CoreRx and Aimmune Therapeutics joint expansion to create pharmaceutical jobs and increase the base of scientific capabilities in the Tampa Bay, Florida area.

CoreRx and Aimmune Therapeutics announced their expansion of Myerlake-3. CoreRx is a contract development and manufacturing organization (CDMO) servicing the pharmaceutical and biotechnology industries, and Aimmune is a clinical-stage biopharmaceutical company advancing a therapeutic approach for the treatment of peanut and other food allergies. Jointly, the companies have increased manufacturing operations at CoreRx's ICOT Center campus in Clearwater, Florida.

This new expansion consists of approximately 20,000 square feet of manufacturing and warehouse space at CoreRx's 5733 Myerlake Circle (ML-3) location.

This growth will necessitate additional staffing at CoreRx including positions within pharmaceutical development, manufacturing, engineering, quality assurance and packaging.

"The Tampa Bay area is a great place to expand the base of scientific capabilities. These expansions in the Private-sector result in high-paying, skilled roles that contribute immensely to society by providing products and services that impact the quality of lives of Americans. These expansions continue to showcase the Tampa regions expertise in high technology manufacturing on a national and global level." said Todd R. Daviau, President and CEO of CoreRx. "And, we will continue to expand our capabilities to meet the growing demands of our clients."

Lupin Expand Base in the U.S.

In May, Lupin announced the completion of expansion activities at its Somerset, NJ manufacturing facility. The Mumbai-based generic maker is planning to increase production to as much as 4.5 billion units out of the 150,000-square-foot factory by the end of next fiscal year. Currently, the plant makes about 3.5 billion units of various drug categories.

For the expansion, Lupin spent $20 million upgrading the Somerset facility. The company acquired the factory from Gavis Pharmaceuticals for $880 million in 2015 as part of its strategy to set up a manufacturing base in the U.S. In addition to the 45,000-square-foot manufacturing facility, the Gavis purchase provided Lupin with another 124,000 square-foot packaging and distribution wing. It is expanding the distribution operations at the Somerset site as well by adding another 40,000 square-feet of space.

The Gavis deal helped Lupin to get into controlled substances and dermatology segments, which the New Jersey-based niche generic firm specializes in. At present, the Lupin plus Gavis portfolio comprises over hundred products. With several approvals pending, the company is targeting to launch more than two-dozen products every year in the U.S. market.

“This expansion was a tenfold expansion in capacity at the Somerset site and was part of a plan to meet the demand for affordable medicine in the U.S.,” said Vinita Gupta, chief executive officer, Lupin. “The need for affordable medicines to all in the U.S. is steadily increasing and Lupin is very committed to meet the need.”

Lupin is one among those Indian generic majors striving to have a deeper presence in the U.S. even as the debate over drug pricing is catching fire in the world’s largest marketplace under President Trump. In line with Lupin, these firms cherish the view that the need for affordable medicines is getting bigger and bigger by the day for patients, government and other stakeholders in the North American country.

With a record number of ANDAs and DMFs, pharma firms from India play a prominent role in the U.S. generic space today. Indian biopharma companies also hold forth that biosimilars with similar levels of quality, safety and efficacy of the transformational innovator products, can provide an affordable alternative therapy for both patients and payers.

Clearly, the Indian generic players discern the preference for cost-effective therapies will continue to rise in the U.S. market. At the same time, they also see the possibility that the new regime is favoring made-in-America drugs. This may, partly, explain expansion activities, of late.

In recent years, several Indian companies have been successful in establishing their own manufacturing bases U.S. soil. According to the Indian Pharmaceutical Alliance, an industry grouping of large Indian firms, its member companies have invested nearly $9 billion while employing over 4,000 people in the U.S. over the past six years.

Foreign Pharmaceuticals Expanding in USA

Glenmark Pharmaceuticals, another generic firm headquartered in Mumbai, is now on a hiring spree to man its manufacturing facility at Monroe. Glenmark is planning to enhance the local workforce by 45% as part of expanding the 102,000-square-foot factory in the Monroe Corporate Center, which the company started building in 2014.

Post-expansion, the plant will be able to churn out 300-400 million capsules and 20-25 million vials and pre-filled syringes. To broaden the manufacturing capacities further, Glenmark is in the process of purchasing another five acres of land near the 15-acre Monroe campus.

The company says it will manufacture more in the U.S., according to Robert Matsuk, president, North America and global API business of Glenmark. The company’s U.S. sales grew over 50%.

Glenmark expects to bolster North American operations as the company gets into differentiated product lines including complex generics and drug-device combos. Glenmark is also seeking approval from the FDA to manufacture commercial batches of controlled substances. The company recently obtained clearance from the Drug Enforcement Administration (DEA) to manufacture Schedule II drugs.

Reports indicate that Aurobindo Pharma is looking to establish its second U.S. facility for local manufacturing. The Hyderabad-based company began construction on its injectables factory at the 90-acre campus on Windsor Center Drive in New Jersey late last year.

Meanwhile, others, including Cipla, which bought out generic manufacturers InvaGen and Exelan for $550 million in February 2016, are keeping a close watch as the scenario unfolds.

Covance Opens Diagnostics Laboratory

LabCorp’s Covance has opened a new companion diagnostics laboratory as is prepares for an increasing demand for precision medicine – a market expected to reach $112.62bn by 2025.

The dedicated companion diagnostics laboratory leverages Covance’s drug development experience and LabCorp’s complementary commercialization abilities.

The new laboratory is part of a multi-use facility in Morrisville, NC. The facility also includes a genomics and molecular pathology laboratory and an FDA-approved nuclear magnetic resonance (NMR) spectrometer.

With the new laboratory the company is preparing for increasing client demand, said Sue Maynard a LabCorp representative.

According to a recent report, the global precision medicine market is projected to grow at a compound annual growth rate of around 11.2% over the next decade to reach approximately $112.62bn by 2025.

“In 2016 alone, we participated in more than 60 companion diagnostic programs supporting 145 clinical protocols,” Maynard explained.

The company’s companion diagnostics capabilities include applied genomics, next-generation sequencing, anatomic pathology and histology, flow cytometry and clinical immunoassays, as well as preclinical and exploratory biomarker development.

Maynard said there are currently 25 people at the laboratory who are dedicated to the development of companion diagnostics.

Sarepta Opens Research and Manufacturing Center in Andover, MA

Sarepta Therapeutics is formally opening its Research and Manufacturing Center in Andover, MA, with plans to double its workforce there over the next year to year-and-a-half—less than a year after winning a controversial first-ever FDA approval for a Duchenne muscular dystrophy (DMD) treatment.

Sarepta plans a grand opening for the facility, whose cost was not disclosed, and where approximately 50 employees are now based. That number will grow by 100% over the next 12 to 18 months, the company said.

The facility’s initial focus, Sarepta said, will be to advance its pipeline R&D programs. The company said it could have up to seven investigational DMD treatments into clinical phases by year’s end.

According to its website, Sarepta’s pipeline includes separate Phase III DMD treatments that skip exon 53 and exon 45, as well as a preclinical candidate designed to skip exon 52, and discovery-phase candidates designed to skip exons 8, 35, 43, 44, 50, and 55. Sarepta’s DMD candidates are designed to skip an exon in the dystrophin pre-mRNA to enable the synthesis of a shortened, functional form of the dystrophin protein.

Sarepta has been based in Massachusetts since 2013 and moved into its current Cambridge, MA, headquarters the following year. Also in 2014, Sarepta disclosed plans to expand its operations in the Commonwealth, shelling out $15 million to acquire from Eisai the 26-acre Andover site, at 100 Federal Street, which the Japanese pharma giant shut down the previous year.

Last year, Sarepta shifted to Andover and Cambridge operations that were based in Corvallis, OR, in a consolidation and restructuring that shrunk the company’s workforce 19%.

“Sarepta has benefited enormously from the Commonwealth’s talented and highly educated workforce. This expansion underscores our ongoing commitment to patients with Duchenne and investment in the vibrant Massachusetts economy,” Edward M. Kaye, M.D., a director on Sarepta’s board and a special regulatory and scientific advisor to the company, said in a statement.

