased capacity will positively impact the firm’s headcount, he said: “We are increasing our staffing to accommodate the expansion.”

The expansion follows on from a number of facility investments for the CDMO last year.

In September 2017, CordenPharma completed its early development suite for highly potent, oral solid dosage products at its facility in Plankstadt, Germany.

The following month, the CDMO bought an ex-Hospira API plant in Colorado from Pfizer – which it will take over by the end of 2019 – and announced plans to increase its small molecule development services at its site in Liestal, Switzerland.

Novogene Gets CLIA Certification for US Lab

Beijing-based sequencing service provider Novogene announced that it has received CLIA certification for its US clinical laboratory.

The lab is located within Novogene's sequencing center at the Sacramento campus of the University of California, Davis. The company opened the center in early 2016 to provide its US and global customers with whole-genome sequencing services for human, plant, and animal samples for biomedical and agricultural research.

"CLIA certification is an important milestone for Novogene, allowing us to provide genomic solutions not only for scientific research, but also for clinical testing," David Jiang, general manager of clinical and consumer genomic solutions at Novogene, said in a statement. "We are excited to offer our clinical partners high-quality sequencing services at low cost with fast turnaround time."

In addition to its facilities in China and the US, Novogene also operates a sequencing lab in Singapore.

Catalent Bolsters Drug Development Capabilities

Catalent Pharma Solutions has unveiled plans to invest $5 million in the creation of a new drug development center of excellence (CoE) at its Somerset, NJ facility and headquarters. The investment will see the site focus on preclinical to clinical phase 2b formulation, analytical, and manufacturing solutions for orally delivered small molecules. It will also build upon the site's expertise in the development of modified release formulation, bioavailability solutions, the application of OptiMelt hot melt extrusion (HME) technology, and its status as the company's CoE for handling potent compounds and controlled substances.

"This latest investment in Somerset will significantly strengthen our early development offering with focused formulation expertise and capacity for additional speed and flexibility," said Jonathan Arnold, president of Catalent's oral drug delivery business unit. "It is highly complementary to Catalent's West Coast facility in San Diego, CA and further positions Catalent as the strategic partner of choice for the early development of solid oral dose forms."

Catalent's 265,000 square-foot headquarters and development center in Somerset has a long track record of successfully developing, launching, and manufacturing many oral treatments for leading global innovators. The site features state-of-the-art analytical labs, pilot and clinical scale equipment including HME and fluid bed processing, and significant expertise in coating technologies, capsules, tablets, minitablets, and multi-particulates.

Catalent's early phase drug development sites are closely connected to Catalent's clinical supply services network, to optimize transition from finished dose manufacture to clinical packaging and distribution. In addition, the Somerset facility will offer seamless transfers to Catalent's integrated commercial manufacturing network in: Kansas City, MO; Winchester, KY; Swindon, UK; and Schorndorf, Germany, for later stage clinical trials using compatible, scalable equipment.

Cambrex Expands Continuous Capabilities

Cambrex has completed the installation of multiple continuous flow reactor platforms at its High Point, NC facility. The investment underpins Cambrex's on-going commitment to new technologies and aims to reinforce the company's existing experience in continuous flow. This latest investment in continuous flow for process development will focus on the rapid and successful development of processes to supply clinical as well as commercial demand for chemical syntheses.

The investment in developmental capabilities builds upon the recent expansions made at the commercial-scale in the dedicated continuous flow production unit, at the Karlskoga, Sweden facility, which is capable of producing multiple metric tons of high purity intermediates per annum.

The new development center at High Point will be led by Dr. Shawn Conway, who has joined Cambrex as director of engineering R&D. With extensive experience in both pilot and commercial scale continuous processing, Dr. Conway will be supported by a team of chemical engineers.

"We are seeing significant interest in continuous flow development and production, predominantly from established pharmaceutical companies looking for process improvements in Phase II," said Brian Swierenga, vice president, operations and site director for Cambrex High Point. "We have designed the new laboratory and GMP pilot plant with maximum flexibility in mind, allowing us to explore the possibilities for both new and existing production projects, either on a FTE or custom contract basis."

The continuous flow development center is the latest investment at Cambrex's High Point site which has recently seen the completion and qualification of a new 11,000 sq.ft. analytical laboratory and a 400 sq. ft. pilot plant expansion with a reactor capacity of 4,000 liters.

Thermo Fisher Invests in Biologics Footprint

Thermo Fisher Scientific is investing $50 million in its St. Louis, MO site, one of the company's Centers of Excellence for biologic commercial manufacturing. The investment is part of the company’s expansion strategy for its global network of biologic drug substance capabilities for clinical and commercial supply.

The project includes expansion of the existing manufacturing building with an additional 64,000 sq.-ft., which will double manufacturing capacity and will be operational in 2019. The expansion will use the Thermo Fisher bioproduction "eco-system" for bioreactors, consumables and factory automation and will be among the largest single-use bioproduction capacities at a CDMO. The investment will also allow for further expansion in the future. Approximately 80 new technical jobs are expected to be added.

"Biologics have the potential to benefit millions of patients around the world," said Michel Lagarde, president of pharma services for Thermo Fisher. "Patheon Biologics, with this expansion, will be better equipped to meet the needs of our customers and ultimately the patients who rely on these life-saving therapies."

The Patheon Biologics Network of four global sites is growing rapidly and has standardized on the 2000L, single-use platform as the preferred option in new drug development through to commercialization. The St. Louis site currently provides process development, clinical cGMP manufacturing and commercial manufacturing using both fed batch and perfusion processes and has in-house analytical capabilities for Quality Assurance and Quality Control.

"Thermo Fisher's investment in the Patheon Biologics Network is a recognition of the extremely strong growth in demand for outsourced biologic development and commercial manufacturing," said Stephen Lam, head of Biologics. "This expansion is a tangible demonstration of the company's commitment to excellence in our biologics capabilities and to maintaining a leadership position. Over the past two years, we have doubled our manufacturing capacity at all of our locations including the St. Louis site – to meet our customers' growing demand."

WuXi AppTec Opens Laboratory Testing Facility in NJ

WuXi AppTec has opened its expanded Laboratory Testing Division (LTD) facility in New Jersey. The grand opening event was attended by state and local officials including State Senator Linda Greenstein. The new facility will enhance WuXi's integrated testing service portfolio enabling drug developers to accelerate their projects from labs to patients.

The expansion will double total operation space to more than 115,000 square feet, and will create over 200 jobs. After the expansion, LTD's combined New Jersey operation will be one of the largest laboratories for preclinical and clinical drug development testing in the U.S.

The new site will establish a center of excellence for drug development and provide high quality services to the U.S. pharmaceutical and biotech industries.

"The Garden State continues to be an important life science hub. This expansion will allow our team to deliver high quality service with faster turnaround times, better leverage the resources and expertise of the local pharmaceutical and biotechnology community, and develop a stronger connection with our customers," said Jason Liu, senior vice president of WuXi AppTec and chief operating officer of the LTD.

"We are delighted for this opportunity to better serve our global customers and to support local economic development in New Jersey," said Ge Li, chairman and chief executive officer, WuXi AppTec. "We will continue to enhance WuXi's capabilities and capacities to enable our global partners to discover and develop drugs more efficiently and cost effectively ultimately benefitting patients worldwide."

WuXi AppTec is a global company headquartered in Shanghai, China. In addition to the New Jersey site, WuXi also has U.S. facilities in Philadelphia, PA; St. Paul, MN; Atlanta, GA; San Diego, CA; and Boston, MA.

Celgene to Open Biopharma Incubator in New Jersey

Celgene has unveiled plans to open the Thomas O. Daniel Research Incubator and Collaboration Center, offering entrepreneurs state-of-the-art lab space, resources and support to scientists and companies with potentially transformational approaches to accelerate medical discoveries and innovations. The facility houses 16,000 sq. ft. of shared and fully equipped lab facilities located on the Celgene Summit West Research campus in Summit, NJ, to create an environment that can help medical innovators accelerate discoveries that may lead to life-enhancing medicines for patients in need. The Incubator, set to open this year, is dedicated to Thomas O. Daniel, M.D., who served as executive vice president and president of research and early development at Celgene from 2006 to 2016.

“When it comes to the challenges we face in healthcare, the facts are clear and compelling that medical innovation is the solution, not the problem. That is why Celgene is excited to offer an innovative environment for promising scientists and start-up companies to cultivate their ideas and medical discoveries,” said Robert Hugin, executive chairman, Celgene. “Hosting the incubator at Celgene aligns with our mission to pursue bold science and provide potentially transformational treatments that will ultimately benefit patients, healthcare and society.”

“Celgene has always recognized the need to harness disruptive sciences that lead to the development of life-altering medicines,” said Thomas O. Daniel, M.D. “I am honored that the distributed research and development model that I helped establish in my tenure at Celgene will continue to thrive through Celgene’s incubator and the work of tomorrow’s medical innovators.”

The Incubator has the potential to bolster the entrepreneurial ecosystem in New Jersey, creating a global epicenter for biotechnology by seeding innovation in life sciences. New Jersey hosts a multitude of biopharmaceutical leaders that are committed to medical innovations, with strong manufacturing capabilities. The state is home to a majority of the world’s top 20 research-based biopharmaceutical companies and over 3,000 life sciences establishments. In addition, 13 teaching hospitals, five research universities and four medical schools are located in New Jersey. Based on this wealth of life sciences talent, the state is well-positioned to drive innovation and possibly cures for the 21st century.

“As a hub of medical innovation, New Jersey is a prime location to establish research facilities that will provide state-of-the-art resources to entrepreneurs, innovators and start-up companies hoping to enhance their research and discover scientific breakthroughs,” said Debbie Hart, founding president and chief executive officer of BioNJ. “We look forward to working with the Thomas O. Daniel Research Incubator and Collaboration Center to grow our economy in New Jersey and deliver new therapies to improve patients’ lives.”

