PHARMACEUTICAL & BIOTECHNOLOGY

Evonik has announced a €35 million expansion of its contract development and manufacturing capabilities in North America to meet growing demand for controlled release injectable formulations. The expansion of the US and Canadian facilities, which includes the installation of a new filling line, production facilities and analytical labs, will create more than 50 jobs.

The investment plan includes the installation of automated vial filling line for advanced injectables, and the construction of a new RESOMER production building at Evonik Birmingham Laboratories in Alabama, US.

In addition, Evonik Vancouver Laboratories in Canada will double in size to meet growing demand for its liposomal formulation development and manufacturing services.

“Evonik is a global strategic partner to pharmaceutical companies seeking enabling solutions for polymer and liposome-based dosage forms,” said Don Enns, Global Head of Drug Delivery for the Evonik Health Care Business Line.”

“By increasing the production capacity of our RESOMER functional excipients and expanding our contract development and production services, we can further help customers transform their APIs into high-performance parenteral medicines.”

Birmingham Laboratories

Evonik Birmingham Laboratories (BHM) is a global center of excellence for biomaterials and polymer-based injectable dosage forms.

To further expand its range of parenteral drug development and manufacturing services, Evonik has installed an automated, custom-designed filling line for complex injectable products.

Supplied by Bausch + Stroebel and scheduled to be fully operational later this year, the modular VarioSys line will support the liquid, lyophilized or powder-filling of drugs in vial sizes of up to 50mL to be used in clinical or commercial applications.

Evonik is also constructing a new 31,204 sq. ft. (2,900 square meter) building at its BHM site that will significantly expand the global production capacity of its RESOMER portfolio of bioresorbable polymers. The new building, which is scheduled to be commissioned later this year, will strengthen Evonik’s technological and supply leadership for bioresorbable polymers and provide customers with additional dual-source supply options.

Evonik Vancouver Laboratories:

In 2016, Evonik acquired Transferra Nanosciences Inc., a CDMO specializing in the development of lipid nanoparticle-based parenteral drugs. It is now named Evonik Vancouver Laboratories.

To help meet growing demand for its advanced CDMO services, Evonik is upgrading the existing facility and adding a second adjacent building that will more than double the total size of its Vancouver site to 46,268 sq. rt. (4,300 sq. m.)

The investments, which include the upgrade of GMP manufacturing facilities and the expansion of laboratories and scale-up services, will support new and existing customer programs.

Headquartered in Germany, Evonik is deemed one of the world leaders in specialty chemicals. The company is active in over 100 countries around the world with more than 36,000 employees. In fiscal 2017, the enterprise generated sales of €14.4 billion and an operating profit (adjusted EBITDA) of €2.36 billion.

Mesquite, Texas To Receive 60-Acre ‘Wellness Village’

Construction is anticipated to begin on the initial phase in mid-2019.

The Verde at Peachtree is a new 60-acre master-planned wellness campus in Mesquite, Texas that will serve the health and well-being of the 700,000 people who live within 30 minutes of the development’s planned location.

At full build-out the development will comprise a $250+ million patient centered medical campus. The project is designed to function as a walkable village with a 25+ acre amenity center that follows the banks of a creek. The amenity center will include a series of healing gardens, walking trails, a hotel and conference center, a fitness center, and a senior living community.

The first phase of the project will include the creation of over 15 acres and up to 600,000 sf of medical inpatient, outpatient, and physician office facilities. Currently, final planning is underway to begin site work, mass grading, and infrastructure improvements necessary to tie Peachtree Road with an internal traffic circulation grid.

Verde Center at Peachtree is being developed through a partnership between Ryan Companies US, Inc., Medical Campus Group, Lang and Company, and the Peachtree Foundation, with development financing being supplemented by financial incentives provided by the State of Texas and the City of Mesquite.

Novacap to Expand Pharmaceutical Offering

Novacap, a worldwide player in pharmaceutical synthesis and advanced specialties, announced that it has signed an agreement to acquire Boston-based PCI Synthesis, a leading U.S. pharmaceutical contract development and manufacturing organization (CDMO), further reinforcing Novacap’s capabilities and offering for the pharmaceutical industry.

Located in Boston’s booming biotech and pharmaceutical hub, PCI Synthesis offers its customers a wide range of services, including process research and early stage development as well as commercial production of new chemical entities (NCEs), generic APIs and other specialty chemical products.

The company operates a R&D facility in Devens, MA, and a manufacturing facility in Newburyport, MA, and generates a turnover of $32 million. Leveraging its wide business offering and technologies, proximity to customers, reactivity and undisputed project management skills, PCI Synthesis has achieved tremendous growth over the last years, most recently closing its fifth consecutive year-to-year of double-digit growth. This has been driven by more than forty new customers and an expansion into new offerings such as GMP manufacturing for nutraceuticals and pharma foods, large-scale cryogenic manufacturing, large-scale chromatography, controlled substance development, and medical-grade polymers. The company is North America’s most awarded drug substance manufacturer and has become a strategic partner for the U.S. pharmaceutical and biotechnology industries.

The combination of the two companies will provide PCI Synthesis with additional resources to continue its development while reinforcing Novacap’s global leadership in pharmaceutical synthesis with 12 cGMP sites, 2 main R&D centers and its comprehensive range of services and technologies dedicated to clinical development and commercial manufacturing.

"This acquisition validates our strategy, resources, offerings as well as our great employees and wonderful customers. Since we started the company more than 20 years ago, we’ve continued to evolve and innovate, and by teaming with Novacap, we will continue to do so, now with access to Novacap’s deep technical expertise to better serve our customers," said Ed Price, Founder and President of PCI Synthesis.

“The acquisition of PCI Synthesis perfectly fits with our strategic roadmap as it will strengthen our offering to the pharmaceutical industry and provide Novacap with a strong and innovative platform to accelerate our development in the U.S. We have been impressed by the outstanding achievement of PCI Synthesis over the last years and its promising pipeline of projects. The two companies operate complementary CDMO activities and share common values such as entrepreneurship, operational excellence and dedication to customer satisfaction. We look forward to working with the PCI Synthesis team,” said Pierre Luzeau, CEO of Novacap.

The closing of this acquisition remains subject to customary merger control approval.

BlackArch Partners served as the exclusive financial advisor to PCI Synthesis.

Alta View Specialty Clinic, Sandy, Utah

Size: 108,000 sq. ft.

Project team: Perkins+Will’s LA studio (Head Architect)

Description: The Alta View Specialty Clinic is a 108,000 square foot, four story clinic. There are 840 patients per day, anticipated in 2017 and 1,016 projected in 2022. The new clinic will provide clinical space for a variety of primary and specialty care clinics, including family medicine, internal medicine, pediatrics, senior clinic, allergy clinic, cardiology, endocrinology, optometry and ophthalmology, InstaCare and KidsCare, physical therapy/occupational therapy and speech, podiatry, pulmonary, infusion, urology and orthopedics. In addition to these clinical areas, the new addition will provide an optical shop, cafe, educational center and clinic administration areas.

Completion date: December 2017

Vertex Opens Expanded Research Site in San Diego

Vertex Pharmaceuticals Incorporated announced the opening of its new 170,000 square foot research facility in Torrey Pines, San Diego. The new site represents a significant expansion of the company’s research presence in the area, and its continued investment in the local economy. The San Diego site is one of Vertex’s three global research hubs, and is where the company’s three breakthrough cystic fibrosis (CF) medicines were discovered.

“Our researchers in San Diego have spent the last 20 years doing what was once thought impossible – developing the first medicines that treat the underlying cause of cystic fibrosis,” said Dr. David Altshuler, Executive Vice President, Global Research and Chief Scientific Officer. “This team is a critical part of our global research effort, and the new site will allow us to continue investing in science to bring more transformative medicines to people with serious diseases.”

More than 70 percent of the new facility is dedicated to state-of-the-art lab and research space. It features a 1,500 square foot learning lab for science, technology, engineering, arts and math (STEAM) education programs, expanding on the company’s commitment to inspire and equip the next generation of leaders in science; and a 4,000 square foot incubator suite for external collaboration.

The new building, located at 3215 Merryfield Row, is LEED Gold certified and is surrounded by two acres of dedicated outdoor space. Construction of the new building was completed on schedule, in less than 18 months, and was overseen by Alexandria Real Estate. Vertex has committed to a 16-year lease to fully occupy the site.

Aldevron GMP Plasmid Manufacturing Facility, Fargo, North Dakota

In March 2018, Aldevron initiated the construction of a good manufacturing practice (GMP) compliant plasmid manufacturing facility in Fargo, North Dakota, US.

Scheduled for completion in the second half of 2018, the new facility is expected to be the world’s biggest plasmid DNA manufacturing facility.

