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

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

The firm has capacity to service these deals, but according to CEO Igor Fisch the number of clients is anticipated to double over the next few years, and thus Selexis will begin a "major expansion" by the first quarter 2017.

“The company will be able to triple its capacity for generating stable high producing clonal cell lines,” he said, adding Selexis is also planning to launch two new product platforms to aid biomanufacturers within the next eight months.

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

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

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

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

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

Avid to Construct Third Plant

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

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

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

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

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

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

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

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

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

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

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

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

Hikma Expanding US and European Manufacturing Capabilities

Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.

In 2015, drugmaker Hikma invested over $80m (€71m) into its global manufacturing network in order to help bring its injectables sector back to growth, and for the first six months of 2016 the firm has continued to spend.

“Capital expenditures was $55m in H1 2016, up from $37m [on the same period 2015],” said CFO Khalid Nabilsi.

Over half of this was invested in the US, he said, “maintaining and expanding our injectable and non-injectable manufacturing facilities,” while in Europe the firm is expanding its injectable manufacturing capacity for lyophilized and oncology products.

“We also made investments to maintain our facilities across MENA including Jordan, Saudi Arabia, Egypt and Sudan,” he continued, adding the firm’s CapEx is likely to be around $150m for the full year.

CEO Said Darwazah gave some more focus on the call: “We look to build new capabilities including delivery systems such as pre-filled syringes and complementary products like ophthalmic. And we'll be looking for new markets where we can leverage our portfolio.”

Hikma stripped the assets from the regulatory-problematic Ben Venue injectables facility in Ohio, acquired as part of its $300m Bedford Labs purchase in 2014.

Manufacturing equipment was transferred to injectable facilities in Cherry Hill, New Jersey, a site in Germany, and a facility in Portugal – the subject of a now closed-out 2014 US Food and Drug Administration warning letter – which saw the addition of nine lyophilisers.

“Our broad product portfolio and large manufacturing capacity across Cherry Hill, Portugal and Germany allow us to be one of the largest volume suppliers in the market,” said Darwazah.

With its intent to grow its network and a general lack of capacity for sterile injectables manufacturing in North America and Europe, Hikma was asked whether it would be looking to operate production space as a third party manufacturer.

The firm is obliged to make products for clients of Roxane Laboratories which it acquired for $2.6bn from Boehringer Ingelheim in July 2015, and while Nabilsi said these would be honored, he added there would be further opportunity to contract manufacture from the site in Columbus, Ohio.

“We are taking a look at what agreements we do have and new contract manufacturing coming through the plants. But we are also optimizing our portfolio there as well to have additional capacity for contract manufacturing, so it doesn’t have a negative impact on the business moving forward.”

Catalent WI Biologics Plant Expansion

Catalent has more than doubled its biologics business since it went public in 2014, but the sector still represents less than 5% of the CDMO’s revenues.

The contract development and manufacturing organization (CDMO) announced its Q4 fiscal year 2016 figures, and saw sales in its Drug Delivery Solutions segment of $238m (€213m), up 10% on the same period last year.

The sector includes Catalent’s biologics business, and part of the growth for the quarter was attributed to increased volumes related to its biologics blow-fill-seal offering.

And according to management, biologics services - led by its GPEx cell line platform and its SMARTag bioconjugation technology - are an increasingly important area for the firm, and one Catalent plans to “aggressively” grow organically.

“We continue to believe that our Biologics business is well positioned to drive future growth and comprise an increasing percentage of our overall business,” CFO Matt Walsh told stakeholders, citing the CDMO’s $600m conjugation deal with Roche earlier this year.

“At the time of the IPO [July 2014 ], our dedicated Biologics business was approximately 1% of sales and that has since grown to approximately 3% of sales in FY16, so more than doubling the business over approximately three year timeframe.”

As such, the firm said it has begun a $34m expansion at its biomanufacturing facility in Madison, Wisconsin to add two 2,000L single-use bioreactor systems in what CEO John Chiminski said would “help meet customer demand for this fast growing business.

“The new fleet will be capable of running either 2,000L or 4,000L batches to support late-phase clinical and commercial production for our customers using single use bioreactor technology,” he said.

“This expansion is an important part of our growth strategy, and builds on previous investments in our biologics capabilities.”

Last year, the firm completed the installation of a 1,000L bioreactor at Madison.

For the fiscal year 2016, Catalent reported net revenues of $1.85bn, up marginally from the year prior, while sales from the firm’s softgel technologies – its largest single product line - fell $13m to $775m.

The sector was blighted by a manufacturing suspension at Catalent’s Beinheim, France facility after out-of-place softgel capsules were discovered in several product batches during quality control procedures last November.

Full production began in May, but the halt and investigation cost the firm approximately $50m in lost revenues, according to Jefferies analyst David Windley who said in a note the CDMO has successfully “battled through short term issues” and the business is showing “signs of improving stability.”

Fresenius Kabi to Expand Melrose Park IL

German firm Fresenius Kabi is to invest approximately $250 million over 10 years to expand its Melrose Park, IL site in the US.

The plant currently produces a range of generic, sterile injectable medicines.

The multi-stage, multi-year project at Melrose Park will start next year, with final project completion in 2026.

Fresenius Kabi's US headquarters is in Lake Zurich, Illinois and in total the firm employs more than 1,500 people in the state.

The company operates more than 70 manufacturing sites worldwide and the Melrose Park location will be one of its largest. Its global headquarters is in Bad Homburg, Germany.

The project will include new buildings for automated aseptic filling lines connected to the existing manufacturing site, expanded lyophilisation capabilities, formulation areas, as well as a dedicated warehouse.

An administration building with conference center, laboratories, office space and a cafeteria, is also included in the expansion.

'Our goal is to expand our US manufacturing capabilities while ensuring continued compliance with increasing regulatory and quality requirements and improve production capacity and efficiency,' said Steven Nowicki, Senior Vice President of Global Operations for North America, Pharmaceuticals Division at Fresenius Kabi.

In addition to its Melrose Park locations, Fresenius Kabi has other plants in Illinois, including Bensenville, Skokie and Lake Zurich.

The company also has manufacturing sites in New York, North Carolina and Pennsylvania and employs more than 2,500 people in the US.

Earlier this year, Fresenius Kabi bought a pharmaceutical manufacturing plant in Wilson, NC from Becton, Dickinson.

The deal also included a small portfolio of drugs in ready to use prefilled glass syringes.

The firm said the acquisition would allow it to offer a broader range of specialty injectable medicines in vials, as well as ready to use presentations.

Capsugel Invests in Enhanced Micronization Capacity and Capabilities

Capsugel has announced an expansion of its facility in Quakertown, Pa., to meet increasing customer demand for its micronization services for both clinical and commercial manufacturing. The company will double the size of its current pilot-scale capacity for clinical trial quantities and increase the number of suites dedicated to commercial manufacturing.

