Restarting production at the former Ben Venue facility in Ohio will be a “significant task” says Xellia Pharmaceuticals which plans to invest after buying the site from Hikma.

At the end of 2013, Boehringer Ingelheim closed the doors at its beleaguered CMO Ben Venue Laboratories in Bedford, Ohio after years of quality and manufacturing issues – resulting in a number of major drug shortages - made remediating the sterile manufacturing site an unviable option.

Ben Venue was picked up for $85m as an option in 2014 when Hikma bought specialty pharma firm Beford Labs, though the firm said it had no plans to reactivate it, and Xellia Pharmaceuticals has announced it is set to give the site – which is one of the largest sterile manufacturing sites in the world – a new lease of life.

“We have purchased around two-thirds of the site which equates to approx. 23 acres and includes four manufacturing units for sterile injectables,” said Carl-Aake Carlsson, CEO of the Danish pharma firm. Financial terms were not disclosed.

“The four units are all designed for the manufacture of sterile injectables but are of a different state and age,” he continued, adding “Xellia only plans to recommence operations in the new manufacturing units” which are more modern and built after 2000.

The firm hopes to begin commercial production of its sterile injectable anti-infectives there within 24 months though Carlsson told us it will be “a significant task” requiring additional investment.

“The start-up of the facility will take place in a considered, stepped manner, using the new, modern units. We will not refit the entire site at this stage but will do what is needed to meet the compliance requirements.”

Hikma transferred a large number of modern, high quality machines - including lyophlizers and filling lines - to its manufacturing facilities in Portugal, Germany and the US following its acquisition, he continued, and so Xellia “will invest in new machinery” at the production site.

Furthermore, Carlsson said the firm would be working closely with the FDA to bring the site back online, and was well aware of the challenges faced by the site’s previous owners.

“Our operations at the site will be different compared to Ben Venue and we will manufacture different products. The site will be run according to the Xellia quota system, and we will invest both in the new facility and a new organization with high quality management.”

Approximately 170 staff will be employed in functions including manufacturing, supply chain, distribution, quality, engineering, HR and finance over the next two years.

Baxalta Biologics Facility, Georgia, United States of America

Baxter's biopharmaceutical spin-off company, Baxalta began construction of a new biologics facility in August 2012. It selected a site for the proposed facility in the city of Covington, Newton County, Georgia, US. The company plans to invest more than $1bn on the new facility between 2013 and 2017.

The facility will help Baxalta to meet the needs of patients worldwide who are dependent on the company's plasma-based therapies.

The planned investment will create approximately 1,500 full-time jobs in the state. It will also create roughly 2,000 direct and indirect jobs. The plant will begin commercial production in 2018. It started recruiting full-time staff in 2014.

A biotech training center in Stanton Springs operated by Georgia Quick Start, a customized workforce training programme, will provide technically trained personnel to Baxalta and other biopharmaceutical companies in the state.

The facility focuses on the manufacture of products related to immunoglobulin therapy and albumin, a protein commonly found in animal tissues and liquids.

Immunoglobulin therapy is offered to patients with immune deficiencies. Patients who require critical care or those facing trauma or burns are principally treated with albumin products. Albumin therapy helps to maintain fluid levels in critically ill patients.

The site for the new facility is located in Stanton Springs, a business park spread across four counties, namely Jasper, Morgan, Newton and Walton. Baxalta acquired 100 acres for the project in the business park.

The site is strategically located in the I-20 corridor, which provides quick access to road transport. It is also close to a number of plasma collection centers in the US.

The new plant will have facilities to support the development of plasma-based treatments such as plasma fractionation, purification and fill-finish operations for biologic medications of Baxalta. .

The fractionation facility will have annual capacities of up to three million liters.

In addition, there will be a testing laboratory, and separate buildings for warehousing, utilities and administration.

Baxalta started construction on the new facility in August 2012.

Baxalta plans to develop the Covington site in a phased manner. The current development forms part of the initial phase of the project. The gross built-up area in the initial phase will be one million square feet.

The later phases will expand the facility, depending upon the demand for the manufactured products. The facility will be, therefore, designed with flexibility to expand the infrastructure when the global market needs mean an expansion is required.

The construction of Covington facility also calls for the expansion of the existing filling and finishing capacity at Baxalta's manufacturing facility in Round Lake, Illinois.

The associated expansion will result in the creation of about 200 more jobs. It will include addition of production capacity for the company's plasma-based albumin treatment known as Flexbumin, which is offered in a flexible container.

The licensed immunoglobulin therapy currently marketed by the company in the US and Canada is the Gammagard Liquid. It is marketed under the name Kiovig outside the US and Canada. It is used to treat patients with primary immunodeficiency.

The U.S. FDA also approved Gammagard Liquid 10% for the treatment of multifocal motor neuropathy, making it the first immunoglobulin treatment to be approved for that indication. In addition, the company provides blood protein therapies for alpha-1 antitrypsin-deficient patients.

Headquartered at Bannockburn, Illinois, Baxalta is a global biopharmaceutical company that develops, manufactures and markets transformative therapies in hematology, immunology, and oncology.

The product portfolio of the company includes treatments aimed at curing hemophilia, cancer, trauma and diseases related to kidneys and acute medical conditions. The company has been a leading developer of innovative plasma-derived therapies. Its focus is on unmet needs of patients requiring these therapies for a long time.

Fluor and Turner Construction were selected to provide construction management services for the project.

Cirrus Expands

Contract development and manufacturing organization (CDMO) Cirrus Pharmaceuticals is set to launch its services for manufacturing cGMP materials for early phase clinical trials in its newly constructed state-of-the-art flexi-suite at its Raleigh-Durham, NC site in the U.S.

“We are very excited about this new service offering to customers. Cirrus will be one of the few CDMOs with development and manufacturing capabilities for some of the niche dosage forms we have to offer. Specifically, we will be able to perform manufacturing for metered dose inhalers (MDI) on our Pamasol pressure filling line. The typical batch size offering is up to 25L and Cirrus will be able to perform one and two-step filling as well as cold filling for suspension and solution MDIs. Other than MDIs in the inhaled dosage forms, we will offer our clients dry powder filling in capsules for dry powder inhalers (DPI), and manufacture of nasal solutions, suspensions and powders,” said Andrew Hamer, vice president of R&D, Cirrus.

“This new addition helps drive our goal to keep our customers competitive. We will now offer customers a seamless service from pre-formulation to clinical trial manufacturing in the U.S., and for oral solids and injectable products we can continue to offer commercial manufacturing from our plants in Sweden and India,” said Karan Bagaria, vice president of corporate development, Kemwell. Clinical manufacturing of other dosage forms that will be offered from the site are topicals (creams, ointments and gels), oral solids (tablets, capsules) and oral liquids.

News Velesco Pharma Expands

Velesco Pharma has boosted its cGMP analytical testing capabilities with an expansion of its analytical laboratory in Plymouth, MI. The addition of a new cGMP analytical testing laboratory increases the breadth of services to more fully meet the needs of its broad client base.

The main activity supported in the new cGMP-compliant laboratory is the testing of clients’ stability samples. Specific testing activity includes: • Assay and related substances by HPLC (UV and RI) and UPLC-UV; • Assay by titration; water content (Karl Fisher); pH; viscosity; osmolality; density/specific gravity; disintegration; dissolution and UV; and • Hardness and friability for tablets.

In addition to executing clients’ cGMP stability programs, the laboratory is ideal for the testing of samples for cleaning validation studies, in vitro equivalency determination and test article characterization.

“Our new cGMP analytical laboratory is impressively designed, equipped and staffed so that we can meet our clients’ growing demand for analytical services,” said Dave Barnes, chief executive officer, Velesco. “We look forward to collaborating with our clients to ensure strong cGMP testing programs. Our clients can be confident their testing will exceed FDA compliance requirements.”

Mayo Clinic Has New Lab

Mayo Clinic's breakthrough research lab puts evidence-based design to the test.

There’s been a lot of talk over the past 20 years about evidence-based design. EBD is the idea that improvements to the design of buildings, particularly to their interior spaces—more daylight, improved air quality, better lighting—can have a positive effect on human health and performance.

The problem with EBD is that it’s very hard to conduct truly rigorous scientific studies on humans. Was it the improved lighting that enabled students to boost their test scores, or was it better airflow in the classroom? Did that hospital patient heal more quickly because she had a window with a view to the outside, or was she just a fast healer? Too many variables, not enough controls, so it’s anybody’s guess how much, if anything, the design contributed to the outcome.

The Mayo Clinic and Delos, the developer of the Well Building Standard, have teamed up to bridge this information gap. They have built a 7,500 sq. ft. laboratory at Mayo’s Rochester, Minn., campus, where researchers will perform sophisticated, reproducible (that’s important) scientific studies on design’s impact on human health and performance. The goal, according to Delos COO Peter Scialla, is to expand the concept of environmental sustainability to embrace what he calls “biological sustainability.”

The Well Living Lab, designed by Centerbrook Architects & Planners (with Knutson Construction as CM), has six experimental modules that can be formed into a variety of indoor spaces: an open-plan or closed office floor, a kitchen, a hotel or hospital room, a classroom, etc. The walls, floors, ceilings, fixtures, and plumbing—yes, even the plumbing—can be completely reconfigured.

The Well Living Lab has six experimental modules that can be formed into a variety of indoor spaces, including an office, kitchen, and hotel room.

The modules, as well as the furniture, casework, and finishings, are loaded with sensors so that test subjects’ responses can be captured without having to attach wire leads to them. For example, bed sensors will determine a person’s lying-down position and how much pressure is being exerted on specific body parts—information that one day could lead to ways to relieve bed sores in long-term hospital patients, or just give weary hotel guests a better night’s sleep.

In certain studies participants will wear sensor-enabled wristbands or clothing to gauge heart rate, galvanic skin response, motion, skin and near-body temperature, respiration, and physical posture.

Sensors embedded in walls, ceilings, appliances, and fabrics will measure factors like sound, street noise, room temperature, humidity, air particulates, and light (including spectral power density). High-definition cameras will zoom in on test subjects to record facial expressions and gestures.

