PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Oncorus Inc., Cambridge, Mass.

Project team: TRIA (architect), The Richmond Group (general contractor), AHA Consulting Engineers (MEP/FP engineers), BioMed Realty (landlord), Fletcher Martin Corp. (facility management)

TRIA, a partner-led architecture firm with a focus on science and technology organizations, completed a new 12,300 sf headquarters for Oncorus Inc., a biotechnology company developing a portfolio of next-generation immunotherapy products to treat several types of cancer. Located at 50 Hampshire Street in Cambridge, Mass., Oncorus’s new headquarters features an efficient and flexible workspace that supports the company’s scientific research mission and reflects the company’s branding and culture.

The TRIA design team took a holistic approach to the design of Oncorus’s headquarters. The interior designer and lab designer worked closely to design a cohesive integrated space with a variety of work areas, including labs to support highly specific needs, conference rooms for technical presentations, and collaboration areas for impromptu meetings and social interaction.

Special attention was paid to the separation of work spaces and work flows in the company’s specialty lab functions. Work stations along the window line allow natural light to penetrate deep into the space, and conference rooms on the interior feature glass walls to offer transparency. One of the conference rooms features a wall-sized window to the company’s lab, providing a view to the exciting scientific discoveries taking place.

Oncorus’s headquarters also includes a versatile kitchen/break area that can accommodate all-company meetings. Specialty design features, such as a rustic-inspired reception desk and a barn door in the kitchen area, bring a stylistic edge and uniqueness to the space. Pops of selective color in the furniture and wall paint convey warmth and energy. Sustainable materials were used wherever possible, including LED lighting with automated controls, recycled materials and locally sourced products.

Completion date: January 2017

Metrics Unveils Details for New $80M Commercial Mfg. Facility

Metrics Contract Services unveiled details about its new $80 million commercial manufacturing facility at AAPS 2017 in San Diego. Metrics is the contract development and manufacturing division of Mayne Pharma.

Construction of the company’s new oral solid-dose commercial manufacturing facility in Greenville, NC, is complete, with production beginning in January. This $80 million, 126,000-sq.-ft. facility quadruples the company’s U.S. manufacturing capacity.

The facility allows Metrics Contract Services to offer comprehensive development services from “concept to commercialization” in one location under one site registration. It offers larger scale and increased capabilities for scale-up, reducing the technical and regulatory complexity of site transfers.

This expansion includes commercial-scale, solvent-based, fluid-bed processing and film coating, a first for its operations in the U.S. With this new facility, Mayne Pharma will triple its worldwide fluid-bed processing capacity.

Chemistry Research Building, Colorado State University, Fort Collins, Colo.

Cost: $33.5 million

Size: 56,814 gsf; 32,898 nsf; 23,297 nsfl

Project team: RFD (laboratory planner); Hord Coplan Macht (project architect); RATIO Architects (design architect)

This new 56,000 gsf building includes 23,000 nsf of state-of-the-art collaborative research environments to support research, retention and recruitment in the CSU Chemistry Department. Specific research themes include Synthetic Organic Chemistry, Synthetic Inorganic Chemistry and Biosynthetic Chemistry. The building is designed around several open research laboratories to promote flexibility, collaboration, and interaction. Specialized lab support spaces include a Central Instrument Facility, a Catalysis Center and a flexible future core. The building design arranges offices, write-up areas, interaction spaces and offices to create an environment that supports interdisciplinary collaborative research.

Completion date: Fall 2017

University of Southern California Michelson Hall, a Hub for Biotech Research

A simple blood test could tell patients whether they have cancer. A smartphone app could predict heart failure before it strikes. A map of developing memory in the brain could be used by doctors to solve issues with traumatic brain injuries or neurological disease.

A few interesting statistics about the new home for the USC Michelson Center for Convergent Bioscience:

699,700 - Hours worked by construction workers and tradesmen to build the facility

275 - Number of construction workers and tradesmen involved

100 - Fiber connectivity speed in gigabits per second, the fastest on campus

3 - Depth in feet of the concrete slab that forms the building’s base

These are some of the research efforts underway by scientists and engineers at the new USC Michelson Center for Convergent Bioscience. More than two dozen researchers are unraveling the mysteries of cancer, exploring the development of the human brain and advancing scientific understanding of the human body and its interactions with a range of diseases on a cellular level. Michelson Center researchers aim to speed the development of new drug therapies, high-tech diagnostics and biomedical devices from the bench to the bedside.

USC opened Michelson Hall, the new hub for this groundbreaking research endeavor as a cornerstone for biotech in Los Angeles. The grand opening of the $185 million building caps nearly seven years of planning and design, including three years of construction. All that had once existed only in blueprints is now a reality, thanks to a generous $50 million gift from retired orthopedic spinal surgeon Gary K. Michelson and his wife, Alya Michelson.

“It was a privilege for Alya and me to have been able to have been a part in the creation of this world-class convergent bioscience research center,” Michelson said.

In addition to impressive curriculum vitae and a long list of publications, many of the Michelson Center researchers boast a portfolio of patents and successful startup launches. Entrepreneurs and inventors, they appear to be cut from the same cloth as Michelson himself, who holds more than 950 patents, issued and pending. His inventions have revolutionized spinal surgeries, making them safer for patients by reducing blood loss.

The Michelson Center’s diverse network of premier scientists and engineers represent a long list of research fields ranging from biological science and medicine to physics and engineering. They hail from the USC Dornsife College of Letters, Arts and Sciences, the USC Viterbi School of Engineering and the Keck School of Medicine of USC, and will work to solve some of the greatest intractable problems of the 21st century in biomedical science.

The scientists and researchers at Michelson Center are in many ways driven by personal passion.

Michael Quick

“The scientists and researchers at Michelson Center are in many ways driven by personal passion, and recognize that curiosity-based science is one of the greatest paths toward revolutionizing how we diagnose and treat cancer, cardiovascular disease and neurological issues,” USC Provost Michael Quick said. “At Michelson, we aim to deliver meaningful solutions to address disease, solve the challenges that impede care and expand our scientific knowledge for the betterment of health across the lifespan.”

The new building has been a collaboration from the start. The scientists and engineers who will be part of Michelson Center all had a hand in designing the building’s spaces and selecting many of its assets and furnishings.

The four-story building features the fastest fiber connectivity on campus — 100 gigabits — as well as wet labs, research centers, a fabrication lab, offices and conference rooms. The building also features a cleanroom — a dust-free environment for testing products such as nanoscale chips and biomedical devices.

“It is absolutely the most complex research building that we have ever done,” said Joe R. Back, associate senior vice president for USC Campus Development and Facilities. “All the mechanical, electrical and plumbing systems that are required for lab work that are not required for other buildings are densely packed into the walls of that building.

“Michelson Hall was planned down to the inch, including what pipe goes next to another pipe.”

The cleanroom was an intensive project. USC officials said they had to conduct soil testing to determine the best locale for the cleanroom on the site to insulate it from the vibrations of the nearby Metro Expo Line light rail. Other measures taken to protect the lab included a 3-foot concrete slab for the building’s base. The ductwork alone for Michelson Hall would span 6 miles if laid from end to end.

More than 275 construction workers and tradesmen spent a combined 699,700 hours to build Michelson Hall. Designed by HOK and erected by DPR Construction, the work involved a half dozen engineering firms and subcontractors: John A. Martin and Associates based in Los Angeles, Vanderweil Engineers, ACCO Engineered Solutions, Murray Plumbing, CSI Electric, Masonry Concepts and Largo Concrete. Abbie Gregg Inc., a consulting firm based in Tempe, Ariz., oversaw the design and construction of the cleanroom and the spaces that will house the large electron microscopes.

