PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Novartis-Penn Center for Advanced Cellular Therapeutics

Laboratory facility tours were offered as part of the 2018 Laboratory Design Conference in Philadelphia, organized by Controlled Environments’ sister publications Laboratory Design and R&D.

One of the five lab tours offered on April 25 was the Novartis-Penn Center for Advanced Cellular Therapeutics (CACT). Located on Penn Medicine’s campus, the lab facilities assist in Penn Medicine’s research using Chimeric Antigen Receptor (CAR) technology, which enables a patient’s own immune cells to be removed from their bodies, and reprogrammed as hunters to locate and destroy tumors.

The tour was led by Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine; Stephen Copenhagen, LEED AP, Principal, CannonDesign; and Kurt Buchholz, Director of Facility Operations, Center for Cellular Immunotherapies at University of Pennsylvania.

The cGMP facility employs 100 highly specialized professionals, and hosts 6,400 sq. ft. of cleanroom space as well as 24,000 sq. ft. of laboratory space. It has the capacity to manufacture cellular therapies for 400 patients per year.

The CACT facility is located on the ninth floor and houses eight processing cleanrooms, an automation room, a media prep room, and gown-in/gown-out rooms. The interior hallway and common areas are Class 100,000 (ISO 8) and the individual cell processing rooms are Class 10,000 (ISO 7). The CVPF-CACT footprint of the cleanroom manufacturing area measures about 4,500 sf, and processing is performed in Class 100 (ISO 5) BSCs.

Then-Vice President Joe Biden visited the facility in January 2016, days after then-President Barack Obama’s State of the Union address in which he asked Biden to head up a national “moonshot” effort to eradicate cancer.

Wuxi Apptec Opens Second NJ-Based Site

WuXi AppTec is converting its Plainsboro, NJ lab into a fully GLP-regulated bioanalytics facility after opening a new site in Cranbury which doubles the company’s total operation space to more than 115,000 square feet.

“The company’s strength in bioanalytical and DMPK services has been heavily driven by increasing customer demand for regulatory-compliant solutions over the past two to three years,” said Dr. Jason Liu, SVP of WuXi AppTec, COO of the Laboratory Testing Division.

“The site expansion bolsters WuXi’s Laboratory Testing Division in these services and establishes New Jersey site as a center of excellence in providing IND and NDA enabling services,” he said.

When fully configured, Liu said the new facility add 55,000 square feet of laboratory space to WuXi AppTec’s Laboratory Testing Division (LTD) as well as more than 200 new jobs.

“This addition expands upon our established Plainsboro facility, offering testing services to pharmaceutical and biotech companies,” he explained.

Additionally, “through the expansion efforts,” Liu said the company will be converting its current Plainsboro laboratory into a fully good laboratory practice (GLP) regulated bioanalytics facility with double the space.

WuXi’s Laboratory Testing Division provides in vivo and in vitro assays from early screening to clinical sample analysis, as well as medical device testing from development to product lifecycle management.

Catalent Investing in Early Development Offering

Catalent plans to invest $5m to create a new drug development center of excellence focusing on preclinical to clinical phase IIb formulation, analytical, and manufacturing solutions.

The delivery technologies and development solutions provider this week announced the investment, which will establish its Somerset, NJ facility and headquarters as a center of excellence (CoE) focused on early phase formulation, analytical, and manufacturing solutions for orally delivered small molecules.

“There is a big trend in the industry where the molecules are getting more and more complex, both on the development side and the manufacturing side,” said Elliott Berger, VP of global marketing and strategy at Catalent.

“They need more expertise, they need more technology, they need more focus to get them through the system so they don’t fail for formulation purposes,” he explained. “There are plenty of other problems to overcome in this industry; you don’t need to fail for formulation purposes.”

Catalent is currently working on the expansion plans, said Berger at CPhI North America, explaining that the company needs “some additional pilot-scale equipment [and] some additional lab equipment.”

“We also need some additional expertise to move these molecules around faster through the process,” he added.

However, the company is going to start talking to customers before any plans are solidified. Berger said: “We didn’t want to do a lot of planning until we talked to all the customers. Some of the stuff needs to be done in conjunction with the customer and we want to make sure we do it in a way that they would like it done.”

According to the company, the investment also will build on the site’s modified release formulation development capabilities, bioavailability solutions, and its application of OptiMelt hot melt extrusion (HME) technology.

Avid Plans Expansion with Focus on Biologics Development

There is no slowdown in sight, says Avid Bioservices CEO, as the company announces further expansion to support new client projects and optimize its novel CHO-based expression system.

Roger Lias, president and CEO of Avid Bioservices said the company has seen a “tremendous surge” in interest since formally transitioning to a full-service, dedicated contract development and manufacturing organization (CDMO) earlier this year.

The company in February raised more than $20m to grow its contract manufacturing business.

Avid announced that it is expanding its Orange County, CA-based process development laboratory space to more than 6,000 square feet. Conducting work in phases to avoid disruption, the first new laboratories are expected to be operational during the third quarter of calendar 2018.

Lias said: “Our announced expansion is driven by strong in interest in our process development and clinical stage services, but we are also in the unusual position of having multiple single use 2,000 L bioreactors available in our state-of-art Myford facility.” This, “at a time when many competitors are starting expansion projects that will not yield available capacity until 2019 and beyond,” he added.

In addition to upgrading its existing infrastructure, Avid is also installing new equipment to support client manufacturing demand from clinical development to commercial production. The expansion will also support technology transfer and on-boarding of later stage manufacturing projects, Lias said.

“The final phase of the program will be the relocation of our pilot facilities into remodeled space within the company’s legacy Franklin manufacturing facility,” he added.

Focusing on the development and manufacturing of biologics derived from mammalian cell culture, Lias said the company sees “no slowdown in broad demand for this class of products.”

Later this year, Lias said the company will be able to share additional information about a novel CHO-based mammalian expression system that is being developed in-house.

“Monoclonal antibodies and derivatives such as multi-specific antibodies and antibody drug conjugates remain hot areas, but we also see strong demand for complex recombinant proteins such as fusion proteins and enzymes based on our long track record with these highly glycosylated and complicated products,” he added.

The company recently signed new agreements with three international drug development companies for which Avid has commenced work.

“The drug candidates involved in these agreements are being developed for application in certain cell therapy, respiratory and oncology indications,” said Lias.

With the recent agreements, the company has on-boarded four new client projects this year to date, compared to the same number in 2017.

Amgen Picks Rhode Island Location for Biomanufacturing

Rhode Island will be the home of Amgen’s first US next-generation biomanufacturing plant, based on the firm’s modular, single-use site in Singapore.

The facility will be located on the same 75-acre campus as Amgen’s manufacturing site in West Greenwich, where the firm makes clinical bulk drug substances.

Two months ago, Amgen announced plans to build a facility at an estimated cost of $300m, but a spokesperson said recently that the cost has reduced to approximately $165m “because it will be built at an existing Amgen site.”

The project is part of a larger plan to invest around $3.5bn (€2.8m) in capital expenditures in the US over the next five years, as a result of the last year’s tax reform.

As of December 2017, the US corporate tax rate has dropped from 35% to 21%, which provides incentive for firms to invest in the country and repatriate cash held overseas.

Site construction will be completed in 2020, and add approximately 150 manufacturing jobs and 200 construction and validation positions.

According to Amgen, a ‘next-generation’ biomanufacturing facility can be built in half the construction time of a traditional plant, and requires half the operating costs.

The concept involves a smaller manufacturing footprint and can help lower water and energy consumption, as well as reduce carbon emissions.

Amgen’s $200m next-generation biomanufacturing plant opened in Singapore in 2014. The site houses single-use bioreactors, continuous purification processing, and real-time quality analysis technology.

Keeping in line with the next-gen formula, the site was completed in half the time required for a traditional plant, and Amgen said its modular design enables the firm to eliminate costly and complex retrofitting when structuring changes.

PPD Expands GMP Biologics Testing Capacity

PPD has expanded its GMP analytical lab in Middleton, WI. The new 32,000 sq. ft. lab supplements the company’s existing biologics capacity and was constructed specifically for the stability and quality control testing of large molecule drug products.

It has space for more than 100 new employees, and was designed to be efficient, containing specialized areas dedicated to particular types of assays and scientific instrumentation unique to biologics. The facility has met GMP regulatory requirements, has been released for use and is already supporting new client projects.

“The expansion of our biologics testing, which nearly doubles our analytical testing capacity, enables us to meet the ever-growing needs of our clients for GMP testing of large molecule products,” said Jon Denissen, Ph.D., senior vice president of the PPD Laboratories bioanalytical and GMP labs. “From early clinical development through commercial release testing, clients rely on our industry-leading capabilities in large molecule product testing. With deep expertise that spans the full spectrum of protein-based and gene-based biologics, we support many of the most cutting-edge immuno-oncology, gene therapy and cell therapy agents being developed or marketed today. PPD Laboratories is the laboratory of choice for companies seeking high-quality data for biologics regulatory submission and product release.”

The Middleton campus expansion also includes the renovation of PPD’s existing cell lab, which will double the capacity for GMP cell-based assays. The expanded 5,900-sq.-ft. lab will support a total of 70 cellular and molecular biology scientists upon completion in mid-2018.

Abzena Remodels ADC Facility in Pennsylvania

Abzena has equipped its $5m Pennsylvania bioconjugation suite with Sartoius and GE Healthcare single-use equipment.

The $5m (€4m) investment at the firm’s site in Bristol, Pennsylvania – added when Abzena acquired The Chemistry Research Solution in 2015 – was announced last year, and recently the firm said facility remodeling for the GMP manufacturing suite has been completed.

Empty space in the building is set to provide capacity for antibody-drug conjugation (ADC) services, and will allow Abzena to expand its process chemistry capabilities, including HPAPI process chemistry.

The remodeling was carried out by local contractors in Bristol, an Abzena spokesperson said, and the suite is scheduled for completion around the end of the second quarter of 2018.

