PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

BNBuilders Completes BSL-3 Lab Remodel at UC Riverside

The project for the University of California's Riverside School of Medicine offered Biosafety Level 3 containment of dangerous biological agents.

This US$2 million project involved converting an existing laboratory space into a BSL-3 suite for faculty research programs. An experienced builder for this type of specialized construction, BNBuilders has completed numerous technologically-advanced life science and research facilities throughout the West Coast of the US.

At UC Riverside's School of Medicine, BNBuilders completed selective demolition of existing laboratory space and infrastructure in an occupied building, and constructed new procedure rooms and research space with new dedicated mechanical systems.

The 1,383 sq. ft. remodel included an anteroom, gowning/de-gowning room, shower area, procedure rooms, an autoclave, biosafety cabinets, and other specialized equipment.

BNBuilders also ensured that the laboratory met BSL-3 specifications to ensure appropriate containment of dangerous biological agents. BSL-3 laboratories must be behind two sets of self-closing doors, and any seams in the floors, walls, windows, and ceilings must be sealed to prevent any microbes from leaving the suite and for easy cleaning and decontamination.

The ventilation system must force clean air into the lab where infectious agents are handled, and air from inside the laboratory must be filtered before it can be exhausted back into the atmosphere. BSL-3 is commonly assigned to facilities that work with tuberculosis, SARS, yellow fever, and West Nile virus.

Jamie Awford, Principal at BNBuilders, said: "This lab will offer new opportunities for UC Riverside researchers to contribute to the worldwide knowledge of and treatments for dangerous pathogens. We are proud to be a part of that important work."

Cambrex Adding Analytical Lab at NC Facility

Cambrex Corporation is adding a new $3.2m, 11,000 square foot analytical laboratory to its High Point, NC-based facility.

According to contract development and manufacturing organization (CDMO), the investment follows an increasing customer demand for analytical development and validation services to support cGMP products at the clinical stage.

“Demand for analytical and process development and manufacturing at early clinical stages is growing as we see the record number of projects in the clinical pipeline," said Brian Swierenga, site director, VP operations, Cambrex High Point.

"At the same time the complexity of the molecules and the more stringent regulatory requirements has led to a greater proportional growth in demand for analytical resources," he added.

Cambrex purchased the 35,000 square foot High Point site from PharmaCore in October 2016, since which time it has invested more than $5m in the site. The most recent investment follows the addition of a fourth reactor suite at the facility in May of this year.

Equipment installation at the High Point facility will begin in Q3 2017. Validation and start up is expected in Q4 2017.

As part of the expansion, the company also plans to add twelve new analytical development scientists to its research and development team.

Last month, Cambrex also announced a $24m investment to open a new facility to manufacture high potent APIs at its Charles City, Iowa plant.

CSL Adding Scalable Stem Cell Gene Therapy Tech

CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.

CSL Behring is set to pay $91m (€76m) upfront and up to $325m in milestone payments over the next eight years for Calimmune.

According to spokeswoman Natalie de Vane, the acquisition is the first step into the cell and gene therapy space for CSL with the addition of an ex vivo hematopoietic stem cell (HSC) gene therapy candidate and R&D facilities in Pasadena, California, and Sydney, Australia “a natural complement” to the firm’s protein-replacement business and its rare diseases focus.

“We have been interested in the field for some time, and believe that Calimmune is an appropriate point of entry into this area for us, and a good strategic fit for our business and our longer-term strategic goals,” she said.

“Calimmune’s preclinical hematopoietic stem cell (HSC) gene therapy, CAL-H, for the treatment of sickle cell disease and β-thalassemia, aligns nicely with our deep expertise and leadership in haematology.”

The deal also brings CSL the Select+ and Cytegrity platform technologies which de Vane said have broad applications in other ex vivo stem cell gene therapies.

“[The platforms] have the potential to address some of the major challenges currently associated with the commercialization of stem cell therapies, such as the ability to manufacture consistent, high-quality product, and to improve engraftment, patient to patient variability, efficacy and tolerability.”

The Select+ platform, for example, looks to reduce the required intensity of the conditioning chemotherapy currently used, which could make HSC therapy an outpatient procedure, while the Cytegrity tech looks to provide a scalable manufacturing platform with high batch-to-batch consistency.

“[This] would be a tremendous advantage as today lentiviral vectors are generally manufactured in small batches through a convoluted process,” she said.

The deal is expected to close in the next two weeks at which point CSL will hope to integrate the business with minimal disruption.

“Immediately after close, Louis Breton, Calimmune’s CEO, will report directly to our Chief Scientific Officer and R&D Director, Andrew Cuthbertson. Additionally, we will form a joint integration team focused on growing and building the Calimmune assets and technologies.”

Gilead to Expand Manufacturing Capabilities

Gilead says it is committed to driving down costs of CAR-T manufacturing after agreeing to buy late-stage cell and gene therapy firm KitePharma for $11.9 billion.

Until the US Food and Drug Administration (FDA) approved the first gene modified cell therapy product in the form of Novartis’ Kymriah (tisagenlecleucel), Gilead Science’s agreement to buy Kite Pharma was the biggest CAR-T cell-related story of the week.

The $11.9bn (€10bn) deal will see Gilead launch into the cell therapy space, adding the chimeric antigen receptor (CAR) T cell therapy candidate axicabtagene ciloleucel (axi-cel), currently under regulatory review in the US and Europe.

According to CEO John Mulligan, Kite showing “manufacturing on an industrial scale could work” helped convince Gilead “that now is the right time to get involved in this kind of therapy.”

He told investors in a conference call: “Kite was the right partner for us to work together because they've everything they need for the first generation. They're already thinking about and working on next generation. They have solved the manufacturing problem.”

Axi-cel is made by isolating peripheral blood mononuclear cells, including T-cells, from the patient’s own white blood cells, which are then sent to Kite’s facility for transduction with a retroviral vector. The site in El Segunda, California opened in June 2016 and has the capacity to produce volumes of the autologous therapy for up to 4,000-5,000 patients per year.

But while axi-cel has been submitted for regulatory review with the EMA, manufacturing plans have yet to be decided regarding the supply in Europe.

“The manufacturing is entirely in the United States and so that will limit what we can do,” Mulligan said, adding his firm and Kite were set to “work together to accelerate the expansion of manufacturing operations.”

Kite is Gilead’s first foray into biological manufacturing and of the benefits of this therapy is that it will not have to commit to large-scale stainless steel “$1 billion plants you often have to build if you want to get into the biologics,” Mulligan continued.

“It's a much more cost effective scale of and that it's reproducible and often you can build in the United States and you can reproduce that in the Europe, again in a fairly cost effective way from a capital expenditure point of view,” he added.

“We became enamored with the Kite philosophy of how to do that, how to do build the station, how do get the workflow through, how to run multiple shifts so that you could achieve the kind of patient flows that you wanted, the kind of flows necessary to support the patient flows that we expect in the future.

“They are committed to simplifying the system, so the future manufacturing is more cost effective and more scalable.”

Nitto Denko Avecia Opens Expanded Manufacturing Facility

Nitto Denko Avecia Inc. has opened its new oligonucleotide API manufacturing facility in Milford, MA. The expansion adds 20,000 sq.-ft. of manufacturing and office space and provides CGMP oligonucleotide manufacturing capacity up to 1.8mol. The total capacity of Avecia’s Milford site has now more than doubled up to 3.0mol, which makes Avecia in Milford, MA the largest oligonucleotide manufacturing site in the world.

According to Avecia’s president Detlef Rethage, “This expansion will help Avecia’s clients to receive timely oligonucleotide API to advance their drug development programs in clinical trials as planned. “Avecia takes pride that our engineers have introduced novel technology, executed this expansion in record time, and in close collaboration with A/Z Corporation to ensure the timely supply of novel oligonucleotide therapeutics,” said Rethage.

Avecia has added more than 120 jobs in the last 12 months in Milford and currently has more than 50 open positions at its four locations in MA, OH, and CA. The new positions will specialize in microbiology, analytical chemistry, manufacturing, quality assurance and engineering.

Q Laboratories Expands Capacity

Q Laboratories has purchased two buildings in Cincinnati, OH as part of its ongoing capacity expansion. The two buildings are adjacent to the 30,000 sq. ft. lab currently under construction, which is scheduled to be completed in spring 2018. The new buildings comprise 25,000 sq.-ft., and will serve as administrative offices supporting the company’s microbiology, analytical chemistry and R&D labs.

Until the new lab building is completed, Q Laboratories has re-located the Microbiology Pharma Lab to the newly purchased buildings allowing for expansion of both that lab and the Microbiology Food Lab, which will utilize vacated space at the current Harrison Avenue location.

Q Laboratories president and chief executive officer, Jeff Rowe said, “Capacity expansion has been a continued focus of the company and we did not want to wait until first quarter 2018 when construction is completed to give these two laboratories much needed space.”

Q Laboratories provides microbiology, analytical chemistry and R&D lab services, including: Method Development and Validation, Pathogen Screening, Indicator Organism Enumeration, Nutritional Analysis, Raw Material Qualification, Microbial Identification, Challenge Studies and Shelf Life/Stability Testing.

Oxford Genetics Opens New Office

Oxford Genetics has opened its first U.S. office located at the NGIN workplace near Kendall Square in the Cambridge district of Boston.

By expanding into the U.S. market, the company is well positioned to respond to its existing customers’ needs, while also leveraging the very attractive sector and growing market.

This is the company’s first office outside of the U.K., and will support its business in the U.S. and reinforce its commitment to delivering solutions that improve the discovery and development of biotherapeutics. Oxford Genetics aims to grow its U.S. commercial team to approx. 10 over the next 18 months, build on collaborative partnerships and will focus on driving sales, as well as strengthening its customer and technical support offering.

This global expansion follows the company’s latest successful round of financing in which it secured a £7.5 million investment that will also support the company’s 6,000-sq. ft. expansion of its U.K. facility at Oxford Science Park. This will include state-of-the-art cell line engineering capabilities, viral vector production and purification suites, high-throughput robotic screening systems and process development facilities.

“Over the past twelve months we have seen increasing demand for our technologies and services from the U.S. market so the decision to expand our presence there was a logical step in the growth strategy of our business,” Paul Brooks, CCO of Oxford Genetics, said. “The Boston area is a thriving hub for biotechnology talent and technologies which we look forward to being a part of, as well as increasing our ability to service a key growing market for Oxford Genetics.”

Avantor Opens Life Sciences Research Centre

Avantor Performance Materials has opened a new life sciences research center in Bridgewater, NJ.

The center will provide contract research capabilities, including gene synthesis, protein expression, final formulation, and drug delivery.

The innovation center employs research specialists including chemists and innovation associates to collaborate with biopharmaceutical and pharmaceutical companies to address their drug manufacturing processing objectives.

The facility was leased in June by Avantor from The Garibaldi Group/CORFAC International, a provider of real estate services based in the US.

Incorporating multiple pharmaceutical research platforms, the new center will serve as a rapid response research hub for biopharmaceutical, biologic, and small molecule markets. It is expected to strengthen the company's innovation capabilities in the pharmaceutical and life-sciences sector, as well as other advanced technologies.

The Bridgewater Innovation Center has a floor area of 26,769ft² and houses a variety of tools required to help pharmaceutical companies with a range of upstream and downstream bioprocesses in the fields of biopharma, analytical science, drug formulation, and drug delivery.

Pharmaceutical research tools available include multiple mass spectrometers, cleanroom facilities, particle size analyzers, and specially constructed bioreactors.

The biopharmaceutical focus areas include facilitation of recombinant protein engineering, mid-scale bioreactor production, protein purification process development, protein expression, custom chromatography resins, host organism expression, and biophysical characterization.

"The new center will serve as a rapid response research hub for biopharmaceutical, biologic, and small molecule markets."

For analytical science applications, the facility will perform characterization and quantitation of products, spectroscopic data for structure elucidation, microbial and endotoxin tests, profiling of organic impurities and elemental impurities down to 0.5 parts per billion (ppb), surface and particle characterization and identification, and chromatographic characterization of organic impurities.

Drug formulation and delivery activities at Avantor's innovation center consist of compatibility assessment of active pharmaceutical ingredients (API) or advanced current good manufacturing practice (cGMP) materials, a selection of excipients, control drug release profiles, loading of API in the drug formulation, and prototyping of drug device combinations.

Avantor's new life-sciences research center is located within the JR1 building of the New Jersey Center of Excellence life-sciences campus, which is situated on an 110-acre site in Bridgewater Township, New Jersey.

Situated on the US Highway 202/206 in the middle of the Boston-Washington wealth corridor, the site is well connected to major transportation routes. It is surrounded by approximately 3,000 life-sciences companies and is located close to top universities.

The research and development (R&D) campus was launched in April 2013 and is owned and managed by Advance Realty and investment firm CrossHarbor Capital Partners.

Headquartered in Pennsylvania, Avantor Performance Materials is engaged in supplying ultra-high-purity materials and solutions. It was originally founded as J.T.Baker Chemical Company in 1904 and serves roughly 7,900 customers globally with more than 30,000 products.

The company's solutions are used for the research and production needs across various industries including pharmaceutical, bio materials, medical device, diagnostics, biotechnology, semiconductor, and aerospace.

Avantor's products are marketed under brands including J.T.Baker®, Puritan Products™, Rankem™, BeneSphera™, POCH™, Macron Fine Chemicals™, CareSil, and NuSil™.