Among Michelson Hall’s distinctions is a series of looming arches and peaked windows — signature features of the collegiate gothic architecture style that is reminiscent of British and New England universities. It is in the same vein of other USC buildings at the University Park Campus, such as USC Village, which opened in August, and Wallis Annenberg Hall, which opened in 2014.

Beyond the more than 250,000 handset bricks that wrap Michelson Hall is a modern interior that could be mistaken for a Silicon Valley work environment. A main highlight of the building is the “living room” — an open lounge-like space that has various pods where researchers, if they run into each other at the espresso machine, can sketch their visions and scribble hypotheses on touch screens, then save their work to the cloud.

Alton Parks

“I call it a collision space,” said Alton Parks, the Michelson Hall architect who noted that even the bar stools in the living room are designed to prop researchers and visitors at eye-level with anyone passing by. “This is what will draw people out of their silos.”

For Michelson Hall, USC had consulted Los Angeles-area designer Richard Holbrook, who had spent two years touring innovative work spaces around the world, visiting cities such as Hong Kong and Kuala Lumpur, Parks said.

Many of the engineers and scientists for Michelson Center have developed new products, including new drugs or biomedical devices, and have a track record of launching startup companies.

The center is greater than the sum of its parts. “This is meant to create a sea-change of collaborative scientific research across the university,” said Steve Kay, director of convergent biosciences at USC.

USC is not the first institution to launch a convergent bioscience institution, but it may well be the second. A similar center, the Whitehead Institute, exists at the Massachusetts Institute of Technology. Other universities across the country have established centers and institutes for biotechnology, but few are so focused on the convergence of research in engineering, the physical sciences and life sciences.

Kay said USC created Michelson Center through careful deliberation.

“At USC, we are doing this with precision and are bringing together the skill sets that will solve unmet medical needs,” Kay said. “Even well before the building is open, some of our biggest successes are certainly coming out in the areas of cancer, personalized medicine and in drug discovery,” said Kay, Provost Professor of Neurology, Biomedical Engineering and Biological Sciences.

Some of the scientists tapped to be part of the Michelson Center were already at the university when leaders began to discuss creating a center for bioscience. Others, like Raymond Stevens PhD ’88, came to USC before the spade broke ground, excited about the promise of bridging the divides that have traditionally separated the disciplines.

Stevens, a Provost Professor of Chemistry and Molecular Biology, moved to USC in 2014 from The Scripps Research Institute in San Diego. As an alum, it was a homecoming for Stevens, who said he has been looking forward to moving into his customized lab at Michelson Hall.

“USC made it easy to come here,” said Stevens, whose breakthroughs in therapeutic molecules have led to the development of Tamiflu, the antiviral used to treat influenza, and treatments for neurological diseases such as multiple sclerosis. “The potential for biotech in Los Angeles is enormous.”

Michelson Hall is opening just as a group of more than 20 organizations and institutions, including USC, have formed the Alliance for Southern California Innovation to promote the growth of entrepreneurship, technology and life sciences in the region. The building itself is USC’s initial footprint in a biotech and tech corridor in Los Angeles.

The researchers moving into Michelson Hall all have a history of innovation and collaboration. Some have already worked together on multiple studies or have partnerships with scientists across the university.

Ellis Meng, a professor at the Michelson Center and USC Viterbi, is accustomed to working with doctors and other scientists on her research that develops medical devices such as tiny sensors and electrodes for monitoring the brain. Meng collaborates with other researchers at the Keck School of Medicine and Children’s Hospital of Los Angeles.

She said she expects many more partnerships will develop as a result of their convergence at Michelson Hall.

“We’re at Michelson because we want to work with others,” Meng said of herself and the other scientists. “We are breaking down some barriers to working with other colleagues in engineering and other colleagues in chemistry and life sciences. Having many collisions frequently is what will prompt us to speak a common language.”

The Michelson building will be the largest on campus when it’s done in September 2017.

Michelson Center aim: Bring biologists, engineers together, fast-track groundbreaking research.

Innovative Lab Design at Pagliuca Harvard Life Lab

The Pagliuca Harvard Life Lab is the newest addition to Harvard University’s Innovation Labs ecosystem, a unique three lab environment focused on supporting Harvard students and alumni in their quest to create ventures that improve the world. Located on Harvard’s Allston, Mass. campus, the 15,000 sf, two-story building, designed by national architecture firm Shepley Bulfinch, creates much-needed space for life sciences ventures that have a connection to the Harvard University community.

The mission of the Pagliuca Harvard Life Lab is to provide students, faculty, post docs and alumni with a fully-equipped wet-lab environment and resources needed to take their ventures to the next stage of development. The Life Lab’s curated community fosters connections among industry, investor, government and academic stakeholders. It offers lab bench space at a subsidized rate and access to shared equipment, along with venture-specific training, mentoring and programming. The design provides a lab space and infrastructure combined with shared equipment for a wide range of life science exploration.

Collaboration and flexibility were the main drivers in Life Lab’s planning. To achieve both, the space challenges the traditional connection between the lab bench and write-up station. The second floor of the Life Lab offers eight write-up stations, while all office and co-working spaces are located on the first floor. An open interconnecting stair is positioned in the lobby and serves to provide a visible and direct connection between the two distinct workspaces, encouraging scientists to spend time out of the lab interacting with and mentoring other students and colleagues.

There are many other benefits to this type of approach. The design also limits the increased air exchange requirements to only areas specific to laboratory work, which leads to significant energy savings. From an operational perspective, having a clear separation of office space and lab space by floor increases safety and security in terms of credentials and access to the lab space. Finally, all food and beverage consumption is clearly confined to the office and collaboration spaces on the first floor and away from the labs.

The second-floor wet lab area is designed to accommodate work focusing on, but not limited to, biotech, genome, drug development, vaccines and medical devices. It’s made up of 30 benches organized around a shared fume hood alcove with equipment benches along the perimeter. Additionally, teams have access to two tissue culture, microbiology, dissection and microscopy rooms. An adjacent suite of six lab benches with a dedicated fume hood alcove and tissue culture room is provided for larger teams. All teams have access to shared tissue culture rooms and storage space.

Harvard University partnered with LabCentral to manage the Life Lab. With limited storage at individual benches—each team is equipped with a six-foot lab bench and two shelves for equipment and supplies—LabCentral’s on-demand ordering through its cloud platform allows teams to request minimum amounts of supplies as needed.

LabCentral provides a wide variety of lab supplies housed in four different kiosks at the core of the second floor. Scientists are issued an access card for the kiosks, which allows them to immediately obtain necessary supplies and pay for them later. Scanned items are totaled in a monthly invoice for each team. A supplier re-stocks monthly, adjusting materials and supplies based on what teams are using.

The Life Lab debunks the common misconception that modular construction is better suited for less technically complex buildings. The creation of the Life Lab leveraged the many advantages of modular construction, not least of which was the speed in which the facility was up and running. By synchronizing off-site and on-site work, the lab opened almost a year earlier than would have been possible using conventional stick-built construction. Perhaps most importantly, there was considerably less disruption to the surrounding campus community.

As venture teams started to occupy the completed Life Lab, Shepley Bulfinch’s interest in the results of its intended connections and venture developments grew. To gain insight, the firm initiated a study to learn how people were interacting with the space. Simple infrared counting devices were installed to anonymously register the direction and number of people passing a doorway. These collectively allowed Shepley Bulfinch to study how much time people were spending in the laboratories (upstairs) versus the open co-working space (downstairs). After collecting data for two months, it became clear that users were spending time in the collaborative first-floor space. Further study will be required to verify these results since the data was collected while the building was not fully occupied. Shepley Bulfinch expects to rerun this study in the near future.

