Laboratory Corporation of America® Holdings announced that Covance Drug Development will open a cGMP-compliant pharmacy at its clinical research unit in Madison, Wisconsin, allowing for on-site production of high-quality, customized pharmaceutical products for clinical trials. Covance, which opened its first cGMP pharmacy at its Dallas, Texas facility earlier this year, is the only CRO to implement cGMP standards for Phase I manufacturing of investigational drug products in a U.S. Phase I clinical research unit.

The Madison cGMP pharmacy will be available for client audits beginning in October.

Small-scale cGMP manufacturing meets the highest regulatory and safety standards and lowers the cost to manufacture pharmaceutical products for clinical trials. Covance’s innovative facilities offer certified clean rooms that support a full range of sterile manufacturing, including aseptically prepared sterile parenteral investigative drugs and radiolabeled doses, as well as non-sterile investigational drug products.

“With dedicated pharmacists, production teams, and direct cGMP Quality Assurance oversight, Covance provides industry-leading quality and cost-effective manufacturing services with greater flexibility to help clients meet their Phase I clinical trial needs,” said Dr. Herman Scholtz, Vice President & General Manager, Early Clinical Services. “These new drug development solutions demonstrate our commitment to providing innovative and differentiated solutions to streamline and enhance clinical trials, bringing innovative medicines to patients faster, and helping change the way care is provided.”

Covance is reshaping clinical trials to transform the industry and improve lives.

ALSO Covance Drug Development (a LabCorp company) has Relocated Its Clinical Research Unit (CRU) in Dallas, TX

Covance Drug Development (a LabCorp company) has relocated its clinical research unit (CRU) in Dallas, TX, to a new, 55,000 sq.-ft., fit-for-purpose clinical research facility. The newly opened unit has expanded from 72 to 100 beds and is located in the same building as the prior unit. Also, a LabCorp patient service center will be co-located in the CRU, where patients will have an opportunity to learn more about volunteering and participating in early stage trials.

The CRU includes a cGMP pharmacy, ophthalmology procedure rooms, an advanced telemetry system, and a glucose clamp suite, as well as dedicated screening and outpatient visit areas. The pharmacy includes three sterile and two non-sterile GMP manufacturing suites.

“Our new Dallas facility combines advanced medical care with numerous volunteer-friendly amenities,” said Dr. Herman Scholtz, vice president and general manager, Early Clinical Services. “We have invested in a highly customized facility designed to facilitate the safety and quality of our studies and to enhance our clients’ and volunteers’ experience. In addition, we are excited about the unique opportunity to educate patients about our clinical trials and complement our local patient recruitment capabilities through the future LabCorp patient service center. This innovative combination of resources is another illustration of the strategic and operational synergies that LabCorp and Covance are gaining through our combination.”

AB BioTechnologies Selected Vanrx Pharmasystems for New Facility Systems

AB is expanding its services to enable customers to develop new drug products from preclinical through clinical trials using a single provider. The company's expansion into automated aseptic filling and lyophilization complements its existing offering of formulation, analytical services, lyophilization cycle development and GLP/tox manufacturing.

AB BioTechnologies says it will be the first company in the U.S. to operate a complete Vanrx system. The full system consists of the SA25 Aseptic Filling Workcell, Accumulator and Lyophilizer Loader. Vanrx offers a gloveless robotic isolator system for aseptic filling and lyophilization of sterile injectable pharmaceuticals. Their systems can support clinical and commercial drug production.

"The flexibility and aseptic assurance of the Vanrx system will enable us to provide exceptional service to pharmaceutical companies,” said Jeff Schwegman, chief executive officer, AB BioTechnologies. “Clients will be able to bring drug products to market faster, with stable formulations and with process development already well underway for commercial production.”

AB BioTechnologies is constructing a 23,000 square foot manufacturing facility in Bloomington, IN. The Vanrx aseptic filling equipment will be installed within a prefabricated modular cleanroom from Biologics Modular, and attached to a lyophilizer from SP Scientific. The SA25 will be installed for liquid GMP manufacturing by the fourth quarter of 2017, with added lyophilization capabilities beginning in 2018.

Vanrx Aseptic Filling Workcells enable the production of liquid or freeze-dried drug products in a variety of vial, syringe and cartridge formats. It is a fully integrated, automated aseptic filling system that combines robotics, gloveless isolator and machine vision technologies.

Sartorius to Acquire Essen BioScience

Sartorius has signed an agreement to acquire U.S.-based Essen BioScience Inc., a provider of cell-based assays and instrumentation used for drug discovery and research applications. The transaction, which is subject to customary closing conditions, is expected to close 1Q17.

Sartorius will purchase Essen BioScience from SFW Capital Partners for $320 million in cash. Essen expects to generate revenues of approximately $60 million in 2017, with continued double-digit growth. The company is headquartered in Ann Arbor, MI, with sales entities in the UK and Japan, and currently employs approximately 150 people.

Novel analytical methods are crucial to enable progress in the advancing areas of immuno-oncology, antibody discovery and stem cell research. Essen BioScience, which specializes in instrumentation, software and reagents for real-time live-cell imaging and data analysis, helps users accelerate discovery and development of new drugs by providing insight into the mechanisms of disease.

Sartorius will significantly expand its portfolio for bioanalytics, a field the company has recently entered via the IntelliCyt acquisition in 2016. "With the Essen real-time, live-cell analysis platform, we will add another key technology for advancing and accelerating drug discovery applications to our lab divisions’ portfolio," said Joachim Kreuzburg, chief executive officer of Sartorius. "This powerful technology offers important synergies with our IntelliCyt business. Going forward, Sartorius will be able to provide our customers the broadest and, we believe, the most innovative portfolio for cell analysis in the industry."

Brett Williams, president and chief executive officer of Essen, said, "We are excited to become part of Sartorius as a ‘Center of Excellence’ and build an industry- leading cell analytics portfolio together with the IntelliCyt business. This is not only a great opportunity to build upon Essen’s market-leading position, but also to continue development and introduction of transformative solutions for life sciences. In addition, we believe that the combination with Sartorius will provide exceptional opportunities for sustained growth and development for our employees, customers and business partners."

Sartorius said Essen expects to achieve sales revenues in the region of $60 million in 2017.

Last month Sartorius reported joining the European Molecular Biology Laboratory (EMBL) Corporate Partnership Program for training and science education.

Pfizer CentreOne Expands Services in Michigan

Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, announced that it has expanded its fill-finish services to its Kalamazoo, MI site. Along with vial-filling of small molecules and biologics, the facility also provides vial-filling of sterile suspensions, expanding Pfizer CentreOne’s service portfolio.

“Kalamazoo was the obvious choice for expansion of our fill-finish services,” said Peter Stevenson, Pfizer CentreOne’s Vice President and General Manager. “Our Kalamazoo colleagues have been doing contract manufacturing for over 40 years on the API side – it’s part of the culture; and this is also one of Pfizer’s premier sterile-injectables sites. It’s a natural fit.” With more than 65 years of experience in injectables fill-finish, Kalamazoo currently supplies drugs to more than 100 countries around the globe.

Services at the Kalamazoo site encompass:

Small molecules and biologics
Sterile suspensions
Potent and controlled substances
Aqueous and oil-based formulations
Lyophilization
Vials 1-100mL; bulk formulation <1-1600 liters
Technical transfer

The Kalamazoo facility has dedicated, onsite technical, manufacturing science, regulatory affairs and quality teams. Over the last five years, they’ve successfully transferred 37 customer and Pfizer compounds into the facility. Among Kalamazoo’s extensive scientific resources are experts in API processes who know how to solve complex issues with active ingredients; and a team of commodities experts who trouble-shoot problems with stoppers, glass and excipients.

“Our biopharma partners will be in good hands at Kalamazoo,” stated Stevenson, “with a dedicated Pfizer CentreOne team by their side who deeply understand their needs, who can leverage a world of top-flight resources at the site on their behalf.”

Said Bob Betzig, Kalamazoo site head, who oversees all operations on the Kalamazoo campus, “We’re thrilled to expand our contract manufacturing services to include sterile injectables. We value our contract manufacturing partners and pride ourselves on producing difficult-to-make injectables. Our team is ready and waiting.”

Quotient Clinical Acquires SeaView Research / Expands Operations

Quotient Clinical, an early phase drug development services provider, has acquired SeaView Research, expanding its operations into the U.S. SeaView’s clinical pharmacology business has 160 employees across two clinical pharmacology units located in Miami and Jacksonville, FL, and a combined bed capacity of 320. Each of the facilities is capable of undertaking complex clinical research studies including first-in-human investigations.

Quotient’s Translational Pharmaceutics platform integrates clinical testing with formulation development and real-time GMP manufacturing. This approach aims to reduce clinical development timelines and associated costs.

Mark Egerton, chief executive officer, Quotient, said, “Establishing an operational footprint in the US is an important milestone in the development of our business. We can now offer our customers the option to undertake their early phase clinical research either in the UK or the USA, and the acquisition of SeaView is a key component of our plan to replicate our Translational Pharmaceutics platform in the U.S.”