Kaye resigned as president and CEO in April, seven months after Sarepta won FDA approval for its exon 51-skipping DMD treatment Exondys 51™ (eteplirsen) despite recommendations by two advisory committees against approving the treatment and over objections from some administrators. Those administrators included the then-director of the FDA’s Office of New Drugs (OND) John K. Jenkins, M.D., subsequently retired from the federal government.

After winning approval for Exondys 51, Sarepta obtained a Rare Pediatric Disease Priority Review Voucher (PRV) that it sold to Gilead Sciences in February for $125 million upfront.

Massachusetts Gov. Charles D. Baker will head a group of dignitaries set to speak at the grand opening, along with Robert K. Coughlin, president and CEO of the state’s biopharma industry group MassBio, and Travis A. McCready, president and CEO of the Massachusetts Life Sciences Center’s (MLSC).

Baker announced plans to provide up to $500 million over five years for strategic investments in public infrastructure, R&D, workforce training, and education, including up to $295 million in capital authorization and up to $150 million in tax incentives tied to job creation. The program is intended to continue the Commonwealth’s life sciences effort spearheaded by MLSC, the quasi-public agency that oversees the commonwealth's $1 billion, 10-year Life Sciences Initiative, set to end next year.

QS Pharma Receives EMA Approval for Medicinal Products Manufacturing

US-based pharmaceutical company QS Pharma has received approval from the European Medicines Agency (EMA) to produce certain medicinal products for commercial use in Europe.

The Contract Development and Manufacturing Organization (CDMO), QS Pharma, was purchased by UK-based early phase drug development services provider Quotient Clinical in February this year.

QS Pharma managing director Nutan Gangrade said: “QS Pharma is dedicated to maintaining a robust quality system, underpinned by our excellent regulatory history.

“This approval by the EMA ensures we are able to support customers with interests in Europe, creating further growth opportunities for the business.”

"This approval by the EMA ensures we are able to support customers with interests in Europe, creating further growth opportunities for the business."

The approval was granted after the company’s manufacturing facility in Boothwyn, Pennsylvania, US, was inspected in February by the Dutch Health Care Inspectorate (IGZ) at the request of the EMA.

The inspection focused on two new drug application (NDA)-filed products and the overall quality systems of QS Pharma.

Following the successful outcome of the inspection, in addition to the past approvals received from the US Food and Drug Administration (FDA) and the Prescription Drug Marketing Act (PDMA), the company has currently been granted permission to manufacture medicinal products for the US, Europe and Japan.

Quotient Clinical chief executive officer Mark Egerton said: “QS Pharma is becoming a major global player in the commercial manufacture of market products, with a focus on high-potency manufacturing, and niche therapies and markets such as orphan drugs, for tablets, capsules and oral liquids. This latest inspection and approval adds further value to the business.”

Children’s Hospital of Philadelphia, Schuylkill Campus, Philadelphia, PA

Phase I Cost: $275 million

Size: 8.5 acres/2 million square feet (four phases)

Project team: Ballinger, Architect of Record and MEP; Pelli Clarke Pelli, Associate Architect; Cooper Robertson, Associate Architect; Thornton Tomasetti, Structural; Pennoni Associates, Civil/Survey; Ground Reconsidered, Landscape; Hughes Associates, Code; The Lighting Practice, Lighting; Acentech, Acoustics; Haahs & Associates, Parking; Cloud Gehshan, Environmental Graphics

Description: Located along the Schuylkill River, the Children’s Hospital of Philadelphia is expanding its facility to include a new, 8.5-acre clinical research campus with public gathering areas located directly across the Schuylkill River from the hospital’s main campus. Positioned along South Street, a major city arterial, and Schuylkill Avenue, a neighborhood street, the master site plan, created by the New York based architecture and urban design firm Cooper Robertson, optimizes the use of the site and address the needs of the new research facility. The addition of public spaces provides amenity to the building’s occupants, as well as to the adjacent community and a new pedestrian bridge links the campus to the trail system along the Schuylkill River.

The completed design includes four distinct public spaces totaling 4.55 acres: South Street Plaza, Schuylkill Avenue Green, Bainbridge Place, and a Promenade overlooking the Schuylkill River; each incorporating cutting-edge resiliency practices to manage stormwater and protect against flooding.

The design plans for the collection, conveyance, and retention of 85% of the stormwater that hits the site, through a combination of green roofs, underground cisterns and rain gardens that are expressed as landscape features.

The first building for the campus is the Roberts Center for Pediatric Research, designed by Ballinger and Pelli Clark Pelli, which was recently completed and is a 466,000-square-foot facility with clinical research and office space.

Completion date: first building was completed in May 2017

Sterigenics Invests in New US Capacity

The expansion will provide enough capacity to process around 50,000 additional pallets of product annually.

Sterigenics International, a global provider of contract sterilization, lab services, gamma technologies and medical isotopes, has completed a $16.8 million expansion to its West Memphis, Arkansas, facility, nearly tripling the facility’s gamma sterilization capacity.

Originally opened in 1999, the current expansion adds a state-of-the art Nordion JS10000 irradiator and boosts the total licensed throughput at West Memphis nearly three-fold, enough capacity to process approximately 50,000 additional pallets of product annually.

Philip Macnabb, President of Sterigenics, said: “We are seeing significant demand for more Gamma capacity in the Southwest, which is why we decided to make this investment in West Memphis. This expansion is a first in a series of investments in capacity that we will be making. It is a very exciting time for our company.”

“Memphis is a key regional logistics hub with a growing demand for sterilization services,” said Susan Hope, General Manager of the West Memphis facility. “Our customers have been anxiously waiting for this expansion to come on line and we are looking forward to working with them to take advantage of the faster turnaround we now offer.”

At full capacity, the expanded West Memphis facility will add approximately 20 new employees and will allow Sterigenics to better serve customers throughout the region.

Sterigenics International operates out of 43 facilities in 13 countries across the Americas, Europe and Asia, providing contract sterilization and ionization services for the medical device, pharmaceutical, food safety, and high-performance materials industries.

Shire Focusing on Biotechnology and R&D Hubs in MA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mayne Pharma, Metrics Contract Services Designate Center of Excellence

Mayne Pharma and its contract pharmaceutical development and manufacturing organization, Metrics Contract Services, have designated their new stability storage facility in Greenville, NC a “Center of Excellence.” According to John Ross, president of Mayne Pharma USA, the $3.5 million facility earned the classification by integrating best-in-class operational standards and equipment during construction.

The 17,000 sq.-ft. CoE triples the company’s previous stability storage capacity and is fully validated and operational. “This world-class facility will allow Mayne Pharma and Metrics Contract Services to readily meet the needs of our clients’ stability storage projects today and well into the future,” Mr. Ross said.

The stability storage facility features back-up power generation, integrated system redundancies for HVAC, chillers and humidifiers, and specialty ICH climatic mapping and tolerances for temperature and humidity. Also, three stability chambers offer available shelving capacity of 900 sq.-ft. One chamber has available shelving capacity of 1,530 sq.-ft., and one chamber has capacity of 6,444 sq.-ft.

Mayne Pharma chose to partner with Weiss Technik North America for high-quality, GMP-compatible and FDA-compliant stability testing solutions. Relying on environmental simulation technology, Weiss Technik stability storage systems are customized for specific users and employ energy efficiency standards. Weiss Technik is accredited with ISO 9001:2008, and its stability storage systems meet ICH Guidelines Q1A for Stability Testing and Q1B for Photostability Testing. They also comply with guidelines established by the U.S. FDA, the World Health Organization and the EMA’s Committee for Proprietary Medicinal Products.

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

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

Mayne Pharma is also investing $80 million to repurpose existing capacity and add new facilities and equipment for its pre-commercial analytical labs and clinical manufacturing capacity for Metrics. The 126,000-sq.-ft. facility now under construction expands commercial-scale manufacturing capability to include multi-particulate layering and bead-coating fluid bed technology, as well as significantly increased capacity for manufacturing highly potent products.

University of Illinois at Urbana-Champaign/Everitt Laboratory Renovation

O'Shea Builders has partnered with the University of Illinois at Urbana-Champaign to transform the historic Everitt Laboratory building, at 1406 W. Green Street, in Urbana, into a state-of-the-art bioengineering laboratory. The project includes the renovation of approximately

124,206 sq. ft. of space, while converting over 10,000 sq. ft. into new research areas and associated support spaces for the Department of Bioengineering. The project also includes mechanical upgrades that will improve the efficiency of the heating and air-conditioning system.