“The HealthCare Institute of New Jersey (HINJ) congratulates Celgene on the launch of its incubator, which will enhance New Jersey’s expanding innovation ecosystem,” said Dean J. Paranicas, President and Chief Executive Officer of HINJ. “We look for this exciting initiative to create opportunities for new life sciences companies to develop novel treatments and cures that will benefit patients everywhere.”

Mayne Pharma Opens $80M Oral Solid Dose Facility

Mayne Pharma has officially opened its new $80 million, oral solid-dose commercial manufacturing facility in Greenville, NC.

Custom-designed from the ground up and under construction for two years, Mayne Pharma's new 126,000 sq. ft. facility leverages best-in-class containment design to meet or exceed the quality and safety standards of major drug regulatory authorities.

The new facility more than quadruples the company's capacity to manufacture oral solid-dose pharmaceutical products in the U.S. to well over 1 billion doses, and introduces significant capacity to manufacture potent compounds and new capability to manufacture modified-release bead/pellet products.

Mayne Pharma's CEO Scott Richards said, "This new Greenville facility will greatly enhance our internal capacity and capability to support the mid- to long-term growth potential we see for our business and allows us to manufacture in the U.S. advanced drug-delivery technologies that until today were only available in our Australian facility," said Scott Richards, chief executive officer, Mayne Pharma. "The new plant will enable us to better control our supply chain, serve our customers better and reduce product costs. In the next few years, Mayne Pharma expects to introduce more than 20 products and double its manufacturing volumes in the Greenville site, driven by the pipeline of products under development, the transfer in-house of several products currently manufactured by third parties, and by providing our Metrics Contract Services clients with commercial contract manufacturing services.

"Mayne Pharma has a proven track record of success with technology transfers and product launches. This year, Mayne Pharma completed the technology transfer of disopyramide capsules from a Teva site to Greenville, and launched two new products manufactured at Greenville-amiodarone tablets and doxycycline hyclate immediate-release capsules."

With this new facility, Mayne Pharma introduces commercial-scale, solvent-capable, fluid-bed processing and film coating-a first for its operations in the U.S. Fluid-bed processing, also called multi-particulate or bead coating, applies polymers to an active pharmaceutical ingredient (API). Using this advanced drug-delivery technology, scientists can modify how a drug is released after ingestion, such as delaying or sustaining its release to reduce side effects or make the drug more effective.

Specifically designed for containment, the new facility can readily manage the commercial-scale manufacturing of potent compounds-a key growth area for pharma companies today as they develop increasingly complex drugs for the treatment of cancer and chronic diseases. Each of the 13 production suites in the new facility was engineered to meet today's stringent manufacturing demands for mitigating cross contamination-while also offering flexible space and delivering a broad range of capabilities and services. Key features include:

o Single-pass air and multiple distinct and strategically placed airlocks for gowning, material and equipment;

o Segregated product corridors;

o 100-percent HEPA-in and HEPA-out filtered air;

o Dedicated quality control laboratories; and

o Commercial scale up to 450kg per batch.

The facility enables Metrics Contract Services-Mayne Pharma's contract development division-to offer clients a comprehensive "concept to commercialization" solution under one FDA site registration. Metrics Contract Services provides formulation development and analytical chemistry testing services to more than 100 third-party clients. With the ability to offer those clients downstream commercial manufacturing services, Metrics Contract Services can deliver larger scale and increased capabilities for seamless scale-up, and reduce or eliminate the need for site transfers.

While commercial manufacturing is a new offering for clients of Metrics Contract Services, it is not a new capability for the Mayne Pharma team at the Greenville site. The Greenville site has successfully tested, manufactured and packaged commercial products for more than 10 years. Space constraints in the former manufacturing facility precluded Metrics Contract Services from broadly offering commercial manufacturing services to its clients.

Now that commercial manufacturing has been consolidated within the new facility, Mayne Pharma's former manufacturing facility in Greenville will be repurposed during the next two years to expand pre-commercial product development capacity to serve both internal research and development and Metrics Contract Services clients. The repurposing includes the creation of 10+ new processing rooms and expanded laboratories.

Berkshire Sterile Completes Validation of Isolator-Based Lyo Line

Berkshire Sterile Manufacturing (BSM) has completed the installation and qualification of its IMA Lyomax 3, which is equipped with sterilization in place (SIP) and clean in place (CIP) capabilities.

This IMA Lyo is connected to BSM’s Fedegari Isolator Line, providing clients with the highest in sterility assurance.

The qualification involved extensive IOQ’s of the equipment, validation of the SIP and CIP and media qualifications that utilized three complete loads.

The validation involved BSM’s Colanar Flexible Filler, capable of filling vials, syringes and cartridges on the same line. BSM completed the isolator qualification with over 12,000 units/run in triplicate with filling duration’s of over 60 hours per run.

“We are pleased to provide to our clients and our future clients the best available technology for their sterile manufacturing requirements”, said CEO Shawn Kinney.

BSM’s plans for 2018 include additional investment in equipment and the addition of a second formulation suite in 2018. The company seeks to purchase another isolator line (currently scheduled to be online in 2020). This line will expand capacity and utilize higher throughput as well as offer larger volume sterile lyo capacity to service commercial needs.

Labcorp Investing at Former GSK Campus

LabCorp is investing $30m in a new operations center at the former GSK campus in Research Triangle Park with support from a job development grant worth more than $8m.

LabCorp has signed a 15-year lease for two buildings (approximately 222,000 square feet) at the Parmer Research Triangle Park (RTP) campus in Durham County, NC, which was previously owned by GlaxoSmithKline (GSK).

Parmer Innovation Partners purchased the buildings in May 2017 and is investing $80m in renovations that are expected to begin later this year. GSK remains an anchor tenant of the campus.

According to a release from the North Carolina Department of Commerce, LabCorp’s expansion will create 422 new jobs, including positions in information technology design, software development, operations, and management.

In addition to the new positions, the facility will house current information technology staff and personnel from LabCorp’s drug development business who are currently located in several locations in Durham and Wake counties.

LabCorp, headquartered in Burlington, NC, currently employs more than 60,000 employees worldwide, including more than 8,900 in NC.

The state’s Economic Investment Committee today approved a Job Development Investment Grant (JDIG), which authorizes LabCorp to potentially be reimbursed up to $8,172,750 over the next 12 years.

The project is expected to grow the state’s economy by an estimated $880m.

LabCorp is not providing any additional comment at this time.

Lonza Opens Cell and Gene Therapy Manufacturing Facility in Houston, TX

Lonza has opened what it claims to be the world's largest dedicated cell-and-gene-therapy facility located outside the Houston, TX area. The company says it was built in anticipation of the rising demand from developers of cell and gene therapies.

During a grand opening ceremony in Pearland, TX Lonza executives and industry leaders unveiled the 300,000 square-foot (27,870 square-meter) facility and its offerings, highlighting its state-of-the-art, fully integrated, everything-under-one-roof access to some of the world's most innovative cell-and-gene-therapy manufacturing technologies.

"Lonza Houston will serve as a center of excellence for cell-and-gene-therapy process development from concept through pre-clinical, clinical and commercialization, all the way to the patient," said Andreas Weiler, business unit head for emerging technologies at Lonza Pharma & Biotech. "This facility has the potential to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases, under one roof. It will set a new standard in biopharmaceutical manufacturing and stand as one of four centers of excellence in cell and gene therapy in the only global network spanning three continents.

"Outstanding teams of top experts from around the world are gathered here and are empowered to elaborate on innovative concepts, develop and optimize complex processes, and seamlessly deliver cell and gene therapies that adhere to the industry's current good manufacturing practices (cGMP) standards."

The Lonza Houston Center of Excellence is already operational and manufacturing for several customers. This facility is recruiting employees and will have more than 200 full-time staff including scientists, engineers, MBAs and biotechnology professionals by the end of 2018 and continue to recruit high-value positions as market demand increases.

"Lonza is committed to the evolution and cultivation of a diverse medical and life-science community in the Greater Houston area for many years to come," said Marc Funk, chief operating officer, Lonza Pharma & Biotech. "The site is well positioned to meet the demands of the growing cell-and-gene-therapy field. Combining this leading-edge facility with our unmatched experience and expertise in cell and gene therapy will allow us to provide a key advantage to biopharmaceutical companies and academic researchers and ultimately to the patients they serve."

Lonza Expands Encapsulation and HPAPI Capabilities in Tampa, FL

Lonza has expanded its late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms in North America. The company will install a new Harro Hӧfliger Modu-C MS encapsulation unit at its integrated product development and manufacturing facility in Tampa, FL to further strengthen its speed-to-market capabilities.

The specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid dosage forms including dry powder inhaler (DPI) applications. Installation and validation of the Harro unit are on track to be completed by February 2018.

The investment strengthens Lonza's full-service product-development capabilities and capacity to support process development, clinical trial and commercial scale manufacturing utilizing encapsulation. In addition, the investment complements Lonza's abilities in PIC studies based on the company's Xcelodose Precision Powder Micro-Dosing Systems. The Harro unit and the Xcelodose system are key components in Lonza's toolkit for accelerated product development.

In addition, a new dispensing area and two new processing suites are anticipated to be completed by May 2018 that will broaden Lonza's capabilities for the handling of highly potent active pharmaceutical ingredients (HPAPIs).

"Our integrated full-service offering can reduce drug development timelines, complexity and costs, which are priorities for our customers," said Robert Beland, site head for Lonza Tampa. "The Tampa site is well known for exceptional capabilities in Xcelodose-based encapsulation, inclusive of highly potent compound applications. The addition of the new Harro unit allows us to offer our customers the option of one partner from concept to market for their encapsulated drug products."

The Tampa site already has Xcelodose capacity and expertise as teams there have completed more than 600 PIC programs across more than 200 compounds, which has resulted in a set of best practices for handling PIC challenges. This site hosts both developmental and cGMP Xcelodose units with capability to produce more than 15,000 capsules/day for a given product including highly potent compounds. The addition of the new Harro unit will boost operational capacity as it can fill more than 72,000 capsules per hour.