Research experiments will test the effect of single or multiple variables, such as air quality, supplied lighting, and daylighting, on subjects’ stress, fitness, nutrition, eating habits, performance in cognitive and physical skills, and sleep. Further down the line, building product manufacturers may be able to use the lab to test the efficacy of their products on human health. All this activity will be managed and documented from a high-tech control room.

The Well Living Lab is an important breakthrough in environmental design. If it lives up to even a fraction of its promise, it could provide designers of hospitals, outpatient medical facilities, schools, university classrooms, hotels, and office spaces with scientifically valid data to produce designs that really do contribute to human health and performance. Real science, not wishful thinking.

Experiments are scheduled to begin in the next couple of months, once the Well Living Lab has completed its break-in period.

LabConnect Builds New Biorepository Facility

LabConnect, a Seattle-based provider of laboratory services to biopharmaceutical, medical device, and contract research organizations, has built a new biorepository facility to expand services and better meet the evolving needs of the industry.

According to a Feb. 3, 2016 press announcement from the company, LabConnect’s new, 5000-square-foot biorepository in Johnson City, TN, includes space for ambient, refrigerated, cold (-20 °C), and ultra-low temperature (-70 to -80 °C) storage as well as liquid nitrogen vapor phase storage (-190 °C).

“Proper sample management is essential to both today’s and tomorrow’s clinical trials,” said Eric Hayashi, LabConnect president and CEO, in the press release. “Researchers depend on the integrity and availability of their stored biospecimens to retest them to verify trends or unexpected results, or for later retrieval to support specific biomarker research.”

The facility includes storage capacity for more than 8 million samples, fully validated and mapped backup freezers and generators, redundant HVAC systems, whole building and biorepository security systems, and a temperature monitoring system for all freezers and refrigerators with a 21 CFR Part 11 compliant audit trail. LabConnect also tracks sample locations and consolidates data within a centralized database.

Piramal adds Capacity at Coldstream Lab

Piramal has announced its intention to invest $10m (€8.9m) in Coldstream Laboratories, the US sterile injectable CDMO it bought last year.

The investment will be focused at Coldstream’s facility near Lexington, Kentucky and will create 40 new jobs according to the Indian contractor.

The move is being supported by tax incentives of up to $800,000 from the Kentucky Economic Development Finance Authority (KEDFA).

William Wedlake, president of Piramal’s formulations business, said the investment fits with the growth of the firms antibody drug conjugates (ADC) business.

“In addition to developing new clients, the Kentucky facility also allows our current ADC clients to forward integrate seamlessly and address their fill-finish needs” he said.

The expansion will also add specialist containment and chemical handling capabilities according to Wedlake.

“As oncology becomes key in our collaborators portfolio, our ability to handle high potency APIs, develop and deliver high quality, robust, cost effective drug product solutions becomes a key differentiator.”

Piramal bought Coldstream last January for $30.65m.

Founded in 2007 and by University of Kentucky Research Foundation, Coldstream employs 91 people and focuses on the manufacturing of sterile liquid and lyophilized parenterals and injectables.

Coastal Life Technologies Building New HQ

Coastal Life Technologies, a contract manufacturing outsource provider focused on delivering turn-key services for medical devices, is building a new 135,000 square foot headquarters in San Antonio, Texas. The company is breaking ground on the facility in January, and expects it to be completed within a year.

The new building nearly doubles the company's footprint compared to its current facility, with an expansion of 70,000 square feet. This includes 16,000 square feet of office space and a 22,500 square foot manufacturing area with a 12,000 square foot ISO Class 8 clean room as well as space for soft goods production, electronic assembly, testing and staging. The new building will also include warehousing and distribution facilities.

"With our significant growth in recent years, we simply need more space to meet demand. This new building will enable us to streamline our services, from process engineering all the way to end user distribution, with maximum efficiency and room to grow" said Coastal Life Technologies Chief Operating Officer David Huff.

Centrally located in San Antonio, Texas, CLT is a single-source solution for medical device manufacturers who want to increase productivity and decrease time to market in a cost-effective and quality-controlled environment. CLT specializes in the assembly, packaging and sterilization of single-use surgical devices, and offers streamlined solutions including process engineering, warehousing, order fulfillment, distribution and shipping. CLT is ISO 13485:2003 certified with ISO Class 8 cleanrooms.

Biocision Expands Cell Therapy Tech Offering

Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.

The California, US-based technology developer has launched new versions of its ThawStar system that are designed to thaw cell therapies preserved in 1.5mL cryogenic vials and 6mL AT-Closed vials developed by Belgian firm Aseptic Technologies S.A.

The developmental bag-scale thawing system is designed to handle larger volume cell therapies, which is an increasing area of demand for manufacturers with trial and commercial stage products according to Biocision CEO, Rolf Ehrhardt.

“Providing a translational thawing platform that accommodates small- and large-volume closed system formats allows our customers to adopt it early in the research and development phase and have confidence in knowing that it can be seamlessly incorporated into commercial manufacturing, and point of care.”

Thawing is a hot topic for cell therapy developers. Most biopharmaceutical products are sensitive to temperature changes, but personalized cell therapies are particularly susceptible.

As a result cell therapies are usually frozen at the manufacturing facility before being shipped to the clinic for administration back to the patient.

But protecting these sensitive and usually irreplaceable treatments is not enough according to Biocision, which says induced pluripotent stem cells (IPSC), chimeric antigen receptor T- cells (CAR-T) and “natural killer” (NK) cells can also be damaged by the thawing process.

“The common method of thawing cryopreserved cells and cell-based therapeutics involves sequentially placing frozen vials or bags into a warm water bath; a method fraught with challenges that leaves the cells and therapies at risk of contamination and potentially jeopardizes drug efficacy and safety.”

Biocision's system is designed to eliminate water bath thawing using technology that senses the initial starting temperature and phase change initiation and customizes the thaw for each vial.

Novasep Expands API Lab

Novasep has announced it is expanding API synthesis at its facility in Boothwyn, Pennsylvania and confirmed that US growth is important after the sale of Pharmachem.

The expanded lab will house a range of reactors capable of supporting low-temperature – cryogenic – reactions. It will also be a regional base for Novasep’s chemistry and purification business, including its chromatography and evaporation offering.

In addition, the lab will also be equipped with analytical tools for process R&D, including process safety testing capabilities.

Novasep said the expansion will be completed in the next few months and predicted that production will begin in May.

The privately-owned French contract manufacturer did not give financial details of the Boothwyn investment but did say it was a direct response to demand from U.S. customers.

Thierry van Nieuwenhove, president of Novasep’s synthesis business, told us “For many years, Novasep has been offering purification development services from our US facility, based on specialized technologies.

“Customers appreciate the locally based engineers working in close proximity with them to carry out technical transfer, provide development & the scale-up of services and then accompanying them through the transfer to our FDA inspected manufacturing assets in Europe.”

Novasep’s U.S. customer base was reduced by the sale of Pharmachem in 2014.

The divested unit, which was bought by Novasep in 2007, produces the API tenofovir disoproxil for Gilead’s HIV and hepatitis B treatment Viread at its facility in the Bahamas.

According to a Moody’s note Pharmachem generated 40% of Novasep’s earnings in 2014, which the rating agency said “depends upon one single active ingredient, Tenofovir, which is sold to a single customer.”

Last March, the San Diego, California biotech contracted Novasep to supply the active pharmaceutical ingredients (APIs) for its gene therapy heart disease drug Mydicar (AAV1/SERCA2a).

However, Celladon cancelled the contract – and a larger deal it had with Lonza – a few months later after Mydicar failed to meet primary or secondary endpoints in a Phase IIb trial.

Nieuwenhove told us “US sales have always been a very important part of our strategy and turnover. The sale of the Pharmachem site was part of our ‘Back to Basics¹ strategy aiming at refocusing Novasep's activities on core businesses.

“Even without Pharmachem, our presence in the US has remained important. Novasep has built many relationships over the years there and this investment is a step further in the strengthening of our established and future relationship with US-based pharmaceutical companies.”

BAP Pharma Opens U.S. Headquarters in Landing, NJ

BAP Pharma, an award winning UK-based specialist supplier of comparators for clinical trials, announced the opening of its new U.S. headquarters in Landing, New Jersey. The new headquarters is the company’s first location in the U.S.

BAP Pharma manages the clinical trial supply process including sourcing, delivery and customized solutions to provide seamless service to its clients, which include some of the UK’s top pharmaceutical companies. The decision to expand its operations to New Jersey was made in response to the company’s rapid growth, according to founder and Managing Director, Dr. Bashir Parkar. Pharmaceutical industry veteran Lucas Nigro will manage the U.S. headquarters.

“Since 2011, BAP Pharma has been establishing itself as a global leader in the clinical trial supply sector based on attention to quality and best-in-class client service,” said Parkar. “The opening of our U.S. headquarters in New Jersey is an important milestone for our company and will enhance our ability to provide fast, seamless service to our clients.”

Parkar visited New Jersey during 2015 in search of a U.S. location. Choose New Jersey, a nonprofit economic development organization charged with business attraction and marketing the State, and its partners assisted Parkar in identifying real estate. BAP Pharma chose to lease a facility in Landing, which it has equipped with state of the art, fully enclosed temperature controlled ambient and cold room storage facilities.

“The facility and location proved a perfect fit for our company,” said Parkar. “Its proximity to a significant number of global pharmaceutical and biotechnology companies, including our current clients, made it particularly attractive. New Jersey’s excellent transportation network also enhances our ability to deliver products quickly and efficiently throughout the region and around the world.”

“We are excited to welcome BAP Pharma to the State’s thriving life sciences community,” said Michele Brown, President and CEO of Choose New Jersey. “Like New Jersey, the UK is a global leader in the life sciences. We’ve established strategic relations in this market through business trips and lead generation activities. New Jersey is ideally positioned to be the landing pad for international firms, based on its location in the heart of the Northeast, its diverse and talented labor pool, and the presence of the world’s top pharma and biotech companies.”

In addition to the support BAP Pharma received from Choose New Jersey, the company accessed a variety of resources in the U.S. and U.K. The company hired key personnel through the assistance of the Life Sciences Talent Network, managed by BioNJ; the New Jersey Business Action Center made introductions to State regulatory agencies; Select USA provided guidance on establishing and operating a business in the U.S.; and UK Trade & Investment made valuable connections in the U.S. market.

