Reed-Lane, a contract packaging provider for pharmaceutical manufacturers, has installed its sixth bottling line for solid dose RX and OTC products. The new installation expands the company’s packaging capabilities and overall capacity, and is intended especially for the packaging of larger fill levels at smaller overall product volumes.

The new line consists of the following modules:

Bottle unscrambler that cleans and orients bottles
Slat filler that can process tablets, capsules and liquid-gels for a wide range of bottle sizes and fill levels
Metal detector
Capper for both CR and CT closures
Induction sealer
Re-torquer
Labeler that can apply 1-ply, 2-ply or booklet-style labels with a printer and vision system
Topsert feeder

The new line also can be outfitted to place sachet desiccants, canister desiccants, and cotton or rayon in bottles. The line also can incorporate tamper-evident seals to capped bottles and/or bundles of bottles, as desired.

“Reed-Lane is committed to regularly upgrading and enhancing both our overall capacity and service portfolio, stemming from our core set of competencies,” said Patricia Elvin, president of Reed-Lane. “In our current period of growth, incorporating new equipment on an ongoing basis is a key component to meeting and surpassing our customers’ needs.”

Catalent to Acquire Pharmatek Laboratories

Catalent Pharma Solutions, Inc. has entered an agreement to acquire Pharmatek Laboratories, Inc., a San Diego-based drug development and clinical manufacturer, in an all-cash transaction. Financial details were not disclosed.

The acquisition will add early-phase drug development capabilities from discovery to clinic, spray drying formulation and delivery technologies, and expand handling for highly potent compounds. The addition of spray drying will also provide a suite of bioavailability enhancement services, while expanding its OptiForm Solution Suite platform.

Pharmatek provides dosage form development and clinical-scale cGMP manufacturing of oral, injectable and topical products. Its San Diego facility offers an integrated drug development platform, with discovery formulation screening for lead selection and optimization, formulation development and analytical services, and finished dose form manufacturing for clinical supply. Additional services include first-in-man strategies, solutions for poorly soluble compounds, controlled release formulations, and specialized facilities and controls for potent compound handling.

“Catalent continues to expand its industry-leading drug development and delivery technologies to help its pharmaceutical partners to fully unlock the potential of their molecules and provide better treatments for patients,” said Barry Littlejohns, president of Catalent’s Drug Delivery Solutions business. He added, “Combined with Catalent’s existing technologies and network, the addition of Pharmatek’s well-established scientific expertise and spray dry capabilities will create an unparalleled drug development platform, while the San Diego facility will expand our West Coast presence and provides additional access to the Asia-Pacific markets.”

Pharmatek’s cGMP San Diego facility employs approximately 200 people. The facility comprises 68,000 sq. ft. of lab, manufacturing and support space, with two analytical labs, two formulation labs, four engineering rooms and nine Certified ISO Class 8 manufacturing suites. The site also has 18,000 sq. ft. of lab, manufacturing and support space for development and manufacturing of highly-potent compounds.

The transaction, subject to customary closing conditions, is expected to close in the next few weeks.

Moderna Plans Manufacturing Plant

Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.

The facility – which will be built at a site in Norwood, Massachusetts just outside Boston – will make candidates for clinical trials.

The plant will house active pharmaceutical ingredient (API) manufacturing space, a quality control laboratory and a fill finish area. Initially the site will have capacity to produce 40 GMP mRNA lots a year.

It will also be the base of the firm’s personalized cancer vaccines unit and its preclinical testing operations.

A spokeswoman for the firm said, "We will centralize all manufacturing, including GLP toxicology manufacturing as well as GMP mRNA clinical manufacturing at the new site in Norwood."

"We will continue to maintain our corporate headquarters, R&D functions and therapeutic area-focused ventures and New Venture Labs, in Cambridge."

Work on the plant is due to start this year with the aim of making it fully operational by 2018.

CEO Stéphane Bancel said adding the plant to Moderna’s existing manufacturing capacity is in line with the expansion of its pipeline.

“Our Norwood facility will enable us to deliver our mRNA therapies and vaccines quickly, which will support rapid progression from development candidate nomination to human proof-of-concept.”

Approximately 100 of Moderna’s 460 employees will relocate to the facility, however eventually the site is expected to be the base for 220 staff.

Moderna has two clinical trials in progress – one in the US and one in Europe in collaboration with AstraZeneca.

In January, the firm said it plans to have started another four clinical trials before the end of the year.

Almac Invests in Durham, North Carolina Facility

As part of its celebrations to mark 20 years in North America, Almac Group has announced a $5.2 million investment at its Durham, North Carolina plant.

Almac employs around 1,600 people across six facilities in the US and expects to create around 80 new jobs as part of the expansion.

The investment will support expansion of the firm's Clinical Services facility as well as the development of its Diagnostics and Clinical Technologies operations.

'This latest investment and increase in capacity at our Durham facility is a sign of our continuing commitment to offer market driven solutions to our client base,' said Donna Christopher, Global VP Operations, Almac Clinical Services. 'We are delighted to mark our 20th year in the US with such a significant announcement – once again reinforcing our dedication to global expansion.'

Almac first established a presence in the US in 1996 with the opening of its clinical trial operations in Audubon, Pennsylvania.

By 2000, the firm had expanded its North American presence into North Carolina through the acquisition of Applied Clinical Concepts Inc. (ACCI) and Duke Clinical Research Institute Pharmacy (DCRIP), which merged to form Clinical Trial Services based in the Research Triangle Park, Durham.

In recent years, Almac has also announced expansions in Asia, acquisitions in the UK and Ireland.

Alnylam Moves Forward on Multi-Product RNAi Facility

Alnylam Pharmaceuticals, an RNAi therapeutics company, broke ground on a biopharmaceutical manufacturing facility in Norton, Massachusetts to supply RNA interference-based therapeutics for its clinical and commercial needs, the company announced on April 28, 2016. In an Aug. 4, 2016 press release, Jacobs Engineering Group announced that it was awarded a contract to provide engineering services and procurement for the facility. Construction on the 200,000 sq. ft. facility is expected to be completed in 2018, and it will initially employ approximately 150 new full-time employees.

“This flagship multi-product facility represents a key next step in Alnylam’s transition toward a commercial stage company. Increased manufacturing capability is vital to support our rapidly growing pipeline of 10 clinical stage programs, two of which are in Phase 3 trials,” said John Maraganore, CEO of Alnylam, in the release.

Grace Opens GMP and QC Lab at Oregon Facility

W. R. Grace & Co. announces the opening of a Good Manufacturing Practice (GMP) and Quality Control (QC) lab at its fine chemicals manufacturing facility located in Albany, Oregon, expanding support for GMP manufacturing and for the pharmaceutical and dietary-related industries.

The new lab’s capabilities will enable the site to validate analytical methods and perform GMP release of starting materials and advanced intermediates. The lab already has passed customer inspections and completed method validation and GMP release of commercial intermediates for major pharmaceutical companies. The analytical equipment in the lab includes HPLC, UPLC, GC-MS, and GC-MS with head space, along with other common analytical equipment.

“Grace continues to invest and expand our capabilities in custom manufacturing of regulatory materials,” said Brett Reynolds, Global Business Director for Fine Chemicals. “This higher level GMP manufacturing expands our portfolio of products and services to the pharmaceutical and related industries.”

Grace acquired the Albany facility from Synthetech, Inc. in 2010. The Albany site’s operations team has more than 30 years of custom manufacturing experience in multi-step organic, organometallic, and chiral chemistry, and integrated kilos-to-tons GMP production.

Imprimis Expands Capabilities

Imprimis Pharmaceuticals has entered in an equipment lease agreement with Essex Capital Corporation, which provided Imprimis with gross proceeds of $2 million. The agreement covers the sale and leaseback of Imprimis' drug manufacturing equipment and has an initial term of up to three years, with an additional one-year lease extension, subject to Imprimis achieving certain financial milestones.

Imprimis has made significant upgrades and additions to the company's compounding equipment at its newly opened location in Roxbury, NJ, and existing facility located in Irvine, CA. The new equipment will add automation capabilities to many of the company's core filling operations, increasing production volumes and creating new efficiencies for its core aseptic formulations.

"We are constantly seeking non-dilutive ways to finance the expansion of our business,” said Mark Baum, chief executive officer, Imprimis. “We are pleased to announce this agreement with Essex Capital Corporation as it enables us to finance necessary capital expenditures to help accelerate growth and meet growing customer demand for our formulations.”

Brad Wheatley, chief financial officer, Essex Capital Corporation, said, "We are excited to provide Imprimis Pharmaceuticals with this financing. Imprimis is reimagining the pharmaceutical industry, and we are happy to be a part of its vision of driving innovative compounded drugs to the market at accessible prices. This is exactly the type of business we like to partner with."

Alcami to Add HPAPI

Alcami plans to expand capabilities for Active Pharmaceutical Ingredients at their Germantown, WI facility.

The two new cGMP Highly Potent API production suites will focus on primary contained technology with engineering controls designed to meet the established Occupational Exposure Limits for SafeBridge Category 3.

The 5,000 sq. ft. renovation will be operational by 1Q17. The new space will include up to 150L reactor scale with cryogenic capabilities to service a wide range of complex chemistries.

These enhancements follow operational and technology enhancements across development, clinical and commercial manufacturing to increase production capacity by 50for its global API operations in Germantown and Weert, The Netherlands.

"This investment in highly potent capabilities is consistent with our vision to be a technology leader and address unmet market needs. Alcami is committed to ongoing investments in our people, technology, equipment, and capabilities to enable us to exceed our customers' needs – from preclinical to commercial," said Ted Dolan, Chief Operating Officer.

The Germantown, WI facility recently completed an FDA General Inspection that resulted in no 483 observations.

Alcami Announces Completion of Site

Alcami Corporation, a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, has announced additional laboratory-scale capabilities to support prefilled syringes in Wilmington, NC and the successful completion of previously announced investments in Charleston, SC.

Alcami has invested in state of the art, semi-automated vacuum stopper equipment in Wilmington, NC, to generate prefilled syringe samples that can be used to screen & select components, complete compatibility studies, and conduct developmental stability studies. With this equipment, Alcami can generate bench/pilot scale representative samples, minimizing the amount of Active Pharmaceutical Ingredient (API) required to generate this critical data.

Additionally, their clinical and commercial manufacturing facility in Charleston, SC has successfully produced clinical supply from its recently qualified second line with commercial manufacturing to follow. Coupled with the existing fill line, the site has doubled its filling capacity in 2016. A new, mid-scale lyophilization unit is being qualified, doubling the site's lyophilization capacity. To complement the additional equipment capacity, a third shift has been created, further adding capacity and scheduling flexibility with operations running 24 hours a day, five days a week.