Stuart Harris and Celina Alvarez, co-founders of SeaView, said, “We are excited to join forces with Quotient and are looking forward to working together to continue growing the business.

The combination of the Quotient and SeaView businesses enables us to deliver full service support to our customers, and the market potential for Translational Pharmaceutics in the U.S. is significant.”

Apotex Expanding in U.S.

Generics maker Apotex will construct a manufacturing and packaging facility as part of a $184m US expansion.

Apotex Inc. announced it is expanding its footprint by investing $184m (€174m) at a site in Miramar, Florida, set to become the US headquarters for the Canadian generic drugmaker.

Along with office space and an R&D center, the investment will include a drug manufacturing facility as well as housing the packaging operations for Aveva Drug Delivery Systems, acquired by Apotex in 2012.

While Apotex has over three million square feet in manufacturing and R&D facilities in its native Canada, Apotex CEO Jeremy Desai said having manufacturing presence in the US had a number of advantages.

“Expanding our footprint in the US is a central component of our strategy for global growth and reflects the critical importance of the US and Latin American markets to our success, as well as our confidence in the future of the American manufacturing and biopharmaceutical sector,” he said in a statement.

Furthermore: “We are only permitted to manufacture controlled substances in the US when serving this market, so expansion in Canada was not feasible.”

The investment is expected to create over 150 jobs in Florida when construction is complete, expected early 2019.

Sherpa Expands Capacity

Sherpa Clinical Packaging continues to invest in growth and infrastructure with its latest facility addition in SanDiego, CA. The facility expansion will support continued growth in Sherpa's packaging, labeling, and distribution services, especially as it relates to later stage projects and global studies, the company said. The new building will house four packaging suites, a Class 100,000 cleanroom, and various temperature-controlled storage areas including expansive 2-8°C and -20°C rooms, and a Controlled Room Temperature warehouse. The new cGMP facility consists of 24,000 square-feet and is adjacent to Sherpa's existing 38,000 square-foot headquarters.

“I am extremely pleased to see so many of our customers moving into Phase II and III clinical trials,” said Mark Paiz, president and founder, Sherpa. “As the number of global clinical trials that Sherpa supports increases over the next few years, Sherpa's expanded clinical supply offerings, partnerships and facilities are well poised to support this growth.”

Construction of the building has commenced and is expected to be completed by July 2017. In addition to facilities expansion, Sherpa says it plans to add significantly to its operations, quality, and project management teams within the next year.

Capsugel has Expanded Inhalation Capabilities

Capsugel has expanded its late-stage inhalation capabilities for dry powder inhalation (DPI) concepts through late-stage clinical trial and commercial production. The company has completed installation and validation of a new Harro Hӧfliger Modu-C MS encapsulation unit at its Bend, OR facility that includes specialized drum-dosing technology for use in DPI development projects utilizing spray-dry processing.

"Drug delivery via the lung is becoming an increasingly viable treatment option for a wide range of therapeutic areas, including infectious diseases, genetic disorders and acute systemic conditions that have traditionally been treated via other delivery routes," said Devon DuBose, head of Inhalation Product Development at Capsugel's Bend facility. "Spray-dry processing is finding greater utilization in DPI applications because of its superior particle size control, higher drug loading and fewer formulation dependencies compared to traditional lactose blend formulations. Our customers are seeking partners with not only advanced particle engineering technology and expertise, but also integrated inhalation product development solutions that minimize program risk and complexity."

The new Harro Hӧfliger Modu-C MS encapsulation unit includes an operational capacity of more than 72,000 capsules per hour. The technology provides 100% monitoring of dosed powder mass, fill weight ranges between 5mg and 50mg, and dose accuracy of RSD<3%.

AMPAC Fine Chemicals’ Analytical Business Unit Expands

AMPAC Fine Chemicals’ Analytical Business Unit has recently quadrupled analytical services capacity for highly specialized testing, adding 13,000 ft2 of new lab space at a new facility in El Dorado Hills, CA. The company has similar facilities in nearby Rancho Cordova.

AMPAC Analytical has also enhanced its specialized analytical testing capabilities to support existing and new U.S. FDA requirements. Included are Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), techniques used for the detection and quantitation of trace elemental impurities. Added capabilities also include X-Ray Powder Diffraction (XRPD), Particle Size Distribution (PSD), and Dissolution of Drug Product. AMPAC Analytical has also added 10 Ultra Performance Liquid Chromatography (UPLC) units and has expanded stability chamber capacity to support long-term stability testing of drug substances and drug products.

"This expansion builds on over 70 years of our chemical production and analytical testing capabilities. We are proud to offer our vast knowledge and know-how in specialized analytical methods development and validation for both Drug Substance and Drug Products to our customers," said Renato Murrer, executive director of AMPAC Analytical.

LGC Acquires Axolabs and Invests in GMP Manufacturing Capacity

LGC announced that it has acquired Axolabs, a leading Contract Research, Development and Manufacturing Organization, specializing in the development of therapeutic nucleic acids (TNAs)

LGC also announced a major investment at its Biosearch subsidiary in Petaluma, California, USA to expand its GMP oligonucleotide manufacturing capacity to provide TNA synthesis to the 1kg scale in support of early stage clinical trials.

The acquisition and investment in GMP capacity position LGC as a world leading solutions provider for TNAs and strengthen its existing analytical and bioanalytical drug development service offering. Customers will benefit from integrated analytical and manufacturing solutions spanning lead discovery through to the clinic and beyond.

Dr David Griffiths, Managing Director of LGC’s LMS division, said: “We are delighted to be welcoming Axolabs to LGC. With more than 16 years’ experience in the therapeutic nucleic acid market Axolabs enjoys a strong reputation for scientific excellence, quality and reliability – attributes that match LGC’s. Axolabs’ in-depth know-how in the TNA drug development field complements LGC’s capabilities in GMP oligo manufacture, CMC analytical and bioanalytical services and we look forward to working together with the Axolabs team and its customers.”

Dr Hans-Peter Vornlocher, Managing Director Research of Axolabs, said: “It is clear that LGC shares our passion for delivering the highest quality science and service for our customers. This transition of ownership allows us to continue to invest in our team and facilities at Kulmbach. Combining Axolabs’ pre-clinical expertise and LGC’s GMP manufacturing capabilities allows us to support our clients further along the drug development pathway. Moreover, the access to LGC’s leading science and international reach enables us offer a broader set of solutions for our customers.”

Based in Kulmbach, Southern Germany, Axolabs employs 60 people and delivers integrated research solutions for TNAs, covering in-silico design, synthesis, analytics, bioanalytics, biology, pharmacology and consulting services. Axolabs’ expertise spans a wide range of TNA modalities including antisense oligos, siRNAs, immunostimulatory oligos, aptamers, microRNAs and microRNA mimics, synthetic mRNAs and guide RNAs for CRISPR applications. Axolabs’ management team will remain with the business following the transaction.

Sharp Investing in US, UK Operations

Sharp Packaging Services has purchased Daiichi Sankyo’s packaging facility in the US and is tripling its UK-based clinical packaging business.

"Sharp is continuing to see a demand for services particularly as we move towards the serialization deadline of November 2017," said Jeff Benedict, Senior Vice President, Sharp Packaging Solutions.

"We had committed to expanding capacity in order to accommodate the contract packaging needs of our existing and prospective customers," he added.

In the U.S., Sharp – a division of UDG Healthcare plc – has purchased Daiichi Sankyo’s Bethlehem, Pennsylvania-based pharmaceutical packaging facility.

The 146,000 sq. ft. facility was purchased for a total of $14m. "All equipment and employees at the site were also part of the acquisition," said Benedict.

The FDA-approved facility includes four packaging equipment lines (two high-speed bottle lines, two blister lines), cold and frozen storage, office space, warehousing, and a 2,500 sq. ft. analytical laboratory.

Benedict explained the next steps will focus on ensuring an organized and timely integration of the Bethlehem site to the Sharp portfolio.

In the UK, Sharp has also announced a £9m ($11.3m) investment in a new facility in Rhymney, South Wales for its clinical packaging business.

The initial expansion phase is expected to be completed by late 2018 and includes the acquisition and renovation of an 110,000 sq. ft. facility.

The renovation will more than triple the size of the current UK facility and provides the opportunity for further capacity expansion.

Catalent Expands Kansas City Facility

Catalent Pharma Solutions has announced it has completed an expansion project at its Kansas City facility to significantly increase controlled-temperature storage capabilities for its clinical supply business.

The expansion added 70,000ft³ of storage (2°C-8°C) at the site, representing a five-fold increase in controlled-temperature capacity. This is made up of a combination of both pallet and high-density storage options to increase flexibility. To support growing customer demand, two secondary cold packaging areas have been added, with the option to add more as needed.

Catalent's General Manager of the site's clinical supply services Tom Moon said: "Customers have benefitted from our Kansas City campus' integrated analytical, oral solid manufacturing, and clinical supply services, and now we can offer them expanded cold storage and packaging services as well.

"In the past 18 months, we seen an increase in the numbers of both large and small customers, and to meet this growing demand have nearly doubled our clinical supply workforce, as well as introduced additional shifts in both packaging and distribution."