We were told: “The facility is equipped with Sartorius Levmixer, FlexAct & AlphaPlus and GE Akta single-use process equipment.”

Aldevron Selects AES, Begins Construction of Cleanrooms in GMP Plasmid Facility

Aldevron, a global provider of contract plasmid manufacturing services for the biotechnology industry, has selected AES Clean Technology, a leader in the design, manufacturing, and construction of modular cleanroom systems, to design modular cleanrooms for Aldevron’s $30 million, 70,000 square-foot manufacturing facility in Fargo, N.D. Cleanroom construction is underway with target completion date of early summer.

“Aldevron’s new facility is built with the AES modular cleanroom technology that delivers speed, cleanliness, quality and repeatable performance,” said Michael Chambers, Aldevron CEO. “Our building will be the world’s largest and most advanced plasmid DNA manufacturing facility. This project is part of our vision to provide clients with unsurpassed scale and quality. The site delivers on our strategy to maintain leadership in plasmid DNA manufacturing from discovery research through commercial production.”

The state-of-the-art facility includes:

70,000 square feet of space with 17,000 square feet of modular cleanrooms for cGMP production. Unidirectional personnel flow and airlocks within the cGMP production area. Emergency generator backup power for all production and storage areas. Integrated facility and environmental monitoring with automated alarms. Single-pass air for product dispensing and cell banking suites. ISO 8 processing suites with ISO 7 suites for cell banking and fermentation. Fully EU-compliant Grade A product dispensing area.

Henry Hebel, Aldevron COO, added, “Aldevron is pleased to be working with AES, the recognized leader in cleanroom design and construction. Our design includes advanced independent air-handling and modular cleanroom systems to ensure our clients the highest possible quality and compliance. Our GMP capacity will double in the new facility and our fermentation scale will range from 10 L to 300 L single-use systems, with the ability to expand to 2,000 L under the same roof. This capacity and flexibility combined with Aldevron’s 20 years of experience and successful delivery of thousands of lots, including material for the manufacture of commercial products, solidifies our position as the global leader in plasmid DNA production.”

“AES is proud to be designing and building the cleanrooms for Aldevron’s new facility,” said Grant Merrill, AES Director of Project Development. “Our unique set of skills, coupled with our ability to deliver fully customized cleanrooms in an extremely rapid timeframe, will allow Aldevron to serve its growing client base with a reliable supply of cGMP products.”

Aldevron’s facility will be operational in the summer of 2018, with the company now scheduling work throughout 2018 and 2019.

About Aldevron

Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from discovery research to clinical trials to commercial applications. These products are critical raw materials and key components in commercially available drugs and medical devices. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-Source TM quality system. Company headquarters are in Fargo, N.D., with additional facilities in Madison, Wis., and Freiburg, Germany.

Envigo to Create New Center of Excellence

Envigo is increasing its surgical footprint ten-fold to create a West Coast Center of Excellence for surgery and supply myocardial infarction research models regionally.

The nonclinical contract research services and research models provider is expanding its Livermore, CA-based surgical capacity from 500 to 5,000 square feet and will nearly double its number of surgical technicians.

The expansion complements Envigo’s existing offering at its Indianapolis, IN site, and creates a West Coast Center of Excellence for surgical services, according to the company.

Envigo will install ICU recovery chambers and advanced ventilator and microscopic technologies. It will also fit individual ventilated cages (IVCs) and implement RFID and software surgical tracking systems.

Additionally, as part of the expansion, the company’s myocardial infarction (MI) research models will be made available to biotech companies on the West Coast.

“Our MI models adhere more consistently to the standards our biopharmaceutical researchers expect when conducting MI research,” said Brad Gien, head of North America surgery at Envigo.

"Research demand in this area is increasing as companies realize the high cost of keeping a trained surgical staff and surgical suite up and running," he said.

Hovione Expands Capacity

Hovione has recently expanded capacity and plans for future expansion at its sites in Portugal, Ireland and New Jersey. The company will increase capacity in existing technologies, such as spray drying, and grow in new areas to support clients demand.

The capacity expansion began in 2016 and will continue over the next five years. In the first two years, Hovione relocated its development services to a new center in Lisbon with 75,320 sq. ft. (7,000 m2), and is fully equipped to handle potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation and analytical development areas.

The Loures site also expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant, totaling additional 30 m3 of capacity. In addition, one pilot and two large scale spray dryers were installed at the site, which is now equipped with oral dosage form and inhalation manufacturing capabilities.

Hovione doubled the size of its development and manufacturing operations in NJ, adding a range of capabilities, from chemical and analytical development to spray drying and formulation. The site now hosts 14 m3 of reaction vessel capacity with four independent trains, a pilot and a large-scale spray dryer and a continuous tableting unit.

In the Cork site in Ireland, Hovione is reinstating and renewing a production building with 157m3 of chemical synthesis capacity devoted to contract manufacturing. About half of this capacity will be ready for operation by May 2018.

Over the next three years, Hovione will add to the Loures site a new chemical synthesis and spray dryer building for contract manufacturing, with a total of 45,192 sq. ft. (4,200 m2) for 165m3 of reaction vessel capacity, two large spray drying units, new formulation facilities for bigger batch sizes, and a new building that will host additional 12,912 sq. ft. (1200 m2) of analytical laboratories.

These investments are supported by a 39% increase in staff in the last 2 years.

“This addition in capacity expansion will secure our growth and ensure that we continue to provide a truly integrated full-service solution to our customers, as well as showing Hovione’s strategy and commitment to further strengthen its global market leadership in Spray Drying,” said Frédéric Kahn, vice president marketing and sales.

St. Jude Children's Research Hospital's New Advanced Research Center, Memphis, Tennessee

Cost: $412 million

Size: 625,000 sq. ft.

Project team: The Crump Firm (lead architect), Jacobs Consultancy Inc. (lab design), Flintco (construction manager)

A new era of scientific advancement is emerging at St. Jude Children’s Research Hospital with the development of a new advanced research center. Designed as an interactive hub of exploration and discovery, the center will cultivate transformative research and collaboration and attract scientists and clinicians to St. Jude. Slated to break ground in spring 2018 and open in 2021, it is a major component of a $1 billion capital expansion of the St. Jude campus.

The advanced research center builds on the St. Jude legacy of innovations for understanding and treating childhood cancer and other life-threatening diseases. Architecturally, it will be an interactive and interdisciplinary environment designed specifically for generating new ideas and teamwork. Its labs and spaces will enable researchers to collaborate openly and across departments. The center will stream natural light through skylights to atriums and an open-air courtyard and will feature numerous interaction zones uniting key disciplines of science.

The advanced research center will feature customized labs focusing on immunology, neurobiology, cell and molecular biology, metabolomics, epigenetics, genomics, immunotherapy and RNA biology. The center will also house key facilities and transformative technologies, including a state-of-the-art biorepository, a gene-editing center, a stem cell shared resource, and a cutting-edge advanced microscopy and image analysis core, all fully integrated with advanced information technology systems, high-speed connectivity and visualization tools to enhance local and distance information sharing and collaboration. The advanced research center propels St. Jude for the long term, accommodating growth for the next 20 years and beyond, with two of eight floors slated for future expansion and evolving technology.

The first floor will be dedicated to electrical service and lab gas storage and distribution with secured dock and receiving space to safely handle all materials, including hazardous wastes. It also includes a cryo-storage facility to help distribute our stored research cells and products in addition to the existing facility in the Danny Thomas Research Center. The first floor also will include meeting rooms sized to accommodate the research departments in the floors above. A café-like space will enable up to 100 researchers to eat breakfast and lunch, with the main dining facility at St. Jude remaining the primary option.

The second through seventh floors will comprise two lab wings set at a 30-degree angle separated by an open-air entryway and a smaller enclosed atrium space that is open from the second through seventh floors. This design purposefully fosters collaboration in several ways. The space will allow natural light to enter both the outside of the lab floor plates and the inside of the lab bars, which is further enhanced by the use of glass walls in the labs.

Existing labs have desk cubicles inside the labs which preclude food and drink, and the natural exchange of ideas. The new building will be lined inside and outside against the atrium with workspaces adjacent to the labs in a business occupancy office environment to promote collaboration. Huddle rooms are interspersed throughout these zones to facilitate small group collaborations in some privacy. The lab bars are connected across the atrium with a lunch common space visible floor to floor, and also features an open staircase that facilitates vertical as well as horizontal collaborations. The laboratories themselves are a cross between open and modular design, allowing flexible assignments of lab bench space and mentoring between full, associate or assistant faculty members. This space assignment mix has never been accomplished previously anywhere we know.

The principal investigators’ offices are housed on the open end of the lab bars close enough to the laboratories to maintain contact, but separated to take advantage of the views to the west of the campus quad. The eighth floor is primarily mechanical, but does include a small greeting hospitality space and an open green space also overlooking the quad.

The overall design of the advanced research center reflects the institution’s multidisciplinary focus and creates opportunities for collaboration and communication, desired features of a modern biomedical research facility.

Completion date: 2021

Grand River Aseptic Manufacturing to Acquire Land for Expansion

Grand River Aseptic Manufacturing, Inc. (GRAM) signed purchase agreements to acquire land in Grand Rapids, Michigan, to add to its growing presence in life sciences, expand its manufacturing capacity, and serve its growing customer base.

The 1.5-acre lot on Butterworth Street sits less than a quarter mile away from GRAM's existing manufacturing facility on Front Avenue near downtown Grand Rapids and is less than a mile away from its finishing facility on Godfrey Street. The land purchase will significantly increase GRAM’s existing 40,000-square-foot cGMP space. The purchase agreements are with two separate parties, subject to normal due diligence items, and are expected to close within 90 days.

The expansion will house a state-of-the-art cleanroom space, including new isolator technology, and will allow GRAM to serve its clients with high-speed, fully integrated manufacturing and packaging lines. “The substantial growth rate that we’ve experienced in the last several years has allowed us to match the needs of our clients and the industry. With that growing demand, we are excited to add more manufacturing capacity, while remaining a quality-focused organization,” said Tom Ross, president and CEO.