BAP Pharma will celebrate this significant landmark with an official ribbon cutting ceremony planned this spring.

Oxford Pharmaceuticals’ Generic Drug Facility

Oxford Pharmaceuticals, a start-up pharmaceutical company, broke ground for the construction of a generic drug manufacturing and distribution facility in Jefferson County, Birmingham, Alabama, in September 2015.

The facility will design and produce various generic drugs that will be sold worldwide.

The facility, which will comply with good manufacturing practices (GMP), is expected to be completed by the second quarter of 2016 and operational by the third quarter of that year. It will employ 61 people, which will increase by up to 200 people when fully operational.

State, city and county are providing support to the project through a number of incentives. The project will create diversified work opportunities at Birmingham and is expected to help its industrial and economic development.

The plant is being constructed on a 23.3 acre site in Jefferson Metropolitan Park at Lakeshore, 301 Leaf Lake Drive in Birmingham.

The site was acquired from the Jefferson County for $618,000. The county is estimated to gain approximately $1.35m in new tax revenue, including $97,490 in general tax revenue and $1.25m in educational tax revenue, from the project over a ten-year period.

Alabama's largest metro area and resources such as the Innovation Depot and University of Alabama are competitive advantages of the plant.

The new generic drug production facility is estimated to be constructed with an investment of $29.4m.

Birmingham Business Alliance, the City of Birmingham, the Jefferson County Commission, the Jefferson County Economic Industrial Development Authority and the Alabama Department of Commerce co-operated with Oxford Pharmaceuticals by offering $4.9m in incentives such as additional cash and infrastructural incentives.

The city of Birmingham will provide financial incentives of up to $100,000 over ten years in annual payments of $10,000 a year.

The British pharmaceutical maker announced its investment for its first plant in Birmingham in November 2014. The generics facility will span approximately 120,000ft² and will be built over a greenfield site in the Metropolitan Park.

Operations are facilitated initially in Alabama's Innovation Depot until operations are started and staff recruited at the plant by early 2016. It will move to the new facility upon completion of construction.

The rent-free facility from Innovation Depot at the start-up stage and government incentives will aid the company.

Robins & Morton is the general contractor for the project, while NOLA/Van Peursem Architects, a practice based in Huntsville, provided design and architecture services. Sian & Associates, based in Birmingham, provided engineering services.

Oxford Pharmaceuticals is a new venture founded in Oxford, England, that will be based in Birmingham. The company aims to produce, package and conduct research on generic drugs at the Alabama plant. It is determined to produce all varieties of generic drugs and sell them worldwide.

Apart from the rent-free facility through Innovation Depot's Soft Landing Designation, the start-up is also getting life sciences and pharmaceutical consulting support from the University of Alabama at Birmingham.

UC San Diego Health Services, Outpatient Services Pavilion

Rudolph and Sletten recently broke ground on the $78 million Outpatient Services Pavilion on the University of California, San Diego (UCSD) campus in La Jolla, California, designed by CO Architects of Los Angeles. The 145,000-square-foot building will be built on a 3.5-acre site on UCSD’s East Campus. The four-story structure will have one story fully-to-partially below grade with a connection to the adjacent Perlman Ambulatory Care Unit.

Planned to consolidate and centralize outpatient surgical services, the Pavilion will also provide support services for the nearby Jacobs Medical Center. Programs at the newest addition to the UCSD health complex will include ambulatory surgery, outpatient imaging, physical and occupational therapy, rehabilitation, pharmacy, and disease-specific centers for pain, urology, musculoskeletal, breast, apheresis and stem cell treatments. The project is targeting a minimum rating of LEED Silver as well as outperforming energy requirements by 20 percent.

This 239,000-square-foot project will replace a portion of an existing medical facility, increasing the outpatient services available to area residents. The seven-story facility will provide 110,000 square-feet of medical office space, 129,000 square-feet of outpatient and administrative support and an adjacent, four-level parking structure with approximately 390 parking spaces. The project is scheduled to break ground in late spring of 2016 with anticipated completion in late 2017.

Lawrence Berkeley National Laboratory, Integrative Genomics Building (IGB)

Rudolph and Sletten is scheduled to break ground on this 80,000-square-foot laboratory research and office building in the summer of 2016. The IGB will be a state-of-the-art laboratory designed to accommodate 300+ occupants with wet and dry laboratory space, office space for researchers and program managers, a computation center and warm and cold rooms for research.

The project is pursuing LEED Gold certification. The IGB is intended to accommodate two existing Department of Energy research programs currently residing in off-site leased space: The Joint Genome Institute (JGI) in Walnut Creek, California, and the Systems Biology Knowledgebase (KBase) in Emeryville, California. Consolidating existing biosciences research in the IGB will increase resource efficiencies and scientific synergies for the JGI and KBase programs.

Solano Community College – Biotechnology and Science Building

Rudolph and Sletten has partnered with SmithGroupJJR on this design-build academic building scheduled to break ground in early summer of 2016 in Vacaville, California. The 33,310-sqaure-foot single-story Biotechnology & Science Building will have a biotechnology suite consisting of four laboratories with anterooms, prep spaces, cleanrooms and a viewing gallery. This suite will serve Solano Community College in their new Biotechnology Bachelor of Science degree program, and was conceived in conjunction with Solano biotech partner Genentech. Also included are two biology labs with a connecting prep space, an anatomy lab with dry and wet work areas and storage, a chemistry lab with storage and prep spaces, faculty offices and student interactive spaces. The new state-of-the-art building will tie into the existing Vacaville Center Classroom building to promote interaction among the students.

Southwestern College – Math, Science and Engineering Building

Currently underway with preconstruction services, the two-story, 103,000-square-foot academic building will include 21 classrooms and 16 labs for physical science, life science and math and engineering programs, as well as administrative space, faculty offices and meeting rooms. The new facility will provide modern facilities for the MSE disciplines, as well as consolidate departments and classes currently housed in five separate buildings on campus. Rudolph and Sletten is scheduled to begin demolition activities on the estimated $60 million project in the summer of 2016.

Intellia leases New R&D Facility

Intellia Therapeutics, a company developing CRISPR/Cas9-based treatments, has leased 65,000 square feet of space near the Massachusetts Institute of Technology in Cambridge, Massachusetts. The expansion comes as it plans to launch a new division that will focus on research to develop ex vivo therapies such as cell editing.

The long-term lease with BioMed Realty Trust for two floors at 40 Erie Street will quadruple the amount of space the company currently occupies, said Jenn Smoter, an Intellia spokesperson. The bulk of it will be turned into laboratory space.

Currently, Intellia's staff of about 50 employees occupies 15,000 square feet at 130 Brookline Street, also in Cambridge.

Earlier this month, Intellia announced it will create a new division, called eXtellia, to focus on ex vivo therapeutic applications of CRISPR/Cas9 gene editing, while Intellia focuses on in vivo possibilities. The new space will house both Intellia and eXtellia divisions. The new division also means the firm will make new hires.

"We can't confirm the number of people we're hiring, but we're going from 15,000 to 65,000 square feet," Smoter said. "You can make some pretty strong assumptions."

Smoter said the firm plans to move to the new facility in the third quarter of 2016.

In September 2015, Intellia raised $70 million in Series B financing.

Johnson Matthey Expands its R&D and Scale-Up Facilities in Cambridge, UK

Johnson Matthey has completed an expansion of its Cambridge, UK facilities, bringing additional process research & development services and kilo-scale manufacture to the growing site. This investment supports the use of Johnson Matthey’s world-leading catalyst and biocatalyst technology in process R&D and non-GMP production of materials for pre-clinical pharmaceutical and toxicology studies.

The expansion will accommodate teams of chemistry and biocatalysis process R&D scientists who will provide route scouting, process development, optimization and scale-up of heterogeneous, homogeneous and biocatalytic processes, as well as the non-GMP kilo-scale manufacture of APIs and intermediates.

“The completion of this investment follows our recent acquisition of pharmaceutical manufacturing capacity in Annan, Scotland and the Pharmorphix solid form sciences business based in Cambridge, UK,” said John Fowler, Division Director at Johnson Matthey Fine Chemicals. “It further supports our expanding global pharma services offering to enable our customers with the rapid development and sustainable manufacture of pharmaceuticals.”

The expanded facility includes 20 fume cupboards, two new kilo labs with capacity up to 100 L, a 20 L hastelloy pressure vessel (operating to 50 bar) and fermenters for enzyme production.

ISPE Announces Facility of the Year Awards Category Winners for 2016

ISPE FOYA winners were named for categories of operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners in a Feb. 1, 2016 press release. The winners are: Baxter BioPharma Solutions (Operational Excellence), Ethicon, LLC (Sustainability), Genentech (Process Innovation), Janssen Vaccines AG (Project Execution), Pfizer, Inc. (Equipment Innovation), and Takara Bio, Inc. (Facility Integration). FOYA’s panel of judges also awarded Honorable Mentions to Greater Pharma Co., Ltd., University of Strathclyde, and West Pharmaceuticals.

“These facilities epitomize the principles of the FOYA program,” said John Bournas, ISPE President and CEO, in the press release. “ISPE is proud to honor these nine teams for their exemplary projects and outstanding dedication to creating high quality medicines for people around the world.”

Baxter BioPharma Solutions is the winner of the Operational Excellence award for the expansion of its parenteral manufacturing plant in Halle, Germany. The facility demonstrates operational excellence principals and innovative manufacturing concepts with state-of-the-art isolator technology, combined with high flexibility for rapid changeover and broad flexibility to manufacture a wide variety of liquid formulations.

Ethicon, LLC won the Sustainability award for its facility in San Lorenzo, Puerto Rico. The site’s sustainability efforts resulted in energy reduction of 26% (4.4 million kWh), and water reduction of 9% (1.25 million gallons), while increasing production volume by 11%, compared to 2010 consumption levels.

Genentech (a member of the Roche Group) has been named winner of the Process Innovation award for its large-scale Cell Culture Biologics Drug Substance Plant 2 (CCP2). Located in Vacaville, California, this facility revamped an existing CCP2 Facility to support new process technology, which resulted in significant savings in capital ($50M).