"It is exciting to see the successful completion of recent investments that have enabled the doubling of our filling and lyophilization capacity at our Charleston site, and the extension of our development capabilities into pre-filled syringes. The site has introduced 17 new programs this year and is geared to support increasing demand within the Pharma & Biotech industry for sterile drug product development and manufacturing," stated Ted Dolan, Chief Operating Officer.

The Charleston, SC facility recently completed an FDA General Inspection that resulted in zero 483 observations as well as a successful EMA inspection supporting multiple commercial products. These results demonstrate Alcami's ongoing commitment to quality and regulatory compliance. Alcami's sterile manufacturing facility has a long-standing track record of compliance supporting numerous clinical and commercial regulatory filings globally.

Core Facilities and Satellite Vivariums / Case Studies

The National Institute of Health (NIH) defines a core facility as a “centralized shared research resource that provides access to instruments, technologies, and services.” Vivariums, a core facility by definition, are often discretely located away from research labs and are separated by floor or by building from other core facilities.

Intentional placement of vivaria, in basements, separate wings or even separate buildings, away from other resources, is important for biosecurity, animal health and safety, and regulatory compliance. However, this can create a bottleneck for certain types of research where smaller cohort studies are used.

This is sometimes solved by bringing the core facility into the vivarium. For example, when a researcher has an imaging need, if the vivarium is setup with its own MRI, PET or CT, the workflow and data capture cycle can be much more efficient. Because of space and funding challenges, most vivaria do not have dedicated imaging resources so researchers must transport an animal elsewhere, creating inefficiencies in workflow.

In recent decades, advances in in vivo imaging, multi-modal imaging, and data processing have resulted in an increasingly inverse relationship of imaging power to cost. The ability to visualize in more powerful ways in smaller footprints has driven animals out of the vivarium and closer to research labs.

Convergence of innovations in big data, photo-acoustics, bio-interfaces, and optical technologies in ever-smaller instrumentation footprints have made their way out of core facilities and into the labs. Microscopy, spectroscopy, optics, and other imaging tools that would have been located in a core facility a decade ago or weren’t invented yet are now standard in neuroscience, biophysics, bioengineering, and biochemistry labs.

Instead of one expensive imaging resource shared by several researchers, a single PI may have several sophisticated imaging setups supporting their work. To get the most efficient workflow out of the experiments used with these tools animals need to be closer to the labs.

Three case studies, the University of Arizona’s Phoenix Biomedical Campus, a lab at Caltech and the new UC San Diego Biological and Physical Sciences building, illustrate three different approaches to embedding satellite vivaria into the research environment.

Each planning effort involved different size teams and project delivery methods. Regardless of project size and cost, the guiding team of stakeholders should include at a minimum, campus veterinarian, owner’s project manager, the principal investigator, the PI’s laboratory technician, facilities manager or supervisor, and a research director who can bring a bigger picture overview of the institutions scientific resources and collaborations to the conversation. Last but not least, on the design team, a strong MEP engineer is critical to ensuring a satellite vivaria blends into the facility as seamlessly as possible. Each of the case studies were designed to meet AAALAC requirements.

CASE STUDY: CALTECH

At Caltech, one neuroscientist’s research measuring sensory processing demanded two modes of imaging to visualize brain activity at different timescales and resolutions.

The researcher shared a sophisticated multi-photon assembly with temperature control and low-particulate air management and a separate confocal imaging room with one other PI. Immediately adjacent to the imaging rooms were modular, flexible benching and several curtained electrophysiology stations.

Rather than make constant trips to the main vivarium in another part of the building, an animal suite consisting of three rooms (Holding, Microscopy, and Surgery) was planned down to the very last inch and placed in an inconspicuous corner of the lab.

Soon after taking occupancy, the researcher was able to secure several six-figure grants. The 7,000 sf project was a renovation for two research labs, in an existing post-war concrete building. The project delivery method was Design-Build and completed in 13 months from planning to occupancy.

CASE STUDY: UNIVERSITY OF CALIFORNIA, SAN DIEGO

The University of California, San Diego (UCSD) is set in a coastal vista ideally situated near some of the biggest names in private and public biotech. The campus is the second highest in the UC system for patents and research grants pushing teaching and research labs to capacity.

A new ground up building was needed to expand teaching and research within the physical and biological sciences. One of the groups set out to create a laboratory floor that was anchored by a satellite animal facility at one end and eight flexible multi-modal imaging and recording bays at the opposite end with open wet labs and shared lab support in-between.

In order to shuttle animals from the main vivarium in the basement of the old building to the new satellite atop the six-story labs, a skyway connection was created. The satellite includes holding, procedure, feed and bedding storage, and an ABSL-2 surgery and holding room. Additional acoustic treatment was added to the perimeter of the vivarium suite to minimize disturbance to the animals from adjacent work areas. A vestibule with acoustic, gasketed doors, servers as a buffer for odors and sound.

The project is 123,000 sq. ft. and currently under construction with completion in 2018.

CASE STUDY: UNIVERSITY OF ARIZONA

The City of Phoenix is quickly becoming a biomedical powerhouse with a new superblock of academic, private and public research, and health care rising up in downtown. The newest building to rise-up is the 10-story University of Arizona Biomedical Sciences Partnership Building (BSPB).

The new research tower will house animal facilities on the basement level and will connect to an existing underground vivarium. The existing vivarium was planned with expansion in mind so the connection was facilitated with pre-constructed knockout panels in the concrete foundation walls.

The satellite increases observation and procedure room capacity and provides shell space, vetted and planned, for a future MRI, CT, or other large imaging core facility. Another additional 3,000 sf of shell space was setup for a scenario of either ABSL-3 holding and procedure or conventional vivarium space. The new satellite relies on the existing vivarium for secure loading dock receiving, autoclaving, and decontamination.

The researchers who ultimately move into the BSPB may engaged in a range of biomedical, biotech, and bioengineering activities, so an adaptable program for the satellite vivaria was essential.

The project is 245,000 sq. ft. and will be ready for occupancy at the January 2017.

CONCLUSION

Leveraging an existing animal facility by adding on a satellite vivarium requires an integrated planning effort with animal resource managers, facilities, owners and principal investigators. A satellite must still meet regulatory, biosecurity, AAALAC, and institutional protocols, but with careful planning, it can co-exist in or near the research lab. Paradigm shifts in electronics, informatics, and optics have made new modes of imaging and visualization within the reach of many more scientists than ever. The effect has made it more advantageous to bring the vivarium to the lab, rather than leave the lab to go to the vivarium.

Jennifer Swedell has 15 years of experience in architecture and in laboratory planning and design, and is currently associated with CO Architects in Los Angeles as a senior laboratory planner and programmer. She has planned, programmed and designed major laboratory facilities in 12 states and Australia, Abu Dhabi and Korea.

Antoinette Bunkley is a senior project manager with CO Architects in Los Angeles. She has over 25 years of experience with advanced buildings for university, college and private biotechnology clients in the science & technology and academic sectors.

Jennifer Andrews is a Design and Construction Project Manager for the University of Arizona specializing in high tech medical related facilities. In her current role, Ms. Andrews is responsible for facilitating the programming, design and construction for capital projects for the ongoing expansion of the University’s Phoenix Biomedical Campus. Currently, she is the Project Manager for the Biosciences Partnership Building—a new 245,000 sf research building 10 story research building with a satellite vivarium.

University of Houston's Health and Biomedical Sciences Building 2 (HBSB2)

Cost: $151 million

Size: 300,000 sq. ft.

Project team: Shepley Bulfinch (programming, planning and design); Tellepsen Builders (construction management); Research Facilities Design (RFD) (laboratory design); Structures + Haynes Whaley (structural engineer); E&C Engineers & Consultants, Inc. (MEP engineer); Kuo & Associates (civil engineer); Asakura Robinson Company, LLC (landscape architect)

Description: The University of Houston’s Health and Biomedical Sciences Building 2 (HBSB2) is in the second phase of development, following the successful completion of the University’s first Health and Biomedical Sciences Building (HBSB1), also designed by Shepley Bulfinch, in 2013. The addition of HBSB2 elevates this Carnegie-Designated Tier One public research institution’s capacity for rapidly advancing research and first-rate educational programs.

The new nine-story facility in the University’s biomedical district on campus will provide a new home for the College of Pharmacy and three floors of expanded research space for the Division of Research. These consolidated lab facilities will promote critical workforce training in the pharmaceutical and biomedical sectors while its flexible lab spaces will support transitional research and collaboration among pharmacological research groups. The new facility will feature specialized research and teaching labs, faculty offices, an expanded library and a mix of teaching spaces. The lower two floors consolidate previously scattered clinical and teaching programs into a welcoming multidisciplinary environment for the treatment of chronic conditions.

Another important component of HBSB2 will be an integrated health care clinic to serve University of Houston faculty, students, staff and the surrounding community. The clinic will be made possible by partnering with a federally qualified health center (FQHC) that will have primary care, OB-GYN, family practice and pediatric physicians.

Shepley Bulfinch was presented with the need to foster agreement around a service model, develop a universal clinic exam room that would work for every clinic, and manage privacy. To do so, a full-scale cardboard mock-up was created for key rooms and UH staff members were invited to participate in a working session in order to reach consensus on room layout and size.

The two buildings, HBSB1 and HBSB2, are interconnected on five levels. The first three are for students and staff while the upper two are for researchers only. This interconnection facilitates circulation and connects like-minded programs in the two buildings: student with student; research with research; and clinic with clinic. A very tight site with access to loading and utility bays located right in the center of that site presented a unique challenge for the design team. Slanted concrete columns and careful coordination of fire separations and all utilities allows the connections between buildings to flow unimpeded.

Completion date: Late 2017

Selexis to Triple Cell Line Capacity

Selexis has inked a deal with Pieris for commercial license of its CHO-K1 (Chinese hamstery ovary-K1) cell line and access to its SUREtechnology expression.

Mammalian cell line developer Selexis has signed a fourth licensing agreement in as many months and is planning a "major expansion" early next year ahead of anticipated demand.

The agreement with Boston, Massachusetts-based Pieris Pharmaceuticals follows similar deals since June with Laboratorios Liomont, Progenics Pharmaceuticals and ASLAN Pharmaceuticals for the commercial license of Selexis’ CHO-K1 cell line and access to its SUREtechnology expression platform.

The firm has capacity to service these deals, but according to CEO Igor Fisch the number of clients is anticipated to double over the next few years, and thus Selexis will begin a "major expansion" by the first quarter 2017. “The company will be able to triple its capacity for generating stable high producing clonal cell lines,” he said, adding Selexis is also planning to launch two new product platforms to aid biomanufacturers within the next eight months.

“These platforms will impact our entire industry in terms of risk mitigation while manufacturing as well as to improve the timelines to generate high producing cell clone with difficult to express proteins.”