GRAM’s last addition to its pharmaceutical fill/finish footprint was in 2014 with the addition of a 28,000-square-foot facility. The 2014 expansion was in response to the need for more warehousing space, as well as a place for finishing activities. “As GRAM has grown and we have continued to add more capabilities, we’ve identified the need for more cleanroom space to serve our client’s needs and to meet the market demand in biologics and generic pharmaceutical markets,” said Nick Bykerk, vice president of business development and finance.

GRAM was formed in December 2010 and opened its doors in January 2011. In seven years, GRAM has increased its employee base from 16 employees in 2011 to over 160 employees today. The company is one of the fastest growing companies in the United States and was recently named by Inc. Magazine as the 9th fastest growing company in the state of Michigan.

Aramark Cleanroom — McKinney, Texas

Aramark announced in February that it opened a 34,350 sq. ft. facility in McKinney, Texas to provide expanded cleanroom services to customers throughout the southwestern U.S. Over the next three years, the new operation is expected to create approximately 120 new local jobs.

Controlled Environments spoke to Brad Drummond, Chief Operating Officer for Aramark Uniform Services, for details about this new cleanroom facility.

Controlled Environments (CE): How long did construction take? Where did production take place during the construction process?

Brad Drummond (BD): Construction of the facility was initiated in the first week of July once the site was identified and the permits were obtained. The construction process was initially completed in the first week of December. Operations started in January after the cleanroom and controlled areas were certified and the equipment was validated. Since this was a new facility there was no need to service existing customers, these were serviced by our other cleanroom processing facilities. Customer garments were not transferred until the new plant was complete and approved by the customer.

CE: What kind of instruments and equipment are used in the clean area?

BD: As a cleanroom laundry we use the typical devices that are needed to clean garments (A short list of the equipment used is below). All equipment is manufactured using cleanroom compatible materials such as stainless steel for garment contact surfaces.

Wash equipment

Washer: Cleanroom compatible pass-thru washers
Cleanroom HEPA filtered dryers
Validated polyethylene bags sealer
Deionized water system

Test instruments

Particle testing apparatus
Helmke Drum
ESD test meters and environmental conditioning chamber
Aerosol particle counters

HEPA filtered dryers.

CE: How many employees do you have? What kind of work do they do?

BD: Over the next three years, the new operation is expected to create approximately 120 new local jobs. Currently, there are approximately 60 employees who are employed in the following areas:

Cleanroom Associates handle the garments once they have been through the wash process; these folks dry the garment and they inspect them and seal them in the cleanroom compatible bag(s).
Packout Operators take the finished product and assemble it into the final shipping configuration.
Shipping/Receiving Associates handle the garments as they come in and subsequently shipped out of the plant. They are responsible for confirming that the appropriate documentation accompanies each clean shipment of garments.
The Quality Assurance Manager monitors the process and products for compliance with required specifications.

CE: What’s the square footage of the cleanroom area? What about other areas like a gowning area/ante room? How big is the overall facility?

BD: This plant has a 5,500 sq. ft. cleanroom/controlled environment. This includes approximately 300 sf of ancillary areas such as gown rooms and de-gown rooms. This is out of a total building footprint of 34,350 sq. ft.

CE: What are some highlights of the new facility?

BD: The new facility includes the newest solid state water deionizing systems as well the most recent version of our wash aisle that allows the processing of garments from various types of customers. The facility features our enhanced goggle drying applications in which the goggles are washed in DI water and then dried in a stream of HEPA filtered air. The final packaging room is designed for maximum efficiency by allowing the presorting of product before it is presented to the operator who scans it.

CE: Describe the cleaning process — does your staff perform these duties, or do you hire it out?

BD: The cleanroom is cleaned by a service company that utilizes MicronSwep, Aramark’s reusable ceiling-to-floor microfiber mop system and cleanroom-laundered microfiber wipes for other surfaces.

Charles River Adds New Biologics-Testing Facility

On March 8, 2018, Charles River Laboratories, a contract research organization, announced the addition of a new 73,000-square-foot facility on Devon Park Road in Wayne, PA, that will more than double the laboratory space available at the company’s existing facilities in Malvern and King of Prussia, PA.

This latest announcement is one of several expansions made to the company’s biologics testing solutions infrastructure to support the characterization, development, and release of biologics and biosimilars.

Certain laboratory operations conducted at the Malvern and King of Prussia sites will begin to move to Devon Park early in the third quarter of 2018. The formal transfer of assays will be done in phases, and, during the transition, both the Malvern and King of Prussia facilities will remain fully operational.

“The high volume of biologics and biosimilars in development has led to a rapid increase in demand for our services,” said Greg Beattie, corporate vice president, Global Biologics Testing Solutions at Charles River, in a company press release. “The continued expansion of our biologics service portfolio and additional capacity will further enhance our ability to support clients’ development efforts from discovery through clinical phases and commercial manufacturing.”

Charles River Laboratories is making a series of expansions to meet growing demand for its biologics services, including doubling its operations in Pennsylvania with the addition of a new facility.

The CRO will transfer all Pa.-based laboratory functions, except for cell banking and manufacturing, from two existing facilities in Malvern and King of Prussia to a new, 73,000-square-foot site on Devon Park in Wayne, which is expected to start operations in the third quarter.

Services offered at the new site include quality control and viral clearance, “where increased capacity will not only improve timelines but will also provide opportunities to expand capabilities and enhance material flow and efficiencies,” Greg Beattie, Charles River’s VP of global biologics testing solutions, told FierceCRO. “In addition, the consolidation of testing and viral clearance activities at one site reduces the need for clients to conduct multiple quality audits.”

Manufacturing at the Malvern site will undergo its own expansion with the addition of 2,800 square feet of clean rooms to support increased demand for microbial and mammalian cell and viral banking capacity. The project will increase cell banking capacity at the site by 40%, as well as upgrade rooms for virus and vaccine production. The company is also adding capabilities for high-volume and high-density cell banks as alternatives to traditional formats.

The company has recently added about 4,500 square feet of laboratory space to its Erkrath, Germany, facility to conduct bioactivity testing, including support for lot release, stability testing, accelerated stress condition testing and the comparability testing of biosimilar products.

Putting key capabilities offered in Malvern and Shrewsbury and Woburn, Mass., under one roof, Charles River recently designated the Shrewsbury site as the Analytical Center of Excellence, which offers similar services as the Erkrath site.

“This location will facilitate the continued expansion of our analytical and protein characterization services, which reflects the growing needs of the pharma and biotech community in and around the greater Boston area,” said Beattie.

Charles River’s recent devotion to biologics services could be traced back to its 2016 acquisition of Blue Stream Laboratories, an analytical CRO focused on the sector.

CEO Jim Foster told investors during the company’s 2017 earnings call in February that the company is seeing rapid increase in demand for its biologics services, as “many of the biologic drugs are being developed by biotech companies that do not have the internal infrastructure to support the manufacturer.”

The company reported double-digit organic revenue growth for its biologics business for fourth-quarter and full-year 2017, and expects it to grow at low double-digit rates in 2018, with the support of additional capacity.

GenCure Biomanufacturing Center, San Antonio, Texas

Size: 1,300 sq. ft.

Project team: Michael J. Fiske, MS, Vice President Cell Therapy Manufacturing; Josh Pena, Supervisor, Process Development and Manufacturing; Victoria Flores, Associate Scientist, Process Development and Manufacturing; Mike Cardenas, Process Technician; Irene Palacios, Process Technician

In January 2018, the GenCure Biomanufacturing Center opened the first phase of a new multi-use, cGMP-compliant facility designed for clinical-scale manufacturing. The facility addresses a critical roadblock slowing the advancement of cellular therapies and the field of regenerative medicine: A lack of access to large-scale stem cell manufacturing and support services required for cGMP-compliant production of biologics for use in human clinical trials and commercial manufacturing.

The new GenCure BioManufacturing Center is one of only a handful of independent manufacturing facilities in the U.S. for human bone marrow-derived mesenchymal stromal cells (hMSCs), the most widely used type of stem cell in both research and clinical settings.

The center is opening with an initial 1,300 sq. ft. of cleanroom space, with build-out to 10,000 sq. ft. to be completed in 2018. Later phases call for a larger pilot-scale biomanufacturing facility to provide additional cleanroom facilities. GenCure, a not-for-profit, wholly owned subsidiary of BioBridge Global, operates an existing 6,600 sq. ft. of laboratory and cleanroom space used for cell and tissue processing.

“The new facility allows us to launch our flexible Biomanufacturing Center, with initial efforts focused on hMSCs because of the significant demand for this cell type,” said GenCure Chief Operating Officer Becky Cap. “However, the facility also allows for production of other cell-based products—hMSCs derived from other sources, such as adipose tissue (fat), birth tissue (placenta and umbilical cord), induced pluripotent stem cells, or extracellular vesicles. We are currently working with companies in these areas.”

Completion date: January 2018

Laboratory Sciences Annex, University of West Florida, Pensacola, Fla.

Cost: $26.26 million

Size: 52,790 sq. ft.

Project team: Caldwell Associates, Perkins+Will

The University of West Florida Hal Marcus College of Science and Engineering broke ground Jan. 5 on a Laboratory Sciences Annex, which will be connected to the Life Sciences Laboratory on the Pensacola campus to provide additional space for classroom and wet research lab needs.

"The University of West Florida is very grateful for the support of Governor Scott, the Board of Governors, and the Legislature for this facility,” said UWF President Martha D. Saunders. “I am especially thankful to our local delegation for their hard work over the last four years to secure the funding. This annex would not have been possible without their diligence on our behalf."