Project team members include Shawmut Design & Construction, Construction Manager; SLB Group, Civil Engineer; LeMessurier, Structural Engineer; R.G. Vanderweil, MEP Engineer; Haley & Aldrich, Geotechnical Engineer; Reed Hildebran, Landscape Architect; Jensen Hughes, Fire Protection; NRB (USA), Inc., Structural Engineer (Modular) and Manufacturing; and Triumph Modular and NRB, Modular Contractor.

McCourtney Hall, University of Notre Dame, Notre Dame, IN

McCourtney Hall, University of Notre Dame, Notre Dame, IN

Cost: $60 million

Size: 220,000 sq. ft.

Project team: BSA LifeStructures (architecture, MEP engineering, lab planning, civil engineering and interior design); TRC Worldwide Engineering Inc. (structural engineer); CPP Inc. (wind modeling and air quality); CCS International Inc. (construction cost estimators); RTM Consultants Inc. (code consultant); Colin Gordon & Associates Inc. (vibration/acoustics consultant); Shiel Sexton (contractor/CM)

The new multidisciplinary research building brings together the College of Science and College of Engineering in an open and collaborative lab environment with a focus on drug discovery, in the four-story, 220,000 sq. ft. building.

In addition to anchoring the new quad, the building will begin the formation of an internal courtyard shared by future research buildings. To promote collaboration between researchers, the design team integrated the large social spaces into the “knuckle” where the two wings of the L-shaped building come together. That section includes conference and breakout rooms, lounge areas, many of the offices and the main entrance, elevators and stairs.

Outside the labs, open areas for graduate students facilitate conversations. The university also grouped researchers with common interests into “neighborhoods” to make collaboration easier. The research labs are modular and adaptable to accommodate evolving science and changing team sizes. Flexibility also included sizing for HVAC, MEP and other building systems. The design team did a lot of analysis to get the building systems forward-thinking and allow them to change over time.

The team also designed modular research labs to accommodate evolving science and changing team sizes. The design team discussed building walls where you need them—but not having fixed walls if you don’t need them. Without a lot of hard walls, there’s more flow between a block of labs. The team also used glass whenever possible to provide transparency and visibility. The modular design allows for more efficient changes without spending more money.

Even though research buildings tend to use more energy, the project is targeting LEED Gold certification. Energy-saving features include heat recovery systems for both air intake and exhaust, LED lighting, occupancy sensors, and high-efficiency lab exhaust hoods. The grounds around the building feature a rain garden and sustainable irrigation.

Completion date: August 2016

PharmaForce to Invest in Facilities Expansion

PharmaForce, a privately held R&D and manufacturing company, announced its $145-million investment to expand two of its Ohio facilities on Dec. 4, 2017. The company will add approximately 140,000 sq. ft. to its New Albany, OH, facility to expand manufacturing and warehouse operations, as well as remodel a section of its existing warehouse and production space in Hilliard, OH. The company will add 1800 sq. ft. to the Hilliard site, with plans to invest in new production equipment and supporting infrastructure.

Construction and remodeling will start in 2018, with hiring for packaging, mechanical, sterile, quality assurance, and validation positions beginning in the first quarter of 2018 for the New Albany facility and in late 2018 for the Hilliard facility. Between the two facilities, 80 jobs will be created.

“Our operations in New Albany and Hilliard have played a critical role in the growth of our company, and the investment in our manufacturing, warehouse and R&D capabilities supports that growth,” said PharmaForce Dante Serricchio, vice president and general manager, in a press release from the economic development organization, Columbus 2020.

Pall Life Sciences Commits to Innovative Technology Advances

Pall Corporation, a global leader in filtration, separation and purification, has strengthened their commitment to advancing the drug production industry through key technology innovations and partnerships leading in to 2018. This commitment includes several recent high-profile partnership announcements in late 2017, including opening a joint laboratory for continuous manufacturing of monoclonal antibodies (mAb) with WuXi Biologics in Shanghai, becoming a key technology contributor for training sessions at the BioFactory Competence Center located in Fribourg, Switzerland, and launching Continuous Bioprocessing Leadership Forums that deliver actionable education to current and prospective customers.

“Over the past decade, our team has created the most comprehensive portfolio of products and services available to support drug manufacturers at any scale. With a truly unique range of traditional stainless steel and single-use offerings, through to semi- and fully-continuous operations, we are now more focused than ever on building key industry partnerships,” said Mario Philips, Vice President and General Manager at Pall Life Sciences, Biopharm.

From process development to production, Pall offers a range of products and services that are tailored to offer each customer their own total solution. Recent Cadence ™ continuous bioprocessing product line introductions deliver integrated single-use technology platforms that ensure process flexibility and eliminate contamination concerns. Regardless of process type, the full portfolio is built to enable reductions in costs and the manufacturing space required at a facility, while increasing efficiency and the quality of production.

About Pall Corporation

Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.

Rest of the World

AMRI Doubles Bulk API Aseptic Manufacturing Capacity

AMRI, a global contract research, development and manufacturing organization, has more than doubled its current bulk active pharmaceutical ingredient (API) aseptic manufacturing capacity

The addition of a new multipurpose aseptic API line at AMRI’s facility in Valladolid, Spain, enhances capacity at the site and complements its other aseptic API manufacturing plants in Bon Encontre and Tonneins, France.

AMRI’s sterilization capability can be integrated with API production or operate as a separate outsourced step for customers that do not have bulk sterile facilities or who may need additional capacity.

Bolstered by a range of supporting technologies, including customized packing, seeding, milling and micronization, this new line ensures aseptic processing of APIs with tailor-made specifications and control of the physical properties of the final product, including particle size distribution.

Further integration is offered with AMRI’s Drug Product capabilities.

“This investment supports our intent to serve our customers’ increasing demand for aseptic APIs linked to the need for physical control of these APIs and customized packaging configuration to improve assembling with customers’ drug product production sites,” said George Svokos, Chief Commercial Officer, AMRI.

“Our state-of-the-art lines are designed to meet requirements from pilot-scale to multi-ton scale manufacturing.”

“Our team on the sterile lines has decades of experience creating the appropriate conditions for the media fill (aseptic process simulation) and process validation, even for very difficult-to-handle or sensitive products.”

Additionally, AMRI recently announced the addition of an aseptic pre-filled syringe line at the company’s manufacturing facility in Albuquerque, US.

This investment supports the company’s aim to have the capacity and technology to serve the increasing demand from customers and meet the evolving requirements for healthcare professionals and patients.

Pall Partners Swiss Training Firm for Continuous Biomanufacturing

Pall Life Sciences will equip a training facility in Fribourg, Switzerland, with its continuous bioprocessing equipment.

Located in Fribourg, Switzerland, the BioFactory Competence Center (BCC) offers theoretical and practical training to biomanufacturers, and is set to launch a series of in-house courses next year focused on advances in continuous bioprocessing.

As such, the firm has selected Pall Life Sciences Cadence platform technologies for the hands-on training, as well as to equip a planned dedicated continuous bioprocessing training facility at the site.

“Pall and the BCC both have operations in Fribourg, and consequently, Pall have had a close collaboration since BCC commenced operations in January 2016,” said Peter Levison, senior marketing director of downstream processing at Pall.

“We also share a common vision related to the importance of comprehensive technical training with a strong practical element that illustrates ‘real’ issues in bioprocessing.”