Fisch attributed much of Selexis’ success to its proprietary technology, the SUREtechnology platform used to insert genes into CHO cells and other mammalian cell lines.

“We believe the SUREtechnology platform is the most powerful for partners who want to generate high producing and stable research cell banks for recombinant proteins,” he said, adding Selexis also stands out as it offers a “unique solution for difficult-to-express and complex proteins.”

“Furthermore, we have ramped up our business development and related external awareness building efforts, and these activities are paying off,” he said.

“Our investments in the whole genome sequencing of our CHO-M Cell Line (CHO-K1) have become a huge interest to our partners. Selexis now has a novel method of barcoding and tracing Master/Research/Working cell banks with a reference point for any potential genetic changes.”

Avid Expansions

Avid Bioservices will construct a clinical manufacturing plant later this year just months after production began at a second facility.

In December 2015, Avid Bioservices – the contract manufacturing subsidiary of Peregrine Pharmaceuticals – completed construction of the ‘Myford’ facility, its second bioproduction plant housing single-use bioreactors of up to 2,000L.

At the time the firm said it was already eyeing up extra capacity to cope with expected demand for contract monoclonal antibody manufacturing, and confirmed that construction of a third plant will begin in the fourth quarter of calendar year 2016.

“The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid calendar year 2017.”

The suite will incorporate two 1,000L single-use bioreactors and, like the firm’s current two facilities, will be located in Tustin, California.

“As Avid continues to expand both its services and manufacturing capacity, we expect demand from biotechnology and pharmaceutical companies to remain high.”

Last year, the firm’s Franklin facility pulled in around $40m of revenue, and the new Myford plant is expected to generate the same annually.

According to the firm’s financial projections, manufacturing revenue for the full fiscal year 2017 is expected to be between $50- $55m.

But the addition of the third plant is expected to push total revenues for the CDMO to over $100m, Peregrine’s CFO Paul Lytle said in a conference call to discuss the firm’s Q1 FY2107 results. “We believe the third facility will again significantly increase our manufacturing capacity and all three manufacturing facilities will have the potential to generate in total approximately $110 million in annual revenue.”

Furthermore, Peregrine reported a disappointing quarter with clinical and commercial biomanufacturing contributing $5.6m, a drop of 42% on the same quarter last year.

The firm attributed this to a backlog at a third-party testing lab that shifted the timing of revenue recognition from the first quarter to the second quarter of fiscal year 2017.

Stanford Genome Technology Center

Set back from the street, the building on California Avenue, in Palo Alto, looks like what you might see on Stanford’s main quad—with pale, beige stucco walls, a series of arched windows framed by columns and a red tile roof. In a former life it was the Stanford Genome Technology Center; now it’s found a new purpose as Stanford’s Laboratory for Cell and Gene Medicine.

With cleanrooms and all the regulatory clearances necessary to safely make cell-based therapies for use in human patients, the lab will create new opportunities for research and to facilitate advances in patient care.

The lab formally marked its opening earlier this month with an open house.

The laboratory is Stanford’s first dedicated facility to comply with the Food and Drug Administration’s current good manufacturing practices. These are standards the agency uses to ensure safety and consistency in medical therapies intended for use in humans.

The lab is devoted to making biological materials for use in phase-1 and phase-2 clinical trials. Until now, Stanford researchers wishing to conduct clinical trials of cells or viruses had to arrange to have them manufactured at other sites around the country.

“Stanford has a vast pipeline of potential cell and gene therapies that can now be realized without having to go off-site to make materials for testing,” said laboratory director David DiGiusto, PhD. “Our hospital and clinics are world-renowned, and we’ve seen an explosion in cell therapy. We’ve built a biologics manufacturing facility to support the translation of cell and gene therapy from the research lab to the clinic. The LCGM expands our capacity more than twofold and will help researchers and clinicians test potential therapies safely and more rapidly.”

These therapies include, among many others, purified blood stem cells to treat genetic diseases, immune cells engineered to attack cancers, and viruses equipped to replace faulty genes with healthy, functional copies in an attempt to treat conditions as diverse as severe combined immune deficiency, sickle cell anemia and a blistering skin disorder known as epidermolysis bullosa.

David DiGiusto is director of the lab, which is the first dedicated facility at Stanford to adhere to the FDA's current good manufacturing practices.

“The Laboratory for Cell and Gene Medicine is going to be a major force in our precision health revolution,” said Lloyd Minor, MD, dean of the School of Medicine. “Our hope is that stem cell and gene-based therapeutics will enable Stanford Medicine to not just manage illness but cure it decisively and keep people healthy over a lifetime.”

Maria Grazia Roncarolo, MD, a professor of pediatrics and of medicine and co-director of Stanford’s Institute for Stem Cell Biology and Regenerative Medicine, helps to lead the school’s efforts to translate basic scientific discoveries in the field of regenerative medicine into stem-cell and gene therapies. She said the new lab is an essential component of that effort.

“The LCGM will manufacture cell- and gene-based cures but also develop innovative technologies to make these therapies more accessible and available to all patients in need,” she said.

The lab is being funded by the School of Medicine, Stanford Health Care and Stanford Children’s Health.

The roughly 25,000-square-foot building has been completely remodeled to include clean rooms with airlocks, poured floors that don’t have cracks that can harbor bacteria, and easily sanitized surfaces. It includes separate areas for cell processing and for the development of viral vectors designed to infiltrate human cells.

Most of our rooms undergo 40 to 60 full changes of filtered air per hour, which is like turning over the whole volume of a room every minute,” said DiGiusto. “We use special, breathable culture bags rather than tissue culture flasks to grow cells, and we transfer liquids with pharmacy pumps rather than pipettes. Everything we do is conducted according to strict, written procedures.”

Current good manufacturing practices require a high degree of sterility, strict chain-of-custody protocol and practices to ensure consistency in products. One focus of the facility will be the generation of banks of induced pluripotent stem cells and other specialized tissues such as heart muscle cells that are derived from stem cells. These cells can be used to test the effects of drugs in a “clinical trial in a dish” or potentially even used to repair tissues injured by disease or trauma.

“We test every product before it goes out the door,” said DiGiusto, who is also the director of stem cells and therapeutic operations at the laboratory. Other directors will oversee quality assurance, regulatory affairs and other aspects of the laboratory’s operations. “We have a high degree of control over all stages of manufacture, and every stage is documented according to federal law.”

In addition to manufacturing biological products, the laboratory will also serve as a kind of pharmacy to dispense cellular therapies that were made in other facilities compliant with current good manufacturing practices.

These therapies will be for Stanford patients, as well as for patients at collaborating institutions. “Unlike a typical pharmacy, we will wash, store and distribute cells, rather than drugs,” said DiGiusto. “This will ensure each patient receives the right product at the right dose and at the right time.”

Plans are also in place to support collaborations among researchers from Stanford and elsewhere. DiGiusto and his colleagues are working to be licensed by the state of California as a biological manufacturer so that materials made in the laboratory can be shipped across state lines. They will also file a facility master file with the FDA so that non-Stanford collaborators can receive approval to use the laboratory.

In the end, the lab’s activities will be driven by the needs of the Stanford community, DiGiusto said.

“This is very much a partnership with the faculty of the medical school,” he said. “We will have a formal process for project management and budgeting, and we are here to help them develop clinical trials. But the ideas of what to produce will come from them.”

VWR Opens Site in Ohio

VWR has opened a 226,000 square foot chemical manufacturing site in Ohio.

The provider of product and services to lab and production customers had six locations in the Solon area (totaling 150,000 sq. ft.) and is relocating five by the end of this year and the sixth in a few years. VWR said the new space allows for all associates to be at one location and offers more square footage with the employee headcount of 365 staying the same.

It acquired PAW BioScience Products to expand its single-use portfolio earlier this year and is the sole US distributor for the DuPont BAX System Q7 instrument, assays and related products.

The firm told us the location was designed purposely for expansion to ensure it can meet the future needs of customers. “Our manufacturing facility in Solon supports customers who produce various kits and reagents for use in both food and beverage testing,” it said.

“The site is serving as a contract manufacturer producing custom media blends in both liquid and powder forms that are further sold and distributed in the market for use in testing common foodborne pathogens.

“The site also serves as a contract manufacturer for those companies who have developed molecular based technologies used in foodborne pathogen testing. The new facility now features a dedicated molecular work center and clean room area dedicated for this purpose.”

Contract manufacturing capabilities include custom products, supply chain and design solutions, high purity biochemicals, life science reagents and diagnostic kits.

The firm supports biopharma, life science, diagnostic and industrial customers by providing chemicals to support testing, production and contract manufacturing of custom goods.

VWR’s Global Manufacturing represents about 5% of company sales.

"The new location will enable better collaboration amongst our employees along with the opportunity for growth to meet market demand," said Manuel Brocke-Benz, VWR's president and CEO. "We are excited to continue enabling science by providing high quality liquid and powder chemical products to our customers."

Solon is one of nine manufacturing sites globally (six in North America and three in Europe).

It was established in 1976 under the AMRESCO brand. Acquired by VWR in 2011, it is part of VWR's larger network of sites supporting the chemical manufacturing needs of customers.

Capsugel Expands Micronization Capabilities

Capsugel announced in early September that the company will be expanding the capacity and capabilities of its Quakertown, PA facility to increase its micronization services output for clinical and commercial manufacturing—the very same facility that Capsugel acquired in January of this year.

Capsugel acquired Xcelience and Powdersize in January 2016, the latter of which its Quakertown facility originated from. Providing particle-size reduction and particle-size control/classification technologies, the acquisition of Powdersize expanded Capsugel’s suite of bioavailability enhancement tools.

But with the expansion close on the heels of the acquisition, not only will the company have additional capacity for manufacturing operations, but product lead times are expected to improve by up to 75 percent.

“By bringing Powdersize into the business model, we have the ability to be a much more relevant and flexible partner for our customers,” said Amit Patel, Sr. Vice President, Capsugel. “Often times, when customers come to us with certain challenges on formulation or drug delivery, it’s important for us to be able to bring multiple solutions to the table from which we can jointly determine what might be the best approach. And I think micronization was a missing link for us (as part of our overall solubility offering).”

Anywhere between 60 and 90 percent of molecules that are being discovered in development or commercialized, according to Patel, have some degree of solubility challenge to them.

“When we were unfolding the Capsugel dosage form business model, we already had a number of technologies that addressed solubility—amorphous dispersions, including spray-dry dispersions, lipids, liquids, nanoparticles, and so on,” Patel said. “But micronization is one other technical means by which one could potentially achieve improved solubility. That’s really the focus that Powdersize has had for many years, and, from our perspective, as we brought Powdersize into the business model, it was a very complimentary offering that we were able to provide.”

