In the midst of a global growth strategy, a German pharmaceutical company plans to make a major investment in Des Plaines, Illinois, a suburb of Chicago.

Last fall, Vetter, a Ravensburg, Germany–based contract development and manufacturing organization (CDMO) that specializes in aseptic filling of syringe systems, cartridges and vials, announced it would be investing €300 million (US$335 million) in expanding and upgrading its manufacturing sites, mostly in and around its home base. In July, the company announced its intention to spend nearly that much in one US location: Des Plaines, Illinois, a northwest Chicago suburb in an area that first welcomed German immigrants by the thousands in the 1840s and 1850s, when German was the primary language in many area homes and churches.

Today the city is a human and cargo transportation hub, just five minutes from O'Hare International Airport, with two Interstates, numerous rail and bus commute options and five railroads all conspiring to fulfill the community's slogan — "City of Destiny" — with destinations worth finding.

The 30,000-sq.-ft. (2,787-sq.-m.) Vetter Development Service (VDS) Chicago facility at Illinois Science + Technology Park in Skokie provides comprehensive clinical development and manufacturing resources from Preclinical to Phase II, including aseptic vial filling. Until now, its smaller-scale work has served as a precursor to full-scale commercial filling contracts carried out at the company's German facilities.

Vetter has signed an economic development agreement with the state, if the project passes muster with the city — and all indications are it will — Vetter is destined to invest $320 million and create at least 300 new jobs. That total would reach 400 to 500 if the company's full 10-year plan of growth comes to pass.

According to the City of Des Plaines Planning and Zoning Board agenda from its meeting on July 26th, the company plans to reuse two existing buildings on the 18-acre (7.3-hectare) property currently owned by the Salvation Army, and construct six new buildings, for a total of over 1.2 million sq. ft. (111,480 sq. m.) of building area. The company has requested that a parking ratio be established for pharmaceutical manufacturing and distribution, and requested planned-unit-development exceptions from the city's maximum height restriction of 50 ft. (15.2 m.) for heights as great as 92 ft. (28 m.).

Vetter's initial concept intends to offer its global customer base a US manufacturing opportunity for their market supply needs of commercialized drugs. If approved, the facility would be the second US manufacturing site of the company, paired with its existing US clinical development support service via a small-scale manufacturing facility located at Illinois Science + Technology Park in the nearby Village of Skokie. That complex employs about 70 of the company's 3,600 employees globally. The purpose and scope of work between the two facilities would not be overlapping, the company stated, but complementary.

“We believe that this project represents a win-win scenario for the residents of Des Plaines and Vetter alike,” said Vetter Managing Director Peter Soelkner at a community meeting July 12, the same day that the Illinois Department of Commerce & Economic Opportunity and the Illinois Business and Economic Development Corporation (ILBEDC) announced the project. “For us, it would be the next step in our plan for continuous growth."

Vetter serves the top 10 pharmaceutical and biopharmaceutical companies, as well as small and midsized firms. One of them is AbbVie, headquartered not far away in North Chicago.

In 2015, Vetter increased sales by 10 percent, and supported nine customer drug approvals.

ILBEDC CEO Jim Schultz and Department of Commerce Assistant Director Andria Winters met with Vetter executives during an April trip to Germany, which occurred following the state’s major presence at Hanover Messe, the world’s largest industrial fair.

“It was invaluable for Jim Schultz and Andria Winters to be able to meet directly with Vetter in Germany. It’s that kind of outreach and customer service that will set Illinois apart and help close deals," said Department of Commerce Acting Director Sean McCarthy, who also gave credit to Skokie Mayor George Van Dusen, area utilities, the City of Des Plaines (whose economic development coordinator is Lauren Pruss) and Cook County for their support.

“Vetter will create hundreds of quality, high-skill jobs for Illinois residents, growing their presence in Illinois with lots of opportunity for future growth,” Illinois Governor Bruce Rauner said. “The collaboration between the State, the ILBEDC and our local partners was instrumental in attracting an investment of this scope and magnitude, which will reap economic benefits for Illinois for years to come.”

In an email interview, Vetter's Peter Soelkner says customers have been asking for commercial manufacturing capability in both Europe and the US over the past couple of years.

"Based on that desire, combined with our long-term strategy for worldwide growth, we started searching for a potential property," he says, noting the April visit in Germany with Illinois officials and the local support. But the search encompassed several US states. "The scales were tipped in favor of Des Plaines," he says, for several reasons:

"Des Plaines offers a diverse business environment that is focused on success and growth," he says. "We discovered a workforce in Greater Chicago that is committed to exceptional customer service. We have the feeling that business gets done here, and that the local workforce is well-educated and hardworking. And of course the high quality of life we have experienced so far is an important additional factor, being relevant for our customer relations and employees' well-being."

A successful approval and purchase process, Soelkner says, "supports our 'ability to act' preparations that put us in the position to offer our customer base greater flexibility in global manufacturing for the future. A facility would enable Vetter to further strengthen its strategic partnership approach with an increased global footprint."

Dr. Susanne Resatz, president of Vetter Development Services USA, Inc., in April was named to the board of directors for the German-American Chamber of Commerce of the Midwest, whose 14-state territory encompasses 1,400 German businesses and about one-quarter of the nation's geographical area, population and GDP. Mark Tomkins, GACC-Midwest president and CEO, says, "We did support Vetter in their search and have had a close relationship since they set up their original US operation" in 2010. That was also the year Resatz arrived in Chicago from Germany. On her appointment to the GACC-Midwest board, she said the company's two-country manufacturing approach aligned perfectly with the organization's mission.

“Actively participating in organizations such as GACC Midwest helps Vetter broaden its horizon, with the goal of contributing to innovative and foresighted business and manufacturing processes," she said. "As such, they are instrumental in helping to strengthen our relationships with customers, suppliers, and other stakeholders.”

Soelkner says GACC Midwest's help "in identifying both the existing small-scale Skokie site and the proposed Des Plaines property for a potential new large-scale facility has been instrumental in assisting in our long-term expansion plans in the US and assisting in US-German trade."

The new investment is just the latest in a series of expansions and upgrades from Vetter, including in Skokie itself, where an additional staff shift for daily clinical manufacturing operations and the doubling of capacities for performing visual inspection and In-Process Control (IPC), among other additional offerings, were completed last June. The facility at that time passed audits and qualifications by as many as 30 companies, including nine of the top 20 leading (bio-) pharmaceutical companies.

"This performance has resulted in a wide-ranging customer base that includes not only those in the US, but also European companies based for example in the UK and Denmark, as well as Asian-headquartered companies such as in South Korea," said the company last June. “Many of our customers have already returned for development work for a second, third, or even fourth molecule,” said Resatz.

Among the company's other recent investments:

In January, a multi-functional building at its Schuetzenstrasse site in Ravensburg — part of the overall investment strategy announced last September — was completed on schedule after two years of construction and €29 million invested. The building was needed due to an increase in demand by customers for support in drug development, as well as the need for enhanced IT systems to meet future customer and regulatory requirements, the company said.

In March, at that same site, the company broke ground on a new €70-million ($79-million), 8,000-sq.-m. (86,000-sq.-ft.), seven-story building that will include a cleanroom, material preparation space, office space and a staff canteen with roof garden. It will begin operations in early 2019.

Elements of the €300-million investment strategy announced last September include the Ravensburg Vetter West center for visual inspection and logistics, expected to be fully operational by 2017; as well as expansion at the Ravensburg Vetter South production site.

In the third quarter of 2015, Vetter opened a new subsidiary in Tokyo to complement the Singapore operating branch created in 2014. “Vetter’s decision to expand their presence in the Asia Pacific region and to open their first office in Japan is a strong message of their commitment to service the needs of this important market,” said Dr. Hitoshi Kuboniwa, senior vice president and general manager of the Pharmaceutical Technology Division at Chugai Pharmaceutical Co., Ltd. The office is located in the rapidly growing Shinagawa district, directly across from Shinagawa rail station with direct access to the international Haneda and Narita airports.