"We listen to our customers' needs and invest accordingly," said Gordon Bates, head of chemical division, Lonza Pharma & Biotech. "Expanding our capability into commercial-scale encapsulation responds to our customers' desire to maintain programs at the site from clinical development to commercialization."

LSNE Expands Capabilities and QC Laboratory Space

Lyophilization Services of New England (LSNE) has unveiled a strategic plan to expand its quality control (QC) laboratory in Bedford, NH, and provide new employment opportunities for its analytical and operations workforce. This expansion is part of LSNE's strategic growth plan to enhance its operations and capacity, to better serve its customers.

LSNE's expansion plan includes 38,000 square feet of new QC laboratory space and centralized warehouse. Additionally, in conjunction with this expansion, LSNE will add approximately 20 new full-time positions. LSNE's current QC lab will remain fully operational to avoid any interruption to ongoing customer services.

"In response to the strong momentum our business has demonstrated over the past several years, we are pleased to announce this new expansion plan," said Thomas McGrath, vice president of quality and regulatory, LSNE. "With the opening of the new, state-of-the-art laboratory, we will be well positioned to increase our analytical and microbiology capabilities to continue to support our clients and their clinical and commercial products. We have received increased customer demand over the last few years, and with the support of the Permira Funds, we are now able to increase our position as a full-service provider for parenteral products."

The laboratory building, located on LSNE's campus, will also house LSNE'S newly renovated centralized warehouse to support the company's continued growth, including the offering of longer term product storage for clients. The laboratory and warehouse are scheduled to be validated and operational during the second quarter of 2018.

Prudential to Open Nashua Laundry Processing Facility

Prudential Cleanroom Services, a US-based cleanroom laundry service provider, has announced the open ceremony of its new cleanroom laundry processing facility in Nashua, New Hampshire (US), will be held on 28 June 2018.

The California-based company started construction of the new site in September 2016.

The project is a 131,371-square-foot commercial laundry facility located on a 14.23-acre land. Prudential is building a one-story facility in three phases, which include offices, industrial space, employee areas and loading docks with 136 parking spaces on site for staff.

Tom Watts, Prudential president, commented: “Our team is excited to show our customers and prospective customers our newest facility in Nashua, New Hampshire. The location will provide our Northeast customers with additional products and service offerings, and will help with our company’s expansion into additional markets.”

Prudential’s completed first phase is a 70,091-square-foot building. The next phase will be followed by a 45,000-square-foot section and, the last phase will be a 16,280-square-foot addition. The building will occupy 12.2 acres of the site once all phases are completed.

Amgen Announces Rhode Island Will Be Location of First US Next-Generation Biomanufacturing Plant

Amgen announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States (U.S.), will employ Amgen's proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets.

A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. Next-generation biomanufacturing plants require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

"Amgen has three decades of experience in biologics manufacturing, and we are proud of our track record of providing a reliable supply of high-quality medicines for patients around the world," said Esteban Santos, executive vice president of Operations at Amgen. "We are pleased to build the first commercial scale, next-generation biomanufacturing plant in the U.S., leveraging Amgen's capabilities and incorporating the latest technologies."

A comprehensive evaluation of global locations was conducted to select the location. Following recent U.S. federal tax reform, which provides company incentives to invest in innovation and advanced technologies, Amgen made the decision to locate the new plant in the U.S. Rhode Island was selected based on the historical success of the Amgen West Greenwich manufacturing facility, its capabilities and talented workforce, and quality of living for staff and potential to grow. The biomanufacturing plant will be built on the current Amgen Rhode Island 75-acre campus and is expected to create approximately 150 additional highly-skilled manufacturing positions and approximately 200 construction and validation jobs.

Amgen opened its first next-generation biomanufacturing plant in Singapore in 2014. This type of plant offers a highly flexible, modular design which can be replicated in future facilities, which enables Amgen to increase production capabilities reliably with greater speed, productivity and flexibility. Within the plant, the equipment is portable, smaller and disposable, which provides greater flexibility and speed when manufacturing different medicines simultaneously. This eliminates costly and complex retrofitting inherent in standard facilities and allows Amgen to respond to changing demands with increased agility, ultimately impacting the speed at which a medicine is available for patients.

"We are excited that Amgen Rhode Island was chosen as the location to build the new biomanufacturing plant," said Tia Bush, vice president of Operations at Amgen Rhode Island. "It is a testament to our skilled, dedicated workforce and Amgen's continued presence in Rhode Island, which will enable ongoing collaborations with local academic institutions and the broader Rhode Island community."

The existing Amgen Rhode Island plant was licensed by the U.S. Food and Drug Administration in September 2005 and houses one of the world's largest mammalian protein manufacturing facilities. The facility manufactures commercial and clinical bulk drug substance. Amgen has invested more than $1.5 billion in its Rhode Island site, adding more than 500,000 square feet of manufacturing, utility, administrative and laboratory space to the campus. There are 625 full-time staff members employed at the Amgen Rhode Island campus.

Amgen Rhode Island has been awarded by the Providence Business News as one of Rhode Island's Best Places to Work more than 10 times since 2007.

Since 2004, the Amgen Foundation has committed over $4.8 million to support science education and community programs in Rhode Island.

Pentec Health Selects G-CON Manufacturing POD for New Compounding Facility

G-CON Manufacturing, producer of prefabricated, flexible cleanroom solutions, has been selected to install a single POD for Pentec Health’s 503B manufacturing site in Boothwyn, PA. Pentec Health, a leader in sterile compounding, will utilize the 18’x 42’ POD to supply an additional 576 sq. ft. of cleanroom space to their new compounding facility.

“As we continue to expand and optimize our operations, it is important to us to have the best cleanroom environment to ensure the highest quality and safety of our product,” said Daniel Martins, EVP of Outsourcing Facility Services at Pentec Health. “We believe the G-CON POD provides us the ability to easily, timely and economically expand our operations with a turn-key cleanroom that already meets our exceptionally high standards for construction, whilst having the convenience of a vendor standardized qualification and still having the modular flexibility we desire.”

Pentec Health launched its FDA Registered 503B Outsourcing Facility to expand its expertise in compounded sterile products. The addition of the G-CON POD complements Pentec Health’s state of the art facilities in the 503B marketplace.

“We are very pleased to be chosen by Pentec for their 503B cleanroom needs,” said Maik Jornitz, CEO at G-CON Manufacturing Inc. “This is the first of several 503B cleanrooms projects that we are able to announce. We look forward to continuing to serve this important industry so that its patients can be assured of purity in the products they receive.”

About G-CON:

G-CON Manufacturing designs, produces and installs prefabricated cleanroom PODs®. G-CON’s cleanroom POD portfolio encompasses a variety of dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The POD cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to be repurposed once the production process reaches the end of its lifecycle. For more information, please visit the company's website at http://www.gconbio.com.

About Pentec Health, Inc.:

For over 34 years, Pentec Health has been an industry leader in providing patient-specific compounded sterile medications. Pentec Health’s medications are used for administration in dialysis centers, as well as providing in-home Specialty Infusion through nursing services and complex pharmaceutical products to patients who require access outside of a hospital setting. Pentec Health is now registered as an FDA outsourcing facility, providing sterile compounds to meet the needs of the nation’s institutional healthcare segments. For more information, please visit http://www.pentechealth.com.

AGC Biologics Adds New Facilities in Bothell, WA

AGC Biologics has added a new building complex, which will house the company’s global headquarters, as the CDMO continues to expand in the US.

The contract development and manufacturing organization (CDMO) provides clinical and commercial manufacturing of therapeutic proteins.

The company announced the addition of a new building complex to house its global headquarters in Bothell, WA – allowing AGC Biologics to continue expansion in the US, according to the CDMO.

The complex spans more than 150,000 square feet and will house the company's process development labs and corporate administrative offices. Located near the existing AGC Biologics facility in Bothell, the new facility will include an R&D center dedicated to novel manufacturing technologies and also provides room for additional manufacturing capacity.

"The expansion of our Bothell site is another substantial milestone for AGC Biologics and a commitment to our operations in Washington State," said Gustavo Mahler, president and CEO of AGC Biologics, in a press release.

"These new state-of-the-art facilities will enable us to meaningfully advance and further integrate the development, manufacturing, and commercial functions within our dynamic global headquarters, as well as provide additional footprint for further manufacturing expansion."

AGC Biologics is the product of the convergence and integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics.

The company currently employs more than 850 employees across three continents, with cGMP-compliant facilities in Seattle, WA; Berkeley, CA; Copenhagen, Denmark; Heidelberg, Germany; Yokohama, Japan; and Chiba, Japan.

AGC Biologics Expands Capacity

AGC Biologics, a clinical and commercial manufacturer of therapeutic proteins, is expanding capacity at its Berkeley, CA facility with the addition of a 2000L single-use bioreactor (SUB).

With this new 2000L SUB, the Berkeley facility has tripled capacity over the last three years, and now offers cell culture manufacturing in scales from 100L to 3000L, with both SUBs and stainless steel bioreactors. In addition to cGMP manufacturing, the facility provides cell bank manufacturing and storage.

While focused on early-phase, the Berkeley facility operates within the global AGC Biologics integrated platform, with support from each AGC Biologics site. This structure is designed to create a seamless transition from early-phase through commercial production.

"We've carefully assembled an experienced team that is tuned in to the unique needs of customers within the critical early-phase development stage," said Vy Nguyen, site head of AGC Biologics, Berkeley. "We continue to expand capacity and capabilities to meet the diverse requisites within the early-phase manufacturing arena, and we value the opportunity to support companies developing tomorrow's breakthrough treatments."

REST of the WORLD

WuXi STA's Site in China

The R&D facility will help clients advance pharmaceutical ingredients from preclinical to commercial stage, says the contract development and manufacturing organization.