Aldevron is a biotechnology company based in the US. It has made a $30m investment in the new facility, which is expected to double the company’s GMP manufacturing capacity and enable it to meet the growing demand for current good manufacturing practice (cGMP) products.

Aldevron’s new plasmid manufacturing facility will have a total floor space of 70,000 ft², including 17,000ft² of modular cleanrooms, which will be used for cGMP production.

The facility will also include ISO 8 and ISO 7 processing suites for cell banking and fermentation, as well as an EU-compliant Grade A product dispensing zone. The fermentation scale of the facility will range from 10l to 300l single-use systems, with provision for expansion to 2,000l in the future.

The product-dispensing and cell-banking suites will feature single-pass airflow, and the production area will feature a unidirectional personnel flow and airlocks. The cleanroom systems at the facility will be designed to provide customers with high-quality manufacturing.

The facility will also be equipped with an emergency generator back-up power, automated alarms and environmental monitoring.

The new facility will provide high-quality plasmid DNA manufacturing services using single-use fermentation (SUF) technology, which minimizes the need for costly cleaning validations and reduces the time between GMP production runs.

The plant will produce a variety of plasmid DNA catalogue items, which will be used to carry out research in mammalian cells. It will produce research-grade plasmid DNA, GMP-Source™ plasmid DNA, and GMP plasmid DNA.

The research-grade plasmid DNA is used in research applications in small, mid-size, large and high-throughput production scales, while the GMP-Source™ plasmid DNA is used as a subsidiary or critical raw material for manufacturing protein and viral candidates used in clinical trials.

Aldevron provides a range of customized GMP plasmid DNA services ranging from early research to commercial supply.

US-based cleanroom expert AES Clean Technology was contracted to design and construct the new GMP plasmid manufacturing facility.

Marketing commentary on Aldevron:

Headquartered in Fargo, North Dakota, Aldevron was initially established as a small laboratory in the North Dakota State University in 1998. It later expanded into a biotechnology firm specializing in the production of nucleic acids, proteins, plasmids, RNA, gene editing enzymes and antibodies.

Aldevron provides clients with critical raw materials and key components, which are used for a wide range of research, pre-clinical, clinical, diagnostic and commercial applications, including gene therapy, gene editing and immunotherapy programs.

The company’s client base spans from some of the largest pharmaceutical companies to small start-ups.

Its Fargo site spans seven acres and includes a 50,000ft² GMP facility.

Fresenius Kabi’s Pharmaceutical Manufacturing Facility Expansion, Melrose Park, Illinois

In August 2016, German pharmaceutical company Fresenius Kabi announced a proposal to expand its pharmaceutical manufacturing capabilities at the Melrose Park village site in Illinois, US.

The expanded facility will be used to produce generic sterile injectable pharmaceuticals for hospitals and clinics across the US.

Construction commenced in September 2017 and the facility is expected to be fully operational by 2026. The expansion will create new jobs for construction and highly skilled workers in Melrose Park.

The expansion will see the construction of new buildings at Fresenius Kabi’s existing 124,267ft² plant In Melrose Park, which was built in 2008 at 2020 N Ruby St.

The site is located in a general industrial area in the outskirts of Chicago, five miles away from the O`Hare International Airport. It employs approximately 700 people.

The plant currently produces a wide range of generic injectable medicines for the treatment of critically and chronically ill patients.

Fresenius Kabi will add four new buildings to the site, with a total floor space of 130,000ft². The facility will include space for highly automated manufacturing, offices, warehousing of materials, and utilities.

The expansion is expected to support the production of injectable drugs used for anesthesia, pain management, cancer treatment and eliminating infections. The project will be completed to meet the latest regulatory and quality requirements.

The new facility will be equipped with a state-of-the-art urban manufacturing campus, including fully-automated aseptic filling lines and sophisticated isolator technology, as well as expanded freeze capabilities and formulation areas. It will also include a dedicated warehouse for raw materials and components, alongside an administration building with a conference center, laboratories, office spaces and a cafeteria.

The multi-stage, multi-year project is expected to be completed in ten years, with an estimated investment of $250m.

Fresenius Kabi is expected to receive $15m in tax-increment financing subsidies from Melrose Park village if it spends at least $80m on the expansion. The company is also expected to obtain subsidies for water usage, while Cook County will offer a 12-year property tax reduction.

Fresenius Kabi will also receive state tax credits for the expansion from the Illinois Department of Commerce and Economic Opportunity.

The new facility at the Melrose Park site was designed by CRB.

Gilbane Building Company was awarded the general construction contract for the new facility.

Marketing commentary on Fresenius Kabi:

Headquartered in Germany, Fresenius Kabi is a global healthcare company engaged in the development of medicines and technologies for infusion, transfusion and clinical nutrition.

Fresenius Kabi’s US headquarters is located at Lake Zurich, Illinois. The company’s pharmaceutical manufacturing centers are located at Bensenville, Skokie, Lake Zurich, and Melrose Park in Illinois. It also has manufacturing sites in New York, North Carolina and Pennsylvania.

The company’s US manufacturing sites mainly focus on the development of pharmaceuticals, but also manufacture medical devices and clinical nutrition products. Fresenius Kabi has a total workforce of approximately 2,500 people across the country.

Thermo Fisher Opens U.S. Precision Medicine Science Center

Thermo Fisher Scientific has opened its U.S. Precision Medicine Science Center (PMSC) in Cambridge, MA. The center offers access to advanced "omics" technologies and expertise to help collaborators develop analytical workflows that generate precise molecular profiles of patients. This information will ultimately be used in clinical settings to more effectively treat disease.

In addition, the company said the PMSC's team of in-house scientists helps partners develop standard protocols that enable them to compress R&D timelines and quickly progress from biomarker discovery to assay development. The team includes Thermo Fisher experts in biochemistry, mass spectrometry, molecular biology and data science.

"For health and science innovators, a bottleneck exists today between the discovery of biomarkers and their widespread use at the point of care," said Emily Chen, senior director, Thermo Fisher Precision Medicine Science Center. "Our goal at the PMSC is to remove that bottleneck and help scientists and physicians reduce the time it takes to demonstrate clinic validity and utility."

"Precision medicine needs to be based on high-quality data, and proteomics is central to that," said PMSC collaborator Jennifer Van Eyk, Cedars-Sinai Medical Center in Los Angeles. "Our work with the team at the PMSC is helping us accelerate the important journey from discovery to patient care."

The PMSC offers access to advanced technologies spanning genomic, proteomic and metabolomic analysis. From analyzing genomic data with next-generation sequencers to identifying proteins and metabolites using advanced mass spectrometry, collaborators can rapidly move from research to clinical workflow development. With support from the PMSC, scientists can:

Put complex analytical technologies at the center of simplified workflows;
Generate reproducible research with an emphasis on scalability and, ultimately, clinical utility;
Enable processes that produce the highest quality data, consistently;
Change the culture of method sharing so a larger community can benefit; and
Overcome lack of technical expertise as a barrier to discovery by quickly accessing the best tools and skillsets needed.

In 2017, Thermo Fisher opened its Precision Medicine Science Center in Guangzhou, China. Like the PMSC, the Guangzhou Center serves as a hub for partners seeking to establish standardized precision medicine platforms as well as for joint research and development.

Wuxi Biologics to Launch in US

WuXi Biologics has announced plans to build a $60m manufacturing facility – offering continuous manufacturing options – for clinical and commercial production in the US.

The Chinese contract development and manufacturing organization (CDMO) will invest $60m (€51m) in the Worcester, Massachusetts-based site and hire approximately 150 employees.

The so-called “factory of the future” will house approximately 4,500L bioreactor capacity, with two 2,000L traditional fed-batch and one perfusion-based for continuous processing.

“Based on what we understand on the competition, this is likely the first GMP [good manufacturing practice] facility offering continuous manufacturing option,” CEO Chris Chen said.

The facility – which Chen said is located within two hours of a number of WuXi Biologics partners – responds to the global demand for increased manufacturing capacity.

“We have a growing portfolio of 161 molecules to be developed from global clients as of Jan 1 2018. Based on progress of the pipeline we know when we need capacity and how much we need. We then plan it in our global manufacturing network,” he explained.

According to Chen, the passing of the Tax Cuts and Jobs Act of 2017 – which reduced the US corporate tax rate from 35% to a flat 21% - also makes the US an attractive option for investment.

“[The] lower tax rate definitely makes the investment thesis much stronger than last year,” he said.

The investment marks WuXi Biologics’ eleventh drug substance manufacturing facility globally and its third outside of China.

In late April this year, the firm said it planned to build a biologics manufacturing facility in Ireland. The following month, WuXi Biologics announced plans to expand manufacturing to Singapore with the construction of a $60m facility.

