Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

On August 4, 2017, Lonza announced that it acquired Micro-Macinazione (Switzerland), a contract manufacturer providing micronization of active ingredients for the pharmaceutical and fine chemical industries, from Cross Equity, a Swiss private equity firm. The acquisition was completed on July 26, 2017. Financial details of the deal were not disclosed.

The acquisition boosts Lonza’s micronization services at its existing micronization clinical and commercial manufacturing site in Quakertown, PA, which Lonza gained through its previous $5.5-billion acquisition of Capsugel (US), a dosage form provider, in early July 2017. Capsugel had gained the Quakertown facility in January 2016 when it acquired Powdersize (US), a contract manufacturer specializing in particle engineering. Lonza/Capsugel has since invested in significant additional capacity at the Quakertown site, which came on stream in early 2017.

A key focus for the new Lonza/Micro-Macinazione combined business will be highly potent APIs (HPAPIs), in which Micro-Macinaziones’s pilot to commercial-scale HPAPI offerings and Lonza’s recent HPAPI capacity expansion at Quakertown will provide the capacity and expertise needed to serve this area of the pharmaceutical market. Micronization via jet milling is an established technique for enhancing the overall bioavailability of drug products by reducing or controlling the particle size of the API. By improving bioavailability, lower drug doses can be prescribed, potentially reducing a patient’s side effects, according to Lonza.

Lonza’s Pharma&Biotech COO, Marc Funk, said in a company press release: “With the acquisition of Micro-Macinazione, Lonza becomes the largest and most diversified provider of micronization services to the pharmaceutical industry. Micronization is an attractive technology for Lonza given its applications across many of the high growth areas of the pharma market. Micro-Macinazione provides micronization technology and expertise that complements our existing US capabilities and provides significant additional capacity to support our growth. Its micronization technology can also add value to other areas of Lonza’ business, including Health & Nutrition ingredients and excipients, enhancing the appeal of this bolt-on acquisition, which strengthens our position across the healthcare continuum.”

ACF Bioservices Completes CGMP Testing Facility

ACF Bioservices has completed construction on its dedicated CGMP-compliant 3,400 square foot facility for gene and cell therapy product testing.

ACF Bioservices develops quantitative cell-based in vitro potency assays to support FDA-mandated product release requirements. These potency assays range from relatively simple protocols to more complex and elaborate designs that determine the mechanism of action of a gene therapy product.

"The dedicated cGMP facility is a natural extension of Absorption Systems' GLP Biology services,” said Patrick Dentinger, president and chief executive officer, ACF Bioservices. “With the emergence of gene and cell-based therapies, in vitro models that predict relative potency in humans is a preferred approach for product release testing and stability testing."

Before the initiation of Phase 3 clinical studies, the U.S. Food and Drug Administration (FDA) mandates a validated potency assay, which is a prerequisite for commercial approval. Once an assay is validated, it is transferred into the dedicated and access-limited ACF Core Facility. All instrumentation and equipment is fully validated and staffed with trained operators who follow established Standard Operating Procedures (SOPs), all in compliance with cGMP guidelines. At this point, the assay becomes a standard protocol that is routinely repeated to support release and/or stability testing of the gene or cell therapy product, which ensures consistency and conformance to pre-determined specifications for each production batch.

ACF Bioservices' parent company, Absorption Systems, develops GLP-compliant in vitro cell-based models utilizing a wide range of molecular biology and cell biology techniques to develop proprietary models for clients in the small molecule and gene/cell therapy space.

Texas Biomed Closer to New High Containment Lab

The San Antonio City Council has authorized a loan of $250,000 to Texas Biomedical Research Institute (Texas Biomed), an independent, not-for-profit biomedical research institution, to help fund a biosafety level 4 (BSL-4) facility on its campus.

In June 2017, Texas Biomed announced that its Board of Trustees had approved moving forward with the construction of its second BSL-4 lab, expanding the organization’s capabilities in developing vaccines and therapies for the world’s deadliest infections (including infectious pathogens with a growing resistance to current treatments).

Texas Biomed’s current BSL-4 laboratory is the only privately owned BSL-4 laboratory in the US.

“Texas Biomed has been a tremendous asset to our City and our nation, working to advance scientific and medical breakthroughs that keep our communities safer and healthier,” said Mayor Ron Nirenberg. “The expansion of the biosafety level 4 lab is crucial to ensuring that this institution, an anchor in our local economy, continues to receive the resources it needs to be a world leader in biomedical research.”

Under the Loan Agreement, Texas Biomed must retain 43 current BSL-4 jobs and create at least nine additional full-time jobs in the new expanded facility.

City Manager Sheryl Sculley said, “Expanding the BSL-4 laboratory and its capabilities will allow Texas Biomed to retain and recruit some of the world’s top scientists in the area of infectious diseases, while also significantly increasing the amount of bioscience research dollars flowing into San Antonio.”

Expansion of the BSL-4 laboratory is part of a larger strategic plan for the Institute under the leadership of recently-hired Texas Biomed President and CEO, Dr. Larry Schlesinger.

“The Institute’s current biocontainment facilities (BSL-3 and BSL-4) must expand if we are to meet the growing demands for discovering more effective diagnostics, therapies and vaccines for these infections,” said Dr. Schlesinger. “We are excited to get started so that we may bring greater innovation, new discoveries and added hope for a safer, healthier future.”

In the past decade, Texas Biomed has contributed significantly to the understanding of infectious diseases. For example, the team has:

demonstrated efficacy of a live vaccine for Lassa Hemorrhagic Fever virus,
identified new inhibitors of Ebola virus disease in systematic screenings of FDA-approved drugs,
identified a viral component that is important for Ebola virus replication and could serve as a potential target for antiviral therapy. This finding was selected by the National Institutes of Health as a top discovery in 2015.

The Institute is also making major advances in new therapies and vaccines for HIV, malaria and tuberculosis, which combined accounts for the majority of human suffering and death due to infections worldwide.

Kansas’ Only Medical School Receives New Building

The building was designed to enhance the medical campus’ existing facilities, curriculum, and classrooms.

Missouri isn’t the only state with a new medical center designed to address the shortage of healthcare professionals as the University of Kansas Medical Center recently opened the Health Education Building with the same goal in mind.

The Health Education Building is a four-story, 171,000 sq. ft. building designed by Co Architects and Helix Architecture that includes high-tech simulation environments and flexible learning studios. Large-scale teaching studios and clinical skills and simulation labs support active, team-based learning.

Two 225-person interactive studios are separated by an operable partition that can be removed to create one column-free 11,000 sq. ft. event space. The studios and labs “float” within the outer glass façade of the building to show off the core of the building’s curriculum to the public.

From the outside, the building’s design uses a transparent “lantern” box design. The ample use of glass allows students to receive natural daylight and provides them with exterior views.

The Health Education Building’s design also called for an on-grade parking lot to be changed into a 22,000-sf green courtyard and a 17,000 sq. ft. vegetated roof with access. The irrigation system for these features uses condensate water from the building’s mechanical system.

A 250-foot-long glass-enclosed bridge passes through the center of the Health Education Building and connects it to existing buildings on the Kansas City campus. The bridge links the campus into a loop that provides 6,000 sq. ft. of lounge, meeting, and student activity space.

The Health Education Building was designed with flexibility in mind and can accommodate a 25% class size increase over its current enrollment.

Avista Pharma Completes Durham HQ Expansion

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

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

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

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

Cambrex Expands HPAPI Footprint

Cambrex Corporation, a manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), is investing $24 million in a new facility to manufacture highly potent APIs (HPAPIs) at its Charles City, IA plant.

The 4,500 sq. ft. production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m³ and have a total reactor capacity of 2,200 gallons, which will be made up from a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300kg.

The project will also reconfigure the existing small scale manufacturing area providing a single high containment building to support early stage development and manufacturing, providing flexibility across a broad range of scale. Construction and installation of all new equipment is expected to be completed by Q1 2019.

“This expansion is in line with Cambrex’s commitment to ongoing investment in small molecule manufacturing, as well as responding to the rising number of APIs that require specialized handling due to potency and toxicity,” said Shawn Cavanagh, chief operating officer, Cambrex. “Cambrex has built a strong reputation in the clinical-scale supply of potent, and extremely potent molecules, and the flexibility that this facility will give allows us to effectively handle projects throughout their development and commercial life-cycle.”

This latest expansion is part of an ongoing strategic campaign to invest in small molecule API development and manufacturing across Cambrex’s global network of facilities, and follows the opening of a $50 million, 7,500 sq. ft. multi-purpose manufacturing facility at Charles City in 2016, which added a total of 70m3 of manufacturing capacity to the site.

Cambrex’s Charles City, Iowa facility is located on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of a limited number authorized by the U.S. DEA to import narcotic raw materials at commercial scale.

SGS Expands Lincolnshire, IL, US, Facility

The pharmaceutical and bioanalytical contract solutions provider is expanding its facility in Lincolnshire, in the northern suburbs of Chicago, Illinois.

The expansion will increase the site’s current footprint from 38,500 sq. ft. to nearly 58,000 sq. ft. and is due to be completed by September 2017.

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

James Nokes, VP of US Agriculture, Food and Life at SGS, said: “This investment allows us to be flexible in our approach to meeting both existing and future customer demands. Analysis and bioanalysis techniques continue to evolve rapidly, and are driven by technological advances and regulatory needs.

"At SGS, it is our aim to ensure we can offer our clients integrated solutions to support their needs, so we continue to invest in capabilities, capacity and our staff to maintain our professionalism and efficiency.”

The expansion at SGS’s Lincolnshire site follows a series of recent investments at the company’s global laboratory network. Increases in extractables and leachables capabilities have taken place at Fairfield, NJ and Shanghai, China; while French facilities at Poitiers and Villeneuve-la-Garenne have seen investment in bioanalytical capabilities and elemental analysis respectively.

In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance, and regulatory consultancy.

Seattle Genetics Gains First Production Site through BMS Plant Buy

Seattle Genetics paid Bristol-Myers Squibb $17.8 million for the bio manufacturing site and says it will spend a further $25.5 million on equipment and improvements to support antibody production.

The 51,000 sq. ft. facility, located near Seattle Genetics’ corporate headquarters in Bothell, Washington, will be used to make antibodies for the firm’s current and future pipeline.

It becomes the antibody-drug conjugate (ADC) maker’s first in-house production facility after it shelled out $17.8 million (€15 million) to buy the site from Bristol-Myers Squibb (BMS).

“This newly acquired in-house manufacturing facility complements our existing extensive network of contract manufacturers,” said a Seattle Genetics spokesman.

“The facility is fully operational and meets our near-term production needs, which is part of the appeal and value for us. We will evaluate renovation and expansion options as we move forward and identify the best way to maximize the facility to support our pipeline.”

Specific details of which antibodies would be made at the Bothell site - which opened in 2014 - were not disclosed but we were told there are plans to manufacture the antibody component of both Seattle Genetics ADC and immuno-oncology pipeline programs, while conjugation capabilities could also be added at the site.

Seattle Genetics is one of a handful of companies to have gained regulatory success with an ADC drug. Its product Adcetris (brentuximab vedotin) was approved in the US in 2011 and last year it clocked in $266 million of sales revenue for Seattle Genetics.