A new 8,500-sq.m. (91,500-sq.-ft.), six-story building at Vetter's Schuetzenstrasse site in Ravensburg contains non-cGMP laboratories for development support, lab space for microbiological analysis, offices for Vetter Development Service and IT, and a data processing center.

As for future growth, Soelkner says, "Right now we are focusing our expansion plans on the US commercial site project." But that doesn't mean the wheels aren't turning. As he puts it, employing a bit of medical terminology, no additional plans are yet "in a communicable stage."

Vernalis Builds in Berwyn, Pennsylvania

Among the more than 100 colleges and universities in the Greater Philadelphia region chosen by Vernalis is the University of Pennsylvania, whose campus soon will be home to a blend of offices, labs and production space known as Pennovation Works.

In October 2014, UK-based Vernalis Therapeutics Inc. established its first-ever US base in Berwyn in Chester County, Pennsylvania, in the Greater Philadelphia area.

A seller of respiratory medicines to Novartis, GlaxoSmithKline and other large pharmaceutical companies, Vernalis worked with the Pennsylvania Office of International Business Development on this project.

“We wanted to be in a location with a rising talent pool,” says Thomas Parker, senior vice president of commercial operations for Vernalis, whose parent firm is headquartered in Winnersh Triangle in Reading, England. “Talent is so critical for startups and emerging companies. If you are constantly looking at relocation for your executive teams, why not avoid that if you can?”

Parker says the entire site selection process took about six months. “We wanted to be in the pharmaceutical corridor,” he says. “A few of our senior management executives, including our CEO and CFO, had experience in the US. Our CFO was familiar with the area because of the Shire Pharmaceuticals location. He was a former Shire executive. The pharma companies around this area made it very attractive for us.”

The initial search cast a wide net, Parker says. “We looked at New York, Boston, Pennsylvania, and the Research Triangle Park in North Carolina,” he notes. “We did a bit of research in South Florida as well. Through our contacts and an official tax assessment, as well as understanding the talent pool in the area, we made our decision to locate in Berwyn in October 2014.”

Parker adds that “the plan was to build the US business with a commercial sales force all across the US, but to do it with the headquarters being in Berwyn in Chester County.”

Vernalis has grown steadily in Pennsylvania since then. “From October 2014 to April 2015, we went from three employees to now 19 in Berwyn. Almost all of them have previous pharma experience. Medical, regulatory and commercial experience are all here. It has been everything we had hoped for when we were ready to hire. In fact, we are now only three new employees away from going to a larger facility. Less than one year after our first approval, we are already seeking out our next office facility.”

Parker says this is an important time for his company. “We are a niche respiratory company right now,” he says. “We do a lot of primary care products. We have about 100 people in sales rep management roles calling on primary care physicians. We make a prescription soft cough cold product. We acquired a product that we are relaunching in June. This move to Berwyn is about being close to our partners. We don’t have to fly across the country to do deals.”

Parker says that with more than 100 colleges and universities in the region, “it is a rich environment with bright people who are looking to jump into this sector and have a career here. Plus, the state supports this sector. We will stay in this area and maybe even right where we are as we continue to grow. I am looking right now at some local space that is available.”

Velesco Pharma Opens Early Phase Materials Handling Laboratory

Velesco Pharma has further expanded its capabilities for materials management by opening a new laboratory in its Plymouth (MI, USA) facility.

The new laboratory will be largely utilized for the storage, dispensing, inventory management and distribution of non-GMP materials such as API, intermediates and compounds transitioning into development.

This addition of increased compound management capacity and capabilities is in response to the needs of Velesco's expanding client base. The company has analysis and formulation expertise to support this compound management activity.

Complementing the current cGMP material storage and dispensing operation in Velesco’s Kalamazoo facility, this new laboratory space enables Velesco to provide compound management services for materials with either cGMP or non-GMP requirements.

These services include long- and short-term storage of materials at ambient, refrigerated or frozen temperatures as well as material aliquoting across a wide weight range, along with labelling and distribution.

‘Our newly expanded materials management laboratory is well suited to meet our client’s increasing need for the storage, analysis and the handling of compounds in the early stage of development,’ said Dave Barnes, PhD, Chief Executive Officer at Velesco. ‘We look forward to collaborating with our clients to efficiently provide the quality services to which they have become accustomed.’

Agilent Technologies to Build New Mfg. Facility in Colorado

Agilent Technologies Inc. plans to build a pharmaceutical manufacturing facility in Weld County, CO. The expansion will more than double its commercial manufacturing capacity for nucleic acid active pharmaceutical ingredients (APIs), and will create 150 to 200 new positions.

“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. “At Agilent, we are committed to meeting the ever-increasing needs of our customers for oligonucleotides.”

“The Agilent project is a huge win for the Town of Frederick, Weld County and all of Northern Colorado,” said Mike Freeman, chairman of the Weld County Commissioners. “The project adds diversification to our thriving economic base, plus significant new jobs and tax base. It also showcases what an amazing growth region Northern Colorado is due to the diverse workforce and business-friendly environment.”

WuXi AppTec Subsidiary Opens on San Diego

WuXi AppTec’s small-molecule process development and manufacturing subsidiary, Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), is opening operations in San Diego. STA provides Process R&D and API manufacturing services for early phase clinical studies.

"STA is a leading global Contract Development and Manufacturing Organization for innovative small molecule active pharmaceutical ingredients and advanced intermediates, from preclinical through commercial," said Dr. Minzhang Chen, CEO of STA. "Our new U.S. based presence with a highly experienced scientific and production team is another step towards better enabling our partners through added capacity, greater flexibility, and our customer-centric approach to drug development and manufacturing services."

"WuXi's open-access capability and technology platform strives to enable anyone and any company to discover and develop healthcare products more efficiently and cost effectively," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "This new facility further brings our comprehensive R&D services closer to our North American customers and partners in their efforts to improve patients' lives."

WuXi also has U.S. facilities in Cambridge, MA, Plainsboro, NJ, Philadelphia and Lansdale, PA, St. Paul, MN, Atlanta, GA and a global presence in Germany, Iceland, Israel, South Korea, and Japan. The company is headquartered in Shanghai with global footprint of more 6.0 million sq.-ft. of R&D space across 26 sites.

Piramal Pharma to Expand Sterile Capacity in Kentucky

Piramal Pharma Solutions, a provider of sterile drug product development and manufacturing services, will invest $25 million to expand its facilities in Lexington, KY.

The company will expand capabilities and capacity for commercial aseptic manufacturing, increasing vial filling capability and lyophilization capacity, as well as upgrades to the associated facilities and utilities.

Phase one of the expansion will add a new manufacturing suite including a high speed vial filling machine that provides controlled/safe environment for handling potent materials with automated Vial Washing and Sterilization. Piramal will also install a new isolator based vial filler in its existing manufacturing suite. Combined, the two fillers will increase the company’s vial filling capabilities by more than five-fold.

Phase two of the expansion will include the installation of two state-of-the-art lyophilizers, which will integrate with the new filler line in the new manufacturing suite with dedicated capacity for both potent and non-potent products

Vivek Sharma, chief executive officer of Pharma Solutions, Piramal Enterprises, said, “Since our initial investment the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this next phase of investment to enhance capability and capacity. We appreciate the active support from the State of Kentucky, the local Government, and most importantly, the community, as we continue our growth plans in Lexington. The expansion in our capacity at Kentucky will help us better serve our customers who are looking for us to deliver solutions that will improve the standard of care.”

MIDI Headquarters and Innovation Center, Smithtown, N.Y.

MIDI’s new headquarters and Innovation Center in Smithtown, NY houses research laboratories, a design and engineering studio, a rapid prototyping lab with a 3D printing system, corporate offices, and conference facilities.

Cost: $5 million

Size: Including the lab: 5,100 sq. ft.; the entire building, including the commercial tenant, a medical diagnostic imaging center: 15,100 sq. ft.