The project is seeking LEED certification.

Pfizer Starts Work on Missouri Biotherapeutics R&D Hub

Pfizer is building a $200m (€179m) R&D center in Chesterfield, Missouri at which it will consolidate biotherapeutics process development operations in the region.

The US drug maker started work on the facility, explaining it will be the base for process development for biologics, vaccines and gene therapies.

The firm also said 450 staff currently working at labs in the St. Louis area will relocate to the new center by mid-2019.

Pfizer spokeswoman Samantha Reardon said, “The new Chesterfield facility will house a non-GMP manufacturing pilot plant to enable non-GMP studies and research supplies. The scale of the non-GMP manufacturing will be 50-1000L, primarily single use technologies.”

At present, Pfizer’s operation in Chesterfield is based at a lab in Weldon Spring in leased space at Monsanto’s research campus. Activities include at biotherapeutics R&D and manufacturing for clinical trials.

When the new R&D site is operational clinical manufacturing carried out at the Monsanto campus will relocate to a purpose built facility being constructed in Andover, Massachusetts Reardon said.

“Clinical scale cGMP manufacturing operations for biotherapeutics currently housed in Chesterfield will transition to our Andover, Mass. clinical manufacturing facility currently under construction.”

Pfizer says it has more than 60 biotherapeutics in its pipeline, with programs related to monoclonal antibodies, vaccines, bispecific antibodies, antibody-drug conjugates, novel proteins, gene therapies, biosimilars and CAR T technologies.

In addition to biotherapeutics process development and the production of materials for preclinical trials, the Chesterfield facility will also be a base for delivery technology research.

Reardon said the site will “primarily work on parenteral liquid and lyophilized drug product presentations with a variety of pre-filled syringe and auto injector technologies. We are also continuously evaluating next generation delivery technologies as part of our R&D efforts.”

Pfizer expects the Chesterfield facility to create 80 new jobs.

TiGenix Opens U.S. Headquarters

TiGenix NV, a biopharma company focused on developing therapies leveraging anti-inflammatory properties of allogeneic, or donor-derived, stem cells, has opened a U.S. office in Cambridge, MA. Establishing U.S. operations will support its strategic goal of developing and commercializing its lead product, Cx601, for the treatment of complex perianal fistulas in Crohn's disease patients, in the U.S.

The U.S. operations are based at the Cambridge Innovation Center in Kendall Square, at the epicenter of the Boston-area biotech hub. TiGenix is in the process of appointing a senior team to support the U.S. and Canadian launch of its global Phase III trial for Cx601.

TiGenix anticipates initiating patient recruitment for the trial in North American centers in 1H18. The global trial is designed to support a future U.S. Biologics License Application (BLA) to the FDA.

Eduardo Bravo, chief executive officer of TiGenix said, "It is very exciting to be establishing TiGenix at the heart of one of the world's leading biotechnology hubs. We are working hard to progress the development of Cx601 in the U.S. and having a team based in Cambridge will add further momentum to these efforts to bring a new treatment option to U.S patients suffering from this severe and debilitating complication of Crohn's disease."

Patheon to Expand Capabilities

Patheon plans to invest approximately $45 million at key sites across its global network to expand service capabilities.

The company’s recently acquired site in Florence, SC, will be adding commercial spray drying capabilities. The 15,000-sq.-ft. dedicated suite will contain two spray dryers delivering development and commercial scale spray-dried dispersion (SDD) services. The suite is expected to be online in 2019.

At the Bend, OR site the company plans to expand existing development SDD capabilities with a new cGMP analytical lab, manufacturing suite and additional development scale spray drying. Together, the expanded capabilities at the Florence and Bend locations will provide clients with services for products with solubility challenges, from development to commercialization.

Additionally, Patheon has invested in a new commercial sterile product manufacturing facility in its Monza, Italy site, which will house three, 40m2 lyophilizers with eight-headed integrated filling equipment for lyo and liquid formulations for small and large molecules, in a range of vial specifications. The equipment will have full CIP/SIP systems, auto loading for the lyophilizers contained in full RABs systems to ensure sterility.

Patheon also plans to expand its sterile product Pharmaceutical Development Services (PDS) at the Monza facility. The sterile suite will contain two 7m2lyophilizers and associated sterile vial filling line and analytical lab. This new facility will provide services for both small and large molecule injectable products (liquid and lyo formulations) and will be operational in mid-2019.

Also, at its Greenville, NC site, the company will expand packaging and serialization capabilities. The company has built a new filling and packaging suite and upgraded another of its packaging lines with new technology to improve efficiency and reduce change-over time. The newly constructed 4,800-sq.-ft. suite will come online this fall and features a filling and packaging line equipped with an Optel serialization system. The system includes cameras, pharma proof stations, line master, and bottle and bundle tracker equipment.

“As outsourcing of Pharma development and manufacturing services continues to grow, our customers will need even more advanced technologies and customized solutions to meet their business needs,” said Michel Lagarde, president of Patheon. “With the increasing marketplace pressures, pharma companies are looking to build more reliable, flexible and cost-efficient supply chains. With our focus on people, process and capabilities, Patheon is uniquely positioned to partner with pharma companies to achieve their objectives – cost effectively while delivering the highest quality.”

Sterigenics Grows

Sterigenics International LLC has just added a new irradiator at its West Memphis, AR, facility, nearly tripling the location’s gamma sterilization capacity. The new Nordion JS10000 irradiator will allow the facility to process approximately 50,000 additional pallets of product annually, the company reported in a news release.

The $16.8 million investment is just part of Sterigenics' plans to meet what President Philip Macnabb calls “growing demand for all sterilization modalities.”

“What we’ve seen in the last 10 years is a decent expansion in EtO sterilization, but gamma expansion had not kept pace with demand. Demand is starting to outstrip capacity, which is why we expanded,” said Macnabb.

Macnabb says his team looked around the United States to see what would make sense for customers geographically and identified Memphis as a key regional logistics hub. The decision was then made to expand its existing West Memphis facility. Plans include adding approximately 20 new employees, the company reported.

The expansion will allow Sterigenics to better serve customers throughout the region as well as around the country. Sterigenics will be transferring some gamma processing from its other facilities to the new irradiator.

“We approached some of our customers to see whether they would be interested in shifting their processing from our other facilities, and several said they would prefer that area.” Macnabb said. “Transferring some of these programs will free up capacity in our other facilities around the United States.”

Sterigenics is also set to complete another expansion in Fort Worth, TX, which will enable the company to further support imports from Latin America, said Macnabb. The company also added additional EtO capacity in Atlanta and is planning additional EtO processing to its locations in Costa Rica and Germany.

While growth remains “steady” in sterilization demand for traditional medical devices and pharmaceuticals, Macnabb is also starting to see “more combination devices, such as medical devices with a pharmaceutical coating,” he said. “We are looking at new techniques for these combination devices.

“We are also anticipating the needs of 3-D printed devices, because they will become more prevalent,” he added.

Novel techniques could include different e-beam configurations as well as ambient-temperature sterilization methods, he said. “We could also employ colder EtO processes or cold-chain management in gamma.”

“We are willing, open, and eager to invest in any technologies to meet customer needs, no matter how complex and wherever they are in the world,” Macnabb said, adding that the company is “technology neutral.”

Globally, Sterigenics International maintains 20 facilities for gamma sterilization, 17 for EtO, and 6 for e-beam. The company and its affiliates provide contract sterilization services; through Nelson Labs, Sterigenics offers microbiological and analytical testing and consultancy.

Eli Lilly Completes Expansion of San Diego Biotech Center

Eli Lilly has completed the expansion of its biotech facility in San Diego. The Big Pharma has more than doubled the size of the West Coast site and installed an automated, remote-controlled drug design and testing studio.

The $90 million expansion has added 180,000 square feet to the 125,000-square-foot campus Lilly moved into in 2009. Lilly has used this extra capacity to provide spaces where its biotech, discovery chemistry and research technology employees can collaborate. It also will house an automated studio remote researchers can use to design, synthesize and screen investigational drugs.

This remotely controlled facility is reminiscent of the labs set up by startup service providers such as Emerald Therapeutics and Transcriptic. It also means researchers other than the 200-plus housed at the San Diego site can make use of the capabilities.

