PHARMACEUTICAL & BIOTECHNOLOGY

INDUSTRY UPDATE

August 2020

 McIlvaine Company

 

TABLE OF CONTENTS

UNITED STATES

 

REST OF WORLD

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UNITED STATES

Fulton Labs, Chicago

Fulton Labs is a new laboratory facility being developed in Chicago, Illinois, US, the first life science laboratory space in Chicago’s Fulton Market.

In July 2020, real estate developer Trammell Crow Company (TCC) started construction of Fulton Labs, aimed to address the demand for lab space across the Chicago area.

The facility, being developed at a cost of $250m, will support the development of the scientific community and serve as a platform to foster creativity and discover, scheduled to open in the fourth quarter of 2021.

The facility is located on a 1.3-acre site at 400 N Aberdeen Street in the center of Fulton Market District.

Spanning 423,454ft², Fulton Labs will feature 16 floors, including 12 advanced wet and dry laboratory floors.

Approximately 407,500ft² of office and laboratory space will be provided on rent, while 35,000ft² will be dedicated for amenities such as rooftop lounge, fitness center and conference facility.

The property is six minutes away from interstate I-290 and seven minutes from I-90 / 94. It is also accessible from mass transit stations including Pink / Greenline Morgan ‘L’ station and Blue line Grand ‘L’ station.

Fulton Labs will feature 34,000ft² of column-free floor plates, which along with the long-span layouts will provide flexibility to researchers. The design features meet the Vibration Criteria-A (VC-A) requirements.

The building is designed to achieve LEED Silver and Wired Gold certifications. It will be incorporated with high-quality safety specifications, ensuring better connectivity and infrastructure.

It will be installed with seven passenger elevators and one freight elevator. Lab support infrastructure will include centralized storage areas for chemicals and lab supplies, scalable spaces to meet the needs of tenants, and extra mechanical and equipment space for each occupant.

There is a provision to install skid and distribution equipment for reverse osmosis deionization (RO / DI), vacuum systems and pH systems.

In addition, the facility will have a fully enclosed loading or servicing area with two loading bays, one of which will be at dock leveler position, while the other will be at grade position.

Additional amenities at the facility will include a wellness center and a collaboration center.

Electrical infrastructure comprises two 12kV feeds to two 2,500kVA secondary unit substations feeding base building loads and penthouse-level central plant services and two 2,500kVA transformers feeding service take-offs.

480Y / 277V, three-phase, four-wire internal distribution network will be equipped with bus duct rises to allow modifications and equipment relocation in future.

The fully heated and air-conditioned building will have several water-cooled chillers and condensing boilers.

Cross-connected air handling units, chillers, boilers and exhaust fans ensure resilience and redundancy.

Each stairwell has an automated combination standpipe system and riser fitted with a floor sprinkler floor control system. The site will be installed with two 750kW emergency diesel generators and one 750kW natural gas generator.

Trammell Crow Company (TCC) is responsible for the construction of the facility. It collaborated with life sciences start-up incubator Portal Innovations to create dedicated space to support early-stage start-ups.

TCC’s parent company CBRE is the leasing agent for the project.

CRB won a contract to provide lab planning and engineering design services. ESG Architects and Power Construction are also involved in the development of Fulton Labs.

 

CoreRx’s New Product Development Centre, Florida

CoreRx, a contract development and manufacturing organization (CDMO) based in the US, unveiled a new facility in Clearwater, Florida, in April 2020.

The facility is the company’s International Centre of Excellence for the development of pharmaceuticals and its fourth facility on the ICOT campus. The company announced that it will continue to invest to sustain increasing demand from customers.

The product development center became fully operational in August 2020 and is expected to hire 35 new employees.

CoreRx is investing in new infrastructure, increasing product development capacity, and expanding capabilities to fulfil customer demand.

It previously invested in the expansion of three other buildings within the ICOT center complex, including the construction of nine new clinical manufacturing suites and installation of additional capacity to its primary and secondary packaging activities, including aggregation and serialization.

CoreRX’s new product development center is located within the ICOT campus at Myerlake Circle in Clearwater, Florida, US.

Spanning 26,000ft², the new facility includes approximately 5,000ft² of analytical laboratory space.

Expansion of the drug product development and manufacturing site allows customers to access more than 150,000ft² of space.