Under terms of the Asset Purchase Agreement, Seattle Genetics will pay around $25.5 million to acquire equipment from BMS and make improvements at the site.

The firm will also retain all 75 BMS employees plus some contract staff who currently operate the facility.

While BMS has invested heavily in its bio-manufacturing sites – including continued expansions at its Orencia (abatacept) production site in Devens, Massachusetts and a $900 million investment in a 322,917 sq. ft. (30,000 m²) biologics facility in Ireland – it has been reshaping its network over the past decade, reducing its number of plants from 27 to 11 since 2007.

Gilead's Facility in La Verne, California

Biopharmaceutical firm Gilead Sciences has opened a facility in La Verne, California, US, which it says will boost manufacturing volumes.

The campus “will help the company substantially increase future manufacturing capacity with state-of-the-art equipment and processes to produce high quality products for decades to come,” said spokesperson Michele Rest.

The 350,000 square foot site will employ up to 500 people once the facility is fully operational, said Rest.

Rest said us the facility will manufacture products currently made at another Californian site. “Our La Verne campus will manufacture all of the products currently being made in San Dimas, as well as any new products launched by Gilead going forward.”

Rest said the first product to be manufactured at the La Verne plant is AmBisome (amphotericin B) liposome for injection, which treats fungal and parasitic infections.

“Our La Verne facility will also package, label and distribute more than 20 different product brands, including our cure for hepatitis C, as well as treatment for hepatitis B and HIV/AIDS,” she added.

Hikma Expanding Injectables Capacity

Hikma has ramped up capacity at manufacturing facilities in the US and Portugal manufacturing to meet the growing demand for its lyophilized and oncology products.

Hikma Pharmaceuticals reported group revenues of $895 million (€760 million) for the first half 2016, up 1% on the same period last year. Capital expenditure for the period was $47 million, including around $28 million to expand its Cherry Hill, New Jersey facility and around $8 million at its site in Portugal as part of plans to increase injectables manufacturing capacity for lyophilized and oncology products.

As such, the firm expects to add significant capacity at the two sites by the end of the year, including an additional 80 million pre-filled syringes, pushing total capacity to 100 million across its network, up from just 20 million in 2016.

Lyophilization space is set to triple by the end of the year to 1,894 sq. ft. (176 m²), while the firm will also push cephalosporin capacity from 46 to 70 million units.

During a call to discuss results, CEO Said Darwazah told investors the investments were to meet demand for Hikma’s generic and branded injectables. “Increasingly, our customers want ready-to-use products. We are ensuring we have adequate capacity to meet this growing demand.”

The firm is also looking beyond this year through a dedicated oncology injectables facility at the Portugal site.

A spokesman from the firm said the site in Terrugem – about 20 km northwest of Lisbon – exports injectables from Portugal to the US and MENA markets and the dedicated oncology facility is expected to be operational in 2019.

While the specific quantum of investment of the new facility was not disclosed, it will bring Hikma 100 million units of liquid capacity (currently its network has capacity for 20 million), and up dedicated lyophilization space for oncology products up by 592 sq. ft. (55m²) on Hikma’s current 377 sq. ft. (35m²).

Science at City University of New York

City University of New York’s “Decade of Science,” designated by the university to cover the years 2005 to 2015, included the cluster hiring of new faculty, establishment of a program to prepare science and math teachers, making new investments in graduate student support, introduction of after-school and summer courses to boost interest in science among middle and high school students, expansion of science competitions — and, crucially, the provision of $1 billion to fund the construction and modernization of science facilities across the university’s colleges.

The capstone of this effort was the opening, in September 2014, of the Advanced Science Research Center (ASRC) and the City College Center for Discovery and Innovation (CDI), two buildings totaling 400,000 square feet that share a ground-floor level housing TEM, SEM, and MRI imaging facilities; NMR suites; and multiple cleanroom labs.

On the floors above that, the objectives of the two buildings diverge. Space in the four-story CDI is devoted to research labs led by senior faculty and populated by graduate and undergraduate students, support areas, offices and conference rooms, and it is intended for use by City College faculty and students. The five-story ASRC, on the other hand, has a broader mission, to house nanotechnology, neuroscience, structural biology, environmental sensing and photonics, with the idea that multiple disciplines will in the future work together on some of the most pressing science issues of the day.

Prior to the project’s opening, CUNY (the nation’s largest public university system) was already successful in its scientific efforts and programs, in attracting top researchers and gaining grant funding, but this renewal of its commitment to science and research is a huge step forward, and the arrangement of space devoted to the effort is apparently without precedent.

Flad Architects designs both undergraduate teaching labs and graduate-level research environments, and the critical difference between the two is that teaching labs are designed to permit textbook science — typically, the professors are in place and consulted beforehand, and the coursework is itself a known quantity. By contrast, a research institute of the type conceived by CUNY is put together without knowing who the different disciplines’ directors will be, or exactly what equipment will eventually be brought into the space. Flexibility is therefore paramount, and in the case of CUNY, where the five disciplines would each inhabit a separate floor, a collaborative framework would have to allow the different researchers and support scientists to interact and work together. Whereas a teaching lab opens and is ready for immediate occupancy, design of a research institute is ongoing, as the disciplines’ directors and their research teams are added and the parameters of the research are fleshed out.

Everyone involved in the development of a new research facility, from the owner to the users to the planners and designers, understands that how the building has to function will dictate certain aspects of the design. While older codes allowed the ASRC to place fume hood-dense labs on upper floors, minimizing distribution of ductwork, most buildings will be bottom-heavy where labs are concerned, so that relevant codes governing allowable amounts of chemical substances can be met, and so that vibration-sensitive equipment rests on the most cost-effectively stable surface available. Routes into and out of the building become more visible and voluminous because of the need to accommodate the movement of large pieces of equipment and large amounts of chemical substances. The research spaces themselves, in order to accommodate the science, will nearly always hew to an orthogonal shape. This means that other components, such as the lobby, conference rooms and offices, can be used to wrap the rectilinear research spaces in contrastive fashion, adding a dynamic and attractive counterpoint that naturally brings building inhabitants together. Each of the new buildings at CUNY utilizes this technique — two rectangular building masses hinge at a central circulation volume, but the exterior’s sinuous lines result from the placement of offices and public spaces that face the science plaza between the two.

Nurturing collaboration among the five disciplines means opening the different floors to each other, which the ASRC does through the introduction of vertical circulation, conference rooms and less-formal gathering places within the central portion of the building. Conference rooms clad in curved clear and frosted glass promote visibility within the atrium and in some cases are used as dry-erase work surfaces, as well. Horizontal circulation is pulled to the opposite side of the ASRC, bringing stunning views of the city to public corridors, encouraging researchers to linger there.

Within lab spaces, a number of different techniques advance the cause of flexibility, which is essential to making research facilities efficient. These include expanded floor to floor heights; column spacing that permits an open floor plan; a modular utility infrastructure, with power accessed from cables that descend from the ceiling; and the specification of lab furniture systems that are movable or feature prewired and pre-plumbed utilities.

Flexibility was particularly critical in the design of the ASRC, given that the entire organization at the time that programming began consisted of one person, then-vice chancellor Gillian Small, who has since moved to another university. While the planning and design process was driven by her vision for developing a truly exceptional interdisciplinary and collaborative environment in which to conduct the highest levels of scientific research, the labs would have to be conceived as somewhat generic spaces that could be fine-tuned once each new director was named by the university. Flad knew the science but not the scientists, a circumstance that has gradually changed since CUNY began occupying the building two years ago.

The long timeline associated with the planning and design of large, sophisticated research buildings makes alterations more the rule than the exception. By its nature, technology changes rapidly, and these types of projects are so technically dependent that architects like Flad who specialize in them have to keep many areas of new buildings in a state where they can continue to accommodate alterations without the necessity of tearing everything apart.

For example, ASRC’s ground floor imaging lab, which houses electron microscopes, fMRI and NMR equipment, was designed around very specific environmental parameters. However, some of the newer TEMs, introduced since the design and opening of the ASRC, have a much tighter tolerance than the older versions in terms of temperature and humidity stability. The greater sensitivity of these new instruments requires that the lab’s mechanical systems are upgraded to follow suit, so that the study of samples isn’t disrupted by fluctuations in temperature or humidity.

A long timeline also describes the movement of scientists from research institution to research institution, which isn’t instantaneous by any means. CUNY’s particular circumstances since the ASRC opened, with new directors coming on board gradually, aren’t extraordinary but have required ongoing consultation and changes (Flad, which was architect of record and lab planner for the project, has since had a series of new contracts with CUNY that delineate consultation and construction administration services moving forward). One aim of Flad’s continuing involvement is to answer users’ questions and help show them how to use the facility, and in particular to help program administrators understand where they can make modifications and where they can’t. The primary goal, though, is to help scientists like Patrizia Casaccia, who was named last August as the founding director of the center’s Neuroscience Initiative, get started in the ASRC. Forthcoming renovations to the neuroscience floor will include accommodations for unique equipment and movement of casework, with everything modifiable within the basic layout of the original, flexible lab module (Flad performed the same type of work on the structural biology floor, and is beginning similar work on the environmental sensing floor).

In all of these circumstances, CUNY has been able to take great advantage of the amount of time it is taking to fully populate the building, aided by the flexibility built into the original plan.

Another good example is in photonics, which as of this writing has yet to name a director. As a result of discussions with one candidate for the position, CUNY opted for a significant change to bring the building in line with that candidate’s current facility — the addition of an ultra-low vibration chamber — under the assumption that this high-tech space, which when planning began in 2006 wasn’t on CUNY’s radar, would be a requirement of whatever forward-thinking scientists the university eventually attracted. Making the change meant the takeover of shell space that had been intended as expansion space for future program areas, which rested on a slab sitting on bedrock. Fortunately for CUNY, Flad had intentionally depressed the slab below the finished floor level by 18 inches in anticipation of floor drains that might be necessary in an expansion, and this allowed for the addition of concrete inertia blocks supported on tuned pneumatic isolators.

Inside the ASRC, neuroscience researchers map the brain’s biochemical circuitry, hoping to provide solutions in the quest to understand and fight Alzheimer’s disease. Nanoscientists seek advances that might lead to new medical treatments. Opportunities for partnerships in pushing the boundaries of applied research abound. But the ASRC’s influence will reach broader CUNY networks (for example, its 55 neuroscience laboratories) and go even farther afield. David Salmon, the ASRC’s facility director, notes the building’s preponderance of core labs, which are shared among the building’s five disciplines but are also available on a pay-per-use basis to outside researchers, something that helps cover operational costs. High on this list is the 4,000-square-foot Nanofabrication Facility, a sophisticated clean room environment that is proving to be one of the most heavily utilized core facilities, with 300-some users not only from the ASRC and other CUNY campuses, but from other academic research institutions and private industry, as well.

“Its core facilities that provide opportunity for scientific processes or analysis, and all the equipment researchers need are there,” Salmon says. “For example, the fMRI suite is there for the neuroscience director and her staff to use, but meanwhile, there are plenty of people in the CUNY system that are ready to use it as soon as it’s up and running. You need state-of-the-art tools if you’re going to have a first-class research facility.”