“We’ve always had a fairly strong emphasis around bioavailability enhancement and solubility as an area that a lot of our technologies address,” said Patel.

When looking to expand its bioavailability and solubility solutions, the company studied the trends in the market place—specifically the thematic questions being asked, such as:

Can solubility help formulate complex formulations that achieve the desired target product profile?

Can micronization be done under a high-containment environment so that the handling of certain types of APIs is done appropriately?

How does one look at multiple different technological approaches to achieve improved solubility so that the team can take a scientific approach as to what is the most appropriate one (or what combination of technologies are most appropriate)?

“These are some of the themes that we’ve been sensing in the marketplace. As part of that, our acquisition of Powdersize has allowed us to expand our offerings and be that much more helpful to many of our customers,” said Patel.

A large portion of Capsugel’s customers work in R&D—with the new projects that are brought on board tending to start at the clinical, or development, phase.

“Micronization tends to be the first-resort approach,” Patel explained. “If someone has a project in R&D, the initial attempt might be to see whether or not that particular API can be micronized. If it can and that achieves the desired outcome, then additional technologies might not be required. Other times, it’s a combination of micronization and other technologies (or evolving into other technical approaches).”

To determine how to best address a customer’s need, Capsugel looks at a host of criteria, including:

What defines a particular API?

What type of formulation is being developed?

What is the target product profile that a customer is looking to achieve?

“We apply a number of different criteria to see what other technologies may be relevant. But the options would include anything from lipids and liquids, to spray-dry dispersions, to hot-melt extrusions, and a number of others,” said Patel.

As these R&D projects progress, get filed, and are eventually approved, the commercial revenue is driven.

“The client mix is diverse. It spans clinical and commercial, and the facility’s capabilities span both as well. I’d say that the near-term growth of the number of customers and the number of projects that we’re working on in Quakertown tends to start at the clinical phase and then evolve over time and transition towards commercial,” said Patel.

Capsugel’s technology enables high-potency micronization with containment.

What Does this Mean for the Quakertown Facility Expansion?

“The overall facility, the buildings themselves, has existed as part of Powdersize prior to Capsugel’s acquisition and post. The announcement is largely around the expansion of capabilities and capacities within those existing facilities,” Patel explained.

The underlying expansion is based around jet-milling technology, a technology that Powdersize is a specialist in.

Using compressed air to create high velocity within a piece of equipment, jet milling grinds particles into smaller particles in order to achieve specific sizes and other characteristics.

“The [jet-milling] technology that exists at Powdersize is very custom,” said Patel. “It has a number of different proprietary characteristics and processes around it.”

The expansion will also focus on introducing new pilot suites specifically for programs in the developmental phases.

“As we bring additional pilot suites online, it also gives us the flexibility to take existing commercial-scale capacity and upgrade that to support what we think is going to be significant growth in our overall services,” said Patel.

In addition to expanding the amount and type of equipment used at the Quakertown facility, Capsugel will also be addressing improvements to the following:

How the equipment is set up

How exposures affect operators

How to more efficiently clean the equipment

How to best contain highly-potent materials and ingredients

“As those adjacent improvements are implemented, at the end of the day, it should allow us to improve turnaround time for customers as well as make sure that we’re implementing the best working environment for our colleagues,” said Patel.

Servicing more than 4,000 customers, Capsugel’s expansion within the walls of its Quakertown facility has the potential to impact not only current and future pharmaceutical customers, but the Capsugel colleagues and, ultimately, patients.

Ei Augments R&D Capabilities

Ei, A Pharmaceutical Solutionworks will begin moving a 24-person R&D team to the Kannapolis, NC Research Campus, a 10,000 sq. ft. lab with office space.

Ei’s R&D team is currently housed at the company’s nearby 140,000 sq. ft. semi-solids manufacturing facility. The move expands its scientific foundation for dermatological product development and adds a significant skin biology research capability. The NCRC also offers scientific expertise on the health benefits of antioxidants and other bioactive compounds found in fruits and vegetables, which are regularly incorporated into skin care products.

Ei, a subsidiary of Product Quest Manufacturing, specializes in the development and manufacture of therapeutic, OTC, and prescription skin care products for pharma and consumer goods companies. Ei also partners with customers to develop ANDAs for generic drugs.

Ei’s chief scientific officer Charles W. Gray, Jr., Ph.D., said: “By offering best-in-class facilities, advanced scientific capabilities at the David H. Murdock Research Institute and significant opportunities for collaboration with other research centers on campus, the NC Research Campus will significantly accelerate our progress toward creating premier dermatology development capabilities and providing our customers with a robust turnkey service from early development through commercial manufacturing.”

Piramal Pharma to Expand Sterile Capacity at Lexington Site

Piramal Pharma Solutions, a provider of sterile drug product development and manufacturing services, will invest $25 million to expand its facilities in Lexington, KY.

The company will expand capabilities and capacity for commercial aseptic manufacturing, increasing vial filling capability and lyophilization capacity, as well as upgrades to the associated facilities and utilities.

Phase one of the expansion will add a new manufacturing suite including a high speed vial filling machine that provides controlled/safe environment for handling potent materials with automated Vial Washing and Sterilization. Piramal will also install a new isolator based vial filler in its existing manufacturing suite. Combined, the two fillers will increase the company’s vial filling capabilities by more than five-fold.

Phase two of the expansion will include the installation of two state-of-the-art lyophilizers, which will integrate with the new filler line in the new manufacturing suite with dedicated capacity for both potent and non-potent products.

Vivek Sharma, chief executive officer of Pharma Solutions, Piramal Enterprises, said, “Since our initial investment the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this next phase of investment to enhance capability and capacity. We appreciate the active support from the State of Kentucky, the local Government, and most importantly, the community, as we continue our growth plans in Lexington. The expansion in our capacity at Kentucky will help us better serve our customers who are looking for us to deliver solutions that will improve the standard of care.”

LI-COR Expansion Offers Early-Phase cGMP Services

LI-COR Biosciences has expanded its production facility to offer contract manufacturing for early-phase cGMP materials.

The facility in Lincoln, Nebraska currently produces reagents and dyes for surgery.

As a result of the expansion - financial terms of which were not provided - it will now offer synthesis and conjugation services for the production of early-phase materials for trials.

Bambi Reynolds, senior business development manager, said the expansion will help “researchers and biotechs to conjugate fluorophores to their specific biomolecules.”

Reynolds added: “We have expanded our production facility to accommodate contract manufacturing for both pre-clinical and early phase clinical applications.”

She also said demand for LI-COR dye used during fluorescent-guided intra-operative surgery had increased.

LI-COR (previously Lambda Instruments Corporation) was founded in 1971.

The company focuses on biological and environmental sciences, with documented experience in global climate change, cancer research, and small animal imaging.

LI-COR was one the first biotechnology companies to use near-infrared (NIR) technology as a detection method.

Near-infrared DNA sequencing technology was initiated by LI-COR in the early ‘90s.

These developments led to the introduction of two NIR dyes into the clinical trials using targeted NIR as a method for detecting and treating various cancer types.

Avid to Construct Third Plant with Two 1,000L Single-Use Bioreactors

Avid Bioservices, based in Tustin, California, will construct a clinical manufacturing plant later this year just months after production began at a second facility.

At the time the firm said it was already eyeing up extra capacity to cope with expected demand for contract monoclonal antibody manufacturing, and now construction of a third plant will begin in the fourth quarter of calendar year 2016.

The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid calendar year 2017.

The suite will incorporate two 1,000L single-use bioreactors and, like the firm’s current two facilities, will be located in Tustin, California.

“As Avid continues to expand both its services and manufacturing capacity, we expect demand from biotechnology and pharmaceutical companies to remain high.”

Last year, the firm’s Franklin facility pulled in around $40m of revenue, and the new Myford plant is expected to generate the same annually.

According to the firm’s financial projections, manufacturing revenue for the full fiscal year 2017 is expected to be between $50-$55m.

But the addition of the third plant is expected to push total revenues for the CDMO to over $100m, Peregrine’s CFO Paul Lytle said in a conference call to discuss the firm’s Q1 FY2107 results.

“We believe the third facility will again significantly increase our manufacturing capacity and all three manufacturing facilities will have the potential to generate in total approximately $110 million in annual revenue.”

Furthermore, Peregrine reported a disappointing quarter with clinical and commercial biomanufacturing contributing $5.6m, a drop of 42% on the same quarter last year.

The firm attributed this to a backlog at a third-party testing lab that shifted the timing of revenue recognition from the first quarter to the second quarter of fiscal year 2017.

Alexion Pharmaceuticals Global Headquarters, New Haven, CT

Alexion Pharmaceuticals started construction on its new global headquarters in June 2013, located at 100 College Street, New Haven, Connecticut, US.

The new headquarters includes a sophisticated laboratory and an office building. It was opened in February 2016. Construction was sponsored by the city of New Haven, the State of Connecticut, and the US Department of Transportation.

The new building will provide employment for 200 to 300 people by 2017.

Alexion's new headquarters is located on a 12-storey building with a total floor space of around 500,000ft². It includes a separate parking garage with 600 to 800 spaces. Existing 400 employees at the old facility in Connecticut were transferred to the new headquarters.

The new laboratory at the headquarters is used for developing life-transforming therapies for patients with severe and life-threatening disorders.

Winstanley Enterprises was awarded a $100m development contract in June 2013. The scope of the contract included construction of new laboratory and office building for Alexion to accommodate its new headquarters. It also involved the refurbishment of the College Street Bridge, pedestrian and bike improvements, as well as access to the neighboring Air Rights garage.

The total expected investment for the construction of the new headquarters is $140m. The Connecticut state government contributes $51m for the project under its Department of Economic and Community Development (DECD) First Five programme.

The assistance is provided as a ten-year loan of $20m at 1% interest for five years. It also includes around $25m towards industrial sites reinvestment tax credits, and a $6m grant for the laboratory construction and equipment.

Between $16m and $20m are rebated under loan forgiveness schemes if the promised 200 to 300 permanent jobs are created.

The new headquarters building was constructed using eco-friendly methods. It is designed to obtain the LEED Silver environmental standard certification.

Alexion Pharmaceuticals is a leading international biopharmaceutical company currently headquartered at Cheshire, US. The company is engaged in innovation, development and commercialization of life-transforming therapeutic products for severe and ultra-rare disorders. It employs around 1,700 people across 50 countries worldwide.

Alexion operates a manufacturing facility located in Rhode Island, and offers the product services to the patients in 50 countries.

Alexion's therapeutic products portfolio includes sole marketing drug Soliris (eculizumab), which is approved by both the US Food and Drug Administration (FDA) and the European Medical Agency (EMA) for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) indications.