Eisai to Launch Center for Genetics Guided Dementia Discovery

Eisai will launch the Eisai Center for Genetics Guided Dementia Discovery, which will harness the power of human genetics to develop next-generation medicines for Alzheimer's disease (AD) and other dementias. Guided by emerging insights from human genetics, coupled with Eisai's recognized strengths in neuroscience and novel chemistry, the Center will specialize in immunodementia drug discovery.

It will be located in a new, dedicated state-of-the-art facility in Cambridge, Mass. Eisai plans to commit over $100 million as an initial investment to establish the new discovery center over the first three years, and anticipates substantially increasing funding as its pipeline develops.

"By focusing on human genetics, our discovery labs have recently made rapid progress towards the next horizon of targeted immunodementia medicines. Recognizing this advancement, Eisai plans significant investment over the next 10 years in dedicated research funding to further accelerate human genetics-guided drug discovery at the new Eisai Center for Genetics Guided Dementia Discovery in Cambridge," said Ivan Cheung, chairman and CEO of Eisai Inc. "With this commitment to R&D, our robust pipeline and Eisai's successful legacy in AD treatments, we believe we will be able to accelerate our efforts towards identifying the next-generation of dementia therapeutics to help millions of patients and their caregivers."

The new 50,000-square-foot facility is being constructed in the Alewife Research Center in Cambridge, and is expected to be fully operational in early 2019. At that time, Eisai will close its current site in Andover, Mass., and transition operations to the new Center in Cambridge. Nadeem Sarwar, president of the Andover Innovative Medicines (AiM) Institute, will lead the new site.

The Center will be organized around four key functions: data sciences, immunodementia, discovery technologies, and precision chemistry.

"Innovations in human genetics and related sciences enable the discovery and development of novel therapeutics with increased odds of success. Over the last two years, at the AiM Institute as well as through our network of external collaborators, we have focused not only on how human genetics can help identify and validate therapeutic targets and their biomarkers, but also guide novel chemistry approaches to drug such targets," said Sarwar.

"This integrated approach has yielded exciting drug discovery progress in a short time-frame, especially for immune targets in pathways highlighted by human genetics. Creation of the new Center in Cambridge provides Eisai with the opportunity to build upon these successes and take a leadership position in human genetics-guided drug discovery. We will apply our unique novel precision chemistry approach in the context of human genetics to deliver tailor-designed small molecule and anti-sense oligonucleotide solutions. Our goal is to discover next-generation targeted immunodementia therapies to complement and go beyond targeting A-beta and tau."

The Cambridge biotech hub location has been strategically selected to enable Eisai to focus on and identify new scientific and business relationships for drug discovery, while providing the company with greater access and flexibility to foster its current collaborations with research institutes and strategic partners. Eisai already has a presence in Cambridge through its subsidiary H3 Biomedicine, a clinical stage biopharmaceutical company specializing in precision cancer therapeutics.

According to statistics from the Alzheimer's Association, AD currently affects more than 5.7 million people in America, and results in an estimated $277 billion cost to the nation. Over 14 million Americans are predicted to be living with Alzheimer's by 2050, which would have an estimated $1.1 trillion cost to the U.S.

Q Laboratories Opens New Lab Facility

Q Laboratories has opened its new 30,000-sq.-ft. lab in Cincinnati, OH. Completion of this new facility combined with the purchase of two existing buildings on adjacent property will comprise the Q Laboratories Campus allowing for continued growth and a more efficient workspace for its 130+ employees. With this expansion the company’s total square footage grows from 25,000 to 55,000, with plans to expand again in three to five years.

David Goins, chief operating officer, has been with the company for more than 29 years and has seen the company grow from a small regional firm to a large organization serving companies around the world. “We have been fortunate to have a fantastic team that has enabled us to continue to grow,” Mr. Goins said. “Opening this beautiful new building is a testament to the dedication of all of our employees and the excellence they bring to the lab each and every day. This is a proud day for all Q Laboratories employees, past and present. With any successful business, it takes talented personnel to make it work. Q Laboratories history is filled with exceptional people doing extraordinary work.”

Founded in 1966, Q Laboratories provides microbiology, analytical chemistry, and research and development laboratory services to the pharmaceutical, cosmetic, health and beauty care, and dietary supplement industries. The lab offers quality control and testing services for manufacturers and distributors, including method development and validation, pathogen detection, elemental impurities analysis, raw material qualification, microbial identification, and stability studies.

LSNE Announces Acquisition of PSC Biotech’s Parenteral Manufacturing Facility

April 23, 2018, Bedford, NH – Lyophilization Services of New England (LSNE), a leading contract development and manufacturing organization (CDMO), announced that it has acquired PSC Biotech’s cGMP aseptic fill finish manufacturing facility located in Madison, Wisconsin. This acquisition allows LSNE to expand its manufacturing capabilities, add new service offerings and accommodate its customers’ project timing requirements. The new facility will be called LSNE-Madison. Financial terms of the transaction were not disclosed.

LSNE-Madison is a 37,000 square foot multi-product facility that will be used for the manufacturing of final drug products for pre-clinical to Phase III/commercial use. The facility currently includes a high speed, automated aseptic fill line and a 144-square foot lyophilizer with existing space for additional equipment and the ability to expand to over 100,000 square feet of production space over time.

The facility will complement LSNE’s existing full-service parenteral manufacturing capabilities, which include vial filling, lyophilization, process development, QC analytical, secondary packaging, stability studies and regulatory support for clinical and commercial products at its three other FDA-inspected manufacturing sites. This new facility will also increase LSNE’s capabilities to include the terminal sterilization of final product and additional quality control services.

“This acquisition is a key part of our strategic growth plan to increase our operations and capacity and better serve our customers,” said Matthew Halvorsen, Chief Executive Officer at LSNE. “We have experienced strong growth and increased demand over the last few years, and as the market continues to expand, we know it is imperative to be able to offer increased scheduling flexibility to existing and new clients. With the support of the Permira Funds, we are increasing our capacity to provide our clients with additional manufacturing redundancy backed by the outstanding level of service that LSNE is known for.”

“With this acquisition, we are gaining strong talent that complements LSNE’s experienced and successful teams,” says Shawn Cain, Chief Operation Officer at LSNE. “We look forward to working with the staff to build LSNE-Madison into a world class aseptic fill/finish facility focused on the manufacturing of lyophilized and liquid drug products. “

LSNE anticipates full manufacturing activities to commence later this year, following a short period of renovation and validation of the facility. Additional information regarding the acquisition and capabilities will be available on LSNE’s website.

About PSC Biotech

PSC Biotech is global life sciences technology company serving customers in North America, Europe, Asia, South America and the Middle East. PSC Biotech provides professional technical services such as commissioning, qualification, validation project management, regulatory affairs, quality, compliance, conceptual engineering, Information Technology, metrology services, computerized system validation, etc., to life science, pharmaceutical and software companies. It also provides world class enterprise quality management software solutions – Adaptive Compliance Engine™ (ACE) and AuditUtopia™.

About LSNE

LSNE is a privately held company with four GMP facilities – three located in New England and one in Madison, WI. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill finish, and lyophilization. Through the thoughtful integration of four processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.

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.

Mayne Pharma Opens Oral Solid Dose Facility

The 126,000 sq. ft. facility quadruples Mayne Pharma's capacity to manufacture oral solid-dose pharmaceuticals in the US.

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" He added, “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:

Single-pass air and multiple distinct and strategically placed airlocks for gowning, material and equipment;
Segregated product corridors;
100-percent HEPA-in and HEPA-out filtered air;
Dedicated quality control laboratories; and
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.

REST OF WORLD

Telstar Wins Baccinex Design and Build Contract

Pharma CMO has awarded Telstar the design and build contract for an aseptic filling process plant in Switzerland.

Baccinex, a full-service pharmaceutical contract manufacturing organization (CMO) that specializes in the fill and finish of sterile lyophilized or liquid dosage forms, has entrusted Telstar with the design and construction of a cleanroom installation to accommodate an aseptic and lyophilized filling process line. The project expands Baccinex’s existing manufacturing plant in the Switzerland region of Jura near France.

The new building, which will be completed in 2019, includes approximately 10,760 sq. ft.

(1000 m2) devoted to the production of sterile pharmaceutical batches for clinical trials. The turnkey project, equipped with a fully automatic aseptic filling line, comprises a vial washing machine connected to a depyrogenation and sterilization tunnel, and a vial filling machine — operating under laminar flow — that’s equipped with a restricted access barrier system (oRABS).

Vials are transferred to two freeze-dryers with automatic loading systems via a conveyor belt; a subsequent capping machine completes 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 a number of auxiliary manufacturing processes, including raw material dispensing, compounding, washing and preparation for the sterilization process. The state-of-the-art plant design derives from specific requirements to implement oRABS isolation technology and minimize the risk of product contamination.