Catalent's 450,000ft² Kansas City facility provides a range of fully integrated services, from development and analytical support through to packaging and distribution. In 2015, the site completed an investment project that expanded its high-potent and cytotoxic clinical drug packaging capabilities.

Catalent has also recently announced investment and expansions to its workforce in its clinical supply network at Bolton and Bathgate in the UK, and in Singapore.

Lilly invests in U.S. Manufacturing Operations

In an announcement on March 24, 2017 Eli Lilly said it will be investing $850 million in capital projects in the United States throughout 2017. Much of the company’s investments will be in Indianapolis, Indiana, where Lilly manufacturers its diabetes treatments.

Lilly revealed it would be investing $85 million in an expansion of its Trulicity (dulaglutide) device assembly operations in Indianapolis and $140 million in an insulin cartridge production facility. The subsequent investments are part of a five-year plan by Lilly to expand diabetes manufacture in the US. In the past five years, the company has invested $1.1 billion in expanding US diabetes operations. Lilly also mentioned that it has made a $70-million capital commitment in a small-molecule laboratory on its Indianapolis campus.

In 2016 Lilly struck a pay-for-performance deal with Harvard Pilgrim, giving Trulicity preferred status on the company’s formulary. According to the terms of the deal, if patients achieve a less than 8% HbA1c while taking Trulicity compared to other GLP-1 receptor drugs, Harvard Pilgrim will pay a lower net cost to Lilly for the drug. This new investment in Trulicity manufacture may mean that the company is confident in the success of its diabetes treatment, which outperformed similar drugs in clinical trials.

Lilly’s investment announcements came with a direct message for the new Presidential administration. The company said in a statement that “more investments can be expected, particularly if the US adopts a more favorable tax environment.” During a press conference on March 24, 2017, Lilly CEO David A. Ricks said that the company supports lowering the federal corporate tax rate to 20%.

Ricks called the US federal tax system “outdated” and said that it is forcing biopharma manufacturers to expand overseas, in countries including Ireland, Switzerland, and France. Ricks said lowering the tax rate would make it possible for more companies to remain in the US and that hiring US workers “makes good business sense.” Ricks specifically mentioned the Swiss company Novartis, a Lilly competitor, which likely pays a national corporate tax rate in Switzerland of 8.5% compared with the 35% companies pay in the United States. Ricks said he supports lowering the tax rate and said, “We need to stop taxing US companies for simply being American.”

Lilly Announces Investment in U.S. Capital Projects

Eli Lilly and Company announced plans to invest $850 million in its U.S. operations in 2017. The company's investments span facilities across its U.S. enterprise, including research laboratories, manufacturing sites, and general and administrative areas. The investments are being driven by demand for Lilly products, as well as its robust pipeline of potential medicines in development targeting cancer, pain, diabetes and other unmet medical needs.

Company leaders were joined by federal, state and local government officials at Lilly Technology Center, where the details of the investments were unveiled, including plans for a new $85 million expansion of its Trulicity (dulaglutide) device assembly operations in the U.S. This expansion is part of a massive five-year investment by the company to expand its diabetes products manufacturing operations in the U.S., which also includes a $140 million insulin cartridge production facility that was officially dedicated at today's announcement.

David A. Ricks, Lilly's president and chief executive officer, said that Lilly's potential for growth and its long-standing commitment to the U.S. market led to its decision to invest in its U.S. operations and expand its manufacturing footprint in Indianapolis.

"Our future at Lilly is bright, as we're on a path to launch 20 new products in a 10-year time frame," Ricks said. "As we have for our entire 140-year history, we continue to see Indiana and the United States as attractive places to research and make the medicines that we sell around the world."

Ricks explained that Lilly's $850 million investment will fund both projects that are already underway as well as new projects that will be initiated throughout the course of the year, including additional projects in Indianapolis.

Company officials focused the announcement around its massive investment in diabetes products manufacturing. Over the course of the last five years (2012-2016), Lilly has invested approximately $1.1 billion to boost its diabetes products manufacturing operations in the U.S. These investments include upgrades to existing facilities, as well as the addition of new capacity and capabilities based on the evolution of the company's diabetes pipeline and portfolio and the increased prevalence of the disease.

During this period, Lilly has increased its U.S manufacturing workforce by more than 1,000 employees—from 5,000 to 6,000 roles—with approximately 400 added in Indianapolis.

"More than 400 million people around the world have diabetes—and that includes approximately 30 million people in the U.S. alone," said Enrique Conterno, president, Lilly Diabetes and Lilly USA. "Lilly has spent more than 90 years providing solutions to people with diabetes, and today's announcement extends the deep commitment of our heritage. This manufacturing expansion, along with the introduction of several other new treatments over the last two and a half years, will allow Lilly to continue to be a leader in diabetes care."

Conterno added that the new investments underscore Lilly's diabetes manufacturing presence in Indianapolis. Lilly's state-of-the-art manufacturing facility in Indianapolis is part of the company's nine-decade legacy of producing insulin.

"In addition to providing the capacity necessary for the safe and reliable supply of medicines to patients, these investments have allowed us to add U.S. manufacturing jobs," said Maria Crowe, president of Lilly Manufacturing. "These include highly-skilled technicians, scientists and engineers, which are an economic catalyst for local communities."

Further, Crowe noted that during the past five years, construction-trade staffing has averaged nearly 500 jobs, and had a peak level of nearly 1,000 workers. The ongoing operations together with the investment programs will continue to require a significant level of construction-trade workers at the Lilly Technology Center.

"Lilly's announcement today is a clear example of what a fiscally sound state with a strong business climate—coupled with a world-class company—can achieve," said Indiana Gov. Eric J. Holcomb. "I am grateful for Lilly's continued investment in Hoosiers and in our home state, and will work to maintain the strength of the life-sciences industry and advanced manufacturing in Indiana."

"Despite a global presence and diverse interests, Lilly's continued investment in Indianapolis is a testament to their exceptional level of faith in our workforce and a decades-long commitment to this community," said Indianapolis Mayor Joe Hogsett. "As the biotech industry continues to grow in Indianapolis, Lilly remains a clear leader, bringing advancements to the field and high paying jobs to the city. I'm excited for what today's announcement means for the company's future and look forward to Lily's continued advancements as their footprint in our city grows."

Ricks concluded by saying that Lilly has invested approximately $5 billion in its U.S. facilities during the last decade and that more investments can be expected, particularly if the U.S. adopts a more favorable tax environment.

"The equitable treatment of foreign earnings, a lower U.S. corporate tax rate, and U.S. innovation incentives—similar to the rest of the world—will encourage significant investment in the U.S., creating economic growth and good jobs for Americans," said Ricks. "The House Republican Blueprint with border adjustability is designed to achieve these priorities, puts America's global companies on a level playing field with competitors around the world, and creates economic growth and employment within the U.S."

NY Genome Center, Technion-Israel Institute of Technology Form Research Partnership

The New York Genome Center and the Technion-Israel Institute of Technology are teaming up to advance biomedical and genomics research, and to translate research into new treatments and clinical applications.

"New York and Israel share an unbreakable bond and through this innovative partnership we are further strengthening our economic ties and cementing our common future," New York State Governor Andrew Cuomo said in a statement. "The Empire State is leading the way in groundbreaking life sciences research, and by bringing together these two industry titans, we are positioning New York at the forefront of the next generation of medical research and discovery."

Both institutions have expertise in bioinformatics and computational biology, they said. The Technion-Israel Institute will share its expertise on translating research into commercially viable applications with the goal of advancing personalized medicine and developing new therapeutics.

"The New York Genome Center prizes entrepreneurial spirit, innovation and discovery, and the Technion has built its significant success on these principles. We look forward to forging new paths in genomic research through this collaboration, leveraging the unique strengths of each institution to advance discovery in genomics," added NYGC Chief Operation Officer Cheryl Moore.

This deal extends Cuomo's aim to create a life science research cluster in New York, an initiative he announced in December and which he intends to invest $650 million in building. This includes $250 million in tax incentives for new and existing life science companies, $200 million in state capital grants to support investment in new wet lab spaces, $100 million in investment capital for early stage life science initiatives, and an additional match of at least $100 million for operating support from private sector partnerships, NYGC said.

Invivotek Completes Solar Farm and Facility Expansion

Invivotek, LLC, a Genesis Biotechnology Group® (GBG) company and in vivo pharmacology contract research organization (CRO), announced the completion of the Genesis Solar Farm adjacent to its newly expanded preclinical research facility in Hamilton, New Jersey. The solar farm provides a cleaner, renewable energy source to reduce costs and lessen the CRO facility's impact on the environment. Completion of the Genesis Solar Farm follows Invivotek's recent expansion from a 19,712 square foot to a 26,453 square foot facility. The expansion translates to a 100% increase in capacity.

Invivotek joins many other pharmaceutical and biotech companies worldwide who have made a commitment to invest in solar power. This project advances the efforts of GBG to reduce high energy costs associated with research and improve their environmental profile. "Construction of the solar farm at Invivotek's research facility will not only reduce its carbon footprint, but it's also a good business decision," said Dr. Eli Mordechai, CEO of Genesis Biotechnology Group. "We are committed to good stewardship, not only of our clients' projects, but also of our community and the environment."