MilliporeSigma’s Life Science Campus, Burlington, Massachusetts

MilliporeSigma, the life sciences division of Merck KGaA, Darmstadt, Germany (Merck), is constructing a world-class life science hub in Burlington, Massachusetts, US. The $115m project was announced in July 2016 and is slated for completion in 2017.

The new facility will replace MilliporeSigma's existing facility in Billerica, Massachusetts. It will enable both its employees and customers to work in a sustainable and collaborative working environment. All 850 employees of the Billerica facility will be relocated to the Burlington campus.

The 280,000ft² Burlington campus will be spread over five stories. It will include Merck's trademarked collaboration laboratory named M Lab™ Collaboration Center, which will be spread across 15,000ft² as an open two-story section of the first floor.

M Lab™ is a shared laboratory in which customers work alongside Merck's scientists and engineers in a non-GMP environment to solve major biomanufacturing challenges.

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

Other M Lab™ centers are located in Brazil, China, France, India, Singapore and South Korea. The Burlington campus will replace the existing center at the Billerica facility.

The Burlington facility will also include office space featuring flexible workspaces, labs, and a customer service and call center. Training, display, storage and instrument repair rooms are also provided in the facility.

The Burlington campus will be LEED-certified and also include 70,000ft² of space for future expansion.

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

Merck's project is being provided with a 15% exemption on property taxes for a period of 15 years.

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

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

The Gutierrez Company based in Burlington has been contracted to build the new facility.

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

The life sciences division provides products and services based on three business areas, including process solutions, research solutions and applied solutions. The combined portfolio of the division includes more than 300,000 products.

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

Clinical Sciences Building, Cincinnati, Ohio

The construction of a new 15-storey clinical science building at Cincinnati Children's Hospital Medical Center (CCHMC) began in June 2012. The new facility was constructed next to the existing research center known as S Tower, which is located on the Burnet campus in Cincinnati, Ohio, US.

The new building was opened in June 2015. It is used for conducting translational research.

The new research center is a 15-floor tower with a total floor space of 445,000ft². The tower is known as T Building and accommodates new laboratories, a research imaging facility, a research-focused outpatient clinic, offices and supporting infrastructure. It has 11 floors dedicated to research, including wet and dry laboratories, a data center, dining facilities and meeting rooms.

The building is integrated with the existing research facility that opened in 2007 by CCHMC, and subsequently increases the center’s pediatric research space to a total area of roughly 1.4 million square feet. The new building provides a physical link between discoveries in laboratories and animal models, as well as the application of patient care in the clinical locations.

The new facility is able to accommodate approximately 1,500 top researchers and clinicians and is used as a translational research center for developing evaluating breakthrough discoveries. Clinical staff also uses it to apply these discoveries to improve the health of children.

The building is designed to promote collaboration across disciplines and interactions among basic, translational and clinical investigators. Two floors are dedicated for the laboratory, which features a transparent design that not only draws natural light into the building, but also enables views throughout.

A collaborative space, known as Beehive, connects the research centers located in the two towers. A rooftop respite garden was built on the top floor terrace and sunshades were built on the southern façade of the T building.

Cincinnati Children's Hospital Medical Center's board of trustees approved the construction of the clinical sciences building in May 2012. Ground breaking was held in June 2012. The installation of the windows and the façade began in October 2013 and the facility was opened for operations in June 2015.

Construction was carried out using building information modelling, a three-dimensional digital model that eliminates waste and adds efficiency to the building.

The design for the clinical sciences building was provided by GBBN architects in collaboration with Geier Brown Renfrow Architects and HDR, while the general construction contract was awarded to Messer Construction.

Pioneer Glazing and Cladding was awarded with a contract to provide design and installation of curtain wall, windows, skylights, sunshades, and structural and point-supported glass walls for the facility.

The total estimated investment for the construction of the clinical sciences building is $205m. It was financed through a combination of operating cash, investments, future operating cash flows and private donations.

REST OF WORLD

Rentschler Doubles Capacity with New Manufacturing Plant

Rentschler Biotechnologie has opened a facility at its site in Laupheim, Germany and plans to create 200 new jobs.

The plant – which cost €24m ($26m) - houses two 3,000 liter stainless steel bioreactors linked to a protein purification system. Clinical-stage protein therapeutics and commercial products will be made at the site.

Rentschler CEO Frank Mathias said: “An increase in sales of over 30% in the past two years has enabled us to make this significant investment. We have already received manufacturing orders for the new facility, extending into 2018.”

He added that: “Increasingly, our growth is being driven by international business, with more and more orders coming from abroad, particularly the United States."

Rentschler also said it plans to hire 200 employees, explaining this will include process engineers and laboratory technicians in bioprocess development and manufacturing as well as GMP (Good Manufacturing Practices) experts, as it continues to expand its business.

The new facility is the second expansion Rentschler has undertaken in a year. In April last year the German contract manufacturing organization (CMO) installed a single-use bioreactor at its older facility at the Laupheim site.

That expansion coincided with Rentschler being contracted to make Apeiron’s neuroblastoma candidate monoclonal antibody (mAb) APN311. A few months later the CMO was hired by Probiodrug to makes its Alzheimer’s disease drug candidate PBD-C06, a pGlu-Abeta-specific mAb.

Johnson Matthey's Refurbished Annan API Plant

The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.

The UK active pharmaceutical and ingredient (API) and catalysts firm announced the approval, explaining it followed the completion of renovation and refurbishment work.

The Annan facility, which was built by GSK in 2010, produces controlled substance APIs and provides drug firms with custom manufacturing services.

Johnson Matthey bought it from Bakhu Pharma in 2014. Shortly afterwards, the firm began a multi-million pound” refurbishment of the site, citing customer demand as the driver for the investment.

The firm also plans to hire 35 additional staff at the facility.

Spokesman Nick Johnson told us "We see sustained demand for our existing portfolio of products and the Annan site has brought significant additional large scale capacity to service our broad customer base.

"The manufacture of opioids and controlled substances will be a core activity, together with supporting our growing contract manufacture services business" he added.

In July, Johnson Matthey revealed it had seen API sales decline in the first quarter of its fiscal year – the three months to June 30. At the time it attributed the fall to the timing of orders.

The firm’s API manufacturing business supplies ingredients for pain medications, attention deficit hyperactivity disorder (ADHD) treatments and bulk actives used in addiction therapy and Alzheimer’s disease.

The ingredients are produced at the Annan plant, a site in Edinburgh and at facilities in the U.S.

Last October, Johnson Matthey acquired Sigma-Aldrich’s Pharmorphix unit, which provides polymorph studies, salt selection, co-crystallization, chiral separations and process scale-up for API development. At the time it said the deal would add a 'significant' customer base and expand its European API business.

GE’s Single-Use Modular Biologics Plant in Ireland

GE Healthcare is in discussions with companies looking to buy four fully-equipped ‘off-the-shelf’ facilities as part of a €150m investment into a biomanufacturing campus in Ireland.

The bioprocessing technology and services subsidiary of General Electric announced it was constructing the four off-the-shelf facilities as part of a biopharmaceutical manufacturing campus on Industrial Development Agency (IDA) Ireland’s site in Ringaskiddy, County Cork.

“GE BioPark Cork will be a GE-managed campus including four fully-equipped off-the-shelf KUBio factories owned by independent biopharma companies manufacturing proprietary medicines, with GE running centralized shared utilities and site services,” said the BioPark’s general manager David Radspinner.

Around 100 people will be employed by GE on the site to support the four plants, though a further 400 will be employed by the biopharma firms which buy the facilities.

“We are in the process of in-depth discussions with a number of companies who are very interested in the concept of BioPark and KUBio in Europe,” Radspinner said.

“The rapid construction time for KUBio is a very attractive proposition, as it will help companies get their products to market more quickly than a traditional stick built facility.”

GE’s modular platform KUBio, he continued, enables construction and assembly of a cGMP facility fully equipped with single-use technologies within 18 months – about half the time of a traditional biomanufacturing plant.

The firm recently completed the world’s largest modular antibody production plant for JHL Biotech in China using the KuBIO platform, and in June inked a $350m deal with Pfizer for a KUBio biomanufacturing Centre in Hangzhou.

But the planned investment will be the first examples of GE’s modular biomanufacturing platform in Ireland, which has become a major bioprocessing region through major investments from companies including Shire, Pfizer, Bristol-Myers Squibb, Eli Lilly and Merck & Co.

In a double boost for Ireland’s bioprocessing business, GE also announced it creating a single-use Centre of Excellence at the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin.

NIBRT – described as a “flight simulator for biopharma manufacturing” – is a government-funded center founded in 2011 and, according to Radspinner, has since trained almost 4,000 bioprocessing professionals.

“Some manufacturing sites in Ireland are already working with single-use systems and we believe this technology is poised for enormous growth in Ireland. GE's investment will help catalyze the rapid development of the sector in Ireland and globally.”

In a statement, NIBRT’s CEO Dominic Carola said the Centre is: “delighted to partner with GE on the next generation of bioprocessing equipment, which will accelerate the introduction of these new technologies to the biopharmaceutical manufacturing industry, helping to reduce manufacturing costs and increase the access to these valuable therapies.”

Sartorius Offers Upstream Suite

Sartorius Stedim Biotech claims it has a platform that can help biopharma companies carve months off the development time for new products.

The Franco-German company has bundled all its upstream bioprocessing products and services into a single platform - dubbed Connect Upstream - that it says can help biopharma companies go from concept to clinic in a little over a year.

It is pitching the system particularly at companies developing biosimilars as a means to reduce the time to market and cut productions costs, taking projects from cell line development through to 2,000-litre commercial manufacturing.

Biopharma companies often face significant challenges scaling up their processes so they are robust, comply with regulations and which deliver high titers that can keep cost of goods down, according to the company.

The new platform relies heavily on disposable technologies and also draws upon Sartorius Stedim's proprietary Cellca Chinese hamster ovary (CHO) cell expression system, Ambr cell-line selection system and 100-plus range of BioOutsource pre-qualified biosimilar assays.

The Cellca and BioOutsource products were acquired by the company last year and have helped drive a 22% increase in revenues at the company in the first half of the year.

Sartorius Stedim's growth is being driven by the increasing proportion of global drug market sales accounted for by biological products. This has nearly doubled over the last ten years, recently reaching just under a quarter of the total market, according to IMS Health data.

Time to clinic is particularly important, according to Miriam Monge, Sartorius Stedim's director of integrated solutions." Due to growing pipelines, efficiencies must be gained in process development [but] in the past cell line and process development has been slow and labor-intensive," she said.

Sartorius Stedim's system "now means that starting with a gene you can have a robust, high-titer cell line, upstream process and fully characterized product within 14 months."

WuXi Biologics Commenced Operations at Biomanufacturing Plant

WuXi has responded to a global demand for perfusion technologies by opening a commercial scale manufacturing site in China with two 1,000L disposable bioreactors.