Pall is not the exclusive supplier of bioprocessing technologies, but the BCC will use its range of continuous production tech – including Pall’s Cadence Acoustic Separator for continuous clarification and separation, the Cadence BioSMB PD system for multi-column chromatography, and the Cadence Inline Concentrator for continuous concentration at various process steps – at the center.

According to Levison, Pall is at the forefront of continuous bioprocessing through the development of its portfolio of continuous technologies, which covers all steps from harvest to formulation of the bulk mAb.

“Pall believes continuous bioprocessing philosophy will make a significant impact on the future of bioprocessing, so [is] investing in continuous ready technology and supporting associated education around continuous bioprocessing.”

He added: “Pall is looking to help facilitate the evolution of this paradigm. We certainly aim to keep ahead, but as you know this market does not stand still.”

WISAG Constructs 18 Meter Cleanroom Tower for Client

The German cleanroom construction company has built a cleanroom and tower structure for Bischof + Klein to house a film extruder

Medicines, surgical masks, rubber gloves or medical tools used by hospitals, doctors and pharmacies require ultra high quality packaging, environments

Medicines, surgical masks, rubber gloves or medical tools need to be delivered to hospitals, doctors and pharmacies in ultra clean, high quality packaging and the packaging process takes place in specially designated cleanrooms. The packaging itself must also be manufactured under high-purity conditions.

Bischof + Klein is one of Europe's leading full-service providers of flexible packaging and technical films made of plastic and plastic composites. The globally operating company not only needed a cleanroom for the production of packaging materials but also for its film extruder, which produces packaging foils of all kinds from plastic granulate.

For this purpose, industrial service provider WISAG recently erected a cleanroom with a steel tower 18 meters high in order to integrate the film extruder with the cleanroom.

A large hole in the roof was needed to install the steel tower in the existing production hall of Bischof + Klein, located in Lengerich in North Rhine-Westphalia.

WISAG began back in June 2016 on the structural build and with the aid of 25 staff – project and site supervisors, designers and fitters – both the cleanroom and its steel tower were erected. The externally clad and thermally insulated tower has walls and a ceiling that have been adapted to meet cleanrooms requirements.

The first film was produced at the new facility recently. In addition to existing products, the new machine will in future also be used for new developments that have not yet been produced under cleanroom conditions.

For WISAG the project was a new challenge. "Although colleagues have been working in the cleanroom sector since 1990 and have already built a wide range of models, from containers to solar factories, a cleanroom of such dimensions and of steel construction had not yet been attempted", explained Axel Tesch WISAG sales engineer, building and industrial services, in Dresden.

WISAG Industry Service Group, is one of Germany's largest industrial service providers with branches all over Germany. Its range of services includes: maintenance, technical cleaning, industrial facility management, electrical engineering, plant construction, building technology, production logistics, production support and industrial assembly.

PCI Expands Highly Potent Capabilities for Clinical Services

PCI Pharma Services has made an investment in fully contained Xcelodose 600S technology at its UK-based center of excellence for contained manufacturing in Tredegar, Wales.

This investment delivers another capability for the facility in the development and manufacturing of highly potent molecules. The pharmaceutical landscape continues to evolve with more and more products in development being deemed potent. As the biological activity and specificity of active pharmaceutical ingredients (API) increases, dosage strengths are decreasing, which has led to molecules becoming more potent in nature.

The pharmaceutical industry’s on-going demand to shorten drug development times, saving both time and money, is driving technological advances. The traditional product development route of formulating a solid dosage form for Phase I studies typically involves a range of complex activities including analytical method development, prototype development, short-term stability, process/formulation refinement, validation and finally clinical manufacture.

According to the company, manufacturing drug in capsule (DIC) is a way to reduce both the time and financial investment at the early stage of the drug development process, providing faster delivery for first-time-in-man. This approach minimizes the use of costly API, and reduces the amount of formulation and analytical development necessary to support an investigational new drug (IND) application or investigational medicinal product dossier (IMPD).

Xcelodose technology delivers this drug in capsule process, removing the need for initial formulation/analytical development and the associated stability testing, enabling users to achieve faster times to first-in-man studies. In 2010 PCI invested in Xcelodose 120S technology, a semi-automated system to provide early stage clinical supplies. The company said this additional investment in fully automated Xcelodose 600S technology delivers a programmable system providing high levels of accuracy and precision.

This state-of-the-art technology has the capability to fill amounts as low as 100 micrograms at speeds of more than 600 capsules per hour. Waste of API is minimized and batch documentation allows traceability of individual capsules that meet GMP requirements. The Xcelodose 600S technology is further enhanced by a PCI-designed, custom-built Xceloprotect containment system providing an early stage development solution for the management of highly potent molecules. The high levels of containment provide occupational exposure limits (OEL) as low as 0.1µg/m3 over an eight-hour time weighted average, meeting Safebridge 3 and 4 categorization, preventing operator exposure and adhering to the very latest regulatory requirements.

“This is a very exciting time as we add this important technology to our capabilities,” said David O’Connell, director of pharmaceutical development, PCI. “Being able to offer this service for early stage development programs will deliver both time and cost efficiencies for our customers. As molecules increase in potency, API is often very expensive and in short supply. By being able to fill drug directly into capsules and accelerate first-time-in-man studies, customers will be able to assess very quickly whether the project will progress to the next stage or ‘fail and fail fast,’ thereby minimizing costs, and enabling informed decisions to be made.”

Arcinova Strengthens Its API GMP Manufacturing

On Nov. 10, 2017, Arcinova, a multi-service contract research and development organization, introduced two new 20-liter GMP vessel streams at its active pharmaceutical ingredient (API) manufacturing facility Alnwick, Northumberland, UK. The addition of the two new streams gives the company the ability to offer fully integrated drug substance and drug product capabilities in one site.

With the two new 20-litercapacity GMP streams and one five-liter GMP stream installed earlier in 2017, the new systems give Arcinova over 140-liters of cumulative reactor volume at their Alnwick site. The company now has the capability to produce between 0.5 g to 4 kg of API or an intermediate per batch, giving it an annual total capacity of approximately 500 kg.

The vessel streams are housed in a fully GMP-compliant facility and can operate between 180° C and -80° C and use active data logging of vessel temperature, pressure, and stirring rates. They operate with a contained Nutche filter for API isolation and a 128-liter vacuum oven for drying intermediates.

The company has also further invested in Flowsyn flow equipment to enhance its API GMP manufacturing capabilities and will continue to invest in flexible modular manufacture technology to increase its drug substance manufacturing capacity.

The company’s services encompass drug substance synthesis, drug product manufacture, chemistry, manufacturing and controls, bioanalytical and metabolism services, radiolabeling synthesis, and synthesis of toxic/highly potent APIs.

Eurofins Inaugurates Nantes Laboratory Extension

Eurofins Scientific, a global specialist in bioanalytical testing, revealed the result on an investment of more than €22m in a new 102,220 sq. ft. (9,500 m2) extension to its food testing laboratory in Nantes, France, next to the company’s first-ever laboratory.

The newly-completed facility brings total size of the campus to 254,366 sq. ft. (23,640 m2), making it the largest independent food testing laboratory site in Europe, including 45,192 sq. ft. (4,200 m2) of spare capacity which can be readily used for future growth.

This new site will help Eurofins better serve the food industry in France, as well as throughout Europe, and provide a solid basis to support the strong acceleration in market share gains.

The new laboratory layout is expected to significantly improve efficiency, scalability and turn-around times. The extension will also increase the breadth of service offerings of the various Eurofins companies present at this site. These services include, among others, contaminants testing and authenticity testing.