Micronization of active pharmaceutical ingredients (APIs) is accomplished using proprietary jet milling equipment. The Quakertown facility, which Capsugel acquired as part of its purchase of Xcelience and Powdersize in January 2016, operates as a full-service provider of particle-size reduction and particle-size control/classification technologies for pharmaceutical customers. The acquisition expanded the company’s suite of bioavailability enhancement tools aimed at improving the bioavailability of APIs with either dissolution or solubility challenges – an issue faced by more than 70 percent of new chemical entities. The expansion enables the company to add capacity for commercial manufacturing and is expected to further improve product lead times by up to 75 percent.

“Our customers are increasingly seeking specialized partners in early-stage compound assessments and product design, with poor dissolution and/or solubility often being at the forefront of their challenges,” said Amit Patel, Sr. Vice President, Capsugel. “Micronization and nano-milling technology is a significant component of Capsugel’s overall service offering, and this investment further strengthens our ability to rapidly advance challenging compounds to clinic and ultimately commercialization.”

In addition to enabling increased capacity, the added suites will feature new state-of-the-art, single-use containment technologies to accommodate continued growth in potent and highly potent compounds. The new equipment and suites are scheduled to be operational by January 2017.

“One of the many reasons we were eager to join Capsugel was the opportunity to become a part of its unique design, development and manufacturing offering,” said Wayne Sigler, President, Powdersize, a division of Capsugel. “This investment further supports the role of micronization and sub-micronization in compound assessments and product design through commercialization, bringing more benefits to our customers. It also enables us to stay ahead of rising customer demand, so we can help our customers meet aggressive development and clinical timelines.”

LI-COR Expansion with Early-Phase cGMP Services

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

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

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

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

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

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

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

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

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

Near-infrared DNA sequencing technology was initiated by LI-COR in the early ‘90s, which prompted pre-clinical developments including protein and small animal NIR imaging.

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

Catalent to Add Bioreactors in Biologics Plant Expansion

Catalent has more than doubled its biologics business since it went public in 2014, but the sector still represents less than 5% of the CDMO’s revenues.

The sector includes Catalent’s biologics business, and part of the growth for the quarter was attributed to increased volumes related to its biologics blow-fill-seal offering.

“This expansion is an important part of our growth strategy, and builds on previous investments in our biologics capabilities.”

Last year, the firm completed the installation of a 1,000L bioreactor at Madison.

Alcami Plans to Increase API Production Capacity

Alcami has announced plans to expand its facilities in Germantown, Wisconsin, in order to increase its Active Pharmaceutical Ingredient (API) production.

According to Alcami, a pharmaceutical and biotechnology supplier with facilities in the Netherlands and the US, the additional highly Potent API production capacity will help to meet a growing industry demand.

The project will include an upgrade of existing kilo labs, as well as two new fully qualified cGMP Highly Potent API production suites. Designed with an emphasis on primary containment technologies, the suites will be dedicated to the development and manufacturing of Highly Potent APIs for the potent Drug Product market. These will meet the established Occupational Exposure Limit (OEL).

The new facilities will incorporate up to 150L reactor scale with cryogenic capabilities. Construction will begin this year to be operational by Q1, 2017.

Chief Operating Officer, Ted Nolan, said the investment in highly potent capabilities will “address unmet market needs.”

The expansion will increase Alcami’s API production capacity by 50%.

The announcement comes just five months after the amalgamation of AAIPharma Services Corporation and Cambridge Major Laboratories, Inc. to form the organization today known as ‘Alcami’.

Since then the firm has expanded production and testing capacity.

In June, it converted Approximately 5,000 square feet of space at its technology center in Wilmington, North Carolina into a laboratory.

The conversion included space for dissolution testing (Apparatus I, II, III, IV and intrinsic dissolution), Karl Fischer testing (humidity controlled room), microbiology, and formulations development.

China's Greenland, Ping An, Agile to Invest in U.S.

China's state-backed developer Greenland Holdings said it would jointly invest more than $1 billion in a biotech industrial park in south San Francisco with smaller peer Agile Group, Ping An Trust and Poly Sino Capital.

The Shanghai-based company, the largest investor in the 2,259,600 sq. ft. (210,000-square-meter) project, said in a statement it aims to enhance cooperation between China and the United States on biotech research and development via the investment.

In a filing, the company said it owns 49 percent of the project, while Ping An and Agile hold 36 percent and 10 percent, respectively. The land was acquired for $171 million.

Greenland Holdings have been aggressively expanding outside China and the traditional real estate industry as margins at home slow.

It said its infrastructure business aimed to achieve more than 100 billion yuan ($15.1 billion) in revenue this year, becoming another growth driver after property.

The company has so far invested over $7 billion in the United States, with projects in Los Angeles and New York.

Separately, Ping An Insurance Group Co of China Ltd, China's second-largest insurer, plans to substantially ramp up its overseas investments to between five and 10 percent of its overall insurance assets, its group chief financial officer told Reuters.

($1 = 6.6266 Chinese yuan)

QuVa Buys New Jersey Manufacturing Plant

QuVa Pharma has agreed to buy a manufacturing facility in New Jersey, US at which it plans to compound sterile pharmaceutical products for hospitals.

The Texas compounder explained that the facility will allow it to access key regional markets.

The firm said it plans to make modifications and register the compounding facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also said it plans to hire 100 staff when the site is operational next year.

Further details of the deal were not disclosed.

A spokesman for the firm told us "We are not permitted to say which company QuVa is purchasing the building from."

QuVa currently operates two 503B compounding facilities. One of the facilities - in Sugarland, Texas – was acquired from Healix in August last year in a deal that also saw QuVa hire staff employed at the site.

QuVa’s other facility in Temple, Texas was purchased in November when the firm acquired Unique Pharmaceuticals.

At the time QuVa said the deal was designed to increase its capacity to make sterile injectable products for hospitals

Peter Jenkins, co-founder, said: “This acquisition broadens our catalogue of available compounded products, and gives us the capability to compound preparations from API to meet supply shortages.”

Pfizer to Repurpose Space in Michigan

Pfizer will convert warehouse space at its Kalamazoo-Portage plant to provide extra manufacturing capacity for sterile injectable products.

According to Pfizer spokesperson Kimberley Bencker, the firm is investing $146m (€130m) at its Kalamazoo-Portage, Michigan facility which makes Injectable products for off-patent generics for global markets.

She said the investment was “for routine capital upgrades,” but added this involved the repurposing of the site’s current warehousing capacity.

“The manufacturing facility has reached capacity so production is moving into existing warehouse space requiring an addition to the building for new warehousing space,” she said.

While there will be a modest increase in jobs, she was unable to be precise on numbers, saying: “We are a large and diverse operation and changes in other areas of the operation may impact headcount independent of this investment.”

But according to local news site Michigan Live, the new production space will add 15 jobs while all 26 warehouse staff will be retained.

The site also said Pfizer is seeking a number of tax breaks on the projects, including a 50% abatement on the facility expansion, to be discussed in a public hearing scheduled by the city later this month.

The news is the latest endorsement for the Michigan facility, which was one of the sites to suffer cuts and restructuring following the failure of Pfizer’s inhaled insulin drug Exubera almost a decade ago.

Since then, the pharma giant invested $107m to upgrade to its sterile area in 2010, and injected a further $21m the following year to upgrade a production, packaging and quality inspection area at the plant.