WuXi Biologics commenced operations at a new biomanufacturing plant in WuXi City, about 100km west of Shanghai, China.

The plant boasts two 1,000L single-use bioreactors offering perfusion processes to the contract manufacturing organization’s (CMO) biopharma customers.

Compared to traditional batch-fed biomanufacturing processes, perfusion allows the continuous feeding and harvesting of biologics like monoclonal antibodies for several months at a time, and according to WuXi there is large demand for such technologies.

“Globally there is limited capacity,” said Dr. Chris Chen, CEO of WuXi Biologics, adding the new facility is the largest single-use perfusion biomanufacturing facility in Asia and will cater for “great needs” in the space.

Single-use perfusion technologies are viewed as an important advance in the continuous manufacture of monoclonal antibodies and vaccines, but continuous downstream processes are less established with fewer off-the-shelf options available to manufacturers and limited technologies bridging the gap with the upstream.

“We are developing the continuous purification technologies together with vendors,” said Chen but the firm – and industry – is challenged by the fact continuous chromatography hardware isn't readily available.

The opening of the plant itself is the first part of a $150m (€134m) investment in WuXi City announced in 2014, with construction beginning in May 2015.

Another biomanufacturing suite will house fourteen 2,000L disposable bioreactors for batch-fed cell culture, set to begin operations early next year.

Avara Acquisitions and Expansions

Avara Pharmaceutical Services, Inc. recently celebrated their first year since the acquisition of their Arecibo, Puerto Rico, site from Merck. Since that time, Avara, headquartered in Norwalk, CT, (USA), now has four manufacturing facilities with about 800 employees in 4 countries.

Most recently, Avara announced the acquisition of the AstraZeneca manufacturing facility located in Avlon, Avonmouth, England. The active pharmaceutical ingredient (API) formulation and manufacturing capabilities in Avlon complement the existing API operation in Shannon, Ireland. The Shannon, Ireland facility was acquired from UCB earlier in 2016 and is also an API site.

Avara also recently announced the acquisition from Astellas of their Norman, Oklahoma secondary manufacturing and packaging facility, which complemented the secondary manufacturing and packaging capabilities of Arecibo, which include state-of-the-art manufacturing facilities for secondary formulation, manufacturing and packaging.

Created in 2015, Avara Pharmaceutical Services is a state-of-the-art contract manufacturing and technical services organization providing both API formulation and manufacturing and secondary manufacturing and packaging of small molecule drugs, including highly potent compounds. Their secondary manufacturing technologies include granulation, coating, blending, encapsulation, compression and drying of tablets and capsules.

Avara Pharmaceutical Services now has five sites. Two in the US, including our corporate HQs; one in Puerto Rico one in the UK and one in Ireland.

"As we celebrate these key milestones, we continue with great confidence to build a pharmaceutical services company with complementary offerings in key regions in this rapidly growing market. Each site has significant professional experience, state of the art capabilities and a long history of delivering high quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements in every major market around the world. The people that are a part of the Avara team are the key to our long term success," said Tim Tyson, Chairman and CEO of Avara. "Our rapid growth has been facilitated by expert counsel and support from Results International and Skadden, Arps, Slate, Meagher and Flom."

Custom Pharma Services Adds New Location

Custom Pharma Services, a full-service contract development and manufacturing organization (CDMO), has acquired a new building to expand its high containment manufacturing and development operations.

The new facility, the Custom Pharmaceutical Innovation Centre, is co-located on the Fairway Trading Estate in Brighton, adjacent to the company’s existing packaging and warehousing operations. Acquisition of this site will allow Custom Pharma Services to increase its capacity for clinical and product development of highly potent molecules and advance its commercial manufacturing capabilities with high containment capabilities to meet customer demand.

“Since 1979, Custom Pharma Services has provided solid dose manufacturing and development services. We offer our customers a full range of services, from clinical to commercial, including design of process and formulation development prototypes, stability and analytical testing, certification, contract manufacturing, primary packaging, shipment, consultancy and customer support,” said Nigel Richardson, CEO of Custom Pharma Services.

“Later this year, we plan to commence work on the building. This expansion is a tremendous opportunity to consolidate our operations and concentrate on broadening our scope of services,” said Richardson. “Custom Pharma has earned a reputation for providing dependable customer support and innovative products. This is a big step, enabling us to deliver a wider range of services aligned with current industry requirements.”

Marken Announces New Operations Center in Zurich

Marken announced the opening of their latest GDP-compliant operations center in Zurich, Switzerland, responding to increased demand from local pharmaceutical companies with growing clinical development programs.

The new location is within close vicinity to the Zürich Airport (Kloten) freight terminal and is strategically located near major Swiss highways. The facility, which operates 24/7/365, includes office and warehouse space with refrigerators and freezers available for temperature controlled packaging, full security and is connected to Marken’s global ‘Maestro’ operating system. The operation will be fully staffed, capable of collecting and shipping clinical drug product from the Zurich gateway to anywhere in the world. The facility also conforms to the Swiss Minergie (green) standard, a registered quality label for new and refurbished low-energy-consumption buildings.

Wes Wheeler, Chief Executive Officer for Marken, commented, “Marken has built a global logistics network specifically designed to meet the needs of the global pharmaceutical industry. Our newest site in Zurich replaces our smaller office with expanded capabilities so that we can be ready for the increased clinical logistics demands from our clients. We have also set the standard for GDP compliance – especially in Europe – and will certify the operations according to our own ‘Gold Book’ standard.”

Wheeler concluded: “We are the only 100%-dedicated, patient centric supply chain organization in the life sciences industry. We will continue to expand our global footprint to meet the increasingly demanding requirements of our clients.”

Avacta Expands into New Facilities in Cambridge and Wetherby

Avacta Group, the UK developer of Affimer biotherapeutics and research reagents, has opened two new facilities, in Cambridge and Wetherby in the UK.

The new buildings almost double the company’s total footprint, from 9500 sq. ft. to 18500 sq. ft. (880 m2 to 1700 m2), including new laboratory facilities.

The new laboratories and office space will allow operations at both sites to expand to meet increasing commercial demands and accommodate Avacta’s growing R&D programme.

The new Cambridge site is located on the Lion Works Business Park in Whittlesford, and covers 5500 ft2 (510 m2), of which around 70% houses laboratories.

In Wetherby, the Thorp Arch Estate has provided a new 13000 ft2 (1205 m2) building, which Avacta has fitted with offices and laboratories accommodating around 60 people.

Dr Alastair Smith, Chief Executive Officer, Avacta, said: 'I am delighted with the new labs that the company now has in place in Wetherby and Cambridge.

'The teams will be working in truly world class facilities that will also help in attracting talented new staff and will present the company well to potential customers and partners.'

Dalton Completes Expansion

Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider to leading pharmaceutical and biotechnology companies, announced the completion of a $5 million expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

The project added three new sterile processing suites and an active pharmaceutical ingredient (API) manufacturing suite, and included the addition of a semi-automated powder filling line with significant scale-up of lyophilization capacity. Also included were increased analytical capabilities, increased chemistry capacity, and facility upgrades to meet increasingly stringent sterile manufacturing GMP API standards. Approximately 20 new skilled jobs have been added over the past year.

This project was supported by $2.085 Million (Canadian Dollars) in FedDev Ontario funding through the Investing in Business Growth and Productivity Initiative. Combined with the company’s initial investment of $3.5 Million, the expansion project brings the total investment at the site to more than $5 Million.

This expansion and improvements to Dalton’s sterile manufacturing facility were planned to meet growing clients’ requirements ranging from preclinical development and small/medium clinical trial batches to commercial production, for both API and sterile finished doses.

“Increasing sterile filling capability and capacity for both powders and liquids has been a key part of our plan for strategic growth,” commented Peter Pekos, President and CEO. “Completion of this expansion is a major step designed to meet the increasing global demand for sterile filling development and production, and supports the integrated drug development and manufacturing we offer our clients.”

Aquila BioMedical Expands

Aquila BioMedical, a niche preclinical contract research organization (CRO), has expanded its laboratory space and capabilities in response to growing demand for its specialist immuno-oncology and histology services.

Since forming in 2011, the CRO has built a strong reputation for supporting biotech and pharmaceutical companies’ early drug development programs through offering specialized assays to investigate therapeutic manipulation of immune cell function.

The success of Aquila’s immuno-oncology offering has supported rapid growth of both the scientific team and laboratory space in Edinburgh’s bioincubator building. The team of 14 has more than doubled in the last year and is likely to reach 22 in 2017.

Funding from Scottish Enterprise’s Regional Selective Assistance (RSA) grant has allowed the CRO to accelerate its recruitment plans and expand through investment in people and capital equipment. Aquila has added capacity to offer assays using an IncuCyte Zoom, allowing its team to deliver insights into cellular processes, such as T cell killing of tumors via real-time quantitative live-cell analysis.

Clare Doris, Chief Operating Officer (COO) at Aquila BioMedical, said: 'Since our company formed in 2011, it has been our goal to bring innovative models and a new dynamic CRO experience to biotech and pharmaceutical companies across the world. In recent years, we have strategically developed our expert immunology offering, establishing a significant presence in immuno-oncology and building services to deliver high end mechanistic biology in an area of large unmet demand.'

'This year has proven a phenomenal success. Our expert team has provided high value data to our international client base, allowing go/no-go decisions to be made earlier in the drug development process and ultimately reducing clinical attrition. As the cancer immunotherapy field is evolving rapidly, many of our clients are now seeking to understand questions about potential combination therapies and we have the assays to deliver this information,' she added.

Aquila Histoplex LLP, which specializes in histology, RNAscope and multiplex immunofluorescent staining services, has also been formally integrated into Aquila BioMedical. The division will help to address questions around biomarker and target expression in tumor tissues. Clare continued: 'We have an exceptional team who are highly motivated by the research that we are conducting and we are excited to be advancing company growth, building in dedicated space for tissue culture, multiplex cytokine analysis, flow cytometry and PCR. The expansion also provides a new home to our histology services with space for multiple high-throughput staining robots.'

Dr Howard Marriage, co-founder and chairman at Aquila BioMedical, added: 'I am delighted to see the progress of Aquila BioMedical. Under Clare’s leadership the company has built a highly skilled biology focused scientific team delivering vital insights into client drug programs. I am very pleased to welcome the team from Aquila Histoplex LLP into Aquila BioMedical as a new division. The advanced histology services provide clients with innovative approaches to biomarker discovery and mechanism of action from models into clinical samples.'

'Support from Scottish Enterprise has helped us further develop the company into areas of advanced biology, clearly seen as an evolving aspect of the pharma services industry. I look forward to seeing Aquila BioMedical being increasingly integrated into clients’ R&D immuno-oncology programs,' he added.