Eurofins Nantes contributes to ca. 45% of Eurofins’ Food Testing revenues in France, processing nearly 1.5 million samples and performing 5 million analyses per year.

François Vigneau, General Manager for Eurofins Food Testing South Europe, commented: “Eurofins is proud to have completed the Nantes extension project as planned. It is remarkable that in just 30 years, Eurofins Nantes has transitioned from a small beverages testing specialist to a global leader in food, pharmaceuticals and environmental testing. This large investment in laboratory expansion is another demonstration of the Group’s strong commitment to always offering its clients faster, more sensitive and more cost-effective advanced testing services.”

Capsugel Expands Edinburgh Micro-Dosing and High Potency Capabilities

New cleanroom, warehouse and capabilities support the company’s growing pipeline for pharmaceutical customer projects using liquid-filled hard capsule technology

Capsugel a global specialist in delivering innovative pharmaceutical dosage forms and solutions, and now part of Lonza, has expanded its clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products utilizing liquid-filled hard capsule (LFHC) technology, at its Edinburgh facility in Scotland.

The Edinburgh facility expansion includes additional high-containment capabilities for handling highly potent and cytotoxic compounds at all stages of product development and manufacturing. The facility, which is the largest dedicated site in the world for the manufacture of liquid and semi solid-filled hard capsule pharmaceutical products, is now capable of producing an additional 250 million LFHC dosage forms annually.

Capsugel is enhancing its micro-dosing services offering for early-phase cGMP manufacturing at its Edinburgh facility. The company is combining its proprietary Xcelodose Precision Powder Micro-Dosing Systems with industry-leading powder-in-capsule/powder in bottle (PIC/PIB) expertise to provide rapid product assessment and Phase I-II clinical trial material manufacture.

The new Xcelodose 600S equipment, which is housed in a dedicated suite designed for handling highly potent APIs, complements existing Xcelodose capacity at Capsugel’s Ploërmel (FR) and Tampa, FL (USA) facilities and is now fully operational.

“We are pleased to add API-in-capsule micro-dosing services to our clinical services offering at our Edinburgh facility,” said Jane Fraser, Site Head at Capsugel’s Edinburgh facility. “By adding new Xcelodose-based micro-dosing capabilities to our traditional liquid-filled hard capsule technology and high-potency capabilities, we are providing our customers with industry-leading solutions for rapid feasibility assessments and early stage clinical evaluations for their drug pipelines.”

Capsugel’s micro-dosing services play a valuable role in pharmaceutical product development by minimizing the cost and time requirements associated with early phase development and cGMP manufacturing.

The company’s Xcelodose technology facilitates rapid, automated and consistent PIC/PIB programs that eliminate the need for excipient compatibility and stability studies for Phase I evaluations, allow for the rapid screening of API candidates, and can reduce early-stage product development time by as much as 45%.

With nearly 10 Xcelodose units in the US and Europe combined, Capsugel offers best-in-class micro-dosing capabilities and capacity for its clients.

The Edinburgh facility expansion includes additional high-containment capabilities for handling highly potent and cytotoxic compounds at all stages of product development and manufacturing. The facility, which is the largest dedicated site in the world for the manufacture of liquid- and semi-solid-filled hard capsule pharmaceutical products, is now capable of producing an additional 250 million LFHC dosage forms annually.

The expansion, initially announced in 2015, includes the addition of a third cleanroom, state-of-the-art quality control and analytical capabilities, and a 5,000-ft2 GMP environmentally controlled warehouse for additional storage capacity. The expansion also includes new isolators for high containment pre-dispensing and compounding, high- and low-shear compounding and holding tanks, an additional high-speed encapsulation machine, and a capsule banding unit. With these enhancements, the facility is equipped to make complex formulations feasible from containment, bioavailability and/or targeted delivery perspectives.

“As highly potent and cytotoxic drugs become increasingly prevalent in the drug development pipeline, our customers are turning to us for LFHC technology, specialized high-containment facilities and expertise that complies with heightened regulatory and operational requirements,” Fraser said. “Capsugel’s customers benefit from working with one partner to manage their drug product pipeline from bench to full commercial scale – resulting in faster development times and reduced risk, among other benefits.”

CRC Completes Facility for MeiraGTx

Work on a multimillion-pound cleanroom suite for a pioneering London-based gene therapy company has been completed by design and build specialist Clean Room Construction (CRC).

MeiraGTx appointed CRC as Principal Contractor for the state-of-the-art £5.7 million project to design and build a suite of GMP compliant cleanrooms which will be used for the stem cell production of medical treatments for eye conditions.

The fully validated 12,912 sq. ft. (1,200 m2) facility incorporates clean change areas, material and personnel air locks as well as associated support and circulation spaces. It also includes the facility for automated vaporized hydrogen peroxide sterilization of individual suites, without impacting on the operational status of surrounding areas.

Project Director Ian Isted said: “CRC is proud to have delivered this complex facility on time and on budget. The project necessitated working at sub-basement level in a central London location which presented its own logistical challenges. Due to the excellent working relationship we established with the client from the outset of the project, we have together created a facility of which we can all be rightly proud for this pioneering medical area.”

Swiss CDMO Expand Newly Bought Glycotope Biomanufacturing Plant

Celonic says it will immediately begin expanding the former Glycotope site in Heidelberg, Germany adding two 2,000L single-use bioreactors.

“Glycotope Biotechnology GmbH business operations in Heidelberg, with all its tangible and intangible operating assets, are being acquired by Celonic AG,” said Vikalp Mohan, Celonic VP of Global Commercial Operations at Swiss contract development and manufacturing organization (CDMO) Celonic.

“It’s an all- cash assets deal,”he said, though further financial details were not disclosed.

The site consists of five GMP biomanufacturing suites equipped with varying operational capacity of up-to 1,000L single-use bioreactors, he continued, adding Celonic is set on increasing capacity going forward.

“We will be immediately initiating work on expanding capacity with two new modular-expandable clean rooms with 2,000L single-use bioreactors each [a total of two], with plans to keep adding similar scale capacity in future.”

Around 120 staff working at Heidelberg will be kept on by Celonic, which will also manufacture for Glycotope at the site, However, Mohan said his firm’s “core business model continues to be serving bio-pharmaceutical customers, beyond Glycotope.”

The CDMO will also add Glycotope’s GEX human cell line platform to its own CHOvolution development platform, offering customers what it says is a “unique opportunity” to select a tailored expression system suitable for their biotherapeutic development needs.

The GEX platform offers clients glyco-optimization and high yield production of a variety of fully human glycosylated biopharmaceuticals, and by using a range of glyco-engineered proprietary human cell lines aimed at optimizing a series of different determining sugars.

Curevac Starts Work on RNA-Based Drug Plant

Curevac AG has started building a RNA therapeutics plant in Tubingen, Germany.

The plant – known as GMP IV – will be located at Curvac’s headquarters. It is intended for commercial production and will have capacity to make 30 million doses of RNA-based medicines a year when fully operational in 2019.

Curvac said the facility – funds for which will be provided by long-term investor Dietmarr Hopp and other backers – will produce a variety of RNA therapeutics from its pipeline.

The firm added “We will also be well prepared for the needs of our partners’ programs, including our newly established collaboration with Lilly.”

A Curevac spokeswoman confirm this, "We have four different facilities for GMP production of mRNA. Our Lilly collaboration will have an impact on all four facilities. All facilities will be engaged for delivering of Lilly RNA."