Project team: Client: MIDI Inc.; general contractor: Stalco Construction; structural engineer: Design Bureau of Leonid Krupnik; civil engineer: RMS Engineering; mechanical, electrical and plumbing (MEP) engineer: Mottola Rini Engineers

Completion date: May 2016

Built by Stalco Construction, MIDI’s bio-tech and medical product design and engineering studio features an open plan layout, which supports collaboration and exchange of ideas among the firm’s 30 engineers, industrial designers, market researchers, and branding specialists.

The project encompasses a new 15,100 sq. ft. building that houses headquarters and the Innovation Center for an international medical product research, design, and engineering firm MIDI, as well as a separate diagnostic imaging center of a commercial tenant.

The section occupied by MIDI houses the firm’s corporate offices, research, design and engineering studio, a mechanical and electrical laboratory, a rapid prototyping lab containing a 3D printing system, a manufacturing shop and a conference room with a teleconferencing system. MIDI’s staff includes 30 engineers, designers, software programmers, ergonomics specialists, market researchers, and support personnel. The research and design studio features an open-space layout to promote collaboration between different specialized teams within the company.

The architecture of the new $5 million, one-story building reflects the colonial feel of the historic Village of the Branch neighborhood, which dates back to the late 1600s. The building’s façade features brick face, columns and other ornamental architectural elements prevalent in the landmark structures neighboring the new development.

The construction work included new landscaping, a new surface parking lot for employees and visitors, new curbs, exterior lighting, a keystone retaining wall, and an easement road to provide courtesy access for a church located adjacent to the property.

Research facilities at MIDI’s new Innovation Center include a mechanical and electrical engineering laboratory and a prototype fabrication lab.

Sharp Packaging Expands Contract Packaging

Sharp Packaging Solutions has increased its packaging capacity by 30% for its life science customers with a $45 million investment in a new facility for specialty/biologic/cold chain packaging in Allentown, PA. The company is also and adding four new bottling lines within its adjacent 270,000 sq. ft. contract packaging facilities. The new facility marks Sharp’s third expansion within the Allentown campus since 2014. The contract packaging building at 7529 Keebler Way opened in 2014 and houses six packaging suites, and a technical warehouse and office suite facility opened in 2014 at 7350 William Avenue.

Sharp seized the opportunity to purchase the 112,000 sq. ft. Penn Am Drive building in 2014, and began interior demolition and construction to offer a state-of-the-art biologic and specialty product packaging operation, complete with comprehensive cold chain and serialization capabilities. After internal construction was completed earlier this year, Sharp moved the company’s existing specialty and biologic packaging lines from its Keebler Way plant to the new Center. It then installed 2 to 8° Celsius cold storage to house 600 pallets, doubling its total refrigeration capacity, and invested in additional packaging and serialization equipment. The investment in this new facility increases Sharp’s ability to handle specialty packaging requirements, with room to increase capacity for these products an additional 30%. Qualification and commissioning of the facility was completed in April 2016, and Sharp commenced commercial packaging activities in June.

By consolidating all its specialty and biologic equipment in the new site, Sharp will open up additional packaging capacity for bottling at its Keebler Way facility by September 2016. All bottling lines will be serialization ready, as well as all lines in the new facility in advance of industry requirements for meeting track and trace regulations by 2017. An industry pioneer in serialization, Sharp has been providing serialization services to clients since 2008, with over two billion units serialized in six different formats for 35 client programs, from bottle and individual blister to pallets in support of seven international programs. With the addition of the new capabilities at the new facility, Sharp will be offering serialization at five of its packaging sites, with the intention of adding 4-5 lines per quarter through 2017.

Sharp’s decision to make this investment in its Allentown campus was fueled by the increasing industry demand for contract packaging services of bottled and blister-packed pharmaceutical products business, coupled with the explosive growth of specialty product and biologic package outsourcing.

“Customers with specialty drugs and biologics require complex equipment,” said Doug Hill, senior vice president and general manager, Sharp Packaging Solutions. “We have customers with vials that need labeling and serialization, syringes with a label pack-out, oral thin film strips and then those with automatic, self-injected devices requiring special assembly. With our new facility, we have the dedicated space to meet the most demanding requirements.”

Due to the proximity of the new building to Sharp’s current packaging facility with the use of the same management team, processes and procedures, the FDA is considering a campus approach in their evaluation of Sharp. A new registration with the FDA will not be required for the Penn Drive facility.

“We are working very closely with the FDA,” said Mr. Hill. “Their only request so far has been to be advised on when we anticipate the first production for the building. That information will be provided and the agency will then determine if they will review the building at that time or as part of our next GMP Inspection anticipated in late 2016 or early 2017.”

Kite Opens Commercial CAR T-cell Plant

Kite Pharma has opened a T-cell manufacturing facility in California it says can overcome the logistical problems of autologous therapies and treat up to 5,000 patients per year.

The 43,500 sq. ft. plant in El Segundo, CA officially opened its doors, ahead of the US approval and launch of Kite Pharma’s lead candidate, KTE-C19, anticipated by the firm next year.

The product is intended to treat chemorefractory diffuse large B-cell lymphoma (DLBCL) and is an autologous chimeric antigen receptor (CAR) T-cell therapy, meaning it is made using a patient’s own modified cells, as Kite’s EVP of technical operations Timothy Moore explained.

“[Our] therapies involve a process of extracting cells from a cancer patient and air shipping them to our El Segundo facility,” he said. “In a six to eight day process utilizing Kite’s proprietary genetic engineering technology, the cells are re-engineered to seek and selectively destroy cancer cells while leaving normal cells unharmed.”

The modified cells are then frozen and shipped back to the patient, Moore continued, where they are re-infused into the patient. “The entire vein-to-vein process takes about 14 days, one of the fastest in the industry.”

Time is critical for patients who receive CAR T therapies, and this was a factor in the location of the new facility. “Our facility’s location, next to Los Angeles International Airport, one of the largest and busiest airports in North America, is ideal for expediting the shipment of CAR T therapies.”

As for the manufacturing process, Moore said the El Segundo site will have the capacity to produce up to 4,000-5,000 patient therapies per year using semi-automated equipment source from multiple suppliers.

“The facility is equipped with technology that separates, washes, expands and genetically modifies cells to meet the necessary potency and dose for patients.”

The site will also produce clinical trial material for Kite’s other CAR and T-cell receptor (TCR) candidates, complementing Kite’s existing clinical manufacturing facilities in Santa Monica. However, as the site is focused on commercial quantities, we asked how Moore how confident the firm was KTE-C19 would be approved next year.

“As reported, early results achieved with this therapy have been very encouraging. Approximately half of the treated patients achieve a complete response. Of all patients treated, the overall response rate is 70 to 80 percent. So we remain on track for FDA review in 2017.”

Teligent Advances Facility Expansion

Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, recently held the formal groundbreaking ceremony for the ongoing expansion of its manufacturing and research and development complex in Buena, NJ. The $45-50 million project will increase the facility's footprint by more than 75,000 square feet, a 200% increase to current operations. Once completed, the expansion will include the installation of a new isolator-based sterile injectable manufacturing suite and will deliver a significant increase to the company's manufacturing capacity for topical pharmaceutical products.

''We are making very good progress on our expansion, and this ceremony was an opportunity to celebrate what we are building together,'' commented Teligent's President and Chief Executive Officer, Jason Grenfell-Gardner. ''We continue to be on track for project completion by the end of 2017.''

The Lieutenant Governor of New Jersey, Kim Guadagno, and officials from state, county and local government offices also participated in the groundbreaking event.

As part of the event, the company also published the results of an economic impact study of the expansion recently conducted by Richard Perniciaro, Ph.D., Center for Regional & Business Research at Atlantic Cape Community College. The analysis determined that the construction phase of the project will provide $78 million in new economic activity to the Southern New Jersey region. In addition, Teligent expects to increase the number of employees at the facility by nearly 70%, to almost 200, after the expansion is complete. The complete economic impact study can be found here.