The facility comprises nine research and formulation development and manufacturing suites. It also has an office and administrative space.

The center is designed to expand the company’s development division for oral and topical dosage types. It also increases the capacity to support the growth in its drug development services portfolio.

It is equipped with formulation technologies such as blending, wet granulation, spray drying, roller compaction, fluid bed drying, and extrusion spheronisation.

CoreRx opened the facility and expanded its research and development (R&D) capacity to meet the growing demand for contract services.

The expanded capacity will help pharmaceutical chemists develop robust and reliable dose form solutions.

The production center will improve workflow and increase the efficiency of product development, benefitting from the synergy offered by the collocation of different teams including analytical development, pre-formulation, and formulation development.

The expanded space will allow CoreRx to accommodate new equipment and a growing workforce to develop more products for its customers.

The company has a total of four buildings, namely Myerlake I (ML1), Myerlake II (ML2), Myerlake III (ML3) and Myerlake IV (ML4), on the campus center.

ML1 is a 35,000ft² building consisting of 14 current good manufacturing practice (cGMP)-compliant manufacturing and packaging suites and two cGMP analytical labs that support method validation, QC, and stability.

The 47,000ft² ML2 facility includes ten cGMP manufacturing suites, a cGMP warehouse, and an office and administrative area.

Spanning 47,000ft², the ML3 features a dedicated manufacturing space and a dedicated analytical laboratory for clients, and a cGMP warehouse. ML4 is the company’s newest product development lab.

Marketing commentary on CoreRx:

CoreRx is a clinical-stage pharmaceutical company supporting clients’ supply chain requirements during the entire clinical trial process. It assists clients in clinical-industrial niche commercial manufacturing.

The company offers a range of services to meet the development, manufacturing and testing needs for solid, liquid and semi-solid dosage forms. It offers pre-formulation, formulation development, manufacturing and packaging, as well as analytical and stability services.

Founded in 2006, CoreRx has a network of 18 manufacturing suites, six formulation suites, two analytical laboratories, and cGMP warehouse and office rooms.

 

CenExel Clinical Research Sites Tackle COVID-19 Vaccine Testing

CenExel Centers of Excellence are participating in U.S. Operation Warp Speed projects to advance COVID-19 vaccine research quickly without sacrificing quality. The Centers are already supporting seven ongoing trials for this novel coronavirus, beating recruiting targets by averaging more than 200 patients per week.

CenExel relied on internal expertise in expanding its capabilities within its network to offer world-class service in vaccine studies. Over the past several years, staff at CenExel's Centers of Excellence have conducted over 100 vaccine trials across a wide spectrum of infectious and biodefense indications, enrolling well over 3,500 patients and surpassing recruitment goals by 110%.

"We understand the urgent nature of conducting these studies and reporting accurate results," said Tom Wardle, CenExel CEO. "We take our role in helping to solve the COVID-19 healthcare crisis very seriously, and we're laser-focused on the quality of our clinical research."

CenExel's five Centers average more than 25 years of professional experience in clinical research. Key principal investigators involved at the various facilities have worked on thousands of studies. Although the sites vary in size, they offer a collective 217,000 square feet of research space. With diverse metropolitan locations, the CenExel network has strong access to roughly 35 million people and well over a quarter million individuals within CenExel databases.

To speed up study implementation, CenExel provides centralized budgeting and contracting for sponsors engaging multiple Centers of Excellence. All Centers also adopted new pandemic standard operating procedures at the outset of this crisis and recently secured cutting-edge, rapid COVID-19 testing machines at each facility. These necessary precautions maintain safety for staff and patients across CenExel, as well as enable trials to proceed at the same pace as before, just with heightened standards.

 

$1.1 Million to Biotech Center in Buckingham for COVID-19 Work

Four state grants for COVID-19 research have been awarded to the Pennsylvania Biotechnology Center in Buckingham

Pennsylvania Biotechnology Center of Bucks County is once again in the spotlight, this time as the recipient of more than $1 million in state grants to help with research in pursuing a treatment and vaccine for COVID-19.

Of 23 state awards, the biotechnology center, located next to the Doylestown Airport in Buckingham, received four grants, bringing in $1.1 million of the $10 million statewide allocation. The money will help support the biotech center's renovation plans, which will add research and training labs, more than 100 new jobs and new offices for COVID-19 research and development.