Salmon, and everyone involved in the ongoing ASRC project, expects those tools to change, just as the researchers will and the focus might, over time. The flagship project of CUNY’s Decade of Science, the nucleus of the university’s science enterprise, will be able to change with it. %

David Halpern (dhalpern@flad.com ) is a senior associate and project manager with Flad Architects in New York City.

ABEC Has 4,900L Single-Use Bioreactor

ABEC says its latest offering has twice the working volume of the 2,000L bioreactor systems generally deemed to be the upper limit in single-use bioprocessing.

Increased titers combined with a shift away from large-scale dosage demands have made single-use bioreactors a viable option for commercial bio-manufacturing.

But the significant pressure from the increased weight of the liquid medium in larger volume bags, coupled with the significant learning curve for an end-user to manage, has meant “2,000L is really a ceiling for single-use bioreactor bags,” said Eric Isberg from the trade association Bio-Process Systems Alliance (BPSA).

Therefore it is no surprise the major vendors of disposable bioprocessing systems – Sartorius, Thermo Fisher, GE Healthcare and MilliporeSigma – all offer a maximum of 2,000L in their bioreactor ranges.

But one supplier, Bethlehem, Pennsylvania-headquartered ABEC has bucked the trend, and after launching a 4,300L bioreactor (with 3,500L of working volume) in 2015 is now upping the volume further, launching a single-use bioreactor with a production volume of 4,000L it says overcomes disposable systems’ limitations and performs comparably to stainless steel.

“The total volume is nominally 4,900L but it can be customized for the application, as can all other aspects of the system,” said ABEC spokeswoman Susan Cooper-Curcio.

She added the issue of increased pressure from a system bearing double the weight of cell culture and media is a “non-issue with simple support structures at the lower ports,” and furthermore the bioreactor would take up approximately the same floor space as a 2,000L unit.

This ability to redefine the process economics of single-use, as well as provide a much larger process window within a single-use bioreactor is driving “significant” demand for larger systems, she related, as is the reduction in cost of goods where “dramatic reductions” are possible based on a drop in consumables, facility and operating costs using larger systems.

With such demand and cost benefits, we asked Cooper-Curcio why rival suppliers have stopped at the 2,000L limit:

“Other vendors have developed standardized designs in line with their legacy consumables businesses. These designs have relatively poor mixing and mass transfer performance, especially at the larger scales. Performance is already compromised at 2,000L, and their designs are not scalable larger than that.”

Largest Sterilization Facility in Sterigenics' Global Network

Sterigenics International LLC, the leading global provider of contract sterilization, lab services, gamma technologies and medical isotopes, and a portfolio company of Warburg Pincus and GTCR, announces the completion of another major expansion, this time to its Fort Worth, Texas facility, making it the largest sterilization facility in the company's global network.

The $17.5 million expansion includes the installation of a new, state-of-the art Nordion JS10000 gamma irradiator that will dramatically increase Sterigenics' total capacity, allowing customers to better address their geographic needs by taking advantage of Fort Worth's growing importance as a commercial gateway to the United States.

"Fort Worth's location along major transportation links makes it a natural distribution and logistics hub for manufacturers and for imports into the United States," said Philip Macnabb, President of Sterigenics. "Our investment gives Sterigenics the extra capacity we need to benefit from these opportunities and will help make us the provider of choice for sterilization services in the Southwest."

Opened in 1984, Sterigenics' Fort Worth facility provides routine gamma, GammaStat^® rapid processing and process validation, and offers laboratory testing services through its Nelson Labs business. The expansion increases the facility's total sterilization throughput by 60%, adding 50,000 pallets per year in capacity, 20 new employees, and 60,000 sq. ft. to the building's footprint. At 145,000 sq. ft. Fort Worth is now the largest operation in Sterigenics' global network.

"Local and regional demand for sterilization in Fort Worth has been growing for years," said Aaron Morrison, General Manager. "This additional gamma capacity can shorten turnaround times for sterilization customers, helping them get their products into the market faster."

To address the growing need for sterilization in many parts of the world, Sterigenics is making significant investments in technology to expand both Gamma and Ethylene Oxide (EO) capacity throughout its global network. On the Gamma side, in June, 2017, Sterigenics completed a project that tripled throughput at its operation in West Memphis, AR, and opened a significant expansion in Gurnee, IL, in 2015. In addition, Sterigenics has expansion projects underway at its EO facilities in Ontario, CA, Costa Rica, and Wiesbaden, Germany. Further announcements are expected in the near future.

Jinyu Bio-technology Research Facility in Kansas

China's largest animal vaccine company Jinyu Bio-technology unveiled plans to establish its first US-based vaccine research lab and office facility in May 2017.

The new facility will be situated within the Kansas State University Office Park phase II building, which is located on north side of the Kansas State University in the city of Manhattan, Kansas.

The ceremonial ground-breaking for the project was held in June 2017.

Jinyu's new laboratory is scheduled to become operational in August 2018 and will employ between four and six scientific researchers, who will focus primarily on animal health research.

Jinyu USA will also collaborate with the State of Kansas, the City of Manhattan and Kansas State University to develop and produce new animal health products for the Chinese, Asian, African and American markets.

Jinyu's vaccine research lab and office facility will house three offices, a 2,400ft² research lab 800ft² and cleanroom space.

The site will feature state-of-the-art equipment to conduct research and design of vaccines to treat and control parasites in swine and cattle.

The facility will also focus on the development of educational materials to assist Chinese companies and veterinarians.

The new facility is part of the 60,000ft² phase II expansion of the Kansas State University Office Park, located in the Kansas City Animal Health Corridor.

It is being developed by the fundraising arm of Kansas State University, KSU Foundation.

The site will be situated close to approximately 300 animal health companies, the Kansas State University College of Veterinary Medicine, the National Bio and Agro Defense Facility, Biosecurity Research Institute, and several cutting-edge research facilities.

The company intends to deploy its future manufacturing facilities in the Corridor.

Jinyu held discussions with the officials of the state of Kansas, the city of Manhattan, and other organizations for two years for the construction of the research lab and office in the Kansas State University Office Park building.

Jinyu's new vaccine research site will allow the company to build long-term, mutually beneficial relationships with partners in Kansas.

It will also help the company to develop technical innovation and expertise in animal health research.

"Jinyu's new laboratory is scheduled to become operational in August 2018 and will employ between four and six scientific researchers, who will focus primarily on animal health research."

Additionally, the incorporation of Jinyu's new laboratory into the Kansas State University Office Park phase II building is expected to support Kansas State University's research and development activities in the biopharmaceutical sector.

The facility will also contribute to the economic growth in Pottawatomie, Riley and Geary counties by creating employment opportunities and partnerships.

Jinyu Bio-technology was founded in March 1993 and has an employee base of approximately 1,100. It is currently headquartered in Hohhot, the capital city of Inner Mongolia.

The company is engaged in the development, manufacturing and sale of foot and mouth disease (FMD) vaccines and veterinary biological products to Chinese and international markets, including Mongolia, Bangladesh and Egypt.

Jinyu was responsible for the construction of China's only Veterinary Vaccine National Engineering Lab in 2008, which covers 117,327 sq. ft. (10,900 m²) and conducts scientific research and experiments relating to animal health, and the production of veterinary vaccines.

The company is currently building Jinyu International Biotechnology Industrial Park in Hohhot, China, to research and develop advanced animal vaccines. The park is expected to be opened in 2018.

Virginia Cancer Specialists (VCS) Research Facility, Virginia

Virginia Cancer Specialists (VCS) opened a phase I clinical research facility in Fairfax, Northern Virginia, US, in June 2017.

The new state-of-the-art facility will provide the space and equipment required to carry out early-stage drug development and advanced cancer trial programs.

VCS is capable of offering a higher number of clinical trials compared to other facilities in the region.

It also facilitates access to a vast number of emerging treatment options to patients, which are not yet approved by the US FDA.

The new facility will enhance VCS' cancer research program by improving its overall phase I clinical capabilities.

The clinical facility has total floor space of 4,000ft² and includes four treatment chairs equipped with special heating and massage features.

The site's design provides a comfortable and peaceful environment, while enabling communication and bonding among patients.

Each of the facility's treatment areas can be closed with curtains to offer private space for the patients.

The phase I clinical trials protocols often require patients to be present on site for more than 12 hours, and the facility has provision to accommodate the resident's family members and caregivers accordingly.

It includes a committed team of experts such as physicians, data coordinators, nurses and clinical research coordinators that are trained in clinical research among its staff.

Additionally, the facility contains a number of pharmacists who can ensure strict adherence to testing standards, and offer specialized nursing services round-the-clock to monitor the patients.

VCS established the new phase I clinical facility to realize its long-term objective of transforming the site into an Immuno-Oncology Centre of Excellence.

The company notes that phase I clinical trials are usually only available at large academic research centers, and very few companies can offer phase I services during the initial stages of drug development.

"The new state-of-the-art facility will provide the space and equipment required to carry out early-stage drug development and advanced cancer trial programs."

The new facility will enable VCS to focus on investigational immuno-oncology (I-O) trials, while providing patients with access to promising new therapies.

I-O therapies are the latest advancement in cancer research and have proven tolerability and strong responses after the completion of treatment in the cancer community.

VCS is a cancer care and research center based in Northern Virginia and has been carrying out phase 1 clinical trials since 2013.

It has also been offering the most advanced cancer treatment facilities to patients for more than 40 years.

The research center has a total of nine offices across Northern Virginia, which offer the latest treatment technology to help achieve the best outcomes for patients.

It also has a number of cancer specialists, including oncologists, hematologists, oncology nurses, and oncology pharmacists.

The addition of the new facility further enhances the VCS' ability to provide novel early-stage studies, while also allowing the company to carry out ground-breaking trials and focus on promising new advancements such as immunotherapy.

Pfizer Commits to Gene Therapies Plant in North Carolina

Pfizer will spend about $100 million to expand a gene therapy manufacturing operation in Sanford, North Carolina that it acquired last year in its $688 million deal for Bamboo Therapeutics.

Pfizer committed to building a $100 million gene therapies plant in North Carolina and in exchange, North Carolina committed to providing the drug maker with a quarter-million dollars' worth of help.

Pfizer will expand an 11,000-square-foot plant in Sanford, North Carolina that it acquired last year when it bought gene therapies biotech Bamboo Therapeutics in a deal valued at up to $688 million. Bamboo bought the facility last year from the University of North Carolina about the time that Pfizer made is initial investment in the company.

The drug maker considered building a facility in Massachusetts where it has other research and manufacturing operations but decided on North Carolina where it will receive a $250,000 performance grant from the state for the project and its 40 jobs.

“Pfizer is proud to further expand our presence in North Carolina, particularly as we build our leadership in gene therapy,” Lynn Bottone, site leader at Pfizer Sanford said in a statement. “We look forward to the next phase of this expansion as we build a clinical and commercial manufacturing facility.”

A Pfizer spokeswoman said in an email that it was too early in the process to provide any details about the size of the expansion or when it might be producing materials.

Bamboo has already produced phase I and II materials in the facility using what Pfizer said was “superior suspension, cell-based production platform that increases scalability, efficiency and purity.”