The scope of the project involves conceptual, basic and detailed engineering, the construction of a new manufacturing area and the provision of pharmaceutical production equipment — almost entirely designed and manufactured by Telstar. It also covers cleanroom architecture, an HVAC system fitted with integrated decontamination technology, critical utilities (highly purified water, water-for-injection [WFI], pure steam and nitrogen gas), non-critical utilities (compressed air, softened water, chilled and hot water, industrial steam), electricity and the entire automation system, which controls the HVAC process, decontamination and particle monitoring system, among others. The new plant will also be fitted with two liquid nitrogen freeze-dryers with automatic vial loading and unloading systems — operating under laminar flow oRABS — and two autoclaves used for material sterilization and, when required, terminal product sterilization.

Ten items of containment equipment have been purchased, including weighing booths, pass-through boxes with an integrated biological disinfection system, and laminar air flow cabinets.

Telstar will also perform and manage the validation process, including risk analysis, design qualification (DQ), commissioning, installation qualification (IQ), operation qualification (OP) and performance qualification (PQ), as well as providing support services for quality assurance.

The company, a specialist in the development of aseptic manufacturing facilities, undertook both the design and complete execution of the project, from concept to final validation, as well as supplying equipment that has been designed and manufactured using in-house technology.

Having completed the engineering, design and equipment definition phases in May 2017, the project was awarded in July 2017 and is expected to be completed during the first quarter of 2019.

Taking GMP compliance and the latest industry trends into account, the design of the new plant benefits from integrated energy efficiency systems that both generate power and save money. And, prompted by the newly revised European Pharmacopoeia monograph 169 on WFI, which, since 1 April 2017, allows water to be obtained by non-distillation methods, Telstar has implemented a WFI generation system that uses reverse osmosis and ultrafiltration in the new plant. The facility can also product WFI by distillation when and if required.

Cherwell Laboratories Completes Transition to ISO9001:2015

Cherwell Laboratories, UK-based manufacturer of Redipor prepared media and supplier of environmental monitoring solutions, has successfully completed the migration of its quality management system to the new ISO9001:2015 version. This enhancement affirms that Cherwell is operating to stringent quality assurance and manufacturing standards, enabling its pharmaceutical customers to have complete confidence in the company’s range of cleanroom microbiology products.

The British Standards Institute (BSI) assessed the quality management system at Cherwell during two surveillance visits in November 2017 and May 2018, raising only two very minor issues that required attention and which were addressed rapidly.

Managing Director at Cherwell, Andy Whittard commented, “Our business has always been focused on delivering high quality products for our customers. We were keen to ensure that the new version of ISO9001 helped us improve our systems and therefore our offering to our customers. Our experienced in-house quality team have spent the past 18 months working on this project ensuring we attain value from the process.”

Cherwell’s clients are mainly within the pharmaceutical sector, operating to the rigorous standards laid out in Good Manufacturing Practice (GMP). These customers demand high quality and as such any supplier must have robust procedures and processes in place. The 2015 version of ISO9001 quality management places greater emphasis on the leadership of the business and risk assessment to understand issues that could affect the business.

Steven Brimble, Quality Manager at Cherwell added, “The quality team at Cherwell were keen to ensure not only a smooth transition to the new standard, but also to seek improvements in our current procedures. Along with the deployment of Q-Pulse to manage complaints; audit findings; non-conformities and document control; our enhanced quality management system provides a sound basis for Cherwell going forward.”

Cherwell’s product offering includes the Redipor range of prepared media which it has been manufacturing at its Bicester facility for over 30 years. Developed to service industrial markets, the range offers flexibility, reliability and choice for users and includes a selection of petri dishes, settle plates, bottled media, injection vials and DIN bottles, broth bags and ampoules. Cherwell has a strong understanding of users’ needs and an ability to offer bespoke products as a solution to help resolve issues.

Tudertechnica Builds Cleanroom for Silicone Hose

Italy's hose manufacturer Tudertechnica has announced a US$8 million investment to add 40,000 sq. ft. to its factory in Padua. The project includes a cleanroom for silicone hose.

The expansion centers on adding 20,000 sq. ft. cleanroom that will be used to produce silicone hose for the pharmaceutical, cosmetics and food industries.

The addition will bring the total space at the Italian facility to about 100,000 sq. ft.

Andrea Deregibus, general manager and CEO, has said the cleanroom will be built to ISO 8 classification and that the remaining space will be available for future expansion plans.

With construction scheduled for completion by the end of June, Tudertechnica expects that the cleanroom and machinery to be installed around the beginning of October to allow full production to start by the end of the year.

Tudertechnica will have the capability to produce 130-foot long hose in the cleanroom, much longer than the current industry standard of about 20 ft.

The expansion plan is part of Tudertechnica's five-year strategy.

According to Deregibus, the three target markets the company serves have trends calling for more safety in its products. The company also estimates that the food industry, in particular, will be in need of more silicone hose in the coming years.

Tudertechnica will market these hoses through its distribution channels, for which it is seeking suitable partners to join.

"We need someone who is professionally prepared, with very good skills in silicone and the application in order to sell our solution in the correct way, which is a really high level," Andrea Compostella, marketing and sales manager, said. "We believe this is the way that will bring us more results. It also gives the opportunity to the distributor to have a stronger relationship with the end user, who will decide to start with this new solution."

Tudertechnica has started this process, identifying some prospective candidates in Europe, and will continue with this in North America, Asia and other parts of the world.

In recent years, Tudertechnica has seen growth with silicone and rubber-covered PTFE hoses with volumes more or less doubling every two years.

Deregibus said, "This is the right moment. The investment must be made when the market is up to be ready to take opportunities for the future."

Tudertechnica expects to add some new products to the PTFE lines by the end of the year. Deregibus said the new portfolio will have "immediate impact on the market".

In line with Tudertechica's strategy for growth the company is set to focus on the North American, European and Chinese markets.

Currently, 20% of sales for Tudertechnica come from Italy. Other parts of Europe account for 40%. Deregibus projected sales for 2018 will be closer to US$23 million.

Sanofi Expands R&D in China with Chengdu Hub

Sanofi will support development of polypeptides, gene therapy, monoclonal antibodies and multi-specific antibodies through the expansion of its R&D plant in Chengdu, Sichuan province, China.

Sanofi China said it would invest €66m ($77m) in an R&D site to focus on digitalization and big data analysis of clinical trial data, in Chengdu, Sichuan province. The Chengdu Hub site will manage clinical trial data and files for Sanofi’s pipeline, which targets therapeutic areas including diabetes and cardiovascular diseases, oncology, vaccines, and rare diseases.

According to the French drugmaker, “the Hub will accelerate the availability of trial results, from Phase I to Phase IV…[and] leverage global cutting-edge biological technology for polypeptides, gene therapy, monoclonal antibodies and multi-specific antibodies.”

Sanofi plans to employ approximately 300 local R&D experts at the site over the next 18 months.

The Chengdu Hub will join Sanofi’s Asia-Pacific R&D Centre in Shanghai – which opened its doors in 2010 – and 11 regional offices across the firm’s growing Chinese network.

China is the ‘third pillar’ of Sanofi’s global clinical sciences and operations, after France and the US, the firm said in a statement.

"Our goal is to link China's innovative achievements with the global ecosystem and develop innovative drugs in China that could benefit patients around the world," global head of Sanofi R&D operations Zhang Ji added.

Tot Biopharm Launches Mab Manufacturing Plant in China

Tot Biopharm has opened its second monoclonal antibody (mAb) production plant in Suzhou Industrial Park, China.

The Chinese biopharmaceutical company has launched a 16,000L capacity mAb production site with upstream R&D, pilot-scale, clinical, and commercial production facilities.

Tot Biopharm will also use the 139,880 sq. ft. (13,000m² plant )– which houses lyophilization capabilities for antibody-drug conjugates (ADCs) – for commercial-scale production of both biologic and small molecule drugs.

The company initiated construction in 2016 in response to growing demand for oncology drugs. The firm planned to install disposable bioreactors and processing systems to build five production lines with a cell culture capacity of 2,000L.

The firm’s specialized cancer drug production plant, including a 500L biologic pilot plant, a BSL-2 certified viral facility, an OEL-5 isolator for ADCs, and a small molecule site, was completed in 2012.

The new mAb facility joins a growing number of antibody production plants in China. Germany-headquartered Boehringer-Ingelheim launched its mammalian cell culture facility in Pudong, Shanghai last year, and in January announced it had made its first commercial mAb – BeiGene’s tislelizumab – at the facility.