Construction of the Alewife Research Centre (ARC) Started in February 2017

The Alewife Research Centre (ARC) will be located at 35 Cambridge Park Drive. Initiated in February 2017, it will provide laboratory space for life science and pharmaceutical companies. Scheduled to be completed by mid-2018, the center will enable more companies to contribute to Cambridge's reputation as a prime center for research and development (R&D).

Alewife Research Centre is being constructed next to Alewife subway station, which is nearby Kendall Square and Harvard Square. The area can be accessed via the MBTA Red Line subway and the Metro West suburbs via Route 2.

The ARC will be situated in a five-story building with a total floor space of 223,000ft². It will feature flexible lab and R&D spaces, an employee lounge, conference and meeting areas, a fitness workout area with showers and lockers, and a bike room with secure storage.

In addition, the building will include a 29,000ft² penthouse to support the tenant roof-top equipment.

A grand lobby with a two-story atrium and gathering spaces will be provided, as well as a service elevator with a capacity of 5,000lb running between the first floor main lobby and the penthouse.

The center will also include a loading dock area with dock levers and feature concrete slab floors with a live load capacity up to 100 per ft². It will have a floor-to-floor height of 11ft on the first floor and 14ft 6in on the other floors. The column bay spacing will be 22ft 6in x 22ft 6in for the first floor and 22ft 6in x 45ft for floors two to five.

The laboratory in the ARC will feature air-handling units with pre-filters, final filters, and chilled and hot water coils. It will have a paring at a ratio of 1.5 spaces per 1,000ft².

Spagnolo Gisness & Associates (SGA) was awarded a contract to design the core, shell, and lobby elements of the research building. McNamara Salvia, VHB, and AHA Consulting Engineers were awarded the structural engineering services contract.

John Moriarty & Associates was awarded the general construction contract for the research facility. Ipswitch Bay Glass (IBG) was contracted to provide curtain walls and windows for lab building.

Headquartered in Boston, The Davis Companies (TDC) is a real estate investment, development, and management firm. The company has invested more than $4bn in gross asset value through real estate equity, debt and fixed-income securities. It owns real estate portfolio of approximately 12 million ft² across the Eastern US.

High School Students Excel in State-Of-The-Art Biotech Lab

Imagine you are a teenager doing research in a lab reserved for professional scientists. That’s pretty close to reality for South San Francisco High School students.

Welcome to the Science Garage, a state-of-the-art biotech lab located on the campus of South San Francisco High School. Biotech giant Genentech spent nearly $8 million to build the lab, part of a partnership with the school district. The goal is to get kids excited about STEM fields.

It’s also about being a good corporate neighbor. Genentech employees also mentor local elementary students, and host a science competition for middle-schoolers. The company says it recognizes the need for all schools to have equal opportunity for all kids.

“In South San Francisco, 30 percent of students are English language learners, 40 percent of students are low income, and they have bigger barriers to pursuing a high quality career in their own backyard,’ explained Kristin Campbell Reed, Genentech’s Director of Corporate & Employee Giving. “[So we are] really trying to make it clear that this science drives so many things around them.”

But it’s not all serious. The learning is meant to be fun and engaging. Lessons include a chimpanzee paternity mystery, a tainted meat mystery, and a doggie allergy test, with no actual animals used, of course. After a year-long pilot program, about 1,000 high school students in South San Francisco are using the Science Garage curriculum.

Teachers get mentoring too, and volunteer in-class help from Genentech employees. In the hands-on program, 9th graders get four weeks of biotech work as part of their biology class. Students can then take two more years of biotech classes, and do an independent research project. The electives also meet the high school requirements for entry into the University of California as well as California State University.

The program seems to be working. After soaking in lessons about protein analysis and DNA sequencing, 17-year-old Nick Arcega is ready to pursue a STEM field when he goes off to college.

“Getting to use the tools that a possible researcher would use,” said Arcega. “Yes, this is exciting.”

Arcega said his plan is to pursue a career in forensic science.

It’s an outcome South San Francisco Unified School District Superintendent Shawnterra Moore is thrilled to see.

“It’s really created hope and inspiration,” said Moore. “For our kids to really think, ‘I can do this.'”

Alcami Opening St. Louis Facility in Cortex Innovation Community

Alcami announced its new analytical testing facility in the Cortex Innovation Community, a 200-acre innovation hub and technology district. The facility will be Alcami’s new Center of Excellence for its advanced analytical testing operations.

Alcami’s centrally located new St. Louis campus is easily accessible for both domestic and international business partners. The site offers a variety of essential technologies for development and testing. It offers a significant laboratory expansion as well as a range of new capabilities, including a low humidity room used to test and handle hygroscopic materials; isolator technology that will serve as an upgrade from traditional sterility capabilities; Inductively Coupled Plasma Mass Spectrometry (ICP-MS) equipment designed to assist clients in their transitions from USP wet chemistry heavy metal requirements; a photosensitive materials handling lab to protect light-sensitive materials and more.

“We are delighted to expand our laboratory capabilities in St. Louis and are proud to call the Cortex Innovation Community our new home,” said Dr. Stephan Kutzer, CEO, President and Chairman of Alcami Corporation. “The successful completion of this investment is an integral moment in Alcami’s history and will solidify our position as a leading analytical testing solution provider for the pharma and biotech industry.”

The site specializes in chemical and microbiological analysis, including raw material and antibiotic testing, drug product release and stability, and full drug product manufacturing evaluation, including water analysis, environmental monitoring, and in-process evaluations for both sterile and non-sterile drug product including controlled substances.

ChromaTan to Develop Continuous Purification Tech with US FDA Grant

ChromaTan will develop an integrated and continuous downstream purification platform through provisions in the 21st Century Cures Act to support manufacturing initiatives.

The $2.5m (€2.1m) grant from the US Food and Drug Administration (FDA) will be used to develop the Continuous Countercurrent Tangential Chromatography (CCTC) platform at ChromaTan’s laboratory located in West Philadelphia.

Oleg Shinkazh, ChromaTan’s founder and CEO, said the two-year project was part of the 21st Century Cures Act – signed into law in December 2016 – which has dedicated funding to support advanced manufacturing initiatives and continuous bioprocessing.

According to Section 3016 of the Act, the US Health and Human Services department (under which the FDA falls) may award grants “for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.”

Shinkazh could not make any statements related to the FDA and its motivations. “That's explicit in the contract.”

Continuous chromatography is an area which has been cited as “the next logical step” in bioprocessing, with the need to develop such processes to reduce the costs of making biological products, on the back of his firm’s deal with Wales, UK-based bioprocessing resin maker Purolite for the supply of Protein A resin in the CCTC system.

The project aims to develop a platform that can continuously purify a monoclonal antibody (mAb) harvested from a CHO cell-based bioreactor system through multiple purification modalities, and will include process development, design, and testing of a multi-unit operation process train.

It will also create three jobs this to be filled this year, and potentially a further three to be filled in 2018, Shinkazh said.

New STEM Center Building, Hartnell College, Salinas, California

Cost: $23,940,653
Size: 57,350 sq. ft. (Gross Building); 37,236 sf (Net (Assignable) Building); 20,502 sq. ft. (Laboratory & Laboratory Support)
Project Team: Research Facilities Design, laboratory planner; Lionakis, architect

The new STEM Center Building at Hartnell College comprises 20,502 sq. ft. of laboratory and laboratory support space in a 57,350 sq. ft. building for the Department(s) of Biology, Chemistry, Physics, Astronomy, Geology and Engineering. The facility includes teaching laboratories and associated prep and storage spaces for Anatomy, Field Sciences, Microbiology, Molecular Biology, Geology/Environmental Science, General Chemistry, Organic Chemistry, Physics and Engineering/Astronomy. Special support spaces include a Biotechnology Laboratory, Aquaria Room and a Chemistry Instrument Room.

Completion Date: September 2016

Bridgeport Hospital OR

Bridgeport Hospital Hybrid OR, Bridgeport, Conn.
Cost: $5 million
Size: 1,500 sq. ft.
Project team

Architect: Shepley Bulfinch

Mechanical, Electrical, Plumbing, Fire Protection: Bard, Rao + Athanas (BR+A) Consulting Engineers

Structural Engineer: Spiegel Zamecnik & Shah Inc. Structural Engineers

Construction Manager: Turner Construction

The Elizabeth M. Pfriem Hybrid Operating Room Suite at Bridgeport Hospital combines integrated technology and sophisticated imaging facilities into a state-of-the-art operating theatre that will be used for cardiac, vascular and thoracic surgery.

The new hybrid OR combines two existing operating rooms, an associated scrub room and a storage room to accommodate the new facility. Previously, heart surgery, vascular surgery and thoracic surgery were performed in two separate operating rooms, but the new hybrid OR can accommodate either or all of these procedures in the same space. The integrated imaging capabilities enable minimally-invasive surgery, supplanting the need for high-risk, major open surgeries. This is less traumatic for the patient and allows staff to monitor the success of the surgery in real time, thereby cutting down on both procedure and recovery time. Additional benefits of hybrid OR procedures to patients include less trauma, less scarring, faster rehabilitation and a more positive overall patient experience.

The highly sophisticated GE Discovery 740 System selected for the OR demanded a number of unique design requirements, including special attention paid to the flooring which had to be extremely accurate in terms of materials and leveling. Since construction took place in an otherwise occupied and working hospital, thorough consideration of noise and vibration control was also required. The new facility includes new solid surface walls and epoxy painted ceilings to mitigate hospital acquired infections.

This project was completed on a relatively short timeline of only one and a half years from pre-design to completion, and on a limited $5 million all-in budget.

Completion date: April 2017

Althea Opens New GMP Production Suite

Ajinomoto Althea, Inc. has opened a GMP production suite in its newly constructed High Potency Products (HPP) commercial manufacturing facility in San Diego, CA.

The San Diego-based contract development and manufacturing organization (CDMO) purchased the facility on May 1, 2015. Phased construction and retrofitting have been progressing since January 2016.

The 57,000 sq. ft. plant will offer several services. The facility is currently offering process development and analytical services and will be open for GMP bioconjugation and complex formulation in November 2017.

Full manufacturing services, including high containment fill and finish, are expected to begin in Q4 2018.

The first manufacturing contract for the facility has been secured, and while the deal’s terms are confidential, it will include technology transfer, analytical method implementation, process validation, and GMP Drug Product manufacture in preparation for commercial launch of the client's key therapeutic drug, according to Althea.

In August, the CDMO also added a new aseptic fill/finish line at its San Diego headquarters in response to client’s concerns regarding active pharmaceutical ingredient (API) manufacturing costs.

LabCentral, Pfizer to Open Next-Stage Facility

LabCentral and Pfizer announced plans to open LabCentral 610, a new LabCentral offering located at Pfizer’s Kendall Square Worldwide Research and Development campus. The 33,000-square-foot facility is slated to open in December and will house up to six early- to mid-stage companies. Eligible startups include those with high-impact science, excellent execution, and significant prospects for achieving scientific and business success whose space needs exceed current LabCentral offerings. The companies may be ‘graduates’ from the current LabCentral space, or those interested in securing space in the thriving bioscience Kendall Square neighborhood.

A joint steering committee made up of representatives from LabCentral and Pfizer evaluate potential companies. Three local biotechs have been accepted: Affinivax, EnBiotix, and Aquinnah Pharmaceuticals. Companies interested in applying can learn more here on LabCentral’s website.

As our resident startups have met their scientific milestones quickly and efficiently, they’ve thrived and grown – often citing LabCentral’s support and coworking model as a key factor,” said LabCentral Cofounder and President Johannes Fruehauf, M.D., Ph.D.”

LabCentral developed the LabCentral 610 site in response to requests from resident startups outgrowing or “aging out” of its original facility who want to remain within LabCentral’s supportive environment as they continue on in their next stage of development.

“Pfizer is proud to add LabCentral 610 to our growing Kendall Square Worldwide Research and Development campus,” Pfizer’s Chief Scientific Officer of Internal Medicine Morrie Birnbaum, M.D., Ph.D. said. “Collaborating with leaders such as LabCentral to foster scientific exchange and grow the next generation of biotechs is core to our mission, and it’s a testament to the strength of the area’s biomedical ecosystem to see these types of collaborations develop.”

Dr. Birnbaum serves on the LabCentral 610 joint selection committee and is also the Pfizer Worldwide Research and Development site’s senior scientific director.

Fresenius Kabi Starts Work on Sterile Drug Plant

Fresenius Kabi has started work on a $250m (€220m) sterile drug manufacturing plant in Illinois, US.

The German drug manufacturer announced plans for facility last year, explaining that construction at the site in Chicago’s Melrose Park suburb will help it capture a greater share of the US injectables market.

The project will create several manufacturing suites equipped with automated aseptic filling lines, expanded lyophilization capabilities, and formulation areas, as well as a dedicated warehouse for raw materials.

Brammer Plant Expansions

The contract development and manufacturing organization (CDMO) has selected Pall Life Sciences as its single-use equipment partner at its sites in Florida and Massachusetts.

This year, Brammer Bio has invested in its biomanufacturing capabilities, with a $40m expansion at its late-stage and commercial-ready cell and gene therapy facility in Cambridge, Massachusetts and a $10m expansion at a Phase I/II plant in Alachua, Florida.

