Clariant (Muttenz, Switzerland (www.clariant.com ) will expand its plant in Lewiston, Maine, and install a new compounding line to help meet growing demand for pre-colored medical plastic compounds that are supplied under the Mevopur brand name. The new capacity will come online in Q4 2017.

The new compounding line, built around a new 70-mm extruder, will be able produce larger batch sizes (for example, 3,000 to 6,000 kg /6,000 to 12,000 lbs. or larger) at high throughput rates. Production will focus on materials such as polyolefins, ABS, PC and PC alloys, as well as specialty resins like TPU, and cyclic olefins. The EN-ISO13485 (2012) certified site in Lewiston is also being expanded to improve process-flow and material-handling.

“Over the last five years,” says Steve Duckworth, Head of Global Segment Healthcare Polymer Solutions, “Clariant has pioneered the development of masterbatches for the healthcare sector. These are color and additive concentrates that are added to natural polymers during molding or extrusion of finished products. However, in some cases, medical processors may prefer to use a pre-colored compound instead, perhaps for ease of handling or because of technical difficulties in the molding or extrusion process. And yet, they have the same need for Controlled, Consistent and Compliant materials.”

Clariant’s Mevopur materials are offered for applications in medical devices and pharmaceutical packaging, where strict regulations on materials and change control apply. The Lewiston plant is one of three global sites designed and operated to produce materials used in medical devices and pharmaceutical packaging. The other two facilities are located in Malmö, Sweden, and Singapore.

This new capacity complements equipment and plant investments aimed at compounding engineering resins and high-temperature polymers and, most recently, completion of a special installation in Lewiston for processing fluoropolymers such as FEP, ETFE, and PVDF.

Clariant already operates several smaller lines – in Lewiston and Clariant’s other Mevopur facilities — which produce masterbatches and pre-colored compounds in lot sizes ranging from 25 to 2,500 kg/50 to 5,000 lbs. In addition, production capacity for compounds is also being added during the first half of 2017 in Singapore, to handle increasing demand of color compounds for local and international customers. These small- and medium-sized lots are in high demand, especially in the medical market, since many resin producers have discontinued or severely curtailed their custom-color offerings in anything smaller than full-truck or railcar quantities.

Symbiosis Opens North America Office

Symbiosis Pharmaceutical Services is opening an office in North America to support biopharma companies with its vial-filling services, including liquid and lyophilized formulations in injectable dosage forms.

The company will open a commercial site in Cambridge, MA, to support clients on both the East and West Coast, as well as provide a base for reaching new customers in this region. The company is currently recruiting to expand its U.S. commercial team.

Colin MacKay, chief executive officer at Symbiosis Pharmaceutical Services, said, “Given Cambridge is the epicenter of the global biotech community, it is the ideal location for us to open an office in the US. Back in 2015, we made the decision to strategically focus on the North American market after we identified a surge in funding for early stage biotech companies, which are exactly the type of drug development company that are best suited to seek our manufacturing scale and specialist capabilities.”

Mr. MacKay added, “At a macro level, demand for biologic and highly potent products is likely being driven by the increased emphasis on the development of treatments for small patient populations in the case of orphan indications, new oncology products requiring containment capabilities and novel tailored personalized medicines. Those kind of products require specific GMP manufacturing skills for the small-scale production of sterile batches for clinical trials, hence the clear uptake in demand for what we do at Symbiosis.”

University of Illinois Pharmacy Compounding Simulation Lab, Chicago

Project Cost: $825,000

Size: 4,200 sq. ft.

Project Team: Bailey Edward

The University of Illinois at Chicago College of Pharmacy’s 1960s-era second floor pharmacy laboratory space was dated. It did not accurately reflect the environment students would work in after graduating or the University’s commitment to cutting-edge teaching and excellence in education. Designed by Chicago-based Bailey Edward, the new flexible laboratory maximizes the existing space for operational efficiency and student needs. The design features a dedicated corridor and three laboratory spaces interconnected by doors, windows, specimen pass-through interlock cabinets and simulated magnehelic gauges. The spaces can be transformed from non-sterile to sterile working environments and back through the reconfiguration or storage of equipment and furnishings, allowing students to experience real-world work conditions.

New technology was also incorporated into the design to increase the functionality of the space and improve the gathering and dissemination of information, especially for long-distance learners. For example, cameras in the hood and a mobile podium were added to provide on-site students a clear view of the instructor’s hands via broadcast on a wall-mounted TV.

Completion Date: Fall 2016

NewAge Plant Expansion

Preparations at NewAge Industries are underway to expand and renovate 40,000 square feet of space for more cleanroom suites, inspection areas and warehousing. The company is using an existing area at its headquarters and manufacturing facility located just north of Philadelphia.

The need to expand arose primarily from the success of NewAge’s AdvantaPure product line. AdvantaPure’s tubing, hose and molded components are manufactured for high purity, single-use biopharm and pharmaceutical applications such as vaccine production and cell culture media transfer for harvest, filtration, fermentation, sampling and storage.

“AdvantaPure has come a long way in a relatively short time period,” said Ken Baker, CEO, of the division, which was started in 2002. “Our expertise in tubing, hose and fluid transfer solutions positioned us to advise our customers on how to meet their unique challenges in this highly technical market, and now we’re expanding to meet this demand and prepare for the future.”

NewAge will invest $9.5 million into the project. The area within NewAge’s building was previously rented to other businesses for several years — it even housed the local fire department, free of charge, while the firehouse was undergoing renovation — and more recently had been used for NewAge’s inventory overflow. The space will consist of 20,000 square feet of ISO Class 7 cleanrooms and an equal amount of area for warehousing. Demolition of existing structures within the expanse was completed last fall, and then followed by painting, utility work and other preparations.

The project’s next stages involve cleanroom engineering, design and construction by AES Clean Technology Inc. of Montgomeryville, PA.

“Knowing the quality centric culture at NewAge Industries, we at AES were honored to be selected by NewAge for the design and construction of their new cleanroom facility,” stated Ralph Melfi, vice president of sales and marketing at AES. “During the 'basis of design' phase of the project, NewAge called on their entire team, from manufacturing to quality control and engineering to facilities, to participate in the project planning. Process flows, materials of construction and mechanical systems were all challenged and vetted out."

NewAge expects to be able to move equipment from its existing cleanroom manufacturing areas to the newly renovated space during the second quarter of 2017.

Baker noted that because the company has multiple tubing extruders and presses for molded components, the move-in will occur in phases, with one piece of equipment being shutdown, moved, validated and restarted at a time. There will be no production stoppages or shortage of products due to the plant expansion.

This is not the first time NewAge’s building has undergone major changes. In recent years the company invested in new lighting, new windows, floor resurfacing, new motors for its manufacturing equipment and air conditioning units, a new roof and a rooftop solar panel array consisting of over 4,000 panels. These panels currently produce half of the company’s electricity needs.

Northeast Georgia Medical Center Eco-Friendly Design

Northeast Georgia Medical Center (NGMC) Braselton in Georgia received a gold certification under the U.S. Green Building Council’s Leadership in Energy and Environmental Design (LEED) for healthcare rating system. LEED certification measures NGMC Braselton’s water and energy use, sustainability, indoor environment quality, material and resource use, and more.

NCMC Braselton made efforts to reduce energy use by 35 percent and reduce water use by 33 percent compared to similar hospitals. Geothermal wells use the ground to heat and cool the hospital. Eliminating greenhouse gas emissions and the use of fossil fuels reduced the building’s carbon footprint. LED lighting and Energy Star rated appliances and equipment reduce energy consumption. Rainwater has been repurposed. And 92 percent of the waste during construction was recycled.

Lannett Invests in Wyoming Facility

Lannett Company, Inc. has announced it will invest $50m into its generic analgesic manufacturing subsidiary Cody Labs, creating 45 new jobs in the Wyoming facility.

Cody Laboratories, Inc. was bought by the Philadelphia-based active pharmaceutical ingredient (API) manufacturer Lannett in 2007.

The labs specialize in pharmaceutical manufacturing of generics including Hydrocodone and Hydromorphone, both common opioid-based drugs prescribed for pain management.

In addition to Cody Lab’s current 130 employees, the new $50m (€46.8m) expansion will create 45 new jobs in the town of Cody, Wyoming.