This latest investment also comes off the back of several multi-million dollar investments across Pfizer’s manufacturing network.

In June the firm announced it was teaming up with GE Healthcare to construct a $350m modular biosimilars facility in China, while the firm also broke ground on a new $200m clinical biomanufacturing facility in Andover, Massachusetts.

Piramal Announces Kentucky Investment

Piramal Pharma Solutions will spend $25m (€22m) to expand the Coldstream Laboratories site it bought in 2015.

The Indian-based manufacturer announced the expansion, explaining it will increase filling and freezing drying capacity at its drug manufacturing facility in Lexington, Kentucky.

The first phase will see it install a vial filling line with capacity to handle potent active pharmaceutical ingredients (APIs). Phase two of the project will see Piramal add two lyophilizers.

Piramal cited growing demand for sterile drug manufacturing services and consolidation in the services sector as the driver for the investment adding that it “believes that it can take advantage of the market situation and grow it Lexington business multi-fold.”

The firm bought the site along with Coldstream Laboratories for $30.65m at the beginning of last year.

Alnylam to Construct RNAi Manufacturing Plant

Alnylam’s RNAi manufacturing plant will be operational by 2018 and the firm says it is willing to invest in a second facility depending on its pipeline success.

Earlier this year , Alnylam Pharmaceuticals announced it had secured 12 acres of undeveloped land in Norton, Massachusetts to construct a $200m (€180m) facility to manufacture its clinical and commercial drug products, based on siRNAs (small interfering RNA) and siRNA conjugates.

The firm has contracted Jacobs Engineering Group to provide engineering services and procurement for the 200,000 sq. ft. multi-product facility.

“We designed the Norton facility to be a multi-train facility, so that we can run multiple products simultaneously if we are as successful as we hope to be in our pipeline,” said COO Barry Greene. “How much drug would be produced by the plant is highly dependent on dose and frequency of that drug.”

Due to the high potency and infrequent dosing of Alnylam’s candidates, the site is expected to support demand across its Genetic Medicines pipeline, consisting of a number of RNAi therapeutics for the treatment of rare diseases based on its own GalNAc-siRNA delivery platform.

GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to liver cells through uptake by the asialoglycoprotein receptor. This, according to the firm, enables such drugs to be delivered subcutaneously and offers an alternative to intravenous injections needed for administering RNAi therapeutics using lipid nanoparticles (LNP).

However, with a number of early-phase cardio-metabolic and hepatitis candidates in development, commercial success would see a surge in Alnylam’s potential patient population, which Greene said “would probably require another investment in yet another facility, which - if those programs hit - we're very prepared to do.”

Alnylam’s CEO John Maraganore said the firm would still rely on third-party manufacturers, at least until the Norton plant comes onlines, expected in 2018.

“We'll still use third-party CMOs and leverage our third-party CMOs as well. But increasingly over time, the Norton facility will be doing the bulk of our drug substance manufacturing.”

Bayer and CRISPR Therapeutics Joint Venture, Casebia Therapeutics

Casebia Therapeutics, the joint venture founded by Bayer and CRISPR Therapeutics, started its operations in Cambridge, MA, U.S. In December, 2015 Bayer and CRISPR Therapeutics agreed to create a joint venture (JV) to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders, blindness, and congenital heart disease. The two parties formally closed the transaction in the first quarter of 2016.

The JV has recently been incorporated as Casebia Therapeutics, a UK entity with its primary base of research operations in Cambridge, MA, U.S. The name Casebia derives from the CRISPR-associated, or Cas, family of nuclease enzymes – key components of the breakthrough gene editing technology on which Casebia will base its therapeutic programs. Casebia has access to gene-editing technology from CRISPR Therapeutics in specific disease areas, as well as access to protein engineering expertise and relevant disease know-how through Bayer.

Casebia has recently entered into a sublease agreement for approximately 33,000 sq. ft. of laboratory and office space that will host up to 80 employees and form its primary base of operations. The space is located in Cambridge, MA at 610 Main Street North, a brand new, nine-story, MIT-owned building currently under construction in Kendall Square adjacent to the MIT campus. Casebia will be co-located with CRISPR Therapeutics and will enter the new location in early 2017.

Meanwhile, research efforts are performed via the various R&D sites of Bayer and CRISPR Therapeutics in the US and Germany. An additional location on Bayer's campus in San Francisco, Mission Bay will house research operations in hematology indications.

"We are excited to engage the broader life science community in Boston now through Casebia. As we establish and grow Casebia's therapeutic programs, this new location will provide us with state-of-the-art infrastructure, access to the vibrant biotech environment of the Kendall Square area, and facilitate close collaboration with CRISPR Therapeutics," said Dr. Axel Bouchon, who is serving as interim CEO of Casebia.

Agilent Plans Expansion of Oligo Manufacturing Capacity

Agilent Technologies announced on Aug. 9, 2106 that the company has acquired 20 acres in Weld County, CO, on which it plans to build a pharmaceutical manufacturing facility that will more than double its commercial manufacturing capacity for nucleic acid APIs. The expansion will add 150–200 jobs, the company reports.

"The products manufactured at this site will be used by our customers to improve the lives of patients suffering from a variety of diseases," said Skip Thune, general manager of the company's Nucleic Acids Solutions Division in a press statement. "At Agilent, we are committed to meeting the ever-increasing needs of our customers for oligonucleotides."

Agilent's 65,000-sq.-ft. facility in Boulder, CO, manufactures oligo APIs for clinical trials. Capabilities include four synthesis/purification trains and two lyophilization units. A commercial GMP plant expansion was completed in 2010 and can produce multi-kilo lots of late-stage clinical materials, as reported on the company website.

Allergan Plans to Expand in New Jersey

On August 9, 2016, the Board of the New Jersey Economic Development Authority (EDA) approved Grow New Jersey (Grow NJ) tax credits in order to encourage Allergan to remain in NJ. The EDA is also encouraging Allergan to combine its four existing company locations into a 431,495-square-foot facility in Madison, NJ.

The Board approved Allergan for Grow NJ tax credits of up to $58.2 million over 10 years based on the expected creation of 300 new, high-paying jobs, the retention of more than 1000 jobs at risk of leaving the state for Pennsylvania, and private investment of more than $103 million. The project is expected to result in a net benefit to the state of more than $384 million over 20 years.

Allergan subsidiaries Watson Pharmaceuticals, in Parsippany, and Forest Laboratories, in Jersey City, have existing projects approved under the Business Employment Incentive Program. Those grants will be required to be withdrawn in order for Allergan to qualify for the Madison Grow NJ project, forfeiting more than $15.2 million in future payments.

Arbutus Biopharma Moving to Facilities in Warminster

The company is relocating to an unoccupied 35,000-square-foot building in Warminster on Veterans Circle near Street and Jacksonville roads.

Based in Canada, Arbutus — a biopharmaceutical company working on a cure for hepatitis B — was created following the merger of OnCore BioPharma and Tekmira Pharmaceuticals of Vancouver, British Columbia. OnCore was founded at the Pennsylvania Biotechnology Center by a group of researchers led by Michael J. Sofia, the inventor of Gilead Sciences Inc.’s multibillion-dollar drug Sovaldi that is used to cure hepatitis C. After the merger, the company continued to maintain research space at the biotechnology center, an incubator created just outside of Doyestown, Pa., for startup companies in the life sciences industry.