Pall Life Science announced it had been chosen as a preferred technology partner “to deliver an end-to-end single-use platform solution from upstream to downstream,” according to Mario Philips, vice president and general manager of Pall Biotech.

The Alachua site will feature cell culture capabilities of up to 500L, while Cambridge will have a scale of up to 2,000L, both fully equipped by Pall. This includes Allegro STR single-use stirred-tank bioreactors range, fixed-bed bioreactors for the scale-up of adherent processes, and 25 bi-axial rocking bioreactors.

In the downstream, Pall will supply the sites single-use tangential flow filtration (TFF) systems, Allegro MVP systems for fluid automation, and Allegro single-use chromatography systems.

“With Pall’s critical process solutions and process support, we look forward to building on more than 100 executed projects and 150 clinical cell and gene therapy lots in Florida—including many first-in-human trials—and 600 plus commercial biologics batches produced in Massachusetts,” Brammer’s CSO Richard Snyder said in a statement.

Irvine Scientific Expansion

Irvine Scientific has expanded its cell culture dry powder facility in California to support the projected increase of biotherapeutic production.

The facility in Santa Ana, California has increased its dedicated capacity for Irvine Scientific’s animal component free (ACF) dry powder, used in the cGMp production of biologics, vaccines and cell therapies, to 12,000L through the expansion.

While financial details were not divulged, spokeswoman Lori Serles said the expansion is continual and linked to the firm’s long-term growth strategy. She added the expansion was necessary to feed demand for the number of biopharmaceuticals in development.

“Every market report shows an expected increase in the production of biotherapeutics, both in quantity and in number of approved drugs. Coupled with that is a projected increase in demand from existing customers and new customers as our account base expands.”

The new tumble blending enables the company to provide customers with homogeneous powder media in single production batch sizes of up to 7,000 kg.

“As more companies learn of our capabilities and the quality of our products the demand for our media keeps increasing. We are very confident that we will be making full use of our expanded production capacities.”

The expansion will not lead to new hirings, per se, though Serles said the firm has been growing in headcount in recent years though and expects that trend to continue.

Irvine’s manufacturing process follows regulatory guidelines for current good manufacturing practice (cGMP).

“In very simplistic terms the components, or qualified raw materials, of our media are processed in an impact mill, then blended in our tumble blender to achieve a dry powder media that is homogeneous for consistent particle size as well as uniform distribution of components,” Serles explained.

“Formulas, processes and material transfer are all designed and optimized to minimize the potential of contamination, thermal damage or de-blending of media that other processes such as mechanical conveyance can have.”

Germfree’s Mobile Pharmacy Trailer

Germfree has been providing equipment for compounding sterile IV and hazardous drug preparations to the hospital pharmacy industry since the early 1970’s. Germfree’s HEPA filtered, unidirectional airflow equipment, also called Primary Engineering Controls (PEC), provide an aseptic environment that allows the pharmacist to handle sterile products in a contamination-free environment. As regulations in the hospital pharmacy have evolved, a shift toward placing PECs into ISO 7 Cleanrooms (Secondary Engineering Control (SEC) has occurred. The United States Pharmacopeia (USP) ‘Guidelines for Pharmaceutical Compounding – Sterile Preparations’ (USP 797) and ‘Hazardous Drugs – Handling in a Healthcare Setting’ (USP 800) define the requirements for these SECs and PECs.

Controlled Environments spoke with Jeff Serle, Senior Vice President/Chief Design Engineer of the Mobile Pharmacy Trailer, about the use of the mobile cleanroom facility.

Controlled Environments (CE): What led to the need for this cleanroom facility?

Jeff Serle (JS): Regulations in the hospital and healthcare pharmacy have evolved significantly, especially over the last 12+ years. These regulatory changes have impacted the demand for cleanrooms needed to prepare sterile IV preparations. When hospitals renovate their facilities to augment, add or improve cleanroom space, compounding operations must continue without interruption. Germfree developed the Mobile Pharmacy Trailer (MPT), the first USP 797/USP 800-compliant mobile cleanroom to allow for seamless drug compounding operations during hospital renovations.

CE: Who was involved in designing it?

JS: The MPT Cleanroom facilities were designed by our in-house engineering and design teams, with input from the user community (hospital pharmacists) and the cleanroom testing community, including the Controlled Environment Testing Association (CETA) certifiers. The design was based on the requirements of USP <797> and USP <800>, with an eye on State Board of Pharmacies, who can adopt USP guidelines into law or develop their own guidelines, which may or may not be directly in alignment with the USP guidelines.

CE: What challenges were faced along the way?

JS: We faced a couple of challenges in the development of the MPT. Our engineering team’s biggest challenge was designing the environmental control system that can maintain the demanding indoor air requirements in a hospital pharmacy across the varied climatic conditions experienced in the U.S. From a process side, a key challenge for us was to develop a standard product, the MPT, that would satisfy the regulatory requirements of each state.

The challenge to develop the MPT cleanroom was a natural fit for our design and engineering teams. We utilized our experience in manufacturing high containment mobile laboratories and our background in Primary Engineering Controls (PECs) to create this new type of flexible cleanroom to fulfill a critical need.

CE: Can you comment on the size and cost?

JS: The Hospital Pharmacy Cleanroom is built around a Germfree-specified version of a semi-trailer platform suited for the extensive modifications required to create the critical interior cleanroom environments (zones). The overall trailer is 8.5’ wide x 13.5’ tall x 53’ long (plus an additional 2’ for the redundant Environmental Control Units ECUs). Cost for these units varies based on duration of use or special requirements. The price includes all the equipment required to operate a hospital pharmacy, including the primary containment devices, also manufactured by Germfree.

CE: Who will be utilizing this space?

JS: The space will typically be used by a hospital pharmacy for their compounding sterile operations. The cleanroom can accommodate a hospital pharmacist and three to four technicians during a normal shift and operates 24 hours a day, seven days a week. The units can also solve space constraints or surge capacity demands on a healthcare facility. The MPT is also an option for cancer treatment centers, as well as use for clinical drug trials.

JS: Hospital and healthcare facilities will continue to find applications where the MPT can fill a gap in cleanroom capacity. Practitioners, process engineers and researchers are now able to see that a viable, advanced cleanroom space can be built into a mobile platform. This creates the next-level in rapid deployment and flexibility.

In other sectors, we currently provide similar units used by pharmaceutical manufacturing companies for applications ranging from production of FDA-approved drugs for human use, manufacturing drugs for clinical trials as well as training and evaluation of personnel that operate within these critical environments. As the industry transitions toward emerging biopharmaceutical therapies and small-batch personalized medicine, Germfree’s Mobile BioPharmaceutical Cleanroom Trailers will provide a flexible bioproduction platform. This will help companies dramatically reduce the time to gain regulatory approval for innovative new therapies.

SGS Expands Capacity at Lincolnshire Facility

SGS, a bio/pharmaceutical analytical and bioanalytical contract services provider, is expanding its facility in Lincolnshire, IL. The expansion will increase the site’s current footprint from 38,500 sq.-ft. to nearly 58,000 sq. ft. and was scheduled to be completed by September 2017.

The expansion will allow the facility to increase capacity for a wide range of services, including analytical method development and testing, microbiological evaluation, drug stability studies, testing of containers and medical devices, and utilities qualification and monitoring. Additional staff will be employed to meet the demands on the lab.

“This investment allows us to be flexible in our approach to meeting both existing and future customer demands,” said James Nokes, vice president, U.S. Agriculture, Food and Life. “Analysis and bioanalysis techniques continue to evolve rapidly, and are driven by technological advances and regulatory needs. At SGS, it is our aim to ensure we can offer our clients integrated solutions to support their needs, so we continue to invest in capabilities, capacity and our staff to maintain our professionalism and efficiency.”

This expansion follows a series of recent investments at the company’s global lab network, including increases in extractables and leachables capabilities in Fairfield, NJ and Shanghai, China; and an investment in bioanalytical capabilities and elemental analysis in Poitiers and Villeneuve-la-Garenne, respectively.

Investment in R&D and Cleanroom Expertise by Indivior

Cleanroom and laboratory design and construction specialist, Boulting Environmental Services (BES) has completed the construction phase of a £13 million project for global pharmaceutical business and world leader in the treatment of opioid addiction, Indivior.

The new research and development (R&D) facility will be used to test and manufacture a non-addictive alternative to methadone, in order to improve patient experience on a global scale.

Boulting Environmental Services was the principal designer and principal contractor for the project, carrying out a complete turnkey package that included groundwork, piling, shell construction and the internal specialist architectural fit out of cleanrooms and laboratories.

The two-story cGMP facility provides 53,800 sq. ft. (5,000 square meters) of ISO7 and ISO8 product development cleanrooms and laboratories, along with highly specified offices, meeting rooms and a restaurant for staff.

Due to the nature of the facility, a full inspection from the Home Office was required after construction. The auditor not only gave the building approval, but referred to it as state-of-the-art — a testament to the quality of work that Boulting Environmental Services carried out on the site.

Ex-Dupont Scientists’ Nonprofit CRO STRIDE to Open

Several ex-DuPont scientists let go during the American chemical giant’s recently completed megamerger with Dow Chemical have formed a nonprofit CRO, which will start operating at a new lab on Oct. 1.

With a “generous” startup fund consisting of an undisclosed amount from the Longwood Foundation, the CRO, called the Science, Technology and Research Institute of Delaware (STRIDE), has leased lab space at the Delaware Innovation Space.

The hub is a science-related business incubator set up by DuPont, the State of Delaware and the University of Delaware at DuPont’s underused Experimental Station campus in Wilmington, Delaware.

The governance and business model of the CRO are in place, but only when it moves into the new shop will it officially be able to offer its innovation and R&D services to startup companies in biology, chemistry and related industries through its affiliate, STRIDE Services. Those services include polymers, computational chemistry, as well as technical, patent and marketing strategies consultancy.

“We can help our industrial clients innovate and develop new products and technologies, either by collaborating with their scientists when requested and/or working as an extension of their R&D departments,” STRIDE’s president Seetha Coleman-Kammula said in a statement.

The organization also has an 85-person-strong team, most of whom are former DuPont scientists who have innovative ideas but lacked access to resources to test them out, let alone bring them through to commercialization. For them, STRIDE offers access to resources, including the new lab space, so that they can advance their research to a stage where they can patent their inventions, attract funding and launch new businesses, the company said in the statement.

STRIDE is also growing its scientific talent pool by offering members other services, including networking, training events and marketing of members’ scientific services.

Both STRIDE and the Space were formed on the backdrop of the Delaware government’s effort to keep many former DuPont scientists and their work within the state. The new lab space leasing deal “gives them a home that will allow them to do what they love to do—get back to work in the lab,” Sen. Chris Coons, D-Del., said in a statement.

Avista Pharma Completes Durham Expansion

Avista Pharma Solutions, Inc. has completed the expansion and upgrades to its Analytical Laboratories at its Durham, NC facility. The investment significantly increases capacity as well as a range of capabilities for its pharmaceutical and medical device clients.

The Analytical Research and Development (ARD) and Quality Control (QC) labs have doubled in size and expanded the service offerings. The completed Analytical Laboratories’ systems and equipment include a Thermo Scientific Orbitrap High-Resolution Mass Spectrometer, Mass-Directed Preparative Chromatography, Agilent UPLC-tandem Quad MS, Waters H-class UPLCs with six-column switching capabilities and PDA/ELSD/CAD/Single Quad MS detectors, along with upgraded Laboratory Information Management System (LIMS), Empower 3 Chromatography Data Software and Agilent MassHunter software with Enterprise Content Manager.

“Expanding our laboratory and adding new service offerings reinforces our commitment to providing our clients with a world-class center of excellence to assist in their product development efforts,” said Patrick Walsh, chief executive officer at Avista. “Our clients choose to work with us because our skilled teams are relentless in support of their project needs.”

Avista’s full-service offering includes: Chromatographic method development for assay and related substances, potential genotoxic impurities, organic volatile impurities and residual solvents; Spectral identification using upgraded FTIR, NMR and UV-Vis instrumentation; Structural chemistry and impurity identification through accurate mass LC-MS and generation fragmentation (MSn), 1D and 2D NMR and preparative chromatography isolation.

REST OF WORLD

Merck Kgaa to Replace Filling Line at Bari Facility

Merck KGaA will install a new aseptic filling line at its facility in Bari, Italy for multiple sclerosis drugs, fertility treatments and growth hormones. The German drug manufacture announced the plan, explaining it will spend €35m ($41m) to replacing an existing filling line at the facility.

A spokeswoman said, “The new line will replace an existing one, leveraging the latest technological developments while providing an increase in capacity. She explained the plan “is part of continuous investments in our manufacturing network to maintain state-of-the-art industry level and adapt its capacity to patient needs for our medicines.” The line will be used to fill Merck’s multiple sclerosis Rebif, its fertility disorder treatments Gonal-f and Ovidrel as well as the growth hormone Saizen. It is due to become operational in 2022.

The Bari facility was established in 1992 as a hub for fill finish activities. Drugs made at the site are shipped to 150 countries.

The new investment is the second in the past five years. In 2014 Merck spent €50m to install a fully automated production line under isolator and set up an automated warehouse at the site.

Clegg Construction Overhauls Building at UK's Aston University

Aston University is revamping its School of Engineering and Applied Sciences facilities.