Construction is planned to begin this spring, to be completed by Q3 2018 and for commercial operations to start by end of 2020.

Lannett has previously shown significant investment into its manufacturing capabilities in the Mid-West of the US.

Arthur Bedrosian, CEO of Lannett, said “[the] plan to invest in our pain management facilities will significantly increase our active pharmaceutical ingredients (APIs) production and bolster our efforts to vertically integrate,” in an SEC filing.

SGS to Increase Capabilities at Fairfield Lab

Bio/pharmaceutical, analytical and bioanalytical contract solutions provider SGS will increase services in extractables and leachables

It will be testing within the pharmaceutical and related industries at its laboratory in Fairfield, New Jersey. It is a North American Center of Excellence for extractables and leachables (E&L).

Two state-of-the-art instruments have been installed and validated and hiring is underway for additional analysts.

The new instruments are a Liquid chromatography tandem-mass spectrometry (LC-MS/MS) and Gas chromatography mass spectrometry (GC-MS) with head-space capability.

They are both high resolution and high throughput systems, for rapid identification of trace unknown extractable compounds.

The laboratory currently offers testing facilities for a wide range of E&L applications, including final pharmaceutical packaging, single-use systems and medical devices.

Kelly Bertrand is General Manager of SGS’s Fairfield facility. “The additional capabilities we have now at Fairfield allow us to overcome greater analytical challenges for our existing clients, and ensure we can remain competitive and have the capacity to attract new customers,” she said.

SGS is an inspection, verification, testing and certification company. It has 21 laboratories offering contract analytical and bioanalytical services in North America, Europe, and Asia.

It provides Phase I-IV clinical trial management, data management and statistics services, pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation, pharmacovigilance and regulatory consultancy.

Wells Pharmacy Network Completes Building Expansion

The pharmacy is among the first in the US to build negative pressure hazardous chemical storage rooms and cleanrooms as per the new USP General Chapter 800 guidelines

Wells Pharmacy Network has completed a multi-million dollar 5,000 sq. ft. expansion and facility enhancement of its existing 16,000 sq. ft. 503A compounding pharmacy located in Ocala, Florida.

The move is intended to meet the growing demand of physicians and patients throughout the US for high-quality human anti-aging and wellness compounded medications, and will expand its Pharmacy Operations, Quality Assurance, Customer Service, and Shipping departments.

Ben David, President & CEO of Wells Pharmacy Network said: “Businesses operating in the compounding pharmaceutical industry currently are faced with the need to execute with a different skill set than they have historically possessed.

"Companies that wish to be successful, in the short run as well as in the future, must adapt to this ever-changing environment. To meet these demands, both market driven and regulatory, businesses in the compounding pharmacy industry must invest in both personnel and infrastructure.

"Wells Pharmacy Network has always been committed to providing the highest quality products and service to all of our customers. The expansion of our 503A facilities are a testament to our commitment to continue to be one of the leaders in this industry.”

The privately held 503A compounding pharmacy has locations in Ocala, Florida and Dyersburg, Tennessee and a corporate office in Wellington, Florida.

The company says it is among the first in the country to build negative pressure hazardous chemical storage rooms and negative pressure hazardous cleanrooms in accordance with the new USP General Chapter 800 guidelines, providing standards to protect compounding personnel when handling hazardous drugs.

The expansion also focused on equipment and process enhancements to Wells Pharmacy’s in-house endotoxin, sterility, potency, method suitability, and particulate testing. New equipment includes:

Biological safety cabinets (BSC) for compounding hazardous materials
Class 100 laminar airflow hoods inside the cleanrooms
Advanced HVAC systems
Continuous environmental monitoring system
Motion detector door systems

Wells Pharmacy says it has always invested in quality and safety and continues to use:

Third party independent testing to validate in-house test methods
Chemicals purchased through FDA registered facilities
Five-point quality control process
Images of the contents of every order captured during packing and shipping
Experienced clinical pharmacists and registered pharmacy technicians to process and verify all prescription orders
PhD Biochemist on site to manage Quality Control laboratory testing process
Sterility reports available upon request for every order

PPD Opening Phase I Unit in Las Vegas

The 24-bed clinical research unit in Las Vegas supports PPD’s Phase I and early development clinical research capabilities.

Cindy Doerfler, vice president of PPD’s early development division said, “with the opening of this new clinical research unit, PPD is expanding its early development services to support studies involving complex, procedurally intensive early phase clinical research.”

The operation will support first-in-human through proof-of-concept trials in both healthy and patient volunteers.

Offered services will range from nonclinical consulting to protocol writing, protocol optimization, project management, laboratory services, monitoring, medical writing, data management, biostatistics, and clinical pharmacology.

The company chose Las Vegas for this new unit for several reasons, Doerfler said.

“Las Vegas offers logistical and geographic access to the west coast, it is in close proximity to multiple universities—including two medical schools—as well as six local research sites to optimize volunteer recruitment, and its location adjacent to the Dignity Health-St. Rose Dominican, San Martín campus allows us to utilize the facility’s hospital-based services and medical expertise on behalf of our clients,” she explained.

First studies are expected to commence in the third quarter of 2017.

Chinese CDMO buys New Jersey J-STAR

A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organization, J-STAR Research, Inc.

Porton’s wholly-owned subsidiary Porton USA, L.L.C. will acquire the 21-year old J-STAR business for $26m (Eur24m) in cash.

J-STAR offers outsourcing of early clinical development of small molecule APIs, including custom synthesis, crystallization R&D and analytical services.

The firm has a team of 47 based in South Plainfield, New Jersey, which Porton claims will support its new technology center team of around 75 nearby in Cranbury, NJ.

"The strategic acquisition of J-STAR allows us to accelerate the fulfilment of our goal of providing integrated outsourcing services in the development and manufacturing of new drugs," said Oliver Ju, Chairman of Porton.

J-Star has two kilo lab cGMP production suites for API synthesis, with reactor sizes varying between 5L to 100L permitting production of materials at around 5Kg.

The firm’s QA QC suite uses Gas and liquid chromatography, as well as Proton, Carbon, Fluorine and Phosphorus Varian Inova NMR instruments (400 MHz and 300 MHz).

J-STAR’s Crystallisation R&D suite includes an OptiMax HFCalorimeter for ‘Plug & Play’calorimetric studies, and an EasyMax synthesis reaction system, both automated and from Mettler & Toledo International, Inc.

“With the integration with Porton platform, we shall find a perfect match connecting our customized development ability with Porton's advanced manufacturing experience to better serve new drug industry," said Andrew Thompson, CEO and co-founder of J-STAR.

Founded in 2005, Porton Fine Chemicals is headquartered in Chongqing, China, with a market cap of approx. 1.2Bn USD (8.5Bn CNY).

The firm opened its US-based Technology center October last year, close to major Big Pharma firms such as Pfizer and Merck & Co.

On the opening, Todd Nelson Porton USA VP and General Manager of Porton Technology Center (PTC) said “Integrating PTC’s CRO capabilities with PFC’s manufacturing expertise centered in a lower cost geography, such as China, will offer powerful end-to-end solutions and seamless supply chains to the biopharmaceutical community.”

The J-STAR sale is expected to close March 26.

Patheon Acquires Roche’s Manufacturing Facility in South Carolina, US

Drug development and delivery solutions provider Patheon has completed the acquisition of a manufacturing facility from Roche in Florence, South Carolina, U.S.

The company started integrating the site into its network, which will add a 300,000 sq. ft. facility with manufacturing capacity for active pharmaceutical ingredient (API) ranging from development to manufacturing services.

The addition of this site will enable Patheon to expand its capacity for manufacturing highly potent compounds and also supports solid state chemistry, micronisation and future commercial spray drying.

Patheon drug substance services president Lukas Utiger said: “We are extremely pleased to add this facility to the Patheon network and the talented professionals that will support a wide range of drug substance services.

"Patheon has extensive experience and success integrating new sites into our global network and quickly leveraging the capabilities for the benefit of our clients."

The pharmaceutical manufacturing facility’s production space features reactors ranging from 50l to 11,000l capable of producing multiple products simultaneously.