“It was a tough decision [to move] in some respects,” said Sofia, the chief scientific officer for Arbutus, “but we were just so crowded. We needed more space and there just wasn’t space there to expand.”

The founders of the Pennsylvania Biotechnology Center, the Hepatitis B Foundation and Delaware Valley University, have been involved in a dispute for more than a year about the management of the center which had delayed expansion plans for the facility.

Sofia said the Arbutus plans to spend the next seven to eight months renovating and creating lab space at the building that will serve as its new home in Warminster. The building occupies a site that was once part of the Johnsville Naval Air Warfare Center, which closed in 1996.

Arbutus, which has several hepatitis B therapies in clinical and preclinical testing, has grown to more than three dozen employees and expects to have 50 employees at the new location.

Chemistry Biology Building, University of Wisconsin-Stevens Point

• Project name and location: Chemistry Biology Building, University of Wisconsin-Stevens Point, Stevens Point, WI.

• Cost: $75 million

• Size: 176,500 sq. ft.

• Project team: HOK, in association with Potter Lawson; General Contractor: Miron Construction Co.; Mechanical and Plumbing Engineers: AEI; Electrical Engineers: Potter Lawson

• Description: Following a May 5, 2016, groundbreaking, the University of Wisconsin-Stevens Point is targeting a 2018 completion for a new $75 million science building.

HOK, in association with Madison, Wisc.-based architectural firm Potter Lawson, designed the 176,500 sq. ft. chemistry biology building. The four-story academic and research facility will contain classrooms, lecture halls, research and teaching labs, faculty and staff offices, and a tropical conservatory. It will be the first major freestanding academic facility built on the UW-Stevens Point campus since 1971.

“The building design links the university’s science programs to create a community of science and research,” said Joseph Ostafi, IV, AIA, LEED AP, Science + Technology practice leader for HOK in St. Louis. “The university also wanted to celebrate science by integrating the building into campus life.”

The University of Wisconsin-Stevens Point’s student-centered education prepares students for their future science careers while encouraging community outreach and ecological stewardship. The new Chemistry Biology Building is located along a major pathway connecting student housing with the university’s’ social amenity spaces. The design also puts science on display throughout the building with electronic kiosks and high visibility into biology labs and the tropical conservatory, which will be open to all students and visitors. The first floor will also feature artwork inspired by the natural environment. Inside the building, teaching spaces will be clearly visible to students and campus visitors. To integrate academic and research functions, the design purposefully places research, instructional and prep spaces close to each other to enable equipment sharing. Flexible classroom configurations include movable furniture that accommodates collaboration among teams of varying sizes. State-of-the-art technology will facilitate hands-on learning and research.

The team incorporated several sustainable design strategies. Large windows optimize daylighting, while mechanical and electrical systems are highly efficient. The facility is projected to use 40 percent less energy and 26 percent less water compared to a conventional design. In addition to the conservatory, green space around the building includes bioswales and rain gardens. The third floor has an outdoor patio with a rooftop garden and space for casual gatherings.

• Completion date: 2018

Mallinckrodt to Build New Campus in NJ

Specialty pharma company Mallinckrodt unveiled plans to build out a new campus for its specialty brands organizations in the Somerset Financial Center, 1405-1425 Route 206, in Bedminster. Mallinckrodt will invest more than $80 million in New Jersey, and anticipates approximately 400 employees will occupy the new space in the first quarter of 2017.

The company is also continuing its investment in St. Louis, MO, having recently begun the next phase of construction at its downtown St. Louis manufacturing facility—part of the more than $140 million in capital projects and related expenses it has invested in offices and plant locations that house Mallinckrodt's legacy businesses and key administrative functions in the area.

Having acquired multiple companies in 18 months, by late 2015, Mallinckrodt found itself with commercial and development operations spread across more than a dozen U.S. sites. The Bedminster, NJ, campus will consolidate operations for its specialty brands groups, co-locating more than 400 commercial and science employees focused on marketed and development products in its autoimmune and rare diseases and hospital businesses—growth platforms the company continues to build on as indicated by its recently announced acquisition.

"As we began to transform Mallinckrodt into a specialty pharmaceutical organization, we acquired a base of established operations on the East Coast," said Mark Trudeau, president and chief executive officer, Mallinckrodt. "With this base, and recognizing the important concentration of specialty pharmaceutical talent and intellectual capital in the area, we believe consolidating our specialty brands organizations in New Jersey provides compelling value. We believe the state will be a great business destination for the company."

As also noted, Mallinckrodt continues to reinvest in St. Louis, where the company's roots date back nearly 150 years. Recent investment includes the commitment of more than $8 million for expansion of its downtown St. Louis manufacturing facility, as well as a $12 million site addition opened in mid-2015 to increase manufacturing efficiency.

"For decades, Mallinckrodt has proudly maintained a significant presence in St. Louis, where many of us continue to live and work," said Mr. Trudeau, "and we're excited to reinforce that presence in this region with continued reinvestment."

REST OF WORLD

Stem Cell Treatment Facility in Guadalajara, Mexico

Biostem Technologies’ world class stem cell treatment facility is located within San Javier Hospital in Guadalajara Mexico. San Javier is a private hospital utilizing the newest state-of-the-art medical technologies.

San Javier Hospital was the first hospital in Western Mexico to obtain a “Specialty Hospital” certification by the General Health Council of Mexico. The hospital boasts the newest and best medical technologies as well as a highly trained physician and medical staff to provide the highest level of service available anywhere.

Biostem Technologies’ team of physicians and scientists have been conducting research and performing stem cell therapies since 2008 having treated hundreds of patients. Specializing in cardiovascular, auto-immune, joints, and anti-aging protocols using the patient’s own stem cells, and their incredible healing properties to increase the quality of our patient’s life

EAG Labs Expands Environmental Testing Capabilities

EAG Laboratories has completed an expansion of its environmental testing facility in Ulm, Germany. The new 30,000 sq.-ft. facility triples capacity for environmental risk assessments required for global pesticide and chemical registrations and to comply with evolving U.S. EPA, EU, OECD, SANCO, REACH and TSCA regulations.

EAG recently announced that it will operate all its subsidiaries under the trade name EAG Laboratories. The company’s Ulm, Germany, location, which specializes in residue analysis, environmental fate, metabolism, was acquired by EAG in 2012 together with its California partner laboratory PTRL West.

“EAG Laboratories is investing in a number of key areas aimed at bringing greater breadth of services and technical expertise to our customers,” stated Siddhartha Kadia, president and chief executive officer of EAG. “This investment in state-of-the art, GLP-compliant laboratories reflects EAG’s ongoing commitment to our agrochemical, pharmaceutical, consumer products, and chemical industry customers, and to serving the global community’s need for scientific problem-solving expertise.”