The $26.26 million, state-of-the-art facility, comprising 52,790 sq. ft., is being designed by local architecture firm, Caldwell Associates, and Perkins+Will, a global firm with a specialty in higher education science and technology. It will house 12 new teaching facilities for the University’s growing biology and chemistry programs, providing space for a steadily increasing number of students. More than 5,000 students were enrolled in biology and chemistry labs during the 2016-17 academic year, and over 2,400 students enrolled in the Fall 2017 semester. Based on this semester’s headcount, more than 1,000 students in biology, biomedical sciences, chemistry and marine biology will be able to utilize the new facility once it is completed in Summer 2019.

In addition to space, the facility will provide necessary technology upgrades and continued enhancement of the high-quality, hands-on educational experiences provided to STEM students at UWF. The Annex will also provide opportunities to expand research efforts currently underway in the college through the conversion of existing teaching labs into renovated research facilities.

“Breaking ground on the Lab Sciences Annex is a substantial step forward into UWF’s next 50 years,” said Dr. George Ellenberg, provost and senior vice president. “The STEM disciplines will continue to play a central role in UWF’s future, because they are crucial to Northwest Florida’s future. The Annex will help address critical classroom, research and office needs for students, faculty and staff in the Hal Marcus College of Science and Engineering.”

Completion date: Summer 2019

Frontage Laboratories Opens Third NJ Location

To meet the growing demand for laboratory and clinical services solutions in the Mid-Atlantic Region, Frontage Laboratories, a global contract research organization (CRO) with headquarters in Exton, PA, has opened a new branch office located at 101 Carnegie Center in Princeton, NJ.

The Carnegie Center location adds 4,500 sq. ft. of office space to support the continued growth of both Frontage Laboratories and Frontage Clinical Services.

"We are very pleased to be able to add a third New Jersey location. This new site will allow us to better serve our pharmaceutical and biotech clients located in the Mid-Atlantic Region," said Song Li, founder and chief executive officer, Frontage Laboratories.

Frontage is a full-service early-stage CRO. With locations in the U.S. and China, the CRO has been assisting global biopharmaceutical organizations in their drug development efforts since 2001. Spanning from discovery through late-stage development, its full-service offerings include DMPK, bioanalysis using 60 LC-MS/MS instruments, analytical testing, product development, and full biometrics support. Frontage also provides turnkey product development services to generic, innovator and consumer health pharmaceutical companies to support IND, NDA, ANDA, and 505(b)(2) submissions. Frontage has successfully enabled biopharmaceutical and generic companies of all sizes to advance hundreds of molecules through clinical development to commercial launch in global markets.

AGC Biologics Expands Capacity

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

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

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

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

Green Leaf Farms Gets Approval for Expanded Cultivation Site

US manufacturer of cannabis products has begun operations in a state-of-the-art cleanroom.

Green Leaf Farms, a US-based manufacturer of medical and recreational cannabis products, has received approval for expansion of its state-of-the-art facility and commencement of operations in an additional cultivation site.

Both sets of permits were tied together, the company said, due to the complexity of the structural and mechanical engineering that was needed to integrate the operations.

Based in Denver, Green Leaf Farms is a Division of Player’s Network (PNTV). The company took home the approved building permits for Phase Three development of its production and cultivation build-out, and officially began operations in an 8,000 sq. ft. cultivation room. The site was completed last November.

According to PNTV, the expanded building has been designed to develop new products that will differentiate Green Leaf Farms in the emerging legal marijuana industry.

Cleanroom Technology understands that the expansion includes a state-of-the-art cleanroom, genetics lab, development laboratory and an extraction facility. The project also considers a commercial kitchen, product development space, automated water purification including custom dosage and nutrient center, a bio-testing facility, curing, packaging, and media center.

"These design approvals will allow Green Leaf Farms to complete its build-out and become what I believe will be among the most advanced marijuana production and cultivation facilities in the world," Mark Bradley, CEO, commented.

He added: "We have combined technology with an amazing, creative workspace that will encourage innovation, product development, differentiation and operating efficiencies."

Scapa Healthcare Opens Three New Cleanrooms

Scapa Healthcare now operates new R&D facilities in Tennessee, New York, and Ramsbury (UK), each with a Class 7 or Class 8 cleanroom.

Scapa Healthcare, the strategic outsource partner of skin-friendly solutions for the global healthcare industry, has unveiled three new R&D Centers of Excellence. Each facility has been designed to offer full turnkey development services, extensive design and engineering expertise and the latest manufacturing technologies to help customers bring innovative products to market rapidly.

Located in Knoxville (Tennessee), Orangeburg (New York), and Ramsbury (UK), Scapa Healthcare’s R&D Centers of Excellence have a Class 7 or Class 8 cleanroom, robust quality systems and are compliant with ISO and FDA registrations for medical device manufacturing facilities.

“Each Centre features state-of-the-art manufacturing capabilities, R&D labs, specialized engineers, scientists and program

managers to drive each program from development to manufacturing to commercialization in an efficient, controlled and expedited manner,” the company said in a statement.

The programs, Scapa Healthcare said, are managed through a structured, lean and effective product lifecycle management process, ensuring that all products delivered to market are under full compliance.

The product development team works jointly with the customer throughout the entire process; from product design and materials selection, to prototyping and user studies, and finally to product validation, manufacturing and commercialization.

Beyond product development, Scapa Healthcare can assist with regulatory services including building technical files, stability studies, sterilization validation, product registration and post-market surveillance.

Commenting on the new facilities, Mike Muchin, VP of product development at Scapa Healthcare, said: “We recognize that speed to market is critical in our industry, so we have made significant investments in technology, capabilities and personnel to help our customers bring products rapidly into the global healthcare market."

He continued: “Seamlessly working side by side with our customers, even those with manufacturing capabilities, we ensure that their products are collaboratively developed and commercialized quickly and efficiently. By leveraging our development and manufacturing expertise, they can focus their efforts on marketing and commercialization of their products.”

University of Texas at Arlington to Open New Genome Sequencing Center

The University of Texas at Arlington (UTA) announced that it has partnered with the University of North Texas Health Science Center to launch a new center for next-generation sequencing.

Slated to open later this month, the North Texas Genome Center (NTGC) will feature five Illumina NovaSeq 6000 systems and offer whole-genome and exome sequencing services to academic and corporate researchers in Texas and the surrounding six-state region. The center will be housed on the UTA campus and be part of the university's new 229,000-square-foot Science & Engineering Innovation & Research building.

The NTGC will also collaborate with Illumina in order to have access to the company's latest technologies, UTA said.

"The new North Texas Genome Center aligns with UTA's strategic focus on both health and the human condition and data-driven discovery, and will lead to future programs and partnerships in genomics, computational sciences, and genetic counseling," UTA President Vistasp Karbhari said in a statement. "The center will also catalyze the university's emergence as a leader in precision health and the transformation of the region into a high-tech science hub."

BMS Expansion of International Immuno-Oncology Network with Yale Cancer Center

Bristol-Myers Squibb Company announced that Yale Cancer Center has joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational Immuno-Oncology (I-O) science. Formed in 2012 by Bristol-Myers Squibb, the II-ON was one of the first networks to bring academia and industry together to further the scientific understanding of I-O, and has since expanded from 10 to 16 sites across North America, Europe, Japan and Australia. Today, the partners collaborate to generate innovative I-O science, launch biology-driven trials and apply cutting-edge technologies with the goal of translating research findings into clinical trials and, ultimately, supporting efforts to improve survival outcomes across tumor types.

“The II-ON gives us the chance to work more efficiently and collaboratively with Bristol-Myers Squibb and the other II-ON academic centers to address scientific questions in I-O,” said Roy Herbst, M.D., Ph.D., director of the Center of Immuno-Oncology at Yale Cancer Center and Yale’s principal investigator of the II-ON team. “The hope is this early research can someday inform clinical trials and ultimately help us to achieve our goal of transforming the way we treat people affected by cancer.”

The II-ON was formed on the foundation of three fundamental scientific pillars aimed at addressing key research priorities in I-O: understanding the mechanisms of resistance to immunotherapy; identifying patient populations likely to benefit from immunotherapy; and exploring novel combination therapies that may enhance anti-tumor response through complementary mechanisms of action. By providing a streamlined framework for peer-to-peer collaboration among global cancer research leaders, the network is able to more rapidly facilitate I-O innovation and drug discovery.

“Translational medicine and the understanding of cancer biology are foundational to our oncology R&D program, which is why we’re invested in furthering our understanding of early I-O science through the II-ON,” said Nils Lonberg, head of Oncology Biology Discovery at Bristol-Myers Squibb. “By adding Yale Cancer Center to the network, we are strengthening our collective ability to address essential scientific questions and advance clinical discovery, which we hope will eventually translate to meaningful outcomes for patients.”

Bristol-Myers Squibb believes the future of cancer research is dependent on investments in science and partnerships. In addition to the II-ON, the company has invested in several other models of scientific collaboration with academic partners across the globe, including the Global Expert Centers Initiative (GECI), the Immuno-Oncology Integrated Community Oncology Network (IO-ICON) and the Oncology Academic Research (OAR) Group.

MilliporeSigma’s Life Science Campus, Burlington, Massachusetts

MilliporeSigma officially opened a life science hub in Massachusetts, US, in October 2017.

The $115m project was announced and began construction in July 2016. Located in Burlington, the new facility replaced MilliporeSigma’s existing location in Billerica, Massachusetts.

The new building will provide employees with a sustainable and collaborative working environment. All 850 employees of the Billerica facility have been relocated to the new campus, which is home to nearly 1,000 employees.

MilliporeSigma is the life sciences division of Merck.

The 280,000ft² Burlington campus is spread over five stories and includes office spaces with flexible workspaces, laboratories and a customer service and call center. Training, display, storage and instrument repair rooms are also available.

The facility is also Leadership in Energy and Environmental Design (LEED) certified and includes 70,000ft² of space for future expansion.

In addition, the building hosts Merck’s M Lab™ Collaboration Center, a 15,000ft² trademarked laboratory on the first floor. This shared laboratory allows customers to work alongside Merck scientists and engineers in a non-good manufacturing practice (GMP) environment to solve major bio-manufacturing challenges.