Boehringer Ingelheim Consolidates with Biologics Centre

Boehringer Ingelheim says Germany-based biologics development facility will support both its research pipeline and contract manufacturing business.

Boehringer Ingelheim has announced plans to invest €230m ($269m) in a Biologics Development Centre (BDC) at its R&D site in Biberach, Germany. The facility – set to launch in 2020 – will house analytical, process development, and manufacturing capabilities for biologics.

According to the Germany-headquartered firm, the site will ‘free up’ capacity for its contract manufacturing business: “In the BDC we will conduct development for biologics from both our research pipeline as well as biopharmaceutical contract manufacturing,” said spokesperson Matthias Reinig.

“As overall development capacity will increase, more resources overall can be dedicated to contract manufacturing development,” he added.

The BDC will bring development activities – currently “spread over various places” at Biberach – together, Reinig explained: “With the BDC, they will locate under one roof while adding another 100 staff to further extend capacity.”

The investment is the latest in a series of biopharmaceutical facility expansions for Boehringer Ingelheim. In 2017, the firm broke ground on a €700m mammalian cell culture production plant in Vienna, Austria, and opened a contract biomanufacturing plant in Shanghai, China.

In addition, in July 2017, the firm announced plans to expand, upgrade, and increase headcount at its biologics manufacturing facility in Fremont, California.

Umicore API Facility Passes cGMP Audit

The plant manufactures four oncology APIs produced for global markets according to the latest international guideline

Umicore’s Active Pharmaceutical Ingredients facility in Pilar, Buenos Aires, successfully passed its second cGMP audit by the US Food and Drug Administration.

The Auditor acknowledged that both the production area and the associated documentation were well maintained, rewarding Umicore’s constant focus on the quality of its production processes and systems.

Umicore manufactures in Pilar cisplatin, carboplatin, oxaliplatin and arsenic trioxide: four oncology APIs produced for global markets according to the latest international guidelines. It additionally exclusively manufactures a few high potency APIs under customer contracts. The facility in Pilar opened in 2009 and offers high quality products, professional services – such as exclusive development and synthesis and regulatory support or IP management and strategy.

CellGenix Expands Germany HQ

CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, successfully completed the first phase of its headquarters’ expansion as more customers approach late-stage clinical development and commercialization.

In a first step, the company added additional space to its headquarters in Freiburg, Germany. Quality control, research and development laboratories as well as logistics and warehouse space have already been put into operation. As the next step, a state-of-the-art, automated filling and freeze-drying line will be implemented in the existing GMP facility increasing finished product capacity for recombinant proteins by more than tenfold. This second phase of expansion is expected to be completed in the spring of 2019.

Positive clinical data, a supportive financing climate and clearer regulatory requirements have led to a strong growth in the cell and gene therapy space. This is predicted to persist. The building extension allows CellGenix to continue meeting the increasing demands for GMP-grade raw materials as more and more promising cell and gene therapies approach market authorization and commercialization.

“We are really excited about our new facility and the additional flexibility it provides. It supports our goal to become a key provider in the fight against disease, the preferred supplier of raw materials and tools and trusted partner for large scale manufacturing in the cell, gene therapy and regenerative medicine space. The expansion of our facility is a result of the robust, sustainable and profitable growth we achieved over the last years,” says Prof. Dr. Felicia Rosenthal, chief executive officer of CellGenix.

WuXi Biologics Expands with ADC Build in China

WuXi Biologics has started building its antibody-drug conjugate (ADC) center in Wuxi City, China, where it will offer biologics conjugate services for clients.

Chinese contract development and manufacturing organization (CDMO) WuXi Biologics has initiated construction of a 645,600 sq. ft. (60,000 square meter) ADC solution center near Shanghai, China.

ADCs are composed on an antibody linked to an active cytotoxic payload. Traditionally, ADCs have been used to target and kill cancer cells, but are also being developed to target antimicrobial and anti-inflammatory targets.

The $20m (€17.2m) facility – first announced in December 2017 – will offer services from "concept to commercialization" for biologics conjugates, including ADCs and other protein conjugates, when it opens next year.

According to the firm, the site will become a "world-class" ADC research and development and manufacturing platform, which aims meet US, EU and Chinese current good manufacturing practice (cGMP) standards.

“In collaboration with chemistry division of WuXi AppTec Group, WuXi Biologics is one of the few global companies that can provide the one-stop service to global partners for antibodies, small molecule payloads, ADC drug substance and drug products,” CEO Chris Chen said in a statement.

The center will join WuXi Biologics’ single-use mammalian cell culture site, monoclonal antibody (mAb) continuous process laboratory, and WuXi AppTec’s antibody discovery and development laboratory in Wuxi city.

Earlier this year, WuXi Biologics announced plans to expand manufacturing for clinical and commercial production in Northern China, Ireland, Singapore, and the US.

Investment in Scotland to Strengthen the UK’s Place in the Global Pharma Industry

A new £56 million UK innovation center, which will revolutionize how medicines are manufactured, is to be located in Renfrewshire.

Protecting future generations by bringing new medicines to market safely and quickly is one of the biggest health challenges facing the world today.

A world-first, the new industry-led Medicines Manufacturing Innovation Centre (MMIC) will offer pharma companies, from start-ups through to multinational organizations, a unique service to develop and adopt novel manufacturing techniques to adapt into their own manufacturing processes. By transforming processes and technologies, the speed of bringing new drugs to market could improve drastically.

With a global market worth £98 billion, this investment will help put the UK, and Scotland, at the forefront of technology and innovation in small molecule pharmaceutical and fine chemical manufacturing which still makes up the bulk of how new medicines are made. The pharmaceutical sector in Scotland employs 5000 people directly and supports a further 16,500 jobs.

Supported by Scottish Enterprise (£15 million), UK Research and Innovation, through Innovate UK (£13 million) GSK and AstraZeneca (£7 million each), the MMIC is one of the early projects across the UK to receive funding from the UK’s Industrial Strategy Challenge Fund.

Benefiting companies right across the UK, industry has played a key role in shaping and developing the MMIC to ensure its success.

The new center will be positioned next to the £65 million National Manufacturing Institute for Scotland (NMIS) and at the heart of an Advanced Manufacturing Innovation District. The MMIC aims to attract over £80 million of R&D investment by 2028 and will create 80 high value jobs directly by 2023. Up to 90 jobs will also be created or retained in companies involved in the design and build phase and post-construction.

Indirect employment will be generated through start-ups, SMEs and large companies that will grow their businesses using the transformative manufacturing technologies developed within the MMIC.

Scottish Government Minister for Business, Innovation and Energy, Paul Wheelhouse, said: “I am delighted that the Medicines Manufacturing Innovation Centre (MMIC) will be located in Scotland, given its potential to become a global center of excellence and bringing significant benefits to Scotland’s economy. The location of the MMIC is also a very positive endorsement of Scotland’s Life and Chemical Science sectors and will build on our internationally recognized strengths in both Research and Development and manufacturing.

“Scottish Enterprise, on behalf of Scottish Ministers, is investing £15 million in the MMIC helping to fulfill the vision of Scotland’s Life Sciences Strategy. This will help to make Scotland the location of choice for the life sciences community and help us grow the industry’s contribution to the Scottish Economy by 90%, to £8 billion by 2025.

“As well as helping to attract further manufacturing investment to Scotland, the Centre will also be well placed to support new business start-ups and spin-outs and enable established life and chemical science companies to profit from innovation.

“Whilst the Centre will be located within the Advanced Manufacturing and Innovation District in Renfrewshire, alongside the National Manufacturing Institute for Scotland, we are taking a range of steps to ensure that the Sector across the whole of Scotland is able to benefit from the project.”

UK Government Minister, Lord Duncan, added: “This is great news for the UK’s Life Sciences sector and especially important for Scotland in re-enforcing its global reputation as a center for cutting edge scientific endeavor. We need more new medicines to tackle deadly diseases more quickly and through our modern Industrial Strategy we want to see more of this world leading research and manufacture done here in the UK, bringing highly skills jobs and greater prosperity with it. The UK Government has provided significant backing to this project, with UK Research and Innovation investing £13 million through the Industrial Strategy Challenge Fund.”

Linda Hanna, Managing Director at Scottish Enterprise, said: “We are delighted to welcome the new MMIC to Scotland. There is no other facility like this in the world and is a fantastic endorsement of Scotland as an ideal place to invest in global excellence in high value manufacturing drawing on our skills, innovative companies and academic expertise.

“Industry leadership and co-investment has been central to shaping this center and will remain at the heart of what makes it a success, providing a platform for companies right across the UK to collaborate, innovate and develop world-leading medicine manufacturing processes and technologies.”