Bamboo is working on gene therapies for certain rare diseases related to neuromuscular conditions and the central nervous system. With gene therapies, genetic material is introduced into a patient’s body to replace mutations that cause disease and the expectation is that treatments may cure the condition.

Pfizer is among a number of companies exploring the new area and added to its portfolio this spring when it struck a licensing deal with Richmond, California-based Sangamo Therapeutics, which is working on gene therapies for treating hemophilia A. Under the deal, Sangamo got $70 million upfront and could gain $475 million in biobucks and sales royalties on any medications from the collaboration that gain approval.

Others are building manufacturing facilities as well. California-based BioMarin, recently completed the renovation of a 25,000-square-foot building in Novato, California, for manufacturing the gene therapies for hemophilia A which it has in clinical trials, the Marin Independent Journal reported.

Pfizer R&D Facility, Chesterfield, Missouri, United States of America

US-based biopharmaceutical company Pfizer began the construction of a new research and development (R&D) laboratory and office facility in Missouri, US, in June 2017.

The new facility will be located at 875 West Chesterfield Parkway in the city of Chesterfield, St. Louis County, and is set to accommodate more than 450 scientists and researchers and create up to 80 new jobs in the state.

Pfizer aims to transfer its current R&D and manufacturing facilities at the Monsanto Chesterfield Village Research Center and at the Missouri Research Park in St. Charles County to the new Chesterfield building, which is scheduled to be completed in 2019.

The new facility will help increase the company's product and process development capabilities in biologics and vaccine therapy, while strengthening its overall presence in the region. Pfizer's new R&D campus has been designed in accordance with LEED sustainability certification standards.

It will incorporate flexible laboratory layouts, utility spaces, scientific casework, advanced conferencing technologies, and open office design to encourage a collaborative work environment.

The lab section is linear in shape and will be situated parallel to the office zone. A generous corridor will connect the lab with the office space to ensure easy access to both sections. The first floor will feature a dining facility, while the other floors will be provided with a centralized cafe.

Pfizer's new state-of-the-art manufacturing and process development facility is set to cover an area of 295,000ft², and will allow the company's BioTherapeutics Pharmaceutical Sciences group and partners to conduct research and development activities.

A team of researchers and scientists will be employed at the new facility to develop manufacturing processes and dosage forms using analytical technologies, non-GMP manufacturing and scale-up studies.

The work conducted at the facility will help develop new biotherapeutic medicines for inflammation, vaccines, immunology, oncology, internal medicine, monoclonal antibodies, rare diseases, and biosimilars.

Pfizer initially unveiled plans to build the Chesterfield facility in November 2016. The site plan was then approved by Chesterfield's Planning Commission in January 2017.

Total investment on the new facility is estimated to be approximately $200 million.

The State of Missouri and St. Louis County agreed to offer a strategic economic incentive.

Pfizer selected a team comprising CRG, Forum Studio, and Clayco to design, construct, finance, manage and lease the new facility.

Clayco and its subsidiary CRG are providing design-build services, while Ewing Cole and Forum Studio are responsible to provide landscaping design, engineering and architecture, as well as interior and lab design.

Pfizer was established in 1849 and is primarily engaged in the development and manufacture of medicines, vaccines and other healthcare products.

The company has a global presence in 46 countries and a workforce of approximately 96,500. It currently has 63 manufacturing facilities worldwide, including St. Louis, Missouri; Pearl River, New York; Cambridge and Andover, Massachusetts; Groton, Connecticut; Sandwich and Cambridge, UK; and San Francisco and La Jolla, California.

Pfizer reported $52.824 billion in revenues for the fiscal year 2016.

AJ Manufacturing Moves to Larger Facility

AJ Manufacturing, supplier of stainless steel air distribution products for critical environments, recently completed its move into a new 70,000-square-foot manufacturing facility and headquarters building that has resulted in a 50 percent increase in capacity.

The company, which specializes in serving critical environments such as hospitals, laboratories, and cleanrooms, produces a range of standard and custom stainless steel HVAC products, including diffusers, grilles, dampers, and louvers. McNeil Pharmaceuticals, Walter Reed National Medical Center, University of Kansas Hospital, and University of Texas Health Science Center are among users in the pharmaceutical, medical, and healthcare space.

The new facility in suburban Kansas City, MO more than doubles the space of AJ’s previous manufacturing plant, according to the company. A new tower loader for its laser cutting machines gives the company multiple automated high-speed lasers capable of running 24 hours a day. The facility also features a new powder coating system for a more homogeneous finish with improved color quality.

“We were able to design the new building from the ground up to maximize efficiency and plan for future growth. The increased space and new equipment will speed production, dramatically increase capacity and help reduce our already excellent lead times,” Tony Williams, general manager of AJ Manufacturing, said, adding that the company's Criti-Clean fan filter unit includes higher cubic foot per minute (CFM) output, room-side CFM display and control, and optional built-in surgical-grade lighting.”

Whitehouse Labs Expands Capabilities

Whitehouse Laboratories has expanded its drug delivery device testing capabilities to encompass the full series of ISO 80369 standard test procedures. The ISO 80369 series of eight test standards provides comprehensive evaluations of fittings for medical device and drug delivery systems. With this recent expansion, Whitehouse Labs becomes one of the only facilities in the United States to provide compliance testing services for these standards.

“At the end of 2016, a full gamut of specifications and performance test methods were published by ISO to reduce the risk of misconnecting fittings in medical procedures. Through the design of connectors for specific procedures and applications, it is now very difficult for healthcare providers to physically connect delivery devices from one procedure to the next,” said Mark Stier, Vice President, Global Analytical Sales and Business Development. “To meet the drug delivery device industry’s demand for testing of new fittings, Whitehouse Laboratories is now fully equipped to cover all eight standards with the required gauges and reference fittings to evaluate compliance to this series of test requirements and implement the latest standards in response to regulatory and customer demands."

Alcami Announces Global Headquarters Transition to Durham

Alcami announced plans to transition its global headquarters to Durham, North Carolina. The decision to expand Alcami's presence within Research Triangle Park (RTP) reinforces its commitment to the ongoing innovation and growth within the region.

"We are very excited about this relocation, which prominently positions Alcami in a region known for its culture of diverse expertise, cutting-edge innovation and invention," said Dr. Stephan Kutzer, Ph.D., Alcami President and Chief Executive Officer. "Our stronger presence in the Triangle is necessary to meet the evolving needs of our clients, accommodate growth, recruit top talent, and attract investors and new customers."

Alcami employs approximately 50 people at its current Durham, NC laboratory services site and anticipates adding critical new jobs to support its technology expansion into biologics and establishment of its new headquarters location in 2018. The company will continue to house executive offices in both its current Wilmington, NC headquarters and Durham, NC facilities until the full transition is complete.

Alcami will maintain its strong community ties in Wilmington, NC, where it employs over 450 employees and recently established a collaboration with the University of North Carolina Wilmington. The company remains committed to its Wilmington manufacturing and laboratory operations, where it recently invested approximately $6 million as part of its 5,000 sq. ft. laboratory services expansion and serialization upgrade for drug product packaging. Alcami's Wilmington operations account for approximately 35 percent of the company's overall business

Luye Life Sciences Opens Boston R&D Center

The Luye Life Sciences Group announced the opening of its new Boston R&D Center, the second global R&D facility set up in the United States. The Boston R&D Center will collaborate with multiple business divisions of the Luye Life Sciences Group including Luye Pharma, Luye Medical, and Luye Diagnostics.

As an integral part of Luye Life Sciences Group's global R&D system, the newly-built Boston R&D Center will focus on international R&D collaboration. Joint efforts between Chinese and U.S. teams will accelerate the research and development of new drug candidates in key disease areas. The Boston R&D Center will act as an important center of excellence to internalize novel early-stage biopharmaceutical assets and disruptive drug delivery technologies.

"The opening of our Boston R&D Center marks another milestone in the Group's exploration of pharmaceuticals," said Dr. Youxin Li, Global R&D President of Luye Pharma Group. "Building on existing R&D platforms for the drug delivery system（DDS）and Mab biosimilars, Luye Pharma is moving towards next-generation biopharmaceutical products and intelligent drug products. With Boston's leading position in the global biopharmaceutical industry, we look forward to laying a solid technical foundation through collaboration on new platforms and projects, to help ensure the sustainable pipeline development of Luye Life Sciences Group."

Several biotechnology companies have already expressed their interest in working with the Boston R&D Center, tracking and analyzing a number of new early-stage drugs and technologies. These projects will effectively promote and strengthen the R&D capabilities of Luye Life Sciences Group in key areas such as cancer, schizophrenia, depression, cardiovascular anomalies, and Parkinson's disease.

Luye Life Sciences Group currently has operations in China, the United States, Europe, Australia, Singapore, South Korea, and Japan. Globally, the Group has 15,000 employees, of which more than 60 percent are from outside of China. The Boston R&D Center will support the Luye Life Sciences Group to accelerate its globalization strategy and realize its vision of becoming one of the most respected global leaders in the healthcare industry through optimization and integration of global R&D resources, international talent recruitment and exchange, and cooperation on various new projects and technologies.

Avantor Opens New Life Sciences Research Center

Located in Bridgewater, NJ, Avantor’s new Innovation Center serves as a rapid response research hub to help biopharma and pharma customers solve their drug development challenges.

Avantor has opened a new research center in Bridgewater, New Jersey to help biopharmaceutical and pharmaceutical customers with a full range of upstream and downstream processes, from gene to protein expression through final formulation and drug delivery.

With nearly 27,000 square feet of laboratory space, Avantor’s Bridgewater Innovation Center features state-of-the-art life sciences and advanced materials research tools, including cleanroom facilities, multiple mass spectrometers, specially constructed bioreactors, particle size analyzers and more.

“Our facility is distinct in that we are combining more than 100 years of expertise producing high-quality, high-purity cGMP materials with a cross-discipline of research and capabilities, all under one roof to address today’s customized drug development processes,” said Ashish Kulkarni, Avantor’s executive vice president and chief technology officer.

The facility will also be used to conduct research and development on electronics materials, with chemistries that require purity at the parts-per-trillion level.

Avantor’s Bridgewater Innovation Center is housed in the New Jersey Center of Excellence, a 110-acre life sciences campus centrally located in the northeast U.S. bioscience technology corridor.

Approximately 3,000 med-tech companies are situated within a 100-mile radius. The campus is also close to major transportation routes and institutions such as Princeton University, Rutgers University and the New Jersey Institute of Technology.

Mayne Pharma, Metrics Contract Services, Designate New Center of Excellence

Mayne Pharma and its contract pharmaceutical development and manufacturing organization, Metrics Contract Services, have designated their new stability storage facility a “Center of Excellence.”

The $3.5-million standalone facility located in Greenville, N.C., earned the classification by integrating best-in-class operational standards and equipment during construction, said John Ross, president of Mayne Pharma USA.

The Stability Center of Excellence, which is 17,000 square feet in size, triples the company’s previous stability storage capacity. The center is fully validated and operational.

When designing the new facility, company officials incorporated cutting-edge standards at every level, ranging from walk-in chambers to back-up generators.