The site additionally provides flexible operations, allowing the company to adapt to new production needs quickly.

Serving as Patheon’s US API operation for commercial scale and mid-scale API production, the site will also improve the company’s pharma presence in the US market.

The latest acquisition is the company’s sixth in the last five years and supports its plans to create an integrated provider of pharma development and manufacturing services.

Whitbeck Laboratories Opens Facility

Whitbeck Laboratories has opened a 7,500 square foot research and testing facility.

The site in the Springdale Technology Park means the microbiology lab has more than doubled. The company employs 19 people having added six positions within the last two years.

Whitbeck Laboratories offers a laboratory for the food and poultry industries as well as diagnostic services for local veterinarians.

The company works with food industry research and development companies, providing facilities and testing.

Gordon Whitbeck, company president, said food safety is of the utmost concern for anyone in the business.

“With the dramatic increase in food safety regulations and policies by federal regulators and food producers, we have seen a significant increase in the demand for the services our lab offers.”

Whitbeck Laboratories holds National Poultry Improvement Plan (NPIP) certification and will host training seminars required by the NPIP program.

In 2012, Whitbeck Labs acquired The Poultry Federation laboratory in Fayetteville to add serology assays and it bought A&A Laboratories in 1989 to add chemistry testing.

Cambrex Global Expansions

Limited US manufacturing capacity and a growing demand for innovator APIs will drive continued growth, says Cambrex.

For the full year 2016, Cambrex Corporation announced sales of $492m (€460m), up 13% year-on-year. This included a 17% increase in sales from innovator drug active pharmaceutical ingredients (APIs), representing $330m in revenues, offsetting flat generic API sales.

Discussing these results with stakeholders Friday, CEO Steven Klosk said innovator drugmakers are showing a strong preference for Western suppliers, claiming firms like Cambrex – with sites in Charles City (Iowa, US), Karlskoga (Sweden) and Paullo (Milan, Italy) – offer “excellent regulatory records and world-class quality systems.”

Along with “a robust and growing clinical development pipeline, with strong year-over-year increases in the number of Phase II and III small molecule products,” and the continued reduction in pharma’s in-house small molecule manufacturing footprint, Cambrex is well-placed to continue growing.

“There is limited third-party large-scale GMP capacity in the US to fulfil this demand. We believe the capacity utilization in Europe is exhibiting similar characteristics,” he told investors. “Our strategy is aligned with these positive market dynamics and should allow us to continue to benefit from them.”

As such, full-year 2017 net revenues are expected to grow in the high single-digit to low double-digit percentage range.

Klosk said the firm was strengthened by two new projects during Q4, pushing Cambrex’ active late-stage clinical projects to 16 active and placing the firm in good stead for the coming year.

“If the clinical projects within this group are approved for commercial sale, or when we successfully validate the manufacturing process for a product that is already commercial, we expect to negotiate supply agreements to provide commercial volumes,” he told stakeholders.

He added industry data shows 60% to 70% of the Phase III products are likely to be approved, with drug going into registration being much higher, while only around 25% of Phase II projects are commercially successful.

So “we're definitely aggressive about winning both the late-stage and the commercial,” he said, for the “obvious reasons” of scale-up and lengthy contract extensions.

Cambrex has also completed a number of capacity expansions and acquisitions which Klosk said will further reinforce the firm’s position.

“We continue to expect utilization of our large scale expansion in Charles City, Iowa to ramp up steadily throughout 2017,” he said. “We recently added large scale capacity at our Swedish facility and are currently implementing a smaller investment to increase 2017 capacity within the existing footprint at Charles City.”

Furthermore, the firm acquired PharmaCore last year for $25m, and Klosk said Cambrex the integration of the North Carolina-based controlled API maker will be “the next large capacity expansion,” expected to begin later this year.

Opexa Selling Texas Facility to KBI

CDMO KBI Biopharma, Inc. has acquired the lease and assets of Opexa Therapeutics’ facility in Texas after the firm’s lead MS candidate failed Ph IIb.

Based in The Woodlands, Texas, Opexa’s cGMP cell therapy manufacturing facility was acquired for a lump sum by the contract development and manufacturing organization (CDMO) KBI.

KBI will assume Opexa’s lease for the site, which has four of the remaining five years left on facility lease, and two years remaining on equipment.

The facility was originally the key manufacturing site for Opexa’s autologous cell therapy, Tcelna, based on the firm’s proprietary immunotherapy platform, ImmPath.

However, in October Opexa released results for a Phase IIb trial for Tcelna saying it had failed both primary and secondary endpoints for secondary progressive multiple sclerosis (SPMS), which led the firm to reduce its workforce by 40%.

KBI will now use Opexa’s facility to offer manufacturing services, including use of ImmPath, to other biotech and pharma companies developing cell therapies.

“Being able to exit from those two leases and the related future obligations was a priority for us,” said Neil Warma, President and CEO of Opexa Therapeutics, Inc.

Warma added “[The lease] enabled us to eliminate our two major liabilities for Opexa shareholders, as we continue to assess strategic opportunities.”

Opexa’s Chief scientific officer, Donald Healey, has also transitioned to KBI to serve as Senior VP of Operations and Site Head, relinquishing his position with Opexa.

Opexa’s Abili-T study was a 183 patient Phase IIb trial of the efficacy of Tcelna (imilecleucel-T) in treating SPMS. On October 28, Opexa announced Tcelna had failed both primary and secondary endpoints: reduction in brain volume change (atrophy) and reduction of the rate of sustained disease progression in SPMS patients, respectively.

In response to the results, in November the firm cut 40% of its workforce and accepted the resignation of its chief development officer, Donna Rill.

At the time, Warma said “This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna.”

He added Opexa “would review cash preservation options while [it] considers the best path forward for the company.”

The facility in The Woodlands is a 10,200 sq. ft. site with three ISO7 cGMP manufacturing suites and a specialized Flow Cytometry laboratory. The build also has QA QC, R&D and microscopy labs, and a warehouse for materials management.

Warma commented “[Opexa’s former CSO] Healey will provide expertise in managing the operations of the local facility should result in a smooth transition and provide a solid foundation from which KBI can build and offer services to cell therapy companies across the country.”

The annual lease value including tax and insurance is $1 million, and KBI’s ownership came into effect February 1.

Vetter’s Skokie Site New Filling Line

Vetter, a leading international contract development and manufacturing organization (CDMO) that specializes in aseptic filling for its (bio)pharmaceutical customers, has announced that its new clinical syringe line has already manufactured for its customers a double digit number of batches for use in early clinical trials.

The line is part of growth expansion activities that have been undertaken at its Skokie facility to help satisfy growing customer demand. It also includes an increase in storage that is designed to help manage the continued growth in syringe fills and overall larger batch sizes.

Since beginning full operations in late 2011, Vetter’s clinical manufacturing facility located at the Illinois Science + Technology Park in suburban Chicago has been expanding to meet growing customer demands. Recently, this included six new chest freezers, two upright freezers and two refrigerator units.

As a result, storage will be expanded by the end of the year to increase capacity by 150%. Combined with the new syringe line, these activities will help manage the increase the CDMO is experiencing in syringe projects for early clinical stages and in overall larger batch sizes.

In addition to the many clinical batches filled for customers in vials – both for aseptic liquid and lyophilized products – the solution provider has successfully launched an aseptic syringe filling line.

“Year to date, a double digit number of clinical batches have been manufactured for customers and we anticipate a significant increase in the number of batches in the coming years,” explains Dr Susanne Resatz, President of Vetter Development Services USA. This reflects the trend the company sees through its continuous dialogue with new and existing customers, as starting syringe work in the early clinical phases can cut up to 18 months off time-to-market. “Given our experience at this facility with filling and lyophilisation, many of our customers are returning for development work for a second, third or even fourth molecule. As a result of this, our outlook for future performance is very positive as demonstrated by a solid pipeline filled with high quality customer projects for biologics,” Dr Resatz adds.

Vetter’s Skokie facility is the company’s US clinical manufacturing site, providing development support for preclinical through Phase II injectables, primarily complex biologics. The facility, currently operating with a growing staff of more than 60, has solid experience with a variety of complex compounds, and has already made more than five transfers to the company’s European commercial facilities to prepare for commercial launch, with more to follow in the near future.