Lilly has talked up San Diego as a “game changer” for its drug discovery operation. But the remote drug design studio has contributed to the facility expanding faster than the number of local scientists it employs. Lilly employed “nearly 200 scientists” at the original, 125,000-square-foot campus in 2009. Today, Lilly employs “more than 200 scientists” at the expanded, 300,000-square-foot operation.

Lilly put the cost of the expansion at $90 million. Management framed the outlay as part of its plans to invest $850 million in its U.S. operations this year. Lilly unveiled that President Donald Trump-appeasing number in March. But work on the expansion—and the associated expenditure—started long before this year.

Lilly first unveiled plans to expand the facility in July 2015. At that time, Lilly aimed to complete the work in 2016. But in the end the grand unveiling was pushed back until now.

That allowed Lilly to unveil the facility while San Diego is hosting the BIO International Convention.

The hope now is that the expanded San Diego operation can drive forward an R&D group that has suffered its fair share of setbacks in recent years.

“Expanding our presence in San Diego will not only help us discover and deliver innovative medicines faster, but will also help us achieve our goal of launching 20 new medicines in 10 years,” Lilly EVP Jan Lundberg, Ph.D., said in a statement.

KBI Biopharma Acquires Alliance Protein Laboratories

“As part of KBI, Alliance is now able to offer a much broader range of analytical and biophysical characterization services to the biopharmaceutical industry,” said Tim Kelly Ph.D., president of KBI Biopharma.

The contract development and manufacturing organization’s (CDMO) analytical capabilities in its North Carolina and Colorado facilities include mass spectrometry (Q-TOF and triple TOF), HPLC/UPLC, CE, iCE, ELISA, Biacore, ForteBio, DSF, ICD, FTIR, extensive visible and subvisble particle analyses, among others, Kelly explained.

Moving forward, Alliance and its management team will continue to serve their clients in its San Diego facility and the Alliance name and brand will be retained, Kelly said. Additionally, Dr. Philo and Dr. Arakawa will join KBI’s executive management team and will continue to oversee Alliance operations.

“Scientists in KBI’s NC and CO sites will collaborate with Alliance as needed to perform additional services, and expand the data sets we can provide for comparability and other biopharmaceutical characterization applications,” added Kelly. “We are beginning the integration process to enhance the value that KBI and Alliance can deliver to our client partners.”

The announcement follows previous expansions in 2017, including the acquisition of Opexa’s cGMP cell therapy manufacturing facility in February, and more recently, plans to expand sites in in Durham, NC and Boulder, CO.

Additionally, KBI’s parent company, JSR Life Sciences, is set to acquire Selexis SA, which will be integrated with KBI.

Cambrex Increases API Capacity in U.S., Europe

Cambrex Corporation, a manufacturer of small molecule innovator and generic APIs, announced facility expansions in the United States and Europe.

On May 16, 2017, the company reported a $2.4 million investment to expand pilot plant capabilities at its High Point, NC facility, increasing the site's reactor capacity by 30%. The new 400-sq.-ft. suite—the site’s fourth reactor suite—will feature two 2000-L reactors and a 0.6-sq-meter Hastelloy filter dryer and is expected to be operational by early 2018.

In a second investment at the High Point site, the company plans to upgrade its analytical chromatography data systems for quality control and analytical R&D to Empower 3 software (Waters) in Q3 and Q4 of 2017.

On May 30, 2017, the company announced the expansion of large-scale manufacturing capacity and additional continuous-flow manufacturing capacity for high-purity intermediates at its cGMP facility in Karlskoga, Sweden.

The expansion includes the installation of multi-purpose reactors ranging from 4–12 cu. meters and upgrading of the control room within an existing plant on site. Installation of the new equipment, including a 9-cu. meter hydrogenation reactor, is expected to be completed by Q3 2017.

The company also introduced a dedicated continuous flow production unit, capable of producing multiple metric tons of high-purity intermediates per year.

Patheon Completes Expansion in North Carolina

On May 8, 2017, Patheon announced that it has completed an expansion project at its Greenville, NC manufacturing site. The company invested approximately $26 million to update its sterile pharmaceutical development service (PDS) suite and to build an integrated sterile PDS suite that is compliant with regulatory authorities. The PDS suites provide 7000-square-feet in GMP sterile manufacturing space.

The newly built PDS suite will manufacture sterile liquid and lyophilized drug products. It features freeze dryers and a fully integrated filling line fitted with a restricted access barrier system for sterile drug products. The company has made the investment in disposable manufacturing in this suite eliminating the need for cleaning verification for liquid filling, reducing set up time/product losses, and enhancing sterility assurance. This suite is fully integrated and designed for products in clinical development with the ability to scale up to much larger batch sizes.

Emergent BioSolutions Unveils Expanded Maryland Facility

On May 10, 2017, Emergent BioSolutions held a ribbon cutting ceremony with Rick Bright, PhD, director of the Biomedical Advanced Research and Development Authority (BARDA) and Daniel J. Abdun-Nabi, president and CEO of Emergent, to mark the formal opening of the company’s newly expanded Center for Innovation in Advanced Development and Manufacturing at its Bayview Campus in Baltimore.

The facility is one of three centers designated by the US Department of Health and Human Services to provide advanced development and manufacturing of medical countermeasures to support the US government’s national security and public health emergency needs. Emergent has doubled the Bayview facility’s footprint to 112,000 square feet with investments to the original 56,000-square-foot facility purchased by the company in 2009. The facility, comprised of laboratory, manufacturing, and office space, offers flexible manufacturing of drug substance from microbial, cell culture, or viral production platforms and is equipped with disposable manufacturing technology.

The new suite within the expanded facility is expected to come online with cGMP production capabilities in late 2018. Since its inception, the Emergent Center for Innovation in Advanced Development and Manufacturing has been awarded four task orders by BARDA to develop Ebola and Marburg therapeutics and a Zika vaccine.

REST OF WORLD

Thermo Fisher Scientific’s New Customer Evaluation Centre (CEC)

In order to support the growing need for single-use technologies in the development and production of therapeutics, Thermo Fisher has opened a customer evaluation center (CEC) at its production facility in Cramlington, England, to showcase the latest innovations in single-use technologies. The CEC lab replicates an actual cleanroom and houses single-use mixers, bioreactors and fermentors as well as controllers, support containers and other single-use system components used throughout the manufacturing process. The CEC’s state-of-the-art meeting space will be used for training sessions, workshops and seminars.

“Our new single-use technologies customer evaluation center is designed to provide a wide range of workflow solutions for bioprocessing manufacturers,” said Jim Bylund, vice president and general manager, single use technologies, for Thermo Fisher. “Our customers want to engage in deep technical evaluations and rely upon us to provide comprehensive solutions. The CEC will allow us to better showcase our capabilities and to provide on-going single-use education.”

SGS Expands Extractables and Leachables Testing Capabilities

SGS announced that it has significantly increased its capabilities to undertake extractables and leachables (E&L) testing at its Shanghai, China, laboratory. Its investment includes the installation of multiple analytical instruments, including an isothermal static headspace gas chromatograph with flame ionization detector (HS-GC/MS-FID), two liquid chromatography–mass spectrometers (LC-MS) and one system. A liquid chromatography with time of flight mass spectrometer (LC-TOF-MS) has also been acquired, along with two inductively coupled plasma mass spectrometers (ICP-MS) and one inductively coupled plasma optical emission spectrometer (ICP-OES).

All instruments have undergone installation and validation and are fully 21 CFR part 11 compliant to ensure integrity of information for regulatory submissions.

In June 2016, SGS announced that it had expanded the laboratory in Shanghai and invested in instruments to undertake comprehensive drug compatibility study testing at the facility and to evaluate E&L contamination. This additional investment allows SGS to increase its capacity to handle E&L projects for applications including container testing, medical device evaluation and testing equipment used in pharmaceutical production.

“Extractables and leachables testing continues to be a much sought after service by the pharmaceutical industry, and SGS is renowned around the world for its expertise and experience in this area,” commented Andy Yi, General Manager, SGS Life Sciences, China. “This continued investment in the facilities in Shanghai doubles our capacity in the E&L field, and is in response to the rapid increase in demand from our clients, for whom regulatory compliance is paramount and who trust SGS to overcome analytical challenges effectively and efficiently.”