UK-based Clegg Construction has started a £4.5m contract to overhaul part of the main building at the University's campus, close to Birmingham city Centre. It will involve remodeling existing under-utilized space in the building and transforming it into new labs for the University's School of Engineering and Applied Sciences, which will use the space for research into fiber optic communication.

Clegg Construction will carry out a range of works including internal demolition, stripping out of existing services and the creation of new rooms and lab spaces, including a cleanroom.

Work is due to be completed by the end of October 2017.

The work is part of a wider multi-million pound redevelopment of the entire estate at Aston University.

Clegg is familiar with the campus after completing a £5.2m remodeling of the School of Engineering and Applied Science's chemical engineering and applied chemistry facilities, also in the Main Building, in 2013. Aston University's Director of Estate's, Ian Oldacre, said: "Clegg Construction has shown a flexible approach that enables success in delivering schemes in sensitive and live buildings. This is a factor why Aston University has enjoyed successful projects with them."

Clegg Food Projects has also recently completed a testing lab for Eurofins, a global providers of pharmaceutical, food, feed and environmental testing services, Eurofins will be using the new laboratory to test water and pharmaceutical products.

The project worth £4 million was to transform a property in Livingston near Edinburgh into high-tech laboratories. Approximately 40% of the overall 58,000 ft² property has been developed, with plans to expand further over the next three years. As part of the five month-long renovation, Clegg Food Projects also created high-end staff facilities including office space and amenities.

The new laboratory building is part of Eurofins' plans for growth, specifically developing its pharma offering and GMP testing capabilities in the UK, as customer demand continues to rise.

Alembic Sells Baddi Formulations Plant to Scott Edil Pharmacia

Alembic Pharmaceuticals Limited has sold its drug plant in Baddi, Himachal Pradesh to Scott Edil Pharmacia Limited. The sale was announced in a Bombay Stock Exchange (BSE) filing. Alembic said the formulations plant was divested on a “slump sale basis,” meaning that Chandigarh-based Scott Edil paid a lump sum. Alembic – which generated revenue of INR31.34bn ($490m) in the 12 months ended March 31 - also revealed the Baddi plant had made an “insignificant” contribution to its sales in fiscal 2016. According to its website, Scott Edil Pharmacia operates a manufacturing facility and an R&D facility in Baddi.

News of the facility sale comes a few weeks after Alembic inaugurated a drug manufacturing plant in Panelav, Gujarat. According to Alembic, the Panelav facility will supply international markets with generic drugs. The firm also said it will cater to domestic demand at a facility it set up in Namthang, Sikkim. A number of drug companies have set up manufacturing facilities in Sikkim in recent years.

In 2007, the Indian Government said manufacturers which set up in the region before April 2017 would not have to pay taxes on revenues generated by products made there for 10 consecutive years.

Alembic set its plant up in 2014 joining peers Cipla, Sun Pharma, Zydus Cadila, IPCA, Alkem Lab, Intas Pharma, Torrent Pharma and Unichem which all operate facilities in the state.

Lonza Expands Swiss Drug Product Site

Lonza will feed demand for its drug quality testing and formulation capabilities through an expansion at its Drug Product Services site in Basel, Switzerland. The Stücki Science Park-based facility launched in November 2016 and focuses on parenteral dosage form development.The expansion will add drug product process development functions to the GMP site, and increase its formulation development, drug product analytics and quality control (QC) capabilities. Spokesperson Dominik Werner said the decision to expand the site came from an increased market demand.

“The Drug Product Service [DPS] offering was immediately successful in the market, filling up our capacities. That’s why we decided to expand our footprint for parenteral dosage form development with a further build-out of its DPS.” “The expansion after only one year of operations shows the significant customer need and interest leading to different new business opportunities,” he said. The firm said the expansion will add more than 50 roles to the site.

Werner added the facility’s services will include options for small and large molecule drugs. “Services will include options for monoclonal antibodies, other biologics, drug conjugates, peptides and small molecules that require a parenteral dosage form,” he said.

The contract manufacturing organization (CMO) offers services for parenteral dosage forms including products for injection and infusion for intravenous, subcutaneous, and intraocular routes of administration.

Specialized services also include excipient and surfactant characterization, extractables and leachables assessment, container closure integrity testing and particulate identification, characterization and quantification.

Navesta Opens Plant in Sri Lanka

Sri Lanka-based Navesta Pharmaceuticals has opened the country’s first sterile pharmaceutical manufacturing plant in Horana. It also represents Sri Lanka’s first pharmaceutical facility that is compliant with EU Good Manufacturing Practices (EU-GMP) and Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which will enable the company to export their products to most global markets that accepts these accreditations. Additionally, the facility is also equipped with the country’s first EU-GMP compliant A and B Grade Microbiology (MB) laboratory, capable of carrying out comprehensive, advanced in-house testing methodologies.

The company says it will primarily meet the local demand of 12 products in the penicillin category—dry powder injectables that were previously imported to the country.

“We have and will continue to generate numerous employment opportunities for Sri Lankans who specialize in pharmaceutical fields such as biochemistry, pharmacology, chemistry, pharmacy and engineering as well as Sri Lankans who are interested in developing this new industry further,” said Sanjaya Jayaratne, chairman, Navesta Pharmaceuticals. “Most importantly, Navesta’s ultimate aim is to provide a reliable, vertically integrated local supply chain, which will provide accessibility of high quality pharmaceuticals for our citizens. All our efforts surround the idea that we as a company, have a social responsibility to this generation and the next in providing our citizens better opportunities of a livelihood through our continual industry development, reinvestment in the communities, and empowerment of our employees to carry this vision forward for Sri Lanka.”

Navesta’s 40,000 square-foot manufacturing facility has a capacity to produce 50 million vials, saving millions in foreign expenditure for the country. Navesta Pharmaceuticals will expand the facility in the coming years to increase its production capacity by three-fold and contribute significantly to the Sri Lankan economy with exports. With the set-up of this facility, over 100 direct employment opportunities were created to include local graduates from chemistry, engineering, finance and pharmaceutical studies, while over 500 indirect employment opportunities were created through local home industries and ancillary services.

Navesta’s manufacturing facility houses 13 incubator chambers and 2 walk-in incubators which are Sri Lanka’s first 21 Code of Federal Regulations (CFR) compliant equipment sets. All test and measuring instruments that are used within the facility are calibrated up-to-date, from local and foreign agencies with ISO 17025 or ISO 9001 accreditations.

In 2015, the Government of Sri Lanka enacted the new National Medicinal Drugs Policy, which encouraged more local companies to explore the opportunity of manufacturing pharmaceutical products, to drive Sri Lanka towards the vision of becoming self-sufficient in pharmaceuticals by 2020.

Cordenpharma Completes Early Development Suite at Plankstadt Facility

CordenPharma has completed development of an early development suite for highly potent, oral solid dosage products at its Plankstadt, Germany location. According to the contract manufacturing organization (CMO), the new facility enables the production of small batches from 100g to approximately 1,000g. The facility is able to provide compounds with various potencies and containment degrees.

"The setup in the new facility of CordenPharma Plankstadt is very flexible – it allows for operations to take place at three different levels of containment," said Jason Bertola, director, global highly potent and oncology platform, CordenPharma International. "Basically, it progresses from an open system for non-highly potent compounds, to a semi-closed system (sliding glass pane) to a fully enclosed system for OEL below 1mg/m3. The containment systems can be connected by Rapid Transfer Port (RTP) to allow the transfer in and out of the individual barriers safely," he said.

As Bertola explained, the production of small technical batches was a gap in CordenPharma's service offering and the new facility addresses this gap. "This area is non-GMP and designed for development work," he added.

The addition follows a series of investments made during the past year, including expanded capacity and capabilities at its Boulder, Colorado facility in the US. The company has also recently implemented a program to address corporate and quality systems, organization structure and infrastructure, and includes a process to involve customers in improving transparency.

The Centre for Cancer Immunology, University of Southampton, United Kingdom

The University of Southampton's Centre of Cancer Immunology is currently under construction at Southampton General Hospital site, located adjacent to the Somers Building, and will be the first and only Centre in the UK when completed. It is being developed by the University Hospital Southampton NHS Trust and Southampton City Council. The Centre will have well equipped research facilities, including a clinical trials unit, suite of molecular biology laboratories, and a pre-clinical immunology lab to support the development of new cancer immunotherapies. Construction of the facility is expected to be completed with an estimated investment of £25m ($32.46m) this autumn, while the official opening is expected next spring.

The University of Southampton launched a campaign to raise £25m ($32.46m) fund for the construction of a new cancer immunology Centre in 2015. The Centre received donations from the Wolfson Foundation, Matthew Hodgson of Warwick Capital Partners, and Coldplay. Solent LEP contributed £4.5m ($5.84m) for the construction of the Centre, which is being carried out as part of the 21+ NHS procurement framework.

The planning application for the construction of the Centre was approved by Southampton City Council in February 2016. The topping out ceremony of the building was held in October 2016.

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

The ground floor of the building will include an impressive atrium, along with space for meeting rooms and the clinical trials unit, and an open plan and dedicated office space.

The first floor will include an open-plan work space, in addition to interdisciplinary breakout areas. It will also include space for meeting rooms for researchers, PhD and undergraduate students, senior academics, and clinicians in cancer immunology.

The second floor of the building will be a hub for laboratory research. It will have space dedicated for study and work areas for students and staff.

The Centre for Cancer Immunology will accommodate world-leading immunotherapy scientists, clinicians and technical experts to collaborate in an interactive environment to generate new knowledge and to develop new treatments.

It will include sophisticated research equipment for the development of new cancer immunotherapies ranging from discovery in the lab to clinical trials. It will act as a hub for academic and industry partners worldwide, and will enhance clinical trials to explore new areas to develop lifesaving drugs for cancer.

It will include a clinical trials unit, a suite of molecular biology laboratories, and a pre-clinical immunology lab. It will significantly enhance the number of staff working on cancer immunology and the number of patient clinical trials.

The new facility will attract leading scientists from all over the world in the development of immunotherapy treatments, and will partner with Francis Crick Centre in London. It will perform research in multiple cancer forms from lung to skin, and pancreatic to neuroblastoma.

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

Capella Biomedical Research Laboratory, Cambridge Biomedical Campus, UK

Construction of a new laboratory building known as Project Capella was initiated at the Cambridge Biomedical Campus in February 2016. Located next to the Cancer Research UK building near Addenbrookes hospital, the new facility will allow collaborations between scientists and clinicians to further advance the application of stem cell discoveries into the patient setting. The University of Cambridge was granted planning permission for the Capella building in February 2016. The project is expected to be completed with an estimated investment of £79m ($112.48m) by Q2, 2018.

The Capella research facility will be a six-story building with a total floor space of 193,680 sq. ft. (18,000m²). The exterior will feature a two-story glazed box with gold metal detail and double-height entrance foyer. The spine of the building will be clad with flat-faced graphite panels. The building will include a green screen to enhance the public area surrounding the development. It also will feature a bespoke timber frame structure with green roof, which will provide 324 cycle spaces on site. The facility will include sophisticated laboratory spaces, offices, cafés, seminar rooms, exhibition spaces, and meeting suites to accommodate a variety of biomedical research groups.

It will also accommodate the Cambridge Institute for Immunotherapeutics and Infectious Disease, the Milner Therapeutics Institute, and Cambridge Stem Cell Institute. It aims to advance a Centre of excellence and initiate a foundation for the development of new medical treatments.

The facility will also include robotics suites for customized drug screening and gene editing, as well as bioinformatics support.

Construction of the Capella biomedical laboratory began in February 2016. The facility is being constructed using building information modelling (BIM) techniques. More than 80% of the frame and façade was built off-site as precast modules comprise precast columns, edge beams, and precast floor slabs with structural toppings. The topping out ceremony was held in April 2017.

Installation of mechanical services inside the building commenced after installing 6m pre-fabricated modules on the ground floor and fan coil units from ground to third floor in January 2017.

Installation of all external cladding panels and gold box glazing was completed in March 2107.

The designs for the Capella biomedical research laboratory were provided by Fairhurst Design Group (FDG).

The building construction contract was awarded to Kier Construction, which is being assisted by a team of consultants including Arup (consulting engineer), Arcadis (project manager), and Aecom (cost consultant).

PCE was selected as offsite superstructure construction partner, which provides hybrid precast columns with a combination of precast concrete edge beams and structural steel delta beam spine beams.

Alcrete Building Systems was appointed by PCE to provide design, manufacture, deliver, and install more than 100 precast units.

The building is being constructed with the aim of achieving Building Research Establishment Environmental Assessment Method (BREEAM) excellent rating.

Riboxx Completes GMP Facility

The German biotech company can now supply its proprietary ligand on a GMP industrial-scale for clinical applications in immune-oncology.

Riboxx Pharmaceuticals, a German biotech company specializing in the development of toll-like-receptor (TLR) and RIG-I-like-receptor (RLR) ligands, and Accinov, a biomanufacturing center located in Lyon, France, announced the manufacture, including packaging and quality control, of Riboxxim, a potent TLR3-ligand, on an industrial scale and in compliance with good manufacturing practices (GMP). Riboxx manufactured the ligand using its patented Tenpora process according to European Union GMP requirements.

Riboxxim is the company’s experimental immuno-oncology drug that activates the innate immune system to eliminate cancer cells. It has been validated in pre-clinical studies for immunotherapy of cancer. It is available for clinical applications in immune-oncology and therapeutic vaccines.