Dalton Pharma Services Completes Expansion

Dalton Pharma Services, a privately owned Canadian contract development and manufacturing organization, has completed a $5 million expansion in sterile filling and API manufacturing at its cGMP facility in Toronto. The expansion has created around 20 new skilled life sciences jobs at its sterile filling and API manufacturing operation.

The firm, which offers manufacturing, chemistry and analytical services on a contract basis to the global pharmaceutical and biotechnology industries, has added three new sterile processing suites and an active pharmaceutical ingredient (API) manufacturing suite.

A semi-automated powder filling line with significant scale-up of lyophilisation capacity is also included.

The firm has also increased its analytical capabilities, its chemistry capacity, and has made facility upgrades to meet sterile manufacturing GMP API standards.

The project was supported by CA$2.085 million of funding through FedDev Ontario's Investing in Business Growth and Productivity Initiative, which aims to help established businesses to expand their operations, invest in productivity improvements and compete globally.

Combined with the company’s own investment of $3.5 million, the expansion project brings the total investment at the site to more than $5 million.

With the expansion and improvements to its sterile manufacturing facility Dalton Pharma Services aims to meet growing demand for preclinical development and small/medium clinical trial batches for commercial production, for both API and sterile finished doses.

'Increasing sterile filling capability and capacity for both powders and liquids has been a key part of our plan for strategic growth,' said Peter Pekos, President and CEO.

'Completion of this expansion is a major step designed to meet the increasing global demand for sterile filling development and production, and supports the integrated drug development and manufacturing we offer our clients.'

Dalton's full range of services in-house include drug discovery, flow chemistry, formulation and process development, custom synthesis, cGMP sterile fill/finish, cGMP API manufacturing and/or dosage form manufacturing, all at one location.

Hikma Expands US and European Manufacturing Capabilities

Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.

“Capital expenditures was $55m in H1 2016, up from $37m [on the same period 2015],” said CFO Khalid Nabilsi during a conference call. Over half of this was invested in the US, he said, “maintaining and expanding our injectable and non-injectable manufacturing facilities,” while in Europe the firm is expanding its injectable manufacturing capacity for lyophilized and oncology products.

CEO Said Darwazah gave some more focus on the call:

“We look to build new capabilities including delivery systems such as pre-filled syringes and complementary products like opthalmics. And we'll be looking for new markets where we can leverage our portfolio.”

Hikma stripped the assets from the regulatory-problematic Ben Venue injectables facility in Ohio, acquired as part of its $300m Bedford Labs purchase in 2014.

“Our broad product portfolio and large manufacturing capacity across Cherry Hill, Portugal and Germany allow us to be one of the largest volume suppliers in the market,” said Darwazah.

Fermion Extends Capabilities

Fermion strengthens its particle engineering capabilities by investing in micronization of both standard APIs and HPAPIs in small to medium scale commercial production.

With the new equipment Fermion is capable of micronizing compounds that require a 0, 1 µg/m3 containment level, e.g. respiratory APIs. Currently, Fermion has large commercial scale API micronization capabilities at its Hanko site with different types of equipment intended for both standard and HPAPIs. The new equipment will be located at the Oulu site and it will be operational in 2017.

Particle engineering at Fermion is a larger solution package including not only micronization but also R&D expertise in crystallization, online monitoring and characterization of physicochemcial properties. The current investment completes the set of Fermion’s extensive particle engineering capabilities and ensures a continuous value chain for customers requiring API and HPAPI micronization from laboratory scale to commercial production.

Streamlined Production for Purolite

Welsh chromatography resin maker Purolite says it aims to capture 30% of the Protein A market through its 100,000L facility on track to open next year.

Purolite Life Sciences announced it has selected Briggs of Burton as a partner in creating the manufacturing process design at its new facility in Llantrisant, UK, expected to begin making Protein A media for the biomanufacturing industry next year.

“The facility build is moving along well,” said sales director Chris Major. “The capex and fabrication contracts for the equipment have now been awarded to suppliers and we remain on track for an opening mid-2017.”

Protein A is regarded as being the gold standard in capturing monoclonal antibodies and is manufactured in a similar way to an actual biological product, thus costing as much as $12,000 per liter.

But this new facility - first announced in March – will make Purolite’s Praesto resin and could bring down the overall price of Protein A media for end-users.

“We have streamlined manufacturing which has allowed us to pass savings back to customers, helping them to lower their development costs,” he said, adding the firm has also had 35 years’ experience in making resins across a number of industries and can implement best practices to lower costs further and drive innovation in the sector.

“Soon we will be implementing Purolite’s patented uniform particle manufacturing technology, which will further enhance product performance for the end user.”

According to Major, the new plant will grow Purolite’s share of the agarose Protein A market to 30% and compete directly with GE Healthcare which he said currently holds a near monopoly.

But due to regulatory reasons, he admitted it is unlikely GE’s current customers will switch to Purolite for their supply. “However, the pipeline for new drugs far exceeds the numbers of those currently manufactured, with expectations that the market will double in 5 -10 years.”

“Our philosophy is that competition is the mother of innovation, so now end users will benefit significantly. Purolite is 100% focused on improving resin technology, and our customers enjoy the highest level of customer dedication from the best minds in the industry to solve their most challenging problems.”

“There are many suppliers on the market and we welcome competition because it drives innovation in both product design and in the total service offering for customers,” Jonathan Royce, product manager of antibody affinity media at GE, told us in March.

AGC Acquires Biomeva

AGC Asahi Glass, a manufacturer of glass, chemicals and high-tech materials, has acquired all of the shares of Biomeva GmbH (Biomeva) from Biomeva Holding GmbH. Biomeva is one of the leading biopharmaceutical contract manufacturing organizations (CMO) in Europe. With Biomeva now a part of the AGC Group, AGC’s Life Science Business will be offering wider geographic coverage and a wider range of capacities.

Based in the Bio Cluster City of Heidelberg, Germany, Biomeva has almost 25 years of experience in providing contract development and manufacturing services using microbial expression technology to European and other International customers. Biomeva’s services include process development for highly efficient therapeutic protein expression, cGMP compliant fermentation, purification and bulk filling, as well as analytical testing and cell banking.

Dr. Thomas Pultar, CEO of Biomeva says “By combining Biomeva’s capabilities and AGC’s large scale manufacturing capacities we will generate a new and strong international microbial CMO, offering the complete services from process development to large scale market supply. To me, this is a perfect synergy between Biomeva’s strength in clinical manufacturing and AGC’s expertise and capacity for commercial production. I look forward to continuing my role as CEO of Biomeva under this new ownership.”

Under the management policy AGC plus, the AGC Group has designated Life Science Business as one of its strategic areas. The synergy generated through the business integration of AGC and Biomeva being an important addition, the AGC Group is dedicated to speeding up and expanding its biopharmaceutical contract services business.

E&O Laboratories Expand in Scotland

Scottish microbiology firm is setting up a new £1m production facility in Cumbernauld, North Lanarkshire

E&O Laboratories, the UK’s biggest, privately-owned manufacturer of microbiological culture media, is expanding with the aim of increasing its export capacity.

The family-owned company, founded in 1989, manufactures clinical diagnostics and microbiological testing products for use in the clinical, pharmaceutical, food, water and environmental industries.