The investment in Shanghai is the latest undertaken by SGS in E&L testing capabilities, which has also seen the opening of a new global Center of Excellence for Extractable Studies and Impurities Profiling in Wiesbaden, Germany, and the expansion of services offered at its Fairfield, NJ, laboratory.

Bristol-Myers Squibb to Sell Manufacturing Facility in Ireland to SK Biotek

Bristol-Myers Squibb and SK Biotek have signed a definitive purchase agreement to sell Bristol-Myers Squibb’s small molecule active pharmaceutical ingredient manufacturing facility in Swords, Ireland, to SK Biotek, a wholly-owned subsidiary of SK Holdings, based in Seoul, South Korea. The companies intend to complete the deal by the fourth quarter 2017, at which time SK Biotek will continue to manufacture the current portfolio of small molecule pharmaceutical products at the site.

The Swords facility currently manufactures active pharmaceutical ingredients (APIs) for a number of medicines including Bristol-Myers Squibb’s and Pfizer’s Eliquis. Through the years, the site has produced medicines for cancer, cardiovascular disease, hepatitis, HIV/AIDS and psychiatric disorders. SK Biotek will operate the plant as a stand-alone Contract Development Manufacturing Organization (CDMO), and intends to add marketing, research and development (R&D) talent, and invest in upgrades to bring additional capacity to the site. Bristol-Myers Squibb and SK Biotek will manage a smooth transition to ensure reliable supply for customers and patients.

“This transaction is an important step to achieve our goal of becoming a leading global CDMO.” Junku Park, Ph.D., chief executive officer of SK Biotek, commented, “It allows us to enhance technological and manufacturing capacity and build long-term partnerships with existing and new customers. We have chosen to invest in Ireland because of the welcoming business environment and the exceptionally talented workforce, and we look forward to growing our presence in Swords in the coming years. We are very pleased to welcome the Swords facility to SK Biotek.”

SK Biotek has been a supplier to Bristol-Myers Squibb for 10 years and a key producer of commercial API starting materials and chemical intermediates.

Bristol-Myers Squibb and SK Biotek anticipate that the transaction will close during the fourth quarter of 2017. Closing of the transaction is subject to SK Biotek’s receipt of certain environmental permits in addition to other customary closing conditions. The transaction has been approved by the boards of directors of both companies.

BASF to Up Ibuprofen Capacity in Europe and US

BASF has said it will build an ibuprofen plant in Ludwigshafen, Germany and increase production capacity for the API at a facility in Bishop, Texas in the US.

The German chemicals firm described the new facility – which is due to be operational in 2021 – as the “first world-scale ibuprofen plant in Europe.”

BASF said the Texas plant expansion is designed to "fill current supply gaps for ibuprofen in the market" adding that the "expansion will come onstream in early 2018."

The company said it will invest approximately €200m ($227m) in both projects.

Ibuprofen is one of only a handful of active pharmaceutical ingredients (APIs) that BASF still makes.

The firm sold most of its drug ingredient portfolio and several manufacturing facilities to Swiss firm Siegfried Holdings in 2015. The only APIs that BASF retained, in addition to ibuprofen, were its portfolio of omega-3 based actives.

BASF declined to disclose its current ibuprofen production capacity when contacted, but did say it "is a market leader for Ibuprofen in regards to sales and total capacity."

The firm also told us "the investment will create in Ludwigshafen additional jobs that number in the range of the middle double digits."

BASF's remaining API business had a mixed 2016.

In July last year the firm reported that lower demand for drug actives had seen sales volumes dip in its nutrition & health division.

However, in its full year report BASF said the division had seen sales volumes increase, explaining that "demand grew, especially in the pharmaceuticals and animal nutrition businesses."

Alcon Lab Build Completed in Puurs, Belgium

Alcon, Novartis’ ophthalmic division, offers a wide range of surgical, pharmaceutical, and vision care products to treat various eye diseases and conditions. The Puurs manufacturing site plays a role in the global supply of eye care services and products.

Alcon retained international building project delivery company PM Group to provide project management, architecture, HVAC and utilities design for this expansion, which was realized in two phases.

Phase One involved development of a new 10,760 sq. ft. (1,000 m²) chemical lab on the ground floor and an 9,146 sq. ft. (850 m²) microbiology lab on the first floor.

The second phase involved the conversion of an existing 4,300 sq. ft. (400 m2) microbiology lab into a chemical lab and connecting it to the new extension.

Clean Room Construction Completes Science and Technology Projects

Cleanroom design and build specialists at Clean Room Construction have completed numerous projects across the science and technology sectors in its fiftieth year in business.

UK-based Clean Room Construction (CRC) has completed the detailed design for a project with a major British technology company and completed a test laboratory installation for the same company.

CRC has also concluded the stage 3 design for the new International Centre for Engineering and Physical Science at the University of Leeds as well as a multimillion-pound design and build project for Aspar Pharmaceuticals in St Albans, transforming an empty industrial warehouse into a brand new 43,040 sq. ft. (4000 m²) MHRA-compliant tablet manufacturing and packaging facility.

Work on a 12,912 sq. ft. (1200 m²) cleanroom suite for London-based gene therapy company MeiraGTx is also set to finish this summer while work starts soon on a project at Royal Holloway, University of London.

Steve Lawton, CRC’s Managing Director, said: “Demand continues to grow for our in-house expertise and experience built up over 50 years of delivering complex and critical cleanroom facilities for the science and technology sectors.”

Neopharma Buys Plant in Japan, Will Build One in Middle East

With its purchase of a 65% stake in Japan's Cosmo ALA, UAE-based Neopharma procured this plant in Japan.

United Arab Emirates-based drugmaker Neopharma is continuing expansion of its manufacturing footprint with plans to build a $100 million plant in Abu Dhabi just weeks after committing to spend more than twice that for manufacturing plant and development rights to a diabetes treatment in Japan.

Neopharma has acquired a second site in the Khalifa Industrial Zone where it already has a facility, B.R. Shetty told Gulf News. Shetty owns controlling interest in the company. Combined, the two facilities will occupy about 160,000 square meters (1.7 million square feet) of space.

The plans for expansion in Abu Dhabi follow the company's May announcement that it would pay Dhs880 million ($240 million) for a 65% stake in Japan’s Cosmo ALA (now known as Neo ALA) from Cosmo Energy. With that deal, it got rights to develop NatuALA, which it says is a dietary supplement to decrease glucose levels in patients with type 2 diabetes.

Neopharma says it will spend about $140 million on clinical trials in hopes of getting approval for the drug in the U.S., Japan, U.K. and Bahrain. The investment included about $26 million in a plant in Japan to produce the drug if approved.

VxP Expands Sterile Fill and Lyophilization Capabilities

Contract research and manufacturing organization VxP Pharma, along with sister company VxP Biologics, has expanded its lyophilization development and manufacturing capabilities.

This expansion will serve their global pharma and biotech customer base, and will allow VxP to offer end-to-end development and manufacture of lyophilized cGLP tox materials, cGMP clinical trial material (CTM), and also commercial-scale finished product.

“Our sterile products business has expanded rapidly in recent years, with lyophilized products being a major factor in that growth,” said Raymond Peck, chief executive officer, VxP. “This added clinical and commercial scale capacity will support this expansion, and will help us better serve our global client base.”

VxP’s team includes some of the industry’s leading experts in lyophilization, and focuses on the development and manufacture of lyophilized products, including those that are cytotoxic or potent.

The new capacity will support VxP’s continued expansion into the biologics market, and will begin with the screening of effective combinations of solvents, buffers, and bulking agents, in order to deliver robust lyophilized products.

VxP’s formulation team can then develop compounding processes and lyophilization cycles that can be seamlessly transferred from lab-scale to cGMP production, including at a commercial scale.

“Through this expansion, we are adding much needed contract development and manufacturing capacity for the Lyophilization development needs of our clients,” said Mr. Peck. “Until now, we were somewhat capacity constrained, but with this expansion, we can now handle almost anything that comes our way."

SCHOTT Selected to Provide Glass Tubes to PBR Facility, Austria

Microalgae manufacturer ecoduna has selected SCHOTT's glass tubes for its new photobioreactor (PBR) facility after a successful 18-month testing period.