The site offers all the resources needed for efficient early-stage clinical manufacturing, including chemical analysis and microbiology labs, material preparation and compounding functions. At the heart of the facility are its cleanrooms, followed by visual inspection capabilities and GMP storage. The facility has collaborated with (bio) pharmaceutical companies from various continents including the US, Europe, Asia and the Middle East.

REST OF WORLD

BBI Announces Investment

The investment will include a new global HQ and manufacturing center in South Wales, as well as a new cleanroom.

120,000 sq. ft. facility at Border Technology Park, Crumlin

BBI Group, which offers products and services to the diagnostic, healthcare, research, defense and food industries, has announced a £14m investment to boost capacity and long term growth. The announcement takes the company’s overall investment to approximately £20m across 2016 and 2017.

The plans – supported by a £1.8m grant from the Welsh Government – will see BBI Group move to a new 120,000 sq.ft. headquarters at Crumlin, Caerphilly with easy access to the M4 corridor and Cardiff International Airport.

The investment will aim to consolidate BBI’s existing operations in Blaenavon, Cardiff and Dundee, providing improved manufacturing and enzyme production facilities to serve the global diagnostics and healthcare market place.

CEO Lyn Rees said: “The investment will give us the pedigree to compete more effectively in our expanding markets in Europe, USA and China.”

“We will develop our products in an enhanced cleanroom environment and to the highest European and US regulatory standards.”

With Welsh Government and local authority backing, the investment also aims to create around 50 new positions up to 2020. This will provide career opportunities in the South Wales Valleys region and foster closer links to the scientific and academic community.

Economy Cabinet Secretary Ken Skates said: “This will not only create and safeguard a significant number of high quality jobs, but will also support the local economy through an annual spend of more than £1m with supply chain companies.”

“BBI Group is a made-in-Wales success story; a highly successful company and a strategically important player in the life science sector globally.”

As part of the £14 million investment package, the company will upgrade its Sittingbourne manufacturing operation, which provides cell culture products, proteins and antibodies to clients across the world.

RSSL Microbiology Laboratory Expansion

Reading Scientific Services Ltd has opened additional space in its pharmaceutical microbiology laboratories.

Many customers rely on RSSL for a range of tests focused on ensuring the microbiological safety of pharmaceutical products.

Routine services include microbial limits testing for specific pathogens, bacteria, yeast and molds (EP, BP, USP, CP and JP), quantitative endotoxin analysis, preservative efficacy testing, environmental monitoring, water testing and method development and validation.

Regulatory pressures have pushed cleaning validation higher up the agenda of pharmaceutical manufacturing.

RSSL offers consultancy and training in this discipline alongside the services of its testing laboratories (chemistry and microbiology). The predominant growth area for RSSL in recent years has been in cleaning validation.

Darlington Nwodo, RSSL's Microbiology Manager, said: “As a GMP requirement, cleaning validation must be undertaken with the utmost care. Our additional lab space and new Biological Safety Cabinets will enable us to support more customers in meeting their obligations to provide safe pharmaceutical products.”

A key role for the microbiology laboratory is to test the efficacy of chemical disinfectants used in pharmaceutical and healthcare environments to ensure they achieve the required standards.

The laboratory follows British and European Standards, applying a variety of tests which include suspension and surface testing. The surface test procedure involves inoculating relevant surfaces with a level of various organisms.

The disinfectants are applied to the artificially contaminated surfaces after a drying phase. The level of log reduction achieved from this process is used to determine the efficacy of the disinfectant and if it is fit for purpose.

RSSL is established in the provision of analytical, investigational, consultancy and training services to clients in the pharmaceutical, biopharmaceutical and healthcare sectors.

The company's chemical, physical, biochemical, biological and microbiological services are wide ranging, and provide support through the full drug product lifecycle. RSSL is routinely inspected by the MHRA, FDA and UKAS.

Quotient Buys QS Pharma in U.S. Expansion

Quotient Clinical Ltd. has bought Charles River Laboratories’ contract manufacturing business, QS Pharma LLC.

On Feb 10 Charles River Laboratories International sold its holding in the business to UK-based Quotient for $75m (€71m) in cash.

Charles River, which bought QS Pharma last April, said: “the CDMO business was not optimized within Charles River’s portfolio at its current scale.”

The takeover is the second Quotient Clinical has made in a month. Last week, it also bought Florida-based SeaView Research Ltd.

Mark Egerton, CEO of Quotient, said the firm aims to “replicate” its Translational Pharmaceutics platform in the US to address increasing customer demand over there.

Quotient provides development services for oral, inhalation, dermal and intravenous formulations, 90% being small-molecule products.

The firm’s platform is built to house both formulation development, GMP manufacturing and clinical trials at one site, to shorten time to the market and permit formulary changes as patient data is collected.

“It sounds simple, but it's actually quite unique and difficult to replicate. This is because CDMO businesses typically don't have much insight into the clinical data and objectives of a trial. The CRO and CDMO industries are very siloed structures, where there's little or no integration,” Egerton explained.

Quotient focuses on early phase drug development services, by integrating formulation development, real-time manufacturing and clinical testing to a single UK location – Nottingham.

A second facility in Edinburgh employs around 50 people to process clinical data, which Quotient also bought off of Charles River back in 2009.

The firm claims this affords its clients the opportunity to modify dose and formulation compositions in response to emerging clinical data (safety, pharmacokinetic or pharmacodynamic).

Egerton explained there is a qualified person overseeing the whole process, rather than passing on paperwork from one site to another: “They're actually intimately involved as the product is being manufactured. It's a real advantage, as no one else really offers that, which is why we have so many US customers.”

Therefore, Egerton said the firm’s priority with QS Pharma is to replicate the platform in the US market too, rather than embark on a UK expansion.

“A UK expansion may still happen in the future, but we felt the US move was the priority, driven by the concentration of clients out there investing into Pharmaceutical R&D - it's really where the action is,” he added.

QS Pharma will work exclusively on small molecules formulations, despite SeaView’s Florida sites having capabilities for biologicals too.

Quotient also has multiple biosimilar products ongoing at its Nottingham site, however, this is just for patient dosing and not manufacturing.

“The biosimilar work in Nottingham we've done to date has all evolved around a conventional process - where the pharma company has taken the responsibility to manufacture that we're going to dose (so simply a clinical trial unit) for these,” he explained.

“Although our platform development plan for QS Pharma could be translated to biologicals, this requires a completely different skill set and manufacturing infrastructure.”

SGS Expands Elemental Analysis Capabilities

SGS is expanding its elemental analysis testing capabilities at its Villeneuve-la-Garenne, France lab. The site has invested in a new inductively coupled plasma mass spectrometry (ICP-MS) system to address the updated ICH Q3D regulatory guidelines on elemental impurities.

According to the company, the new instrument, a Thermo ICP-MS: iCAP RQ C2 – ICP-MS quadrupole analyzer, offers accurate, high-throughput testing, and is currently undergoing validation. It is expected to be fully operational by the end of February 2017. The investment complements the atomic absorption spectroscopy, inductively coupled plasma optical emission spectrometry (ICP/OES) and ICP-MS systems at the facility.

“With this investment, SGS and its dedicated elemental impurities team are in a position to support pharmaceutical and biopharmaceutical companies through the challenges of the new regulatory guidelines,” said Paul Beyou, general manager of SGS’s Villeneuve-la-Garenne facility. “SGS is dedicated to offering its clients access to the very latest technology and expertise to ensure regulatory demands can be met efficiently and with no disruption to developmental timelines.”

ICH Q3D Step 4 was published in December 2014. Since then, it has required that a risk analysis be deployed for all drug products on the specified list of elements and their permitted daily exposure (PDE) limits. The guideline came into effect in June 2016 for new drug products, and existing products will have to comply by December 2017.

Novo Nordisk Enters Collaboration with University of Oxford

Novo Nordisk enters collaboration with University of Oxford on type 2 diabetes and invests £115 million ($144 million) in new research center.

University of Oxford and Novo Nordisk announced a landmark research collaboration focused on type 2 diabetes. The partnership will enable scientists from Novo Nordisk and University of Oxford to collaborate to discover innovative approaches for treating type 2 diabetes. As part of the collaboration, Novo Nordisk is also investing in a new research center on the premises of the University of Oxford.