The multimillion pound project has been funded by £1m from the Bank of Scotland and a Regional Selective Assistance grant from Scottish Enterprise.

The new larger production facility will include two new cleanrooms.

Managing director Virginia Lucey said: 'This project is going to take our business to the next level. After an extensive research and development programme we devised a strategy to grow our presence on the world stage.'

Novogene, AITbiotech to Open Genomics Center in Singapore

Novogene, a Beijing-based sequencing service provider, and molecular diagnostic company AITbiotech plan to establish a joint genomics venture in Singapore, the companies said.

The facility, NovogeneAIT Genomics Singapore, will include next-generation sequencing capabilities on the Illumina HiSeq X Ten and will provide NGS and research services to the Association of Southeast Asia Nation and Southeast Asia region. In addition, researchers there will collaborate with other institutions in Singapore, including a whole-genome sequencing project with an unnamed research entity in Singapore.

"Our joint venture with AITbiotech represents a key milestone in Novogene’s strategy to become a truly global high-throughput next-generation sequencing services provider," Novogene CEO Ruiqiang Li said in a statement.

He added that the new facility will be Novogene's third NGS center, adding to ones it has established in China and the US. Novogene will invest in research and development of next-generation genetic testing products and services, especially in oncology at the new center.

"AITbiotech sees this joint venture as a model of collaboration between a global company and a smaller local enterprise to jointly penetrate the large, complex ASEAN and South Asian scientific services and diagnostics markets," Alex Thian, AITbiotech CEO, said in a statement.

Avara Acquires AstraZeneca UK Manufacturing Facility

Avara Pharmaceutical Services acquired AstraZeneca's manufacturing facility located in Avlon, Avonmouth, England. Under the terms of the agreement, about 210 Avlon employees will remain employed at the site, and the plant will continue to manufacture critical AstraZeneca pharmaceutical products on a contract basis. AstraZeneca will continue to source a stable supply of high-quality products from the facility under the new ownership of Avara following the acquisition.

"We are excited to have the Avlon organization join the Avara team and to add this significant capability to the Avara company," said Tim Tyson, chairman and chief executive officer, Avara. "We are honored to have the strategic partnership with AstraZeneca and to manufacture key products for them. We are excited to be able to transition this AstraZeneca center of technical excellence to a worldwide pharmaceutical services center of excellence. This exceptional facility will be the fifth site in our global network with other facilities in the U.S., Puerto Rico, Ireland and now the UK.

"We thank the AstraZeneca employees in Avlon for their dedication, and we wish them well as they transition to Avara,” said Marc Jones, executive vice president, supply, EMEA, AstraZeneca. "We have confidence that Avara is the right company to oversee the continuing supply of the AstraZeneca products that are made at the facility, as well as to build a long-term sustainable future for the site. We look forward to partnering with Avara as the new owner of the site to ensure the continuous supply of our products for the patients who need them."

Syngene International Commissions Dedicated R&D Center for Amgen

Syngene International, one of Asia’s largest R&D focused contract research organizations, has announced the establishment in Bangalore, India, of an integrated, multi-disciplinary drug discovery and development center for Amgen, Inc. This center, named Syngene Amgen Research and Development Center (SARC), will be Syngene’s fourth such exclusive R&D center. Syngene already operates dedicated R&D centers for Bristol-Myers Squibb, Abbott Nutrition and Baxter Inc.

The state-of-the-art dedicated center will be staffed by a team of more than 100 highly qualified Syngene scientists, working in close association with Amgen researchers around the world on the discovery and development of innovative medicines.

In addition to being customized to meet Amgen's functional requirements, the facility complies with the highest regulatory standards. Its design includes a range of environmentally-friendly features and flexible layouts, and is configured to minimize solvent and effluent waste with a strong emphasis on laboratory safety and “green” chemistry.

Commenting on the Syngene Amgen Research and Development Center, Jonathan Hunt, Chief Executive Officer, Syngene International, said, "We are delighted to announce the establishment of our dedicated R&D center for Amgen. Bringing together into one place, the range of activities we conduct on behalf of Amgen indicates the strategic nature of our relationship and also reflects the ability of Syngene’s scientific teams to deliver world-class science towards our partners’ R&D programs in both biotechnology and small molecule medicines.”

Syngene has partnered with Amgen in a variety of discovery and development projects. With the establishment of SARC, this association now extends into a multi-discipline collaboration spanning capabilities in medicinal and process chemistry, biologics, bioprocess, drug metabolism, pharmacokinetics, bioanalytical research, and pharmaceutical development.

Vibalogics Expands German Fill/Finish Site

German CDMO Vibalogics has upped its capabilities 300% citing a lack of worldwide capacity for biologics fill and finish.

The contract development and manufacturing organization (CDMO) has added a Bosch ARF 1020 filling machine, and a Seidenader visual inspection station and automatic labelling machine at its Cuxhaven, Germany manufacturing facility. The firm will now be able to fill 7,200 vials per hour with a maximum validated batch size for automatic liquid filling of 30,000 vials.

According to John Shaw, head of business development at Vibalogics, the investment was “significant” and bolsters its aseptic fill and finish capability by around 300% to support demand for early phase biologic products.

“There is a lack of aseptic fill and finish capacity worldwide for live products requiring BSL-2 [Biosafety level] facilities, especially at the small to medium scale,” he said

While the expansion was therefore driven through lack of availability in the marketplace for fill/finish at such a scale, he added the extra capacity was also brought online in preparation for infectious disease outbreaks.

“The Ebola outbreak [in 2014/15] is a great example of this where a number of companies needed to get clinical trial material available to patients in a very short space of time. We are in a much better place to be able to help with these instances in the future now.”

Many of the larger biologics manufacturers – Eli Lilly, Novartis, Celltrion etc. – have signaled their intention of keeping complex biologics manufacturing processes in-house, but according to Shaw, fill and finish activities buck the trend.

“Biologics companies choose to outsource fill and finish activities of this nature due to the highly specialized facilities, equipment and staff required to perform such activities,” he related.

Furthermore, “for clinical trial material, routine batches are not necessarily required, so it might not make sense for a company to make the investment in this area.”

Cambrex Capacity Expansion at Karlskoga Facility

Cambrex will spend $9m (€8m) to add large-scale manufacturing capability at its API production facility in Karlskoga, Sweden.

The US active pharmaceutical ingredient (API) manufacturer announced the expansion, citing customer demand and a desire to improve efficiency. The plan is to add multi-purpose reactors to accommodate the production of various drug actives.

Cambrex also said it will upgrade the site’s control room. In June the firm installed an Answerthink laboratory information management system at the facility.

The reactors are expected to be operational before the end of the year. Bjarne Sandberg, managing director of the Karlskoga site, said: “By creating greater capacity within the current infrastructure, we have combined expansion and efficiency at the site.”

A spokesman said, "The expansion at Cambrex’s Swedish site is part of our ongoing strategic campaign to invest in small molecule API manufacturing across our global network of facilities, in response to an increase in demand for larger scale, multi-purpose manufacturing capabilities."