''This plant expansion reflects the reality that you can never stand still in our industry," concluded Grenfell-Gardner. ''More importantly, it represents the vision and courage that all of our employees have to build a stronger, more capable, and more resilient organization for the future.''

Georgia BioScience Training Center, Social Circle, Ga.

Size: 40,000 sq. ft.

Team: Mark D. Jensen, Principal, and Nate Williamson, Associate Principal, Cooper Carry

The Georgia BioScience Training Center reflects Georgia’s commitment to developing a world-class bioscience industry workforce. The facility currently trains employees at Baxalta, a nearby pharmaceutical plant.

Operated by Georgia Quick Start, a division of the Technical College System of Georgia, the Center will serve as a highly visible component of Georgia’s strategic plan to brand the state as a global destination for bio-related industries, and to recruit new industries to locate and create jobs in Georgia.

This 40,000 sq. ft. facility houses state-of-the-art laboratory spaces, classrooms, computer labs, meeting rooms, administrative spaces and all associated storage and functional spaces. The building also includes a large multi-purpose conference space, and a small general food service area. The design is open and transparent, with heavy glass use and ample natural light coming from an outdoor event space in the heart of the facility.

Completion date: Sept. 2015

SGS Adds Genotypic Microorganism Identification in Chicago

SGS has invested in a new Genotypic DNA sequencing MicroSeq^® Rapid Microbial Identification System from Applied Biosystems at its Chicago, IL facility, located in the suburb of Lincolnshire. The molecular identification system is undergoing validation and is expected to be fully implemented in Q3, thus enabling the site to provide accurate, high speed microbiological testing for the identification of microorganisms.

The FDA’s 2004 guidance, “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice,” states that genotypic methods have been demonstrated to be more accurate and precise than traditional biochemical and phenotypic methods, including fatty acid based analysis. With the installation and validation of the new Genotypic DNA sequencing MicroSeq^® ID system, SGS clients will be able to minimize transit delays by consolidating their testing requirements through a single laboratory, rapidly obtaining identification of bacterial and fungal isolates, and facilitating a rapid response to the investigation of contamination.

“The accurate and speedy identification of bacteria and fungi using a built in library will assist our clients with investigations related to sterility contamination, media fill study failures, product bioburden testing, raw material testing and environmental monitoring excursions,” commented Mark Rogers, Vice President for Life Sciences, SGS USA. He added, “We will be able to build custom libraries for our clients so that they can identify and track specific microorganisms quickly and efficiently.”

The investment at SGS’s Chicago site follows recent microbiological testing expansions at the company’s Villeneuve La Garenne, France facility, which provides services to address the growing biopharmaceutical pipeline with capabilities for mycoplasma tests and amino acid analysis, and in Shanghai, China, where a highly active compound laboratory, designed to test products such as antibodies and hormones, is located.

Cambrex Completes Large Scale API Manufacturing and Storage

Cambrex Corporation has announced the completion and validation of a $50 million state-of-the-art production and warehousing expansion at its cGMP Charles City, Iowa site. The investment in capacity and capabilities was made in reflection of strong market demand for small molecule APIs and high utilization of Cambrex’s existing large scale assets.

The new 7,500 sq. ft. multi-purpose manufacturing facility will initially add a total of 70m³ of glass lined and Hastelloy reactors ranging in size from 7m³ to 16m³, along with 6m² Hastelloy agitated filter dryers to provide a flexible, multi-purpose configuration, and will be capable of handling potent APIs at an Occupational Exposure Limit (OEL) of down to 1μg/m3. The facility complements the three existing large scale manufacturing facilities at the Charles City site.

The 36,000 sq. ft. cGMP warehouse provides general cGMP storage for 2,720 pallets and segregated 2-8°C refrigerated storage for 360 pallet spaces and features Distributed Control System monitoring and control for temperature and humidity. The facility employs a barcode system for automated bin location and has a dedicated sampling room with appropriate extraction and handling for flammable materials.

Additionally, a further 7,500 sq. ft. manufacturing shell has been constructed which will be fitted out to customer specification.

“There is high demand for US based suppliers with large scale cGMP contract manufacturing capacity and world class quality systems,” commented Steve Klosk, CEO of Cambrex. He added, “We have invested over $125 million at the Charles City site since we acquired it in 1991 and believe that this expansion, combined with a very talented and experienced team, provides an ongoing foundation for our customers’ small molecule product manufacturing needs while supporting our goal of bringing our customers’ products to market quickly.”

Cambrex’s Charles City, Iowa facility sits on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of a limited number authorized by the US DEA to import narcotic raw materials at commercial scale.

Pfizer Biologics’ Clinical Manufacturing Facility

Pfizer began construction of a new biologics clinical manufacturing facility at its existing manufacturing facility located at Andover, Massachusetts, US, in June 2016. The new facility will be used for the production high-quality, complex biologics and vaccines. It is expected to come on stream by January 2019.

Estimated to cost $200m, the project will create 200 construction jobs, and 75 new job opportunities for people to support clinical manufacturing. It will have clinical manufacturing options designed to provide the low cost and greatest flexibility for efficiently driving new treatments to patients.

The new facility will be a five-story building with a total floor space of 175,000ft². It is designed to have five independent manufacturing suites to support Pfizer's highly complex and diverse biologics research effort.

It will be equipped with flexible design to fully enable next-generation manufacturing strategies, and will use sophisticated single-use bioreactors and disposable process technologies.

The new biological clinical manufacturing facility is being built as an expansion to Pfizer's existing manufacturing facility located in Andover campus in Massachusetts. The new facility will provide added capacity to produce complex biologics and vaccines with the new building.

The Andover facility is spread over in a 70-acre campus, which has seven buildings equipped with laboratories, clinical and commercial manufacturing suites and support areas. It also includes purification facilities and a clinical drug product manufacturing facility.

Andover is located in a strategically integrated site, which serves as an essential part in both Pfizer's research and development (R&D) and global supply network. It has both R&D and flexible, multi-product manufacturing capabilities facilities. It is a hub for R&D in Cambridge and has approximately 2,000 employees based in Massachusetts.

Massachusetts attracted a major investment from pharmaceutical companies including Bristol-Myers Squibb's $280m plant in Devens and several other firms opening up research centers in Cambridge.

The new facility will be used for the production of vaccines as well as complex biologics, including BeneFIX^®, Coagulation Factor IX (Recombinant) and bone morphogenetic protein (rhBMP). It will also produce polysaccharides, components of Prev(e)nar-13, and Pneumococcal 13-valent Conjugate Vaccine (Diptheria CRM197 Protein).

The Andover facility's building B was approved as a multi-product facility that can allow clinical and commercial products to be produced simultaneously and was also designated as the launch site for Pfizer's mAb drug substances.

The Town of Andover approved a five-year tax-increment financing agreement for Pfizer at its annual town meeting held in May 2016. According to the agreement, Pfizer will pay tax at the current value for the first three years, and at 65% of value for fourth and fifth years regardless of increase in property value due to the new facility.

As a result, Pfizer will get approximately $2.9m in tax breaks, while generating roughly $3.9m in tax savings for Andover over ten years.

Pfizer is a global pharmaceutical company with headquarters in New York, US. It is engaged in the discovery, development and manufacture of healthcare products. It develops and manufactures medicines and vaccines for a wide range of medical disciplines including immunology, oncology, cardiology, diabetology and neurology.

Its global portfolio includes medicines and vaccines as well as many of the well-known consumer healthcare products.

A major part of Pfizer's revenue comes from the vaccine business, which is mainly driven by strong uptake of its pneumococcal vaccine Prevnar 13.

Gibbs Cancer Centre & Research Institute

Gibbs Cancer Centre and Research Institute initiated the construction of its $65m new facility at Pelham, North Carolina, US, with an official ground breaking ceremony on 17 May 2016.