Synpromics Expansion to Support Growing Gene Control Business

Moving to a larger facility will help Scottish firm Synpromics Ltd increase its gene control and cell line services presence, the firm says. The gene control and synthetic promoter development firm has moved into a new facility at the Roslin Innovation Centre, about 10km south of Edinburgh, UK adding over 5,000 sq. ft. of lab and office space.

The expansion fits with the firm’s growth strategy which saw revenues reach over £1.2m ($1.6m) in 2016, and according to Synpromics founder and CSO Michael Robert, further growth is expected this year.

“Synpromics is committed to be the global leader in gene control,” he said. “This move into a world-class facility enables us to realize that goal, giving us access to an excellent infrastructure and cutting-edge research being undertaken at the Roslin Institute.”

He added the firm is looking to grow in size by an extra 25% over the coming year, and the move will provide the room for new staff and equipment.

“It gives us the space that we need for the expanding team, in particular providing the creative environment that allows our scientists to flourish, meaning we can more effectively build on our PromPT platform and meet the growing demand for our technology.”

Synpromics’ PromPT platform is a bioinformatics database for the design, build and screening of synthetic promoters. These promoters allow for precise control of gene function, impacting gene therapy, cell therapy and gene editing.

In the past year, the firm has inked a number of agreements, including separate deals with GE Healthcare and Sartorius to increase stability and yield, and reduce the lead time, of CHO cell lines used in bioprocessing.

It also received a £5.2m boost in April in the form of funding from UK-based companies Calculus Capital, the Scottish Investment Bank, the investment branch of Scottish Enterprise, and private shareholders.

Kaneka Eurogentec to Build Plant in Belgium

Kaneka Eurogentec has announced plans to build a biopharmaceutical manufacturing facility in Seraing, Belgium. The facility – which will be adjacent to the contract manufacturing organization’s (CMO) plant – will produce protein-based drugs, antibody fragments and plasmid DNA for therapeutics. The plant will house a 2,200L fermenter.

The firm – which is owned by Japanese chemical producer Kaneka – cited “current market need” as motivation for building the new plant.

Executive vice president Lieven Janssens said: “The rapid growth in cell and gene therapy products is driving the need for large batches of plasmid DNA. He added that: “Our existing pharma and biotech customers have already expressed the need for kilo-scale manufacturing capabilities and we have developed equipment and methods to respond to these needs with the new facility.”

Work on the plant is due to start this year according to Kaneka Eurogentec, which said it will be equipped with a 2,200L fermenter for the production and purification of biomedicines using microbial strains. The firm also said it plans to hire 40 additional production staff to work at the plant.

Wuxi Single-Use Capacity Expansion

Momenta says flexibility built into its contract with WuXi Biologics will offset fluctuations in demand for global biosimilars.

During the Wells Fargo Healthcare Conference, Momenta’s CEO Craig Wheeler spoke about the associated costs of using WuXi Biologics for the manufacturing of a number of its biopharmaceutical products from its site in WuXi, China. “If you look at China in general, certainly costs have gone up because the labor costs have gone up substantially,” he told investors in Boston. But, he continued, the biggest driver of economics in the cost of biomanufacturing is the utilization of the plant. “The more utilized it is… the lower the costs you can get,” he said, “and so what we like about Wuxi so far is they had actually been able to keep the plants very efficient, and effective and operating which means that they have relatively cost effective production.”

Momenta does not own or operate its own facilities for commercial scale manufacturing but according to Wheeler WuXi makes “the majority of our portfolio” for the global market.

He added as WuXi is already “one of the largest” biologics product manufacturers in the world, and growing – the WuXi site is soon to open a 28,000L single-use facility – his firm would benefit from available capacity when needed to feed fluctuations in biosimilar demand.

“One of the things that clearly attracted us to Wuxi is that they were actually building their whole concept of the plant based on [disposable] technology,” he said.

“The challenge of biosimilars is that we talked about with the portfolio, for each product, you don't know what capacity you need. And it's very hard when you have 20,000L reactors to scale down. It's very hard if you only have 1,600L reactors to scale up, only have a flex pack, so you can scale up or down pretty easily.”

Fujifilm Diosynth Opens UK Cell Culture Process Development Labs

The new labs will support the Saturn mAb Platform cell culture Process Development activities, speeding development of monoclonal antibody therapies.

Fujifilm Diosynth Biotechnologies, a CDMO focused on the development and manufacture of recombinant biopharmaceuticals and advanced therapies, has opened its new 10,000 ft² cell culture process development laboratories in Wilton Centre, Teesside.

The biotech company has locations in Billingham and Redcar, UK, and North Carolina and College Station, Texas, US. It has more than 25 years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules and also offers cell line development using FDA-approved commercial manufacturing.

The new laboratories were realized through a 1 billion Japanese Yen (US$9m) investment which is part of the greater JPY14 billion ($130m USD) expansion announced by Fujifilm Corporation in April 2017. A grant from Let’s Grow, which is part of The Regional Growth Fund also contributed to the overall investment as part of Fujifilm Diosynth Biotechnologies’ continued growth in the Tees Valley.

The facilities will be dedicated to support the Saturn mAb Platform cell culture Process Development activities. The Saturn mAb Platform is designed to enable rapid access to process development and manufacturing capacity.

“These laboratories are designed to incorporate the latest high-throughput technologies, including fully automated high throughput bioreactors and chromatography systems,” said Andy Topping, Chief Scientific Officer, Fujifilm Diosynth Biotechnologies.

“The Saturn Process Development Laboratories are a huge differentiator in the cell culture and monoclonal antibody process development space,” said Paul Found, COO, Fujifilm Diosynth Biotechnologies UK sites “By dedicating these facilities and bringing new technologies we will be effectively supporting our customer’s in the rapid delivery of monoclonal antibody therapies to patients all over the world. This is part of our commitment as Partners for life in the advancement of medicines.”

“Fujifilm’s investment in a new facility on Teesside demonstrates the strength of the UK’s life sciences sector and brings more highly-skilled jobs to the region,” said Lord Prior. “The UK has a very strong science and innovation base and through our Industrial Strategy we are ensuring we continue to be at the forefront of pioneering research and the destination of choice for inward investment.”

Lord Prior of Brampton and Daisuke Matsunaga, Consul General of Japan in the UK addressed the audience of local government members and the biotech community during the event.

FDA Approves ROVI Contract Manufacturing Plant in Madrid

Laboratorios Farmacéuticos Rovi (ROVI) has announced that the US Food and Drug Administration (FDA) has approved its contract manufacturing injectables plant in Madrid for filling syringes that are prefilled with water for injection using the terminal sterilization process. Syringes prefilled with water for injection by ROVI at its contract manufacturing plant will be able to be commercialized in the US in the coming months.

CEO of ROVI Juan López-Belmonte Encina said: "FDA approval represents a significant milestone in our manufacturing capacity and an excellent opportunity to penetrate the US market and maximize the plant's potential. In addition, it reflects our continuous interest in serving the globalized pharmaceutical market."

With more than fifteen years of experience, ROVI specializes in filling and packaging parenteral solutions in prefilled syringes and vials. ROVI is currently one of the world's leadingmanufacturers of prefilled syringes, with annual production capacity of 180 million prefilled syringes.

Tjoapack Invests in Bottle Packing Ops

A Dutch contract packaging organization (CPO) has strengthened its bottle filling capacity with a major investment.

Tjoapack has added an additional bottling line to its facility in Etten-Leur, the Netherlands, to meet growing demand for this service, particularly from generics customers in Europe. The new line triples the CPO’s bottle packing capacity by using the latest high-throughput technology. Tjoapack can now process 13,000 tablets per minute.

“Our decision to invest has been fueled by greater demand for bottle packaging services from our customers, particularly in the Nordic markets,” said Dexter Tjoa, director corporate strategy, Tjoapack. “The new line will not only help us to meet this demand, but gives us access to the latest technology.

“As a CPO, we see our role as being more than just packaging product. We strive to improve supply chain efficiencies and reduce time to market for all of our customers. Our new line is twice as fast as our existing line, meaning we can deliver products to our customers faster, while guaranteeing the highest quality bottle packaging service.”

Tjoapack specializes in primary packaging for solid dosage forms, secondary packaging and unit dose packaging and now has a total of 19 packaging lines for blisters, wallets and bottles.

“This year we have been focused on making the necessary investments to prepare Tjoapack for growth in 2018 and beyond,” said Mr. Tjoa. “As well as investing in new machinery to increase our capabilities and capacities in areas where we are approaching full demand, we are also making a significant investment into the latest technology. This includes revamping our entire software platforms to ensure the most robust quality and documentation management systems are in place.”

Founded in 1989, Tjoapack is an independent contract packager of medicines servicing clients across five continents and 42 countries. The CPO packages around 25 million packs of pharmaceutical products per year, which is equal to 1.3 billion tablets.

Concept Life Sciences Adds Two Lab Facilities at Alderley Park

Concept Life Sciences has taken two new lab spaces at Alderley Park’s Mereside campus in Cheshire, U.K., increasing its scientific capacity by over 30%, including 55 scientists. The aim is to further drive its growth in discovery and development capabilities.

The two facilities, one 10,111 square feet for the chemistry team and one 2,284 square feet to host the biology team, will be focused on Concept’s drug discovery services, which encompass chemistry, pharmacology screening, assay development and ADME.

This adds on to the company’s existing 10 locations across the U.K., including its headquarters in central Manchester, and brings its total employees to about 700. Each location specializes in areas of the company’s two sectors—discovery and development, and analytical chemistry, toxicology, bioanalysis, food safety and environmental testing.

Though spread out in different places, the new Alderley Park labs “form part of a seamless service to clients in conjunction with the other group sites,” said Michael Fort, Concept’s executive chairman. Alderley Park will be the main hub of the group’s program management team that drives this integrated service, he said.

A research hub located close to Concept’s headquarter, Alderley Park has close links with universities, NHS institutions and research organizations, Chris Doherty, managing director at Alderley Park, said in a statement.

“Building a presence in the heart of Alderley Park not only makes the Concept Group a very attractive place for the recruitment of world-class scientists, but it also sits within a leading scientific environment, giving access to leading technologies which complement the company's core service offerings,” Fort said.

Fort said the new addition is a key step in the company’s plan to further expand. The company has enjoyed fast growth since establishment in 2014. The entire company has grown over 30% in the last 12 months, according to Fort. It also started offering drug discovery and development services in the U.S. with a new U.S. life sciences team set up last June.

To break it down, the discovery and development services grew almost 36% year over year, while the analytical services delivered a 12% growth rate. “In discovery and development services the key drivers have been expansion and integration of scientific services, broadening the appeal to a wider field of pharmaceutical and biotech businesses internationally,” Fort said.

The company’s total revenues in 2017 are approaching $60 million, and Ford said he expects similar growth rates during 2018, “albeit slightly higher in analytical and development services as we reposition the company’s services toward more esoteric services and markets in pharmaceutical development.”

Roche Spanish Plant Becomes Eighth Solid Dose Site for Recipharm

Recipharm has acquired a Spanish manufacturing plant and signed a supply deal with former owner Roche for a range of solid dose products worth €35m a year.

The contract development and manufacturing organization (CDMO) has added the Leganés, Spain solid dose manufacturing plant to its network after coming to an agreement with former owner Roche.

While financial details have not been divulged, a long-term contract agreement between the firms will add approximately €35m ($42m) to Recipharm’s annual sales – equating to more than 6% of the CDMO’s total revenue – from the manufacture of a range of solid dose products from the facility for Roche.

According to Recipharm CEO Thomas Eldered, solid dose formulation was already the firm’s largest business segment before the acquisition but with the Leganés facility the firm will now operate eight solid dose facilities. “Our ambition is to continue offer competitive services in this area,” he said.

The added facility will also offer opportunity for collaboration with Recipharm’s facility near Barcelona, Spain.

Eldered added Recipharm – which has been aggressive on the M&A front after going public in 2014 will continue to look for expansion opportunities.

“We have a pretty full range service offering but we are looking for some further niche technologies. We are continuously evaluating additions that would be beneficial for our customers.”

The Leganés site, located near Madrid, was one of a number put up for sale by Roche in November 2015 as part of a plan to reduce its small molecule manufacturing footprint.

In June 2016, Greek CDMO Famar struck a deal with Roche to buy the plant but this subsequently fell through.

Earlier this month, Italian CMO Delpharm completed its acquisition of Roche’s solid and liquid forms manufacturing facility in Milan/Segrate, Italy and – like Recipharm today – inked a supply contract with the Swiss pharma giant.

Other sites Roche earmarked in the restructure included an API production plant in Florence, South Carolina sold to Patheon last year, and a site in Clarecastle, Ireland which is being shuttered.

PSI Opens in Taiwan, Looks to Hong Kong For 2018

The Switzerland-headquartered contract research organization (CRO) has opened offices in Taiwan following a string of investments in the Asia Pacific region. The new office will be listed as Taiwan PSI Health Development Co. Ltd. According to the CRO, its expansion has been driven by demand in oncology, infections, IBD (ulcerative colitis, Crohn’s Disease), and other therapeutic areas.