STA Pharmaceutical (WuXi STA) – a subsidiary of WuXi AppTec – has signed an investment agreement with the government of Shanghai, Jinshan District, China to build a research and development (R&D) site.

The facility will be located next to the firm’s active pharmaceutical ingredient (API) and intermediates manufacturing site, adding 322,800 sq. ft. (30,000 square meters) of laboratory space at the campus.

The firm said it will employ more than 500 scientists within the next two to five years at the center, which it plans to open in 2020.

According to the contract development and manufacturing organization (CDMO), the campus will offer a “one-site solution” for firms looking to advance APIs and intermediates from preclinical and clinical development through to commercial manufacturing.

Spokesperson Yu Lu said the facility will serve STA’s global customers – the majority of which are based in Europe and the US.

“However, we are also seeing a rapidly rising demand coming from Chinese biotechs, which is a reflection of the booming innovative drug development ecosystem in China,” said Yu.

STA Pharmaceutical merged with WuXi AppTech’s Pharmaceutical Development Services (PDS) in July last year.

Three months later, the newly formed WuXi STA announced plans to launch an API R&D and manufacturing facility in Changzhou, China.

Baccinex Awards Telstar the Design and Construction of Aseptic Filling Plant

Baccinex has entrusted Telstar with the design and construction of a cleanroom installation to accommodate an aseptic and lyophilized filling process line, enlarging the existing pharmaceutical plant in the Switzerland region of Jura.

Expected to be completed in 2019, the new building will cover around 10,760 sq. ft. (1,000m2) and will be devoted to the manufacturing of sterile pharmaceutical product batches for clinical trials.

This complex turnkey technological project will be equipped with a complete automatic aseptic filling line, which is made up of a vial washing machine followed by a depyrogenation and sterilization tunnel, as well as a vial filling machine operating under laminar flow equipped with a restricted access barrier system (oRABS).

Vials are transferred to two freeze-dryers with automatic loading systems via a conveyor belt, following on to a capping machine to complete the packaging process. There is also an option for both non-lyophilized products and products requiring terminal sterilization to be manufactured, providing improved versatility.

The aseptic area integrates some auxiliary installations intended to complete the manufacturing process, including raw material dispensing, compounding, washing and preparation for the sterilization process.

The plant design, for which the latest technological solutions existing in the markets have been taken into account, responds to a demanding implementation of oRABS isolation technology whereby the product is exposed to minimize the contamination risk.

The scope of the project awarded to Telstar incorporates the conceptual, basic and detailed engineering, the construction of a new manufacturing area and the provision of process equipment for pharmaceutical production, almost entirely designed and manufactured by Telstar.

The project covers the cleanroom architecture provision; a heating, ventilation and air conditioning (HVAC) system fitted with integrated decontamination technology; critical utilities such as highly purified water, water for injection using a distillation method, pure steam and nitrogen gas; non-critical utilities such as compressed air, softened water, chilled and hot water and industrial steam; electricity and the complete automation system, which integrates HVAC control process, decontamination and particles monitoring system.

In connection with the pharmaceutical process production equipment, the new plant will be fitted with two liquid nitrogen freeze-dryers with vial automatic loading and unloading systems performing under laminar flow oRABS, as well as two autoclaves used for material sterilization and product terminal sterilization.

In addition, ten items of containment equipment have also been purchased, including weighing booths, pass-through boxes integrating biological disinfection systems and laminar airflow cabinets.

Telstar will also perform and manage a validation service, including risk analysis, design qualification (DQ), commissioning, installation qualification (IQ), operation qualification (OP) and performance qualification (PQ), in addition to support services for quality assurance.

Telstar specializes in the development of aseptic manufacturing installations, undertakes both the design and the complete execution of the project from its conception to the final validation, as well as the supply of equipment designed and manufactured using in-house technology.

The allocation of the turnkey construction project was agreed in July 2017, after completing the engineering, design and equipment definition phases in May 2017. The complete installation is planned to be finished in Q1 2019.

Taking into consideration aspects related to good manufacturing practice (GMP) compliance and the latest trends in the industry field, the design of the new pharmaceutical plant has also integrated energy efficiency systems, generating power and production cost savings.

The review of the European Pharmacopoeia monograph 169, promoted by the European Medicines Agency (EMA) on water for injection, allowed water to be obtained by non-distillation methods from the 1 April. It has led Telstar to implement a generation system for WFI using reverse osmosis and ultrafiltration in the new plant for Baccinex. The installation has also got a small production of WFI by distillation.

Baccinex:

Headquartered in Courroux, Baccinex is a full-service pharmaceutical contract manufacturing organization (CMO) specialized in filling and finishing of sterile lyophilized or liquid dosage forms.

The company cooperates with major international companies offering complete services from pharmaceutical development and manufacturing of clinical trial batches to commercial manufacturing, packaging, analytical services and logistics.

Porton Biopharma Opens New Fermentation Facility

In a ribbon-cutting ceremony, John Glen MP for Salisbury and South Wiltshire has officially opened Porton Biopharma’s (PBL) new fermentation facility, which will be used to manufacture the company’s leukemia drug Erwinase®.

The state-of-the-art facility has been designed and built around a new 3,000l fermenter, which is a significant increase over existing capacity, and will enable PBL to increase the amount of product it will be able to manufacture in the future.

The new multi-million-pound building has a footprint of approximately22,596 sq. ft. ( 2100m2). This includes the main fermentation hall, down-stream processing rooms for harvesting product, plus all the associated services of purified water, steam, air and effluent treatment that are required in a modern pharmaceutical facility that meets the latest regulatory standards. These systems have been designed to interact seamlessly and are operated by the latest process-control system, enabling PBL’s production technicians to easily view and control any of the component parts via a series of high-tech interactive screens.

Director of engineering for PBL Mike Raine said: “Today represents an important milestone where we can see the physical results of all the hard work in the design, planning and build that have gone into this project. We are now looking forward to the next challenge of qualifying and validating the equipment to ensure that everything is working as specified, before going into full production sometime over the next year.”

Commenting on the ceremony John Glen said: “I was delighted to be welcomed back to open this new facility after having performed the ground-breaking ceremony in May 2016, the transformation of the site is astounding.

“Having this facility in Wiltshire is also a superb local example of the government’s industrial strategy, which specifically includes supporting the life sciences sector and building prosperous communities, a good news event for Salisbury!”.

Dr Roger Hinton MD of PBL said: “We are looking forward to the day when this facility comes on-line because that, along with the other investments that we have made, means that we will be able to meet the growing global demand for our product. This helps to grow the value of Porton Biopharma Limited, but most importantly it means that we will be able to save the lives of more children who suffer from this form of leukemia in future.”

WuXi Biologics to Build Facility in Ireland

An Taoiseach Leo Varadkar, Prime Minister of Ireland announced that WuXi Biologics, a Hong Kong-listed global open-access biologics technology platform company, is to invest €325 million ($392 million) and create 400 new jobs over five years in a new biologics drug substance manufacturing facility on the Industrial Development Authority's (IDA) greenfield site in Mullagharlin, Dundalk, Co. Louth.

Headquartered in Wuxi city, Jiangsu province, China, WuXi Biologics is a global platform company providing end-to-end solutions for biologics with a mission to accelerate and transform biologics discovery, development, and manufacturing to benefit patients around the world.

This facility will be built upon the novel approach WuXi Biologics has pioneered deploying multiple single-use bioreactors for commercial biomanufacturing and is also designed to be able to run continuous bioprocessing, a next generation manufacturing technology to be first implemented globally in this campus. A total of 48,000 L fed-batch and 6,000 L perfusion bioreactor capacity will be installed, representing the world's largest facility using single-use bioreactors.

The manufacturing project in a 26-hectare campus, the company's first site outside of China, is supported by the Irish Government through IDA Ireland.

Speaking in Dundalk, An Taoiseach Leo Varadkar, Prime Minister of Ireland said, "This is the start of something special. We will see the Factory of the Future, right here in Dundalk. It's the first sizable greenfield project from China in the pharma sector and I am delighted to see it located here in Dundalk. It's also the latest in a number of investments in this town which has become a hub for a range of sectors, mainly in the new knowledge based and pharmaceutical sectors."

Louth hosts National Pen, PayPal, Xerox, Wasdell, and Prometric, to name just a few. In 2017 there were 24 IDA-supported companies in the county, and the number of jobs created by them has tripled from 1,300 in 2010 to almost 4,000. It's all part of the Government's goal to increase regional investment and associated jobs by up to 40 percent.

"We have been engaging IDA and Ireland Strategic Investment Fund (ISIF) for several years before finalizing today's exciting investment in this community. This is our second major partnership in Ireland, following WuXi NextCODE's work with Genomics Medicine Ireland (GMI). These ventures showcase how competitive Ireland is for global enterprise and investment, and we are grateful for all the support local agencies and the talented people here have provided for us," Dr. Ge Li, Chairman of WuXi Biologics, commented.

Dr. Chris Chen, CEO of WuXi Biologics, added, "We are all excited to initiate our first global site to enable local companies and expedite biologics development in Europe. In addition, this is the start and a critical part of our global biomanufacturing network to ensure that biologics are manufactured at the highest quality and with a robust supply chain to benefit patients worldwide. We are committed to Ireland and will work with all local partners to build this state-of-art next generation biomanufacturing facility as a showcase to the global biotech community."

The announcement expands upon the partnership established among IDA, ISIF, and WuXi AppTec Group companies. WuXi Biologics' sister company, WuXi NextCODE, has partnered closely with GMI and ISIF since inception. Both investments and collaborations share a common goal: to advance cutting-edge technologies and high-value-added jobs based in Ireland and serve customers and markets worldwide.

Selexis Will Speed Up Cell Bank Delivery Time

Cell line developer Selexis has invested in laboratory equipment to reduce delivery times of its high expressing and stable research cell banks.

The $2m (€1.6) investment will help the Switzerland-headquartered develop technologies and procedures aimed at reducing the 14-week process.