The center provides application and technology demonstrations, as well as optimization and scale-up of complex applications, development of optimized protocols and procedures, and troubleshooting unit operations. It also provides hands-on training, including formal bioprocess educational courses, webinars and instructional videos and troubleshooting guides.

Other M Lab™ centers are located in Brazil, China, France, India, Singapore and South Korea.

The Burlington project was approved by the City of Massachusetts under the MassWorks Infrastructure Program, which provides funding for projects that support economic development and job creation.

Merck’s project received a 15% exemption on property taxes for a period of 15 years.

MilliporeSigma is one of many biopharmaceutical companies setting up operations in Massachusetts and nearby areas. With the presence of Massachusetts Institute of Technology (MIT), Harvard University and other academic institutions, the region is known to be one of the top hubs in the world for biopharmaceutical research and development (R&D).

Biopharmaceutical companies such as Bayer and Bristol-Myers Squibb have also set up innovation centers and shared laboratories similar to the M Lab™ center in Massachusetts to accelerate their R&D activities.

Burlington-based The Gutierrez Company built the new life science campus.

Merck was founded as a family-owned business in 1668. Operating as MilliporeSigma in the US and Canada, the company’s life sciences division, includes 65 manufacturing sites worldwide.

The life sciences division provides products and services based on process solutions, research solutions and applied solutions. The combined portfolio includes more than 300,000 products.

Some of the process solutions provided by the division include single-use manufacturing, pharmaceutical raw materials and engineering and validation services. Research solutions include bioscience reagents, specialty chemicals and lab separation tools. Applied solutions include lab water systems, critical raw materials, analytical reagents and point-of-use devices.

Biodesign C Research Building, Arizona State University, Tempe, Arizona

Arizona State University (ASU) is constructing a research building named Biodesign C in its Biodesign Institute complex in Tempe, Arizona, US.

The new state-of-the-art $120m research facility will have a total floor space of approximately 188,000ft². Construction began in October 2016 and is expected to be completed in April 2018.

The facility is being built to expand ASU’s capacity and capabilities in a number of scientific research areas, including chemistry, biological sciences and engineering. It will house 80 researchers and 300 personnel from the Biodesign Institute, the College of Liberal Arts and Sciences and the Ira A. Fulton Schools of Engineering.

The Biodesign C facility is part of ASU’s master plan for the Biodesign Institute, which comprises four interlinked buildings spanning an area of 800,000ft².

Completed in December 2004, the Biodesign A building is a four-story facility that occupies 172,000ft² of floor space, while the 175,000ft² Biodesign B building is a gateway to the complex. The reception area in Biodesign B consists of a cafe and a theatre for public seminars and institute meetings. Construction of the building was completed in January 2006.

Upon completion of Biodesign C, the three buildings will occupy a total area of 535,000ft².

The Biodesign C building will feature five floors and a basement. It will feature laboratories for scientific research, including wet laboratories and offices.

In addition, the ASU-Banner Neurodegenerative Disease Research Center and the Biodesign Center for Applied Structural Discovery will be part of the new facility.

The basement of the Biodesign C building will house a compact X-ray laser for use by the Center for Applied Structural Discovery. The new laser tool will be one of the world’s first compact X-ray free-electron lasers and is estimated to cost approximately $25m.

The new laser will be a cost-effective drug discovery and research tool accessible to scientists across the US.

Zimmer Gunsul Frasca and BWS Architects were contracted to provide architectural services for the project, while McCarthy Building Companies was awarded a contract to provide construction services for the building.

Advanced Structural Engineering-KPFF was awarded a contract to provide structural engineering services.

Biodesign C is being constructed to meet ASU’s green building standards with an aim to achieve Leadership in Energy and Environmental Design (LEED) Platinum® with an energy savings goal of 44%. The building will be equipped with a new heating, ventilation and air conditioning (HVAC) system to save energy and reduce its environmental impact.

The Biodesign C is a part of ASU’s future plans for its Biodesign Institute. ASU plans to increase its research expenditure to $700m by 2020, with the Biodesign Institute assigned with a target of $100m research expenditure a year.

Half of the planned 800,000ft² original master plan has been constructed so far and it is operating at full capacity. Further expansions will be made in the future depending upon the needs of the ASU.

Some current expansion plans include the establishment of five new centers, hiring of new recruits and an increase in clinical and industrial partnerships. ASU also plans to collaborate with international universities such as Dublin City University, Mexico and China.

Siemens Laboratory Diagnostic Manufacturing Facility Expansion

Expected Completion 2020

In June 2017, Siemens Healthineers initiated the expansion and refurbishment of its laboratory diagnostic manufacturing facility located in Walpole, Massachusetts, US.

Estimated to cost $300m, the expanded facility will be used to manufacture the company’s Atellica™ Solution. The expansion is scheduled to be completed in three years.

The project is in line with Siemens’ strategic growth plans and is expected to increase the area’s property tax revenue by approximately $10m over the next 20 years.

In addition, the project will create 700 new jobs over the next ten years, increasing the total number of employees at the facility to 1,600 by 2026.

Siemens Healthineers’ existing 500,000ft² manufacturing facility will be expanded by an additional 300,000ft² as part of the project.

The additional space will include more manufacturing spaces, a warehouse, office spaces, and a lab complex.

The facility will be used to produce laboratory diagnostics assays for immunoassay instruments, as well as consumables for molecular and blood gas testing instruments.

The expansion will be undertaken in multiple phases. Topping off of the steel frame structure of the building was completed in January 2018.

The expanded facility will produce the AtellicaTM solution, which is a flexible, scalable and automation-ready immunoassay and chemistry analyzer.

The solution enables laboratory diagnostics professionals to spend more time on driving outcomes and less time on operations. It is designed to overcome common clinical laboratory challenges and combine immunoassay and clinical chemistry analyzers to deliver better outcomes.

Massachusetts’ local governments are providing investment incentives for the expansion project.

The Commonwealth of Massachusetts is providing job creation tax incentives through the Massachusetts Life Sciences Centre and infrastructure support under the MassWorks and workforce training grants.

In addition, Walpole is supporting the project through tax increment financing and property tax abatement.

Jacobs Engineering Group was awarded the contract to provide engineering and construction support for the expansion project in July 2017.

Work includes masterplan development for production capacity enhancement, expansion of office and laboratory spaces and the addition of a warehouse at the existing facility.

Siemens Healthineers offers products and services in the areas of diagnostics, imaging and molecular medicine. The company produces 10bn diagnostic tests a year.

The company also develops digital health and enterprise services and has a workforce of 46,000 employees worldwide.

Established in 1979, Siemens’ Walpole manufacturing facility is one of the company’s 60 manufacturing sites in the US. The facility underwent an initial expansion in 2007 and was selected for a further expansion due to the advantages the location offers in terms of infrastructure and manufacturing costs.

Financial support provided by the Commonwealth of Massachusetts and Massachusetts Life Sciences Centre also contributed to the decision.

REST of the WORLD

Sterling Invests in Pilot Plant

The contract development and manufacturing organization is investing £6m into its pilot plant facility in the UK, to enhance its scale-up and small to midscale commercial API manufacturing capabilities

The expansion will increase the capacity of Sterling's pilot plant by 33% and enhance the site’s production capabilities and flexibility for small to mid-scale batch production.

The investment will add three new reactor trains at scales of 225 liters, 500 l and 1360 l to the cGMP facility. This will help to meet growing market demand for API batch sizes in the 10-100 kg range and will complement the CDMO’s API full service offering and current scale-up capabilities from grams to tons.

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

Kevin Cook, CEO at Sterling Pharma Solutions, said: “In the last decade API manufacture has steadily started to move back to the west, as customers begin to look for partners who can offer reliability, high quality and the ability to handle increasingly complex products.”

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

The expansion follows an investment in 2017 into the site’s milling, marinization and solid form facility. Both investments form part of a strategic development plan totaling almost £12m. The facilities are expected to be operational by mid-2018.

Established in 1969, Sterling’s site has a strong heritage in API services and a successful track record of compliance with both the MHRA and FDA. The company, which specializes in handling hazardous products, is now the UK’s largest provider of API development and manufacturing services to the pharmaceutical industry.

The CDMO also has an extensive technology and innovation strategy designed to find ways to integrate the latest technologies into its operations.

PCI Launches High Containment Packaging Facility in Ireland

PCI Pharma Services (PCI) premiered its new contained packaging facility for the primary and secondary packaging of highly potent products at its newly acquired site near Dublin, Ireland, EU.

This latest investment in contained packaging capabilities at the PCI Ireland site most recent part of PCI’s strategic initiative to develop its High Containment Operations (HCO) services globally.

“We are very excited to officially launch our state-of-the-art high contained packaging facility here in Ireland,” commented Bill Mitchell, President and CEO. “The recent acquisition of Millmount Healthcare and further investment in this newest specialized facility adds considerable capacity and capability to our global supply network, enabling us to meet our customers’ ever changing and evolving needs in many different geographies. Moreover, as our fourth acquisition outside the US in the past four years, this expansion further demonstrates our ability to provide our clients with a comprehensive solution to any uncertainty brought upon by ongoing negotiations between the UK and EU as a result of the evolving Brexit situation.”

Since the acquisition of Millmount Healthcare, PCI has added approximately 30 positions at the Dublin area facilities and anticipates adding more than 100 positions over the next five years as the sites continue to expand and grow its operations.

PCI was supported in the planning and execution of its newest facility by IDA Ireland.

Janssen Biologics Manufacturing Facility Expansion, Ringaskiddy, Ireland

In October 2017, Janssen Sciences Ireland began constructing an expansion of its biologics manufacturing facility in Ringaskiddy, County Cork, Ireland.

The expanded facility will produce antibodies for the treatment of rheumatoid arthritis, psoriasis and cancer. The expansion was aimed to increase production capacity to meet patient demand.