“The result is a world-class facility that will allow Mayne Pharma and Metrics Contract Services to readily meet the needs of our clients’ stability storage projects today and well into the future,” Ross said.

Features that establish the stability storage facility as best in class include:

100-percent back-up power generation providing 1,200 kilowatts of electricity, fueled by an uninterrupted supply of natural gas.
Integrated system redundancies for HVAC, chillers and humidifiers.
100-percent seamless and sealed construction inside and outside units.
Specialty climatic mapping and tolerances that include each International Conference on Harmonization (ICH) stability zone for temperature and humidity.
Sufficient square footage to double the number of chambers initially installed, providing room to grow for years.
Included in the facility are three stability chambers with available shelving capacity of 900 square feet each; one chamber with available shelving capacity of 1,530 square feet; and one chamber with available shelving capacity of 6,444 square feet.

Stability testing is a critical part of the drug approval process. Testing determines how a particular drug product, including packaging, reacts over time under the influence of temperature, humidity and light. The process determines whether any physical, chemical or microbiological changes affect the efficacy and integrity of the final product, thus ensuring that it is safe and effective, regardless of where it will be supplied. Stability testing also establishes the shelf life and recommended storage conditions of a finished pharmaceutical product.

For the purpose of stability testing, the ICH divides the world into four climatic zones based on a combination of temperature and relative humidity. The climatic zones are replicated in long-term stability studies to simulate conditions a drug product could be subjected to worldwide. Mayne Pharma has significant capacity to support studies for all major ICH climate zones and reach-in chambers to support specialized conditions.

Mayne Pharma investigated a number of stability storage room and chamber manufacturers before choosing to partner with Weiss Technik North America, a Schunk company. Weiss Technik has supplied high-quality, GMP-compatible and FDA-compliant stability testing solutions to leading pharmaceutical companies in Europe and Asia for years. Relying on proprietary environmental simulation technology, Weiss Technik stability storage systems are customized for specific users and employ energy efficiency standards that top competing systems by as much as 50 percent.

Weiss Technik is accredited with ISO 9001:2008, and its stability storage systems meet ICH Guidelines Q1A for Stability Testing and Q1B for Photostability Testing. They also comply with guidelines established by the U.S. Food and Drug Administration, the World Health Organization and the European Medicines Agency’s Committee for Proprietary Medicinal Products.

In addition to installing state-of-the-art rooms and chambers, Mayne Pharma carefully designed the facility to ensure robust primary and auxiliary infrastructure.

The facility is served by back-up generation capable of producing and delivering 1,200 kilowatts of electricity throughout the entire site. The system has a dedicated and uninterrupted natural gas supply similar to that in use at the academic medical center down the road. System redundancies have been implemented for chillers, HVAC and humidifiers.

“If we were to lose any aspect of our system, we would be operational right away,” Ross said. “We have invested more than most companies in stability storage to ensure the continuous integrity of our clients’ products.”

The need for the Stability Center of Excellence was driven by growth across all of Mayne Pharma’s businesses, including Metrics Contract Services. With the addition of commercial manufacturing to its portfolio, Metrics has seen an increase in late-phase and registration-batch stability programs, which support various international markets. The company’s expanding client base also required additional stability storage capacity.

The Stability Center of Excellence is part of planned expansions at the Mayne Pharma site in Greenville, N.C. Mayne Pharma is investing $80 million to repurpose existing capacity and to add new facilities and equipment — doubling pre-commercial analytical labs and clinical manufacturing capacity for Metrics. The 126,000-square-foot facility now under construction expands commercial-scale manufacturing capability to include multi-particulate layering and bead-coating fluid bed technology, as well as significantly increased capacity for manufacturing highly potent products.

Nitto Denko Avecia’s Expanded API Site to Open in Massachusetts

Nitto Denko Avecia has announced it will launch its expanded Milton, Massachusetts-based oligonucleotide API facility in August.

The site’s expansion will increase manufacturing and office space by 200,000 square feet, and its cGMP oligonucleotide active pharmaceutical ingredient (API) manufacturing capacity by 1.8 molecular weight (mol).

The contract manufacturing organization’s (CMO) president Detlef Rethage said the expansion, which makes the Milford site the largest oligonucleotide API manufacturing facility in the world, will serve existing clients.

“This expansion will help Avecia’s clients to receive timely oligonucleotide API to advance their drug development programs in clinical trials as planned,” said Rethage.

The company said it has hired over 120 employees in the past year at the Milford facility, and currently has 50 positions available across its Massachusetts, Ohio and California-based sites.

Oligonucleotides are short nucleic acid polymers designed to fuse with DNA or ribonucleic acid (RNA) sequences.

Avecia processes and develops oligonucleotides in pre-clinical, clinical and commercial stages of manufacture, with focus on immunostimulatory oligonucleotides, antisense therapies, and small interfering, micro, and short RNA

Shire Focusing on Biotechnology and R&D Hubs in MA

Shire will consolidate both R&D and biomanufacturing facilities in Massachusetts to establish a rare diseases hub in Cambridge and a ‘Technology Center of Excellence’ in Lexington.

In 2016, Shire substantially increased its operational footprint through the acquisitions of Baxalta and Dyax Corporation, at a cost of $32 billion (€28 billion) and $5.9 billion respectively, ending the year with a network of manufacturing 17 sites.

The firm has begun reorganizing this – an ex-Baxalta plasma fractionating plant in LA has been earmarked for closure, for example – and now a spokesperson has confirmed Shire’s six sites in Massachusetts will be consolidated into two.

“As we assess our operations after the Baxalta acquisition, we have decided to establish ‘hubs’ of focus and expertise in R&D and Manufacturing,” said Katie Joyce.

In Cambridge the firm is establishing a ‘Rare Disease Innovation Hub’ focused on R&D, and by moving some of these functions away from its Lexington headquarters and manufacturing site, Shire will free up space to build a Technology Center of Excellence.

“We will align and build teams working on device development, biologics process development and manufacturing, launch activities and IT. Roles at our Alewife manufacturing facility in MA will eventually be redeployed to Lexington and we will exit that site,” she said.

“Since the acquisition of Baxalta, movement both ways between Lexington and Cambridge has been ongoing and will continue as we work to co-locate ‘like’ teams and support functions for better collaboration and ultimately expand into a second facility in Cambridge.”

Plans are still being finalized and Joyce was unable to comment on how the reorganization would affect the estimated 3,000 employees who work for Shire in Massachusetts.

“We are in early stages of determining which exact employees and functions will be located in Cambridge and Lexington, MA in the future, in addition to new hires. It will take time to finalize plans,” she said.

“Our focus throughout the establishment of all of these hubs will be to minimize impacts to colleagues, innovate, and operate efficiently to ensure supply continuity for patients. The transitions will occur over multiple stages, over the next few years.”

Austrian activities

Shire is also establishing a Centre of Excellence for aseptic fill/finish in Austria.

“We have decided to transfer process development, manufacturing and quality operations out of Orth to other Shire facilities—this includes a subset of process development and quality operations that will move to Vienna,” Joyce said, adding gene therapy activities will continue at the Orth site.

However, a former Baxalta facility in Krems, Austria once earmarked for a €138 million expansion and modernization closed its doors last December and has been put up for sale.

And according to facility transaction services company PharmaBioSource, the 340,000 square foot facility is under agreement, though details of the proposed buyer are yet to have been made public.

Stryker Breaks Ground on Research and Development Center

Stryker Corp.'s groundbreaking ceremony for its $154 million research and development facility in Portage, Michigan drew more than 250 people. The groundbreaking featuring company officials and government leaders ushers in what will be the beginning of actual building construction on Wednesday, July 26.

The project for the 75-acre development includes a 485,000-square-foot facility with a customer experience center, functioning showroom and R&D and bio-skills labs. It will also have space for sales, marketing and support functions. In total, it is projected to retain 966 jobs and create an additional 105.

"I love the sight of dirt," said a smiling Stryker CEO Kevin Lobo, as he looked over the acres of earth moving that includes roads and site preparation. "It means we are growing. This is going to be a flagship site for the company, not just here in Southwest Michigan but globally."

Spencer Stiles, president of the Stryker Instruments division, called it a "major milestone for this organization." It is more, he said, than bricks and mortar. It also represents "an opportunity to connect with our global customers," innovation opportunities and culture and engagement that focuses on Stryker employees.

"We are doing this to make sure we create an environment to engage our employees," Stiles said.

University of Pennsylvania Steven A. Levin Neural and Behavioral Sciences Building

Construction Cost: $48,000,000

Size: 78,000 SF

Project team: SmithGroupJJR (Architecture | MEP/Structural Engineering | Lab Planning | Interiors), Pennoni Associates – Civil Engineering, Christopher Allen – Landscape Architect, P. Agnes Inc. – Contractor, Shen Milsom & Wilke - AV/Acoustics, Kewaunee Scientific Corporation – Lab Casework & Fume Hood Manufacturer, Becker & Frondorf – Cost Estimator, Kimbal & Krug – Furniture Manufacturers.

Description: The study of complex behaviors is becoming a fundamental focus in the 21st century, integrating the study of genes, the brain and behavior. The University of Pennsylvania Stephen A. Levin Neural and Behavioral Sciences Building, planned and designed by SmithGroupJJR, speaks to this dynamic new direction, bringing together biology, psychology and associated programs into one building, encouraging a unified and interdisciplinary approach to research and teaching.

UPenn had long sought to create a common facility— shared by the Department of Biology, Department of Psychology, the Biological Basis of Behavior Program, the Program in Life Sciences and Management and the Behavioral Economics Program—that would bring together faculty, staff and students studying the full range of life sciences. The school envisioned an environment that could increase the level of dialogue and collaboration across these disciplines, from cell biologists to social psychologists.

Carefully sited among an existing laboratory complex, the new building quite literally connects fields of study. It creates a newly integrated Life Sciences precinct that fosters collaboration in a new academic quadrangle. And it provides a welcoming new link between community and campus, transforming a dark and derelict perimeter into an open and inviting gateway.

Completion date: June 2016

Q Laboratories Expands Capacity

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

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

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

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

Boehringer to Expand Fremont Facility

Boehringer Ingelheim is investing $217 million to upgrade and expand its Fremont, CA manufacturing facility. This investment will add nearly 300 skilled positions in the area. The site was recently awarded $25.5 million in two separate tax credits from the state, making them the largest award to a pharmaceutical company. The expansion will allow the company to increase its manufacturing capacity by one-third.

"The Bay Area is the largest biotech cluster in the world. We are happy to have made Fremont our home and are grateful for the support we have received from the community and the State of California," said Jens Vogel, president and chief executive officer of Boehringer Ingelheim Fremont, Inc. "We have made a commitment to the region and are excited to continue to invest in the Bay Area and expand our workforce to help increase patient access to high-quality medicines."

Boehringer’s Fremont facility focuses on manufacturing medicines for immunology, rheumatology and oncology.

REST OF WORLD

University of Global Health Equity (UGHE)

Size: 68,000 sq. ft.

Project team: Shepley Bulfinch (architect); Oak Consulting Group (civil engineer); Mazzetti GC/CM (building systems engineer)

Description:

The University of Global Health Equity (UGHE), is a new health sciences university owned and operated by Partners in Health (PIH) and supported by the Rwandan government. The first phase of construction for its Butaro, Rwanda campus will include 68,000 sq. ft. across 12 buildings and the full campus will support more than 1,000 students and faculty when completed.