“We believe by combining whole-genome sequencing with novel clonal selection technologies, we can deliver an RBC [research cell bank] in eight to nine weeks,” said CEO Igor Fisch.

“This can have a huge impact on helping partners get their promising candidates into the clinic faster,” he added.

Fisch said he has observed a shift in demand from monoclonal antibodies (mAbs) to more complex proteins, such as bi-specifics and FC-fusions.

This includes biotherapeutic proteins – that can be difficult-to-express in CHO (Chinese hamster ovary) cells – such as bi-specific proteins, DARPins, triabodies, and novel scaffolds decorated with peptides, enzymes, or growth factors, he said.

“We have spent a lot of time interrogating and characterizing our propriety CHO-K1 cell line (CHO-M),” he added.

In May last year, Selexis opened its cell line development laboratory in Geneva, Switzerland. The following month, Selexis was acquired by contract development and manufacturing organization (CDMO) JSR Life Sciences.

In the same year, Selexis signed deals with Merck KGaA, Pelican Therapeutics, and Sanofi, and this year entered an agreement with Compugen and resigned Xencor to boost their cell line development programs.

Sterling Pharma Invests to Expand Offerings

Sterling Pharma Solutions, a CDMO, is investing £6m into its pilot plant facility at its UK site to enhance its scale-up and small to midscale commercial API manufacturing capabilities.

The expansion will increase the pilot plant’s capacity by 33% and enhance the site’s production capabilities and flexibility for small to mid-scale batch production. Three new reactor trains will be added at scales of 225L, 500L and 1,360L to the cGMP facility. This will help to meet growing market demand for API batch sizes in the 10-100kg range.

As part of the investment the 40-acre site in Dudley, North East England, will also add a range of new capabilities to expand the ability to handle potent compounds across a range of equipment scales.

Kevin Cook, chief executive officer at Sterling Pharma Solutions, said, “This latest investment has been driven by demand for a full-service API development and manufacturing offering. More and more of our customers are interested in outsourcing the entire process and by adding more small-scale equipment to our facility we’ll be able to increase our capacity and cater for additional projects from proof of concept through to commercial manufacture.”

The expansion follows an investment in 2017 into the site’s milling, micronization and solid form facility. Both investments form part of a strategic development plan totaling almost £12m.

Arcinova Receives UK Grant

Arcinova has received a £1.5 million Innovate UK grant for the development of new flexible modular manufacturing technologies, a project which is set to demonstrate the operating feasibility of world first innovative continuous production tools.

The three-year project will be carried out in collaboration with a team led by Professor Mike George, with Professors Pete License and Sir Martyn Poliakoff at the University of Nottingham.

The aim of the project is to develop a continuous, flexible modular manufacturing technology platform which will enable Arcinova to handle increasingly complex chemistries with more discreet manufacturing steps. The platform will be used in manufacturing operations where manufacturing inventories need to be kept low and product purity needs to be maximized, where manufacturing throughput and efficiency are maintained at a high level and equipment changeover can be rapidly facilitated to cope with low batch numbers.

The developed continuous modular manufacturing technology will be easily scalable, with a reduced manufacturing footprint when compared to more traditional, batch reactor approaches. The developed technologies will enable Arcinova to enhance manufacturing capacity and minimize inventories for highly reactive hazardous processes whereas for a batch process the reaction scale would be severely constrained

“I have spent over 20 years championing the way that pharmaceuticals are manufactured in the UK and have been an enthusiastic advocate for new manufacturing technologies including continuous manufacturing and synthetic biology as enablers for new and radically different pharmaceutical production approaches," said Ian Shott, chief executive officer, Arcinova.

Mike George, professor of Chemistry at the University of Nottingham, said, “My colleagues and I at Nottingham are firmly convinced that flow chemistry can transform chemical manufacture in the UK and this partnership with Arcinova is an opportunity to turn our vision into reality.”

Wacker Buys Dutch Biotechnology Plant

Wacker Chemie AG has acquired a Dutch site for manufacturing biopharmaceuticals, live microbial products and vaccines, plus the associated business, from SynCo Bio Luxembourg for an undisclosed amount.

"This strategic acquisition is a key step for our ongoing expansion in the high-growth biopharmaceuticals market," said Auguste Willems, a member of Wacker's executive board. "The new plant will enable us to satisfy robust market demand today and in the coming years and to strengthen our position as a leading contract manufacturer of microbial-derived biopharmaceutical proteins."

Founded in 2000, SynCo Bio Partners has roughly 110 employees and operates two fermentation lines with current capacities of 1,500 and 270 liters. These lines manufacture microbial-derived biopharmaceuticals, not only for clinical testing, but also for the commercial market. There is a further line of single-use fermenters, which provides additional and flexible production capabilities. SynCo's service offering is rounded out with a "fill and finish" facility, which enables the complete manufacture of pharmaceuticals from the active agent to the filled product. The facilities meet Good Manufacturing Practice (GMP) quality standards, and they have already been inspected by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) and approved for the manufacture of specific pharmaceutical proteins.

"Expanding our production capacity strengthens our market position sustainably," said Gerhard Schmid, president, Wacker Biosolutions. "The additional fermentation lines double our current capacity, which increases our ability to produce key pharmaceuticals cost effectively, using advanced microbial techniques. We look forward to continuing the comprehensive support for SynCo's existing customers, while also offering them the proprietary technologies of Wacker Biotech. The acquisition will significantly expand our portfolio of technologies and services."

Wacker said SynCo's expertise in manufacturing live microbial biopharmaceuticals is a valuable complement to its know-how as a full-service supplier. Live microbial products represent a promising new class of actives, offering innovative therapies for serious illnesses and new vaccines against cholera, for example.

Boehringer Ingelheim to Invest in High-Tech Building

Boehringer Ingelheim, the German pharmaceutical group, will invest €65 million in avian vaccines. The company has laid the first stone of a 61,332 sq. ft. (5,700 sq. m.) building at its Lyon Porte-des-Alpes (LPA) site in France.

Known as F2IVE (Formulation and Filling of Inactivated Vaccines Extension), this major project will comprise a three-story building, including 10,760 sq. ft. (1,000 sq. m.) of cleanroom space mainly for formulating and distributing avian vaccines.

“As poultry consumption continues to rise around the world, there is an increasing demand for avian vaccines. This meant that our LPA production site in Saint-Priest was going to reach a saturation point by 2020. We had to do some forward planning and find additional production capacity”, explains Erick Lelouche, president of Boehringer Ingelheim Animal Health France.

The new building, which has an environmentally friendly design, will house two formulation lines, a multi-format bottle distribution line and a bag distribution area.

Earthworks for the new high-tech building began in March 2018 with the first batches expected in spring 2020 for a range of avian vaccines destined for the world market, with the exception of the US.

Fifteen months after the acquisition of Merial (a Sanofi company) in January 2017, this new investment will lead to the creation of 42 new jobs, primarily consisting of qualified operations staff (flow and maintenance managers, production technicians).

“An investment such as this confirms the commitment made by Boehringer Ingelheim at the time of the acquisition to put France, and Lyon in particular, at the heart of its growth strategy in the animal health market”, commented Lelouche.

Over the past 22 years, more than €350 million have been invested in the LPA site. This new investment will eventually result in a threefold increase in the site’s inactivated vaccine production capacity.

Thermo Fisher to Build Pharma Services Facility

Thermo Fisher Scientific is expanding its footprint in the EU and investing $35 million in a state-of-the-art pharma services supply chain facility in Rheinfelden (Baden) Germany.

The new facility will leverage the latest technology and modern infrastructure to increase European capacity for cold and ambient clinical trial materials in support of complex clinical research and so meet the growing needs of customers. The facility will be scalable for mixed-use space and provide a strategic logistical location for shipping either by road or air.

The company expects to start construction in Q4 2018 for the 86,080 sq. ft. (8,000 square meter) facility at the 270,760 sq. ft. (26,000 square meter) site with an anticipated completion within 12 to 18 months. Once complete, this new facility will provide up to 200 new jobs locally. The investment includes the option for additional expansion with the potential for doubling the footprint.

"This is an exciting time for our business, and it reinforces our commitment to best serve our clients globally. By creating a best-in-class supply chain facility in the EU, we open new opportunities to support client and patient need," said Astrid Frank, vice president and general manager, Europe, Fisher Clinical Services.

The company's decision to expand is in response to a growing demand for global clinical supply services, worldwide. The new facility will also serve to address GDP guidelines, Clinical Trial Regulations Annex 6 and the new Falsified Medicines Directive 2019. This GMP/GDP facility builds on the company's existing footprint of 20 purpose-built cGMP facilities globally.

Merck To Develop Vaccine Manufacturing Facility in Ghana

Merck has announced plans to build a vaccine manufacturing facility in Ghana.

Ghana will become the first country in Sub-Saharan Africa to have a dedicated human vaccine manufacturing factory. With 99% of the vaccines produced by Merck imported to Africa, the company hopes the new facility will streamline its manufacturing processes.

Merck signed a Memorandum of Understanding with Ridge Management Solutions in December 2017 to build a facility for the manufacture of a diverse range of products. Merck will provide technology and training to a local team.

Merck Life Science executive board member and CEO Udit Batra said: “We want to support emerging economies by sharing our expertise, helping them streamline their manufacturing processes while supporting technology transfer and local facility startup.”

In 2015, Merck acquired Sigma-Aldrich as part of a plan to increase its presence in Africa, which currently has 0.1% of the world’s vaccine production.

The cost of vaccination in developing countries has risen substantially in recent years. A report by Medecins sans Frontieres (MSF) in 2015 found that the cost of vaccines recommended by the World Health Organization’s childhood immunization schedule had risen by 68% from 2001 to 2014.

MSF has called for pharmaceutical companies such GlaxoSmithKline and Pfizer to lower the price of vaccines against pneumococcal disease, calling for the price to be reduced to $5 per child in developing countries.

In a statement, Merck said the partnership would further the company’s commitment to improving global health by making vaccines more affordable and available.