Aquila BioMedical uses cutting-edge research to enhance drug discovery and development programs for clients across the world, with a particular focus on immuno-oncology, immunology and multiplex histology.

Through close collaboration with clients, Aquila BioMedical offers innovative and tailored biology solutions and will continue to build new services to facilitate generation of high value mechanistic data that will inevitably result in better medicines reaching the clinic. This is all with the ultimate aim of playing a role in the development of the next generation cancer immunotherapies.

SGS Opens New Dedicated Facility for Extractables and Leachables Testing

SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, has opened a new facility in Wiesbaden, Germany, exclusively to offer extractables and leachables testing to the pharmaceutical and related industries. SGS had previously offered these services from its Taunusstein, Germany laboratory, approximately 20 kilometers from the new site, but customer demand has seen the need for a dedicated facility and increased investment for this business.

The 5,380 sq. ft. (500 sq. m.) facility accommodates increased number of scientists. Equipment and instruments that have been both transferred from Taunusstein, and newly acquired, have been qualified and validated in the new laboratory. Ongoing projects being undertaken for clients have been successfully transferred to Wiesbaden, and the space vacated at Taunusstein creates an opportunity for SGS to expand its quality control release testing capabilities at that facility.

“This investment in both a new facility and advanced analytical technologies is in response to increased awareness of regulatory requirements globally and growing customer demand,” commented Dr. Sheida Hoenlinger, Director, Life Sciences Germany. “SGS has a very strong reputation within the industry for extractables and leachables testing, and this step, to build a dedicated facility, allows us to offer our clients greater opportunities to identify the unknowns through more sensitive and accurate impurity profiling techniques.”

The new facility in Wiesbaden will be the global Center of Excellence for Extractable Studies and Impurities Profiling, as a hub across the global network of laboratories.

Alphora Research Proceeds with $8M Plant Expansion

Alphora is pleased to announce its decision to expand plant operations with an $8M capital investment. The expansion will double the size of the plant operations, adding additional 500L, 200L and 50L vessels. The new plant is expected to be fully validated and operational by July 2017.

The addition will complement existing operations, providing additional capacity for new business and redundancy to support commercial programs. Alphora has an active pipeline of near-commercial molecules, with approvals anticipated as early as late 2016. As well, Alphora has a growing client base and the additional capacity will provide for further growth.

Alphora Research Inc. provides API Technology Development and scale-up services for complex small molecules, including niche API’s, high potency and cytotoxic compounds. Our services cover IND enabling development, phase II & III, and commercial manufacturing of niche API’s.

Founded in 2003 by Dr. Jan Oudenes, Alphora Research is staffed by 100 employees, and is FDA inspected and approved. Their 50,000 sq. ft. facilities include synthetic laboratories, analytical laboratories, GMP Kilo Laboratories, GMP Pilot Plant, GMP high potency & cytotoxic and GMP warehousing. Mississauga, Ontario, Canada

ALS Pharmaceutical Invests in Expansion

UK top microbiology and chemical analysis company ALS Pharmaceutical has invested in excess of £2m to quadruple the size of its facility in Ely. The new laboratories, with more than 35 staff, were officially opened at the beginning of September.

The company, which has five sister laboratories located across the UK and Ireland and is part of the £700m ALS Global company, offers a comprehensive range of high quality analytical testing services. Clients include local NHS hospitals and many of Europe's leading manufacturers of medicines, as well as nutritional and cosmetic producers.

The Mayor of Ely, Ian Lindsay, himself a retired RAF physician, cut the ribbon leading to the expanded facilities, and then toured the state of the art HEPA filtered laboratory, purpose-built chambers for stability trials, and the batch release testing capabilities.

'Our laboratory has experienced double-digit growth for the last five years, and we now perform more than 40,000 chemical and microbiological tests every month, helping to ensure medicines and cosmetics meet safety standards and their stated shelf-life,' says Sharon Hanly, General Manager of ALS Pharmaceutical.

Fuji Chemical Completes High Containment Closed Spray Drying Facility

Mr. Mitsunori Nishida, CEO of FUJI Chemical Industries Co., Ltd., has announced that its new high-containment spray dryer for drugs with high pharmacological activity drug profiles is now fully operational.

In 1999, FUJI established commercial manufacturing technology with a closed spray dryer (CSD) and has since received a significant number of orders from major international and domestic pharmaceutical companies. Continued growth necessitated the need for the second facility “2CSD” (High Containment Spray Dryer), which was built and became operational in the summer of 2015. “In addition to this, we are anticipating further needs of our customers for anti-cancer drugs for aging populations, and we have therefore installed a new High Containment Spray Drying facility to accommodate these and future needs,” Mr. Nishida stated.

Recently, he added, scientific studies have emphasized the importance of developing oral medications that have improved absorption characteristics in the gastrointestinal tract.

This trend is particularly evident in new drugs with high pharmacological activity profiles that deliver high pharmacologic effects in small doses. Accordingly, the demand for High Containment CSD’s is increasing since this manufacturing process improves systemic absorption of newer drugs in the gastrointestinal tract. FUJI’s new facility is a high-containment system, which is compliant with the Chemical Hazardous Act, enabling FUJI to provide service to a variety of customer needs. “FUJI can now expand its business with new drug manufacturers worldwide (USA, EU, Japan, etc.) through our continuous production CSD process for high potency drugs,” Mr. Nishida asserted. “FUJI can provide customers with all their spray drying requirements including high potency drug processing solutions.”

Thermo Fisher Scientific Opens Clinical Services Facility in South Korea

"Thermo Fisher Scientific was established in South Korea in 1994, and over the past 22 years our goal has been to invest in local infrastructure and presence to better support the market specific needs of our customers"

To address the growing global demand for clinical services, Thermo Fisher Scientific, the world leader in serving science, announced the official opening of its new state-of-the-art GMP1 standard facility in South Korea. Strategically located in Seoul, the new site will provide local, regional and global pharmaceutical and biotech companies with a one-stop service for clinical supplies − from cGMP storage, local labeling, secondary packaging, comparator sourcing, handling and distribution of ambient and cold chain supplies to clinical site returns management.

A supportive government, modern infrastructure and an easily accessible patient population are helping this Asian nation become a top location for clinical trial research. Over the past few years, clinical trials have consistently grown in South Korea, and with an increased number of core clinical trial sites certified by the Ministry of Food and Drug Safety (MFDS), formerly known as the KFDA, South Korea boasts the second highest number of approved clinical trial sites globally, making it a leading emerging nation for clinical trial research in Asia. In addition, South Korean R&D pharmaceutical companies have demonstrated a strong passion for innovative drug development resulting in a robust industry contributing to therapeutic healthcare developments at local and global levels.

“Thermo Fisher Scientific was established in South Korea in 1994, and over the past 22 years our goal has been to invest in local infrastructure and presence to better support the market specific needs of our customers,” said Tony Acciarito, vice president and general manager of Thermo Fisher South Korea. “Now, with over 430 employees across the organization, the new facility represents another step towards this goal which is aligned to our company Mission to enable our customers to make the world healthier, cleaner and safer.”

“Asia Pacific continues to be our fastest-growing market and a central contributor to our growth,” said Leon Wyszkowski, Thermo Fisher’s vice president of clinical services for North America and facility network. “In September 2015 we opened a new facility in Singapore to serve as a central hub for our Asia Pacific region, which complements our clinical services facilities in Beijing and Suzhou, China; Tokyo, Japan and Ahmedabad, India. The opening of this new facility in South Korea is testament to our commitment to continue investing in the region as we build on the expertise of our local teams to strengthen our regional and global presence in the clinical supplies industry.”

Saneca Pharma Invests in Small-Scale API Capabilities

Contract development and manufacturing organization (CDMO) Saneca Pharma is investing in its API capabilities to support demand for smaller batch sizes and streamlined scale-up.

The Hlohovec, Slovakia-based firm is strengthening its infrastructure and expanding its equipment within its five API production units to reinforce its expertise in opiate and synthetic drug development and production.

The firm is investing in several smaller reactors that will enable it to handle batches from approximately 1 to 30kg in its new kilo lab. This lab then allows for scale-up and optimization activities that simulate the CDMO’s large-scale production processes.

Chief Executive Anthony Sheehan said the investment gives the firm greater flexibility in supporting clients with development projects. It also gives them the option to tech-transfer products in at an earlier stage.

'As our R&D operations are integrated with our API manufacturing facilities and our finished dosage form production capabilities, we can offer clients an end-to-end service and a very efficient and cost-effective process all from one location in Slovakia,' he said.

'This is a very exciting time for our business and this latest investment allows us to cater for development on demand. This ultimately gives clients greater flexibility at an earlier stage, while enabling their project to go from phase III development, to pilot plant, to commercial scale – all on the same site.'

Operating from a site that has manufactured APIs since 1941, Saneca Pharma has a track record in developing and manufacturing synthetic and bio-mass APIs, especially controlled substances based on morphine and other poppy straw alkaloids.

With a dedicated morphine production unit, Saneca Pharma has specialist expertise in opiate API manufacturing, with full supply chain integration from raw materials to oral and semi-solid finished dosage forms.

The firm currently manufactures more than 30 different APIs on-site.

Rentschler Doubles Manufacturing Capacity

Rentschler Biotechnologie, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, has opened a new facility at its site in Laupheim.

The expansion includes an innovative Twin system, which consists of two 3,000-litre stainless steel bioreactors. It is designed to run the two bioreactors in parallel or staggered, with one shared downstream processing unit, thus providing higher throughput while reducing costs. This system integrates well into the existing 3,000-litre facility and more than doubles Rentschler's manufacturing capacity for cell culture-derived proteins.

This is the second increase in Rentschler's manufacturing capacity in a year; a new 2,000L single-use bioreactor was put into operation in 2015.

With the growing demand for biopharmaceuticals and increased industry manufacturing outsourcing, Rentschler has more than doubled its manufacturing capacity, investing a total of €24m. The Twin system was completed three months ahead of schedule. Proteins for the clinical development of drug candidates, as well as already approved drugs, will be produced.

'The growing demand for biopharmaceuticals and the rising number of drug candidates in clinical development was recognized by Rentschler early on. For this reason, the company has been strategically expanding its manufacturing capacity, most recently in 2015,' said Dr Frank Mathias, Chief Executive Officer of Rentschler Biotechnologie. 'Today, only one year later, we have completed another major step in this expansion, achieving an important milestone in the longstanding track record of Rentschler.

'An increase in sales of more than 30% in the past two years has enabled us to make this significant investment. We have already received manufacturing orders for the new facility, extending into 2018. Increasingly, our growth is being driven by international business, with more and more orders coming from abroad, particularly the United States.'