A subsidiary of ecoduna, eparella will operate the sustainable 2.5 acre plant, which is scheduled to be built this year using 143 miles of glass tubing. The facility will be one of the largest in Europe that is dedicated to the harvest of omega-3 fatty acids from microorganisms and production is expected to begin in 2018.

SCHOTT will deliver several hundred thousand units, which can hold more than 780,000l of photoactive volume. The facility will produce 100t of algae annually.

In vertical PBRs, algae is grown in transparent tubes filled with water and nutrients to fuel photosynthesis. ecoduna produces and harvests different algae such as chlorella or spirulina for use as food supplements, cosmetics ingredients, animal food, biofuel, fertilizer, and pharmaceutical components. The market volume of algae production has already exceeded $1bn and continues to grow.

Omega-3 fatty acids are one driver of that growth. They're considered important for brain health, but they cannot be produced by the human body. They must be found in food, but the most common sources such as oily fish like salmon, mackerel, and tuna, are prone to overfishing. By growing omega-3 fatty acids in algae, ecoduna helps take pressure off of fish populations and provides a cost-efficient source of this crucial nutrient.

As PBR technology improves, facilities are increasingly converted from plastic to glass. Glass's cleanability, strength, and clarity improve output and lower costs. Companies expect to replace plastic tubes and panels every few years, while glass can last longer than five decades. In the long run, glass tubing is more cost-effective.

Chief operating officer of ecoduna Silvia Fluch says: "The transition from plastic to glass was an important step for our company.

"The use of recyclable glass in our manufacturing plant perfectly fits our idea of being sustainable and protecting our environment and nature."

Astrazeneca to Expand Sydney Manufacturing Plant

Pharmaceutical company AstraZeneca is investing an additional $100m to expand its manufacturing facility in North Ryde, Sydney, to develop inhaler products for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Over the last few years, the company has invested $100m on the development of the manufacturing unit. It is the global sole supplier to China of a primary respiratory product used in the treatment of asthma.

The facility currently manufactures respiratory medicines, including Pulmicort Respules for asthma patients, reported Sky News.

At a meeting with Australian Prime Minister Malcolm Turnbull in London, AstraZeneca chief executive Pascal Soriot said: “We intend through this incremental investment to generate about $2.6bn of exports out of Australia to a great variety of markets, including China.

“And these products are growing very rapidly and we expect to generate even more investments in jobs in Australia over the next few years.”

"We intend through this incremental investment to generate about $2.6bn of exports out of Australia to a great variety of markets, including China."

The investment will see the construction of three new production lines and about 60 new job opportunities are expected to be created over the next four years, reported The Australian.

The Sydney plant currently has eight manufacturing lines, each with the capacity to produce 70 million units annually, according to media sources.

The company completed an agreement with Recordati for the commercial rights to Seloken / Seloken ZOK (metoprolol tartrate and metoprolol succinate, respectively) and associated Logimax fixed-dose combination (metoprolol succinate and felodipine) medicines in Europe.

Metoprolol succinate is a beta-blocker for the control of hypertension, angina and heart failure.

The firm also said the expansion will create 60 jobs.

Beigene Selects GE’s Flexfactory™ Biomanufacturing Platform

GE Healthcare Facility will manufacture biologics for clinical trials.

GE Healthcare’s Life Sciences business and BeiGene, Ltd. announced that BeiGene has selected GE’s FlexFactory™ biomanufacturing platform for its first current Good Manufacturing Practices (cGMP) biomanufacturing facility in Suzhou, China. Currently under construction, the facility is expected to be operational in 2017. BeiGene is a clinical-stage biopharmaceutical company focused on discovering and developing innovative, molecularly-targeted and immuno-oncological drugs that address severe unmet medical needs in a variety of cancer indications. Announced in August 2015, the company’s new pilot-scale facility will manufacture monoclonal antibodies in its biologics pipeline for clinical trial use.

Predominantly based on single-use technologies, the integrated FlexFactory platform installed at the Suzhou facility will help Beigene to significantly reduce the build-up and commissioning time and help to increase the speed to global markets, including the United States, Europe and China.

John V. Oyler, Chief Executive Officer, BeiGene, said: "We’re excited to be working with GE in connection with our new pilot production facility as we seek to accelerate and expand our development programs. GE’s FlexFactory gives us the speed, flexibility and quality that allows us to continue to focus on developing global, potentially best-in-class drugs for various cancer treatments."

Olivier Loeillot, General Manager, Commercial BioProcess Asia, GE Healthcare Life Sciences, said: "BeiGene is an outstanding exponent of the new wave of exciting biopharma companies coming out of China. Their need to accelerate the development pathway and then reach the market quickly, coupled with a desire to meet global regulatory standards, is something GE is well-placed to support. Not just with the exceptional scalability and applicability of the FlexFactory, but with all the accompanying support for validation, training, and service."

PSL Completes Advanced Process Installations for Pharmaceutical Manufacturing

Powder Systems Limited (PSL), a manufacturer of filtration, drying, and high-containment isolators for the bio/pharmaceutical industries, announced that it has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.

The first project consisted of a pilot-scale pressure agitated nutsche filter dryer (ANFD) and a discharging isolator achieving a design occupational exposure limit (DOEL) of less than 1 microgram per meter cube 8 hours time weighted average. The discharging isolator allows a full recovery of the dried product from a 0.125-m² filtration area vessel, sampling without process disruption, powder dispensing, and packing off within a safe and contained environment for the protection of both operator and product.

The offloading glovebox of the ANFD was designed for the end user with specific requirements linked to the production room where the installation was planned. The entire system consisting of the filter dryer and its discharging isolator needed to be lowered and mobile to fit in to the room. PSL provided a unique system of raising and lowering the complete installation with the isolator still fitted to the filter dryer. To do so, the lower chamber used during packing off of the final product can be disconnected as well as the filter dryer plate, both fitted with castors to be wheeled easily. The installation can then be lowered automatically via a hydraulic system from a 3.28-m height during operation to 2.15 m during transport.

As part of a new batch extension hall at the same manufacturer, PSL also installed a 0.6-m² filter dryer and discharging isolator with the same features as the pilot plant ANFD. For this installation, instead of a mobile lowering mechanism, this large-scale facility was fixed but supplied with a platform. This addition allows operators to feed products from the top lid nozzle of the vessel with a local control box and have visibility via a sight glass. With the filtration area being much larger, this filter dryer has a bayonet style filter plate, which allows for an automated raising and lowering of the filter plate for maintenance, thanks to a hydraulic system.

PSL also installed a 1-m² scalping filter in Singapore in 2015. This large-scale filter is used to recover and treat the filtrate of a slurry coming from another vessel. The filtrate is dissolved with purified water and waste liquid can then be recovered for a more manageable waste treatment. One of the unique features is the minimum gap between the agitator and the filter plate. Removal of the agitator for maintenance is easy and compact. The overall height required for access above the vessel has been greatly reduced. The filter plate is a single piece with no screws or bolts for optimum cleanability and its design allows for interchangeability between filtration media materials.

PSL has been exporting to Singapore since 1990 and more installations are planned in this market. To support this demand, PSL announced plans to open a new office in Singapore for a faster response time to local user requirements.

Cellnovo Adding Device Line in Romania

French technology firm Cellnovo has selected Flex Ltd to build a production line in Romania, to manufacture insulin cartridges for its diabetes management system.

Cellnovo said now that its first large-scale production line - located at Flex’s facility in Austria - has reached capacity, it is looking to increase production and lower costs.

“We are building a second production line to increase the total production capacity of our insulin cartridge,” Cellnovo spokesperson Nicolas Merigeau said.

“One of our goals has been to reduce the cost of production of our insulin cartridges, which is the consumable part of the Cellnovo Diabetes Management System. The location decision for this new production line allows us to benefit from cost efficiencies by significantly reducing the overall cost of goods sold,” he said.

Similarly to the Austrian line, the Romanian facility has a production capacity of 600,000 cartridges per year. The second line is expected to reach capacity in H1 2018.

Cellnovo’s insulin pump includes a mobile touchscreen controller and a blood-glucose reader. The device transmits data automatically, which enables the patient’s condition to be monitored by health care professionals and family members in real-time.