The cancer center is being constructed on the existing Pelham Medical Centre campus and is expected to serve the generations to emerge as a community and academic cancer and research center.

Located close to the Greenville-Spartanburg International airport, the new cancer center will be easily accessible to more than five million people throughout Greenville-Spartanburg area.

The construction on the facility is expected to be completed by mid-2018.

The cancer center is named after Jimmy and Marsha Gibbs and was first established in 1999. With 15 years of experience in cancer care and treatment, the center aims to grow as a world-class destination for cancer care through the new facility in Pelham.

The new cancer center will be a seven-story building, spread over a 198,000ft² area. It will be connected to Spartanburg Regional Healthcare System's Pelham Medical Centre Campus, located at 250 Westmoreland Road in Greer.

The facility will house cancer treatment and support services, research, education and a healing environment for cancer patients under one roof.

The existing Gibbs Cancer Centre and Research Institute currently provides services such as multi-disciplinary planning committees to discuss individual patient cases, clinical and translational research, clinical trials for patients, radiation, medical and surgical oncology, and integrative medicine, which includes therapeutic massages and support groups.

It is also equipped with advanced technologies such as Cyberknife M6 Radiosurgery System, TrueBeam Radiotherapy System, and InCise Multileaf Collimation System.

The new cancer center will continue these services along with academic approach to cancer care, clinical, translational and basic research and aims for a potential expansion of the services in future. The medical teams consisting of multi-disciplinary experts from different specialties will work together in the new cancer center to discuss patient's healthcare plan and treatment options, and provide cutting-edge clinical research services.

The project is expected to contribute to the economic development by generating approximately $100m to the rapidly growing Greer area.

The Spartanburg Regional Foundation has announced a $65m investment in the project and launched a $15m capital campaign in November 2015 to support the project and help the patients diagnosed with cancer.

Gibbs Cancer Care and Research Institute was established on the campus of Spartanburg Regional Healthcare System. It has numerous satellite locations throughout the Upstate of South Carolina to provide the patients throughout the region with best clinical expertise and most advanced treatments.

The center runs under the supervision of a diverse group of professionals all responsible for the maintenance and advancement of its mission toward cancer care.

REST OF THE WORLD

Proxy Biomedical Announces Facility Expansion in Ireland

Minister of State for Gaeltacht Affairs and Natural Resources, Sean Kyne, visited Proxy Biomedical, an Irish manufacturer of medical implants, to meet the management team and formally announce the expansion of the facility, including a total investment of €3.5 million.

The company’s development plan is supported by Údarás na Gaeltachta and will lead to the creation of 35 new jobs in Coilleach, Spiddal, Co. Galway.

Following significant investment in research and development and in state-of-the-art processing technologies, Proxy Biomedical expanded its portfolio for the vascular, general surgery and orthopedic markets. The expansion will double the firm's ISO Class 8 cleanroom manufacturing facilities, while including dedicated R&D laboratories. It will also accommodate additional capital equipment to support textiles, biomaterials implant covers, coatings and resorbable materials processing.

Welcoming the expansion, Sean Kyne TD, Minister of State for Gaeltacht Affairs, said: 'This is great news for the area. This expansion phase will provide much needed highly-skilled jobs in the Galway Gaeltacht, as the company increases its workforce to 75 employees over the next two years.'

Peter Mulrooney, Proxy Biomedical CEO, said: 'The new facilities will support the company’s ongoing growth and strategic development initiatives, as Proxy Biomedical continues to broaden its technology portfolio to address unmet needs and deliver innovative solutions for our key markets.'

Steve Ó Cúláin, CEO of Údarás na Gaeltachta, added: 'We have been working closely with this company since it relocated its operations to an Údarás-owned facility in An Spidéal in 2008. Since then, the company has doubled its employment, invested heavily in research, and developed a highly innovative solutions portfolio. This is a sophisticated and technologically advanced company, servicing a global medical device market. We are delighted to be in a position to support Proxy Biomedical’s next expansion phase and very much welcome the new jobs that this development will bring to the area.'

Proxy Biomedical is currently recruiting positions in manufacturing engineering, biomaterial engineers, quality and regulatory, as well as production operatives.

Parker Domnick Hunter Invested in an ISO Class 7 Cleanroom

Parker Domnick Hunter – a division of the Parker Hannifin Corporation – has invested in a new ISO Class 7 cleanroom at its site at Birtley, UK, from which it will produce single-use manifolds incorporating tubing, bioprocess containers, filters, sensors and other components for use in the bioprocessing industry.

The company designs, supplies and delivers whole systems for both upstream and downstream pharmaceutical and biopharmaceutical manufacturing and serves clients throughout the world. The UK manufacturing facility further enhances the division’s single-use production capabilities, adding to its manifold production operation in Oxnard, California, US.

The manufacture of manifolds in the UK will enable the company to supply European markets more effectively, making it easier for biopharmaceutical companies to access specialist manifolds and shortening the supply chain, with resulting benefits for production turnaround and operational continuity. It will provide Parker Domnick Hunter with a more robust manufacturing capacity, based around the capabilities of its dual sites.

The company specializes in the development of custom automated processes, incorporating sensor and control technologies, filtration products and single-use consumables. These single-use solutions help to standardize operations, identify, monitor and control bioprocess variation and ensure product quality and consistency when upscaling from development to manufacturing scale.

As part of its work, Parker Domnick Hunter has developed configured solutions for the rapid design, testing and manufacturing of single-use assemblies, based around a dynamic and validated design space. Working in a pre-designed and optimized configuration space creates significant time-efficiencies for biopharmaceutical manufacturers, resulting in decreased product lead time, and this streamlining process can enhance performance and quality.

'Biopharmaceutical manufacturers design processing systems which incorporate specific, customized manifolds, so it is important that they are able to be supplied with products rapidly, and have confidence in their own ability to access products when they need them. We believe that by manufacturing manifolds in Birtley we will be giving our customers both greater flexibility and peace of mind,' the firm said.

Venn Life Sciences Plans Expansion

Venn Life Sciences is a European CRO providing drug development, clinical trial management and resourcing solutions to pharmaceutical, biotechnology, medical device and academic organizations.

With a new contract signed worth €2.8m ($3.13m), the growing contract research organization (CRO), Venn Life Sciences, is eyeing future expansion.

According to Venn Life Sciences, the new contract is with a “European Biotechnology client,” and involves a Ph II clinical trial to evaluate Immunotherapeutic treatments for Multiple Sclerosis. The trial will include patients across six countries in Europe and is set to begin in October 2016.

Much of the company’s growth has been facilitated by acquisitions as well as organic growth, which Tony Richardson, CEO of Venn Life Sciences Holdings, told us has allowed Venn to build “a truly pan-European footprint.”

“Our focus on Europe has really helped and we are focusing on study sizes and regions where we can execute to a high level,” he added. Growth has also been driven by repeat business and demand in the rare disease space.

In the next five years, Richardson said he expects to see Venn competing for and securing larger contracts as the company continues to grow its capabilities.

“This will see us extending our business into the USA and will also see the further development of areas of specialism that will make Venn a higher value business,” he said. “We are also developing strategies to position us in the clinical information technology arena.”

Venn also announced that its Interactive Response Technology (“IRT”) department has successfully qualified as a service provider to a top ten pharmaceutical client and has been awarded an initial project with thirty sites in China.

“Our Interactive Response Technology department is home to our in in-house solution developed through the successful collaboration of our statistician, logistics and IT experts,” said Richardson. “Since 1999, our IRT has been used by our sponsors to centralize the randomization of patients for their national and international Phase I to IV clinical trials, in addition to the logistics management of their studies,” he added, explaining that the team focuses solely on delivering IRT services.

The IRT system is regulatory compliant (21CRF part 11 – EMA & FDA inspected) and is developed and validated with a GAMP 5 approach.

According to the company, the vendor qualification is a “significant milestone” for the IRT division.