The university is sited on a 37-hectare greenfield site on top of a plateau and site preparation work included significant infrastructure projects such as grading, digging the water well, and developing the access road.

Each of four project phases will feature academic buildings arranged around a common area, similar to nodes on a necklace. Phase one includes six academic buildings, encompassing 36,000 SF of space. Rwanda’s temperate climate allows for many activities to take place outdoors, so buildings are designed to promote learning both inside and outside. A dining hall/welcome center, library/Research Commons, simulation center and a variety of teaching spaces including a wet lab, case study room, flat floor studio, seminars and classrooms are all connected by a translucent canopy.

Particular attention was given to sustainable practices relying on passive techniques, use of local labor and materials, and minimizing adverse impacts on the environment by “doing no harm”. Buildings and landscape are designed to harness natural ventilation and daylight and the roofs are designed to harvest rainwater which is then recycled for greywater. Potable spring and well water are stored in a water tower clad in the local volcanic rock, creating a distinct landmark and symbolic focal point for the overall architectural composition. Hardy indigenous trees and plants requiring no irrigation are used for their restorative and regenerative impact on the land.

Completion date: Fall 2018.

Oxford Genetics Expands UK Facility

Oxford Genetics will expand its bioproduction services in the UK and target the US market through an office in Boston after receiving a £7.5 million ($9.6 million) investment.

The investment comes from existing investor Mercia Technologies PLC, and Invesco Perpetual and will help the bioprocessing support firm expand its global presence and increase its DNA, protein, viral and cell line service offerings.

The UK extension adds another floor in its building in Oxford which will be fitted out to increase capacity across the firm’s entire service offering, allowing the segregation of material flow and the isolation of individual projects, said a spokesperson from Oxford Genetics.

“This will allow us to continue to exceed regulatory requirements and provide quality assurance for our clients. We will also add more analytical, purification and process development equipment, for instance small scale bioreactors, to enable us to fully support our clients from research up to the point of GMP bioproduction.”

The 6,000 sq. ft. extension is expected to be ready by November, and will include cell line engineering capabilities, viral vector production and purification suites, high-throughput robotic screening systems and process development facilities.

The US expansion, meanwhile, will see the firm open an office in Boston to target the large US market.

“A US office is integral because it is the single largest market for our technologies and services,” we were told. “There has been a significant increase in the demand for our viral expression systems and cell line development for virus production.”

The firm, founded in 2011, licenses its technology platforms on a non-exclusive basis to all biopharma and according to the spokesperson has had “tremendous interest” from firms looking for bioproduction optimization solutions.

“We have already begun to sign licenses and collaboration deals. The latter agreements are particularly interesting since they are allowing our collaborators accelerated access to some of our virus production platform technologies, which will fully mature over the next 18 months.”

In the past year, Oxford Genetics has benefitted from several funding projects including a £1.6 million and £1 million, both from Innovate UK, to explore computational and synthetic biology approaches for optimizing mammalian biomanufacturing processes, and to overcome the inefficient and costly scale-up of viral vector production, respectively.

Micro-Sphere Expands Capsule Filling Facility

Spray drying and capsule filling-focused Micro-Sphere is expanding manufacturing capabilities at its facility in Ticino, Switzerland.

The firm is investing 21 million CHF ($21.7 million) in the site, which will see the 15,231 sq. ft. (1,415 m²) facility expand to 31,269 sq. ft. (2,905 m²).

Managing director Stefano Console said the decision to expand came from growing market demand, predominantly in Europe and North America.

The company’s founder Michele Müller also observed an increased demand for fill & finish services.

“Both GMP spray drying as a particle engineering technique and low dose capsule filling are becoming increasingly popular across the market and at present there are very few CDMOs [contract development and manufacturing organizations] offering this level of capability,” said Müller. “From our expanded facility, we will continue to produce both clinical and commercial products, with a particular specialism in dry powder inhalers,” he added.

Console said he expects the increased GMP capabilities to increase the company’s client base, which currently includes firms in the US, Europe, New Zealand and Asia.

“The expansion is already attracting new business, and we expect this to continue in the coming months,” he said.

The expanded facility - expected to be operational by Q4 2017 - will create 20 new roles, he said.

BioVectra Builds Fermentation and Complex Chemistry Facility in Nova Scotia

BioVectra, a Mallinckrodt Pharmaceuticals company and CDMO based in Canada, announced in a May 24, 2017 press release that its fourth cGMP facility will be fully operational by December 2017. The late-stage to commercial-scale microbial fermentation and complex chemistry facility is located in Windsor, Nova Scotia.

BioVectra’s $30-million investment has equipped the 50,000-ft² facility with 40,000L of fermentation capacity, downstream processing equipment, and new preclinical fermentation and potent chemistry suites. The new facility is an investment in BioVectra’s core development and manufacturing competencies: microbial fermentation and complex chemistries. The company provides scalable cGMP operations from 30L to 17,000L. BioVectra has the capability to handle the development and cGMP scale-up of high-potency APIs, handling potent substances such as antibody-drug conjugate warheads, with occupational exposure limit levels of < 20 ng/m³ (Safebridge Band 3 and 4).

The new facility increases BioVectra’s ability to partner with global pharmaceutical companies by offering dual-site risk mitigation. “This expansion helps BioVectra keep up with the growing demand for our products, while also meeting an underserved need for large-scale microbial fermentation in North America,” said Heather Delage, vice-president of Business Development. “In addition to the facility’s large-scale fermentation capability, the site also offers a complementary footprint for synthetic process development and laboratory-based activities.”

BioVectra’s three additional cGMP facilities and headquarters are located in Charlottetown, Prince Edward Island.

JRS PHARMA Announces New Laboratory in Brazil

JRS PHARMA has announced the upcoming grand opening of a new laboratory located at their Diadema, Brazil location. The lab is scheduled to be opened during JRS PHARMA’s Latin America Technical Seminar on June 26-27, 2017.

The lab, which will focus its efforts on direct compression and coatings applications, is being opened to offer customers in Latin America increased technical service for formulation development and troubleshooting. This is the next step towards improving service to customers in the region, offering help in project development and expediting the resolution of formulation challenges. It will be equipped with state-of-the-art equipment for lab-scale development that offers the ability to monitor all important parameters needed for scale-up.

“We are glad to fulfill another important step towards growing relationships with our valued customers and offering them more tools to make their daily development life easier, while achieving faster time to market for their end products,” Nicolas Kaufmann, Plant Manager, shared.

Torbay Opens Injectables Mfg. Facility

Torbay Pharmaceuticals, a part of the Torbay and South Devon National Health System Foundation, has opened a new £26 million sterile injectables manufacturing unit in Paignton, UK. The new plant will make a range of injectable products for NHS hospitals.

“We are incredibly proud of Torbay Pharmaceuticals and all that they have achieved over the years,” said Richard Ibbotson, chairman of Torbay and South Devon NHS Foundation Trust. “Not only have they created a range of highly skilled career opportunities, but they generate income which directly supports the health and care of local people.

Emma Rooth, managing director, Torbay Pharmaceuticals, said, “Torbay Pharmaceuticals is proud to be such a successful part of Torbay and South Devon NHS Foundation Trust. Being part of the NHS enables us to have our finger on the pulse of healthcare needs and respond appropriately with new products, plugging shortages and anticipating the latest developments in medical science.

Avara Buys Sterile Manufacturing Facility from Pfizer

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.

Avara Pharmaceutical Services (Norwalk, CT), a contract development and manufacturing organization (CDMO), has signed an agreement with Pfizer to acquire Pfizer’s sterile manufacturing facility in Liscate, Italy, according to a company press release on August 8, 2017. The acquisition gives Avara five manufacturing sites in total.

In addition to the Liscate sterile manufacturing facility, Avara also has two API formulation and manufacturing facilities in Avlon, United Kingdom, and Shannon, Ireland, and two secondary manufacturing and packaging facilities in Norman, OK, United States, and Arecibo, Puerto Rico.

"This acquisition is an important component of our strategic plan and expands our services by adding sterile processing capability, which is in very high demand," said Timothy Tyson, Avara’s chairman and CEO, in the press release.

Avara provides both API formulation and manufacturing, along with secondary formulation, manufacturing, and packaging of small-molecule drugs, including highly potent compounds. The company has secondary manufacturing technologies including granulation, coating, blending, encapsulation, compression, and drying of tablets and capsules.

"As we celebrate another important milestone, 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 capability 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 who are a part of the Avara team are the key to our long-term success," said Mr. Tyson in the press release. "We are focused on delivering on our commitments and earning the trust of every customer we deal with."

UK Children's Hospital Introduces Technology to Combat Infections

The Royal Manchester Children's Hospital has introduced Surfacide UVC room disinfection technology to further reduce healthcare-acquired infections (HCAIs)

As part of its ongoing effort to combat HCAIs, the Royal Manchester Children's Hospital (RMCH) recently added the Surfacide Helios Ultraviolet C (UV-C) Disinfection System to its cleaning protocol. The Helios system is a triple-emitter UV-C hard surface disinfection system that eradicates multi-drug resistant organisms in the patient environment.

Surfacide says the RMCH is the first hospital within the NHS to use UV-C technology as a complement to traditional cleaning methods joining many healthcare organizations around the world.

The hospital will deploy four UV-C Disinfection Systems (12 emitters) throughout the hospital to protect patients and staff.

"Our number one goal is to keep our patients safe, not only through the advanced care we provide, but also through the environment in which we provide that care," said Julie Jolly, Matron – Service Improvement, Enhanced Recovery and Care Co-Ordination, and V2A Programme Lead (Children's), for Royal Manchester Children's Hospital.

"We are extremely pleased with the efficacy and impact of Surfacide's Helios system in protecting our patients from the bacteria and viruses that can cause HAIs."

RMCH conducted an independent pilot study using the UV-C Disinfection System in the hospital's Oncology/Hematology Unit. The eight month independent study compared standard cleaning protocols alone to those including Surfacide Helios UV-C Disinfection. The result was an 83.7% decrease in contaminated sites and a 43% decrease in HCAIs when the Helios system was introduced into the patient environment along with standard cleaning procedures.

The Helios system was effective at reducing and eliminating a variety of drug-resistant microorganisms and has been shown to eradicate multi-drug resistant organisms, including C.Diff, MRSA, VRE, CRE and Acinetobacter.

The Helios system introduces three UV-C energy emitting towers in the patient environment versus other systems that only use one. The triple emitter approach decreases the distance to contaminated surfaces thereby reducing disinfection time and improving overall efficacy. In addition, the system is highly effective at covering all areas of the room, including the bathroom and other hard-to-reach areas. Finally, it reduces the amount of time to clean a room since the emitters do not need to be moved during the cleaning process.

The 10-20 minute Helios disinfection cycle is performed in an unoccupied room after an environmental services cleaning professional has manually cleaned the area and wiped down surfaces. The system uses an automatic laser mapping feature to measure the room and detect potential areas of contamination. These measurements are then incorporated into an algorithm to determine an optimal time to complete the disinfection process.