Estimated to cost €300m ($354.38m), the expansion will create employment opportunities for approximately 450 people during construction and 200 more upon commissioning in 2019.

The existing biologics manufacturing facility in Ringaskiddy began operations in 2005. Established by Centocor Biologics (now Janssen), the facility has a total built-up area of 305,584 sq. ft. (28,400m²) on 40.1ha of land.

The facility can undertake fermentation and purification tasks and includes a process development center, which enables technology transfer for development of production processes coming through clinical trial stages.

It was designed to provide pre-clinical, clinical and commercial capacity, as well as multi-product capability. The facility employs approximately 555 personnel.

The expansion primarily involves the construction of a new building with a total floor space of 205,688 sq. ft. (19,116m²) It also includes expansion of the existing warehouse, laboratory administration buildings, support infrastructure and utilities.

The new production facility will be a single-story building with a core process area located on the ground floor. It will be equipped with four 15,400l production bioreactors for the manufacture of biologic drug substances. Its capacity can be further expanded with four additional 15,400l bioreactors.

“The facility can undertake fermentation and purification tasks and includes a process development center.”

The warehouse expansion will increase material weighing, dispensing and storage capacity, and will add a designated waste material segregation and storage area.

Other facilities to be expanded will be a new steam supply from existing boilers, and new process and potable water supply lines from existing on-site systems. The project will also involve the construction of two new cooling towers for supporting production and cold storage requirements.

Utilities, car parking, underground services, internal roads, yards and pipe racks, will also be upgraded. The capacity of the on-site waste water treatment plant will also be increased as part of the project.

Other upgrades will include expansion of the existing low-voltage power infrastructure, underground fire main around the new building footprints, and BioCork1 lighting and CCTV services.

The expanded facility is expected to produce 72 batches of monoclonal antibody product a year.

The Ringaskiddy facility manufactures products used for the treatment of conditions, including rheumatoid arthritis, psoriasis and cancer. It produces antibodies and therapeutic proteins derived from cell cultures of genetically modified microorganisms through a water-based process.

The production process involves a cell culture stage and a purification stage. Protein is harvested in the cell culture process and the product goes through a series of purification steps in the purification process before being filled and frozen as a bulk product. The cells are developed in controlled conditions.

The newly expanded facility will be engaged in the production of immunology and oncology treatment products.

PM Group was contracted to provide site evaluation, master-planning and permitting, as well as architecture and engineering design, procurement, construction management support, commissioning and qualification services for the expansion.

John Sisk and Son was awarded the construction contract, while MCSherry was contracted to provide power distribution, plant installation, instrumentation, lighting and general services for a water treatment plant located in the facility.

Based in Beerse, Belgium, Janssen Sciences Ireland is a part of the Johnson & Johnson family of companies. The firm offers healthcare products and associated services.

Johnson & Johnson has 11 sites located in Ireland, including six manufacturing plants, four commercial offices and an IT center of excellence. It employs approximately 2,700 skilled people in Ireland.

AstraZeneca’s New Biologics Manufacturing Facility, Sodertalje

Anglo-Swedish pharmaceutical group AstraZeneca is developing a state-of-the-art facility to manufacture biological medicines in Södertälje, Sweden.

The new biologics manufacturing facility will be used for filling and packaging of protein therapeutics.

AstraZeneca is investing more than Skr2.5bn ($300m approximately) into the state-of-the-art facility. The investment in the facility is the first phase of the company’s potential three-part program, which is designed to expand biologics manufacturing capabilities.

AstraZeneca initiated plans to invest in the new facility in May 2015 and began construction in August 2015. The plant will supply medicines for clinical trials from the end of 2018, while drugs for commercial use will be delivered from 2019.

The new factory is expected to create more than 150 jobs in Södertälje by 2019.

The new biologics manufacturing plant is being constructed at the Gärtuna plant in Södertälje, Sweden.

AstraZeneca selected Södertälje as the location for biologics manufacturing due to the availability of skilled workforce.

It intends to combine its expertise in biologics with the operational excellence of its Sweden operations unit, through the establishment of the new facility.

The new plant will enable AstraZeneca to increase its capacity and flexibility to handle clinical trials and support further commercial production of biologics.

It will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm.

It will support the development of drug candidates across the main therapy areas, and be aligned with investments in the existing biologics manufacturing centers.

The factory will be installed with advanced technologies, which have not been used previously by AstraZeneca.

Machinery for filling, formulation, sewing and packaging form a major part of the equipment in the factory.

The new facility recruited 80 people with majority of them residing in barracks next to the factory by the first half of 2017. A structured program was created for preparing the manufacturing plant to start biologics production.

The validation and testing of the equipment available on-site began in early-2018. The process operators are being simultaneously trained to handle the equipment before the start of operations.

The plant will start manufacturing drugs, once it achieves compliance with the good manufacturing practice (GMP) standards.

Marketing commentary by AstraZeneca:

AstraZeneca is a leading biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines. It is one of the world’s biggest manufacturing and export companies in Sweden, with operations in Gothenburg and Södertälje.

The company’s operations in Sweden range from research and manufacturing to marketing. AstraZeneca employs more than 6,700 people in its operations across Sweden.

It produces 30 different medicines in Södertälje for approximately 100 markets across the world. AstraZeneca’s Nordic-Baltic marketing company is also headquartered in Södertälje.

With extensive research and manufacturing presence in Sweden, AstraZeneca Södertälje produces more than ten billion tablets a year.

AstraZeneca exports medicines worth Skr40bn ($4.75bn) from Sweden, which accounts for approximately 3.5% of the total export of goods in Sweden. The company invests more than Skr15bn ($1.78bn) a year in research and development for its Sweden operations in Södertälje and Gothenburg.

Baccinex Awards Telstar the Design and Construction of Aseptic Filling Process Plant

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hanmi Invests In ‘Smart Plant’

South Korean firm Hanmi Pharmaceutical has invested 150bn won ($140.7m) in a manufacturing ‘smart plant’ to increase its contract services.

The Paltan Plant – located on a 392,674 sq. ft. (36,492m2²) site in Hwaseong, Gyeonggi Province – was built last year by Samsung Engineering and designed by Japan’s Kajima Construction.

The facility – which has an annual production capacity of up to six billion tablets – has vertically-placed production lines in order to maximize manufacturing efficiency.

Further, the firm installed a ‘split valve’ system to reduce contamination risk when transferring products from one vessel to another, and announced plans to install GEA’s ConsiGma continuous solid dosage manufacturing platform.

The plant also provides visitors an “independent tour route”, in order to view manufacturing processes through glass windows.

CEO Woo Jong-see said the plant creates a ‘one-stop’ infrastructure, from R&D to manufacturing and distribution.

“Our global CDMO [contract development and manufacturing organization] business will get into full swing at the plant, giving Hanmi another opportunity to bolster its international presence,” said Jong-soo.

Hanmi also makes its own products on-site, including hypertension drugs Amosartan and Rovelito, anti-thrombotic drug Pidogul, and cholesterol-lowering Rosuzet.

ProMedica Health and Wellness Center

With 23 interconnected standard clinic modules, the center is designed for ease of movement for patients, staff and supplies.

When global architectural firm HKS met with ProMedica to discuss the regional health system’s plans to consolidate 11 physician practices into its new Health and Wellness Center in Sylvania, Ohio, the medical provider made its expectations clear: the building needed to foster connectivity, flexibility and a sense of place within the community. Solarban® 72 solar control low-e glass by Vitro Glass, featuring an ultra-transparent Starphire® glass substrate, was integral to achieving that mandate.

HKS and a multidisciplinary team from ProMedica mapped out existing processes and defined a future operational mode in which more effective and collaborative care could be delivered. The result is a state-of-the-art, three-story, 230,000-square-foot structure. With 23 interconnected standard clinic modules, the center is designed for ease of movement for patients, staff and supplies. It also delivers the personal environment the ProMedica team desired, along with the flexibility to expand and contract to meet evolving space demands.

To enhance the sense of connection and complement its open concept design, HKS created two exposed-to-the-elements courtyards and a glass atrium that flood the gallery space with natural light and provide visual access to the outdoor environment. The firm chose Solarban® 72 solar control low-e glass specifically to maximize the effects of that natural light and to provide a calm, healing aesthetic to patients.

Doug Dewar of glass fabricator Oldcastle BuildingEnvelope’s (OBE) Perrysburg, Ohio, location said Vitro Glass easily accommodated the above-average amount of glass needed for the job—more than 60,000 square feet—and credits the Vitro Concierge Program™ for keeping the project on track. “Everything went smoothly. The glass sizes were requested in phases, and once we called Vitro with an order, the glass would be on our floor virtually on a just-in-time basis,” Dewar explained.

“The Vitro Concierge Program gave us the flexibility to bring in the glass when we needed it. Knowing that the glass was readily available helped us schedule our manufacturing and service our customer in a timely fashion,” added Dewar, who works at OBE’s Perrysburg, Ohio, location.

Solarban 72 glass provides higher levels of transparency than Solarban 70XL glass without sacrificing solar control performance. With a triple-silver coating that is engineered for use on Starphire Ultra-Clear® glass, Solarban 72 glass has visible light transmittance of 71 percent in a standard 1-inch insulating glass unit, which is 11 percent higher than Solarban 70XL glass.

The ProMedica Health and Wellness Center, which opened in 2016, received an honorable mention in the 2016 Healthcare Design Showcase.

Covance Launches Immunology & Immunotoxicology Unit

LabCorp's Covance business has formed a global immunology and immunotoxicology (I&I) unit dedicated to the specific needs of biologic drug development.

The company says that this new team brings together Covance’s operational expertise in flow cytometry, immunoassays and cell-based assays with its scientific expertise in immunotoxicology study design, direction and operation to provide a more comprehensive offering for large-molecule drugs.