Janssen Vaccines AG is the recipient of the Project Execution award for its “Fast Track Refurbishment for Ebola Vaccine Production” project based in Bern, Switzerland. In response to the 2014 Ebola outbreak in West Africa, Janssen committed to accelerating the development of its candidate Ebola vaccine. Through parallel activities in process development, facility design, and construction, the facility was completed for engineering runs by September 2015.

Pfizer is the winner of the Equipment Innovation award for its Portable, Continuous, Miniature and Modular (PCMM) prototype unit for oral solid dosage forms, which transforms raw materials into uncoated tablets in minutes. The equipment fits into a portable facility called a POD that can be shipped to any location to get medicines to patients when and where they are needed. The PCMM model increases project speed, enhances product quality, and reduces project cost and environmental footprint.

Takara Bio has been awarded winner of the Facility Integration award for its Center for Gene and Cell Processing (CGCP) in Shiga, Japan. In order to improve operational and cost efficiencies, Takara housed cell products, viral vectors, and recombinant proteins all within the same facility. To eliminate risk of cross contamination, Takara incorporated well-considered facility and operational containment measures, including a restricted access barrier system (RABS) sterilization process using dry-type vaporized hydrogen peroxide, segregated air-conditioning systems, and full-height partitions to close contamination pathways.

Greater Pharma Co. Ltd. received Honorable Mention for its facility in Bangkok, Thailand. Greater Pharma is the first of its kind to apply western standards to design, build, and operate a pharmaceutical facility for tablets, capsules, sachets, and liquids to produce pharmaceuticals for the local Association of Southeast Asian Nations (ASEAN) market.

University of Strathclyde received Honorable Mention for its Centre for Continuous Manufacturing and Crystallisation (CMAC) in Glasgow, Scotland. The collaboration between industry, academia, and government represents the future of pharmaceutical manufacturing and supply chain R&D framework. The students working with this technology in a collaborative environment will be the pipeline for the pharmaceutical professionals of the future.

West Pharmaceuticals received Honorable Mention for its facility expansion in Kinston, North Carolina. The facility was upgraded to align with industry trends and meet regulatory requirements. West has been recognized for its industry leading efforts to align primary components manufacturing process with current industry trends and standards.

Source: ISPE

REST OF WORLD

Biogen Breaks Ground on Switzerland Plant

Cambridge biotech giant Biogen broke ground this past week on a new, $1.4 billion manufacturing plant in northern Switzerland, said Adam Koppel, vice president of the company’s corporate development and strategy.

Koppel, speaking on a panel at this week’s Harvard Business School Healthcare Conference, said the enormity of this plant investment is reflective of Biogen’s commitment to pursuing its Alzheimer’s disease strategy. The company announced last April it plans to spend $2.5 billion developing drugs for the disease.

News of the Switzerland plant’s development first came out last July, when the price tag was placed $1 billion. Koppel cited a higher figure – $1.4 billion. This $400 million increase comes on the heels of a rough 2015 for Biogen – in which it cut 11 percent of its workforce, or 880 jobs. Its Alzheimer’s route is considered rather risky, a sink or swim program for the biotech.

That said, Biogen is expected to add 400 new jobs when it opens its Switzerland plant. The plant’s aim would be to triple Biogen’s capacity to develop biologics – preparing for future demand of these drugs, the Boston Globe reported at the time.

Outside of this Luterbach, Switzerland plant, Biogen has three others: one in Cambridge, which manufactures its multiple sclerosis and hemophilia drugs, one in North Carolina’s Research Triangle Park, and one in Hillerod, Denmark. Work on the plant is expected to be completed by 2019, according to a Swiss publication.

Porton Biopharma Opens Manufacturing Facility

UK-based Porton Biopharma has opened a new multi-million dollar pharmaceutical manufacturing facility to increase the capacity of its existing production center used for making the cancer drug Erwinase, a drug that is mostly used to treat childhood leukaemia. Based at Porton Down in Wiltshire, UK, the company was commercialized out of Public Health England (PHE) in April 2015.

In addition to Erwinase, Anthrax Vaccine was developed at the Porton Down site as well as other products including Dysport and Voraxase, which have subsequently been out-licensed to other companies.

The site was previously operated by the Health Protection Agency (HPA), which dissolved in 2013 and its functions transferred to PHE, an executive agency of the UK Department of Health. Following this the company says a strategic review concluded that a separate corporate structure would be most appropriate to support the strategic objectives of its pharmaceutical development and manufacturing operations.

As a result, Porton Biopharma was formed, and became operational in April 2015. The company has approximately 250 staff and is co-located with PHE on the same campus.

Selvita to Open New Lab in Poland

Discovery services firm Selvita plans a new laboratory in Poland citing a desired to develop the facility as its “second heart.”

The laboratory will be at the Wielkopolska Centre of Advanced Technologies in Poznan where Selvita has leased a 5,500 sq. ft. unit. The facility, which is due to open this summer, will increase the contract services’ firm’s capacity by 20 percent.

Krakov-headquartered firm said it initially plans to employ 50 chemists and biologist at the laboratory. However, it plans to increase headcount over time and establish the facility as the "second heart of Selvita.”

Board member Dr. Miroslawa Zydron said: “Wielkopolska region has a fantastic scientific potential. We are fully aware that for many talented graduates from local universities, the decision to relocate to Krakow can be very difficult, and for this reason we decided to come to them."

She added that: "Recently we have been recruiting locally in Poznan” explaining that “candidates are being invited to join Selvita for a few months in Krakow, so they can have the opportunity to get to know our company and its organization, before they start working in Poznan."

Selvita said that in addition to offering drug discovery services to customers, the new laboratory will also “actively participating in internal R&D projects.”

The planned expansion is in keeping with the strategy Selvita has followed since completing its initial public offering (IPO) at the end of 2014.

Last year the firm set up two offices in Boston and San Francisco in the US citing proximity to customers as the driver.

Teva UK Sterile Site Upgrading

Up to 80 UK sterile manufacturing jobs could be lost as part of a technical overhaul at a Teva site near Liverpool.

Teva’s Runcorn facility, near Liverpool in the UK, makes sterile products for use in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD), primarily for export to the US.

Denise Bradley a spokesperson for the generic drugmaker told us the site is being assessed as part an ongoing reassessment of it pharmaceutical production network.

“The transformation we are undertaking requires investment in the skills and capabilities of our employees on the Runcorn site, building their technical expertise, and increasing the number of specialist roles in order to support the greater use of technology and automation now required in complex drug process development and manufacture,” she said.

The plans would involve the potential loss of around 80 positions, she continued, though around twenty new specialist roles would be created, “reflecting the overall upskilling of the site.”

She added: “During the consultation period Teva will endeavor to mitigate the number of roles potentially lost and wherever possible to source suitable alternative redeployment opportunities within Teva for colleagues at risk of redundancy.”

Teva has been restructuring since 2013, looking at saving around $2bn annually by 2017. The firm has also been resolute about investing in its complex generics production network and specialist technology platforms.

Among the drugs made at Runcorn, Bradley said, is a Teva “leading medicine for the treatment of multiple sclerosis (MS).”

Teva’s blockbuster specialty MS drug Copaxone (glatiramer acetate injection) lost its exclusivity in 2014 but since then the firm has seen a thrice-weekly reformulation of the product approved by the US FDA.

Austrianova Offers Cell Banking and Fill Finish Services

Austrianova has launched cell banking and fill finish services for cell therapy developers at its facility in Singapore.

The new offering– called GMP4Cells – will include the production of master cell banks and working cell banks for products in Phase I and II clinical trials.

The fill finish offering is also intended to support research rather than commercial supply.

CEO Walter Ginsburg said cell banking is a logical addition to Austrianova’s core cell encapsulation business and suggested the new offering is particularly suited to smaller developers.

“These services should allow start-up companies and academic based cell products, vaccines to enter clinical trials in a quality assured manner but at lower cost than other, more conventional, cell banking companies offer.”

The launch of the new services and expansion of the recently established Singapore facility follows a year after Austrianova set up a GMP manufacturing facility in Bangkok, Thailand for its encapsulation service.

The Bangkok facility was set up in collaboration with Austrianova’s partner Nuvilex, a cancer and diabetes-focused clinical-stage biotechnology company that is now known as PharmaCyte Biotech.

In addition to being the regional base for Austrianova’s cell encapsulation business, the facility is also where cells used by PharmaCyte’s developmental pancreatic cancer treatment are prepared and shipped to trial sites.

The treatment is based on ifosfamide, which is a widely-used chemotherapeutic agent that prevents DNA replication in cancerous cells. The drug‘s therapeutic properties are triggered by a liver enzyme called cytochrome P450 that converts the prodrug into its active form.

Ifosfamide has demonstrated significant efficacy against pancreatic cancer. However, the doses required to achieve this are associated with significant side effects.

PharmaCyte’s focus is reducing these side effects by encapsulate combinations of the Ifosfamide prodrug with liver cells that have been modified to a large number of express cytochrome P450 enzymes.

Expansion of Second Onyx Facility

Onyx Scientific will add a 6,250 sq. ft. facility at its site in North-East England to cope with a surge in demand for its small-scale API services.

The news is the second expansion within twelve months for the small-scale manufacturer and contract research - a subsidiary of India’s Ipca Laboratories - which last year added a new cleanroom at its site near Newcastle, UK.

That investment was driven by a growing demand from clients for Phase I and II trial material, and similarly this latest expansion - providing a 30% increase in capacity – is also due to increased customer demand for its services.

“The new site will actually be used for both manufacturing APIs and carrying out preclinical development work,” said Commercial Director Denise Bowser. “This has been general demand as opposed to one specific project or client.”

She added the site is expected to be online within the next 6-12 months and in terms of equipment, it will be furnished with more of the same equipment already in place at its existing, adjacent facility.

There are no plans for commercial manufacture of APIs from the UK, she said, as Onyx is able to scale-up successful later-stage projects using its parent company’s large scale API manufacturing sites in India.