The solar system is expected to produce over 1.2 million kilowatt hours per year. The savings to Invivotek will be in excess of $230,000 per year (enough to power 127 households for one year) and will provide over 60% of Invivotek's energy needs.

Pharma Tech Industries Cleanroom

Pharma Tech Industries, a pharmaceutical contract manufacturer and packager of powder products, recently introduced a highspeed bottling line for the production of Rx, OTC, and nutritional ingestible products at its facility in Union, Mo. The bottling line is housed in a new, specially-built ISO 8 Class 100,000 controlled environment designed for non-sterile Rx pharmaceutical-grade oral products. All equipment is of modular, quick-change design to enable minimal downtime between campaigns.

Controlled Environments spoke with Tee Noland, Chairman and CEO of Pharma Tech Industries, about this cleanroom facility addition.

Who designed/built the new cleanroom? What was the cost?

Designed by Alan Alewine with architectural services provided by Bates & Associates Architects of Springfield, Mo., and mechanical engineering design completed by Design Mechanical Inc. of Chesterfield, Mo. The cost was $1.5 million.

How long did construction take? Where did production take place during the construction process?

Construction took eight months. Production took place on a slower existing line until construction was complete.

Secondary packaging line at Pharma Tech Industries’ facility in Union, Mo. Featuring several units from production equipment manufacturer PneumaticScaleAngelus, the line includes premium unscrambling, filling, checkweighing, metal detection, capping, induction sealing, bundling, and casepacking equipment.

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

Facility is 55,200 square feet; gowning and airlock is 441 square feet; processing is 3,146 square feet; secondary case packaging is 1,715 square feet; 428 square feet of equipment cleaning room.

How does the new facility differ from your previous facility?

The new facility separates the filling process into rooms or cells to reduce risk of contamination and allows each cell to support the output of the high speed line.

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

A high speed filling line includes unscrambling, filling, checkweighing, metal detection, capping, induction sealing, bundling, and casepacking equipment. The filling occurs in an ISO 8, Class 100,000-capable controlled room designed for non-sterile Rx pharmaceutical grade oral products.

The new processing line is comprised of modular, quick change-capable equipment for minimal downtime between campaigns. It is part of a multimillion-dollar investment that has added 55,000 square feet of manufacturing space to Pharma Tech’s plant in Union, Mo. Image: Pharma Tech Industries

How many employees does the cleanroom area have? What kind of work do they do?

[We have] 12 employees. Seven employees work the production line; they are responsible for keeping machines running according to the validated process. Two employees monitor the product coming from the production line; they are responsible for AQL checks per customer requirements. One employee leads the production line and is responsible for staffing, documentation, and reporting. One employee supplies the line and is responsible for keeping components loaded for employees to use. One employee in maintenance is responsible for any maintenance work needed during process or while room is down.

Describe the cleaning process — does your existing staff perform these duties, or do you hire it out to another company?

The cleaning process is done by the production crew (10 of the 12 employees). The cleaning process was established and validated before the production line started. Contact parts are rinsed with hot potable water, scrubbed, rinsed with hot potable water, rinsed again with USP Purified water, and sanitized with 70 percent alcohol. The processing room and equipment that cannot be removed are cleaned with hot potable water and sanitized with 70 percent alcohol.

Datwyler Plans New Plant

Swiss-based supplier for drug packaging and medical devices, Datwyler, is channeling more than $100m into building a new plant in Delaware.

The plant will run in accordance with Datwyler’s most advanced standard, First Line. It will produce the company's specialisms: elastomer formulations, coatings, aluminum seals and processing technologies.

The First Line production standard is specially designed to manufacture pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment.

The new facility will be used to manufacture high-quality elastomer components for injectable drug delivery systems. Production is scheduled to start in 2018.

Once up and running, the largely automated plant will provide jobs for around 120 employees. This investment will enable Datwyler to better provide customers in the US, Europe and Asia with locally produced components.

The First Line standard is a manufacturing concept for elastomer components based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection and a unique validated washing process.

This approach is certified to ISO 15378 and “exceeds the most stringent quality standards of the European and US regulatory authorities,” according to the company.

Datwyler has developed three different offering categories:

Bio Care offers solutions for the most sensitive, large molecule drugs - components of this category also provide the lowest available particle levels in the industry.
Pharma Care addresses the needs of small molecule drugs which require production flexibility and outstanding quality.
Med Care offers medical companies a broad range of materials and technical support.

Vertex to Close Canada Site, Focus on 3 Hubs in R&D

Vertex Pharmaceuticals announced in its annual filing that it's closing an R&D site in Canada as part of an overall research consolidation.

After posting a disappointing forecast for 2017, Vertex is consolidating its R&D operations, according to a securities filing. The company plans to close a site in Canada, cutting 70 jobs, and trimmed its headcount in Boston, according to a source close to the company.

Vertex “decided to consolidate our research activities into our Boston, Milton Park and San Diego locations,” according to its 10-K. The decision was made last month, the company said, as analysts were chewing over reduced expectations for Vertex's star cystic fibrosis med, Orkambi.

The drugmaker chose to close the R&D outfit in Canada "after careful consideration" and offered some employees the chance to relocate. Vertex will expand research efforts at its three remaining hubs, said a spokesperson.

Meanwhile, at the Boston location, an internal reorganization left 5 to 15 longtime employees without jobs, a source close to the company told FiercePharma. A few employees moved from the Canada office to Boston, the source said, "but most were cut loose." The cuts in Boston followed a trickle of departures by other veteran staffers.

Vertex's spokesperson didn't answer a specific question about cuts in Boston.

About 70 Vertex employees in Canada face losing their jobs. The move will result in restructuring expenses of about $10 million. Radio Canada reported the Laval site is set to close in May.

"Having the right expertise in the right places with the right resources is critical to our mission of bringing more transformative medicines to people with serious diseases," a Vertex spokesperson wrote. "We are constantly looking for ways to improve the odds of success for our business and for patients."

Massachusetts' Labor and Workforce Development office doesn't have a WARN notice filed from Vertex, according to a spokesperson with that agency. Vertex has about 2,150 employees worldwide, according to its 10-K.

Drugmakers have been focusing their R&D efforts in geographic hubs to save money and, they hope, create collaborative environments where scientists in daily contact build on one another's ideas. Vertex's three remaining R&D locations sit in three regions where pharma companies, academic centers and teaching hospitals have created active research networks. Vertex's Milton Park site is near Oxford, U.K.

CMC Expands to Offer cGMP Processing

Custom Milling & Consulting (CMC) has constructed a brand new state-of-the-art class 100,000/ISO 8 cGMP cleanroom. The new area allows CMC to expand on their current contract manufacturing services. For years CMC has offered its expertise in fine particle size reduction with liquid materials, and now is taking that knowledge and increasing the capabilities that they will be able to offer customers.

The new area will be equipped with CMC horizontal media mills and mixers that have been specifically designed for a clean and sterile environment. The equipment is made with stainless steel materials and designed for easy teardown, making the cleaning and sterilization process more effective and efficient. All processes, procedures, and productions will be well documented to ensure cGMP and ISO standards are met and to satisfy the most stringent customer standards.

Features that are available include HEPA filtration, a climate controlled environment, 2,560 cubic feet of refrigerated storage space, and the latest in fine media milling equipment and technology. These features will make it ideal for processing cosmetics, skin care, dental care, essential oils and many more products that require stricter processing practices.

CMC will be concentrating on assisting companies that are looking for a place that they can take their product from conceptualization to production. With the ability to produce batches as small as 1 gallon up to 300 gallons.

In addition to production CMC can provide a full turnkey service that includes raw material acquisition, labeling, packaging, storage and shipping. To ensure product quality and consistency customers have full access to all analytical equipment, from particle size analyzer to HPLC analysis.

BioStem Expands Services

BioStem Technologies has opened its new laboratory and corporate offices in Pompano Beach, FL, enabling it to leverage its vertical integration strategy in the health, wellness and biotechnology sectors. The lab will serve as the quality, R&D, and pharmaceutical manufacturing laboratory, not only for the company's in-house operations, but also for its contract formulation and contract manufacturing services.

The company is in the process of finalizing its certifications for the ISO 8, 7, and 5 suites, as well as validation of the cGMP and cGLP areas. Corporate operations are expected to move to the new facility in the second quarter of 2017, while the operations of qualified pharma ingredients, one of the company's subsidiaries, will remain at its current location in Oakland Park, FL.

"With the recent regulation changes we amended our original facility design to comply with FDA 503b regulations, which caused an extension to our timeline, but I couldn't be prouder of this new state-of-the-art facility,” said Henry Van Vurst, founder and chief executive officer, BioStem.

Aptar Pharma Inaugurates Congers Site Expansion

Aptar Pharma’s site expansion in Congers, NY, was inaugurated on March 20 by Stephan Tanda, president and chief executive officer, AptarGroup; Salim Haffar, president, Aptar Pharma; and Alex Theodorakis, president, Aptar Pharma North America. The expanded state-of-the art manufacturing capabilities will be used to complete premium injectable elastomeric component manufacturing.