“With the formation of this team, we continue to demonstrate Covance’s commitment to strengthening our biologics solutions with key investments in scientific staff, technology and facilities,” said John Ratliff, chief executive officer of Covance. “Biologics make up more than one-third of biopharma’s pipeline. Integrating our scientific and operational know-how into a seamless group allows us to deliver even richer scientific insights and faster cycle times for clients’ biologic programs, which helps our clients bring cutting-edge new drugs to patients faster.”

Covance says the new I&I unit’s comprehensive offering also includes a seamless bridge to bioanalysis for use in regulatory submissions and to Covance Phase I clinical research units for first-in-human and first-in-patient studies. As studies progress, the I&I team can complete its unique set of solutions by drawing on additional expertise from Covance’s clinical development and commercialization, translational biomarker, immuno-oncology and central laboratory teams, as well as LabCorp’s specialist scientific and technical capabilities.

In 2017 alone, Covance more than doubled its I&I laboratory footprint, including additional space in three locations and establishing a new innovation laboratory for method development and validation. Staff size has also doubled, driven by an increase in the number of scientists with advanced degrees. Covance’s recent investments in technology and innovation capabilities have enabled the business to further scale production, as well as support the development and implementation of new services within the rapidly growing biologics market.

Hovione Expands Capacity

The capacity expansion began in 2016 and will continue over the next five years. In the first two years, Hovione relocated its development services to a new center in Lisbon with 75,320 sq. ft. (7,000 m2) and is fully equipped to handle potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation and analytical development areas.

Over the next three years, Hovione will add to the Loures site a new chemical synthesis and spray dryer building for contract manufacturing, with a total of 4,200 m2 for 165m3 of reaction vessel capacity, two large spray drying units, new formulation facilities for bigger batch sizes, and a new building that will host additional 1200 m2 of analytical laboratories.

These investments are supported by a 39% increase in staff in the last 2 years.

Wuxi Biologics Adds Bioreactors at Fully Single-Use Site

The CMO says adding the single-use offering from ABEC will make the newly opened biomanufacturing site in China comparable to stainless steel for commercial mAb production.

Housing 14 times 2,000L single-use bioreactors provided by Thermo Fisher, WuXi Biologics describes its $150m facility in Wuxi City, Jiangsu, as the world’s largest mammalian cell culture manufacturing site using disposable systems.

But the firm is increasing capacity by installing the largest available single-use bioreactors at the site: 4,000L Custom Single Run (CSR) disposable bioreactors from ABEC. Through the configuration of six bioreactors together, the site will be able to offer commercial volumes of 24,000L in a single, disposable run.

According to Chris Chen, CEO of WuXi Biologics, the investment is not due to a specific client but rather future demand.

“This is a WuXi initiated development to potentially enable 24,000L run using disposables, making it comparable to large scale stainless,” he stated.

“Each batch can produce 4-20kg,” he continued, adding the systems will be operational by April 2019.

Bethlehem, Pennsylvania-headquartered ABEC spokesperson Susan Cooper-Curcio said: "WuXi’s selection, as well as our activities with other customers, further validates the industry’s need for flexible and scalable solutions as customers look to transition single-use technology from R&D and clinical applications to cost-effective commercial manufacturing or approved products."

The time-saving and reduced contamination risk benefits of single-use bioreactors are well documented, but a major criticism made by end-users – including Pfizer and Janssen – concerns their limited scale for commercial production, compared to the 15,000L, 20,000L and beyond capacity of stainless steel tanks.

2,000L is considered a ceiling for single-use bioreactor bags due to the significant pressure from the increased weight of the liquid medium in larger volume bags, coupled with the significant learning curve for an end-user to manage.

However, ABEC launched a 4,300L bioreactor (with 3,500L of working volume) in 2015 and the 4,900L system (with a 4,000L working volume) last year.

According to the firm, these systems overcome the pressure issues due to “simple support structures at the lower ports.”

ABL Europe Chooses Sartorius

Sartorius Stedim Biotech (SSB), a specialist technology partner in the biopharmaceutical industry, has been selected by ABL Europe to be its primary supplier of single-use systems.

ABL Europe, a subsidiary of ABL, provides dedicated viral vector good manufacturing practice (GMP) services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.

Through a supply partnership with Sartorius, ABL Europe has successfully increased and brought online new viral vector manufacturing capacity at its European facility in Strasbourg.

Sartorius Stedim Biotech has delivered a comprehensive GMP viral vector manufacturing solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration and mixing. These have been installed at the Strasbourg facility, which is now in the process of manufacturing batches of viral vector products for ABL’s clients.

The company said its process solutions in single-use (SU) format have helped ABL expand its existing drug substance capacity, with a fully disposable manufacturing capability for different viral vector product types produced in non-adherent cell lines.

Patrick Mahieux, general manager of ABL Europe, commented: “The introduction of non-adherent cell culture capacity complements our existing adherent cell culture viral vector production technologies."

He continued: "It is the only pure-play, dedicated viral vector production site capable of manufacturing drug substance and drug product materials for toxicological studies, all clinical phases and even commercial launch. Everything from process development, manufacturing and QC release testing is performed under one roof.”

PCI Expands Analytical Laboratories at Tredegar Site

Global pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced a laboratory expansion at its site in Tredegar, Wales, UK.

The Tredegar facility is PCI’s development and manufacturing Center of Excellence with specialist expertise in the processing of highly potent molecules.

The site has undergone significant investments in recent years; this latest project ensures analytical capacity and capability to service increasing customer demand.

The investment will see PCI’s laboratory increase its analyst headcount by approximately 60% and increase its high-performance liquid chromatography (HPLC) capacity in excess of 20%, in addition to tripling its capacity for sample receipt.

The layout design of the facility incorporates optimized safety, combined with leading ergonomic principles, to deliver enhanced throughput and efficiency improvements.

PCI commented that after launching its contained manufacturing facility utilizing the latest in containment technology at Tredegar, the site has seen significant growth in its global customer base. The company hopes this latest project will ensure PCI is able to service both existing and potential new clients, and offer a project initiation in terms of analytical transfer within 4-6 weeks.

The site offers a Center of Excellence for the development and manufacturing of pharmaceutical products in a variety of dosage forms and has more than 30 years of experience in the specialist handling of potent molecules.

According to PCI, investment in state-of-the-art contained equipment, combined with the creation of a ‘Potent Passport’ philosophy to identify the specific handling requirements for every highly potent active pharmaceutical ingredient (HPAPI) project, defines PCI as a market leader within this space. The contained technology includes Xcelodose micro-dosing for early stage development drug-in-capsule (DIC), fluid bed granulation and roller compaction for products sensitive to heat and moisture.

Commenting on the expansion, PCI senior international VP, Richard Yarwood said: “Expansion of our laboratory services is an important program for the Tredegar site. Speed to market is of critical importance to our clients. We pride ourselves on continually improving our service for both existing and potential new clients and our analytical service is integral from the early stages of analytical development through to commercial launch and the associated annual stability testing.”

He continued, “Among our many key strengths is our ability to on-board projects faster than our competitors. This additional footprint will ensure we are able to continue to offer this speed of project initiation addressing customer need.”

Connect 2 Cleanrooms Builds Pharmaceutical Cleanroom Suite for Cubic Pharmaceuticals

Connect 2 Cleanrooms has been commissioned by Cubic Pharmaceuticals to build a cleanroom suite for the manufacture of solid and liquid dose medicines.

Cubic Pharmaceuticals is the first life science company in the UK to achieve a patented design for its novel continuous granulation process for processing water insoluble active pharmaceutical ingredients (APIs) using hot melt extrusion (HME).

With a unique continuous manufacturing technique for processing most challenging APIs, its technology increases the solubility of ibuprofen to 80% within 15-20 minutes and 97% within two hours.

"We invented the manufacture of Ibuprofen through hot melt extrusion, which is a world first,” said Saumil Bhatt of Cubic Pharmaceuticals.

"We also use platform technology to manufacture another 30 different non-soluble molecules through hot dry extruded granulation."

"This GMP grade cleanroom will transform Cubic Pharmaceuticals to a contract research organization (CRO), allowing pharma companies to benefit from our technology breakthroughs."

The single block cleanroom suite encompasses five areas for mixing, production, cleaning and dispensing, plus a change area for operatives. It will be constructed offsite for efficient installation.

Minafin Invests in Contract Manufacturing

Minakem, the contract manufacturing division of Minafin, specialized in custom development and manufacturing of building blocks, intermediates and active pharmaceutical ingredients (APIs) for the pharmaceutical industry, has initiated the extension of its manufacturing capacity at its Dunkirk site in France.

The $18 million investment from parent company Minafin is the first of this magnitude. It will enable the company to set up a new production line, increasing production capacity by 28 cubic meters. In parallel, existing production assets are being upgraded in order to increase flexibility. This will free up an additional 26 cubic meters production volume. In total, the production volume at the Dunkirk site will increase by 54 cubic meters to a total capacity of 148 cubic meters.

"We are pleased to announce the initial phase of an additional production line at our Dunkirk site. Thanks to this major investment by the Minafin Group, we are excited by the growth potential for Minakem," said Thierry van Nieuwenhove, chief executive officer, Minakem. "It fits into our 'Jump 21' strategy and follows Minafin's objective to increase overall production capacity at Minakem's sites. This will also enable us to better respond to growing market needs and will undoubtedly contribute to the expansion of our product and service offering and to our growth."

This investment comes at a time when Minakem is seeing an increasing number of innovations and new molecules hit the market, which is driving the need for more production capacity among quality suppliers in Europe.

More volume capacity means that Minakem can extend its product range and continue meeting client expectations in terms of international standards and flexibility. The increased volume will also enable Minakem to remain competitive as a supplier of active ingredients to the pharmaceutical industry.

The engineering phase has already started on the site; a former AstraZeneca facility that Minakem bought in 2009. It meets the highest standard requirements from all authorities worldwide. Commission tests are planned for early 2019, with an expected operational starting date in May 2019.

A previous investment of $1.9 million was made by Minafin in 2016 to ensure continuous flow manufacturing and increased capacity in cryogenic production.