Bowser also said the investment comes off the back of Onyx’s best financial performance in the company’s 15 year history

“Although we have come to the end of a very positive year, we have never been a firm to rest of our laurels. With the support of our parent company Ipca Laboratories, we are very much investing in our physical capacity, equipment and technical resource.”

She did not disclose further financial details when asked, but according to Ipca’s accounts , Onyx brought in sales of 34.4m INR ($507,000) for the twelve months ending March 31 2015, nearly a 500 percent increase from the previous year.

Clariant’s Healthcare Packaging Plant, Cuddalore, Tamil Nadu, India

Clariant, a leading specialty chemical company, broke ground for building its new manufacturing and healthcare packaging plant in Tamil Nadu, India, on 20 January 2016. The facility is being built in Kudikadu region of the SPICOT industrial complex in the Cuddalore district.

The company is investing approximately Sfr10m ($9.85m) through its wholly owned Indian subsidiary for the construction of the new packaging plant. Completion and inauguration of the plant is expected in 2017.

The new plant will be built with state-of-the-art global healthcare manufacturing infrastructure that will be compliant with all cGMP and US FDA standards. It will support the production of Clariant's market-leading moisture control products and high-quality desiccants, by expanding the current capacities and providing ready access to the customers in the pharmaceutical packaging segment in India.

It will initially manufacture desiccant canisters and packets, which will be inserted into pharmaceutical packaging to control moisture levels and maintain the stability of the medicine during its shelf period. The production area will be compliant with Cleanroom Class 100,000 and certified ISO 8.

The new manufacturing and packaging plant will serve globally active, generic and branded pharmaceutical companies, as well as the Indian domestic pharmaceutical market. Once operational, it will procure Clariant's global-standard products directly produced in India for the customers.

The facility will enhance Clariant's medical specialty business and provide end-to-end solutions to the customers.

Clariant's new greenfield plant in Cuddalore along with its ten production sites in Gujarat, Maharashtra, Madhya Pradesh and Tamil Nadu, as well as its regional innovation center in Mumbai are part of its growth strategy in India.

Clariant is a specialty chemicals manufacturing company based in Switzerland. It is the biggest producer of pigments, and textile and leather chemicals in India.

Clariant Healthcare Packaging is a member of Clariant's Masterbatches business unit, which manufactures controlled atmosphere packaging solutions such as pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers.

It employs both active and passive packaging technologies, and offers an array of standard components and complete systems. It manufactures and markets textiles, leather, paints, plastic, printing inks and agrochemical products.

Chugai Antibody Active Pharmaceutical Ingredients (API) Manufacturing Plant, Ukima, Japan

The new plant is being constructed at the existing Ukima Plant located in Kita city near Tokyo.

Chugai Pharmaceutical announced its decision to construct a new plant for manufacturing antibody active pharmaceutical ingredients (APIs) at the existing Ukima Plant located in Kita-ku, Tokyo, Japan, in October 2015.

The plant will enable high-mix low-volume production of antibody APIs for investigational drugs in late-stage clinical studies to initial commercial products.

Its construction began in January 2016 and is scheduled to be completed by December 2017, while operations are expected to commence by June 2019.

Reactors are expected to be installed by July 2018. Demolition of old facilities at the existing Ukima plant is currently underway.

The new API facility will be situated on a 23,636m² (5.84 acre) site and will have a built up area of 43,750 sq. ft. (4,066m²). Combined floor space of the old and new facilities will be 492,792 sq. ft. (45,780m²), on completion of the project.

The manufacturing plant will produce antibody APIs, injection products and investigational drugs for clinical studies. It will expand Chugai's capability to meet demand for initial commercial products in the future.

It is also expected to support Chugai's plans to obtain global top-class competitiveness by minimizing the time required from the development to launch a new drug by introducing simultaneous development of multiple drug candidates.

The new plant will be installed with six 6,000l capacity bioreactor tanks.

It will enhance the total capacity of the site to 49,000l bioreactor tanks together with the existing Ukima plant, which has two 2,500l capacity bioreactor tanks used for antibody API production and four 2,000l capacity bioreactor tanks used for the production of antibody APIs for investigational drugs.

"The plant will enable high-mix low-volume production of antibody APIs for investigational drugs in late-stage clinical studies to initial commercial products."

Total investment for the construction of the new plant is estimated to be ¥37.2bn ($310m). Chugai invested ¥2.9bn ($25m) at the Ukima plant to double its antibody drug production capacity.

Kajima Corporation is in charge of general construction of the project, while Hitachi is responsible for the manufacturing facilities.

Chugai Pharmaceutical is a subsidiary drug manufacturer headquartered at Tokyo, Japan and is controlled by Roche Holding. The company is engaged in biopharmaceutical and molecular-targeted drug discovery to create innovative drugs.

It also manufactures and commercializes pharmaceutical products in Japan and internationally.

The company develops product candidates in the areas of oncology, bone and joint diseases, autoimmune diseases, central nervous system, and other diseases. Its oncology product portfolio includes Avastin, Herceptin, Rituxan, Xeloda, Tarceva, Neutrogin, Perjeta, Kadcyla, and Alecensa.

Joint disease products produced by the company include Actemra, Suvenyl, Edirol, Alfarol, and Bonviva, while renal disease products include Mircera, Oxarol and Epogin.

Origin is the First Pharmaceutical Packaging Company with UK Distribution Site Certification

Origin Packaging has received confirmation that the ISO Board of Certification approved Origin's ISO 15378 certification.

The ISO: 15378 standards are specifically for suppliers of pharmaceutical primary packaging. Origin's Pharmaceutical Packaging, Distribution and Innovation Centre and team was subjected to a comprehensive auditing process involving a multiple day inspection.

This included evaluating GMP trained operators, the supplier approval process, change controls, quality assessments and release.

Origin invested substantially to achieve this pharmaceutical recognized standard, and identifies with GMP principles and specifies requirements for a quality managed supply chain applicable to primary packaging materials for medicinal products.

This is a key achievement for Origin as it is consistent with the commitment to 'bring healing home' and underpins their clients' own mission.

Origin managing director Keith Wade said: "Achieving the ISO 15378 certification further differentiates Origin Pharma Packaging and reinforces our position of leading Hybrid Packaging Partner.

"From design through to supply of primary packaging in the pharmaceutical industry, we continue to strengthen our processes to ensure they match pharmaceutical standards.

Origin Packaging is an expert in supply chain management and new product development (leading in child safety) for the pharmaceutical primary packaging market. Origin is based in Melton, UK, and works strategically across Europe with major license holders and contract manufacturing organizations.

Japan’s PuRec to Supply Stem Cells

Regenerative medicine developers now have a new supplier for mesenchymal stem cells (MSCs), the multipotent stromal cells derived from marrow and other tissues like muscle and dental pulp for tissue repair.

The company, called PuRec, is located in Shimane University in Japan’s Shimane prefecture.

Jointly funded with JPY80m ($662,700) by the local San-in Godo Bank, the Gogin Capital and the local investment arm of Regional Economy Vitalization Corporation of Japan, PuRec will manufacture and sell ultra-high-purity MSCs, or rapidly expanding cells (RECs), to global pharmaceutical companies and research institutes for basic research and clinical studies.

Developed by Professor Yumi Matsuzaki of Shimane University Faculty of Medicine, RECs are “1000 times more effective” than the average MSCs in terms of proliferation and differentiation potential, according to Shimane University.

“Our RECs are ideally for developing treatments for osteogenesis imperfecta caused by hypophosphatasia, graft vs host disease and neonatal chronic lung disease,” said Prof Matsuzaki, now also director at PuRec,.

She said the REC manufacturing facility is currently under construction, and will start operation after April, but REC samples are available upon request.

Shimane University is experienced in MSCs clinical studies, during which its researchers successfully formed bones for a child with achondroplasia.

MSCs –related research has been popular among Japanese pharmaceuticals and academic institutes. In December, Osaka-based two pharma companies - Dainippon Sumitomo Pharma and the regenerative therapy provider Sanbio - announced their joint project SB623, an allogenic cell therapy for ischemic stroke to improve motor abilities, started to recruit volunteers for Phase IIb studies in the US. SB623 uses MSCs derived from bone marrow fluid of healthy individuals.

In July, Hyogo prefecture-based JCR Pharmaceuticals, a biotech company that

develops bio therapies for rare diseases like lysosomal shortage diseases, announced its joint research with Nippon Medical School proved that MSCs could improve Duchenne muscular dystrophy symptoms.

Expansion of Second Onyx Facility

Onyx Scientific will add a 6250sq ft. facility at its site in North-East England to cope with a surge in demand for its small-scale API services.

“The new site will actually be used for both manufacturing APIs and carrying out preclinical development work,” said Commercial Director Denise Bowse. “This has been general demand as opposed to one specific project or client.”

Bowser also said the investment comes off the back of Onyx’s best financial performance in the company’s 15 year history

Domainex and Cresset Team to Offer Services

Domainex and Cresset have partnered to offer small molecule drug discovery services that combine their respective strengths in chemistry in biology.

The accord – financial terms of which were not disclosed – will focus on the provision of laboratory-based and computational drug discovery services.

Domainex will provide is protein expression, biochemical assay, computational and medicinal chemistry capabilities to the partnership.

Fellow Cambridge, UK based Cresset will focus on the provision of computational hit identification and drug design services.

Domainex CEO Eddy Littler said the enlarged offering provided by the partnership would be of benefit to pharmaceutical industry customers, particularly those with discovery projects requiring chemistry and biology expertise. He said: “Together we can offer customers an unrivalled capability to identify novel hit compounds against important drug targets, and to progress these all the way to candidate drugs.

Littler said Cresset’s “field point technology and associated ligand-based approaches to targets such as GPCRs and ion-channels” dovetail with his firm’s enzyme and protein expertise.

Cresset CEO Rob Scoffin was similarly enthusiastic about the partnership. He suggested that together the firms “offer unrivalled capabilities in drug discovery and development.

“We are able to provide integrated services which will include access to Cresset’s existing applications as well as our pipeline of cutting edge computational science and yet-to-be-commercialized methods.”

Formation of the partnership follows shortly after Domainex announced it would relocate its laboratory to a larger facility at Chesterford Research Park in Saffron Walden in Essex.