Kyowa Hakko Kirin Completes Manufacturing Plant in Japan

Kyowa Hakko Kirin has completed construction on a ¥7.1bn mammalian cell-based manufacturing plant in Japan equipped with a 12,000L bioreactor.

The HB6 plant in Takasaki city – about 100km north-west of Tokyo – will begin manufacturing a number of active pharmaceutical ingredients later this year, with commercial production for the Japanese, US and European markets set to commence in 2019.

The 43,040 sq. ft. (4,000m2) facility cost around ¥7.1bn ($70m) and is equipped with a 12,000 L bioreactor which the firm says is one of the largest of its kind in Japan.

The plant will focus on monoclonal antibodies, but the firm has not revealed which products in its pipeline may be made there.

The firm’s lead is brodalumab, a mAb being developed with Amgen for Psoriasis, approved in Japan, but there are also several mAbs in the Phase III stage, including benralizumab being co-developed with AstraZeneca to target asthma.

Completion of the plant had originally been set for April this year, but Kyowa Hakko Kirin did not respond to this publication when contacted as to why there was a delay.

In April 2014, the firm completed construction of the HA4 plant at the Takasaki site. The plant is of comparable size to the HB6 facility and also boasts a 12,000L stainless steel bioreactor.

Pfizer and GE Team on Modular Biosimilars Plant in China

Pfizer has struck a strategic partnership with GE Healthcare to construct and equip a biomanufacturing center focused on producing biosimilars for China.

The $350m (€315m) investment is the latest spend by Pfizer in its biologics network, and comes just days after the firm broke ground on a $200m clinical biomanufacturing facility in Andover, Massachusetts.

The new facility in Hangzhou Economic Development Area (HEDA), China will make biosimilar products for the local market once production begins in 2018, said Pfizer spokesperson Loucineh Mardirossian.

“Not only will this Biotechnology Centre ensure the local production of high-quality, affordable biosimilar medicines that will benefit patients in China and across the world,” she said, but “it will also help contribute to the continued development of the biotechnology industry in China and support nation healthcare reforms.”

Production capacity is set to be 25 million vials per year, in the first phase, she added.

The site itself will use multiple 2,000L single-use bioreactors with associated downstream systems implemented through a strategic partnership with life sciences technology firm GE Healthcare, which is managing the facility set-up from conception to completion on behalf of Pfizer.

“GE Healthcare is providing a complete turnkey approach to Pfizer, including proof of concept, transportation and construction of the KUBio [GE’s modular facility platform], manufacturing process optimization, validation of the facility and training of Pfizer’s manufacturing professionals in China,” GE’s Saara Nordenström told this publication.

She added the approach was similar to GE’s partnership with JHL, which saw the opening of the world’s largest modular cGMP biomanufacturing facility in Wuhan last month.

GE boasts its KuBio modular platform can significantly reduce a facility’s build time of 18 months, compared to the approximate three years for a traditional plant. “This rapid deployment translates to reduced risk and faster time to market,” Nordenström said.

But, she continued, the platform is customable, and thus Pfizer’s KUBio design differs from JHL’s and includes the additional feature of a fill/finish unit for packaging of the final product, constructed in the same off-the-shelf modular approach as the main KUBio.

Like the Andover investment, this latest news shows further support from Pfizer for single-use technologies within its own biologics network.

Mardirossian said the facility will be equipped with disposable technologies, and while it is not 100% single-use, "this Global Biotechnology Center in Hangzhou represents the most significant investment in single use technology within Pfizer to date."

She continued: "Pfizer is currently investing in GE technologies for the manufacture of biopharmaceuticals for our innovative development lab in Andover, Massachusetts. Combined with Hangzhou, and another new investment in GE technologies that we are making at our Global biotechnology site in Grange Castle, Ireland, Pfizer will have a fully integrated and standardized biotechnology development and manufacturing capability in one platform."

Porton Biopharma (PBL) Started Construction of Pharmaceutical Fermentation Facility

Porton Biopharma Limited (PBL) started construction of a new pharmaceutical fermentation facility at the Porton Down Science Park located near Salisbury, Wiltshire, UK, in May 2016. The facility is expected to be ready for operation by 2018.

It will be PBL's second major investment after opening of a multimillion pound new freeze drying facility in November 2015. The new facility will help PBL to develop and produce a range of life-saving products.

The new fermentation facility will spread over 225,960 sq. ft. (21,000m²) area and will be used for manufacturing medical products in a modern environment, which will be constructed fully in compliance with the latest pharmaceutical regulations. It will be equipped with a fermenter, process train and associated utilities to develop a range of life-saving products.

The new facility will include a viewing gallery that will allow visitors to see the high-tech process without having to go through the gowning-up process that is obligatory for entering cleanroom pharmaceutical manufacturing facilities.

PBL is currently continuing to manufacture in its existing plant, but addition of the new plant will bring the new capacity on stream to meet the increasing global demand for its product.

The groundbreaking ceremony for the construction of the pharmaceutical fermentation facility was held in May 2016, which was attended by John Glen, MP of Salisbury.

The new facility's construction will be followed by demolition of older facilities and construction of a new workshop and a water plant room to support the facility. The equipment installation and pharmaceutical validation will be implemented at the newly constructed facility in a phased program.

The new facility will be equipped with technical capabilities to translate research methodologies into production processes. It will include capabilities from 2L benchtop fermenters to 100L production vessels, cell processing, prokaryotic and yeast fermentation. It will also include a range of production platforms, including Wave™, roller bottles and multi-layer disposable vessels.

The plant will also include product purification technology with sophisticated analytical methods including LC-mass spectrometry, HPLC, UPLC, electrophoresis, ELISA and dynamic light scattering. It will use in process and final product analysis including forced degradation studies and stress testing.

PBL is the sole manufacturer of the UK-licensed anthrax vaccine, which is manufactured for, and on behalf of, the UK Government and supplied for occupational health purposes and to protect service personnel from the use of anthrax as a biological weapon.

PBL is working together with US Company NanoBio to develop next-generation anthrax vaccine at the new facility in Wiltshire.

PBL also produces Erwinase®, which is used for the treatment of acute lymphioblastic leukaemia (ALL) in children. The drug was approved by the US FDA in November 2011. It is also registered in 20 countries and commercialized in more than 75 countries world-wide. Erwinase is distributed and commercialized by Jazz Pharmaceuticals worldwide.

Based at Porton Down in Wiltshire, UK, PBL was established in April 2015 to commercialize the pharmaceutical development and manufacturing capabilities that were previously within Public Health England.

The company offers expertise in development and production of biologicals, including product characterization, process and analytical validation and scalability for market. It also develops new vaccines, therapeutic proteins and enzyme products and also undertakes contract manufacturing at all stages of the product development/commercialization lifecycle.

CordenPharma Caponago Sterile Injectable Facility Gains Approval

CordenPharma, the pharmaceuticals arm of the International Chemical Investors Group, has completed and has received approval for its aseptic filling line installed at its CordenPharma Caponago CDMO in Monza Brianza, Italy.

The Italian Medicines Agency (AIFA) has approved the line for clinical and commercial supply.

This addition to the existing terminal sterilization capabilities of the manufacturing facility will support customer development and commercial programs by providing expert service in aseptic filling of liquid and lyophilized vials and pre-filled syringes, the firm said.

The project was initiated in 2014 after CordenPharma experienced increasing demand from its customers in this market segment – in particular as it relates to the fully integrated supply of injectables as well as peptide APIs.

Ernesto Petroselli, President of CordenPharma International, said: 'This new investment in the aseptic development capacities of CordenPharma Caponago strengthens our injectable platform and positions us as a fully integrated CDMO. Furthermore, it is a testament to our overall commitment in responding to customers’ needs.'

The expansion, which complements the already existing sterile capability at the site and at CordenPharma Latina in Sermoneta, Italy, is an additional step in the ongoing capacity expansion process that CordenPharma continues to pursue. The firm aims to supply complete injectable manufacturing services spanning development to commercial scale, including integrated peptide and oligonucleotide manufacturing capabilities.