“The new expansion supports growth in three directions,” said Bas van Buijtenen, president, injectables division, Aptar Pharma. “It adds capacity to our network of global manufacturing sites and will be equipped with the latest technologies to meet growing quality requirements. The proximity to our North American customer base improves our service and responsiveness.”

Pharma Packaging Solutions Launches Low Relative Humidity Packaging Suite

Pharma Packaging Solutions has introduced a new low relative humidity primary packaging suite in Clinton, TN, designed to maintain low relative humidity levels. The company provides oral solid dose packaging solutions including bottling, blistering and cartoning to the pharmaceutical industry.

The new packaging suite maintains low relative humidity levels to protect humidity-sensitive products that require special handling. At a temperature of 70 degrees, relative humidity (RH) can be maintained as low as 6% according to the company. For some product types, it is critical to safeguard the production environment as moisture can modify the rates of chemical degradation. The low relative humidity packaging suite extends the work-in-progress (WIP) time, which affects how long components can be opened or exposed.

Piramal Pharma Solutions Expands Capabilities

Piramal Pharma Solutions (PPS) has introduced new and expanded manufacturing capabilities at its facilities in Lexington, KY following a $25 million investment.

The company develops and manufactures sterile finished dosage forms at the Lexington site using isolator technology. The expanded capacity and capabilities in manufacturing, is being rolled out in phases. The first of which is now complete and includes the installation of a new high-speed vial filling line, expansion of laboratories, and associated utility support. The new filling line will double the capacity at Lexington, as well as enhance efficiency and productivity. A large portion of the new capacity has been committed to current clients to support commercial product launches. The next phase includes expanding lyophilization capability and is expected to be operational by the end of 2018.

"With the completion of this first phase of expansion at Lexington, Piramal Pharma Solutions expects to support our customer product launches that address a broad range of adverse human conditions ranging from cancers to pre-term labor to rare childhood diseases. It is our privilege to partner with customers as they seek to improve the quality of life of patients and we thank them for their continued trust and faith in us," said Vivek Sharmachief executive officer of Piramal Pharma Solutions. "We continue to focus on customer delight and execute on our strategy of becoming the 'partner of choice' for our customers, who lever Piramal's unique broad based capabilities for both integrated offerings and standalone drug substance or drug product offerings. Our world class talent at Lexington will be a key driver in ensuring that we sustainably delight our global customer base."

PCI Expand Cryogenic Storage Capacity

PCI Clinical Services (PCI) has announced a second 400% increase in cryogenic storage capabilities as it looks to support “considerable growth.”

According to the pharmaceutical outsourcing services provider, the announcement follows an initial capital investment in specialist cryogenic storage in Rockford announced in November of last year.

Upon completion, the expanded facility will feature larger-scale specialized storage to accommodate two- and five-milliliter vials in addition to blood bags.

Brian Keesee, General Manager, US Clinical Services at PCI explained the enhanced capability in the US is the latest in a series of major investments to support clinical trial supply.

“This current investment will support considerable further business growth in this segment,” said Keesee, adding that the investment enables PCI “to meet the growing need of the pharmaceutical and biotech market for large-scale, high quality storage of temperature-sensitive products and breakthrough therapies.”

The expansion follows a similar 400% storage capacity gain at PCI’s Bridgend, UK-based site. The site now features a purpose-built and dedicated -40°C facility in addition to expanded frozen storage at -80°C.

Avista Completes Expansion at Former Microtest Labs

The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.

The contract testing, development, and manufacturing organization (CDMO) announced the finished expansion at Interphex last week in New York.

The expanded facility features an additional 4,200 square feet of space to house a new microbiology laboratory and a modular cleanroom area, which features isolator technology and an ISO 6 cleanroom for sterility testing.

The site, formally Microtest Labs, has “an extensive client base through historical testing services as well as expanded services since being acquired by Avista Pharma,” said Patrick Walsh, CEO of Avista Pharma.

“We believe that continued investments in facility renovations, equipment, and services at this facility are important to maintain best-in-class service levels,” he added.

Walsh further explained the new service offerings were requested by clients and the facility expansion “is necessary to keep pace with our intended growth targets.”

Additional capabilities include isolator sterility testing, which enables Avista to provide sterility testing with comprehensive evaluations and a lower risk of false positives.

“This capability complements the services that we provide and is particularly sought by manufacturers such as parenteral pharmaceutical manufacturing clients,” Walsh added.

Facility improvements also include a new microbiology laboratory and support area with new autoclaves and glassware washers.

“We continue to invest in our existing service offerings and to rapidly expand new offerings,” Walsh explained.

In addition to the expansion at its Agawam, MA facility, Avista is currently making investments at other Avista Pharma facilities, including increased scale of API manufacturing and solid dose finished product manufacturing at its Longmont, CO facility.

ISPE Announces 2017 Pharma Facility Winners

The International Society for Pharmaceutical Engineering (ISPE) says its Facility of the Year Award (FOYA) program recognizes innovation and creativity in manufacturing facilities serving the regulated healthcare industry. Projects selected for the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations.

“We are proud to honor the eight organizations that share ISPE’s commitment to innovate and advance pharmaceutical manufacturing technology for the benefit of all global patients,” said John Bournas, ISPE CEO and President.

The 2017 Facility of the Year Category Award Winners include:

Abbott: Winner of the Operational Excellence category for success of its “Operational Excellence – A New Quality Approach" project initiated at the Abbott Diagnostics facility in Longford, Ireland. The site has increased productivity, improved changeover efficiencies, eliminated backorders, and enhanced product quality--while also reducing cost per unit, cycle times, equipment downtime, and inventory holdings.

Bristol-Myers Squibb: Winner of Facility Integration category for its Biologics Development Building and the Clinical Manufacturing Building project located in Devens, Massachusetts. These facilities were recognized as outstanding examples of how to integrate new capabilities within an existing plant through careful design, good collaboration, as well as creative engineering.

Cook Pharmica: Winner of Equipment Innovation category for its Flexible Filling Line project in Bloomington, Indiana. This collaborative development between owner, suppliers and engineering experts delivered a novel application of commercially available and custom developed equipment innovation manufacturing solutions that drove superior commercial market changing technology and supply chain flexibility in a unique “ready-to-use” vial platform.

Eli Lilly and Company: Winner of the Process Innovation category for its Continuous Direct Compression Manufacturing Kits 2 & 3 project located in Indianapolis, Indiana, and Carolina, Puerto Rico. Their forward thinking approach brought on the implementation of Continuous Direct Compression (CDC) Process and other process innovations in their oral solid dose (OSD) facilities across their manufacturing network.

Eli Lilly and Company: Winner of the Facility of the Future category for its process development, production platform commitment, and deployment of three replicate operational continuous oral solid dosage (OSD) production facilities. Fundamental to the success of the project was the development of the progressive mass balance control scheme anchored by advanced automation and PAT technology— key to insuring consistent control, low process variability, and high quality assurance.

Jazz Pharmaceuticals Ireland Limited: Winner of the Project Execution category for its creation of a greenfield manufacturing facility in Athlone, Ireland. Having no prior experience internally on building or operating a manufacturing facility, the Jazz “Project Rock” approach was highly pragmatic, and a model for lean project execution and integration of the investment from “project” phase to licensed GMP operations.

Nephron Pharmaceuticals Corporation: Honorable Mention for its facility in West Columbia, South Carolina. The Nephron S.C., project was recognized for its use and integration of a suite of industry leading technologies such as laser guided vehicles, automated warehousing, robotics to eliminate human intervention and track and trace technology.

Novartis-Penn Center for Advanced Cellular Therapies: Honorable Mention for its Center for Advanced Cellular Therapies (CACT) project in Philadelphia, Pennsylvania, USA. The facility leverages pharmaceutical engineering principles to successfully merge academic, corporate, and medical considerations thereby creating an innovative center to advance personalized medicine.

PT. Kalbio Global Medika: Honorable Mention for its greenfield Biotech Facility project in Jakarta, Indonesia. Kalbio’s young and highly motivated project team is an outstanding example of the “can do spirit”. It is a fine demonstration of the talent and potential for biomanufacturing in the region.

The 2017 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet on June 6, 2017, in Arlington, Virginia. The 2017 FOYA Overall Winner will be announced at the 2017 ISPE Annual Meeting & Expo from Oct. 29–Nov. 1 in San Diego, California.

For more information, visit www.FacilityOfTheYear.org.

REST OF WORLD

R-Pharm to Expand Biopharmaceutical Production

Russian pharmaceutical company R-Pharm opened a new biopharmaceutical production plant in Yaroslav, one of the main pharmaceutical clusters in Russia located 250 kilometers (160 miles) northeast of Moscow. The new factory will support production of biologics and biosimilars focused on treating autoimmune diseases and cancer, and provide increased access to these critical therapies for patients in the region.

Biopharmaceuticals, also called biologics, are the world’s fastest-growing class of medicines – of the top ten therapeutics on the market today, seven are biopharmaceuticals, and these drugs are about to become even more commonplace.