Ian Campbell, Innovate UK Interim Executive Chair, said: “This is a fantastic investment for the UK, and especially for Scotland, as we look to place cutting-edge innovation at the heart of tackling some of society’s greatest 21st century challenges.

“UK Research and Innovation is leading the charge to bring the UK government’s modern Industrial Strategy to life – translating research into commercial success, building on our industrial strengths and sustaining economic prosperity across our communities. Our job at Innovate UK, working within the UK Research and Innovation family, is to help good ideas become great businesses delivering products and services which change lives for the better.

“The new MMIC promises to enhance Scotland’s reputation as a trusted center for high value manufacturing, while transforming the UK’s standing within the global pharmaceutical industry.”

Dr Dave Tudor, Chair of the Scottish Life Sciences Industry Leadership Group, and Vice President, Head of Global Manufacturing and Supply Strategy for GSK, said: “Industry, government, academia and others are working together to secure an internationally competitive leadership position for the UK in life sciences for the long-term. GSK has long advocated the value of collaborations like the Medicines Manufacturing Innovation Centre to capitalize on our world-class science base and deliver innovation that drives growth and improves patient care. As the UK’s largest life sciences company and one of its biggest investors in research, we are delighted to have an active involvement in this new Centre.”

Andy Evans, Chair of the Medicines Manufacturing Industry Partnership (MMIP) and Head of Macclesfield Site for AstraZeneca, said: “The UK must remain a globally attractive and competitive location for advanced medicines manufacturing as this is key element in our economy making a very significant contribution to our exports. Enabling the growth of medicines manufacturing is hence a key part of a successful Life Sciences Industrial Strategy and the MMIP is pleased to see this combined investment between Business and Government in manufacturing innovation.

“For AstraZeneca, our research activities in Cambridge are complemented by our strong presence in the North West of England which is a location for innovation, where our development scientists’ partner with experts in high-tech manufacturing to turn molecules into new medicines. We are very pleased to be a founding partner in the new MMIC, along with others across industry and the Scottish and UK governments. Our ambition is for patients worldwide to benefit from the accelerated adoption of emerging and novel medicine manufacturing technologies developed in the UK.”

The MMIC will be led by the Centre for Process Innovation (CPI) in partnership with the University of Strathclyde’s Centre for Continuous Manufacturing and Crystallization (CMAC) and the Medicines Manufacturing Industry Partnership (MMIP).

Nigel Perry MBE FREng, Chief Executive Officer at CPI, said: "The Medicines Manufacturing Innovation Centre will enhance the UK’s existing competitive advantage by deepening the skills base and strengthening the rationale for companies to invest in new, highly productive medicines manufacturing.

“CPI is delighted to be working alongside the University of Strathclyde, Innovate UK, Scottish Government and our industry partners to deliver this globally unique center that will prepare the pharmaceutical supply chain for vital, next generation medicines and further extend CPI’s healthcare capabilities.”

Professor Sir Jim McDonald, Principal of the University of Strathclyde, said: “Strathclyde has earned an international reputation for research and innovation that accelerates and enhances the manufacturing of medicines and pharmaceuticals. As strategic partners in MMIC, we will have an enhanced role in supporting industry to deliver urgently-needed medicines both swiftly and effectively. The challenges of health are among the biggest facing today’s world; they are changing rapidly and continually and medicine must keep pace with them to provide solutions. MMIC will provide world-class talent, research capability, technology, facilities, knowledge and experience to industry to ensure these challenges are met.”

Mike Thompson, CEO of the Association of British Pharmaceutical Industry (ABPI), said: “This is a strong signal of intent from Government and the pharmaceutical industry that they are ready to get behind the UK as a global leader in medicines manufacturing.

“Medicines manufacturing is no longer the siloed, labor intensive process of yesteryear. This cutting edge center instead provides a unique space for academics, research scientists and manufacturing partners to work side by side designing new ways to transition the medicines of the future out of development and in to the supply chain.

“Global pharmaceutical companies are already excited about UK science, our world leading Universities and unique research centers and this facility means we now have a manufacturing innovation site to rival anything in the world.”

Steve Bates, CEO of the Bioindustry Association (BIA), added: “Improving productivity in drug development is vital to economic innovation for our sector. Enabling that to happen in the UK gives us competitive advantage and is a good example of joined up industrial strategy in action.”

Carleton University Health Sciences Building, Ottawa, Ontario, Canada

Cost: $52 million CAD (about $40.3 million USD)

Size: 132,000 gsf; includes 30,000 sf of research laboratories and support; 10,000 sf of teaching labs and support; a 13,500-sf vivarium

Project team: NXL Architects (research area and vivarium architect); Montgomery Sisam Architects Inc. (lead architect)

Carleton University’s Health Sciences Building broke ground in October 2015 and co-locates two rapidly growing university programs. With seven floors divided between the University’s newly formed Health Sciences department and existing Neuroscience Program, the design and layout of the labs, offices and workspace help to encourage and facilitate collaborative interaction between faculty and students.

This new-build facility includes modular laboratories for teaching and research, vivarium, electronic and interactive classrooms; four lecture theatres; a student resource center; informal student study and social spaces; offices and public assembly space. The interior was also designed to allow for future program growth, while accommodating changing research needs.

The design of this facility incorporates a scalable utility distribution strategy, stacked in a sidehouse concept, which replaces the traditional penthouse, thereby enabling utilities to feed into the building horizontally. This breakthrough in utility strategies has also allowed the vivarium to be located on an upper level, gaining access to ample natural light while remaining isolated from vibration and noise-producing air handling and related equipment (reciprocating chillers, air handlers, compressors, etc.) thanks to a segregated structure. The top floors incorporate a double height sidehouse which stacks the air handlers on top of each other, with internal service stairs and catwalks to provide access to all high-level equipment; while ceiling voids provide access above the vivarium space where required. The sidehouse allows utilities to be right-sized for the program they are supporting, or changed to accommodate new program areas. With all of the equipment within the sidehouse the labs, support, offices and open workspaces can connect in a much more dynamic environment.

The new Carleton Health Sciences building includes the latest technology in high-quality undergraduate teaching labs, providing greater access to experiential learning opportunities for students while encouraging interdisciplinary collaboration and closer interactions within departments.

Completion date: several floors are currently operational, with an official opening expected in mid-2018

Juniper Pharma Services Expands Lab Facilities

Juniper Pharma Services, a contract development and manufacturing organization (CDMO) specializing in the development of challenging small molecules, has announced a significant expansion to its UK-based drug development and clinical trial manufacturing facilities.

The extension provides four additional process development laboratories at its Nottingham site, improving the output and efficiency of its development and clinical manufacturing operations.

Set to be fully operational by summer 2018, the new laboratory space will allow Juniper to work with a growing client base to transform poorly soluble and difficult to formulate molecules into successful products. The expansion will ensure that processing and formulation work is scalable, enabling the efficient manufacture of stability and clinical batches.

The expansion demonstrates Juniper Pharma Services' growth in the drug development arena and its increasing commitment to solving tough formulation challenges. The new facilities, combined with its long-standing expertise in drug formulation development, is desirable to many pharmaceutical clients and enhances the company's reputation as a leading CDMO in the UK and globally.

Nikin Patel, president at Juniper Pharma Services, said, "We are always exploring opportunities to extend our service offerings to meet the evolving requirements of our market and clients. This facility expansion, which has significantly increased Juniper Pharma Services' capacity, is the latest effort in this endeavor."

Jansen Group Completes Interior Of Ultramodern Belgium Hospital

Following several years of construction Jansen Group has officially opened the high-tech AZ Sint-Maarten hospital, in Mechelen, Belgium.

“We turned the empty building shell into a functional, ultramodern hospital,” said Nadia Jansen, CEO of Jansen Group.

The Limburg, Belgium-based construction company was responsible for the entire interior finishing of this new hospital.

AZ Sint-Maarten now has all of its healthcare facilities concentrated in one location. The building is 1,129,800 sq. ft. (105,000 m²), has 654 beds and accommodates 1700 staff.

According to Peter Lowist, COO of Building Group Jansen, with this project and the corresponding set-up of a number of cleanrooms - Jansen Group has reinforced its position as an expert in the healthcare sector.

Lowist commented that: “In a lot of the areas there are strict conditions with regard to hygiene, airtightness, pressure differences, etc. The finishing of the hospital pharmacy and the operating theatres deserve a special mention.”

“From ceilings, floors and furniture to details such as handles, wall protection and floor mats. In the building we used 150,000 m² interior walls, 600,000 m2 plasterboard panels, 450,000 running meters of profiles, more than 6000 interior doors and 525,000 screws. At peak times more than thirty carpenters were working at the same time. Each piece of furniture – from a simple cabinet to the complete fittings of the nursing stations - was drawn and fitted on the construction site down to the last screw,” explained Lowist.