"The new one is GMP IV bound for an industrial automated process for late stage clinical development and early market supply. For entire market supply we are currently planning for a large scale facility, GMP V."

She declined to say how much Curevac will spend on GMP IV, but did say "We will create about 60 new jobs only for new facility near-term."

Plans for GMP IV were announced in 2015 after Curevac secured Gates Foundation funding to develop mRNA vaccines for several unspecified viral, bacterial and parasitic diseases.

Curevac recently completed development of a third manufacturing suite at an existing facility – GMP III – also located at the site.

In addition to Lilly, Janssen, Boehringer Ingelheim and Sanofi Pasteur have all inked multi-million dollar deals with CureVac.

Roquette Opens New Asia Pacific Headquarters and Innovation Center in Singapore

On Oct. 26, 2017, Roquette announced the opening of previously announced new facilities and an innovation center in Singapore, China. According to the company, the facilities will be focused on plant-based pharma, food, and nutrition products specific to regional health trends.

“As a global business leader, we know that we need to adapt our solutions to the specific needs of the different markets. By expanding our international research capability, we can ensure our products contribute to improving health and well-being of millions of consumers around the world,” said Jean-Marc Gilson, CEO of Roquette, in a company press release. “Our facilities in Singapore will allow us to explore new ways to address specific health and nutrition needs of Asian customers and consumers through plant-based ingredients such as sugar alternatives, vegetal proteins or pharmaceutical excipients, among many others.”

Features of the new facilities include a research laboratory, customer technical services, and a new regional headquarters, and will enable the company to partner with customers, universities, and research institutions for solutions, such as Singapore’s Agency for Science, Technology and Research (A*STAR) or the National University of Singapore.

This latest announcement follows a series of recent global investments by the company, including the September 2017 acquisition of Itacel, previously an excipient division of Blanver, a Brazilian multinational company.

Wickham Laboratories Expands Media Preparation Facilities

Wickham Laboratories has expanded its media preparation department. This change includes the purchase of a new autoclave and the construction of an airlock entry with a HEPA filtration system.

As part of the company's commitment to using only the best quality materials in our testing, Wickham Labs operates an in-house media preparation facility where a dedicated Media Preparation team prepares a wide assortment of the routine media used in day to day testing. This includes agars, liquid broths, diluents, wash fluids and sterile instruments.

Ensuring the sterility of the media produced is of utmost importance as it is used in the company’s laboratory in the testing of a wide variety of essential pharmaceutical products and medical devices. The additional autoclave, which was brought as part of this expansion will allow an increase in production capacity and the new airlock system provides a greater deal of control over any potential microbial risks in this aseptic area.

As a GMP/GLP compliant laboratory with more than 50 years of experience, Wickham Laboratories is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. Conducting business with clients worldwide and the combined expertise of our laboratory technicians and managers enables Wickham Labs to be fully conversant with global regulatory expectations.

Regeneron Expands in Ireland with Investment

Regeneron Pharmaceuticals, Inc. announced further expansion of its Limerick Industrial Operations and Product Supply (IOPS) bioprocessing campus in Ireland with an additional 300 jobs and investment of $100 million, bringing the total expected employment at the site to 800 people and total investment to $750 million. The project is supported by the government through IDA Ireland.

Since 2013, when Regeneron first announced plans to invest in operations in Ireland, the company has consistently exceeded job and investment projections for its Irish Operations. In October 2015, Regeneron projected employment in Ireland would reach 500 by the end of 2017. As Regeneron’s Irish expansion continues with employment expected to rise to 800 by the end of 2018, recruitment is ongoing for high-end specialist positions.

Regeneron’s 400,000 square foot, state-of-the-art production facility in Limerick is the largest scale bulk biologics production facility in Ireland and one of the largest biologic production operations in the world. The additional $100 million investment will support the construction of a number of manufacturing suites to increase drug substance production capacity and enable the company to meet demand for its life-transforming medicines for patients with serious diseases.

“Limerick offers an exceptionally good location for U.S. multinationals," Niall O’Leary, Vice President and Site Head, IOPS Raheen, said. "Located just 30 minutes from Shannon Airport with a five hour time difference from New York, Ireland is also a midway point for U.S. executives linking into our partners, such as Bayer in Germany and Sanofi in France. In addition, the very favorable business environment along with the support provided by IDA Ireland and Limerick City and County Council make the city an ideal home for Regeneron.”

Speaking of the investment, Martin Shanahan, CEO, IDA Ireland, said that an additional $100 million investment and 300 jobs commitment by Regeneron is a "huge boost" for the Mid-West Region. "The Irish government is committed to continuing to invest in our education, research and broader ecosystem to ensure that Ireland remains the competitive location of choice for new biotech manufacturing operations."

In addition to the production facility in Limerick, Regeneron’s European business operations for IOPS, the company has a Dublin office, currently employing 30 people and serving as the company’s European business administration headquarters. Regeneron’s total headcount in Ireland is expected to approach 850 by the end of 2018.

Sterling Steps-Up Solid Form Services with UK Facility

Sterling Pharma Solutions has announced a £6m ($8m) investment in solid form capabilities at its Dudley, UK-based site.

The contract development and manufacturing organization (CDMO) said the facility – located at its 40-acre site in North East England – will boost its milling and micronization capabilities.

As part of the investment Sterling will set up four milling areas, where it will reduce drug particle size with mechanical and spiral jet milling technologies, and small-scale trial mills.

It will also add polymorph screening, salt selection, particle engineering and crystallization scale-up capabilities to improve its drug development services, as well as occupational exposure band (OEB) 4 classified molecule capabilities and International Standards Organization (ISO) 9 cleanrooms.

CEO Kevin Cook said the facility responds to increased demand for active pharmaceutical ingredient (API) particle size control.

“This latest investment is an important step in bolstering our offering so we can cater for growing market demand, including the need for high potency capabilities to reflect the global drug pipeline,” he said.

The firm said it expects the facility to open by mid-2018, and create more than 15 jobs.

Centre for Process Innovation Brings ‘Smart’ Packaging Capability to the UK

The Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing, announced it has begun the first phase of its ‘Medicines Smart Packaging’ project

This phase of the North East Local Enterprise Partnership (LEP) funded project, known as SmartMed, will begin the process of crystallizing the needs for innovation in the smart packaging of medicines and medical devices leading to the creation of an innovation capability.

The healthcare sector is in the midst of change, driven by multiple factors including longer life expectancies, a rise in chronic disease and a shift in the pharmaceutical industry towards advanced and personalized therapies.

There is also an increasing number of people taking multiple medicines, putting pressure on the NHS to be able to track exactly where drugs are going and when patients are taking them.

With the Secretary of State for Health, Jeremy Hunt’s target for digital-led NHS treatment by 2018, there is increasing expectation on the sector to use technology, such as smart packaging, to address these issues.

Using smart packaging would also benefit organizations such as distribution companies, who could track and monitor medicines throughout the supply chain, as well as pharmaceutical companies who could use sensors to monitor environmental conditions during storage and delivery including temperature, humidity and damage, to ensure that medicines are effective when they reach the patient.

Smart packaging for medicines could feature printed sensors that can also be used to help with patient compliance. This is a major issue for healthcare, because patients that do not take their medicines as prescribed not only risk their health, but also contribute to significant economic losses for healthcare providers such as the NHS in the UK.

“From manufacture to clinical supply to patients, digital technologies and new types of material have the potential to revolutionize the way in medicines are packaged and therapies of all kinds are delivered. Innovation in this area can help to improve both the effectiveness and experience of treatments for patients,” said Richard Baker, Head of Policy and Strategy at the North East LEP.