Biopharmaceuticals are produced in complex manufacturing facilities that take years to build, and they are often prohibitively expensive for large patient populations around the world. Cost is a key reason why most of the biopharma production is based in North America and Europe. This has not gone unnoticed, and many countries, including Russia are having issues with access to affordable biologics and are creating national programs to accelerate the local production of biopharmaceuticals.

“Since Russia started implementing its federal Pharma-2020 program aimed at reaching 50% of value share of locally manufactured drugs on the Russian market by 2020, many foreign biopharmaceutical companies have made the decision to manufacture within Russia, and thus, the share of pharmaceuticals made locally has gone from 4% in 2009 to 35% in 2015”, stated Olga Kolotilova, Head of Department of Development of Pharmaceutical and Medical Industry for Ministry for Industry and Trade, Russian Federation at the R-Pharm’s opening event.

Vasily Ignatiev, CEO, R-Pharm Russia, also sees that the state initiatives have given a strong impulse to establishing new manufacturing facilities in the country – now the companies are moving from dosage form production to biopharmaceuticals. “The biopharmaceutical sector is still fairly new in Russia, but we see it developing in a dynamic way. Surely there are some challenges, mostly linked to finding and training the staff capable to handle the high-technology manufacturing processes, but generally speaking our company as well as other players in the market manage to deal with it through proper and timely planning and implementation of recruitment and training.”

According to Ignatiev, local production is necessary to minimize the dependence on imports and to bring biopharma manufacturing closer to the end-consumers. It will limit the impact of currency fluctuations on pricing, and make the supply pharmaceuticals more reliable and unintermittent. This is particularly important in Russia due to the ageing population and increasing disease burden: by 2025, almost a quarter of the Russian population will be aged 60 years or older. This and the development of national programs are expected to contribute to the significant biopharmaceuticals market growth in Russia significantly.

“Several biopharma-oriented manufacturing sites in Russia have already been commissioned and are actively producing. I believe that the Russian biopharmaceutical manufacturing will therefore quickly match or even exceed the highest international standards in terms of technologies employed, productivity and range of substances in the coming few years”, Ignatiev continues.

R-Pharm selected GE Healthcare’s FlexFactory biomanufacturing platform for its facility to address the common biopharmaceutical industry challenge: the need to reduce biologic time-to-market and increase production flexibility, all while remaining in compliance with global regulations and quality standards. FlexFactory is comprised of single-use technologies and associated process hardware as well as an integrated automation platform and support components for start-to-finish manufacturing of biopharmaceuticals. “The FlexFactory platform represents technology that utilizes single-use systems that are disposed after a manufacturing run. This solution makes the changes of required tools between the runs much faster and easier and ensures high stability and quality standards, since it eliminates the need for long shutdowns and costly and complicated cleaning procedures techniques when switching production from one batch to another”, Ignatiev says.

“Besides the improved and more reliable access to biopharmaceuticals for internal consumption, it is important to accelerate and support local production, because the global pharmaceutical and biopharmaceutical market is much larger than the Russian one, so the sophisticated modern manufacturing built in Russia will increase the pharmaceutical products export potential. R-Pharm and some other Russian companies are already taking this route. Therefore, the localized production that meets all international technological and quality standards will inevitably become another source for exports from Russia”, Ignatiev concludes.

Merck's Allergopharma Opens Facility in Germany

Merck’s allergy business Allergopharma has opened its new biopharmaceutical production unit in Reinbek, near Hamburg (Germany).

"By this € 42 million investment Merck is supporting the Reinbek site in order to expand the allergies business on a global scale. The new production building is part of this global expansion, and will support our growing business in the allergy market place,” said Simon Sturge, chief operating officer at the healthcare business sector of Merck.

Marco Linari, CEO of Allergopharma, added, “From a technology point of view, the new biopharmaceutical production is a quantum leap. It means an increase in supply safety for patients, a further improvement of product quality and future innovations towards improving therapy.”

Allergopharma, the allergy business of the healthcare business sector of Merck, is a leading player in the allergen immunotherapy (AIT) of type I allergies, such as hay fever or allergic asthma.

Merck laid the foundations for the building in December 2013. Alongside the cleanrooms for biopharmaceutical production, the new building has ultra-modern technological operations, a glass visitors’ foyer with a view of the cleanrooms and the potential for extension to accommodate further filling lines.

Novasep Opens Antibody-drug Conjugate (ADC) Bioconjugation Unit

Novasep, a leading supplier of services and technologies for the life sciences industry, announces that its new €11M bioconjugation facility is now operational. The greenfield facility was erected within 20 months on Novasep's Le Mans site in France.

The 21,520 sq. ft. (2,000m2) facility features two flexible GMP production suites equipped with 10L to 400L vessels to support both clinical and commercial manufacturing of antibody-drug conjugates. The stand-alone facility is purpose-built and offers R&D services, QC and scale-up laboratories.

Novasep has been a leading contract service provider in the ADC arena for more than 10 years; the new unit completes Novasep's ADC manufacturing platform already featuring ADC payloads, drug linkers and monoclonal antibody commercial scale production capabilities.

"We designed the facility to ensure smooth and robust scale-ups and address the ADC-specific analytical and process challenges." Rachel de Luca, General Manager of Le Mans site said. "Our team has a long experience in applying DoE to chemical synthesis and bioprocessing and efficiently develop conjugation and purification steps on a wide range of ADC platforms. Furthermore, the site has established good manufacturing practices meeting the Quality and SHE standards applied to the production of anti-cancer compounds, confirmed by a long track of successful FDA inspections."

ADCs are particularly complex to produce because they are composed of a biological part - the monoclonal antibody, and a chemical part - the linker and the highly potent payload. The conjugation is the critical process step where both parts are assembled.

Although only two drugs have reached the market so far, the pipeline of ADC-based drugs in development is rich and promising. Many research platforms are being developed to control and improve further the activity of ADC drugs through alternative strategies of linkage, site specificity and new payloads. More generally, this approach addresses the patients' demand for more targeted therapies having lower side effects.

Dr Michel Spagnol, CEO and Chairman of Novasep, declared: "We are delighted to inaugurate this new unit which reflects Novasep's strong know-how and expertise. Our Group continues to strengthen its position and pursue its investment strategy to delivering service excellence to its worldwide clients, at the forefront of innovative therapies which can change the life of patients."

Sanofi and Lonza Partner to Establish a Large-Scale Biologics Production Facility

The large-scale facility, to be built in Visp, Switzerland, will be established through a joint venture with an initial investment of around CHF 290 million (€ 270 million) shared equally between Sanofi and Lonza

The strategic partnership leverages Lonza’s expertise in large-scale mammalian cell culture facilities alongside Sanofi’s strength in developing and launching biologics based treatments to address patient needs

Paris (FR) and Basel (CH), 27 February 2017 – Sanofi and Lonza announced that they have entered into a strategic partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The strategic partnership in the form of a joint venture combines the strong biologics development pipeline of Sanofi with the expertise of Lonza to design, construct, start-up and operate a state-of-the-art large-scale mammalian cell culture facility. The initial investment will be around CHF 290 million (€ 270 million), to be split equally between each company.

The initial phase of the facility will commence construction in 2017, pending necessary regulatory approvals, and is expected to be fully operational by 2020. Lonza has previously built and licensed three similar facilities in the U.S. and Singapore.

“In addition to the investments we are making in building our own internal production capabilities, the joint venture between Sanofi and Lonza emphasizes our commitment to provide access for patients to high quality therapeutic monoclonal antibodies,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs, Sanofi. “Approximately sixty percent of our pipeline is made up of biologics, including monoclonal antibodies, dedicated to key disease areas such as cardiovascular, immunology and inflammation, neurology and oncology. Lonza is a highly experienced partner in this field and the capabilities which this joint venture will create are critical to meeting our patients’ needs for these important therapies.”

“By entering into this long-term strategic relationship we have developed a tailor-made business model that best fits both Sanofi’s and Lonza’s requirements. It provides to Sanofi dedicated capacity, which allows for a clear win-win situation for all participants,” said Marc Funk, COO Pharma & Biotech, Lonza. “As part of our strategic roadmap, we will develop further innovative business models based on the requirements of our customers. We intend to address these long-term market needs by establishing a state-of-the-art strategic biologics manufacturing platform. The strategic partnership with Sanofi represents the first module in this undertaking; and we are convinced that with this future-oriented approach, we can serve additional customers.”

The partnership provides both Sanofi and Lonza with substantial flexibility in an innovative setup. Each party will share the available capacity in line with their equity shareholding in the joint venture.

Sanofi will have additional access to bio-manufacturing capacity to support increasing demands for their portfolio of biologic therapeutic products, should they require it.

Lonza will be free to market their share of capacity, if not required by Sanofi, and will also market unused Sanofi capacity, where available.

Lonza will construct the facility and will support the joint venture in its operations of the facility.

The strategic partnership enables Sanofi to react quickly to fluctuations in demand in a short timeframe, reinforcing their capability to launch high-quality, next generation biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture based therapeutic proteins, therefore allowing Lonza to better serve its customers. By adding flexibility in this way, this model will help to optimize biologics production capacity across the whole industry.

Allergan Investments in Ireland

Allergan has committed €42m ($44 million) to increase capacity and capabilities at two manufacturing facilities in Ireland.