Jansen Group worked in a joint venture together with construction company MBG, together with architectural firm VK A&E. For the first time the trio implemented the much-discussed Building Information Model (BIM) working method within a large-scale project.

“With BIM a number of construction partners work together in a clear 3D model. The partners contribute continuously to the plan so that you as architect, building developer or (sub)contractor are always working on an up-to-date version. Moreover, the system indicates possible errors when parties want to set up conflicting actions. By avoiding misunderstandings in advance digitally, you avoid errors on site,” said Danny Jacobs, project manager, Jansen Group.

Zoetis’ Animal Vaccine Research and Manufacturing Complex, Suzhou

In April 2018, global animal health company Zoetis began constructing a new animal vaccine manufacturing and research facility in Suzhou, China.

The new facility will house a global manufacturing and supply facility, as well as a research and development (R&D) center.

The project is expected to be completed and awarded a certificate of good manufacturing practices (GMP) from the Chinese Ministry of Agriculture by 2021. Once in operation, it is also expected to generate more than 100 new jobs in R&D and manufacturing.

The animal vaccine manufacturing facility will be used for the development and production of high-quality vaccines for livestock, fish and companion animals. The products will be sold primarily in the Chinese animal health market.

The plant will allow Zoetis to help livestock farmers in China meet the increasing domestic demand for safe supply of pork, milk, beef and fish in large quantities. It will become the company’s second manufacturing complex in the country, joining an existing site in Jilin.

The vaccines manufactured at the new facility will help safeguard animals from the strains of infectious diseases.

The state-of-the-art Suzhou vaccine research and manufacturing complex will be developed in multiple phases. With a total of 462,680 sq. ft. (43,000m²), the first phase will accommodate six main buildings for vaccine manufacturing and an R&D laboratory.

The campus will also include a production facility, a warehouse and a central utility building.

In addition, the campus will be equipped with advanced technologies for the production of viral and bacterial medicines and include a pilot-scale manufacturing facility for the development of new vaccines.

Zoetis appointed engineering design, architecture, project and construction management services provider PM Group for the conceptual design and master planning of the new complex, while Australian building construction services contractor Cockram will assist in overall construction management.

China is one of the world’s largest animal health markets, with reported $4.3bn of sales in 2017 and witnessing a compound annual growth rate between 7% and 10%. The growth was primarily due to vaccines sales.

China also has one of the world’s largest pig market and raises approximately 700 million hogs a year.

In addition, spending on pet medications and vaccines in 2017 exceeded $300m, and the pet healthcare market and ownership in the country continues to grow.

Marketing commentary on Zoetis:

Founded in 2013, Zoetis is engaged in producing medicine and vaccinations for livestock farmers and veterinarians. The company develops and manufactures a wide range of animal health medicines and vaccines, diagnostic products, genetic tests and biodevices.

Headquartered in Parsippany, New Jersey, Zoetis operates in more than 45 countries. Its products are sold in more than 100 countries worldwide.

Zoetis operates a network of 25 manufacturing sites across 12 countries, with a workforce of roughly 9,000. The company reported revenue of approximately $5.3bn in 2017.

Zoetis opened a medicated feed additive products manufacturing facility in 2015 for the production of water-soluble and pre-mix products, including Linco-Spectin^®, Lincomix^®, Tilmicosin^® and COT (Check-O-Tox^®).

Samsung BioLogics’ Third Manufacturing Facility, Songdo

Samsung expects to be the world leader in biopharmaceutical contract manufacturing with the establishment of a new facility in Songdo, Korea.

The new facility will be operational in the fourth quarter of 2018.

On 21 December 2015, Samsung BioLogics began constructing its third plant in Songdo, South Korea.

The new plant is expected to make the Samsung Group one of the world’s largest biologics contract manufacturing operators (CMO) in the world.

The company planned to invest KRW850bn ($721m) to build the biopharmaceutical manufacturing facility. Construction was completed in November 2017 and operations are scheduled to start in Q4 2018.

In February 2018, Samsung BioLogics received its first manufacturing contract for the plant, which is worth $148m.

The facility is being built in the Incheon Free Economic Zone (IFEZ), which comprises the Songdo and Cheongna regions, as well as Yeongjong Island. The country’s west coast originates at IFEZ and serves as a gateway to Seoul and a metropolitan area of central Korea.

The new plant is designed to have an annual production capacity of approximately 180,000l, which will increase Samsung BioLogics’ total production capacity to 360,000l a year when fully operational.

Annual sales and operating profits are expected to reach KRW2tn and KWR1tn respectively after full completion of the plant.

The new facility will supply biopharmaceutical products to meet growing manufacturing demands from global pharmaceutical companies. It will operate throughout the year and offer services to clients, including small-scale batches for clinical trials to supplying large-scale batches for commercial production.

The number of pharmaceutical products the company will produce is estimated to be 350 by 2020.

Samsung BioLogics has two large-scale facilities located in Incheon, which offer a wide range of solutions in biologics development and manufacturing.

Samsung BioLogics’ biopharmaceutical portfolio:

Samsung BioLogics is a contract manufacturing operator that produces biopharmaceutical products for established brands such as Bristol-Myers Squibb and Roche. It was established by Samsung Electronics, Samsung Everland, Samsung C&T and Quintiles Transnational.

The company entered a ten-year contract with Bristol-Myers Squibb for manufacturing a commercial antibody cancer drug at its new plant.

Samsung BioLogics already has two plants in the Incheon zone. The first plant received production approval from the US Food and Drug Administration (FDA) for the manufacture of biologics drug substances in November 2015 and European Medicines Agency (EMA) in July 2016 monoclonal antibody drug substances, while the second plant received FDA and EMA approvals for the first monoclonal antibody drug substance in October 2017 and December 2017, respectively.

Samsung BioLogics aims to increase the global pharmaceutical capability through its fully integrated production facility that offers process development, drug substance manufacturing and fill and finish services at a single location.

Samsung’s first plant accommodates six stainless steel bioreactors with an upstream capacity of 5,000l each and a total capacity of 30,000l. It is designed and built to carry rapid high protein production.

It contains suites for upstream, downstream, fill and finish units, as well as has an administration building and a warehouse with long-term cold storage capacity.

The second plant contains ten bioreactors with an upstream capacity of 15,000l each and a total capacity of 150,000l.

Services such as cell line generation, process and analytical method development and analytical services are offered at Samsung’s facilities.

Other services include clinical and commercial bulk current good manufacturing practice (cGMP) manufacturing of drug substances and drug products with quality assurance, quality control, regulatory compliance standards and support for customers.

Cambrex Expands in Italy and Sweden

Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.

According to the contract development and manufacturing organization (CDMO), the expansion at the site in Italy also will include the recruitment of additional scientists “to increase the number of generic active pharmaceutical ingredient (API) in the company’s development portfolio.”

The new 1,614 sq. ft. (150 square meter) research and development laboratory will include 14 fume hoods and combine both chemistry and analytical development capabilities.

Cambrex expects building work to be completed by the end of 2018. Equipment installation and validation will follow in Q1 2019.

$5m expansion at Karlskoga, Sweden

Cambrex also recently announced plans to commence a $5m expansion of its Karlskoga, Sweden-based laboratory facilities. The investment will add capacity for process development and scale up, handling of potent substances, crystallization studies, and solid phase characterization.

Work on the new 6,456 sq. ft. (600 square meter) building will begin at the end of Q2 2018. It is expected to be completed in Q2 2019.

According to the company, the building will feature a new technical laboratory to support tech transfer studies – for which the main challenge is the assessment of scale-dependent process variables, explained Ingrid Hegbom Ekman, director of research and development, Cambrex.

“Knowledge transfer between R&D and production can also be a challenge as some observations are more difficult to describe in words than others, and need to be experienced together and discussed while the observation is taking place,” she said.

“The expansion will facilitate experiments at a larger laboratory scale, in close collaboration with receiving unit engineers, giving them first-hand experience of the process,” she added.

After construction has completed, Hegbom Ekman said future investments will focus on equipment “that will allow in-line reaction monitoring and laboratory equipment that mimics that in the plant.” To support this, Cambrex aims to invest in crystallization and solid phase characterization and the equipment required, she added.

Additionally, the investment will enable potent substances handling at large laboratory scales, as well as high-pressure reactions and parallel synthesis for API route scouting and development. Two analytical development and quality control laboratories and new office space also will be added to support 12 new hires – taking Cambrex’s total employee count at the site to 60.

Cambrex Expands Generic API R&D Capabilities

Cambrex has unveiled plans to expand research and development capabilities at its site in Paullo, Milan, Italy. The investment will be in the construction of a new 150 square meter R&D laboratory and the recruitment of additional scientists to increase the number of generic APIs in the company's development portfolio.