The Novo Nordisk Research Centre Oxford will employ up to 100 Novo Nordisk researchers, based in an Oxford University research center. The total investment from Novo Nordisk is expected to be around 1 billion Danish kroner (£115 million/$144 million) over a period of 10 years. The center will focus on innovation within early stage research that has potential to substantially impact future treatment of type 2 diabetes and its complications.

"This collaboration brings together some of the world's sharpest minds in the field of diabetes to seek new targets for therapeutic innovation. It combines Novo Nordisk's 90 years' experience in developing treatments for diabetes with the expertise of world leading scientists from the University of Oxford. Our vision is that the unique combination of industrial and academic know-how will eventually lead to a new generation of treatments to improve the lives of people with type 2 diabetes," said Mads Krogsgaard Thomsen, chief science officer and executive vice president of Novo Nordisk.

The collaboration will actively seek to encourage cross-fertilization of ideas between academic researchers from the University of Oxford and researchers employed by Novo Nordisk with funds to sponsor the collaborative research.

Sir John Bell, Regius Professor of Medicine, University of Oxford, said: "We see the collaboration with Novo Nordisk as an outstanding opportunity to mix competence embedded at our campus with Novo Nordisk's groundbreaking research and results in diabetes. This collaboration underlines the importance of shared research and cutting-edge science across boundaries. Employees at Novo Nordisk Research Centre Oxford and researchers at the University of Oxford will have the opportunity for daily interaction to share knowledge and insights that will potentially produce new medicines for people living with type 2 diabetes and its complications."

James D. Johnson, professor, Ph.D., has been appointed head of the Novo Nordisk Research Center Oxford. He is a researcher in the fundamental biology of pancreatic islets, insulin action, diabetes and related conditions. Johnson is currently professor at the Department of Cellular and Physiological Sciences and the Department of Surgery at the University of British Columbia.

Novo Nordisk and University of Oxford have had a collaboration since 2013 through the International Postdoctoral Fellowship Program. The program was extended in 2015 and will include up to 32 fellows.

Beximco Forms Manufacturing JV with Malaysia's BioCare

Beximco Pharmaceuticals Limited has partnered with BioCare Manufacturing Sdn Bhd to make generic drugs for the Malaysian market.

Under the accord, Beximco is helping BioCare set up a manufacturing plant at Seri Iskandar Pharmaceutical Park in Perak, Malaysia.

When completed the plant will be operated by a joint venture firm in which Bangladesh-based Beximco will hold a 30% stake.

A metered dose inhaler manufacturing site has already been completed and deemed to be in compliance with good manufacturing practice (GMP) standards by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) according to the firms.

Nazmul Hassan, Beximco managing director, said: “Our JV with BioCare will help address the unmet needs of patients and physicians by supporting the Malaysian government’s initiative to promote the local pharmaceutical industry.”

Financial details of the accord have not been disclosed, however, according to Beximco’s statement for the six months to the end of December the Bangladeshi firm Taka 16m ($201,000) in BioCare to date.

The Malaysian Government’s Economic Transformation Program was introduced in 2010. The aim is to increase the average income to $15,000 (€14,000) per person, attract $444bn worth of international investment and create 3.3m jobs by 2020.

Part of the plan is to increase the number of drugs made in Malaysia by repurposing existing capacity by enabling multinational companies to license production to local manufacturers.

The efforts have attracted a number of high profile manufacturers.

For example, in 2011 Indian biopharma firm Biocon invested INR500m ($118m) in an insulin manufacturing plant in Johor. Last week the firm was awarded a contract to supply a biosimilar insulin pen by the Malaysian Ministry of Health (MoH).

Services have also been attracted. In 2015, analytical and downstream technology firm Waters has opened a subsidiary in Kuala Lumpur.

Aurobindo Building Indian Manufacturing Plant

Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.

Aurobindo Pharma Limited announced it has bought four cell culture derived biosimilar products from Visp, Switzerland-based private entity TL Biopharmaceutical AG.

Three of the products are oncology monoclonal antibodies and include a version of Roche’s bestselling drug Avastin (bevacizumab).

A spokesman for the Indian small molecule API and finished formulations maker declined to provide information about the financials involved or the other candidates in the deal.

However, he did reveal that a manufacturing facility in Hyderabad in the Indian state of Telangana to support the deal will be commissioned by the end of the calendar year.

The plant will be the first manufacturing facility dedicated to biologics in Aurobindo's network, which currently consists of eight finished formulation plants and a number of small molecule API facilities.

While the addition of four biosimilar candidates was described in Aurobindo’s press release as a “foray” into biosimilars, the firm confirmed to us there are eight next wave biosimilars in development at its biologics R&D site, which is also in Hyderabad.

Atlas to Invest in Capacity with STI Test Manufacturing Partner Bespak

Atlas Genetics has said it will expand manufacturing capacity for cartridge-based STI tests at a UK facility owned by drug delivery technology firm Bespak Europe ltd.

Atlas announced it would increase capacity at Bespak’s facility in King’s Lynn, Norfolk, explaining it will pay for the expansion with some of the £28.4m ($35.5m) it raised through a recent Series D fundraising round.

UK-based Atlas Genetics – which has received a second equity investment from Bespak’s owner Consort Medical plc in a series D financing round – develops in vitro diagnostic tests for sexually transmitted infections.

Bespak's facility in King's Lynn, Norfolk, UK.

In addition to funding the manufacturing expansion, funds raised during the investment round will finance clinical trials and commercial launch of a combined Chlamydia and Gonorrhoea test Atlas is developing.

Marc Green, spokesperson for Atlas Genetics, said the expansion at the King’s Lynn facility will support commercial launch.

The firm anticipates US and EU regulatory approval for the tests by end of 2017.

Jonathan Glenn, Consort Medical CEO, said: “We are excited about the potential for this rapid testing technology, and remain committed as Atlas Genetics’ development and manufacturing partner through our Bespak subsidiary.”

Bespak’s site in King’s Lynn has also been employed for manufacturing use by Big Pharma firms GSK and AstraZeneca.

The facility is equipped with cleanrooms with injection molding machines and automated assembly suites.

Novasep’s Viral Vector Plant in Belgium

The new viral vector production facility will contain two GMP suites equipped with single-use bioreactors ranging from 200L to 2,000L, says Novasep.

The Lyon, France-based technology and service supplier announced it was investing €27m ($29m) to build a commercial scale production facility at its site in Seneffe, Belgium to support growing demand for viral vectors from gene therapy, immunotherapy, and therapeutic vaccine developers.

Novasep spokeswoman Sophie Baudouin said most of the demand is coming from small biotechs, though “Big Pharma also has its own pipeline from internal R&D or acquisition of drug candidates.”

Viral vectors are used to deliver genetic material into cells and according to the firm there are over 300 such products in clinical studies.

Novasep itself has no viral vectors in its portfolio, but the new facility will produce viral vectors by cell culture as a service to drugmakers through two cGMP suites equipped with a set of single-use bioreactors ranging from 200L up to 2000L.

“Novasep has a wide range of expertise and can produce viral vectors from Lentiviruses, Adenoviruses, and Adeno-associated viruses,” Badouin said, and “the new facility will feature full equipment range for commercial production, including a set of bioreactors, filtration and chromatography skids.”

The 21,520 sq. ft. (2,000m2) facility is expected to be operational in 2019, and according to Badouin will create between 50 and 100 new jobs.

The investment is the latest in the bioprocessing space by the CMO, following investments in its antibody-drug conjugate (ADC) capabilities and chromatography sites and was described as “the new jewel of the set of facilities we have been investing in over the past 5 years” by CEO Michel Spagnol.

Lilly Ireland Investment

Rumors of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.

In October, Eli Lilly sought permission from County Cork Council to construct a three-story facility housing an additional production line at its site in Kinsale.

But over the weekend, Ireland’s Business Post reported that the plan had been put on hold.

The paper suggested Lilly was waiting to see if proposed changes to US tax laws will make pharmaceutical imports more expensive.

Republican members of the US House of Representatives proposed “destination based” changes to the US tax system in June last year.