Batra said: “Merck is committed to expanding access to advanced drug therapies, especially in low and middle-income countries. Together, with our partners, we have shaped how vaccine production is done today and are helping to solve the toughest problems of tomorrow.

Sanofi Pasteur Canadian Headquarters in Toronto, Ontario

Sanofi is investing €350 million for the construction of a new state-of-the-art vaccine manufacturing facility at the Sanofi Pasteur Canadian headquarters in Toronto, Ontario.

"Canada has a strong legacy in the research and development of vaccines. With this investment, Sanofi is renewing our longstanding commitment to making Canada central in our effort to protect and improve human health across the globe," said David Loew, executive vice president and head of Sanofi Pasteur. "Vaccines save three million lives every year and this new facility will take us one step closer to a world where no one suffers or dies from a vaccine-preventable disease."

The new facility will allow Sanofi Pasteur, the vaccines global business unit of Sanofi, to meet the growing demand of five-component acellular pertussis (5-acP) antigen. Upon completion in 2021, the new building will also be equipped to produce the antigens used in the diphtheria and tetanus vaccines.

"This project is one of the most important investments for the Sanofi global industrial network," said Philippe Luscan, executive vice president, Global Industrial Affairs, Sanofi. "It demonstrates our continued commitment to manufacturing excellence and to better serving our vaccines portfolio to people all over the world."

INRS Awarded Funding for New Research Facilities

INRS will receive over $1.57 million in funding for four new facilities to produce innovative research and train highly qualified personnel in strategic sectors. The Canada Foundation for Innovation's John R. Evans Leaders Fund and the Government of Quebec are joining forces to provide matching funds for four promising projects that could lead to scientific breakthroughs in environmental science, health care, bio-imaging, and innovative semiconductor development.

Ecotoxicogenomics Research Centre:

Combining ecotoxicology and molecular biology with chemistry, environmental science, and aquatic biochemistry, this unique INRS facility will equip professor Valérie Langlois to better assess the effects of environmental chemicals on the health of living organisms, especially amphibians and fish. Professor Langlois' work also seeks to discover new molecular biomarkers associated with chemical exposures to generate reliable data to better measure environmental risks

High-speed bio-imaging laboratory:

With this new lab, Professor Jinyang Liang will deploy ultrafast, high-resolution, and ultrasensitive spatiotemporal imaging technologies to map neuronal activity in order to better understand the origin and evolution of neurological disorders. Professor Liang will also explore the biophysical mechanisms underlying multiple sclerosis and late-onset Alzheimer's disease to improve quality of life for people. The laboratory will foster new collaborations in the fields of photonics, biomedical engineering, and neuroscience.

Facility for studying the mechanisms of synaptic dysfunction in motor neuron diseases:

This new facility will enable Professor Kessen Patten to combine genetic, electrophysiological, and real-time imaging approaches to the study the mechanisms that render connections between nerve cell and muscle dysfunctional in amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA). Professor Patten's research aims to identify chemical compounds to restore connectivity between the nerve and muscle, and develop targeted treatments to combat these neurodegenerative diseases

Molecular and Device Physics Laboratory:

Professor Emanuele Orgiu will acquire the instrumentation needed to develop quantum materials and organic-based semiconductors with the potential to replace the silicon widely used in electronic devices. His research program will focus on conjugated polymers and two-dimensional (2D) materials such as graphene, black phosphorus, and certain metals to explore new exotic properties of matter at very low temperatures. The research facility provides fundamental support for the design of new lightweight, transparent, flexible, and large-area devices for applications in electronics, photonics, and energy.

Quotient Opens Allan-Robb Campus

The 85,000 square ft. facility consolidates Quotient's Edinburgh team that had previously been spread over four locations

Quotient has officially opened its state-of-the-art Allan-Robb Campus within the Scottish Enterprise Biocampus just outside of Edinburgh.

Franz Walt, interim chief executive officer of Quotient, said, "Along with research & development and management, the Allan-Robb Campus will house our reagent manufacturing operations and will provide further capacity to supply the reagent requirements for our MosaiQ™ system."

The construction phase of the GBP 29 million manufacturing facility started in 2016. The Allan-Robb Campus is named after John Allan and Gordon Robb, two senior executives who have been key in building Quotient into a global company from its roots as a unit of the Scottish National Blood Transfusion Service supplying immunohematology reagents to the Scottish NHS.

The new facility comprises 85,000 square feet of space, compared with its previous 22,000 square feet at a close-by location, and brings together onto one site Quotient's Edinburgh team that had previously been spread over four locations.

The new facility now also houses Quotient's scientific research team working on developing Quotient's products and accessing new markets. In 2017, the team secured 17 new product license approvals from the FDA for sale in the USA. In addition, the Allan-Robb Campus will provide laboratory and office space for a team of about 50 scientists working with other group companies on the development of the MosaiQ™ system.

Pall Biotech Expands Facility in Hoegaarden, Belgium

Pall Corporation has announced the opening of its expanded Hoegaarden office after eight months of construction.

A ribbon-cutting ceremony held in early December was attended by Pall leadership, local government officials, and Zaventem and Brussels associates.

The expansion included 21,520 sq. ft. (2,000m²) of new office space providing work stations for 100 employees, in addition to new research and development (R&D) lab, customer demonstration labs, and a manufacturing space.

Three Belgian locations have been combined into the one location, bringing headcount in the Hoegaarden office to more than 300 full time equivalent employees.

Vice-president and general manager of Pall Biotech Mario Philips said:“The expanded Hoegaarden site has it all: offices, labs, and manufacturing space for development and optimization of customer processes. With this site, we will be better equipped to provide whole service to customers in the area, while supporting the local economy.

“In this new space, we have consolidated three Pall Belgian offices as one, which is why we have designated Hoegaarden as a hub of strategic importance for our future growth.”

Mario Philips and Pall Hoegaarden plant manager Raf Vanheel were joined by Hoegaarden City Mayor Jean-Pierre Taverniers and City Counselor Hans Decoster to commemorate the official opening of the building.

Ypsomed’s Production Facility in Germany

Switzerland-based medical technology company Ypsomed is constructing a new production facility at the Schwerin industrial park in Germany.

The new facility will add to the company’s existing production sites in Switzerland, which are operating at full capacity. The existing facilities have already been expanded and have no scope for further capacity expansions beyond 2020.

The ground-breaking ceremony for the construction of the new facility took place in September 2017. Construction work is expected to be completed within 18 months, while operations are scheduled to commence in the first half of 2019.

Ypsomed is investing Sfr100m ($102.29m) in the project, with construction of the production facility estimated to cost €50m ($59.94m) and the production equipment estimated to cost another €50m ($59.94m).

The project will initially create 150 new jobs over five years, while additional jobs will be created as the production increases.

The new production facility is being developed in the Schwerin industrial park, which is located between Hamburg and Berlin. It features good infrastructure and is located in close proximity to the port of Hamburg, which provides shorter trading routes.

The industrial park provides facilities for multi-faceted industrial applications. It also offers advanced technologies ranging from primary production to successful distribution. The location also has an ample pool of qualified labor.

The new production facility is being developed on a 1,076,000 sq. ft. (100,000m² site), which will include a production and administration building with a total floor space of 204,440 sq. ft. (19,000m²). It will also have an option to expand by another 1,076,000 sq. ft. (100,000m²) of area in the future.

A logistics warehouse, quality control and technical maintenance facilities will also be available.

The single-story production space of the facility will include a clean room, storage facilities and tool store. It will also include a two-story administrative area equipped with offices, meeting rooms and an auditorium.

The new facility will be equipped with plastic injection molding equipment, printing facilities, and automated assembly and packaging equipment.

It will manufacture Ypsomed’s existing products, which are being produced at the company’s other sites in Switzerland. It will produce injection and infusion systems, and infusion sets for insulin pumps such as pens, auto-injectors and pump systems, which will be assembled, along with supplier parts to form finished end products.

The Schwerin facility will also enable Ypsomed to expand its UnoPen™ and the YpsoMate® autoinjector production capacities.

Specialist personnel who will work at the new facility will be trained in Switzerland.

Munich-based industrial design specialist IE Plast is responsible for the planning and realization of the production facility. IE Plast’s contractual scope includes operation, building and qualification of the facility.

Commentary on Ypsomed:

Ypsomed is a self-care medication solutions provider created following the split of Disetronic Group in 2003.

The co-founder and major stakeholder in Disetronic Holding sold the company, along with its infusion systems division to Roche in 2003. The injection systems division was, however, retained and eventually became an independent company named Ypsomed.

The products Ypsomed manufactures at its Switzerland facilities include ServoPen, UnoPen™, YpsoMate®, YpsoPen, FixPen, VerioJect, and LyoTwist.

Eisai’s New Oral Solid Dose Production Facility, Suzhou

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

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

A ground-breaking ceremony for the project took place in May 2016, while construction was completed in January 2018. Operations are expected to be started in June 2018.

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

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

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

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

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

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

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

Construction of the parenteral production facility was completed in November 2014. The two-story facility covers an area of 612,244 sq. ft. (5,690m²) and manufactures the injection formulation Methycobal®.

The administration building is a two-story facility with a floor space of 23,995 sq. ft. (2,230m²). It features offices, meeting rooms and a cafeteria.

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

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

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

Commentary on Eisai China:

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

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

Eisai China promotes more than ten medicines in China, covering the central nervous system (CNS), the digestive system and the endocrine and orthopaedics systems. The company currently employs 1,849 team members and recorded sales of CNY2.6bn ($4m approximately) in 2015.

The company’s sales are projected to reach CNY3bn ($4.6m) by the end of 2018.

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

Biomedical Engineering and Advanced Manufacturing Centre, Ontario, Canada

The Biomedical Engineering and Advanced Manufacturing (BEAM) center is located in McMaster Innovation Park in Hamilton, Ontario, Canada.