The new laboratory will include 14 fume hoods and will combine both chemistry and analytical development capabilities, with the installation of glass lined reactors, as well as analytical instruments including multiple high and ultra-performance liquid chromatography, and gas chromatography systems. It is estimated building work will be completed by the end of 2018, allowing installation and validation of the analytical instruments to take place in the first quarter of 2019.

"The generic API industry is growing due to the continued expiry of product patents, which results in the constant flow of new generic entrants to the market," said Aldo Magnini, managing director, Cambrex Milan. "The new laboratory will increase the number of programs we can be active in at any one time, allowing us to expand our portfolio of generic products."

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

Parker Details Investment Timeline, Launches New Single-Use System

Parker Bioscience outlines its planned investment to meet demand as the industry shifts from traditional processes to biological – for which single-use products are critical, says exec.

“Biopharmaceuticals now represent the major pipeline of blockbuster drugs for the coming years,” said Mike Brailsford, general manager at Parker Bioscience. “The move from traditional chemical-based processes for pharmaceutical manufacture to biological processes has been growing for the past 15 years.”

Today, this trend is now “fully established,” said Brailsford – a shift which has led to global investment in new biopharmaceutical manufacturing facilities as well as the conversion of existing facilities to biologic facilities.

“This move is driving consistent double-digit growth in this market which is expected to continue for the foreseeable future,” said Brailsford, noting that “single use products are critical to this market as without this cleaning of equipment between batches is very difficult to manage.”

The SciLog SciPure FD System combines fully the automated bulk filtration and dispensing of biopharmaceutical products with a shipping solution to safeguard product integrity, according to the company.

The company created a patent-pending bottle design that has been validated down to -89˚C while undergoing a validated shipping study (ASTM D4169).

To meet increasing demand for biopharmaceutical services, Parker Biosciences late last month announced a multi-million dollar expansion at its UK-based site.

2018

The phased investment program will see the addition of a new Class 7 cleanroom facility for the manufacture of single-use assemblies used in biopharmaceutical manufacturing.

“These assemblies are supplied to biopharma customers fully assembled and sterilized ready for direct use in their sterile clean room facilities in the manufacture of drug products,” said Brailsford.

The expansion also will include a new manufacturing area for single use sensing technologies, which Brailsford explained allow users to monitor process parameters such as temperature, pressure, and conductance.

In November of this year, the company will complete office refurbishment for its expanding workforce, which includes “a significant intake of younger employees into new areas of the business and to support our business growth,” Brailsford said.

The quality control (QC), research and scientific support laboratories also will be expanded at this time. The facilities will provide capabilities including microbiology testing, scanning electron microscopy, through to pilot scale facilities. Additionally, a new facility for the development, manufacturing, and commissioning of automated manufacturing systems will be added.

2019

To “meet the demands of the growing business,” Parker will complete construction of a new warehouse in early 2019, Brailsford explained.

By late 2019, the existing cleanroom manufacturing area will be redeveloped and upgraded to Class 8. The floor area available for manufacturing filter products also will be expanded.

Wasdell Group Invests in New Microbiological and Analytical Lab

New 1,200 sq. ft. facility in Newcastle will support Wasdell's planned move into the manufacture of sterile products later this year

UK's Wasdell Group, the outsourcing partner to companies within the pharmaceutical, medical device and clinical trials industries, is investing £500k in a new laboratory at its site in Newcastle.

The purpose-built 1,200 sq. ft. facility will allow Wasdell to offer in-house microbiological and analytical services to its customers and will support the business’ manufacturing, packaging and quality control (QC) teams.

The investment follows on from a growing customer base as well as an increase in the number of pre-clinical development projects that have recently been awarded to Wasdell.

Daniel Tedham, MD at Wasdell, said: “This latest investment is part of a client-centric strategy that ensures we continue to offer existing and new clients a fast and efficient service that meets their end-to-end supply needs.

“We’ve seen a notable increase in demand for analytical support from our existing clients and the investment in our microbiological capabilities has been driven by our planned move into the manufacture of sterile products later this year.”

The investment is the first phase of the company’s ongoing expansion strategy to bolster its laboratory capabilities and ensure seamless internal operations. The second phase will include the opening of a new laboratory facility in Ireland to futureproof Wasdell’s release testing offering for the European market in the event of a hard Brexit.

A microbiological laboratory team will deliver in-house environmental monitoring, sample analysis, water testing, microbiological identification analysis, component testing and growth promotion testing.

The lab will also offer analytical capabilities for chemical, physical and microbiological analysis including HPLC, FTIR and wet chemistry with QC testing of raw materials, drug substances (currently Schedule III with capacity to cater for Schedule II products) and drug products in accordance with pharmacopoeial monographs and client methods.

The facility is the latest addition to the company’s manufacturing site in Newcastle. The 26,000 sq. ft. facility is MHRA approved for pharmaceutical manufacturing and has a Home Office Controlled Drugs license with onsite storage facilities.

It follows the recent announcement of the company’s new €30m pharmaceutical facility in Dundalk, Ireland, which will offer QC import testing, a variety of current and novel packaging technologies as well as storage and distribution.

More on Cambrex New Lab Expansion

Cambrex Corp., a manufacturer of small molecule innovator and generic APIs, began a $5 million expansion of its lab facilities in Karlskoga, Sweden, to augment capability and capacity for process development and scale up, handling of potent substances, crystallization studies and solid phase characterization. Construction on the 600 m² building is expected to be complete in 2Q19.

The expansion will create space for a new technical lab with walk-in hoods for large scale lab syntheses up to 10 liters, where engineers and chemists will undertake tech transfer studies. The new investment will also enable handling of potent substances at a large lab scale, high pressure reactions and parallel synthesis for API route scouting and development.

In addition to the technical lab, the expansion will feature two analytical development and quality control labs and additional office space for 12 additional scientists and chemists, bringing the total headcount to 60.

“We have a rich history in chemistry at our Karlskoga site, dating back 120 years to Alfred Nobel himself in 1896,” said Bjarne Sandberg, managing director, Cambrex Karlskoga. “The new laboratory expansion will enhance our ability to provide global customers with scientific and chemical excellence.”

In 2017 Cambrex upgraded its continuous flow capabilities in Karlskoga with a dedicated commercial-scale unit, capable of producing multiple metric tons of high purity API intermediates per year. The company also completed the installation of multiple continuous flow reactor platforms at its process development facility in High Point, NC. This investment is focused on development of processes to supply clinical as well as commercial demand for chemical syntheses.

Avara Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and Development Center in Canada

Avara Pharmaceutical Services, a world-class contract development and manufacturing organization (CDMO), announced that it has agreed to acquire the largest sterile manufacturing facility for injectable medicines in Canada from a leading global pharmaceutical company, as part of a continuing expansion of its global footprint.

"This acquisition represents our first entry into the Canadian market and further expands our sterile processing capability, which is in very high demand," said Timothy C. Tyson, Avara's Chairman and Chief Executive Officer. "It comes with a world-class development center and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements."

The proposed acquisition of Novartis Technical Operations' sterile manufacturing facility and the adjacent Sandoz Development Center located on the Sandoz Canada campus in Boucherville, Quebec, is expected to be finalized in the next few months, following the completion of a number of closing conditions including receipt of anti-trust approvals. It follows Avara's acquisition of another sterile facility in the past year, one from Pfizer Inc. in Liscate, Italy, and one solid dose manufacturing facility from GlaxoSmithKline in Aiken, South Carolina. It will bring the number of manufacturing and development sites operated by Avara worldwide to ten: two in Canada; three in the United States, including corporate headquarters; one in Puerto Rico; one in the UK; one in Ireland; one in Italy; and one in France.

The Boucherville site is the biggest injectables production facility in Canada and provides a number of strategic and lifesaving medicines to the Canadian healthcare system, mostly hospitals. As part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of products manufactured in Boucherville. No impact on jobs is anticipated at the moment and Avara intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base.

"We look forward to a seamless transition for employees, patients, customers, partners and other stakeholders," added Mr. Tyson. "We are impressed by the know-how at the Boucherville plant and Sandoz Development Center team and intend to leverage their expertise to develop new opportunities in the contract pharmaceutical market, in Canada and elsewhere."

About Avara:

Avara Pharmaceutical Services, Inc., based in Norwalk, Connecticut is an international pharmaceutical services company that delivers world-class contract manufacturing and technical services to the pharmaceutical industry. Avara has primary and secondary manufacturing facilities in North America and Europe and supplies products to all major markets around the world. Avara's broad experience with supply chain, commercialization, product launch and product transfer allow us to sustain exemplary levels of product quality and regulatory compliance. The company is known to exceed customer service level expectations and consistently deliver on time, in full at a fair price.

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