Domainex has been at the Cambridge laboratory since 2011 when it last relocated in response to growing customer demand for its discovery services.

Cresset moved to its current headquarters in Litlington, Cambridge in 2013. At the time Scoffin said the firm was seeing increased demand for library design services, both from sponsors that have shed in-house capacity and CROs that lack the specialist expertise to carry out such work.

He said: “With many drug discovery companies having restructured their R&D groups the ability for them to outsource library design, ligand based virtual screening and patent analysis is a vital element in their R&D pipelines, but accessed as a cost effective external resource.”

ShangPharma’s Manufacturing and Pre-Clinical Research Facility, Shanghai, China

ShangPharma’s new biologics manufacturing and pre-clinical research facility will be located in the Qidong Biopharma Industrial Zone.

ShangPharma, a leading outsourcing partner in pharmaceutical and biotechnology research and development based in China, signed a deal with Qidong Biopharma Industrial Zone to build a biologics manufacturing and pre-clinical research facility in the Qidong Biopharma Industrial Zone, China.

It will be the first tenant for the biopharma zone in Qidong.

ShangPharma comprises a family of companies, which include China Gateway Biologics, China Gateway Pharmaceutical Development, ChemPartner, ShangPharma Technology and ShangPharma Investment.

The company will invest $60m in the project through a new subsidiary that will be established to provide and develop cutting-edge science and technology aimed at expanding its biologics service portfolio.

China Gateway Biologics, the contract manufacturing wing of ShangPharma, will operate the manufacturing facility, while the pre-clinical research facility will be operated by ChemPartner, ShangPharma's contract research wing.

The manufacturing and research facility is expected to be operational in early 2018. It aims to develop Qidong as China's bio-technology hub and ShangPharma t grow as a distinguished outsourcing and biopharmaceutical service provider.

The facility is being built in the Qidong Biopharma Industrial Zone in Lianyungang, Jiangsu Province.

The project is being jointly financed by ShangPharma and the Qidong Biopharma Industrial Zone.

ShangPharma's manufacturing and pre-clinical research plant details:

"The manufacturing and research facility is expected to be operational in early 2018."

The plant is aiming for high commercial-scale operations with an international focus and overall biopharmaceutical development of ShangPharma.

The facility will be equipped with a 500l single mammalian cell culture unit for clinical phase supply to be handled by ChemPartner and two 2,000l units for commercial manufacturing to be handled by China Gateway Biologics.

The clinical supply and manufacturing units will be complemented with fill and finish capabilities of an appropriate scale.

The investment is expected to grow China Gateway Biologics' biopharmaceutical services by transforming it into a full biopharmaceutical service provider, from pre-clinical development to commercial-scale. ChemPartner will be able to expand its clinical research abilities through the investment.

The state-of-the-art plant will comply with Western standards in order to support and meet expectations of international clients.

ShangPharma has established extensive research and development (R&D) partnerships within the healthcare industry and with organizations.

ShangPharma provides customized services to international pharmaceutical, biotech, agrochemical, chemical, biology, biologics, and pre-clinical development.

It also provides high-quality, cost-effective, integrated services in drug discovery and development processes to help international and Chinese pharmaceutical companies efficiently discover and develop drugs.

China Gateway Biologics provides biologics manufacturing services for the biopharmaceutical industry for Chinese and international customers.

ChemPartner is a contract research organization serving the pharmaceutical and biotechnology industry. It provides integrated services across drug discovery and development, including discovery biologics, chemistry and biology, as well as pre-clinical development.

Samsung BioLogics’ Third Manufacturing Facility, Songdo, South Korea

Samsung BioLogics, a leader in manufacturing biopharmaceutical products, broke ground for the construction of its third plant in Songdo, South Korea, on 21 December 2015.

The company will invest KRW850bn ($721m) to build the world's biggest biopharmaceutical manufacturing facility in Songdo.

Construction on the facility is expected to be completed by 2017 and operations are scheduled to start in the fourth quarter of 2018 after receiving validation.

The establishment and operation of the new plant is expected to make the Samsung Group the world's biggest biologics contract manufacturing operator (CMO).

The facility is being built in the Incheon Free Economic Zone (IFEZ), which comprises three regions namely Songdo, Cheongna, and the island of Yeongjong. The country's west coast originates at IFEZ and serves as a gateway to Seoul and a metropolitan area of central Korea.

The new plant is designed to have an annual production capacity of approximately 180,000l, which will increase Samsung BioLogics' total production capacity to 360,000l a year when fully operational.

Annual sales and operating profits are expected to reach KRW2tn and KWR1tn respectively after full completion of the plant.

The new facility will supply biopharmaceutical products to meet growing manufacturing demands from global pharmaceutical companies. It will operate throughout the year and offer services to clients, including small-scale batches for clinical trials to supplying large-scale batches for commercial production.

The number of pharmaceutical products the company will produce is estimated to be 350 by 2020.

Samsung BioLogics has two large-scale facilities located in Incheon, which offer a wide range of solutions in biologics development and manufacturing.

Samsung BioLogics is a contract manufacturing operator that produces biopharmaceutical products for established brands such as Bristol-Myers Squibb and Roche. It was established by Samsung Electronics, Samsung Everland, Samsung C&T, and Quintiles Transnational.

The company entered a ten-year contract with Bristol-Myers Squibb for manufacturing a commercial antibody cancer drug at its new plant.

Samsung BioLogics already has two plants in the Incheon zone. The first plant received production approval from the US Food and Drug Administration (FDA), while the second plant is expected to begin operations in early 2016.

Samsung BioLogics aims to increase the global pharmaceutical capability through its fully integrated production facility that offers process development, drug substance manufacturing and fill and finish services at a single location.

Samsung's first plant accommodates six stainless steel bioreactors with an upstream capacity of 5,000l each and a total capacity of 30,000l. It is designed and built to carry rapid high protein production.

It contains suites for upstream, downstream, fill and finish units, and also has an administration building, as well as a warehouse including long-term cold storage capacity.

The second plant contains ten bioreactors with an upstream capacity of 15,000l each and a total capacity of 150,000l.

Services such as cell line generation, process and analytical method development and analytical services are offered at Samsung's facilities.

Other services include clinical and commercial bulk cGMP manufacturing of drug substances and drug products with quality assurance, quality control, regulatory compliance standards and support for customers.

Vetter Completes Schuetzenstrasse Facility

Vetter has completed construction of its 91,500 sq.-ft. Schuetzenstrasse multi-functional building. The €29 million investment is part of a €300 million investment strategy for further development of its manufacturing sites and additional manufacturing capacities. The Schuetzenstrasse building will support drug development and provide enhanced IT systems to meet future customer and regulatory requirements.

The facility contains non-cGMP labs for development support, lab space for microbiological analysis, office space for Vetter Development Service and IT as well as its data processing center with enhanced security systems, including a safety cell that protects technology and data from external physical hazards in the event of an emergency.

"With the installation of these future-oriented IT systems, we are early-on addressing the need for increased connectivity between customers and their manufacturing partners, like Vetter, to efficiently share and store data without concern for its safety,” said Oliver Albrecht, a Vetter managing director. “The new building is further evidence that Vetter is well-prepared to meet present and future industry challenges and requirements."

Vetter supports many leading pharmaceutical and biotech companies from development through to manufacturing and final packaging of their drug products.

Continued demand by its large and small customers for enhanced drug development services, as well as future-oriented sophisticated IT systems to protect data, created the need for the 8,500sqm (91,460 sq. ft.) six-story building.

It contains non-cGMP laboratories for development support, laboratory space for microbiological analysis and office workplaces for Vetter Development Service and IT.

In addition, it includes a data processing center with enhanced security systems, including a safety cell that protects technology and data from external physical hazards in the event of an emergency.

AstraZeneca to Replace Warehouse and Packaging Unit at UK Plant

AstraZeneca has invested £75m ($114m) to build packaging and warehouse facilities at its manufacturing site in Macclesfield, UK.

According to AstraZeneca spokesman Andrew Higgins, the site in Macclesfield – about 20km south of Manchester – is the largest pharma production facility in the UK and the second biggest in the Anglo-Swedish firm’s global network.

While the site has been subject to major job cuts in the past, Higgins said this investment is testament to AstraZeneca’s commitment to the facility which - with the construction of a new sterile manufacturing unit - puts the recent investment total close to £200m.

“We are constructing a new packaging unit, comprising of a hi-tech packing lines for tablets and capsules, and an automated warehouse facility on the site, as the old one needs replacing,” he said.

Higgins added the project was complex and would take until 2019 as the firm is ensuring there will be no disruptions to supply.

The project will create around 150 construction jobs, but once complete AstraZeneca's total headcount will not increase, he added.

The site makes a number of products in AstraZeneca’s small molecule portfolio, including the blockbuster drug Zoladex (goserelin) delivered by a subcutaneous injection of a solid state deposit that dissolves in the body over three months in patients with prostate cancer.

Despite the expiration of a number of the drug’s key patents, there are no generic versions and it still clocks in close to $1bn of sales yearly.

This is partly due to the complexity of the manufacturing process, according to Higgins, who further added “the unique production method would be very difficult to relocate [from Macclesfield].”

Such complexity has also been cited as a reason why the firm would never look to outsource production of the drug.

BeiGene Adopts GE Tech for China Biologics Plant

Nasdaq-bound Chinese biopharma BeiGene has chosen GE Healthcare’s Flexfactory platform for the monoclonal antibody (mAb) plant it is building in Suzhou.

The Beijing-headquartered cancer drug firm said the GE system will “significantly reduce the build-up and commissioning time and help to increase the speed to global markets, including the United States, Europe and China.”

BeiGene started building the facility in August after securing a plot at the Suzhou Industrial Park an hour outside Shanghai.

At the time the firm said the facility will support both clinical trials and commercial production of its candidate cancer biologics when operational in 2017.

BeiGene's most advanced candidate is BGB-283 - an RAF dimer inhibitor of solid tumors – that entered a Phase I trial in October after showing promise in preclinical studies conducted by Wuxi AppTec and Joinn Laboratories.

BeiGene has also announced its intention to go public and list on the NASDAQ in the US.