CordenPharma Expands Capabilities

CordenPharma Plankstadt, located near Heidelberg, Germany, has unveiled plans to invest €10 million into new manufacturing capabilities for veterinary drug products. The new line for 500kg scale batch sizes will supply a complex innovative product for application in the veterinary health market. This new line is part of a production plant that is dedicated to veterinary drug products.

The expansion of the production capabilities at CordenPharma Plankstadt are the result of a new, long-term custom manufacturing agreement for an animal health application, which the company recently signed. Work will commence in the second quarter of 2017, with a targeted mechanical completion by the second quarter of 2018 and commercial supply for the global launch campaign planned to start in the second half of 2018. CordenPharma Plankstadt has supported the customer over the last year and a half, from initial technology transfer and development activities to the timely manufacturing of registration batches.

“This is an extremely important and significant investment for CordenPharma Plankstadt. This new production line will allow the fully contained handling of highly potent APIs in a dedicated facility for the manufacturing of veterinary drug products. This is a unique opportunity in the industry,” said Frank Hähner, managing director, CordenPharma Plankstadt.

The investment in CordenPharma Plankstadt is the latest of several announced investments made by CordenPharma during 2017, where further capacity expansion and capabilities were installed in CordenPharma Colorado and CordenPharma Plankstadt to meet growing customer demand.

“CordenPharma’s goal is to be the leading CDMO for the development and manufacturing of Highly Potent & Oncology solid dosage forms, both now and in the future. This investment greatly contributes to that strategy, while further expanding and strengthening our capabilities and service offerings,” said Michael Quirmbach, vice president of global marketing and sales, CordenPharma International.

BASF Outlines Plans for Mumbai R&D Campus

BASF has confirmed the innovation campus it is setting up in India will employ 300 people and cater for multiple markets across Asia and elsewhere.

The German chemicals firm inaugurated the €50m ($59m) campus in Navi Mumbai, India in March, explaining that the site will be an R&D hub serving customers in multiple industries.

The firm announced it had set up a pharmaceutical technical laboratory at the campus at which it will provide formulation development, active pharmaceutical ingredient (API) solubilization and taste masking services.

A spokesman for the firm said, “While the lab will mainly serve our customers and markets in South Asia, it is also well equipped to cater to the needs of our customers, regionally and globally.

He added that: “By leveraging our expertise in delivery systems and related technologies, the solutions from this lab will aim to deliver value added functional solutions to our customers’ formulation challenges.”

He declined to discuss capacity, instead explaining that “the number of projects the lab will undertake every year will depend on the needs of our customers.”

The wider campus will house a number of dedicated R&D labs.

The spokesman said, “The innovation Campus, Asia Pacific, which this new pharma lab is housed in among other labs, will host up to 300 scientists by 2020.”

The pharmaceutical technical lab is one of five such facilities BASF has set up, the others being at sites in Germany, North America, South America, and Shanghai, China.

GSK Opens API Facility in Scotland

GlaxoSmithKline has officially opened its aluminum salts facility in Montrose, Scotland. According to GSK, the facility represents a £44m investment which, when fully operational in 2019, will provide ingredients for more than 40 million vaccinations a year.

The company said the plant will create 15 jobs, on a site which employs more than 450.

The salts plant is situated within GSK’s Montrose facility, which has been making drug ingredients – including APIs for respiratory and HIV vaccine products – for six decades.

Last month, GSK announced it would restructure its UK network by suspending plans for its Ulverston, Italy-based biopharma plant.

In addition, the firm suggested it would sell its cephalosporin antibiotics business and associated facilities, and invest in HIV and respiratory drug capacity.

The company said it is simplifying its business by improving competitiveness of its manufacturing network and increasing focus on its core business.

West Pharmaceutical Services Expansion

West Pharmaceutical Services Inc. expansion, Mulhuddart, County Dublin, Ireland

Size: 60,000 sq. ft.

West Pharmaceutical Services, Inc.’s facility expansion is in response to customer demand for medical device manufacturing—especially in the area of diabetes—and represents West's most recent investment in Ireland, where the company is also building a new pharmaceutical component manufacturing facility. The additional capacity in Dublin will make it possible to better service the company's growing healthcare and medical device contract manufacturing business, which is focused on supplying high-quality molding and assembly solutions for the production of medical devices such as auto-injectors and continuous glucose monitoring systems.

West is also growing its proprietary product business in Waterford, Ireland. The company previously announced the construction of a center of excellence for its elastomeric sheeting and injectable component product lines. This new plant in Waterford, Ireland, is expected to begin full commercial operations in 2018.

Eurofins Expands Services

Eurofins has expanded its services with a couple recent acquisitions. First it signed an agreement with Tata Group to acquire Advinus Therapeutics, a preclinical and clinical phase contract research company for safety assessment, DMPK, CMC services, and analytical R&D services. Located in Bangalore, India, the company operates a state-of-the art 215,278 sq. ft.

(20,000 square meter) facility on a large campus with space for expansion.

Advinus’ expertise complements Eurofins recent contract research, development and manufacturing capabilities following the acquisitions of Alphora in Canada and Amatsigroup in Europe. The company provides GMP testing and manufacturing capabilities, and is positioned to capitalize on the growing R&D outsourcing market in the Asia-Pacific region.

Eurofins also expanded its offering and footprint in drug discovery services with the acquisition of DiscoverX, which offers drug discovery products and services across all stages of discovery from target identification and lead discovery to preclinical and beyond.

DiscoverX develops, manufactures, and commercializes reagents, complete cell-based assay kits, profiling and screening services as well as other disruptive solutions for the drug discovery, screening, and life science markets. The company has over 15 years’ experience in drug discovery and development leveraging on the Enzyme Fragment Complementation (EFC) technology. With over 900 stable cell lines, 4500 drug discovery assays and kits, and both custom and off-the shelf services, DiscoverX offers a broad drug discovery portfolio. The company operates in four locations in Fremont, San Diego, San Francisco (California) and Birmingham (England).

The combination of Eurofins Pharma Discovery Services and DiscoverX provides the pharmaceutical and biotech industries with a partner for end-to-end drug discovery services, enabling customers to improve research productivity and effectiveness of their screening, lead optimization and structure-activity relationships (SAR) campaigns, thus accelerating the discovery and development of new drugs. In addition, DiscoverX’s KINOMEscan platform and epigenetics services, combined with Eurofins Pharma Discovery’s kinase profiling services would result in the largest available portfolio of kinase products and services in the market.

DiscoverX’s expertise complements Eurofins discovery pharmacology capabilities following the previous acquisitions of Panlabs, Cerep, EMD Millipore Discovery and Development Solutions and Villapharma.

BASF Opens Pharma Formulations Lab in India

BASF has set up a pharmaceutical technical laboratory in Navi Mumbai, India citing Asia’s fast growing generic drug manufacturing sector as its target customer base.

The German chemicals firm inaugurated the laboratory this month, explained that the site will provide formulation development, active pharmaceutical ingredient (API) solubilization and taste masking services.

A spokeswoman for the firm said the laboratory is operational.

Tina Low, Vice President of BASF’s Nutrition & Health in Asia Pacific, said: “We see rapidly rising demand and great opportunities for pharmaceutical solutions in Asia.

“This technical lab in Mumbai will provide generic drug manufacturing customers with comprehensive solutions for superior product efficacy. It will also optimize the performance of raw materials in formulation” she added.

The lab is one of five such facilities BASF has set up, the others being at sites in Germany, North America, South America, and Shanghai, China.

Hanmi Pharmaceutical's New Bio Manufacturing Plant, Pyeongtaek, South Korea

Hanmi Pharmaceutical is constructing a new biologics manufacturing facility in the city of Pyeongtaek in the Gyeonggi province of South Korea.

The building is expected to complement the company's first biologics plant in Pyeongtaek. Plans for the facility were unveiled in April 2016.

The new plant will enable Hanmi Pharmaceutical to advance the commercialization of new biological medicines.

The new biologics facility will be located in the Chupal Industrial Complex in Pyeongtaek, offering sophisticated industrial infrastructure to ensure efficient operation of the new plant.

The six-story building will occupy approximately 559,723 sq. ft. (52,000m²), with construction scheduled for completion in the second half of 2017.

The new facility will be equipped with two production lines for insulin. Each line will include centrifugal separators, fermenters, homogenizers, flow components, and aseptic valves. The fermentation and media preparation lines will be integrated with GEA VESTA^® valves. The lines will enable the production of a fragment of human immunoglobulin type G.

The pocket-free and easy-to-install VESTA^® Sterile valves lack membranes and features one of the most effective sterile valve systems. The valves can handle the different media required for operation, cleaning, and sterilization.

Manufactured products will be supplied for global clinical trials and for approval of quantum projects to commercialize new biological medicines. Large-scale license contracts have been signed for such medicines between Hanmi Pharmaceutical and global pharmaceutical firms, including Sanofi.

Samsung Engineering was selected to construct the new biologics manufacturing building for Hanmi Pharmaceutical.

GEA was contracted by Hanmi Pharmaceutical to supply manufacturing equipment for the new plant, in February 2017.

Founded in 1973, Hanmi Pharmaceutical is a Korean pharmaceutical company headquartered in Seoul. The company produces pharmaceutical granules, oral liquids, tablets, and capsules at four manufacturing facilities including Hanmi Paltan plant, Hanmi Fine Chemical, Hanmi Cepha plant, and Hanmi Bio plant.

Hanmi Pharmaceutical's existing bio plant in the Pyeongtaek complex is a two-story building occupying 4,600m². The plant is complemented by dedicated areas for finished product lines, quality control laboratories, and warehousing.

Hanmi Pharmaceutical's prescription and over-the-counter (OTC) drug products portfolio includes anti-biotics for respiratory infections and drugs for obesity conditions, oral care, ophthalmic, diabetes, hepatitis, osteoarthritis, anti-inflammatory, nootropics, epilepsy, smoking cessation aid, anti-cancer, and cardiovascular conditions, as well as dermatological products, probiotics, and nutritional supplements.

The company is engaged in research and development (R&D) with major emphasis on biologics targeting diabetes and obesity, oncology and auto-immune disease targeted pipelines, and fixed-dose combination programs. The company also develops new drugs in collaboration with global companies.

In September 2016, Hanmi Pharmaceutical entered into an exclusive development and license agreement with Genentech, a subsidiary of the Roche Group. The companies will develop and commercialize Hanmi's pan-RAF inhibitor HM95573, which is currently in Phase I clinical development.

Takeda Pharmaceutical’s High-Containment Production Facility, Grange Castle, Dublin, Ireland

Japan-based pharmaceutical company Takeda has initiated construction of a new high-containment production facility at its existing site in Grange Castle Business Park in Dublin, Ireland.

The new facility will be used for manufacturing Takeda's lead oncology product Ninlaro^® (ixazomib) for global markets.

Approved in the US, Europe, and Japan, Ninlaro^® is indicated for the treatment of multiple myeloma in patients who have received at least one prior therapy.

The decision to invest €40m ($42.50m) for the construction of a second production facility at Grange Castle was announced by Takeda in December 2016. The cost for the construction will be supported through IDA Ireland by the Department of Jobs, Enterprise, and Innovation.