One of the proposals is that the revenue US companies generate by selling goods and services overseas is not taxed.

Another proposal is that the money US firms spend on goods and services from suppliers based outside the country is also ignored by the tax system, in other words the company cannot claim the expenditure as a deductible expense.

As a result, when a US firm buys anything from outside the country it effectively pays more than a company that buys from a US supplier because it cannot deduct the expense.

U.S. taxation has been a hot topic since Donald Trump said he wanted to encourage U.S. manufacturing last month.

But the suggestion possible US tax changes prompted Lilly to delay its decision was rejected by spokesperson Louisa Stevenson who told us the media was “getting the wrong end of the stick."

She said the stories were prompted by a statement Lilly sent to the Irish media on Friday, which stated that: “We have not made a final decision to proceed at this time and this decision will be made by Lilly’s global Board at the appropriate stage of the process."

Stevenson said reports the investment had halted in response to the proposed changes were the result of “people writing what they want to write.”

She also questioned the suggestion Lilly had planned to invest $200m (€212m), explaining the firm “would never give out a figure before a decision to invest is made.

Stevenson did tell us the plant over $2bn has been pumped into the site since it began making pharmaceuticals in 1981, with heavy investment over the past few years to support Lilly’s biopharmaceutical pipeline.

Saudi CDMO’s Fill/Finish Plant

Saudi Biotech Manufacturing has selected Swedish engineering firm KeyPlants to design and build a fill/finish plant for biological APIs.

Riyadh, Saudi Arabia-based firm Saudi Biotech Manufacturing Co. (SBMC) – a local manufacturer and supplier of a number of biopharmaceuticals, including analgoue insulin and a number of growth factors – has selected KeyPlants for the design and engineering of the new plant, expected to be opened in 2019.

”This is a pure fill/finish including compounding, formulation, filling, inspection, secondary packaging,” said Jan Lilja, director of commercial management at Sweden-based KeyPlants.

The aseptic facility in the Sudair Industrial City – located about 120km away from the Saudi capital Riyadh – will be capable of filling up to 8,000 vials, prefilled syringes and cartridges per hour, Lilja added.

“It is a modular plug and play modular facility based on KeyPlants´proprietary in-door modular concept to be placed in a warehouse under construction,” she continued.

The modular units – made by Swedish Modules, the former Pharmadule AB main fabrication workshop in Sweden – will include equipment for purified water, parts washers, autoclaves, and combi fillers for ready-to-use containers.

The construction is part of SBMC’s strategy to offer fill/finish as a service to international biopharmaceitical companies looking to increase their access to the Saudi market.

”There is a regulation in force whereby locally produced – in this case filled – will have an advantage over imported drugs in government tenders,” Lilja said. ”All government hospitals are supplied from central tender procurement for all their needs of Rx drugs.”

In 2014, German biopharma Boehringer-Ingelheim teamed up with two companies based in the kingdom for the secondary packaging manufacture of 26 of its products.

Similarly, AbbVie inked a deal with Al-Mukarramah-based firm Arabio for the secondary packaging of its bestselling mAb Humira (adalimumab) in order to become “a strategic partner to the Saudi government and other stakeholders.”

SBMC itself has entered into agreements with several undisclosed Big Pharma firms to act as a CMO for a number of products intended for the Saudi market.

Roche Expands

Roche says it will continue to expand its biologics manufacturing capacity while reducing its small molecule network.

In 2013, Roche announced it was investing CHF 800m ($804m) across its in-house biologics manufacturing network. Two years later and the Swiss pharma giant said it was upping capacity a further 40% on the back of an increased demand for biologics.

And last week, Daniel O'Day – CEO of Roche Pharmaceuticals – told investors during a Q4 financial call that the firm intended to continue to invest in its manufacturing capacity, as it is “essential to the growth of [its] medicines in the future, most of which are biologics.”

For the full year, pharmaceutical sales stood at CHF 39.1bn – up 4.7% year-on-year – driven by the firm’s biological products: eight out of the top ten selling Roche products were biopharmaceuticals, and the top five – Mabthera, Avastin, Herceptin, Perjeta and Actemra – were monoclonal antibodies.

U.S. and European expansions in 2017

Roche spokesman Patrick Barth would not disclose the scale of investment, but confirmed the firm will be “focusing on capacity expansion projects in the U.S. and Europe” in the coming year.

“We have been investing into the expansion of our biologics manufacturing network for several years and will continue to do so in 2017,” he said.

“We do not disclose the capacity at our sites,” said Barth. “However, we can confirm that Roche has the largest biologics manufacturing capacity across the industry.”

Roche’s network consists of production sites in Basel/Kaiseraugst in Switzerland, and Penzberg and Mannheim in Germany. Biotech subsidiary Genentech operates biomanufacturing sites in San Francisco, Oceanside, Vacaville – all California – and Hillsboro in Oregon, along with a former Lonza site in Singapore.

Meanwhile, Roche has been actively reducing its small molecule production footprint. “We are in the process to exit four manufacturing sites to address underutilization across the sites that support our mature portfolio based on small molecules,” said Barth.

A site in Florence, South Carolina was recently acquired by CDMO Patheon, sites in Spain and Italy have been earmarked for closure, and a site in Clarecastle, Ireland has already begun ceasing production.

But, Barth added, the firm will still support small molecule manufacturing when it suits Roche's future technology needs and changing commercial portfolio, citing an investment in a late stage development and launch facility for small molecules in Kaiseraugst, Switzerland.

Pfizer to Shut Australian Neulasta Plant and Move Production to Croatia

Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

The US drug firm said it will wind up operations at the facility in the Adelaide suburb Thebarton by 2021, citing existing capacity and a desire to consolidate manufacturing activities.

The firm said the 89 people employed at the plant will be deployed elsewhere.

A Pfizer spokeswoman confirmed the closure, telling us the “Adelaide produces filgrastim intermediate and ships this to Zagreb for pegylation and filling into pre-filled syringes.

She added that: “The manufacturing of filgrastim intermediate will be transferred to Croatia.”

The spokeswoman also confirmed that "There are no other APIs being made at the facility and no open contracts with other pharmaceutical companies."

The decision to close reverses a plan Pfizer announced last March , which would have seen the US firm spend A$21m (€16m) to add manufacturing capacity in a newly constructed plant on land adjacent to the existing facility.

According to a pipeline update issued by Pfizer in November its candidate Neulasta biosimilar HSP-130 is currently being examined in a Phase II clinical study at sites in Hungary and Spain.

In an official statement sent to this publication Pfizer said: "Our colleagues in Adelaide and work they continue to do will be vital in ensuring a successful launch of the product that is being manufactured there until the transfer of operations is complete."

Chiltern Expands in Bangalore, India

Contract research organization Chiltern has announced the opening of its new process and technology center in Bangalore, India

In total, the company’s offices in India will be able to support more than 600 employees and give Chiltern substantial capacity to advance operations as needed. The first Chiltern office in India opened more than a decade ago with five programmers.

Mark Penniston is Executive Vice President, clinical analytics and general manager at Chiltern. “We need this facility to maintain pace with our continued growth,” he said. “Having an office in the heart of the city provides shorter commutes and a better quality of life for our employees.”

The process and technology center in India positions data teams in time zones around the world, increasing Chiltern’s 24-hour global presence.

Chiltern’s process and technology teams around are based in Central and Eastern Europe, Latin America and Asia, with more than 1,600 data professionals supporting analytics, risk-based optimization, biometrics and pharmacovigilance.

The company provides clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries.

The team of more than 4,300 employees are located across 47 countries, offering Clinical Development, Medical and Scientific Affairs, Data and Analysis, Pharmacovigilance and Strategic Regulatory services. It uses a collaborative approach for more efficient clinical trials.

Ellutia Chromatography Solutions Headquarters, Lancaster Way Business Park, Ely, Cambridgeshire, UK

Cost: £1.8 million (about USD $2.3 million)

Size: 15,000 sq. ft.