“The North East has established strengths in technologies like printable electronics, product formulation and digital application which, if brought together, could make a step change in medicines delivery and also develop approaches of value to other industries such as food and consumer products. We are delighted to be working with CPI and other partners on this project, which will aim to ensure that the North East takes a leading role in this area.”

The Medicines Manufacturing Industry Partnership (MMIP), a partnership between the UK government and industry, has endorsed the creation of a national center of excellence in packaging for medicines.

This will support the development of the next generation of packaging technology and the associated smart devices required for new and novel medicines, including specialist packaging needed throughout the manufacturing supply chain.

The proposed world-class center of excellence would allow medicine manufacturing and medical technology companies to build their niche capabilities and differentiate themselves in the global marketplace, securing activity and creating jobs.

CPI will be hosting a series of workshops to speak to the pharmaceutical industry, distribution companies, NHS, pharmacies and patient groups to assess their need for these innovations and the proposed capability creation.

“The project will focus on defining and crystallizing the user requirements leading to a significant and globally recognized innovation capability in the North East, helping UK companies to stay at the forefront,” says Alex Cole, Centre for Process Innovation.

Batavia Adding Jobs in US Viral Vector and EU Cleanroom Expansion

Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.

The mammalian cell line generation and bioprocess development firm is adding 3,500 sq. ft. of lab and cleanroom space across the expansions at its GMP site in Leiden, The Netherlands, and at its R&D facility in Cambridge, Massachusetts.

Batavia Biosciences did not divulge the size of the investment but said the expansions were driven by an increase in general demand for its range of bioprocessing services.

These include “developing production and purification processes for vaccines, viral vectors, antibodies and proteins from the earliest product idea via full development to manufacturing of clinical material,” said commercial director Vincent Franssen.

“With the increased number of projects, the GMP extension fills in the increased need for the production of cell banks, master virus seeds, drug substance and drug product. At the same time, more projects demand more lab space, which is now covered with the creation of a new dedicated viral vector facility in the US. ”

He added the expansions will increase headcount by 50 across the two sites.

The Cambridge expansion will bolster Batavia’s offering to include complete pre-clinical process development capabilities for viral vectors including AAV, Lentivirus, VSV and Adenovirus systems to its portfolio of CHO cell line generation and process development for recombinant proteins and antibodies.

Franssen said Batavia “is continuously attracting new projects and customers” due to its experience in viral vector projects and the growing interest in such products across the biopharma space.

“With the popularity of adenovirus, lentivirus, and AAV for vector vaccines and gene therapy products the demand for Batavia Biosciences’ viral vector work is rapidly increasing.”

Among the projects the firm is involved in is an attempt to produce an affordable rotavirus vaccine through an $8m grant from the Bill and Melinda Gates Foundation.

The program is based on the RV3-BB rotavirus strain, a naturally occurring attenuated strain developed by the Murdoch Children’s Research Institute, and incorporating fixed-bed, high cell density single-use bioreactors instead of more traditional and expensive vessels. Bio Farm, an Indonesia state-owned vaccine producer and distributor, is charged with manufacturing the vaccine itself.

Pfizer Expands Japan Contracting Offering

Pfizer has expanded its contract manufacturing offering in Japan, adding capacity to make highly potent solid dosage forms at its facility in Nagoya.

The US firm announced the manufacturing expansion, adding it has also set up inspection, packaging and testing capacity for both oral solid dosage forms and sterile injectable drugs at the site.

The investment – financial terms of which were not disclosed – is part of an effort to attract drug developers interested in the Japanese market according to Pfizer.

A spokeswoman said, “Japan is the second largest individual pharmaceutical market and many of Pfizer CentreOne’s biopharmaceutical partners are looking to expand into this important market."

“However,” she continued “the Japanese pharmaceutical marketplace is like no other” adding the country’s exacting quality and aesthetic standards, pharmacy expectations make it a challenge for manufacturers.

She cited Japan’s ease of use requirements as an example, explaining that to be compliant “the package design itself, not just the label, should help the patient know when and how to take the drug.”

She added that: “Japan presents a great growth opportunity for small, mid-sized and large biopharmaceutical companies if they can overcome the obstacles for entering the markett.”

While the Nagoya expansion is focused on helping drug firms tap the Japanese market, the facility will also make drugs for other countries.

The Pfizer spokeswoman noted “Pfizer Nagoya supports the local Japan market but also exports products to Asia Pacific markets. Nagoya has been inspected by MHLW, PMDA, US FDA, EMA, Korean FDA, ANVISA and AIFA.”

Abbvie Opens Biologics Plant in Singapore

AbbVie has opened a mammalian cell culture-based drug manufacturing facility equipped with both stainless and single-use equipment, as part of a $320m investment in Singapore.

The $320m (€274m) investment announced in 2014 marked AbbVie’s first manufacturing venture in Asia. And just over a year on from the opening of a small molecule API plant at the 1,291,200 sq. ft. (120,000m2) site in Tuas, Singapore, the firm has opened its biologics manufacturing facility.

“We indicated expectations to be operational by 2018,” said AbbVie’s director at the Singapore site Marc O'Donoghue. “The opening this week is on schedule with validations ongoing.”

He added the mammalian cell culture facility will be used for both clinical and commercial supply and has a mix of single use and stainless steel equipment.

Between the small and large molecule plants, AbbVie will employ 250 staff in Singapore to support its global immunology and oncology products.

With a small and large molecule production facility now open, there is scope to make antibody-drug conjugates (ADC) in Singapore, something discussed when the ground was broken at the site.

According to AbbVie: “Our strength in discovering and developing highly specific monoclonal antibodies and our experience in small molecule chemistry and analytics make ADCs a strong focus area of development for AbbVie.”

AbbVie has a partnership with a partnership with Seattle Genetics, for access to its pyrrolobenzodiazepine (PBD) dimer ADC technology and EC-mAb site-specific conjugation technology, and last year added a stem-cell based ADC to its pipeline through the $5.8bn acquisition of Stemcentrix.

Lonza Sets Up Innovation Collaboration Center in Israel

Lonza has set up an innovation center in Israel to tap local bioscience and software expertise to bolster its Pharma&Biotech business.

The Swiss life sciences firm said the facility – the Collaborative Innovation Center (CIC) - on the outskirts of Haifa will house a 20-strong staff who will work with local companies and academics.

Focus areas will include process engineering, software development and cell and molecular biology. Lonza has already established collaboration agreements with Tel Aviv University, the Technion R&D Foundation and the Weizmann Institute of Science.

A spokeswoman stated, “Various inventions and technologies identified will be researched at the CIC premises and, if relevant and novel, will be integrated into Lonza's manufacturing technologies.

Technologies that can improve biopharmaceutical production processes will be core to the project according to the spokeswoman.

“We will work and research mainly protein expression and production methods, as well as genomic manipulation, gene editing and high-throughput screening methodologies” she said, adding that “drug-delivery platforms and inventions will also be in the CIC focus.”

She went on to say that Lonza will use a range of partnership models to access the technologies, adding “The CIC will work with external entities in various ways such as in-licensing, collaboration, investment for IP and equity, etc.”

The center is scheduled to become operational before the end of the year.

Deployable Facilities Offer Pay As-You-Go Biomanufacturing Says Just Biotherapeutics

GMT Faster and more ﬂexible biomanufacturing models are necessary to reduce the cost of biologics, says Just Biotherapeutics which is building a deployable modular facility in China. “Biotherapeutics are really just too expensive, especially for people outside the US or without a good insurance programme,” Dean Pettit, founder and CSO of Just Biotheraputics told an audience at Biotech Week Boston, MA. His company is hoping to radically reduce the cost of goods for proteins from what he said was around $150-200 per gram to just $10-15, by addressing every area in the development and manufacture of biological products.