Rentschler is also planning to increase the size of its workforce significantly by creating approximately 200 new jobs, including process engineers and laboratory technicians in bioprocess development and manufacturing as well as GMP (Good Manufacturing Practices) experts.

Recipharm Expands Blow Fill Seal Capacity in Kaysersberg, France

Recipharm has unveiled plans to invest €18 million to expand its blow fill seal (BFS) capacity at its site in Kaysersberg, France.

The investment will see the introduction of a new blow fill seal high speed filling and packaging line, bringing the total number of lines from seven to eight to meet growing demand for the service.

Preparations will also be made to add a further three filling lines over the coming years, more than doubling the size of the CDMO’s operations from 21,520 sq. ft. (2,000 square meters) to 44,654 sq. ft. (4,150 square meters) and increasing its blow fill seal capacity by 50 percent. The first of the four planned filling lines will allow Recipharm to support more drug developers with the aseptic processing of sterile liquids such as eye care and ear drops into plastic containers.

“We are experiencing increased demand for our blow fill seal services from markets including the U.S., Turkey, Australia and Canada and the new filling line will help us to meet this growing need,” said Yves Buelens, general manager at Recipharm’s Kaysersberg site. “The increased capacity will position us well for future growth and allow us to take on new projects from new customers more swiftly. With the site’s big pharma heritage, we are ideally placed to meet the highest quality and regulatory requirements and are committed to investing in the facility to ensure we can continue to deliver the best possible service.”

PCI Pharma Services Increases Tredegar Site Footprint

Pharmaceutical outsourcing provider PCI Pharma Services has unveiled a footprint expansion program at its site in Tredegar, South Wales.

This most recent expansion program saw PCI Pharma Services acquire a further 26,500 square feet of additional footprint at Unit 6 Tafarnaubach Industrial Estate in Tredegar. This represented a continued expansion of its operations as a fully integrated service provider for the global healthcare industry. The new site will house a number of key departments to support the continued business growth, including offices and laboratories.

The Tredegar site expanded its capabilities in 2013 with the opening of a dedicated Contained Manufacturing Facility (CMF), specifically designed and built to enable the specialist processing of highly potent molecules into tablets and capsules utilizing contained technology. This investment resulted in global industry recognition when the site was awarded ISPE Facility of the Year in 2014, a highly prestigious award.

In 2014, PCI acquired Penn Pharma, adding drug manufacturing capability to its portfolio of services and PCI has continued its substantial investment in this specialization. The site undertook a further investment program increasing capacity of large-scale commercial manufacturing capabilities by means of a single pot granulation process. In 2015, the site added additional granulation capabilities in the form of roller compaction technology providing a granulation technique for those products sensitive to heat and moisture. The Gerteis MiniPactor is also fully contained technology, further complimenting the site specialization for the development and manufacturing of highly potent molecules. 2016 saw continued investment in the form of contained Xcelodose technology, providing a cost- and time-effective option for first in man studies.

“I am delighted that we are continuing to grow and expand as a site,” said Norman Barras, managing director, PCI Pharma Services Tredegar. “This additional footprint will ensure that we are even more able to meet the growth demands of our business and deliver excellence to each and every customer.

“The site has benefited from significant investment over the last five or so years, delivering a center of excellence for manufacturing and uniquely positioning PCI Pharma Services within the global market place. This next phase of investment will help deliver a center of excellence for analytical services.”

Ken Richardson, global vice president, engineering, PCI Pharma Services, said, “With world-leading capabilities for the development and manufacturing of pharmaceutical products, this investment in and expansion of the Tredegar site will ensure that we continue to provide a truly integrated full-service solution to our clients. This additional footprint will assist in securing the growth potential for PCI Pharma Services moving forward.”

Spain's Idifarma Bolstered by Investment from API Maker Suanfarma

Spanish API maker Suanfarma has acquired a stake in contract manufacturer and spray-drying specialist Idifarma, boosting its international presence.

The size of the investment by the Madrid-based active pharmaceutical ingredient (API) firm has not been disclosed but Idifarma business development director Manuel Leal Sánchez said both companies, and their customers, will benefit from the deal.

“Suanfarma is acquiring the shares previously owned by three VC companies in Idifarma. The management of the company, our business model and the services we provide will remain unchanged, but we will count with the help of Suanfarma to grow faster internationally,” he said.

Suanfarma has a strong presence in the US, India, China, Brazil and Mexico, he continued, which fellow Spain-based firm Idifarma is keen to capitalize on.

“Suanfarma's position in those markets might help Idifarma to gain additional clients in those areas, - especially outside of Europe - since Suanfarma is essentially an API supplier, which is usually the previous step for any of our clients to outsourcing the pharmaceutical development and/or manufacturing of their products to Idifarma.

“There can be positive synergies for everyone involved: the clients, Suanfarma and Idifarma.”

While the deal is more focused on share ownership than boosting capabilities, but according to Leal Sánchez, Idifarma has continually invested in spray drying technologies to address clients’ low solubility challenges.

The 37,660 sq. ft. (3,500m2) site in Pamplona houses an analytical laboratory, formulation laboratory and a GMP plant containing a complete spray drying suite equipped with a lab-scale Buchi B290 and a pilot-scale Gea Niro Mobile Minor.

Novartis Biotechnology Center Expansion, Huningue, France

Novartis Pharma is carrying out a major expansion of its biotechnology Centre in Huningue, France. Announced in August 2016, the expansion project will increase the facility's monoclonal antibody (mAb) production capacity by 70 percent.

Investment in the Huningue facility is aimed at capitalizing on the strategic importance of its location in France. The expansion will enable the facility to meet the anticipated growth of products already being manufactured at the site.

"The expansion will enable the facility to meet the anticipated growth of products already being manufactured at the site."

A $100m investment will be made for the project, which is expected to be completed by 2020.

Inaugurated in 2005, the Huningue facility is fully GMP-compliant and Novartis' main site for the production of monoclonal antibodies for the global market. Since the start of operations, Novartis has invested €215m ($240m) to equip the facility with advanced facilities and specialized infrastructure.

The facility initially started with a single antibody and has now become one of the world's biggest producers of active substances by mammalian cell culture. It exports approximately 80% of production to the world market.

Active substances produced by the facility are used for the composition of drugs indicated for the treatment of asthma, psoriasis, renal transplantation and anti-inflammation. The facility also produces active substances required for Novartis' clinical studies. Clinical batches of new monoclonal antibodies in development are also produced at the facility.

The facility was expanded in 2011 to enable production of anti-rejection drugs for kidney transplants. In 2012, Novartis invested another €6.2m ($6.9m) in equipment and infrastructure upgrades to increase production flexibility and capacity of the facility.

The Huningue facility manufactured active ingredients equivalent to three million doses in 2012.

The expansion project will extend the main production building and install new cell culture bioreactors. It will also add a new purification line, which will enable multiple drugs to be produced simultaneously.

Installation of the production facilities is expected to be completed by January 2017, while commercial activities expected to commence in December 2018.

The expansion is expected to generate 100 jobs at the site.

The Huningue facility is equipped with 13 bioreactors of 500l each for the production of antihistamine, Xolair. It also features disposable equipment including bags for media and buffer storage. Disposable bags are used for intermediate storage of product as well as final storage of the drug. A fully-disposable filter system including disposable connectors and tubing is also part of the facility.

The facility is equipped with DeltaV™ digital automation system supplied by Emerson Process Management. Installed in 2005 and upgraded from 2008 to 2010, the system features an integrated Wi-Fi network and mobile operator stations. It provides process and plant information to operators and maintenance crew of the facility. The system also helps in improving efficiency and flexibility of production process across the plant.

Jacobs Engineering Group has been awarded the engineering, procurement and construction management contract for the project.

Expansion of the Huningue facility is part of a major overhaul of Novartis' operations. Overreaching operations and generic competition has eroded the company's revenues. Sales of Gleevec, one of Novartis' blockbuster mAbs, have fallen considerably owing to generic competition.

Focus on cutting costs and increasing the production of biosimilar products has been Novartis' strategy over the last few years. The company has closed down more than two dozen of its manufacturing facilities and is also streamlining its research and development (R&D) activities. These moves are expected to reduce annual costs by $1bn by 2020.

In 2015, Novartis announced its decision to invest €800m ($890m), including €100m ($111.9m) annually in R&D over a three-year period. Novartis has also increased its focus on the production of biosimilars and plans to apply regulatory filings for at least 11 biosimilars by the end of 2017.

Jazz Pharmaceuticals’ Development and Manufacturing Facility, Athlone, Ireland

The facility is the company's first directly owned and operated plant capable of developing, manufacturing, and packaging drug products. It is located on a greenfield site in Monksland in Roscommon County near Athlone, approximately 75mi (120.7km) east of Jazz Pharmaceuticals' headquarters in Dublin.

Expanding the company's presence in Ireland, the Athelone facility enables the company to produce high-quality products for patients. It will initially produce narcolepsy drug Xyrem and other product candidates under development.

Jazz Pharmaceuticals began construction of the $68m facility on 10 February 2014 and received approval from the US FDA, as well as Health Products Regulatory Authority Ireland.

The project was also supported by IDA Ireland and the Irish Government's Department of Jobs, Enterprise and Innovation. It created 160 vacancies during construction and is expected to create up to 50 when operating at full capacity.

The Athelone development and manufacturing facility is designed to adhere to multiple regulatory agencies for multi-product development under current good manufacturing practices (cGMP). It occupies a floor space of 5,150m² (55,434ft²) on a 17 acre site.

The main areas of the plant include the administration building, quality control laboratory, manufacturing units, warehouse, utilities, plant area, and fallow space. The plant accommodates air handling units and electrical panels, while the utility area consists of switch and boiler rooms.

Personal change rooms and the production area are located below the plant, as well as personnel airlocks, process rooms, cleaning rooms and office space. The warehouse contains a shipping area, storage, and a sampling dispensary. It also features functional site infrastructure, such as a waste water balancing system, pump house, emergency generator, underground facilities, site roads, parking spaces, and a firewater attenuation pond.

More than 450t of structural steelwork was required for construction and a total of 75,320 sq. ft.

(7,000m²) of roof and floor metal decking and shot fixed shear studs were also installed. In addition, the entire building is coated with flame-retardant paint.

PM Group provided the front-end design and also coordinated the environmental impact assessment to seek planning permission for the project from Roscommon County Council (RCC).

Killeen Civil Engineering was contracted to provide engineering services, while architectural work was provided by Deveraux Architects.

Elcon engineering was contracted to install low-voltage (LV) and medium-voltage (MV) cable glanding and terminations.

Wills Bros was contracted for construction and the company subcontracted P.McHugh & Sons for installation of electrical and telecom ducting, watermain, and rising foul and foul main drainage.

McIlvaine Company

Northfield, IL 60093-2743

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

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Web site: www.mcilvainecompany.com