He added that: "Financial investment is carefully considered prior to commissioning the expansion of any manufacturing plant. Factors include elements such as the value of the products manufactured, the customer base and the customers’ current and anticipated requirements, location, in addition to operating costs.

"We have seen an increased need for larger scale, multi-purpose manufacturing capabilities and we are confident that the expansion will be well utilized."

The Karlskoga investment follows a number of capacity expansions at Cambrex’s US manufacturing site in Charles City, Iowa.

The rationale for all the expansion has been “get ahead of the capacity utilization curve” according to CFO Gregory Sargen. He told investors during Cambrex’s second quarter conference call in July that the previous reactive strategy had meant the firm “lost some opportunities.”

Cambrex's desire to make the most of opportunities comes as observers (here and here) raise questions about its continuing reliance on Gilead Sciences. The firm makes the APIs for the blockbuster hepatitis C drugs Sovaldi and Harvoni for Gilead.

According to Cambrex’s financials results, Gilead contributed 34.5% of its 433m revenue in 2015. Harvoni sales fell 22% in the first six months of 2016.

Hepatitis C is an increasingly competitive field and Harvoni has suffered. In the second quarter the drug generated revenue of $2.56bn, which is down 29% on the year earlier quarter largely due to lower US sales.

Solvadi, Gilead’s successor to Harvoni, saw sales increase 5% to $1.36bn in the period.

The Karlskoga facility makes APIs and intermediates for a variety of drugs. This includes Genzyme's Renagel (sevelamer hydrochloride) – a treatment for dialysis patients with elevated phosphate levels – which it began manufacturing in 2003.

Cambrex had been making the Renagel intermediate at its US facility in Charles City, Iowa, but growth in sales meant that production capacity needed to be expanded.

At the time Cambrex also said Genzyme also wanted production to take place nearer its new bulk active pharmaceutical intermediate manufacturing facility in Haverhill, UK.

SGS Opens Dedicated Extractables and Leachables Testing Facility

SGS has opened a new Wiesbaden-based facility to serve as its global Center of Excellence for Extractable Studies and Impurities Profiling as customer demand increases.

The bio/pharmaceutical analytical and bioanalytical contract solutions provider recently announced the opening of the new facility in Wiesbaden, Germany, which will offer extractables and leachables testing to the industry.

The offerings were previously available at the company’s Taunusstein, Germany-based laboratory, approximately 20 kilometers from the new site. However, as Dr. Sheida Hoenlinger, Director, Life Sciences Germany at SGS told us, “market demand” has necessitated the investment to “enhance capabilities.”

The new facility will span 5,380 sq. ft. (500 square meters) and will accommodate equipment and instruments transferred from Taunusstein as well as newly acquired pieces, which have been qualified and validated in the new laboratory.

Hoenlinger explained the new facility will feature “enhanced capabilities for extractable studies and investment in equipment for high level impurity profiling which is where we are seeing growing demand.”

“We anticipate growing client demand and needs in terms of capacity, quality and delivery time for their extractable and impurity profiling studies,” she added.

According to the company, all ongoing projects have been transferred to the Wiesbaden facility successfully. The recently freed space at Taunusstein will also allow SGS to expand its quality control release testing capabilities at that facility.

BioInvent Facility Expansion

Swedish antibody developer BioInvent is growing its capabilities and has extended a contract with an undisclosed Big Pharma firm.

The deal will covers services for one of the products in the biopharma firm’s development portfolio and is expected to generate around SEK 8m ($1m) for the contract development and manufacturing organization (CDMO).

While the firm would not divulge the client, it said the extension was driven by expansions at its antibody production at its cGMP-certified facilities in Lund, Sweden.

“BioInvent works with antibodies and we also produce antibodies for our customers,” said SVP of Technical Operations, Kristoffer Rudenholm-Hansson. “We currently work with Wave systems with up to 500L working volume in manufacturing but are upgrading the facility now. This contract extension uses the current system.”

While the quantities produced will vary depending on process, Rudenholm-Hansson said a new 1,000L Single Use bioreactor (SUB) at the facility will – with a product titer of 3.5 g - be capable of generating more than 2 kg IgG as drug substance.

“From January 2017 we will expand our upstream capacity by installing 1,000L SUB. This will meet our projected needs for our own requirements for the coming years, and we will utilize any spare capacity for our current and potentially new customers.”

Production is fully based on single use technology and the firm does not use stainless steel or glass bioreactors.

The decision to install the new 1,000L SUB was due to the need “to expand our capacity and to move away from the size limitations that are connected with our current cell culture technology,” Rudenholm-Hansson added.

Spain's Idifarma Receives Investment from Suanfarma

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

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

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

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

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

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

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

Cancer Treatment Lab to Become a Reality

An entirely new approach to cancer treatment is one step closer to the clinic with the opening of Canada’s most innovative lab for T cell therapy development at the BC Cancer Agency. Built 100 per cent with philanthropic funds, the Conconi Family Immunotherapy Lab forms the hub of custom immunotherapy treatment production for cancer patients across B.C.

With $5.5 million raised through the BC Cancer Foundation to launch immunotherapy clinical trials, the lab is a critical component, providing a facility to create promising new treatments. Scientists will now begin testing the facility and T cell therapy production to ready for clinical trials.

The new lab bears the Conconi name, honoring a $2 million gift the family made to the BC Cancer Foundation, which inspired more than 5,900 donors across the province to open their hearts and give.

Dr. Brad Nelson leads the Immunotherapy Research Program at the BC Cancer Agency and he says: “Immunotherapy is beginning to have striking, durable effects against many different cancers and we are immensely grateful to the Conconi family and BC Cancer Foundation for giving us the tools to bring these new treatments to the clinic.”

For the thousands of British Columbians diagnosed with advanced cancer, new treatment options afford hope that a solution is around the corner. Clinical trial lead and medical oncologist Dr. Anna Tinker says: “The hope for all of us is to be able to offer highly effective treatments that help people live better and longer.”

Immunotherapy is an approach that engages the patient’s immune system to effectively eliminate disease. It is one of the most promising areas in cancer research and care today.

The lab’s initial focus will be on Adoptive T Cell Therapy. This is a specific form of immunotherapy that amplifies the power of T cells—immune cells responsible for destroying viruses and tumors—extracted from an individual cancer patient. In a highly selective process, scientists identify the T cells already attempting to destroy the cancer and multiply them by the thousands in the lab. The end product is a supercharged batch of a patient’s own T cells that can be delivered through an IV infusion.

Phase I clinical trials for ovarian and cervical cancer are slated to begin in early 2017.

“The Conconi Family Immunotherapy Lab is a beacon of light for the people of B.C. who are impacted by cancer and we are so proud that thousands of donors have given our scientists the building blocks to bring a new treatment program to life,” says Sarah Roth, President & CEO, BC Cancer Foundation.

The BC Cancer Foundation is the bridge that connects philanthropic support and research breakthroughs in cancer knowledge. As the fundraising partner of the BC Cancer Agency and the largest charitable funder of cancer research in this province, we enable donors to make contributions to leading-edge research that has a direct impact on improvements to cancer care for patients in British Columbia. We fund with the goal of finding solutions.