Upperton Expands Services

Spray-drying service provider Upperton Pharma Solutions has expanded to offer GMP manufacturing for early-stage clinical trials.

The Nottingham, UK-based firm has completed a £1.5m ($2m) expansion to a larger, self-contained facility in order to increase its offering to include a range of new production services.

According to CEO Richard Johnson, the expansion was both driven by demand from clients and a strategic necessity for the company.

“We realize as a business that we need to offer this service to our customers in order to support continued growth,” he said.

The 15,000 sq. ft. facility will house R&D, quality assurance and manufacturing departments, with the latter planned to be MHRA validated for clinical trials manufacturing by the third quarter this year.

It will also focus on dry powder formulations for capsules, tablets (oral dosage forms) and pulmonary and nasal devices, he said, focused on Phase I and II clinical trial supply.

Core equipment will be a Niro PSD-1 and ProCePT scale spray dryers with associated powder handling and dosage form development capabilities, with the larger spray dryer able to make batch sizes of several kilograms of spray dried powder.

Recipharm Completes Capacity Expansion

Recipharm’s new blow-fill-seal machinery is now operational following a substantial investment last year at its facility in Kaysersberg, France.

The ‎€18 million investment added a new blow-fill-seal, high-speed filling, and packaging line to the site, upping the total number of lines to eight and increasing the facility’s manufacturing capacity by 200 million unidoses per year.

In addition, the investment adds 25,824 sq. ft. (2,400 square meters) to the facility, creating space for three more machines, which will ultimately allow the site to manufacture over 1.2 billion unidoses per year.

Yves Buelens, general manager at Recipharm’s Kaysersberg site, said, “Recipharm has only owned the facility for two years and during that time have taken some very fast and positive decisions to invest in Kaysersberg. We have worked hard to develop a flexible service that can cater for even the most complex of projects. Adding the line to our facility will allow us to take on new customer projects more quickly, as well as continue to meet our current customers’ requirements. The additional space we’ve added also means we are also well positioned for further growth in line with future customer demand.”

The Kaysersberg site specializes in blow-fill-seal technology for sterile liquids. The site manufactures single dose units and has an advanced aseptic process for sterile liquid packaging applications.

Glenmark Opens New Discovery Center

Glenmark Pharmaceuticals is enhancing its capabilities in translational research by opening a new discovery center at the Biopôle campus in Lausanne.

Glenmark will continue to invest in, and operate its process development and biologics manufacturing center out of La-Chaux-de-Fonds, Neuchȃtel. Approximately 20% of current employees will be housed in the discovery group at Lausanne.

"The Biopôle is one of the most vibrant ecosystems for life sciences innovation in Europe. This expansion opens a universe of opportunity to foster our innovation capabilities by collaborating with the world class research centers, academic groups and hospitals in the Lausanne vicinity. At the same time, Glenmark's long-term commitment to our development center in the region of Neuchȃtel will remain a key priority," said Dr. Kurt Stoeckli, president and chief scientific officer of Glenmark Pharmaceuticals.

The company's rapidly evolving pipeline of novel biologics and the growing demand for technical development and manufacturing will require further expansion of current capabilities and capacities. Glenmark will continue to evaluate expansions and enhancements to accommodate the increasing demand for biologics development and manufacturing in the canton of Neuchȃtel.

CapsCanada Adds New Facility

CapsCanada, a leading provider of capsules for pharmaceutical drugs and dietary supplements, announced the addition of a new, state-of-the-art, dedicated hydroxypropyl methylcellulose (HPMC) capsule manufacturing facility.

With this investment, CapsCanada has now increased capsule output by 50%. Produced with 100% plant-derived material, CapsCanada's K-CAPS® are ideal for consumers with dietary restrictions prohibiting the consumption of animal byproduct and are suitable for a wide range of formulations.

"The new factory was built because we saw worldwide acceptance of K-CAPS® as the preferred HPMC based capsule. Compared to other HPMC capsules, K-CAPS® have exceptional aesthetics and perform better on automatic capsule filling machines; directly translating into reduced raw material loss and downtime for our customers." according to Jonathan Gilinski, executive director.

The company previously made a $10 million expansion of their Windsor, Ontario site in 2014, experiencing growing global demand for its products. K-CAPS® are already sold in more than 60 countries worldwide.

Torrent Pharmaceuticals and Novo Nordisk Insulin and Parenteral Facility

Torrent Pharmaceuticals and Novo Nordisk India opened a new greenfield insulin and parenteral facility at the former’s parenteral facility in Indrad, Gujarat, India, in December 2017.

The new facility was built as part of an agreement signed by Torrent Pharma with Novo Nordisk India in August 2005 to dedicate a part of its Indrad parenteral facility to carry out works related to insulin formulating and packaging.

The plant has been manufacturing insulin for Novo Nordisk products for more than 15 years. The new greenfield site will enable Novo Nordisk to meet the increasing demand for insulin products in India.

According to the International Diabetes Federation 8th Atlas, India has approximately 72.9 million people with diabetes, which is expected rise up to approximately 134.3 million by 2045. The new plant will enable Novo Nordisk to provide affordable and quality medication to address the growing challenge.

The new facility incorporates state-of-art technology from the formulation of insulin to the packaging of insulin formulations. It has a systematic and single directional movement for both the people and material in the entire pharmaceutical area.

Provisions have been made for utilities such as WFI and Clean Steam Generator with capacities of 3m³/h and 800kg/h respectively. The civil structure of the facility was built using prefabricated modular partitions.

Designed to comply with cGMP and EU GMP standards, the greenfield facility will produce insulin vials, lyophilized products and liquid ampoules/vials.

The existing Indrad parenteral facility has a capacity of 12.5 million insulin vials, 14.4 million vials of lyopholiser and 15 million ampoules. The new facility will increase the capacity to 15 million insulin vials and 30 million ampoules.

The plant’s initial capacity will be enough to meet the market demand for a period of five years, following which a second line is planned to be added. The plant’s capacity will be increased to 300 million insulin vials with the addition of the second line.

The Indrad facility is built on a 2,044,400 sq. ft. (194,000m²) site, with a 150,640 sq. ft. (46,000m²) built-up area for formulations operations and 14,000m² for active pharmaceutical ingredients (API) operations.

Set up in 1989, the plant manufactures finished products in the oral, injectable and freeze-dried sterile injections form. It is compliant with various regulatory norms such as USFDA, WHO, cGMP and MHRA, and is also ISO-certified.

Based in Denmark, Novo Nordisk is a leading global healthcare company that has been involved in diabetes care for more than 90 years. It markets various treatments for obesity, haemophilia, growth disorders and other serious chronic diseases.

Novo Nordisk has more than 41,700 employees in 77 countries and has a global footprint in 165 countries. It partnered with Torrent Pharma in 1992 to manufacture insulin vials.

Apart from the Indrad plant, Torrent Pharma operates formulation and bulk drugs manufacturing plants at Baddi, Sikkim, Dahej, Pithampur and Vizag. The plants are approved by regulatory bodies of the US, UK, Brazil, Germany, Australia and South Africa.

Torrent also has a fully equipped research center with approximately 900 scientists.

Public Health England has a New Harlow Campus, Essex

Public Health England (PHE) is developing a public health science campus and headquarters in Harlow, Essex, UK.

Named PHE Harlow, the facility is estimated to cost £400m ($584m), which will be funded by the UK Government through a capital support program.

The campus is expected to deliver solutions for issues such as smoking, alcohol, diabetes, dementia and environmental hazards. PHE aims to support the training of scientists in the research centre to meet future recruitment needs.

“The visitor area of the campus will allow school groups and organizations in the local community to meet PHE scientists, attend conferences and workshops, and learn about public health, science and research.”

Construction is expected to commence in 2019 and is scheduled for completion by 2024.

The project is expected to generate employment for up to 2,750 people by 2024. It is also expected to generate thousands of construction-related jobs.

The Harlow Council’s Development Management Committee granted approval to develop the health science campus in December 2017 on a site formerly owned by pharmaceutical company GlaxoSmithKline (GSK).

The site is located at the company’s New Frontiers Science Park within the Pinnacles Industrial Estate in Harlow and within the London-Stansted-Cambridge life sciences corridor (LSSC), which is one of the leading life sciences research zones in Europe.

The LSSC corridor comprises 37 life sciences research institutes and 1,400 life sciences businesses. It is expected to create an opportunity for PHE to partner with commercial, academic and government partners.

A business case for the establishment of the PHE Harlow project was submitted to the UK Government in July 2014.

PHE announced its decision to relocate the majority of its functions from Porton to Harlow in September 2015. The decision was followed by a government proposal announced in November 2015 to move the Colindale facilities to Harlow and create a single centralized campus.

In addition to the Porton and Colindale facilities, the Central London headquarters of PHE is also proposed to be relocated.

The design of the PHE Harlow campus includes the construction of a new reception and visitor centre, an exhibition space, a training laboratory and a media center.

A specialist bioscience laboratory building and logistics centre will also be added, the existing laboratories and office areas will be refurbished and site-wide infrastructure will be installed.

Four of the existing buildings created by GSK will be refurbished and reused, retaining 688,640 sq. ft. (64,000m²) of floor space. The draft proposal includes construction of up to 602,560 sq. ft. (56,000m²) of new floor space, including 96,840 sq. ft. (9,000m²) for future expansion.

The visitor area of the campus will allow school groups and organizations in the local community to meet PHE scientists, attend conferences and workshops, and learn about public health, science and research.

Kier Group was awarded a contract worth £160m ($221m) for the construction of the specialist bioscience laboratory building.

Wates Construction was awarded a contract for the construction of the arrivals, administration, and logistics buildings, as well as for renovating the main building, including laboratories and offices.

VolkerFitzpatrick (Royal VolkerWessels) was contracted for the installation of infrastructure, external works, and construction of an energy centre within the campus.

McIlvaine Company

Northfield, IL 60093-2743

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

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