Thailand's AIT to Create Technology, Knowledge Hub

AIT and the National Science and Technology Development Agency have signed a landmark agreement to cooperate in the field of research and education.

The Asian Institute of Technology (AIT) has signed a landmark agreement with the National Science and Technology Development Agency (NSTDA) to create a premier technology and knowledge hub in Thailand.

The partnership allows for 11 NSTDA experts and researchers to work at AIT as special adjunct faculty members, while AIT gets access to NSTDA research facilities.

In his welcome speech, Prof. Worsak Kanok-Nukulchai recalled that Dr. Puey Ungphakorn, the founding chairman of the AIT board of trustees, had been assigned by the Royal Thai government to identify a piece of state land befitting AIT's new campus. Puey handpicked 2,000 rais (800 acres) of land in Rangsit—originally assigned to the Ministry of Industry—with a goal of developing it into a “modern knowledge hub.”

In 1991, the then AIT President Alastair M. North convinced the Thai government of the idea of a "technology park," which subsequently led to the creation of "Thailand Science Park" in 1992. Both AIT and Thammasat University jointly agreed to allocate about 200 rais of land each to build NSTDA.

“It was visualized by Dr. Puey Ungphakorn, and reinforced by our former AIT president, to convert this beautiful piece of land into what would eventually become a technology and knowledge hub of Thailand. This agreement is a step towards the fulfilment of that vision,” Worsak remarked.

Former Deputy Prime Minister H.E. Prof. Yongyuth Yuthavong, who also served as the first president of NSTDA, quoted the example of Boston, where Harvard University, MIT and Tufts University collaborate with each other in a competitive way. Similarly, this agreement between NSTDA and AIT is a significant step in this direction, he remarked.

NSTDA President Dr. Thaweesak stressed upon the importance of working with partners to move towards creating a knowledge-based economy in Thailand. NSTDA has almost 500 doctorates working as researchers who can serve as mentors for AIT students, he said. The NSTDA president added that AIT students are welcome to utilize their science facilities and laboratories. Dr. Thaweesak also signaled towards the proposed Food Innopolis stating that this would be another stellar opportunity for both NSTDA and AIT to work together.

Initially, experts who will be deputed at AIT will come from BIOTEC, National Electronics and Computer Technology Center (NECTEC), National Metal and Materials Technology Center (MTEC), and NANOTEC. Those deputed to AIT include Dr. Wonnop Visessanguan, Dr. Verawat Champreda, and Dr. Sissades Tongsima, BIOTEC; Dr. Supakorn Siddhichai, Dr. Noppadon Nuntawong, Dr. Thepchai Supnithi, and Dr. Pattravadee Ploykitikoon (NECTEC); Dr. Sitthisuntorn Supothina and Dr. Chanchana Thanachayanont, (MTEC); Dr. Uracha Rungsardthong Ruktanonchai and Dr. Rawiwan Maniratanachote (NANOTEC).

The researchers shall serve as special adjunct faculty members at AIT.

Canada Opens Innovative Lab for T Cell Therapy

Built with philanthropic funds, the Conconi Family Immunotherapy Lab forms the hub of custom immunotherapy treatment production for cancer patients across British Columbia.

With CA$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.

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.

University of Manchester and SCIEX Open Biomarker Discovery Centre

SCIEX’s patented SWATH technology enables the quantification of thousands of proteins across large sample sets with a high level of data completeness, quantitative accuracy and reproducibility

The University of Manchester has opened the Stoller Biomarker Discovery Centre, which will focus on biomedical research including cancer, psoriasis and arthritis, using mass spectrometry-based proteomics solutions from SCIEX.

The Centre, which was funded by a philanthropic gift from the Stoller Charitable Trust, the Medical Research Council and developed in partnership with SCIEX, will help to industrialize the process of identifying and utilizing protein biomarkers.

With a large number of SCIEX LC-MS systems, the Centre is one of the biggest clinical proteomics facilities in the world, spearheading a series of biomarker development projects and international collaborations. It is helping to identify and develop markers of disease risk, diagnosis and response to therapy on an industrial scale, aiding in the translation of biomarkers into the clinical lab.

The Stoller Biomarker Centre is located at CityLabs Manchester, in the midst of biotechnology companies, the Central Manchester University Hospitals, National Health Service (NHS) Foundation Trust and The University of Manchester.

The purpose-built, industry-leading laboratory space at Citylabs 1.0 is ideally suited to companies in the biotech or life science sector. Dedicated fume cupboard extraction enables high specification laboratory fit outs. The Grade A space accommodates mechanical ventilation, heating and cooling throughout the building giving individual suite level control of each space.

The Stoller Centre houses a large suite of high-end SCIEX mass spectrometers for targeted next-generation proteomics, including TripleTOF 6600 Systems with SWATH Acquisition, QTRAP 6500+ Systems, and the SCIEX Lipidyzer Platform. The University of Manchester has also invested in a number of liquid chromatography and automated sample preparation components for the Centre, from SCIEX and other Danaher life science companies, such as Beckman Coulter’s Biomek NXP Laboratory Automated Workstation.

Recipharm Increases Blow Fill Seal Capacity in Kaysersberg, France

Recipharm has announced an €18 million investment to expand its blow fill seal (BFS) capacity at its site in Kaysersberg, France

The investment will see the introduction of a new blow fill seal high speed filling and packaging line, bringing the total number of lines from seven to eight to meet growing demand for the service.

Preparations will also be made to add a further three filling lines over the coming years, more than doubling the size of the CDMO’s operations from 21,520 sq. ft. (2,000 square meters) to 44,654 sq. ft. (4,150 square meters) and increasing its blow fill seal capacity by 50 per cent. The first of the four planned filling lines will allow Recipharm to support more drug developers with the aseptic processing of sterile liquids such as eye care and ear drops into plastic containers.

Yves Buelens, General Manager at Recipharm’s Kaysersberg site, said: “We are experiencing increased demand for our blow fill seal services from markets including the US, Turkey, Australia and Canada and the new filling line will help us to meet this growing need”.

“The increased capacity will position us well for future growth and allow us to take on new projects from new customers more swiftly. With the site’s big pharma heritage, we are ideally placed to meet the highest quality and regulatory requirements and are committed to investing in the facility to ensure we can continue to deliver the best possible service.”

Alvotech’s Biosimilars Manufacturing Facility, Reykjavik, Iceland

Leading biopharmaceutical company Alvotech officially opened its new biosimilar facility in Iceland on 8 June 2016. The facility will be dedicated to the production of biosimilars of monoclonal antibodies (mAbs).

Alvotech broke ground on the industry-leading biologics manufacturing plant in November 2013, marking a significant milestone for the company.

The new manufacturing facility is located in the science park of the University of Iceland in Reykjavik. The location provides a favorable environment with strong regulatory system, low operating costs, and a skilled talent pool and high-quality standards for the operation.

The project has generated approximately 200 new jobs during construction and operation.

The state-of-the-art facility is spread over an area of 13,000m² (139,930ft²) for the development and manufacturing of biosimilar monoclonal antibodies, as well as 2,500m² (26,909ft²) of office space.

The vertically integrated biologics manufacturing plant includes fully automated vial and syringe filling capabilities and quality control labs.

The facility will employ the manufacturing process based on 1,000l and 2,000l single-use bioreactor fermentation design with a total capacity of 16,000l spread out in two independent upstream and downstream areas.

The manufacturing laboratories are built using world-class, scalable and cost-efficient manufacturing technologies through the Finesse turnkey SmartFactory GMP manufacturing platform suite, which includes automation platform and best of breed bio-manufacturing equipment from upstream through downstream. The facility employs SmartFactory single-use CGMP manufacturing technology, which eliminates the risk of cross contamination in fermentation and ensures production of high-quality products.