“Taiwan is an important contributor to global clinical trials,” said Olga Alfonsova, head of corporate development at PSI CRO. “That’s why PSI has opened an office in Taipei and will continue to grow within the country to access the most prominent investigative sites in the areas of oncology, infections, inflammatory bowel diseases, neurology and other therapeutic areas,” she said.

The Switzerland-based company is “perfectly on track” with its plans to expand into Asia Pacific, said Alfonsova. So far this year the company has established offices in Sydney, Australia; Seoul, South Korea, and Taipei; Taiwan.

Alfonsova explained Hong Kong will be next at the beginning of 2018.

“The expansion into Asia Pacific region is well-paced and allows global sponsors access to Asian populations across a variety of therapeutic indications,” she added.

ADC Biotechnology Secures Money for Commercial Biomanufacturing Plant

ADC Biotechnology has announced it will spend $11m ($9.2m) build a bio-conjugation facility at a site in Deeside, North Wales. The facility – which is due to be operational in 2018 – will produce antibody-drug conjugates (ADC) for clinical trials and small scale commercial batches. It will also house R&D technical services and quality control laboratories, warehousing and capacity for process development.

Funding for the plant will be provided by Maven VCTs, Seneca and Finance Wales. The Welsh Assembly Government is also providing ADC with a grant.

The investment marks the Wales-based contractor’s move into clinical and commercial production. Previously, its manufacturing focus has been on the production of ADCs for R&D and preclinical development.

ADC’s core technology is its “lock-release” platform. It works by covalently ‘locking’ an antibody to solid polymer beads, prior to conjugation, releasing them as a clean drug substance.

ADC claims its technology is used by 20 customers, including several major pharmaceutical firms. CEO Charlie Johnson said: “We already have confirmation that many of our existing customers will use the facility for clinical development.

“We anticipate adding a number of the new targets entering clinical development from customers in the USA and Europe - especially in light of the added value we can provide through Lock-Release” he added.

Quanticate Opens Indian Facility

Quanticate reinforces global offering with new Indian office.

Quanticate, a global data-focused clinical research organization (CRO), is further expanding its service offering into India with the opening of a new office. Strategically located in Bangalore, with access to the country’s extensive talent pool in the pharmaceutical services industry, the new office will be a base from which Quanticate will broaden its capabilities for the management, analysis and reporting of data from clinical trials and post-marketing surveillance.

The decision to open the office follows a very successful year for Quanticate which saw an increase in sales driving the demand for more resources both in India and further afield. The new 16,500 sq. ft. facility doubles the company’s current footprint in the country.

Praveen Dass, VP of clinical data management and head of Indian operations at Quanticate explains: “By expanding our presence in India, we are able to increase our capacity meaning we can cater for more clients on a larger scale.

“We have an ambitious growth strategy to deliver over the next five years, which aims to employ over 60 new members of staff in the coming months. Our new office provides the perfect platform for this growth and marks an important milestone in our journey.”

As the company’s new operational center of excellence, the facility will also help Quanticate to provide outstanding customer service for its global client base and support further development of collaborative, long-term partnerships with leading pharmaceutical companies.

The CROs increased presence in the region has recently allowed Quanticate to engage with a diverse range of industry-specific groups, including the Society for Clinical Data Management (SCDM) India and Pharmaceutical Users Software Exchange (PhUSE) India. The company has representatives on the steering committee and co-chaired the first Society for Clinical Data Management (SCDM) Single Day Event (SDE).

Quanticate is a data-focused CRO which specializes in the management, analysis and reporting of data from clinical trials and post-marketing surveillance. Its team of experts supports a global portfolio of clients across areas such as biostatistics, statistical programming, clinical data management, statistical monitoring, medical writing and pharmacovigilance.

VWR Opens New Kitting Center in Czech Republic

This new facility will support the growing business of recently acquired Therapak, a supplier of pre-packaged convenience kits and procedure packs for the clinical trial, pharmaceutical and clinical laboratory industries.

Global independent provider laboratory solutions and services, VWR celebrated the opening of its new kitting center in Skalice, Czech Republic. This new facility will support the growing business of Therapak (that VWR acquired in 2016) by expanding its existing footprint in Europe with a state-of-the-art facility and comprehensive kitting services for regional and global customers.

Therapak, a leading supplier of pre-packaged convenience kits and procedure packs for the clinical trial, pharmaceutical and clinical laboratory industries, has proven to be a valued addition to the VWRCATALYST Clinical and Biorepository Services.

Along with the recent acquisitions of MESM and EPL Archives, VWRCATALYST Clinical and Biorepository Services offers a complete solution to its global regulated research and product development clients in the pharma, biopharma, manufacturing and clinical trial industries. Our focus is to eliminate the process complexities and identify service solutions that help labs and production facilities work better, faster and smarter.

"VWR's Czech Republic facility is strategically located to support customers in the EMEA region for all their clinical and commercial kitting needs," said Ulf Kepper, SVP, Services for VWR. "This location expands our VWRCATALYST offering to support the growing demand for quality services to the industries we support."

The 35,000 ft² facility will be fully operational on 2 October, 2017, and is in proximity to major industrial freight carrier hubs, which is ideal for shipping and will allow enhanced service levels compared to VWR's current model.

Providence Care Hospital, Kingston, Ontario

Cost: $353 million
Size: 625,000 sq. ft.

Project team: Parkin Architects Limited in joint venture with Adamson Associates Architects; Parkin Architects Limited, Architect, Interior Planning and Design; Adamson Associates Architects, Architect, Exterior Design

Providence Care Hospital is southeastern Ontario’s leading provider of forensics, specialized mental health care, physical medicine, rehabilitation, geriatrics, complex continuing care (CCC) and palliative care. This project conjoins programs from two existing sites into a new facility of 270 beds; 90 mental health and 180 rehabilitation, CCC and geriatric.

The façade development is rooted in the idea of creating a more human-scaled, home-like, non-institutional and patient-centered environment. Highly-glazed public sequences along areas such as the Concourse and the Cafeteria create opportunities for visual connectivity between public and private realms, offer connections to nature, and serve to embody and communicate the concepts of recovery and transition. These areas of transparency also promote accessibility and diminish the stigma associated with mental health facilities.

The interior design evokes the site’s connection to Lake Ontario through the concept of Water’s Edge, representing the transition and recovery of a patient’s journey at Providence. Water’s Edge materials, glass, wood and stone, are used to distinguish unique areas of the building through their relationships to the surrounding site. The three inpatient units are defined relative to their proximity to these site features. To the west is Lake Ontario Park “Parkside,” symbolized by the use of wood. Glass represents “Lakeview” to the south and the “Heritage” buildings to the east are conveyed symbolically with stone tile. These materials add warmth, color and texture, reinforce the connection to the Hospital’s surroundings and, as wayfinding tools, guide patients and visitors through the facility.

An existing waterfront trail was incorporated along the edge of the site and extended into the property to allow a seamless feel at the site boundary promoting use of the grounds by the wider community.

Completion date: November 2016

Amgen Collaborates for Biosimilar Roll-Out in China

Amgen has partnered with Simcere to develop and commercialize biosimilars in the People’s Republic of China. The agreement states Amgen will co-develop, manufacture and manage the approval application process for four of its biosimilars for the Chinese market. Nanjing, Jiangsu, China-headquartered Simcere will distribute and commercialize approved candidates.

Amgen spokesperson Kelley Davenport said, “The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. At this time, we are not sharing additional details.” Simcere’s president Honggang Feng said the partnership allows the companies access to inflammation and oncology markets in China.

“This strategic partnership between a world-renowned biotechnology company and leading Chinese pharma will help to accelerate development and launch of United States and European approved biosimilars in China,” he added.

Financial terms of the agreement were not disclosed.

Amgen said it sees an increased demand for biosimilars across the Asia-Pacific.

“This agreement furthers Amgen’s efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions,” said Asia-Pacific Region general manager, Penny Wan.

Davenport said the firm sees opportunities in Japan, and is monitoring government incentives in this biosimilar domain.

“In recent years different Japanese government incentives have been put into place to encourage the use of generics and has resulted in significant uptake over the last couple of years, and we are hopeful that the Japanese government and other countries will similarly provide incentives to use biosimilars,” she said.

Milliporesigma Opens Chinese Bioprocessing Centre to Showcase Tech

MilliporeSigma has opened a biopharma process development and technology Centre in China.

The site in Shanghai, China will offer biopharma customers access to MilliporeSigma’s range of end-to-end process development capabilities and services, including cell line development, upstream and downstream process development and non-GMP clinical production.

The Centre will be operated under the Bioreliance brand, added to Germany’s Merck through its acquisition of Sigma-Aldrich in 2015, and is the first such Centre to open its doors outside of Europe.

“Our new BioReliance End-to-End Biodevelopment Center will host small-scale drug manufacturers working on early-phase clinical trials,” MilliporeSigma CEO Udit Batra said in a statement. It is designed to target customers in the APAC region through an integrated suite of services for biopharmaceutical helping to accelerate clinical drug development from molecule to commercial production.

The Centre is modelled on the firm’s site in Martillac, France which offers a single-use, GMP facility for manufacturing clinical-stage batches and is equipped with MilliporeSigma technologies, including the 2000-liter single-use Mobius bioreactor.

The firm has also planned a 280,000 sq. ft. facility in Burlington, Massachusetts.

Micro-Sphere Partners with Harro Höfliger

Micro-Sphere has partnered with German machine manufacturer Harro Höfliger for the latest step in its 21 million CHF (€19 million) investment into its facility in Switzerland.

Harro Höfliger has supplied a Modu-C MS capsule filling machine which boosts Micro-Sphere’s capsule filling production. A notional production of 72,000 capsules per hour and a 100% net weight check control, grant the correct dose when filling capsules for dry powder inhalers.

“Low dose capsule filling is becoming increasingly popular across the market and at present we are the only CDMO in Europe offering this level of capability,” Micro-Sphere founder and president of the Board, Dr. Michele Müller, said. “Harro Höfliger’s powder expertise and technological competence is particularly evident in the Modu-C MS. This investment is an important next step in our expansion plans, allowing us to meet demand for greater capacity and speed up project delivery for our customers.”

Based in Allmersbach, Germany, Harro Höfliger develops and manufactures production and packaging systems and is a valued development partner for many pharmaceutical and medical technology companies.

From its GMP, SwissMedic and FDA approved facility near Lugano, Ticino, Micro-Sphere’s expert team supports customers in the US, Europe, New Zealand and Asia with spray drying and capsule filling capabilities for the development and manufacture of both potent and non-potent pharmaceutical products, with a particular focus on inhalable dosage forms.

Cambrex Opens Large Scale API Manufacturing Facility

Cambrex has completed the installation of new, large scale manufacturing capacity at its cGMP facility in Karlskoga, Sweden and has also undertaken a multi-year construction project to increase the site’s wastewater processing capabilities.

The expansion of the site’s manufacturing capabilities included the installation of various multi-purpose reactors, ranging from 4m3 to 12m³ in size, in addition to a 9m3 hydrogenation reactor.

The construction of a new wastewater treatment plant to support the expansion and improve existing biological processes, is being phased over a three-year period. The 30.5M SEK ($3.5M) investment will process over 4,000m³ of water each day and handle variations in the composition of effluent. The majority of the construction project will be completed in 2017, with additional upgrades in 2018 and 2019. When completed, the facility will reduce the emission of nitrogen, total organic compounds and suspended material, improving the site’s environmental footprint.

“Our Karlskoga site is a crucial part of the company’s global manufacturing network, and these investments, to not only to increase capacity, but also to the supporting infrastructure, will enable the site to work efficiently both now, and into the future,” said Bjarne Sandberg, Managing Director, Cambrex Karlskoga. “At Cambrex we are committed to investing in small molecule development and manufacturing capabilities, and ensuring our facilities are both flexible and efficient to respond to the evolving needs of our customers.”

The expansion at Cambrex’s Swedish site is part of an ongoing strategic campaign to increase manufacturing capacity across its global network, and follows the announcement of the construction of a $24M, 4,500 sq. ft. highly potent API manufacturing facility at the Charles City, Iowa site, which is due to open in 2019.

Germfree’s Mobile Pharmacy Trailer

Controlled Environments spoke with Jeff Serle, Senior Vice President/Chief Design Engineer of the Mobile Pharmacy Trailer, about the use of the mobile cleanroom facility.

Controlled Environments (CE): What led to the need for this cleanroom facility?

CE: Who was involved in designing it?

CE: What challenges were faced along the way?

CE: Can you comment on the size and cost?

CE: Who will be utilizing this space?

CE: Will this be a temporary or permanent fixture on the campus?

JS: The Hospital Pharmacy Cleanroom Trailer is designed as a temporary cleanroom space, which can be relocated for use at multiple facilities during construction/remodeling or as an emergency relief platform. We maintain a fleet of MPTs that are available for short-term lease. MPTs can also be purchased for longer-term projects or by healthcare systems with multiple locations.

Germfree has developed a specific set of quality control and decontamination procedures that are implemented between each new deployment. The unit is also tested and qualified by a third-party certification professional, typically accredited by the CETA National Board of Testing, prior to use at a new site.

CE: What does the future hold for this technology?

Roche Sells Italian Formulations Plant to CMO Delpharm

Delpharm has been contracted to make solid and liquid forms for Roche after buying the facility in Milan.

Contract manufacturing organization (CMO) Delpharm has completed the purchase of a Roche solid and liquid forms manufacturing facility in Milan/Segrate, Italy and inked a supply agreement with the Swiss pharma giant.