BeiGene will use the Flexfactory system to culture cell lines developed using a platform licensed from SAFC, the custom manufacturing business of recent Merck acquisition Sigma Aldrich.

That deal – signed in March – granted BeiGene rights to develop monoclonal antibody (mAb) production cell lines using SAFC’s CHOZN platform.

The platform combines zinc finger nuclease (ZFN) gene editing and the glutamine synthetase CHO cell line that SAFC launched in 2011.

Speed was also a driver for the SAFC deal according to BeiGene’s biologics head Kang Li.

He said at the time “our objective in selecting SAFC’s CHOZN Platform and services was to shorten bioproduction times in early development and to obtain a manufacturing clone quickly with the highest protein quality specifications.”

GE Healthcare acquired the FlexFactory system when it bought Xcellerex in 2012. Since then the General Electric division has sold the system to various drugmakers – including Patheon acquisition Gallus and China-based manufacturer JHL Biotech – and more recently Nanotherapeutics.

The firm welcomed BeiGene’s comments about set-up speed, telling us "the typical time to complete the installation of a FlexFactory is nine months. This includes a planning and design phase, construction and installation, and then validation. The key to compressing the timeline is working in parallel where possible. For example, the customer's initial acceptance testing of the single-use technologies that make up the FlexFactory begins at GE's sites in Marlborough and Uppsala, prior shipping to their own facility."

"The FlexFactory platform, which is comprised predominantly of single-use technologies, will incorporate a 500 L scale single-use bioreactor, the Xcellerex XDR 500, to meet BeiGene's pilot scale requirements. The platform comprises distinct unit operations connected via single-use tubing sets and is controlled by a centralized automation system."

Cambridge University Containment Project

Medical Air Technology (MAT) has recently completed work at the University of Cambridge’s new Department of Chemical Engineering and Biotechnology building, situated in the university’s science and engineering hub in Cambridge, UK.

The new building is the first of its kind to house the whole cycle of scientific investigation in chemical engineering and biotechnology, and its teaching and commercialization, under one roof, from fundamental research through to technology innovation, development and spin out. MAT was brought in to replace the initial sub-contractor when work failed to progress as hoped, and was able to pick up the project part way through, interpreting existing designs and bringing its own new ideas, expertise and supply chain to the project to ensure that it was completed successfully.

MAT installed a containment level 3 laboratory, a Faraday cage or 'shield room' (used to block electric fields), and laboratory cleanrooms in the new building, all of which will help the department as it works to fulfil its vision to develop innovative solutions to a range of global challenges, from finding new ways to create sustainable energies and conserve the environment, to developing innovative healthcare technologies to diagnose and combat disease.

Clariant Breaks Ground on New Packaging Plant in India

Clariant performed the groundbreaking ceremony of a new manufacturing plant in Cuddalore, for moisture-control products, intended for the pharma industry. In December 2015, Clariant had announced plans to invest CHF 10 million in this Healthcare Packaging plant, which will support the growing generic pharmaceutical industry in India. The investment will be implemented through its wholly owned subsidiary in India.  

“The new Healthcare Packaging manufacturing plant here in Cuddalore is another important step within our strategy to intensify growth and increase our market share in the emerging India region by rapidly addressing customer needs,” said Christian Kohlpaintner, member of the Clariant Executive Committee.

The new plant will initially produce desiccant canisters and packets, which are inserted into pharmaceutical packaging to control moisture and protect the stability of the medicine during shelf life. The desiccant production area will be Cleanroom Class 100,000 and certified ISO 8. It will be compliant with all relevant cGMP and US FDA standards.  

“With this new plant, we are responding to our customers’ growing demand for high-quality desiccants. This facility will enable us to expand current capacities and provide easy access to potential as well as existing customers in the pharma packaging segment in the India region,” said Deepak Parikh, Clariant Region President India.

With ten production sites in Gujarat, Maharashtra, Madhya Pradesh and Tamil Nadu and a state-of-the-art Regional Innovation Center in Mumbai, Clariant’s new greenfield plant in Cuddalore will further reinforce its commitment to Make in India and Sell in India. The plant is slated for inauguration in 2017.

SHL Group Announces Groundbreaking Ceremony of New Site

With rapid growth of SHL Group and new innovations and technologies developed for pen and auto injectors, the Taoyuan facility requires expansion, and will be relocating to a the new site in Nankan, Taoyuan.

Construction started in the fourth quarter of 2015 and the building is expected to be completed by the fourth quarter of 2017.

In the first quarter of 2018, all administrative offices and parts of production will be relocated to the new site.

The ground level has 132,875 sq. ft. (12,349m2) area of space, on which a seven-story high office and manufacturing building with 673,608 sq. ft.(62,603m2) total floor space is to be built on.

The new facility will help SHL Group increase production capacity, improve efficiency and raise overall manufacturing quality. This step will open new opportunities for implementing the latest manufacturing technologies.

According to a recent industry report, the auto injector market will reach $2.5 billion globally in 2020.

Auto injectors have emerged as one of the fastest growing drug delivery solutions, driven by factors such as auto injectors' ease of self-administration, allowance for at-home drug administration and decreased hospital visits (reducing the cost of healthcare).

Samuelsson said: "Customer needs has always been one of the top priorities of SHL Group.

"Every strategy that we make, we hope to exceed customer expectations.

"To meet the needs of a growing market for pen and auto injectors, we must constantly invest in more advanced equipment and expand our production capacity."

B. Braun seeks World Bank Loan for Indonesia Parenterals Plant

B. Braun has asked the World Bank for a €55m loan to support construction of a parenteral drug manufacturing facility it is building in Indonesia.

The loan – disclosed by the World Bank in December – is being sought to fund construction of the plant in Kota Bukit Indah, Indonesia.

A spokesman for B.Braun told us “we can confirm that we sought a loan from the World Bank for our Indonesia production plant project.”

The facility – construction of which began in May – will make sterile parenteral drug preparations. The project is expected to be completed next June.

According to a plan posted on the World Bank’s website the plant will feature production areas, warehousing space, offices, a chiller and cooling tower, a flammable and toxic building, a high pressure boiler, a domestic and fire water tank, bus shelter and car park.

The bank said that manufacturing operations will focus on production and packaging of parenteral preparations adding that the products will “supply the Indonesian market but may also be exported.”

B. Braun generated revenue of €840m ($916m) from the Asia-Pacific region in 2014, primarily from the sale of products made at its manufacturing facilities in Europe and in China, India, Japan, Malaysia and Vietnam.

The German firm’s total revenue last year was €5.4bn.

Waters to Open Analytical Lab in UK

Former AstraZeneca R&D site in Alderly Park, Cheshire, is now home to over 1,076,000 sq. ft. (100,000 sq. m.) of scientific laboratory space.

Waters Corporation will offer an open access analytical laboratory and technology support to biotechs based at a former AstraZeneca site in the UK.

Alderly Park, near Manchester, UK, was sold off by AstraZeneca to Machester Science Parks – a public-private partnership – in 2014 , and analytical equipment and technology firm Waters announced it has struck an agreement to launch an open access analytical laboratory there.

“This laboratory is a dedicated Open Access Laboratory, for the benefit of all companies located in the BioHub at Alderley Park [known as BioCity],” said company spokesman Chris Orlando.

“Scientists on the site will gain access to cutting edge Waters capabilities through the Open Access facility which will be managed and run by BioCity, on a fee-for-sample/time/service basis. Support on the use of the facility, and the technology available, will be provided by an experienced laboratory manager.”

The firm already has its mass spectrometry headquarters and demonstration laboratory in nearby Wilmslow, but this new facility will focus on providing “cost-effective access to the kinds of cutting edge analytical technologies which underpin modern life and health sciences research,” he continued.

“Many, if not all, the companies at BioHub are engaged in cutting edge, and diverse, research and development. Close engagement with companies using the facility will give Waters a deeper insight into their needs and challenges.”

The firm’s Ultra Performance Liquid Chromatography (UPLC) systems, mass spectrometry (MS) and informatics technologies will be available at the new laboratory when it opens early this year, as will a nuclear magnetic resonance (NMR) system provided by Manchester Science Partnerships.

Johnson Matthey Expands its R&D and Scale-Up Facilities in
Cambridge, UK

Brings additional process research & development services and kilo-scale manufacture to the growing site.

The expanded facility includes 20 fume cupboards, two new kilo labs with capacity up to 100 L, a 20 L hastelloy pressure vessel (operating to 50 bar) and fermenters for enzyme production.

SAIDAL Cleanroom in Algeria

Astra was selected to provide specialist cleanroom lighting to the new SAIDAL pharmaceutical manufacturing facility in Algeria.

Working closely with the consultant, cleanroom construction contractor and the ceiling panel manufacture, Astra delivered almost 1,000 luminaires from their EVEREST range to this project.

The EVEREST range of luminaires has been specifically developed for large export projects, engineered to provide excellent value together with plug & play wiring connections to simplify the electrical installation on site. Designed to integrate seamlessly into composite panel ceilings, the luminaires can be pre-installed into the ceiling panels to reduce the need for work at heights and accelerate the construction process.

Pod Bays at the Royal Stoke University Hospital

The Royal Stoke University Hospital in the UK is the first NHS hospital to have a bay fully fitted with Bioquell Pods. The hospital’s Elderly Care Unit has increased its single occupancy room capacity following the introduction of the four Bioquell Pods; installed in one of the unit’s bays, this technology will alleviate bed-blocking and increase patient flow through the ward.

For the nursing staff at Royal Stoke, the Pods give the option to quickly isolate patients suspected of having an infection. This rapid action can significantly prevent outbreaks such as norovirus or C. difficile from spreading. They also provide the teams with optimal visibility for better care due to the large clear panel windows.

The new Pods have been shown to be capable of being fully bio-decontaminated in under 50 minutes. This is helping to improve the time between the patient’s discharge and the safe admission of the next patient, given the ‘deep clean’ that has taken place, and avoids the need to empty the whole ward. The Royal Stoke University Hospital is also the first to have Pods commissioned with Bioquell’s latest hydrogen peroxide vapor (HPV) bio-decontamination technology, the BQ-50, which is proven to kill 99.9999% of pathogens.