The project is expected create approximately 40 new jobs in the next two years and construction is scheduled to be completed by August 2018.

The new production facility will have a total floor space of 61,053 sq. ft. (5,672m²), including 2,998m² production areas on the ground and first floors. It will also feature 32,270 sq. ft. (2,674m²) ancillary structures such as electrical building and services yard.

The building will be 15.95m high, supported by steel frames and reinforced concrete. It will help enhance Takeda's vital in-house manufacturing capacity to meet global demands.

The new facility will accommodate a range of production processes required for Ninlaro^®, including drug substance, drug product, primary and secondary packaging, and quality control (QC) lines.

Ninlaro^® was approved by the US Food and Drug Administration (FDA) in November 2015 and by the European Commission (EC) a year later. It was approved in Japan in March 2017 and launched in the country by May of the same year.

The drug is available in 4mg, 3mg, and 2.3mg hard capsules for oral administration.

The ground-breaking ceremony for this second production facility was held in June 2017. It was attended by guests including Tánaiste and Minister of Justice and Equality Frances Fitzgerald T.D, Japanese Ambassador Mari Miyoshi, councilor Guss O'Connell, and mayor of South Dublin County Council Paul Keogh.

Construction is expected to be completed by August 2018 and shipment of secondary packaged product will commence in the second half of 2018.

Project Management (PM) Group was awarded the contract to provide design and to manage construction.

Takeda Pharmaceutical Company is a research and development (R&D) firm focused on oncology, gastroenterology, and the central nervous system therapeutic areas. It has a workforce of approximately 30,000 employees across 70 countries worldwide.

Following the start of its operations in Ireland in 1997, the company chose Dublin as a location for its first active pharmaceutical ingredient (API) facility outside Japan in 2002.

BiondVax Leases Site for Universal Flu Vaccine Plant in Israel

BiondVax Pharmaceuticals Ltd has leased space for a manufacturing plant with capacity to make tens of millions of doses of its flu vaccine, M-001.

The facility, which will be built is at a site at the Jerusalem BioPark in Israel, is intended to make commercial supplies of the vaccine if it goes on to be approved. The lease is for an initial period of 10 years.

Construction of the facility will be partly supported by a grant from Israel’s Ministry of Economy and Industry and a €20 million ($22 million) loan from the European Investment Bank (EIB) that BiondVax secured last month.

M-001 is designed to protect against both seasonal and pandemic flu strains. It consists of nine widely conserved influenza epitopes chosen to allow it to protect against a wide range of viruses.

BiondVax plans to move the vaccine into Phase III, although it has not said when.

In 2015, the firm contracted Cytovance Biologics to help it scale up the manufacturing process used to produce the vaccine for clinical trials.

Alembic Pharma Launches Oncology Site for Injectable and Lyophilized Generics

India-based Alembic Pharmaceuticals has inaugurated its manufacturing facility in Panelav, Gujarat, where the firm will make generic oncology products for international markets.

According to Chirayu Amin, CEO of flagship company Alembic Group, the site has manufacturing capacity for 60 million tablets and capsules, and approximately 20 million vials of liquid injectables and lyophilized concentrates.

Alembic said the facility will make generic cancer medicines for markets in the Middle East and North Africa as well as Australia, South Africa and the US.

Publicly-listed Alembic said the facility – which cost Rs 300 crores (approximately $4.65 million) to build - has been fitted with production and processing equipment supplied by Bosch, GEA, Alexanderwerk, ICOS and Tofflon.

Alembic has six formulation and three active pharmaceutical ingredient (API) facilities in the Gujarat and Sikkim regions of India.

In June last year, the US Food and Drug Administration (FDA) issued the firm’s Halol, Gujarat- based formulation facility – the only Alembic site to make finished formulations for US export – with a Form 483.

At the time, company secretary Ajay Kumar Desai said the four observations “may not have any bearing on the operations / performance of the company.”

Recce Automates Manufacture of Antibiotics for Human Clinical Trials

Recce, a preclinical stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, announced its new automated manufacturing facility in Sydney is producing antibiotic compounds in preparation for human clinical trials.

The delivery of the automated manufacturing process, together with the provision of facilities and staff for assurance of quality, is an important milestone as it will ensure sufficient, timely and quality supply of the company’s synthetic antibiotic compounds, designed for compliance with the high standards of the US Food and Drug Administration’s (FDA) current good laboratory practices (glp).

Arthur Kollaras, Chief Chemical Engineer at Recce, said: “Having our own new facility ensures valuable protection against the costly delays commonly experienced by drug companies, in their efforts to produce, refine or add to the capabilities of their product — limitations recently emphasized by the FDA.”

The automated process, which uses the latest bioreactor technology by German Pharmaceutical equipment manufacturer Sartorius Stedim, is producing 1000 ml batches of Recce antibiotic per day or around 50 x 150 ml sterile drip bags per week. This is estimated to be enough to supply Phase I and Phase II human clinical trials.

Dr. Justin Ward, Quality Manager at Recce, said: “The achievement has been done at very significant economies from alternative outside contracting — and as well, assured that the intellectual properties and their improvements stay right here in Recce.”

Recce’s manufacturing facility at Macquarie Park in NSW and its quality laboratory in the Technology Park of Bentley in WA have been enhanced by the purchase of specialized, high quality analytical equipment and each will remain totally dedicated to the production and quality of Lonza Boosts Micronization Capacity with Acquisition.

Lonza Expands In Asia

Lonza will install four 2,000L single-use bioreactors at its Singapore facility to cater for growing demand for small to mid-volume biologics production.

At present the Tuas facility houses 86,500L of stainless steel bioreactor capacity – including four 20,000L stirred fermenters. Last October Lonza announced it was making an undisclosed investment in single--use technology for mammalian manufacturing at the site.

And speaking in Tokyo recently, SVP of global sales Cindy Reiss-Clark revealed more details:

“We are adding up to four by 2,000L single-use bioreactors, with the first two being on line in early 2018,” she told delegates at the first BioPharma Expo, being held alongside Interphex Japan. “This expansion is supporting the commercialization strategies [of our customers] which require small to mid-scale [bioproduction].”

She added one of the first customers to leverage the new technologies in Singapore would be Tracon Pharmaceuticals, a Californian-based oncology-focused firm which entered into a long-term agreement for commercial production of its lead candidate TRC105 in February this year.

Lonza “will transfer the process to the 2,000L[line] in Singapore,” Reiss-Clark said, while providing ongoing clinical support for the antibody which has orphan drug designation for the treatment of soft tissue sarcoma.

She also spoke about Lonza’s collaboration with Nikon CeLL innovation – part of the Nikon Corporation. The firms are developing a cell and gene manufacturing services business in Japan.

The partnership was first announced in May 2015 and a GMP facility in Tokyo “is on track and will be ready in 2018,” according to Reiss-Clark.

The Singapore site has cell and gene therapy capabilities but this latest project will strengthen Lonza’s presence in Asia.

The firm recently acquired European cell and gene therapy maker PharmaCell in a deal that a spokesperson said, “Places Lonza as the leading contract development and manufacturing organization offering an international cell and gene therapy manufacturing network, spanning the US, Europe and Asia.”

Lonza Pharma&Biotech Launches Biological Manufacturing Concept

Ibex Solutions is a modular manufacturing complex capable of supporting companies looking to carry out activities across multiple technologies — mammalian, microbial, cellular or bio-conjugate — right from late discovery to manufacture.

Lonza has started constructing its new complex in Visp, which offers facilities for those looking at biological development and manufacturing.

Lonza has launched Ibex Solutions — an innovative biological development and manufacturing concept, coupling flexibility in facility-build-out and exploiting Lonza's expertise and service network in Visp (CH).

Ibex biomanufacturing comprises a modular, technology-independent development and manufacturing complex capable of supporting activities across multiple technologies — mammalian, microbial, cellular or bio-conjugate — and from late discovery to manufacture. This flexibility gives customers complete freedom in facility design and implementation and the ability to respond rapidly as their needs evolve.

Responsiveness is further enhanced by the integration of the Ibex biomanufacturing complex into the Visp site with its experienced workforce and established service networks.

Construction began in June with a formal groundbreaking ceremony expected in the second half of 2017. Several hundred new jobs are expected to be created as a result.

The path to market of a modern medicine is complex and uncertain. Under the growing pressure of regulation and competition, biopharma companies must be able to solve critical development steps under tight time and budget constraints.

Ibex Solutions include highly flexible models to match and adapt to each customer’s expectations and forecasts. The availability of a modular complex means time-to-market can be reduced by 12 months or more. These advantages contribute to a significant de-risking of major strategic investment decisions.

Marc Funk, Pharma&Biotech COO at Lonza, said: “Lonza has been creating innovative manufacturing and production solutions for 120 years and we are continuing to pioneer clinical and commercial manufacturing in multiple technologies all over the world. We have been working with our partners to understand what we can offer that will really change the game for them, and that’s why we have created Ibex.”

The solution also offers the opportunity for tailored business and ownership models, providing higher transparency and flexibility.

In addition to enabling, a cost-effective build-out and fast ramp-up, it can provide assured delivery with a simplified supply chain, as well as a stable workforce, IP protection and favorable taxation environment.

An integrated solutions provider serving the healthcare continuum, Lonza offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries.

Lonza Envisions Five New Plants at Visp for Modular Manufacturing Biz

Lonza has started work on a facility to house its new modular tech-based biomanufacturing service at its site in Visp, Switzerland.

The Swiss life sciences launched its service – Ibex Solutions – this week during its half-year results presentation.

It said the aim is to provide flexible production capacity for drugs and bio-conjugates made using mammalian, microbial and cellular systems.

Lonza said the service – which is expected to create “several hundred jobs” – is designed help customers get products to market faster than they otherwise would, claiming the modular approach can cut 12 months or more off development timelines.

Lonza began building a dedicated facility for Ibex at its Visp site in June, although the official ground breaking ceremony is due to be held later this year.

Samanta Cimitan, head of strategic global programs at Lonza, said: "We envision five manufacturing complexes, which we will build on a staged approach, depending on customer’s demand.

"One of the five buildings is being built right now and it is the one dedicated to the previously announced Sanofi-Lonza JV. Simultaneously, we are building one wing of another manufacturing complex to accommodate the first customer projects coming.

Cimitan added that: "An important feature of Ibex Solutions is that we will always be one shell ahead. This feature provides 12 months of time advantage to market and patients. While the first wing is close to fill up, another shell is being built. The construction of the first wing of the manufacturing complex 1 has started in June 2017. When the first wing is fitted out we will trigger the building of the second wing."

Lonza does not have any preference in terms of equipment suppliers Cimitan said, explaining: "We work with the best supplier in the specific area/technology/process. We discuss this openly with our customers and make the best possible decision."

The investment is a continuation of Lonza’s long-running strategy of conducting more complex, higher margin drug product at Visp.

The aim is to offset the negative impact the strong Swiss franc has on the site’s profitability and it ability to compete with producers elsewhere.

The strategy has seen Lonza increase capacity in specific areas – antibody drug conjugates in 2013 for example – and transfer work previously carried out at its plant Hopkinton, Massachusetts to Visp.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com