“The investment will encompass the company’s Clonshaugh and Westport manufacturing operations, supporting increased manufacturing capabilities for some of Allergan’s key current and future products,” said a spokesperson for the firm.

The 61 acre site in Westport, located about 200km west of Dublin, makes sterile pharmaceutical ophthalmic and biologics and was subject to a €270m investment in 2012 to support botox production.

“[The latest investment] will go towards adding additional capacity to its eye-care manufacturing operations and the expansion of its ocular implant manufacturing facility to accommodate both a capacity increase for existing products and also the capability to accommodate new products using this technology platform.”

Clonshaugh, meanwhile, was added to the firm’s network in 2014 when Allergan – at the time known as Actavis – acquired Forest Laboratories for $28 billion.

Operations at the GMP site include weighing, mixing, granulation, tableting, coating and packing of raw materials.

The announcement comes as Allergan celebrates 40 years in Ireland, a country which has become a major small and large molecule manufacturing hub for the pharmaceutical industry.

“Allergan were amongst the early arrivals to Ireland and helped to sow the seeds of what was then our emerging pharmaceutical sector, which thankfully took root with much vigor over the intervening years,” Ireland’s Taoiseach Enda Kenny said in a statement.

“Allergan has undoubtedly made a significant contribution to making Ireland home to a world class pharmaceutical industry and I wish to thank them for their ongoing commitment to their Irish operations.”

Currently the firm employs around 1,700 workers in Ireland, 1,100 of which at the Westport site. We asked if the latest investment would lead to more jobs:

“We do expect the investment into increased manufacturing capabilities and capacity will lead to new job creation,” the spokesperson said. “The company will provide further details as the projects advance.”

Shangpharma to Merge API and Research in China

Shangpharma plans to merge its API unit with its research arm as Shanghai Chempartner, which it will list on the Shanghai or Shenzhen stock exchange.

The firm will combine its China Gateway businesses – which make active pharmaceutical ingredients (API) for small and large molecule drug developers - with its various Chemparter contract research units in China, the US and Europe.

Shangpharma said restructuring will allow it to “better serve its clients, expand its global presence and access new markets.”

The firm plans to float Shanghai Chempartner by merging it with a company that is already listed, but did not provide further information when contacted.

Shangpharma was last a public company in 2010 when it listed on the New York Stock Exchange (NYSE).

However, it went private in 2013 after its share price halved and it was acquired by CEO Michael Xin Hui and private equity firm TPG Star Charisma.

ShangPharma employs more than 2,000 people and is China’s third biggest contract research organization (CRO) behind WuXi Apptec - which recently announced plans to list its biologics and contract research units in China - and Pharmaron.

The firm's manufacturing business comprises China Gateway Pharmaceutical development - which makes APIs for small molecule drug developers - and China Gateway Biologics, which provides large molecule drug production services.

Last year Shangpharma added peptide chemistry to its offering, buying production technology and investing in discovery firm Circle Pharma.

Shangpharma's plan to combine its manufacturing and research businesses prior to taking them public contrasts with the approach taken by rival Wuxi.

Wuxi listed its small molecule API and drug manufacturing business - STA - in 2015 and as stated above is poised to float its biologics and CRO businesses separately

CBMG Completes Wuxi Stem Cell Plant Expansion

Cellular Biomedicine Group Inc. (CBMG) has expanded its stem cell manufacturing facility in Huishan High Tech Park in Wuxi, China.

The firm has added 20,000 square feet of manufacturing space at the facility and installed technologies for the production of plasmids and viral vectors, as well as a cell bank and laboratory for the development of reagents.

CEO Tony Liu said: “We have long recognized the logistical challenges of delivering consistent, quality and clinical grade processes to deliver cell therapies to market and we have differentiated our capabilities to meet this challenge.

“We will now be able to centralize, standardize and automate our manufacturing capabilities fully in-house while enhancing our capacity to meet the production demands of multiple products in development as part of our overall Chemistry, Manufacturing, and Controls process.”

In January, Beijing-based CBMG leased a building at the Zhangjiang High-Tech Park in Shanghai and announced its intention to build a cell manufacturing plant.

The firm said: “By the end of 2017, the Company anticipates that the combination of this Wuxi site, the new Zhangjiang Shanghai and the Beijing GMP facilities will be capable of supporting simultaneous clinical trials for five different CAR-T and stem cell products.”

CrownBio Expands Life Science Division

Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology and metabolic disease research, has unveiled plans to increase focus on the life science division of the organization.

CrownBio's life science division currently provides more than one hundred products across a portfolio of antibodies for in vivo and in vitro studies, recombinant proteins, recombinant cell lines, tumor samples for oncology research and drug development, immune checkpoint antibodies, and tumor tissue microarrays. Driven by market demand, CrownBio is investing in expanding the division and forecasts triple digit growth in 2017. The investment includes an addition to the leadership team with the appointment of Debby Saunders, as executive director of life science development.

In support of the expansion in 2017, CrownBio says it will more than double their offering of recombinant cell lines covering important targets and pathways in oncology. Further expansion of CrownBio's product catalog includes tumor tissue microarrays, allowing for rapid assay screening of molecular targets and diagnostic and prognostic markers, as well as high quality immune checkpoint antibodies to detect immune regulators, some of which will be suitable for in vivo use.

"This investment in new products and leadership demonstrates our ongoing commitment to bring to market an expanding toolset to help advance the rate of scientific breakthrough for oncology drug discovery and development,” said Laurie Heilmann, senior vice president, global strategy, marketing and business development, CrownBio.

Budenheim Site GMP Certified

Chemische Fabrik Budenheim site receives EXCiPACT GMP Certification as pharmaceutical excipient suppliers.

Specialty products and phosphates company, Budenheim, has received a GMP/GDP Certificate for pharmaceutical excipients produced at its Chemische Fabrik site in Germany.

The certificate demonstrates that the site manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) Certification Standards.

Its scope covers manufacturing, testing, storage and distribution of sodium, magnesium and calcium phosphates for use as pharmaceutical excipients.

The certificate was granted by SGS, one of EXCIPACT’s internationally recognized Certification Bodies.

Budenheim does not rely on "off-the-peg" products but rather, custom-made solutions. In close co-operation with the customer, product concepts are tailor-made for the final product.

Budenheim's workforce of 680 produces more than 1,000 products for about 6,000 customers.

In one year, this amounts to 230,000 tons of phosphates for foodstuffs, drugs, water treatment and technical applications in about 100 countries. 75% of the company turnover comes from foreign business.

Surfachem Expands Technical Development Lab

The expansion involves making a second laboratory to separate out the needs of individual markets.

In early 2014 Surfachem, a 2M Holdings Ltd company and UK pharmaceutical ingredients distributor, established a development laboratory within the 3M Buckley Innovation Centre at the University of Huddersfield. Its goal to support and develop the technical expertise and market insight available to their customers.

The technical development laboratory and the facilities in the 3M Buckley Innovation centre have made it possible to conduct multiple training seminars help customers solve problems. Surfachem introduced a number of focus concepts:

High Oil Innovations
Ink Defender tattoo protection, a finalist for the 2016 Laura Marshall award for innovation
Instant effects
Skin care to hair care
Carbon black effects

Surfachem will now open a second laboratory within the 3M Buckley Innovation Centre.

The two laboratories will independently support Surfachem’s core markets, including pharmaceuticals and personal care.

This split strategy considers the separate needs of these markets and allows Surfachem to commit to a vibrant and focused development schedule.

To reinforce Surfachem and 2M’s ongoing commitment to support STEM (science, technology, engineering, math) students, the laboratories will continue to offer work placements to chemistry and science undergraduate students. This scheme has been successfully running since 2015.

NY Genome Center, Technion-Israel Institute of Technology Form Research Partnership

Financial terms of the partnership were not disclosed.

Essentra Completes Investment in Leeuwarden, Netherlands

Global supplier of secondary packaging Essentra has announced completion of a recent investment in its Leeuwarden site based in the Netherlands.

These investments help expand the site's capability to deliver a more comprehensive product portfolio and offer a better level of service to its customers.

The Leeuwarden site has built a strong reputation as a manufacturer of a comprehensive range of folding cartons for some of the world's largest companies, supplying customized packaging solutions with a variety of specialist features and finishes.

With onsite experts specializing in unique print and design capabilities, the Dutch facility is able to provide a brand-enhancing packaging offering to customers through its full reprographic creative design service. Essentra's Design Hub also supports the site's innovative offerings, enabling the adaption of packaging to incorporate unique features, such as window patching, embossing, and debossing, as well as providing premium printing capabilities.

Essentra's Leeuwarden site has effective quality management approach (QMA) and good manufacturing practice (GMP) systems in place, such as ISO9001, British Retail Consortium (BRC) / Institute of Packaging (IoP), ISO 5001, and Forest Stewardship Council (FSC) approval. By having the appropriate regulatory accreditations in place, the operation is able to service a wide array of industries, such as food and beverage, health, personal care, and pharmaceutical.

Recent investment in equipment at the site has further improved efficiency and product turn around. The site offers lead times as short as 48 hours from order to standard commercialized products and collaborates closely with customers.