“The agreement between Roche and Delpharm includes a multi-year manufacturing contract, where it is intended that Delpharm will continue to support solid and liquid forms production for Roche in the future,” Roche spokeswoman Ulrike Engels-Lange related.

“Further to this, Delpharm intends to bring business and volumes from its other customers to utilize the site’s capacity and capabilities to its full potential.”

Financials surrounding the sale have not been disclosed but Delpharm will keep on all of the plant’s employees as per agreement with Roche.

The site will also become the twelfth for Delpharm and its second in Italy, following the acquisition of a site in Novara from Takeda last year. In fact the European CMO has a reputation of growing through the acquisition of Big Pharma plants. Since 2012 it has bought a Sanofi plant in Dijon, a Pfizer plant in Lyon and a Bayer plant in Gaillard (all France).

Roche put the Milan/Segrate site up for sale in November 2015 as part of a plan to reduce its small molecule manufacturing footprint.

“The exit of the site is part of a restructuring of our manufacturing network for small molecules, which is designed to address significant changes in our portfolio,” Engels-Lange said.

The firm has also sold a solid dose pharmaceutical in Leganés, Spain to Famar, and last year sold an API production plant in Florence, South Carolina to Patheon. A site in Clarecastle, Ireland is also being shuttered.

But it is only Roche’s small molecule footprint which is being reduced, as the firm has been vocal about continuing to expand what it says is “the largest biologics manufacturing capacity across the industry.”

Hurricane Damages Puerto Rico's Pharma Manufacturing

by Joseph Keenan, Eric Palmer

As Puerto Rico struggles to get its footing in the wake of the devastation left by Hurricane Maria last week, the pharmaceutical manufacturing industry is scrambling to assess damage to plants and the condition of their employees. Although some facilities are operating with backup power, many of the 50 pharmaceutical plants in Puerto Rico are essentially being idled for the time being as employees dig out of the devastation, USA Today reported. It’s not expected that power to the island will be restored for up to six months, and loss of production could lead to some short-term drug shortages. The FDA, in an email, told the newspaper that it was working closely with pharmaceutical companies to prevent shortages of drug products.

Companies emphasized that assuring the safety of their employees and helping them was their top priority, even as they assess damage to plants and determine what the impact might be on supplies. Several said through supply chain management they would be able to avoid shortages of any medication.

"The company's preliminary assessment is that the critical manufacturing areas in our facility in Juncos, Puerto Rico, have not been significantly impacted by this storm," Esteban Santos, executive vice president of operations at Amgen, said in a statement. The company said it has hundreds of staff on site and that its facility is operating on backup generators. It said that capacity at other sites will cover supply needs.

An AbbVie facility is also "running on independent power generation unit and are intact and operational, with teams working diligently to restore normal operations." The company said it does not expect any supply disruptions as result.

In an email to FiercePharma, Merck spokeswoman Claire Gillespie said the company is still evaluating the impact of the hurricane on its operations. The lack of power and communications across the island was making it difficult for companies to contact employees.

“AbbVie is in the process of confirming the safety of our colleagues and their families in Puerto Rico and the Caribbean,” the company said in a statement. “This effort remains ongoing, as power outages have impacted communications across the island."

Pharmaceuticals make up 72% of Puerto Rico's 2016 exports, which are valued at $14.5 billion, according to the U.S. Bureau of Labor Statistics. Puerto Rico represents 25% of total U.S. pharmaceutical exports.

Eli Lilly and AstraZeneca are among other large pharmaceutical companies with operations in Puerto Rico.

Pfizer Confirms Puerto Rico Plants Damaged By Hurricane Maria

Communication difficulties are hampering drug industry efforts to assess damage to manufacturing operations caused by the hurricane that struck Puerto Rico.

Hurricane Maria hit Puerto Rico, cutting off power to the Caribbean island and leaving millions of people with only limited access to food and water. The storm also damaged drug manufacturing plants according to US FDA commissioner Scott Gottleib, who said "The FDA is currently working closely with pharmaceutical and device companies with manufacturing sites in Puerto Rico to prevent shortages of medically necessary drugs and devices."

A Pfizer spokeswoman confirmed the firm had been impacted by the hurricane. She said, “We have completed preliminary assessment of our manufacturing sites in Puerto Rico. Two of the three sites received minimal damage. One site has experienced minimal to moderate damage to parts of the facility and we are working to repair the facilities as soon as possible. She added that: “We are slowly making contact with our colleagues on this island. To date it has been difficult to confirm all their status with no electricity on the island and minimal cell phone coverage.” Despite the damage, Pfizer is confident it can avoid interruptions to product supplies. The spokeswoman stated, “We have healthy supply of finished goods available for patients and do not see a risk to patient supply at this point.”

Bristol Myers-Squibb (B-MS) has three facilities in Puerto Rico. A spokesman said two of the facilities escaped damage and that the firm is assessing the third.

"The island of Puerto Rico has sustained significant damage, and our primary concern is with our employees, their families and the citizens of Puerto Rico. We are executing contingency plans that we believe mitigates product supply risk as we assess the situation on the island and work to bring our operations back online. We are contacting employees to provide support in their recovery from Hurricane Maria while the Bristol-Myers Squibb Foundation is responding with a $250,000 cash donation to support emergency relief efforts."

Johnson & Johnson's (J&J) Puerto Rico operations appear to have suffered less impact.

Spokeswoman Natália Salomão said, “Our preliminary assessment is that our physical facilities fared well given the magnitude of the storm. We are partnering with local and federal authorities to monitor the state of the infrastructure. “While we helped our employees and campuses prepare, we continue to work with customers and our emergency aid partners to restock products and relief supplies that have been in heavy demand.”

Salomão added, “Prior to the storm, we took steps to adjust our raw material and product supply flow to account for potential interruptions, and we will continue to assess the situation.”

Ongoing assessment

Other drug firms with operations on Puerto Rico are still assessing the damage. GSK said, “We do not have enough information at this time to comment” but promise to provide an update later this week.

Similarly, Eli Lilly and Amgen are both still assessing the situation.

Swiss drug manufacturer Novartis does not have manufacturing operations in Puerto Rico, however, it does ship drugs to the island.

A spokeswoman said, “The safety of our associates is paramount and we are working to confirm all our people are accounted for and to provide them with assistance and support. She added: “We are working closely with our partners, distributors and the government in Puerto Rico to maintain business and supply continuity to the extent feasible.

Fujifilm Diosynth Biotechnologies Opens New UK Lab

Fujifilm Diosynth Biotechnologies has opened a $9m process development laboratory in Teeside, UK. The lab – at the Wilton Centre science park in Redcar, Cleveland – will provide support for customers developing monoclonal antibodies (mAbs) using Fujifilm’s Saturn cell culture process development platform.

COO Paul Found said by “by dedicating these facilities and bringing new technologies we will be effectively supporting our customer’s in the rapid delivery of monoclonal antibody therapies to patients all over the world.”

The expansion is part of the $130m (€108m) bioreactor and processing capacity increase programme Fujifilm announced in April. The majority of the money was spent on the firm’s new facility in Texas, with the remainder being used to up capacity at its site in Billingham, UK.

The opening of the Teeside lab comes six months after GE Healthcare installed a single-use purification system with bioreactors at the Billingham facility. In its first quarter fiscal report last month Fujifilm, the contract manufacturing organization’s (CMO) parent company, said customer demand for flexible capacity prompted the investment.

“In order to respond rapidly to demands for customer for increased production and other future expansions in demand, the company is also bolstering its capacity to produce bio-pharmaceuticals at its production centers.”

BASF to Increase Capacity with New China Plant

BASF has announced plans for a specialty amines plant at its site on the Nanjing Chemical Industry Park in China, citing increasing demand from customers in Asia. The plan – which is due to be operational in 2019 – will make a range of amines including 1,2-Propylenediamine (1,2-PDA), which is used as a building block in the manufacture of a wide range of active pharmaceutical ingredients (API).

Narayan Krishnamohan, senior VP of BASF’s intermediates business in Asia Pacific, said: “This investment will help us to meet the increasing Asia Pacific demand for specialty amines used as intermediates in a diverse range of industries and applications.”

China’s 3SBio Enters North American Market Through Canada’s Therapure Buy

3SBio will leverage Therapure’s downstream purification expertise to bolster its own biologics portfolio while expanding its contract biomanufacturing business and global presence.

The agreement to buy Canada-based Therapure for $290m (€244m) has placed 3SBio’s global expansion strategy on “fast-track,” a spokesman from the Chinese biopharma firm said.

“This acquisition as a strategic investment will provide us with an effective and convenient platform for launching our products in North America, for us to license new and innovative products from North America, and for our entering into the biological CDMO business in North America,” said Steven Zhang.

While the deal will allow 3SBio to “seek and negotiate exclusive licensing and collaborative business opportunities with quality biopharmaceutical companies in North America” with a view to further grow its international presence, it will also bolster the firm’s biomanufacturing capabilities both for its proprietary products and as a third-party offering.

“Therapure’s biomanufacturing expertise in downstream purification and transgenic, plasma-derived proteins could help 3SBio to acquire Chinese rights for certain blood products,” said Zhang. “In addition, we see Therapure’s [expertise] as a good supplement to our existing capabilities in China and in Europe and will contribute revenue and profit to 3SBio in the near term.”

3SBio’s Sunshine Guojian business in China offers 38,000L of production capacity, while Sirton Pharmaceuticals – an Italian CDMO acquired by 3Sbio in 2015 – offers injectable fill and finish capabilities.

“We expect significant cross selling and entirely new revenue opportunities to arise by effectively combining our leading mammalian cell culture capability with the significant expertise in downstream purification and transgenic, plasma-derived proteins that can be offered by Therapure’s CDMO Business.”

Therapure has a 130,000 sq. ft. facility in Toronto, Canada optimized for intravenous immunoglobulin (IVIG) and albumin-based therapies. Its upstream offering includes 200L and 1,000L Pall Allegro stirred-tank single-use bioreactors, 50L and 500L Thermo Scientific HyClone stirred-tank single-use bioreactors, a 200L WAVE single-use bioreactor, and a series of stainless steel bioreactors with up to 2,500L capacity.

Downstream it boasts column chromatography, membrane separation, precipitation and extraction, tangential flow filtration (TFF), ultrafiltration/diafiltration (UF/DF) at scales up to 100 m2 of membrane, and virus inactivation and removal through low pH, solvent/detergent, nanofiltration, pasteurization and chemical inactivation.

BIM Technology Assists ConvaTec in Monobloc Cleanroom Installation

In its largest off-site cleanroom construction project to date, UK-based cleanroom provider Connect 2 Cleanrooms has installed a Monobloc panel system for global medical products and technologies company, ConvaTec

With leading market positions in advanced wound care, ostomy care, critical care and infusion devices, ConvaTec required a cleanroom to be aligned with its current facility, where the corridors incorporate windows and doors, with the ability for future expansion.

To ensure an accurate design in an already sensitive facility, the use of Building Intelligence Modelling (BIM) assisted the design stage for Connect 2 Cleanrooms. The Point Cloud 3D design software allows for a more accurate design, shorter lead times and a more cost effective solution.

Improved communication and coordination between departments and clients provides a greater understanding of the design intent and allows for any errors to be identified and changes to be made at an early stage – reducing waste and saving money.

Spanning 10,233 sq. ft. (951m2) and with a requirement to achieve ISO Class 8, the cleanroom incorporates a separate change area suitable for up to 60 operators and a material transfer area. The main cleanroom area, which was constructed to house ConvaTec’s stitch bonding processes, has a footfall of 9,361 sq. ft. (870m2) and is designed to achieve 21 air changes per hour.

Monitored via Connect 2 Cleanrooms ECO loop control system with temperature and humidity control, the cleanroom has 60 variable speed controlled HEPA ceiling fan filters, which are all accessible externally via the suspended walkable ceiling for non-disruptive maintenance.

A cleanroom of this size would typically use an Air Handling Unit (AHU) to supply HEPA filtered and temperature controlled air. Connect 2 Cleanrooms proposed using localized air conditioning and dehumidifier units to supply processed air to fan filter units. This approach meant a significantly lower initial investment and it is more energy efficient when operational than an AHU.

The touch screen control system was installed to continually log all these data parameters, which integrates with ConvaTec’s current building management system (BMS). The integrated alarm alerts operators when these parameters vary beyond a specific threshold such as pressure differential and temperature and humidity.

Following the install, a detailed commissioning process was carried out to ensure the cleanroom is functioning as it should. Extreme testing of all elements, alongside the design against resilience, ensures the room continues to operate 24/7, even if a unit were to fail.

The cleanroom design incorporates high speed and hinged interlocking doors between the transfer and change areas to aid the flow of materials and personnel, while reducing the risk of contamination entering the cleanroom and in keeping with the aesthetics of the existing sensitive layout.

With increasing business demands and the ever growing need for a less disruptive construction and more efficient design process, Connect 2 Cleanrooms is consistently looking for new processes to offer a more accurate and effective design process and a reduction in installation time for their modular cleanrooms.

The introduction of BIM is just another investment added to its design portfolio, offering customers a more efficient and accurate service. BIM is a process for creating and managing information across a project’s lifecycle. One of the key outputs of this process is the Building Information Model, the digital description of every aspect of the built asset.