Project team: MJS Construction Ltd. (construction); ALS (UK) LLP (subcontractor; laboratory fitting portion of project)

Gas chromatography instruments and solutions company Ellutia Chromatography Solutions unveiled its new state-of-the-art facility in Lancaster Way Business Park, Ely, consolidating its offices, laboratories and production on one premises. Ellutia is the first occupier within the Enterprise Zone at the business park. The premises will enhance the company’s reputation in the design and production of innovative and unique gas chromatography instruments. The site will give Ellutia the room for its planned growth, with the expectation to increase staff levels by 40 percent over the next two years.

Ellutia’s long-term strategy focuses on evolving and enhancing its product offerings, continually improving service to customers and strengthening the network of R&D companies in the Cambridge area. Ellutia has been developing and manufacturing chromatography instrumentation and providing gas chromatography solutions for over 20 years. Ellutia also specializes in the customization of these products, collaborating closely with customers to produce, install and support systems to fit their exact requirements.

Completion date: Jan. 20, 2017

Novo Nordisk Foundation Grants for Pharma Fermentation Pilot Plant

The Novo Nordisk Foundation has awarded a DKK118m ($17m) grant to fund development of a fermentation pilot plant for cell line scale up experiments at the Technical University of Denmark.

The plant is intended to support development of so called “cell factories,” which are bacteria, yeast and mammalian cells modified to produce drugs or chemicals used their production.

A University spokeswoman said “The plant will be located in the headquarters of The Novo Nordisk Foundation Center for Biosustainability – DTU Biosustain – that is at Technical University of Denmark in Kongens Lyngby.”

She added that: “We expect the plant to be fully operational by May or June this year.”

The facility will allow researchers to test how the cell lines are impacted by industry relevant parameters like temperature, pressure and oxygenation according to Bernhard Palsson, CEO of the Novo Nordisk Foundation Centre for Biosustainability.

“Developing a cell line that is very productive in small trials does not guarantee that the cells will produce efficiently in the large bioreactors used by industry.

Palsson added that: “The new plant can give a more realistic idea of the potential and the costs associated with specific types of products.”

The Novo Nordisk Foundation Centre for Biosustainability was established at the Technical University of Denmark in 2011 with the support of a grant from the Novo Nordisk Foundation.

A spokesman said the foundation “supports free and independent research at public research institutions and any research result belongs to the researchers and their institutions

Novartis Unit Lek to Expand Slovenian Plant

Sandoz subsidiary Lek will expand production capacity at its antibiotics facility in Prevalje, Slovenia.

Lek announced the plan, explaining it will expand the existing plant on to land adjacent to the site that it acquired from Koratur last year.

The firm did not disclose how much the project will cost or by how much it will increase capacity, but did say several production lines would be introduced over the next few years.

A Sandoz spokesman said the investment was "based on the high quality of products and processes, expertise of the Prevalje associates, and continuing growth of demand."

The facility produces a version of GlaxoSmithKline's Augmentin, a broad spectrum antibiotic that consists of amoxicillin and clavulanic acid.

According to the Sandoz spokesman "products from this site are treating patients in approximately 60 markets, the majority of the sales are made through our own marketing and sales network."

Lek currently employs 246 people out the site, although it expects to hire more staff when the expansion is completed in 2023.

The spokesman said, "The investment will create new jobs. The number will depend on the development of this investment. The target is that 25% of these new jobs are employees with high education."

Sandoz’s owner – Swiss drug manufacturer Novartis – has invested €30m ($27m) at the site over the past decade.

Wuxi Apptec Small Molecule API Subsid STA to Expand

STA Pharmaceutical Co., Ltd. has announced it will hire approximately 100 additional R&D staff and expand its small molecule API and intermediates facility in Changzhou, China.

The firm – a subsidiary of WuXi AppTec – said it plans to establish a staff of 300 R&D employees at the site by the end of the year citing customer demand for process and analytical chemists as the driver.

Youchu Wang, head of R&D at the Changzhou site, said: “The plan is now to grow the R&D teams in Changzhou to closer to 300 scientists – 230 process chemists and 70 analytical chemists by the end of 2017.”

The facility was established in March 2016.

Currently STA employs 200 R&D people at the Changzhou site, including 160 process chemists, 40 analytical chemists and a team of crystallization technology engineers trained at its Shanghai facility.

The recruitment drive is part of a wider expansion plan that will see STA increase reactor capacity at the site. Specifically, the firm plans to add process chemistry labs, hydrogenation labs as well as a catalysis lab by the end of 2017.

STA also said that the US Food and Drug Administration (FDA) will inspect the facility in the first half of the year, but did not provide additional information.

The firm provides process chemistry services and manufactures small-molecule intermediates and active pharmaceutical ingredients (APIs) for clients conducting preclinical and clinical trials and for marketed small-molecule drugs.

Arven Expands Turkish Biosimilars Production

Arven will use GE Healthcare’s FlexFactory manufacturing platform to increase capacity at its mammalian-cell based bioproduction facility in Kirklareli, Turkey.

Arven Pharmaceuticals, part of the Toksoz Group, is working on developing biosimilars for various oncology and autoimmune indications, as well as inhalation products for Asthma and COPD.

The Turkish firm says the addition of GE Healthcare’s FlexFactory suite to its 301,280 sq. ft. (28,000 sq. meter) facility will help support its biosimilars pipeline.

GE Healthcare acquired the biologics manufacturing platform when it bought US-firm Xcellerex in 2012.

Sven Henrichwark, general manager, Global Commercial BioProcess, GE Healthcare said, “FlexFactory is a cell-line agnostic manufacturing platform. With the right approach during process development, a process for any biopharmaceutical product can be scaled for manufacture using FlexFactory.”

GE Healthcare also has a Fast Trak service center in Istanbul, Turkey, which GE claims will allow it to work closely with Arven as part of the service.

“[We will work with] Arven, one of the country’s key biopharma companies, to help deliver increased capacity as well as support Turkey’s growing pharma industry requirements,” he added.

FlexFactory links single-use seed and production bioreactors, such as the Xcellerex XDR 500, to other modules up to a 2000L capacity.

Arven said it was the flexibility of systems in FlexFactory, along with the local technical support, speed, and collaborative work structure which led it to select GE Healthcare’s platform over others.

Heinrichwark explained “FlexFactory gives manufacturers rapid access to cGMP manufacturing capacity for biologics such as MAbs and vaccines, wherever it is needed, with a lower capital investment than traditional facilities.”

Turkey has said it plans to reshape its healthcare sector so that 60% of pharmaceutical medicines are produced locally by 2023. To achieve this, various Turkish governmental incentives have been introduced, such as tax allowances and duty exemptions, to encourage investment into biologics manufacturing and to move away from relying on imports.

Heinrichwark said, “For companies developing biosimilars, there are advantages to being able to manufacture locally. This is true for Turkey, but also other key markets such as China, Brazil, and South East Asia.”

“FlexFactory provides a strong platform for meeting global regulations and quality standards, which can be important when looking to manufacture your biosimilar for multiple markets.”

Almac expands in Ireland

Almac Group announced that as part of its ongoing global expansion, the company has secured a new facility in Dundalk, County Louth, Ireland. The new facility will be located at IDA Business Park. The new facility will increase the group’s European footprint by 32,000 sq. ft.. The Dundalk facility will be utilized by Almac Pharma Services and Almac Clinical Services.

In November 2016, the company announced expansion projects in Pennsylvania and Northern Ireland. Almac said it would invest £20-million (approximately $25.28-million) at its site in Souderton, PA to expand its existing 240,000 sq. ft. facility in addition to leasing a 26,000 sq. ft. office space in nearby Lansdale, PA. In Northern Ireland, Almac said it would invest around £5 million (approximately $6.32-million) in Craigavon to build an additional laboratory and office facility.

“Almac’s decision to expand into Dundalk provides the company with certainty of access to the European Union in the long term—this certainty of access is an increasingly important selling point for Ireland as we look to win business for Ireland,” Martin Shanahan, CEO, IDA Ireland said in a statement.

AGC increases Capacity with Recent M&A

After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.

Within the past four months, AGC Asahi Glass – a subsidiary of industrial glass, ceramic and chemical maker the AGC Group – has bought two biologics contract manufacturing organizations (CMOs).

In September, the firm launched itself into the space through the acquisition of Heidelberg, Germany-based Biomeva, and weeks later signed an agreement to cement its stake in the industry through the ¥60bn ($516m) addition of Søborg, Denmark-headquartered CMC Biologics.