Also known as the Fraunhofer Project Centre for Biomedical Engineering and Advanced Manufacturing, the C$33m ($25m) facility was jointly developed by McMaster University and the Fraunhofer Institute for Cell Therapy and Immunology (Fraunhofer IZI) under a partnership formed in January 2015.

The joint project was inaugurated in March 2018. It aims to develop technologies for eye care, point-of-care medical devices and cancer treatments.

The project created 74 jobs and will support 35 business-academic collaborations for developing new products, ideas and clinical trials.

Located close to Hamilton town, the BEAM center is easily accessible from Highway 403, the McMaster University and the McMaster Innovation Park. It is also near Toronto Pearson International Airport and John C. Munro Hamilton International Airport.

Ontario was chosen to locate the new facility due to the low business costs and well-educated talent pool. In addition, the region has an emerging life sciences industry with more than 1,600 companies.

The facility covers a 20,000ft² area, which includes 16,000ft² laboratory spaces that facilitate mammalian and bacterial cell culture, synthesis of biomaterials and bio-analysis.

The facility also has 4,000ft² of mixed-use office space, which includes meeting rooms. An atrium area is also available, which is designed to enable researchers to meet and collaborate.

A 50,000ft² area is being developed next to the facility to house incubator space to support commercialization activities for BEAM.

The BEAM center focuses on diagnostics, biomarkers, cell therapies and biomaterials.

The diagnostics unit focuses on printable next-generation diagnostic tests, which can be applied to point-of-care (POC) settings. Some of the core areas within the unit include optimization of sensor surfaces, printable components development for POC sensors, generating application-specific DNA-based sensors, and integration and scale-up of ISO-compliant POC sensors.

The biomarker unit collaborates with the RIBOLUTION Biomarker Centre at the Fraunhofer IZI in Leipzig, identifying novel biomarkers on the basis of ribonucleic acids (RNA). The unit identifies biomarkers using genomic analysis methods and next-generation sequencing to develop new diagnostic tests. Prostate cancer, chronic obstructive pulmonary disease and infectious diseases are the areas of focus of the unit.

The cell therapy unit carries out research and development (R&D) activities on novel targeted therapies applied for different cancer indications. The novel therapies are developed using chimeric antigen receptor transduced autologous immune cells. The unit also offers a systematic approach to the manual production of the autologous cell therapies.

The biomaterials unit at BEAM develops biomaterial for ocular applications such as new drug delivery platforms, better contact lens materials and new intraocular lens materials.

The project received a C$12m ($9.1m) federal grant, which was provided by Hamilton and the provincial governments.

Diamond Schmitt Architects is the architect for the research facility.

The BEAM center will help accelerate product pipelines of its corporate partners and provide operational expertise to characterize test components and optimize assays.

The McMaster and Fraunhofer project management base experience will be helpful to meet deadlines for various projects and achieve the set targets. The center will have access to advanced instrumentation systems from both McMaster and Fraunhofer. Some of the equipment include biological preparation equipment, equipment for high-throughput screening, bio-selectivity, and surface characterization.

The BEAM center will also have access to the existing intellectual property of the two institutes.

Clover Biopharmaceuticals Biomanufacturing Facility, Changxing, China

Chinese company Clover Biopharmaceuticals plans to build a new biomanufacturing facility in the Changxing Economic and Technological Development Zone (CETDZ) of Zhejiang, China.

The new facility will be used to manufacture biosimilars and biological fusion protein products such as novel drugs.

Construction is expected to begin Q2 2018 and completed by the end of 2018.

The new biomanufacturing facility will be situated at CETDZ in Changxing, Zhejiang.

Designed to develop the biopharmaceutical industrial cluster, this national economic development zone is situated at the center of the Yangtze Delta and is surrounded by 50 major cities, including Shanghai, Hangzhou, Nanjing, Ningbo, Suzhou, Wuxi and Wuhu.

The facility will be connected by one national sea-route, two national highways, two highways and three railways.

Clover Biopharmaceuticals’ new facility will be equipped with two 2,000l bioreactors provided by GE.

It will operate on GE Healthcare’s manufacturing platform FlexFactory™, a centrally automated and flexible biomanufacturing platform that enables manufacturers to establish biopharmaceutical manufacturing capacity at an existing or new facility.

The platform will enable Clover Biopharmaceuticals to meet local and global healthcare needs by quickly introducing new treatments to the market. It will also allow the company to reach global markets by complying with regulatory and quality requirements.

The platform features single-use technologies and associated process hardware, and is equipped with automation and control components for the manufacturing of biopharmaceuticals.

The new facility will be used to produce SCB-808, a biosimilar candidate of Enbrel® (etanercept) that is used for the treatment of rheumatoid arthritis.

Existing biosimilar formulations of etanercept that are already available in the Chinese market were not compared to the original Enbrel® formulation in clinical trials to test its bioequivalence. The existent formulations are also only available as lyophilized powders that need to be reconstituted by a trained medical professional before administration to patients.

The etanercept formulation being developed by Clover Biopharmaceuticals is offered as a prefilled syringe that patients can self-administer.

The company received clinical trial application (CTA) approval for conducting clinical trials on SCB-808 from the Chinese Food and Drug Administration (CFDA). Phase I clinical trials on SCB-808 biosimilar are expected to commence in mid-2018.

China has one of the world’s fastest-growing biopharmaceutical industries. Valued at $13bn in 2015, the market is estimated to grow at an annual rate of 13% over the next few years. Construction of the new biomanufacturing facility will tap into the growing Chinese biopharmaceutical market.

The Chinese Government’s 13th five-year plan focuses on biotechnological innovation and is expected to further promote the growth of the pharmaceutical market. The plan includes the development of 20 science parks for biomedicine by 2020 to fast-track local research and development (R&D) activities.

Commentary on Clover Biopharmaceuticals:

Clover Biopharmaceuticals is a clinical-stage biotechnology company headquartered in Chengdu, China. The company is engaged in the discovery, development and commercialization of transformative biologic therapies for oncology and autoimmune diseases.

The company utilizes its proprietary Trimer-Tag© technology platform for the development of novel biologics targeting trimerization-dependent pathways. The technology attacks trimerization-dependent disease targets including tumor necrosis factor (TNF) superfamily, and enveloped ribonucleic acid (RNA( virus antigens.

Ferring Pharmaceuticals’ Biotechnology Centre, Saint-Prex, Switzerland

In February 2018, Ferring Pharmaceuticals announced plans to build a new biotechnology center at its headquarters in Saint-Prex, Switzerland.

The company plans to invest more than CHF30m ($32.06m) in the center over the next three years. The facility will enable the company to expand its biologics capabilities.

The first lab of the biotech center is expected to be operational in 2019, while production of the first batch of biologics is expected to commence in 2020.

Currently in the engineering design phase, the new Ferring biotech center will be built using more than 21,520 sq. ft. (2,000m²) of existing infrastructure.

The facility will be used to develop biologic therapies in the areas of reproductive medicine, women’s health, gastroenterology and urology. It will discover and develop monoclonal antibodies (mAb), as well as manufacture biologics.

The center will also produce the active pharmaceutical ingredients (API) for Ferring’s fertility medicine Rekovelle® (follitropin delta).

Ferring’s existing Saint-Prex manufacturing site covers an area of 23,000m² and comprises production, packaging and administration facilities.

Opened in 2006, the Swiss plant manufactures two products for the gastroenterology and urology markets. The gastroenterology product is used to treat inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease, while the urology product is used to treat bedwetting in children and nocturia in adults.

The Saint-Prex manufacturing plant also serves as the main site for the company’s packaging activities. It packs more than 60% of Ferring’s products and also produces reference samples for more than a thousand finished products and two million boxes a month.

Used for fertility treatment, Rekovelle® is the first recombinant follicle stimulating hormone (FSH) derived from a human cell line. The product is administered based on a woman’s serum anti-Mullerian hormone (AMH) level and body weight.

Ferring’s Israel-based subsidiary, Bio-Technology General (BTG), is currently producing the API for Rekovelle®. The API will continue to be manufactured at BTG after the opening of the new biotech center to ensure continuity of supply for patients worldwide.

Commentary on Ferring Pharmaceuticals:

Founded in 1950, Ferring Pharmaceuticals is a privately-owned research-based specialty biopharmaceutical company. The company is headquartered in Saint-Prex, Switzerland.

The company has manufacturing sites in 11 countries, including Argentina, China, Czech Republic, Denmark and Germany. It also has ten research and development (R&D) centers in China, Denmark, India, Israel, Japan, Scotland, Switzerland and the US.

Ferring manufactures products in the areas of reproductive medicine, urology and gastroenterology and also specializes in peptide development and endocrine research. More than a third of the company’s investment in R&D is directed towards developing novel drugs for mothers and babies.

The company employs more than 6,500 people worldwide and markets its products and treatments in 110 countries. The company recorded revenues of €1.9bn ($2.27bn) in 2017.

Spinco-B&W Tek Center of Excellence Lab in India

The inauguration took place at the Spinco Towers located in Hyderabad, India. It was led by managing director of Spinco Mr. C Ravindranath and CEO of B&W Tek Dr Jack Zhou, with a gathering of distinguished customers.

The opening of the Center of Excellence Lab also included a seminar on Innovative Pharmaceutical Spectroscopy Solutions presented by B&W Tek’s very own experts.

The Spinco-B&W Tek Center of Excellence Lab will provide the South Asian Pharmaceutical and Biotech Industry with the most cutting-edge and innovative spectroscopy solutions and resources. This partnership with Spinco increases B&W Tek’s presence and localized support to provide solutions to customers with dedicated specialists at Spinco.

The center is equipped with a suite of B&W Tek’s mobile spectroscopic systems, including the award-winning STRaman® for see-through package analysis, raw material identification solutions NanoRam®, and NanoLIBS®.

Customers will benefit from the ability to work closely with Spinco for feasibility testing and demonstrations, and application development of B&W Tek’s technologies in the region. Through this initiative, Spinco will provide support and advanced training for implementation and adoption of B&W Tek’s solutions for the industry.