The lack of single occupancy rooms in hospitals around the UK leads to disruption and financial losses. An infected patient, who cannot be isolated, will often initiate a series of disruptive events within a bay. Outbreaks, bed-blocking, ward-closure, longer hospital stays and extra expenses are all potential consequences of the open-bay structure that characterizes many NHS hospitals.’

Wuxi AppTec to Invest in Antibody Discovery and Development Lab

Newly private WuXi AppTec has announced plans to invest $120m in a biopharmaceutical development laboratory and clinical-scale manufacturing facility in Shanghai, China.

The facility – which is due to be operational in 2017 – will provide discovery, development and clinical trial supply manufacturing services.

Early development services available at the site will utilize the antibody generation OmniRat platform – which Wuxi accessed in 2012 in a deal with Open Monoclonal Technology – and phage display libraries developed by the Chinese contract research organization (CRO).

Manufacturing operations at the new facility will use a proprietary Chinese Hamster Ovary (CHO) cell line. The site will house three 2,000L fed batch bioreactors and two 500L perfusion reactors.

Wuxi said that when operational the facility will employ 800 staff.

A spokesman said "The decision to build the lab was driven by strong past, present, and expected future demand for WuXi’s integrated platform of biologics services" adding that "WuXi’s biologics services are and will be offered to both international and Chinese companies."

The facility is the second Wuxi has announced in less than a year.

In May 2015, the CRO's subsidiary Wuxi Biologics started work on a biopharmaceutical manufacturing site.

The facility - in Wuxi city - will "be the largest mammalian cell culture manufacturing facility using disposable bioreactors in the world" according Wuxi, which expects it to be fully operation in 2017.

News of the Shanghai laboratory investment also comes just weeks after Wuxi AppTec completed a $3.3bn (€3.04bn) transaction to leave the New York Stock Exchange (NYSE) and became a private company.

Whether ongoing volatility in the Chinese markets makes a relisting more or less likely remains to be seen.

Aesica Opens New Development Center

Aesica Pharmaceuticals has relocated its development and clinical manufacturing services from Nottingham to Queenborough in the UK. As a consequence, Aesica now intends to provide full manufacturing and development services at its Queenborough site with the addition of a new development center.

From Queenborough, the company now provides API production, formulation development, clinical manufacture through to commercial scale product manufacturing. The new development center will provide development of solid and liquid dosage forms, including the ability to manufacture clinical drug product for Phase I to Phase III studies.

As the new center sits on a commercial site, the technical transfer from development to commercial will be a smooth transition for the customer, according to the company.

The development center will be able to handle potent and controlled drugs, which mirror the commercial offering from Queenborough. Aesica will also still offer semi-solid development. In addition, inhalation services will continue apace with access to technology and knowhow, including metered dose inhalers (MDI), dry powder inhalers being provided by Bespak within the Consort Medical Group.

The new development center at Queenborough has more than twice the capacity of the existing one in Nottingham and as a result provides significant scope for further business expansion.

“The move to establish this development center at Queenborough, with such a fully aligned and comprehensive set of services, forms part of our longer term strategy to meet the future needs of the market and represents a logical evolution for our company,” said Ian Muir, managing director, Aesica Pharmaceuticals. “Indeed, it will serve to further enhance our provision of high quality services to our customers in both formulation and drug device development.

Mr. Muir said the tech transfer component to this is especially important as it is central to ensuring the efficient and seamless transfer of a product from clinical development into the commercial manufacturing arena. “We now have a center of excellence for API manufacturing, early to late stage clinical development right the way through to commercial scale production,” said Mr. Muir. “This means that we offer the market a complete end-to-end service from a single development location—catering for the full manufacturing and development requirements of a wide range of customers, including of course, today’s virtual pharmaceutical companies.”

Catalent Expands Clinical Trials Hub in Singapore

Catalent Pharma Solutions has announced that it will invest $4.6M to further expand its Singapore clinical supply facility by building new flexible GMP space for secondary packaging, doubling its ambient storage space, and quadrupling cold storage capacity. The continued expansion of the site will support global and regional customers’ growth in clinical trials activity in the Asia–Pacific region.

Established in 1998, Catalent’s Singapore site now provides full clinical supply services including project and supply chain management, comparator sourcing, clinical label printing, secondary packaging, clinical storage, import/export management, Importer of Record (IoR) service, and full returns and destruction management services. It has served as a key regional hub for studies in Australia, Singapore, Korea, Hong Kong and other countries in Southeast Asia.

“Our Singapore facility is fully approved by the Health Science Authority for GMP across all its activities,” commented Wetteny Joseph, Catalent’s President of Clinical Supply Services. “Customer demand at the site has increased by 30% over last year, and this expansion, coupled with our recently announced opening of a facility in Japan, will allow Catalent to better support multinational customers’ growing trial’s needs, while providing more flexible solutions for local customers in the region.”

Catalent Bringing Clinical Supply Services to Japanese facility

Catalent will expand its cGMP facility in Japan to bring secondary packaging and clinical supply services to the region.

The 200,000 sq. ft. cGMP facility in Kakegawa, Japan has been operating for over 40 years, providing a range of manufacturing services.

Now Catalent intends to offer local and regional customers clinical supply services direct from the site.

“We previously performed any necessary packaging work at a Catalent facility outside of the region and then imported the finished goods into an in-country depot for distribution to our customers' clinical sites within Japan,” said Amy Lombardi, Group Product Manager, Catalent Clinical Supply Services.

“Having a facility in Japan that offers secondary packaging, along with clinical storage and distribution services, offers our customers greater flexibility and improves supply chain efficiency.”

The site will form part of the New Jersey, U.S.-headquartered firm’s Asian-Pacific clinical supply network, which includes a full service clinical packaging facility in Shanghai, cold-chain and secondary packaging and clinical storage facility in Singapore.

“This investment boosts a critical part of our business capabilities in Asia-Pacific by adding the ability to support global and local pharma companies' clinical trial needs from Japan,” Lombardi continued.

“It will provide local capabilities, with dedicated local resources and expertise, to better serve multinational customers' Japanese studies and Japanese pharma's global studies, in addition to domestic only studies.”

Lombardi did not divulge financial details or whether the expansion would create any new jobs.

The announcement is the latest in a line of recent investments in Japan by the contract development and manufacturing organization (CDMO).

In 2014, Catalent announced it was opening an oral formulation development lab and expanding its OptiGel micro softgel manufacturing capacity at the Kakegawa site.

The firm has also been forging a number of biologics R&D partnerships in the region, including an agreement with the Center for iPS (induced pluripotent stem) Cell Research and Application (CiRA) at Kyoto University and teamed up with Mitsubishi Gas Chemical Company to make cell lines for the region.

Novozymes Spins off Biopharma Business into Albumedix

Danish enzyme maker Novozymes has spun out its biopharma activities into a new independent company called Albumedix.

Albumedix is 100% owned by Novozymes and will continue to focus on technologies and products based on recombinant albumin, a naturally occurring protein that can be found in human blood.

The recombinant albumins products, under Recombumin brand, are used in the pharmaceutical industry to stabilize drugs and vaccines.

Albumin can also be used to extend the half-life of pharmaceuticals to prolong the drugs' effect, Novozymes said.

"We believe (the business) is now ready to be developed further outside Novozymes, where it will have the best possible growth conditions."

Albumedix offers a first and second generation version of this drug delivery technology under the name Veltis.

In 2014, GlaxoSmithKline launched a diabetes drug that utilizes the Veltis technology to allow patients to dose weekly instead of daily.

Novozymes business development executive vice president Thomas Videbæk said: "Over the past nine years, our work in albumin has resulted in a series of new discoveries and technologies, which have led to agreements with major pharmaceutical and biotech companies.

"The business is in good shape with great prospects to make a real difference for patients all over the world. We believe it is now ready to be developed further outside Novozymes, where it will have the best possible growth conditions."

Albumedix will also begin exploring early stage clinical drug development based on its Veltis technology and relevant drug candidates.

Novozymes' biopharma business head Peter Rosholm has been appointed as the CEO of Albumedix.

With headquarters in Lyngby, Denmark, Albumedix will have R&D and production facilities in Nottingham, UK, and will employ approximately 100 people.

"I see a promising future for Albumedix, and together with Don deBethizy and the rest of the team I look forward to expanding our role in the pharmaceutical industry.

"With our heritage, expertise in albumin, and skilled employees, we have a strong foundation for developing superior biotherapeutics for patients," added Peter Rosholm.

Acorda to Acquire Finland’s Biopharmaceutical Firm Biotie

Acorda Therapeutics has signed an agreement to acquire Finland-based biopharmaceutical firm Biotie Therapies for approximately $363m.

Based in Turku, Biotie is involved in developing therapeutics for central nervous system disorders.

The company has designed product candidates to be used in the treatment of Parkinson's disease and related dementia, as well as other neurodegenerative disorders and an orphan fibrotic liver disease called primary sclerosing cholangitis.

Acorda Therapeutics president and CEO Dr Ron Cohen said: "Our acquisition of Biotie positions Acorda as a leader in Parkinson's disease therapeutic development, with three clinical-stage compounds that have the potential to improve the lives of people with Parkinson's."

"The deal will allow Acorda to receive worldwide rights to tozadenant, an oral adenosine A2a receptor antagonist currently in Phase III development in Parkinson's disease (PD)."

The deal will allow Acorda to receive worldwide rights to tozadenant, an oral adenosine A2a receptor antagonist currently in Phase III development in Parkinson's disease (PD).

The company will also be provided with global rights to SYN120, an oral, 5-HT6 / 5-HT2A dual receptor antagonist for Parkinson's-related dementia, which is currently in Phase II trial.

In addition, Acorda will acquire two other assets, including BTT1023 and Selincro.

BTT1023 is a fully human monoclonal antibody that is in Phase II development for the treatment of primary sclerosing cholangitis (PSC), and Selincro is a European Medicines Agency (EMA)-approved therapy for alcohol consumption reduction, which is marketed by Lundbeck in multiple European countries.

ISPE Announces Facility of the Year Awards Category Winners for 2016

ISPE FOYA winners were named for categories of operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

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