For example, Just Biotherapuetics has teamed up with healthcare software ﬁrm Labkey Biologics to fully utilize the masses of data produced, accelerating lab workﬂows and automating project tracking to gain immediate insight into molecules, processes and resources. The ﬁrm is also trying to optimize molecule design by using a suite of computational and predictive software tools, while developing high yielding manufacturing processes through process intensiﬁcation and high throughput robotic.

But Pettit also spoke about the ﬁrm’s deployable manufacturing model based on prefabricated cleanroom modular units from G-CON called PODs. “Schematically we are going from a conventional, to a ﬂexible facility and then ﬁnally to a deployable facility,” he told delegates. “Conventional facilities were historically built for one molecule are large, with ﬁxed equipment and centralized utilities. [They are] valuable because economies of scale are quite important… but they are diﬀerent than the approach that we have been taking which is around small, ﬂexible, portable, reconﬁgurable type facilities that we call J-PODS.” He continued: “It shifts us from a ﬁxed-cost model to a variable cost model. You’re paying for drugs as you make them; you’re paying for raw materials that go into manufacturing that drug as opposed to the ﬁxed cost involved in a monolithic type facility which has to be fully utilized to get full advantage out of that economy of scale.” A conventional facility costs between $300m and $500m Pettit said, and while a ﬂexible facility dramatically reduces this cost, a ‘deployable’ POD-based model requires even less capital expenditure, costing $50-60m per plant.

The ﬁrm uses the POD technology at its clinical manufacturing facility in Seattle, outﬁtted with its process equipment: a 500L perfusion single-use bioreactor system run with a harvesting step. And a commercial facility currently under construction in Hangzhou, China will mirror this design, Pettit said. “That facility should be up in operation for commercial manufacture of drugs in the ﬁrst quarter of next year, but it’s all the work we put into the design feature – designing the molecule, the process – that allowed us to get away with designing a facility that is as small and ﬂexible as it is.”

Tjoapack Invests in Bottle Packing Capabilities

Tjoapack, a Dutch contract packaging organization (CPO), 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 bottling line in the Netherlands, triples the CPO’s bottle packing capacity by using the latest high-throughput technology. Tjoapack can now process 13,000 tablets per minute.

Dexter Tjoa, Director Corporate Strategy at Tjoapack, said: “Our decision to invest has been fueled by greater demand for bottle packaging services from our customers, particularly in the Nordic markets. 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.

Tjoa continued: “This year we have been focused on making the necessary investments to prepare Tjoapack for growth in 2018 and beyond. 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.”

Peli Biothermal Expands European Manufacturing Center

Peli BioThermal, a specialist in temperature controlled packaging, announced the expansion of its European manufacturing capabilities in France.

This extension is in response to meet the rising requirements of the worldwide transportation of pharmaceuticals throughout Europe and globally.

David Williams, President of Peli BioThermal, said: “I am pleased to announce the extension of our production capability in France, to manufacture our single use bulk thermal shipper CoolPall Vertos. It is an exciting development and customers will benefit from the consistent quality and processes implemented worldwide.

“These significant changes and investments represent the ongoing efforts that Peli BioThermal is making and are a clear indication of our commitment to our customers, the industry and our global expansion of manufacturing and services.”

This implementation of the additional European manufacturing capabilities complements the company’s expanding existing facilities, providing solutions for customers globally, which included the recent introduction of new service centers in Belgium and Puerto Rico.

The latest European expansion demonstrates the company’s commitment to significant investment to serve customers globally and follows the qualification of production of the company’s reusable Crēdo Cube line of thermal shippers at its facility in the UK and the expanded manufacturing capability for the single-use Chronos Advance, Chronos Express and CoolPall Vertos product lines to its facility in the US.

Wood Gets Contract Supporting Glaxosmithkline in Germany

Wood is providing GSK Vaccines GmbH (GSK), part of GlaxoSmithKline Group, with engineering, procurement and construction management services for a new biotech facility to be built in Marburg, Germany.

The new multi-million dollar contract includes detailed design, procurement and subcontracting services, expediting and inspection of process equipment and packages, construction management, coordination of commissioning, engineering follow-up during construction, design qualification, as well as the overall project management.

Wood’s Environment & Infrastructure Solutions business has already completed outline design for the facility, which will produce bulk recombinant proteins used in meningitis vaccines. Completion of commissioning is scheduled for July 2019.

The contract builds on Wood’s 12-year relationship supporting GSK Vaccines GmbH across its global portfolio and is the second to be awarded under a five-year master agreement, signed in June 2016.

Robin Watson, Wood’s chief executive, said: “This new contract recognizes GSK’s confidence in our global capabilities and broad, innovative solutions, based on our strong track record of supporting them for over a decade in locations including Singapore, Belgium, Italy, France and Hungary.

“Our focus is applying our vast knowledge and expertise in designing and constructing vaccines facilities, to ensure the safe and efficient delivery of this significant project in Germany. We look forward to working in partnership with GSK on this contract, which is another significant step towards delivering our growth ambitions in the pharmaceuticals sector.”

Wuxi Griffin Opens a New Aseptic Fill Finish Facility

On Jan. 4, 2018, contract manufacturer Wuxi Griffin announced the completion of a new 27,450-ft2 aseptic fill/finish facility in Wuxi, China. The facility is equipped with three filling suits and uses restricted access barrier systems and isolator production technology.

According to the company, the facility is compliant with GMP standards and offers manufacturing services for monoclonal antibodies, vaccines, recombinant proteins, biosimilars, and small-molecule drugs. Small- and medium-sized batch clinical trial manufacturing and commercial manufacturing are also available.

“There are few domestic Chinese contract manufacturers that are international players. There is a gap between the Chinese manufacturers’ capabilities and the regulatory requirements from the West. Wuxi Griffin is filling this gap by offering western GMP compliance from China,” said Torgny Lundgren, CEO of Wuxi Griffin, in a company press release.

Novo Nordisk Expands Insulin Manufacturing Facility in India

Novo Nordisk and its partner, Torrent Pharmaceuticals, an Indian pharmaceutical company, have expanded an insulin manufacturing facility at Torrent’s site in Indrad, Gujarat, India, Torrent announced on Dec. 11, 2017.

The Indrad facility manufactures bulk drugs/active pharmaceutical ingredients (APIs) as well as solid-oral dosage and liquid dosage formulations. Since August 2005, a part of Torrent’s parenteral facility has been exclusively dedicated for the formulation and packaging of insulin for Novo Nordisk.

“With the expansion of the facility at Indrad, we reiterate our commitment to ensuring the provision of affordable, quality insulin for people with diabetes. At Novo Nordisk, we are committed to addressing the growing diabetes burden by working with likeminded stakeholders to change diabetes,” said Frederik Kier, senior vice president, Region AAMEO, Novo Nordisk, in a company press release.

Melvin D’souza, managing director, Novo Nordisk India, said in the press release: “The growth of diabetes in India is alarming and people with diabetes have a right to access affordable, quality medication. Through this partnership, we will continue to ensure the provision of cost-effective yet high-quality medication.”

Novo Nordisk and Torrent Pharmaceuticals have a 25-year partnership in India, which began in 1992 with the manufacture and launch of insulin in 40 IU vials. An integrated manufacturing and vial-packaging plant was inaugurated later in 2009.

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