AF Wins Contract to Modernize Chr Hansen Plant

Will install a complete fermentation line for the production of probiotics at plant in Denmark

Chr Hansen's production plant in Roskilde is to be modernized

ÅF, an engineering and consulting company serving the industrial, infrastructure and energy markets, has signed a new €5.5 million contract with Chr Hansen to modernize the bioscience company's production plant.

Under the terms of the contract, ÅF will upgrade Chr Hansen's plant in Roskilde, Denmark by installing a complete system for the production of probiotics used in the pharmaceutical and food industries.

The new production plant is expected to be completed in November 2017.

The contract covers the installation of a new fermentation line including upstream and downstream equipment.

ÅF is responsible for project management, process and electrical design, installation, commissioning and qualification of all necessary components.

'With a new modern production plant we will meet the higher capacity demands from our customers,' said Esben Terstrup, Director, Human Health Production at Chr Hansen.

'ÅF’s competence and experience from similar projects made them the best partner to us.'

The project will be managed from the ÅF office in Herlev, Denmark with engineers from both Denmark and Sweden.

Avacta Opens UK Facilities

The newly-opened sites in Wetherby and Cambridge, UK adds a total of 9,000 sq. ft. of laboratory and manufacturing space - almost doubling Avacta Group’s current footprint - and focuses on the development of its Affimer technology.

The Affirmer platform – acquired when Avacta bought Aptuscan in 2012 - is based on a small human protein that can be engineered to bind with high specificity and affinity to a wide range of protein targets, and according to chief commercial officer Philippe Cotrel involves a well-established bacterial expression process.

“The process for producing Affimer proteins is a straightforward bacterial expression process using E.coli. It is currently done using benchtop equipment and can be easily scaled up using standard bioprocessing equipment,” he said.

“At this stage, production is not a bottleneck and the expansion is to support our increased therapeutic focus as well as our custom service and reagent R&D efforts.”

The Wetherby facility will focus on reagents for research and diagnostics, as well as providing a third party service, while the Cambridge plant will focus on therapeutics both for both internal and co-development pipelines.

But though Affimer therapeutics are still in the pre-clinical stage of development, Cotrel said such products have “significant potential benefits” over traditional antibodies for therapeutic use.

“Affimer biotherapeutics can be engineered to have tuneable half-life, which can be tailored according to therapeutic need,” he said, adding they are smaller than antibodies and “therefore have the potential to exhibit higher tissue penetration.”

He continued, saying “bi-specificity is much easier to achieve with Affimer biotherapeutics vs antibodies, and fusions to other functional proteins are simple to generate and manufacture, enabling combination targets.”

Novartis Invests in French Biologics Site

The expansion at Novartis' Center of Biotechnology in Huningue, France was first announced in a meeting with French officials in April.

Novartis has recruited Jacobs to undertake a €100m expansion at a French biomanufacturing facility which will add a second purification line and several cell culture bioreactors.

The investment – valued at €100m ($111m) over the next four years – will bolster production at the Huningue, France Center of biotechnology facility, described by the Swiss biopharma firm as “the crown jewel of Novartis's monoclonal antibody bioproduction sites for the global market.”

The decision to expand was driven by increasing demand for Novartis’ global biopharmaceuticals, the firm said when it announced plans to expand during a Conseil stratégique des industries de santé - a strategy meeting between the French Government and healthcare industries – back in April.

The plan was cemented with Novartis awarding a contract to construction firm Jacobs Engineering Group for engineering, procurement and construction management services at the site.

Under predicted timelines, new production equipment will be installed by January 2017 and commercial activities will begin by the end of 2018.

Philippe Barrois, general manager of Novartis Pharma in France said in April: "The scope of this project covers extension of the main production building, creation of a second purification line and addition of cell culture bioreactors. This operation aims to increase the site's production capacity by 70% and to enable parallel production of two medicinal products simultaneously.”

The investment will also bolster jobs at the plant, with Barrois adding around 100 jobs will be added to Huningue’s 430 strong skilled workforce by 2020.

Situated across the French border from Novartis’s headquarters in Basel, Switzerland, Huningue manufactures several active ingredients, including asthma and psoriasis treatments, anti-rejection drug for kidney transplantation and an anti-inflammatory agent within Novartis’ portfolio.

It is also Novartis’ main production site for biotechnology-derived drugs, the firm says, claiming it to be “one of the largest plants for the production of antibodies from mammalian cell culture in the world.”

In 2012, the site made enough antibodies for three million medication doses.

The expansion follows a number of investments by Novartis subsidiary Sandoz, which recently said by 2020 it will have invested a total of $1bn in its Austrian biomanufacturing capabilities over a ten-year period, supporting both a blossoming biosimilar portfolio and providing production capacity for Novartis’ innovative biologics.

Under the terms of the agreement, Jacobs is providing engineering, procurement, and construction management services to increase the site’s production capacity by 70% and create a second line of purification that allows for multiple drugs to be manufactured simultaneously.

Already one of the world’s largest production facilities for monoclonal antibodies from mammalian cells, the expansion project adds cell culture bioreactors to the site. The $100 million expansion project is scheduled to be completed in four years. Jacobs’ services are being led from its operations in Milan, Italy.

Plans for Lab Facility in Newcastle upon Tyne Approved

Newcastle Laboratory will provide more than 70,000ft2 (6,503m2) of specialist facilities for the life sciences and healthcare sector in the region, offering incubation and grow-on space.

The building will join Newcastle's other new builds, The Core, and Urban Sciences Building, forming what is now called Science Central, a 24 acre City Centre site being delivered by a long-term partnership between Newcastle University and Newcastle City Council.

The first building at the site known as The Core has now opened and Bowmer & Kirkland is constructing a second Urban Sciences Building for completion in September 2017.

The building has been developed by a design team led by Aura alongside award-winning architectural firm Ryder, which has been supported by leading industry specialists including CAM-SCI, to ensure the building meets the needs of the healthcare and life sciences sector.

Nick Forbes, Leader of Newcastle City Council said: 'Newcastle Laboratory will provide much needed specialist facilities to support pioneering research and significant expertise happening here already, building on Newcastle’s global reputation for research excellence in life sciences.

'Science Central is already home to three national research centers – testament to Newcastle’s world-class strengths in the science and health sector, and this new facility will help accelerate the pace of growth in this sector, and create the next generation of highly skilled jobs in the region.'

Emma Banks, CEO of Datatrial, who has been working on the life sciences strategy with the North East LEP, said: 'Newcastle and the North East already has a vibrant and internationally recognized healthcare and life sciences industry. With the addition of laboratory space and associated business support services at Newcastle Science Central, we have an opportunity to better meet the needs of our already growing sector, attract more investment to the region, support new businesses as they grow and create new and exciting employment prospects.'

It is anticipated that building work will start on site in early 2017, and the facility is expected to be up and running by spring 2018.

Newcastle Laboratory is being funded by Newcastle City Council, the North East LEP as part of the North East Growth Deal (Local Growth Fund) from Government, and also decision is expected on funding from European Regional Development Fund as part of the European Structural and Investment Funds Growth Programme 2014-2020.

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