For Essentra, understanding customers' needs is crucial, allowing the company to efficiently and effectively deliver both standard and custom product offerings to meet the specific requirements of every customer.

General Manager of the Leeuwarden site Ken Haan said: "Following significant investment and the integration of Essentra's Denekamp site, Leeuwarden has been able to significantly enhance not only its onsite capability but its excellent customer support, quality and delivery.

"We have always prided ourselves on our exceptional offering, and the investment in to the Leeuwarden site presents exciting opportunities to expand our ability to collaborate with existing and new customers alike."

GSK's Investment Plans Underway

The pharmaceuticals giant has broken ground at Barnard Castle, County Durham, UK and started work at Marburg in Germany.

GSK has broken ground for its new aseptic sterile manufacturing facility in Barnard Castle, County Durham, UK.

The project is part of GSK’s £92 million investment in the site announced in July 2016.

The site will produce injectable liquids for HIV treatment and respiratory and auto-immune diseases.

Service Design Partnership of Wakefield, UK, which has been working with GSK at the Barnard Castle plant for almost 30 years, is part of the design and construction team.

Barnard Castle is one of GSK’s largest secondary manufacturing sites, employing over 1,000 people and the new facility was given planning approval in February.

GSK has also begun work on £140m plant in in Marburg, Germany, designed to increase production meningococcal B vaccine, Bexsero. This will involve moving production for three of the four active components of the meningococcal B vaccine to Marburg.

Vertex to Shutter Canada Site, Focus in on 3 Hubs

Vertex Pharmaceuticals announced in its annual filing that it's closing a R&D site in Canada as part of an overall research consolidation.

A spokesperson said the drugmaker chose to close the R&D outfit in Canada "after careful consideration" and offered some employees the chance to relocate. Vertex will expand research efforts at its three remaining hubs, he said.

Meanwhile, at the Boston location, an internal reorganization left 5 to 15 longtime employees without jobs, a source said. A few employees moved from the Canada office to Boston, "but most were cut loose." The cuts in Boston followed a trickle of departures by other veteran staffers.

About 70 Vertex employees in Canada face losing their jobs. The move will result in restructuring expenses of about $10 million. Radio Canada reported the Laval site is set to close in May.

The move comes shortly after Vertex trotted out 2017 sales guidance that hit below Wall Street expectations. Facing a hit to Orkambi’s growth, the drugmaker expects between $1.79 billion and $2.01 billion for the year. At the midpoint, it’d be about 17% lower than sell-side expectations, Evercore ISI analyst John Scotti wrote at the time.

RSSL Expands Capabilities

RSSL's physical chemistry department has recently expanded its capabilities in particle characterization with new equipment for measuring the surface area of powder particles.

This measurement is key for determining the performance of excipients and APIs and is a regulatory requirement for some of the most commonly used excipients.

RSSL's new gas sorption instrument is a Micromeritics TriStar II 3020, used for the measurement of specific surface area (SSA, e.g. by BET) and total pore volume determinations. The new instrument is an important addition to the suite of particulate characterization techniques available at RSSL (including: laser diffraction, dynamic light scattering, dynamic vapor sorption (DVS), microscopy and powder flow) and demonstrates the company’s commitment to providing comprehensive and cutting edge scientific support to the Pharmaceutical Industry both in QC and R&D operations.

SSA is an important property that has a far-reaching impact on physico-chemical and bulk properties of materials. It has an intimate relationship with solubility (dissolution), rate of moisture sorption and overall chemical reactivity of pharmaceutical API’s and excipients, and is a key property in product performance and optimization. It also provides a useful insight into bulk property and processing issues. Not only is SSA a regulatory requirement for some of the most commonly used pharmaceutical excipients, it is also relevant to patent claims. The arrival of the Tristar II 3020 means that RSSL can now determine specific surface area from as low as 0.001 m2/g using Krypton gas.

This new technology means RSSL is uniquely placed to provide comprehensive and data driven support to the Pharmaceutical Industry in dealing with challenges in handling powdered materials.

Butterworth Laboratories Acquires Facility in Middlesex

UK contract analytical chemistry provider, Butterworth Laboratories Ltd, has announced it has secured an additional facility in Hampton, Middlesex as part of a project to expand UK laboratory operations by 15% in 2017. This is the first phase of a longer term plan to deliver increased capacity of 60% by 2020.

The move is a result of consistently strong growth and will secure the Teddington facility as the UK laboratory operations, while providing the platform for continued growth in key areas.

The expansion coincides with the appointment of David Hawkins, formerly the company's Chief Operating Officer, as Managing Director. Doris Butterworth continues on the board as Chairman along with the Finance Director John Gearey and newly appointed Non-Executive Director Patrick Stewart. The changes will provide continuity of leadership and position Butterworth to continue its success in the long term.

David Hawkins commented: "This underlines the commitment of Butterworth Laboratories Ltd to continuing to provide industry leading analytical support to our global customer base for the long-term and shows that independence and success can be maintained over a sustained period of time. Butterworth are showing that we have ambitions in-line with our global partners and continue to go from strength to strength."

Eurofins Expands UK Biopharmaceutical Testing Site

Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.

The planned 62,408 sq. ft. (5,800m2) facility at Brucefield Industry Park will house include a range of GMP pharmaceutical testing services, including method development and validation, finished product and raw material testing, elemental impurity testing, micro testing and stability studies.

The investment will include the addition of a new inductively coupled plasma mass spectrometry (ICP-MS) machine and high-performance liquid chromatography (HPLC) equipment to increase capacity by 40%.

Alison Clayton, general manager at Eurofins, said the investment will add an initial 15-20 staff to the firm’s UK operations, but further jobs will be added from 2018 as the facility’s capabilities grow.

She added that while the site’s clients will primarily be made up of Big Pharma and multinationals initially looking to test their small molecules, the firm “will look to extend capabilities in line with the wider Eurofins strategy” to include larger molecule and biological testing.

“Testing for biologics can be more expensive than small molecules as there can be a greater number of more complex test requirements,” she said. “For example, regulatory bodies require orthogonal analytical techniques when available to better reveal the structure and stability of biopharmaceuticals.”

Furthermore, there are some different techniques used to test large molecules, though Clayton said Eurofins has “a wide capability for these techniques” within its network.

The investment is the latest by the contract research organization (CRO) which announced last August it was adding 47,344 sq. ft. (4,400m2) of lab space at its bioanalytical facility in Dungarvan, Ireland and committed to a further 19,368 sq. ft. (1,800m2) at a second site nearby.

Sharp Announces Major Investment in Pharma Manufacturing Facility

Sharp Clinical Services, part of UDG Healthcare plc, has announced a £9 million ($11.2 million) investment to fund a new multiple-phase pharmaceutical manufacturing, packaging and distribution facility in Wales.

The investment, which also includes £500,000 ($624.3 million) from the Welsh government, will enable the company to satisfy increased demand for Phase III clinical and commercial services.

The initial phase of the £9.5 million ($11.9 million) expansion, which is expected to be completed by late 2018, will involve the acquisition and renovation of a 110,000 square foot facility within the site. Initially 75,000 square foot will be fitted out. The 10-acre site in Rhymney, South Wales also benefits from the potential for further significant capacity expansion.

The build of the state-of-the-art unit will replace the company’s existing site in Crickhowell, Powys and will triple Sharp’s clinical service capacity for the global pharmaceutical, biotech and clinical research sectors.

By developing its manufacturing and analytical capabilities, adding automated bottling, blistering and serialization as well as IRT services for clinical trial management, Sharp will be able to offer full service support for larger global clinical studies from the new European clinical center.

Discussing the new development, Frank Lis, president of Sharp Clinical Services, said: “We are currently working at capacity at our site in Crickhowell, so this investment gives us a blank canvas to design a modern contract packaging, manufacturing and distribution facility that meets the evolving needs of drug development companies with single or multiple products at any clinical scale.

“The move to the Rhymney site will enable us to offer expanded capacity, scalability and automation, meaning we can simultaneously support multiple large scale Phase III studies, as well as projects at an earlier trial stage. It will also allow us to grow both the Sharp team to support current business and to expand our clinical services portfolio to new customers, at a larger scale.

“The efficient nature of our extended operation will also allow us to seamlessly move clients’ late phase clinical projects to commercial scale within our wider global Sharp network of facilities. This really is a major milestone for our business in the U.K. and will ultimately deliver huge value to our clients in North America, Europe and Asia.”

Sharp plans to commence the first phase of the expansion project in 2017, with completion expected for late 2018. The project is a welcome boost to the local economy in South Wales and the wider life science sector in the U.K.

As a result of the investment, Sharp will double its headcount, creating 73 new jobs and safeguarding a further 70 jobs with Welsh government support.

Commenting on the announcement, Wales’ Skills and Science Minister, Julie James, said: “Over the last few years the Welsh government has invested millions in supporting life sciences in Wales and as one of our key priority sectors we are keen to see this important area grow even more. “This expansion by Sharp is welcome news for the sector, the local community and the wider Welsh economy and shows how Wales’ healthcare and biotech industries are going from strength to strength.” (£1 = $1.25 on April 3, 2017)

McIlvaine Company

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