The facility also includes high-yield fermentation and downstream process, aseptic filling and finishing lines for vials and prefilled syringes, cGMP manufacturing capacity for clinical and commercial-scale manufacturing with high-throughput research and development (R&D) capabilities.

The key feature of the facility is that it operates on clean renewable energy. The entire energy supply for the facility is derived from domestically produced geothermal and hydroelectric power.

Alvotech is a biopharmaceutical company involved in the development and manufacturing of biosimilars for the global markets. The company's product portfolio includes molecules for treating conditions in the areas of oncology, respiratory, cardiology and gastroenterology.

Alvotech currently has six biosimilar monoclonal antibodies in its pipeline, which are being developed mainly to treat cancer, autoimmune disease, inflammatory diseases and other diseases. These products will be developed in its five R&D centers located in Germany, Switzerland and Malta, and manufactured at its headquarters in Iceland.

Samsung Biologics Manufacturing Plant

Headquartered in Seoul, South Korea, Samsung Biologics broke ground on its first manufacturing plant in the free economic zone in Songdo, Incheon, in May 2011.

Samsung Biologics is a joint venture established in April 2011 between Samsung Electronics (40%), Samsung Everland (40%), Samsung C&T (10%) and Quintiles Transnational (10%). Samsung Biologics invested $30m in the new venture.

Samsung identified biologics among its new strategic businesses in 2010 and partnered with Quintiles Transnational. Samsung Biologics plans to invest $1.96bn (KRW2.1tn) for strengthening its position in the field of biopharmaceuticals.

It completed construction of the new facility in July 2013 and received approval from the US Food and Drug Administration (FDA) in 2015, to begin the production. The facility is designed to comply with the current good manufacturing practice (GMP) standards. It hired approximately 300 people.

The state-of-the-art facility is spread over 742,440 sq. ft. (69,000m²) within a 2,948,240 sq. ft. (274,000m²) site, with ample space for future expansion.

Designed for multiproduct operations, the facility accommodates a cell culture hall, a research and development laboratory, an upstream suite, a downstream suite and a fill and finish suite, a warehouse and an administration building.

The cell culture hall is equipped with six 5,000l stainless-steel bioreactors and three individual trains, capable of manufacturing 600kg of biopharmaceuticals. Each train is installed with two production reactors capable of batch and fed-batch operations.

It also has three 40l, three 200l and three 1,000l seed reactors. The cell culture suites operate in a grade C environment.

The site also houses dedicated automated glass washers and autoclaves. Two separate grade B inoculation suites minimize the risk of cross-contamination and changeover time.

The downstream process GMP purification area houses four separate suites to improve flexibility and minimize turnover time. Each suite can be configured to suit client requirements.

It includes a column maintenance suite, a grade B classified bulk fill suite with grade A (laminar flow booth) bulk filling capacity and a buffer preparation suite. The temperature-controlled, high capacity buffer preparation suite holds tanks with ranging capacities.

Separate areas are dedicated for pre and post-viral equipment cleaning. Classified as grade C or higher, the suites are installed with chromatography skids, columns, UF/DF skids and virus filtration skids.

The grade B filling area is installed with formulation, aseptic liquid filling, pre-filled syringe lyophilisation and packaging apparatus capabilities. The area is modular in design to support future expansion and accommodate additional pre-filled syringes, liquid fill and lyophilisation units. It also houses a washroom and a media fill suite, a 20,000ft² GMP warehouse designed with long-term cold storage capacity. It also has automated clean-in-place and sterilization-in-place systems.

Access to sensitive zones is via an air-lock vestibule with interlocks. The layout allows optimum flow of personnel, materials, samples, products and waste.

The facility also undertakes contract manufacturing of biopharmaceuticals. Due to rising demand for biopharmaceuticals, Samsung Biologics expects to annually generate KRW1.8tn by 2020.

The expansion programme included the construction of second plant at Songdo site by 2015. The new plant began its operations in March 2016.

The expansion added six 15,000l bioreactors to the facility. Downstream capacity was also added with streamlined purification suites with pre and post-viral segregation.

Samsung also broke ground in December 2015 for the third plant in the free economic zone in Songdo, as part of its expansion plan. The new plant is expected to commence production in 2018.

Pfizer’s Global Biotechnology Centre, Hangzhou Province, China

Pfizer broke the ground for the development of a Global Biotechnology Centre in the Hangzhou Economic Development Area (HEDA) in China on 27 June 2016.

The company announced that it will invest approximately $350m for the development of its first biotechnology center in Asia to support China's national healthcare reforms to provide world-class biological medicines for patients worldwide.

The new biotechnology center is expected to be fully operational by 2018. The company expects that the new facility will increase complexity and value of China's biopharmaceutical manufacturing sector by 2025.

The new Global Biotechnology Centre will ensure the production of high-quality, affordable biosimilars using technologies that meet the international standards for quality, safety, efficacy, construction and superior environmental standards.

It will contain Pfizer China's biosimilars and biologics quality, technical services, divisions for engineering and logistics, commercial manufacturing, process development site and clinical supply site.

It will also contain filling and packaging units for accommodating start-to-finish manufacturing capabilities in a single facility.

The facility will make use of GE's KUBio modules, which will be pre-fabricated with Flexfactory processing technology, to reduce construction and installation time. The technology also helps in reducing the carbon dioxide emissions, water usage and energy consumption by 75 percent.

The advanced modular solutions installed with Flexfactory bioreactors will be used for growing cultures and manufacturing biologics.

The KUBio pre-fabricated modules will be shipped from Germany to China and assembled onsite. It usually consists of bio-manufacturing platforms with approximately 250 components such as single-use technologies, associated process hardware, automation and control components to provide end-to end manufacturing of biosimilars.

The new Global Biotechnology Centre is expected to generate more than 150 job opportunities during its operation phase and strengthen regional biotechnology expertise.

"The company expects that the new facility will increase complexity and value of China's biopharmaceutical manufacturing sector by 2025."

Its establishment will represent the company's further investment in research and development (R&D) and clinical research and also contribute to the growth of China's bio-pharmaceutical industry.

The facility also contributes to growth in local and government economy by attracting additional investments from both domestic and foreign sources into sectors such as healthcare and R&D.

Pfizer is dedicated to discovery and development of new and better solutions to prevent or treat diseases and healthcare challenges.

It works in partnership with healthcare providers, managed care organizations, world governments and non-governmental organizations to provide access to patients across the world to innovative treatments and quality health care.

The company's leading medicines and products portfolio supports wellness, prevention, treatment and cure for diseases in different therapeutic areas.

Cipla will build a Biosimilar Production Facility in Durban, South Africa

Mumbai, India-based Cipla announced its intention to spend R1.3m ($90.7m) on the facility last week, explaining that the aim is to begin manufacturing biosimilars in 2018.

According to Cipla the facility will employ in-house proprietary manufacturing software developed by Cipla BioTec and single use processing technology. The firm also predicted the project will create 300 jobs.

Steven Lehrer, Director of Cipla BioTec said the decision to build in South Africa was about making biosimilar medicines available to patients who cannot currently afford them.

“Biosimilars remain too expensive for broad use outside of major western markets. Cipla BioTec aspires to transform the biosimilars market worldwide, by significantly increasing access with its strategy of one global product standard at affordable pricing.”

This was echoed by Cipla Medpro CEO Paul Miller, who said the firm wants to make biologics available to more “cancer patients through the production and supply of biosimilar medication at an affordable price.”

This idea fits with South African Health Minister Aaron Motsoaledi’s recent comments about the role competition can play in lowering the price of biologic drugs in South Africa.

Motsoaledi likened the current high cost of the cancer treatment Herceptin (traztuzumab) - R500,000 ($34,911) a year – to the price of anti-retroviral drugs (ARVs) in 2000 and suggested that competition, local product and volume sales could make biologics more affordable.

Cipla also wants the facility to be able to supply other markets according to CEO Subhanu Saxena who said “the capacity of this factory will have the potential for a vast majority of the products to be exported.”

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