This model draws on information assembled collaboratively and updated at key stages of a project. Creating a digital Building Information Model enables those who interact with the building to optimize their actions, resulting in a greater whole life value for the asset.

Through BIM, the UK construction industry is experiencing its very own digital revolution, combining efforts of people, processes and technology. A point cloud 3D scan of the entire building was conducted within the initial stages of the project to provide a virtual view of the facilities space. A Point Cloud is a collection of data points defined by a given coordinates system. In a 3D coordinates system, for example, a point cloud may define the shape of some real or created physical system.

"BIM allowed us to think beyond CAD drawings of the cleanrooms and look more towards data extraction, to understand the area that we were building in, so we could apply our cleanroom more efficiently. By analyzing historical data and understanding the length of time to complete our cleanroom installations, we could forecast our activities and the time taken from inception to install of the cleanroom, which meant we could optimize our people and processes more effectively, making cost and time savings." said Joe Govier, MD, Connect 2 Cleanrooms.

The offsite construction method and the Point Cloud 3D scan adopted for this installation ensured that the clients’ cleanroom was brought in on time, on budget.

Boulting Environmental Services Completes Indivior R&D Facility

The UK-based cleanroom and lab design and construction company has completed the construction phase of a £13 million project for global pharmaceutical business Indivior, a specialist in the treatment of opioid addiction

The new research and development (R&D) facility located in Hull, UK, will be used to test and manufacture a non-addictive alternative to methadone, designed to improve patient experience.

Boulting Environmental Services (BES) was the principal designer and principal contractor for the project, carrying out a complete turnkey package that included groundwork, piling, shell construction and the internal specialist architectural fit out of cleanrooms and laboratories.

The two-story cGMP facility provides 53,800 sq. ft. (5,000m2) of ISO Class 7 and ISO Class 8 product development cleanrooms and laboratories, along with highly specified offices, meeting rooms and a restaurant for staff.

“BES completed the project three months ahead of schedule, within budget and to the highest quality,” explained Giles Singleton, Project Manager at BES.

“This was down to our lean programming framework and our ability to overlap different phases of the project to eliminate wasted time. At no point were our engineers waiting for one task to be completed before they could move on to the next. The entire process was efficient and streamlined with the customer’s requirements in mind at all times.”

“Indivior selected BES through a competitive tender process, in which BES came out on top in terms of cost-effectiveness and delivery time,” commented Paul O’Reilly, Facilities Director at Indivior.

“The design and build process was extremely collaborative, with BES listening to our primary objectives and creating a facility that was both technically fit-for-purpose and one that gave Indivior welcoming office space and recreational areas for staff.”

Roche to Increase Russian Supply through Pharmstandard

Local manufacturer Pharmstandard will make the finished dosage form of Roche’s monoclonal antibody Gazyva (obinutuzumab) at its site in Ufa.

Pharmstandard has been working with the Swiss pharma firm since 2010, helping bring Roche/Genentech products such as Pulmozyme (dornase alfa) and Tamiflu (oseltamivir) to the Russian market, and will now produce the drug product for Gazyva, a treatment for chronic lymphocytic leukemia (CLL).

“Our Roche affiliate and the Russian manufacturer Pharmstandard have signed a Memorandum of Understanding for the ‘fill-finish’ production of Roche's drug product Gazyva in Pharmstandard's manufacturing operations in Russia,” said a Roche spokesperson.

“Local production of Gazyva would expand treatment options for Russian patients with chronic lymphocytic leukemia and follicular lymphoma.”

The 451,920 sq. ft. (42,000m2) facility is located in Ufa, Republic of Bashkortostan (a federal subject of Russia), and boasts capabilities for injectables, vials, cartridges and prefilled syringes, as well as solid oral dosage form manufacture.

The partnership allows Roche to access the Russian market which, under its Pharma 2020 policy, encourages a level of protection intended to increase local drug manufacture and reduce reliance on imports.

The idea is Russia will be able to produce 50% of all the drugs it uses - and 85% of the medicines it deems essential - by 2020, though whether this target will be reached is unclear.

The policy has driven most multinationals to sign contracts with domestic drugmakers and invest in local joint ventures. Pfizer broke ground on a facility with NovaMedica in Kaluga in May, GSK formed a JV with Binnopharm in 2011, while AstraZeneca, Novartis, and Novo Nordisk have all invested in Russian production facilities.

Clintec Expands UK HQ

Clintec has expanded its Glasgow-based headquarters with the opening of an additional 4,327 square foot floor. The additional space will form a fully dedicated center of excellence for clinical research and quality assurance capabilities.

The contract research organization (CRO) has also been presented with the Queens Award for Enterprise 2017, in the category of International Trade. The Queens Award, the highest business accolade that can be granted to any business operating within the UK, recognizes outstanding corporate achievement and more than 20 years of consistent business success.

“We are honored to have received the Queens Award for Enterprise for the second time and through which we celebrate 20 years of global success in clinical research,” said Rabinder Buttar, founder and chief executive officer, Clintec. “Furthermore, we are delighted with the expansion of our clinical operational capabilities and HQ office space for the next stage of company growth.”

Amatsigroup Manufactures with Single-Use Isolator

French CDMO develops innovative single-use technology solutions for aseptic formulation & manufacturing.

Amatsigroup, a contract development and manufacturing Organization (CDMO) located in France, unveiled what it says is the world’s first-in-class manufacturing of a clinical injection batch under single-use isolator, a major global breakthrough currently to be used in the treatment of acute ischemic stroke.

In January 2017, Amatsigroup acquired Disposable Lab, which specializes in the production of small batches of pharmaceutical drug products in Martillac, France. The design of the production area is based on the use of the assembly of disposable materials—single use isolator and material in contact with the product—in fresh air modules. This very specific design is a major asset for the production of small batches of bio/pharmaceutical drug products and medical devices (<2,500 units per batch), for small filling volumes (e.g. 15μL), for volatile products, viscous or sticking products and in particular those where the cleaning procedure is problematic. These installations are compatible with the distribution of powders in aseptic condition, with a +/- 0.1 mg accuracy for continuous filling in vials. The isolator and filling line offer great flexibility and allow distribution, in aseptic conditions, of different packaging, including vials, IV pouches, cartridges as well as capsules and any other primary packaging.

This sterile manufacturing site in Martillac has performed its first Media Fill Trial (MFT) for Acticor Biotech on the current line as of May 2017, and produced the first clinical injectable batch for a phase I trial in Europe. According to the company, this single-use technology for the manufacturing of clinical injectable batch is a world breakthrough.

This specific technology is also of interest in the handling and production of small series of hazardous and/or living microorganisms. The site is being accredited for the production of clinical batches requiring to be handled under BSL2 (e.g. bulk of living aerobic bacteria). In addition, Amatsigroup will invest during the year, with the objective to produce live organisms requiring manipulation in a BSL3 environment.

For any other product that does not require this technology or for larger batch productions, the Amatsigroup site in Idron, France, offers batch dispatch technology under fixed isolators. The site of Idron manufactures liquid or lyophilized forms, up to 10,000 - 25,000 units, depending on the packaging format.

“This success is the combination of a fantastic team in Martillac, a great partnership with our supplier of disposable isolators, Solo Containment in UK, and the confidence of Acticor Biotech in our technology,” said Jean-Pascal Zambaux, site director of Martillac - Amatsigroup.

Gilles Avenard, chief executive officer, Acticor Biotech, said, “We have been very happy to experience the flexible fill and finish facility of Amatsigroup, Martillac site, for our first GMP batch. The technology is very promising for small batches as it could be translated very easily according to the ‘single use lab paradigm’ without any impact on the validation process.”

Colorcon Opens New Technology Services Laboratory in Vietnam

Colorcon has opened a new Technical Service Laboratory at Ton Duc Thang University in Ho Chi Minh City, Vietnam. The new facility adds to Colorcon’s worldwide support network and is dedicated to supporting customers and market growth in Vietnam.

The pharmaceutical market in Vietnam is forecast to expand in value from $4.7 billion in 2016 to an estimated $6.6 billion by 2020. An increasing elderly population, rising government support for the healthcare sector and the impending gains from the Trans-Pacific Partnership (TPP) are predicted to be the main drivers of growth for the Vietnamese pharmaceutical market during this period.

“Opening this facility demonstrates Colorcon’s continued commitment to the expanding pharmaceutical market in Vietnam, reducing our customer’s time to market and making a positive contribution to their manufacturing quality and production efficiency,” said David Wei, general manager, Colorcon South East Asia. “The investment highlights Colorcon’s dedication to providing best-in-class products and services across the region.”

Tri Nha Huynh, business development manager for Colorcon in Vietnam, said, “The new laboratory is located at the Ton Duc Thang University, a leading university in Vietnam. This facility enables Colorcon to bring direct support to customers in the pharmaceutical and related industries, providing easy access to our specialist technical services and a quicker turnaround time for their projects, helping to bring local generic medicines faster to market.”

The facility also provides the opportunity to extend the educational events offered through the Colorcon Academy, with resources to conduct Colorcon Coating Schools and Formulation Training Programs, which will facilitate knowledge sharing and benefit individuals as well as their companies.

Colorcon’s investment brings the total number of Technical Service Laboratories around the world to twenty-one and the most recent is the sixth within Southeast Asia.

Tigenix Expands Manufacturing Facility

TiGenix obtains commercial production license for expanded manufacturing facility, to provide the capacity for potential European commercial roll out of investigational stem cell therapy, Cx601; the expansion also secures manufacturing for other pipeline products.

TiGenix, an advanced biopharmaceutical company exploiting the anti-inflammatory properties of allogeneic or donor-derived stem cells to develop novel therapies for serious medical conditions, has obtained a license for the commercial production of expanded adipose-derived stem cells (eASCs) at its expanded manufacturing facility in Madrid.

The manufacturing license follows an inspection by the Spanish Medicines Agency (AEMPS) and provides production capacity for the potential initial European commercial roll out of Cx601, an investigational stem cell therapy, for the treatment of complex perianal fistulas in patients with Crohn's disease.

The expanded facility will also provide sufficient capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611, currently undergoing a Phase I/II trial in severe sepsis.

TiGenix has submitted a marketing authorization (MA) application for Cx601 to the European Medicines Agency (EMA) on the basis of results from its Phase III ADMIRE-CD trial with a decision expected in 2017.

An MA would allow Cx601 to be marketed in all 28 member states of the EU plus Norway, Iceland and Lichtenstein. Cx601 has been licensed to Takeda for exclusive development and commercialization outside of the US.

Wilfried Dalemans, Chief Technical Officer at TiGenix, said: “We are very pleased with this approval for our expanded facility, which confirms our state-of-the-art GMP manufacturing capabilities in the stem cell field.

We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialization of Cx601 in Europe and in the further development of our pipeline.

Clintec’s Research Site Boost at Scotland HQ

Clintec International has opened a Centre of excellence for clinical research and quality assurance capabilities as part of its headquarters expansion in Glasgow, Scotland. A spokesperson said the expansion, which adds 4327 sq. ft. to the contract research organization’s (CRO) site, is attracting new clients.

“Global pharma are very interested in the functional outsourcing/FSP [functional service provision] capabilities which Clintec has, and the expanded Glasgow office supports these clients in analytics, functional resourcing, client relations and quality assurance.”

“We are getting more and more requests from small/medium sized biotech companies mainly from the US who are tapping into our capabilities and expertise especially in the oncology and rare diseases area,” said the spokesperson.

The expansion will create new jobs with varying skill requirements.

“Additional jobs are being created in most areas of our business in the Glasgow HQ including our clinical research functions such as Clinical Operations and Biometrics, alongside corporate functions including client relations and business development.”

“We are creating opportunities for experienced individuals as well as trainees, and are committed to developing the next generation of talent within clinical research,” said the spokesperson.

Clintec said the expanded headquarters will manage operations across Europe, and emerging territories including Turkey, the Middle East and Africa, as well in the US, where is it growing its client base.

“We have embarked on a long-term vision to develop a leading capability in North America.”

“There are strong business links between the UK and USA, and it has been a natural fit to fully support the US operation from the Glasgow HQ,” said the spokesperson.

PSI Opens in Seoul with Sites across South Korea

There are many opportunities in Asia Pacific for mid-sized CROs says PSI, after opening a new office in Seoul, South Korea in response to client requests.

The Switzerland-headquartered contract research organization (CRO) has 1,600 employees globally.

Olga Alfonsova, global head of corporate development at PSI said the company has been getting many requests from customers to include Asia Pacific countries and South Korea in particular in its “Phase II and III clinical trial geomix.”

PSI provides services to biotech and mid-sized pharma in several areas, including antimicrobial and antifungal infections, oncology, hematology, inflammatory bowel diseases, and neurological conditions, among others, said Alfonsova. “We find that sites in South Korea prove to be excellent contributors to global clinical trials in these therapeutic areas,” she added.

"Seoul is a good place to establish an office with staff monitoring sites all across major clinical trial locations of South Korea,” said Alfonsova.

At the same time, the CRO is also opening an office in Taipei, Taiwan, which Alfonsova said will be announced shortly. The office will be the company’s third in Asia in 2017, following Sydney, Australia and Seoul, South Korea.

“There are many opportunities in Asia Pacific for mid-sized, agile, private CROs such as PSI that are fit to support global clinical trials while all along focusing on on-time project delivery,” said Alfonsova.

McIlvaine Company

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