Spokeswoman Tomoko Komazaki said that with Danish manufacturing capacity and US sites in Seattle and Berkeley, the CMC Biologics deal meant AGC has made “a full-fledged launch into not only microbial but also mammalian CMO businesses in US and European markets which are fast growing and account for the main part of biopharmaceuticals business in the world.”

“Life science business is one of AGC’s strategically focusing business areas to achieve further growth,” she said. “CMO business is an important part of AGC’s life science business and we have decided to expand into this field.”

AGC had some biomanufacturing capacity in its network, including a 4,500L fermentor at a site in Chiba, Japan, but once the CMC deal is complete – expected later this month – the Tokyo-headquartered firm will boast 10,000L of microbial capacity and 34,000L of mammalian capacity.

24,000L of the mammalian capacity will be single-use bioreactors, Komazaki said, including three Thermo Fisher 2,000L systems recently added by CMC Biologics in Denmark.

Komazaki also added the company will take into consideration any opportunities further M&A acquisitions in order to grow further its contract biomanufacturing business in the future.

B+K is Setting New Standards

Demand for high-purity packaging for the pharmaceuticals and medical technology industries has been increasing for a number of years. Bischof + Klein is responding to this trend by investing in a completely new coex extrusion line, thus doubling its extrusion capacities.

The existing ISO class 5 cleanroom according to DIN EN ISO 14644 is being extended and a new extruder tower with a total height of 18 meters is being built for this new line. The intention is to manufacture both existing product solutions as well as new developments, which have not yet been produced under cleanroom conditions, on the new machine. The extension is taking place away from the current cleanroom extrusion facilities, resulting in two spatially separated extrusion areas. This is also of importance to risk management, as production can switch to another extrusion area in the event of malfunctions, thereby ensuring supply security.

Planning and construction were undertaken using of state-of-the-art cleanroom construction on the basis of current standards such as DIN EN ISO 14644, and the latest online monitoring technology has been implemented. Following successful initial qualification of the

new cleanroom as well as qualification and validation of the new production line and the products, production is scheduled to start in the spring of 2017.

Sartorius Stedim Biotech Opens a New Validation Service Laboratory at Its Shanghai Site

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, opened a new validation service laboratory at its site in Shanghai Zhangjiang Hi-Tech Park. The opening event was attended by business partners from the biopharmaceutical industry and representatives of the local community.

With its new laboratory, Sartorius Stedim Biotech is making validation of membrane filters even more convenient and time-saving. Chinese customers can have their entire process steps validated locally and will also benefit from direct interaction with Sartorius specialists on site.

“Our Shanghai validation lab provides high-quality services that are fully compliant with applicable GMP and GLP principles. At this validation service lab, we now offer comprehensive process validation studies for the strongly growing Chinese pharma market,” stated Dr. Jörg Lindenblatt, SSB’s Senior Vice President of Sales for Bioprocess Solutions in Asia, in his opening speech. The validation lab, together with SSB’s Application Center in Shanghai, provides a full range of extended services to the biopharmaceutical industry.

SSB’s new Shanghai laboratory covers approximately 4,000 square feet (370 square meters). Equipped with the latest instrumentation, it offers microbiological testing services and physical-chemical testing to provide a full range of data for process validation studies in compliance with all regulatory requirements. Certified according to Biosafety Level II (BSL-2), the facility is permitted to handle specific critical bacteria and customer products.

Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves.

Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech has a global reach. The company employs approx. 4,200 people, and earned sales revenue of 884.3 million euros in 2015

Cipla to Make Drugs in Iran with Ahran Tejarat

Cipla Ltd has formed a joint venture with Ahran Tejarat Company to manufacture and sell drugs in Iran.

The agreement – announced on the Bombay Stock Exchange (BSE) – will see Cipla’s Netherlands-based subsidiary take a 75% stake in the Iran-based JV for €16.8m ($17.5m).

Under the deal, Issat Company, which is owned by Ahran Tejarat, will become the joint venture entity. The firm holds an Iranian manufacturing license, but does not currently produce medicines or generate revenue.

Cipla has been interested in the Iranian pharmaceutical since at least 2014.

In October of that year, the India headquartered drug firm announced its intention to set up a manufacturing plant in Iran in collaboration with a distributor in the country.

Pharmaceuticals and medical equipment are not restricted under international sanctions imposed on Iran after the 1979 revolution. Despite this, drug production in the country is limited with few international manufacturers involved.

A 2013 report by the Woodrow Wilson International Center for Scholars suggested that, despite humanitarian provisions included in the sanctions, some pharmaceutical products are in short supply.

The authors wrote that: "Sanctions are affecting the supply of the most advanced medicines, providing relief in the most dire cases of illness, including cancer, multiple sclerosis, and hemophilia."

Aerie to Build Manufacturing Facility in Ireland

Aerie Pharmaceuticals Inc. will lease a 30,000 sq. ft. manufacturing facility in Ireland to commercialize its eye-drop product for Glaucoma after delays at a third party CMO.

Working alongside the Industrial Development Agency (IDA) in Ireland, the California-based biotech has settled on a site in Athlone, which it claims will be ready for commercialization of the small molecule Rhopressa by 2020.

Rhopressa is Aerie’s ophthalmic solution of small-molecule netarsudil to treat Glaucoma - a group of degenerative eye diseases that can lead to vision loss.

Aerie has also developed a second Phase III product – Roclatan – currently in two trials combining Rhopressa with an FDA-approved small-molecule generic, latanoprost.

Aerie withdrew its new drug application (NDA) for Rhopressa in October after its Tampa, Florida-based contract manufacturing organization (CMO) announced it would not be ready for US FDA inspection.

Following further delays, Aerie has said it will now resubmit the NDA next month, and if successful, both Rhopressa and Roclatan will be manufactured at the Athlone facility instead.

“As we prepare for commercialization, it is increasingly important that we ensure greater independence regarding our finished product sourcing while also meaningfully reducing our future product costs,” said Vicente Anido, CEO of Aerie.

The building shell was initially constructed by the IDA in the Athlone Business and Technology Park, around 130km from Dublin.

Aerie will now lease the space with internal construction with equipment purchase to begin immediately.

Projected costs are expected to total $25M, excluding the lease.

In a statement, the firm claims its move to manufacture in Ireland was also based on some incentives set by the IDA, including employment and capital investment.

Anido added “We are grateful to our IDA colleagues in Ireland for their cooperation throughout this process and the incentives that we have been granted.”

Aerie withdrew their NDA submission of Rhopressa in October after its CMO announced it would not be ready for its FDA pre-approval inspection of the facility in Tampa, Florida.

A second delay in December was announced by the unnamed CMO, further pushing back plans to commercialize the drug.

In a statement, the Aerie decided it would re-submit the NDA this February, with plans to submit a marketing authorization application (MAA) for Rhopressa to the EMA by the end of 2017.

Dutch Qlip Dairy Lab Opens

Qlip’s new dairy laboratory in Zutphen, the Netherlands, has been officially opened by the King of the Netherlands.

In March, 2016, the mayor of Zutphen gave the official go-ahead for the construction and conversion of what is the largest dairy laboratory in Europe.

Qlip said in a statement that the chemical and microbiological departments have doubled in size, and the laboratory is equipped to assist customers with dairy product analysis for food safety and quality.

Qlip’s activities include certification, inspection and testing throughout the dairy chain, from farm to factory to consumer products.

Qlip's chemical and microbiological laboratory processes more than 400,000 samples per year. Testing is undertaken on raw and heat-treated milk, cheese and cheese products, butter and milk fat products, powdered milk products and infant formula.

The laboratory also analyzes more than 2.3m herd bulk milk samples annually. Qlip also performs hygiene checks on milk transport from dairy farms to the processing plants.

Qlip also analyzes more than 200,000 milk samples from individual cows each week.

In December, Qlip became the official partner of the Sino-Dutch Dairy Development Center (SDDDC).

The objective of the SDDDC is to share Dutch dairy expertise with Chinese experts and decision makers to improve production, safety and quality throughout the dairy chain in China.

The SDDDC was created in 2013 by China Agricultural University, Wageningen UR and Royal FrieslandCampina N.V.

McIlvaine Company

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