Merigeau said the second production line will meet an increased demand for Cellnovo’s diabetes management technology.

“All our clients will benefit from this second line; our objective is to increase production capacity to meet the already existing demand for our unique micro-pump for insulin delivery,” he said.

Cellnovo is not disclosing whether the increased production would create jobs.

Lonza Expands In Asia: 8,000L Single-Use in Singapore, Regenerative Meds in Japan

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

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

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

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

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

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

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

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

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

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

Micropharm to Invest in Production Center for Anti-Venom in Wales

The investment in new pharmaceutical manufacturing cleanroom facilities is being backed by the Welsh Government. MicroPharm develops immunotherapy products to target infectious diseases and acute toxic conditions and currently produce two anti-venoms for the treatment of snakebites from the European common adder and the carpet viper in West Africa.

The investment will also enable the company to capitalize on opportunities to increase its product range and support its on-going research to provide treatments for devastating diseases such as infection by Clostridium difficile and Ebola.

Its planned £2m expansion, supported by £150000 from the Welsh Government, will see it open new facilities at Cilgerran while retaining its base in Newcastle Emlyn. The investment is expected to create 15 jobs and safeguard a further 14, bringing the total headcount to 51.

MicroPharm joins other similar companies that have chosen Wales as its base. For example, based in Llandysul, Protherics UK provides antivenin for North American pit viper envenomation in the US. Ig-Innovations, also based near Llandysul, produces antibodies for supply to the research, diagnostic, biotech and pharmaceutical sector including MicroPharm, as well as direct sales.

MicroPharm’s CEO, Ian Cameron, said: “We have outgrown our existing facilities in Newcastle Emlyn and the new manufacturing facility at Cilgerran will provide a platform for the long term growth of the company. The Welsh Government has supported the growth of MicroPharm since its inception and we are grateful for the continued support.”

MicroPharm’s expertise lies in producing a range of immunotherapeutic products for clinical

use — designed to treat acute, life threatening emergencies and required urgently either because no alternative exists or any alternatives are unsafe or ineffective. In addition to anti-venoms, MicroPharm is also working on developing a ricin antitoxin having been awarded a contract, valued at up to £7m, last year by the Defence Science and Technology Laboratory (Dstl) on behalf of the Ministry of Defence (MOD). It involves the production of ovine antibodies to the deadly poison ricin and their further processing and manufacture into a product suitable for human use.

Idifarma Approved for EU-GMP Commercial Capsule Manufacturing

Idifarma, a Spanish contract development and manufacturing organization (CDMO), has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain.

The new Bosch GKF-702 automatic capsule filling machine, which is capable of manufacturing from 3,000 to 42,000 hard capsules per hour, is now fully operational and will support Idifarma in the manufacturing of small-scale clinical and commercial batches, as well as providing the ability to simulate industrial production environments during R&D.

Successfully audited by the Spanish Medicines Agency (AEMPS) in June, the GKF-702 strengthens Idifarma’s position as a specialized contract partner for the development and manufacturing of oral solid dosage forms, with a particular focus on high potent compounds and niche pharmaceutical products requiring small batches.

The new investment includes a minibowl for small R&D batches, resulting in a more efficient use of active pharmaceutical ingredients (APIs) and less wastage. The machine also comes equipped with an industrial PC (IPC), which is 21 CFR part 11 compliant and benefits from a variety of interfaces which makes the batch documentation easier to access.

“The latest addition to our facility in Pamplona is a fantastic development for Idifarma, helping us to bolster our manufacturing capabilities and reinforce our position as a specialist CDMO for small-scale niche products in solid oral forms,” said Luis Oquiñena, general manager and co-founder of Idifarma. “The GKF-702’s modular design will help us to future proof our investment ensuring that we can add real value to our clients’ manufacturing and development projects over the coming years. It is important for us to remain versatile and flexible, however we will continue to focus on specialized low-volume and high potent pharmaceutical products which is a key differentiator for us.”

In addition to its expanded capsule filling capabilities, Idifarma has also recently invested in new analytical equipment at its Pamplona facility, including an Agilent gas chromatography system and dissolution apparatus, as well as four new Waters HPLCs to support its growing client base.

PBL Opens UK Bio-Development Centre

Porton Biopharma has opened a biologics characterization and development facility at its site in the UK.

The Atkinson Development Centre was officially opened, adding 4,300 sq. ft. (400 m2) of laboratory space, plus associated plant room at Porton Biopharma Limited’s (PBL) biomanufacturing site in Salisbury, UK.

“This is a developmental facility that undertakes work to support ongoing research and development into improved characterization of current and pipeline products,” said Commercial & Marketing manager Phil Luton.

The center includes a bank of four 20 liter process-controlled fermenters and an additional 50 liter bioreactor that will enable parallel studies on the growth and scale-up of a range of microorganisms under a variety of conditions.

Material made in the fermenters will then be transferred to downstream processing laboratories for the purification and analysis of the compounds.

As well as being used for PBL’s own product portfolio – which includes Acute Lymphoblastic Leukemia drug Erwinase (asparaginase Erwinia chrysanthem) marketed by Jazz Pharmaceuticals, and the UK’s anthrax vaccine – the firm will offer its capabilities to academia and industry as a third-party service.

In January, the firm was hit by a US Food and Drug Administration (FDA) warning letter citing deficiencies relating to aseptic operations at its manufacturing plant.

PBL is currently undergoing a remediation plan, with Luton telling us: “We have a comprehensive Compliance Action Plan to address the concerns raised by the FDA.”

Drug Producer Takeda Opens Facilities in Germany and Builds in Ireland

The global pharmaceutical producer has opened its new facilities at Oranienburg, Germany while its subsidiary Takeda Ireland has started building a high-containment production facility in Grange Castle, Ireland

Takeda Pharmaceutical has completed the construction of its 230,264 sq. ft. (21,400m2) manufacturing facilities in Oranienburg, Germany.

The new facility was built at a total cost of around €100m (Y12bn) and is scheduled to begin operating at the end of 2017.

The state of Brandenburg and the German federal government each contributed half of the approximately €23m in subsidies for the plant expansion.

Takeda announced in 2014, that as a part of its initiative toward the optimization of its global network, the manufacture of solid dosage form pharmaceutical products would be transferred from the Osaka Plant to the Oranienburg Plant and the Hikari Plant. The completion of this new manufacturing facility in Germany is an integral part of this effort.

The Oranienburg site has a 130-year history of pharmaceutical production and specializes in producing solid forms (pills and capsules).

Meanwhile construction has also started on a new production facility at Takeda Ireland's Grange Castle site.

Takeda’s existing footprint at the Grange Castle site will be expanded with the construction of a standalone, high-containment production facility dedicated to manufacturing its oncology product Ninlaro for global markets.

The construction of the plant will be managed by PM Group with over €40m investment in total. The plant is scheduled to become operational in the second half of 2018.

The new production facility will be unique in that it will house the Drug Substance, Drug Product, Primary and Secondary Packaging and QC processes all under one roof.

The main production facility (ground floor and first floor utilities) will have an area of approx. 32,258 sq. ft. (2,998m2) with ancillary structures (including electrical building, services yard etc.) of approx 28,772 sq. ft. (2,674m2). The investment will create approximately 40 new jobs over the next two years.

Fujifilm Diosynth Biotechnologies Adds Production Capacity

Fujifilm Diosynth Biotechnologies responds to the increasing demand by building UK’s first fully single-use biomanufacturing facility in only 14 months.

Biopharmaceuticals are the world’s fastest-growing class of medicines; of the top ten therapeutics on the market today by revenue, seven are biopharmaceuticals and these therapies are about to make an even bigger impact in healthcare with more than 8,000 biologic drug candidates in research and development.

The challenge, however, is that biologics are protein-based drugs manufactured and isolated from natural sources – mostly from microorganisms like bacteria and mammalian cells, and need to be cultivated and purified in strict and highly controlled environments. This means that the development and manufacturing processes for these therapies are demanding and complicated. Many biopharmaceutical companies choose to outsource their biologics development and manufacturing to contract development and manufacturing organizations (CDMOs), which take the burden of manufacturing for biopharma companies.

This means as populations age, patient demand for global access to treatments for some of the toughest diseases –from diabetes to cancer to autoimmune diseases — are expected to accelerate.