Desitin Implements Track & Trace Solution at Hamburg Plant

Desitin Arzneimittel has implemented Werum’s PAS-X Track & Trace as a serialization and aggregation solution at its plant in Hamburg, Germany. The company is a regional, mid-sized pharmaceutical manufacturer specializing in neurological and psychiatric illnesses including epilepsy and Parkinson's syndrome. Desitin sought a lean, powerful and easy to implement track-and-trace solution to comply with the anti-counterfeiting requirements of its various international target markets, including all EU countries.

“We opted for Werum’s PAS-X Track & Trace solution as the connector between the shop floor and the serialization level because it meets all of our requirements,” said Daniel Weniger, head of Process Engineering at Desitin Arzneimittel GmbH. “It is a proven serialization and aggregation solution that is already used successfully by many pharma and biotech manufacturers around the globe.”

Werum’s PAS-X Track & Trace solution is installed out of the box allowing for a short implementation time as well as future upgrades. Initially the system covers two packaging lines and will be extended later.

Quay Pharma Launches New GMP Suites

Quay Pharma has established specialist GMP suites at its facility in Deeside, Flintshire as part of an investment in their live biotherapeutics services.

Quay is the first UK contracting company to bring live bacteria into a finished product, and it is one of the few companies globally with the ability to handle this work on a large scale. Quay has also already become the first UK company to be granted a license to provide clinical trials materials for BSL Class II live microbes to be administered in non-sterile forms to target the digestive, urogenital, otorhinologic and pulmonary pathways.

As well as the investment in other specialist isolation technology to control the environment around the bacteria during processing, Quay is in the final stages of completing the qualification of new GMP production suites for larger scale projects.

“This is a very exciting development, and there many initiatives in their early stages,” comments Quay chief executive officer Maireadh Pedersen. “Our MHRA license and successful FDA inspection mean we are now ideally placed to help companies prepare and implement a formulation and clinical trials strategy in order to provide the appropriate dosing solution for these live biotherapeutics. We can therefore help to bring these treatments rapidly and effectively to First in Man studies and provide the critical process environment required to ensure the best chance of clinical outcome.”

CMAB Biopharma to Upgrade GMP Facilities

CMAB Biopharma has raised $34m in Series B financing to upgrade its GMP facilities – and has entered into collaboration agreements with “several” biopharma clients, says CDMO.

The funding round was led by the venture capital firm CD Capital and included participation from C-Bridge Capital, Cormorant, Qianhai FoF Fund, and Tigermed.

CMAB Biopharma Inc. (CMAB) is a full-service contract development and manufacturing organization (CDMO) providing development manufacturing services of antibodies and biologics for clients in China and globally.

According to the company, the funding proceeds will be used to upgrade its 2,000L Good Manufacturing Practices (GMP) facilities. The funds will also be used to expand manufacturing capacity and enable the company to provide 50L/200L/500L/1,000L/2,000L bioreactor scale GMP manufacturing services.

The facility, located in Suzhou’s BioBAY Park, will be able to produce pre-clinical and early-stage clinical (Phase I/II) products.

CMAB also recently announced that it has entered into collaboration agreements with several leading biopharma companies.

“This financing furthers our vision to become a fully-integrated CDMO platform providing clinical and commercial production services to the Chinese domestic and the international biologics markets,” said Qibin Liang, president of CMAB, in a press release.

Samsung BioLogics: The story of the world’s largest biologics manufacturing facility

Samsung BioLogics has moved quickly since it began operating in 2011. The South Korean contract development and manufacturing organization (CDMO) has built a series of progressively larger, more advanced facilities, culminating in its 180,000L “Dream Plant.” This facility, the largest single plant of its kind, sets Samsung BioLogics up to become the world’s biggest contract manufacturer.

The latest facility synthesizes the knowledge Samsung BioLogics gained working on its first two plants and its parent company’s experience of designing and running production sites in other industries.

At 180,000L, this new facility in Songdo, South Korea is set to become the largest single biologics plant in the world once operational. The production capacity consists of twelve, 15,000L mammalian cell culture bioreactors, which is two more than are housed at the second site. Once that capacity becomes available, Samsung BioLogics will have 362,000L across its plants, a figure expected to make it the world’s largest contract manufacturer of biologics.

Samsung BioLogics has taken steps to ensure the third plant remains efficient and agile despite its size. These steps involve the use of new technologies, most notably N-1 perfusion. This entails the use of a device that intensifies cell growth before the production bioreactor is seeded. Taking this preparative action increases initial cell densities and, in doing so, cuts the time it takes to complete a production run. Costs and operational risk are also reduced. The CDMO is adopting N-1 perfusion alongside design decisions intended to increase the efficiency of the plant.

This approach has manifested in a site designed to be run 24/7 without an annual shutdown. The maintenance and cleaning schemes developed to achieve such uptime also reduce the time it takes to switch between products and the batch losses suffered when doing so, making it an agile facility well suited to the multi-drug demands CDMOs face in the current medicine era.

Further design-driven efficiencies stem from the use of novel cleanrooms and a central core. The cleanrooms differ from those sometimes used in Europe. There, workplace quality is guaranteed by constructing plants as “cleanrooms” that make the outside visible. Samsung BioLogics thinks this restricts energy efficiency and as such it has rethought its cleanrooms in light of environmental factors. The central core is designed to further increase efficiencies by minimizing the moving line.

The rise of Samsung BioLogics

Samsung BioLogics broke ground on its third facility in November 2015 and completed construction two years later. The CDMO is now validating the facility with a view to getting it GMP ready in the fourth quarter of this year.

Those timelines continue Samsung BioLogics’ rapid progress. When the CDMO broke ground on its first, 30,000L plant in 2011, its parent company Samsung Group had no history of producing drugs. Samsung Group was, and remains, best known for manufacturing smartphones, televisions and the semiconductors inside them. Yet, the conglomerate saw an opportunity to use its experience in other industries to quickly establish itself at the forefront of the contract biologics manufacturing sector.

Drawing on the experience Samsung Group gained designing and running 25 semiconductor facilities and more than 50 petrochemical plants, the CDMO built its first biologics factory in 13 months. Validation of the facility and its six 5,000L bioreactors took an additional 12 months. The first regulatory approval came 25 months after the start of engineering runs when the FDA signed off on an inspection with zero Form 483 observations.

Plant #1 gave Samsung BioLogics mammalian cell culture capacity, a liquid fill/finish line with lyophilization capability, a quality control laboratory and a cGMP warehouse capable of storing materials at temperatures ranging from ambient down to -70℃.. However, with Samsung Group wanting to develop biologics manufacturing into a business on par with its semiconductor operation, the plant represented a proof of concept, not the culmination of its plans.

Samsung BioLogics began working on its longer-term vision while still putting the finishing touches on its first plant. Shortly after getting the first facility GMP ready, Samsung BioLogics broke ground on a second plant. At 152,000L, the second facility was designed to become the largest active single plant of its kind. Construction of the facility took 17 months, after which Samsung BioLogics spent 12 months validating the site and its ten, 15,000L bioreactors. The FDA approved the plant 19 months after the start of engineering runs, with clearance from regulators in Europe following shortly thereafter.

Samsung BioLogics has filled its growing capacity through contracts with large and small biologics companies. The CDMO won early, business-validating contracts with Bristol-Myers Squibb and Roche and has continued to add to its customer base. In February 2018, Samsung BioLogics won the first contract for its third plant, which could be worth almost $150m if the experimental biologic covered by the agreement is approved.

These contract wins reflect the capabilities of Samsung BioLogics’ plants and its approach to client satisfaction. Since its early days, the CDMO has sought to differentiate itself by adapting its activities to the needs of clients and prioritizing tech transfer through the creation of a dedicated team. This team is tasked with ensuring tech transfer, an early, critical interaction between client and service provider, goes smoothly. Samsung BioLogics has assigned industry experts with decades of experience to the team.

As the third plant advances toward GMP readiness and regulatory approval, the ability to quickly win and onboard business, as demonstrated by Samsung BioLogics over the past seven years, will be crucial.

Once the third state-of-the-art facility is operational and filled with new business, Samsung BioLogics will reaffirm the vision it started with in 2011. Back then, Samsung BioLogics envisaged drawing on experience in other manufacturing industries to quickly build large, state-of-the-art plants and win major contracts. The past seven years have demonstrated Samsung BioLogics’ ability to execute this strategy. Samsung BioLogics now aims to establish itself as the world’s leading CMO.

Content provided by Samsung BioLogics.

Idifarma Expands High Potent Capabilities

Idifarma has launched new GMP spray drying capabilities. The new capabilities will allow the contract development and manufacturing organizations (CDMO) to offer spray drying technology for highly potent drugs up to Category 4 OEL/OEB.

The Spanish CDMO, which specializes in niche and highly potent products, says it will be one of only three companies in the world offering this type of contract development and manufacturing spray drying service with the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its 4,000 sq. ft. EU GMP plant.

The new equipment, which involves a significant investment for the company, will be installed and qualified in mid-2018 and will give Idifarma spray drying capacity for niche commercial products and clinical batches.

"We are excited to announce this new service and very proud to be at the forefront of spray drying technology," said Luis Oquiñena, general manager and co-founder, Idifarma. "By making this investment, we will be able to provide contract manufacturing services for intermediate products, and for oral solid drugs we can continue until the finished dosage forms."

This announcement follows recent investment in both serialization and capsule filling capabilities and strengthens Idifarma's position as a specialized contract partner for the development and manufacturing of oral solid dosage forms, including high potency compounds and niche pharmaceuticals requiring small commercial and clinical batches.

"This investment is driven by significant client demand, with the market looking for spray drying solutions as a suitable technology to improve the bioavailability of poorly soluble drugs," said Mr. Oquiñena. "Idifarma now has all the ingredients to support our customers' spray drying projects at different scales and contribute to accelerated drug development and manufacturing timelines."

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com