It’s why, one of the world’s largest CDMOs, Fujifilm Diosynth Biotechnologies, decided to use its role in the booming biologics industry to address this challenge, by opening and building the UK’s first single-use facility in record time to increase their production capacita of biopharmaceuticals. The company decided to do this replicating their existing factory in the US.

“We decided to replicate our single-use facility in North Carolina, USA to Billingham, UK and it paid off. We were able to build the UK’s first single-use facility in only 14 months,” said Nick Martin, Head of Operations, Billingham, Fujifilm Diosynth Biotechnologies.

With hundreds of drugs in the last stages of clinical trials, Fujifilm Diosynth had experienced increasing demand from their global customers for additional production capacity in multiple markets and in meeting international regulatory requirements.

The company realized it would need additional manufacturing capacity that would allow them to quickly turnaround larger numbers of smaller batches. They felt the key was to create the right capacity for their customers – and single-use technologies would allow them to flex and future-proof their production for batches of different biologics, and do so efficiently.

Even though CDMOs provide biopharma companies access to specialized, manufacturing services, expertise and cost control, they are faced with a common industry challenge of expanding manufacturing capacity in a world of a rapidly growing variety of biologics just waiting to be produced. And oftentimes, they choose single-use solutions to deliver that new capacity.

Single-use solutions are disposable biomanufacturing consumables, which have become very popular in the bioprocess industry. With single-use, cleaning and steaming is minimized and sometimes eliminated, leading to reduced energy and water consumption, but most importantly, biopharmaceuticals are increasingly being developed and then produced for smaller patient populations locally or regionally, targeting the unmet medical needs. This has changed the manufacturing requirements.

Parrish Galliher, Chief Technology Officer, Upstream from GE Healthcare Life Sciences explains that many manufacturers are choosing single-use technologies over stainless steel technologies because “new drugs that are coming to the market are going to need additional capacity. The question is whether the capacity that we have is suitable for these drugs coming to the market. Single-use technologies are more suitable for smaller-scale and multi-product facilities.” In other words, single-use technologies can often be an excellent option for high-volume, diverse batch manufacturers like CDMOs.

As a key partner for Fujifilm Diosynth, GE Healthcare was able to help build the right capacity, and bring its expertise and understanding of the local regulatory environment to accelerate the development process in the UK.

The strong collaboration and strategic thinking around Fujifilm Diosynth’s new manufacturing capacity helped to deliver production capabilities for the CDMO in record time, allowing Fujifilm Diosynth to bring access to therapies to patients around the world.

Biopharma in Ireland

A new exceptional facility will train 1,500 people per year in single-use technologies

Ireland’s reputation as a quaint, quiet island of rolling green hills and friendly villagers in pubs belies a new truth about the Emerald Isle: It’s a leader in the biotech industry, with billions being invested in high-quality facilities and research. But as infrastructure grows, so does the need for skilled workers.

In September 2016, GE announced a training collaboration with the National Institute for Bioprocessing Research and Training (NIBRT) to build expertise in next-generation, single-use manufacturing technology for biotech and biopharma companies. The NIBRT-GE Single-use Training Center of Excellence at NIBRT’s facility in Dublin, Ireland will train approximately 1,500 people per year in the application and use of single-use technologies.

“The center of excellence will afford NIBRT trainees the opportunity to actively learn in an exceptional facility and experience fully customized, hands-on training,” says NIBRT CEO Dominic Carolan. “We have over the years incorporated elements of single-use technologies in our plant, but having all manufacturing operations sited in one dedicated area of our facility will greatly improve the overall experience for our trainees. All indications would suggest to us that there will be an increase in the adoption of such technologies, so we need to be ready to embrace the training need that will arise going forward.”

Single-use technologies are a growing trend in the biopharma industry. They’re disposable biomanufacturing consumables – some as large as 2,500 liters – that replace, for example, stainless steel tanks in biopharma manufacturing plants.

“Single-use implementation is dominating a lot of the conversation now, and it’s fair to say that practically every company, and certainly all the companies that we engage with from a training perspective, are all very much driven by the adoption of disposables where it makes sense,” says NIBRT Training Director John Milne.

But single-use technologies require a specialized set of skills – which will be critical for GE BioPark Cork, Ireland, a GE-managed campus, including four prefabricated, off-the-shelf factories for monoclonal antibody production that use single-use bioprocessing technology. When fully functional, it’s estimated that GE BioPark Cork will create up to 500 jobs.

“When you have people involved in the manufacturing of biopharmaceuticals, their training becomes a very important factor,” says Milne. “When companies implement single-use strategies, there is necessarily more engagement with and manipulation of the systems. This obviously requires a very high level of training and understanding because if you make an unsatisfactory connection, this may lead to a contamination event.”

This Center of Excellence includes a full cell culture upstream process train and downstream purification equipment to focus training on cell culture and protein purification. It will allow NIBRT to offer hands-on, experiential courses for single-use technologies for both new users of single-use technologies or biologics and users familiar with these technologies. In addition, GE customers can practice and train on single-use equipment before it arrives at their facilities.

“What’s exciting about the GE investment is that for the first time, we’re going to create a dedicated space within our facility, a fully integrated facility where we can operate the systems,” says Milne. “We train for competency, attitude and to have people think and understand why they do things, rather than just simply following a procedure. That makes them better at what they do. It makes them more comfortable with what they do. Which could prevent some problem in production because they’re much more aware and clued into what they’re doing.”

According to Milne, single-use technologies reduce capital expenditures because the facilities are typically smaller and less expensive to commission and manufacture. Single-use technologies also allow manufacturers to speed up turnaround time because it eliminates the need to clean and sterilize vessels between production batches.

“The flexibility of single-use technology is what’s really driving the industry. It makes facilities much more versatile, much more flexible, and you can respond to the needs of patients, or the requirements for a particular product, much more quickly than you can with steel,” says Milne. “The key driver behind all of this is ultimately to reduce the cost of goods, which hopefully will have a direct spin-off to patients and to health insurers in terms of costs of our drugs.”

NIBRT is a global center of excellence for training and research in biopharmaceutical manufacturing located in Dublin, Ireland.

But what about the plastic?

In today’s eco-friendly world, plastic might as well be a four-letter word. But Milne says that single-use technologies are ready to change that perception. In fact, single-use technologies can reduce CO2 emissions by up to 75%, and water and energy uses by up to 80%, compared to stainless steel.

“If you compare single-use systems with traditional manufacturing operations across a whole variety of criteria on a head-to-head comparison, plastic will trump steel up to a certain scale,” he says. “I think these systems are environmentally more sustainable than stainless steel solutions, which you may not intuitively think when you talk about plastics.”

Single-use technologies are disposed of by incineration or autoclave, eliminating the need to clean and purify the vessel before moving on to the next process. Milne notes that when facilities incinerate plastic consumables, the energy produced can be harnessed to produce electricity. There’s also a process to burn plastic and convert it into diesel, which can be used as a fuel for agricultural use, such as fueling tractors.

Single-use technologies require a specialized set of skills.

NIBRT staff will be trained by GE experts in July, and in September they’ll run the first collaborative training program to kick off the launch of the training program. Simultaneously, NIBRT will incorporate the facility into regular routine training programs.

CEO Carolan expects the biopharma industry to grow exponentially over the next decade, giving NIBRT trainees exceptional opportunities to work in emerging fields.

“The drive toward increased flexibility and cheaper cost of goods will be underpinned by the use of innovative single-use strategies,” he says. “All indications are that the single-use market will experience great growth over the next 10 years.

From a NIBRT perspective, we will ensure that our facility and training programs remain excellent and current to meet these needs.”

Milne agrees that NIBRT is well-positioned to meet the growing demand for single-use technologies.

“Single-use technologies are here to stay, and there’s only going to be more of it in the future,” says Milne. “As long as we can train the people to work within these modern biopharmaceutical plants, everybody wins. That’s why we’re here.”

Cambrex Increases API Capacity in US and Europe

Cambrex Corporation, a manufacturer of small molecule innovator and generic APIs, announced facility expansions in the United States and Europe.

The company also introduced a dedicated continuous flow production unit, capable of producing multiple metric tons of high-purity intermediates per year.

BioVectra Builds Fermentation and Complex Chemistry Facility in Nova Scotia

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

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

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

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

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