Two grants will go to scientists developing potential COVID-19 treatments at the Baruch S. Blumberg Institute at the biotech center and a hub for virology research for more than 17 years.

John Kulp received $165,406 to continue his work on a new compound that binds to the SARS-CoV-2 spike protein and prevents viral entry, and promote it to human clinical trials. Kulp's work has potential to provide the first small molecule drug for treatment of COVID-19.

Timothy M. Block was awarded $207,900 to conduct a study to determine if a small molecule, iminosugar, alone or in combination with the drugs Remdesivir or Favipiravir, has useful antiviral activity against SARS-CoV-2, the cause of COVID-19.

Dr. Tim Block, co-founder, president and CEO of the biotechnology Center, The Blumberg Institute and Hepatitis B Foundation, is among the recipients of four state grants awarded to the

Pennsylvania Biotechnology Center of Bucks County in Buckingham. The center, and its founding institute, are the recipients of more than $1 million in state grants to help with research in pursuing a treatment and vaccine for COVID-19.

“We are very appreciative of the confidence shown in our work by Gov. Wolf and the state’s Office of Technology and Innovation, as well as the Legislature, which funded this important program,” said Block, co-founder, president and CEO of the biotechnology center, the Blumberg Institute and Hepatitis B Foundation.“We’re also proud to be among this very select group of grant recipients, such as the University of Pennsylvania, Penn State, Pitt, Jefferson University, Drexel and Carnegie Mellon.”

The biotechnology center, where more than 300 highly skilled scientists, staff and students work, is managed by the Blumberg Institute, which is the research arm of the Hepatitis B Foundation. Both are nonprofits.

One of the grants, $430,000, will be used to renovate existing space for COVID-19 research and development. That project will complete a $19 million construction project already now underway on a new 37,000-square-foot building between the center's two existing structures, which will create 40% more space and add more than 100 jobs and dozens of new companies to the center.

Another $322,000 grant is going to one of the center's member companies, Evrys Bio. The company’s scientists are developing host-targeted antiviral drugs that can block the growth of different respiratory viruses including coronaviruses, and that can provide a high barrier to drug resistance.

Lillian Chiang, CEO of Evrys Bio, said her company's goal is to develop broad-spectrum drugs that treat multiple viruses causing respiratory disease, rather than a single virus.

"We are grateful for these funds from the state of Pennsylvania that will enable us to extend our testing to SARS-CoV2, speeding our efforts to contribute to a COVID-19 solution,” said Chiang.

The biotechnology center, which opened in 2006, has more than 70 member companies, 41 of which have offices or labs in the facility.

“The PA Biotech Center is an important part of our region’s response to the COVID-19 crisis, ushering in some of the first diagnostic tests in Bucks County through on-site companies, as well as hosting a number of other entrepreneurs who are developing new drugs to manage this disease,” said state Sen. Steve Santarsiero, D-10, Lower Makefield.

After announcing the awards, Gov. Tom Wolf said: “We know that the only way we can get back to our normal lives is by developing a robust testing and tracing infrastructure combined with effective, safe and affordable treatments and vaccines. The funding ... will jumpstart a number of promising projects that would help Pennsylvania overcome this devastating global pandemic, setting us on a path to recovery and protection both now and in the future.”

 

Network of AI Centers to Be Built Across US

This national network of Artificial Intelligence Research Institutes is said to represent the nation’s most significant federal investment in AI research and workforce development to date.

The US Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) and the National Science Foundation (NSF) have announced they are establishing seven new artificial intelligence (AI) institutes across the US to accelerate agrifood research, expand America’s workforce and transform society for the future.

The $20 million investment in each of five NSF AI institutes and two USDA-NIFA AI Institutes is reportedly the first of more institute announcements anticipated in the coming years.

“This major federal investment in next generation agriculture signals our commitment to keeping American agricultural innovation on the leading edge of global science,” said USDA-NIFA Acting Director, Parag Chitnis. “These future-focused centers of innovation will use the latest techniques from all corners of science including molecular science, engineering and robotics to seek solutions for myriad challenges facing agriculture, from crop improvement and animal welfare to labor shortages and farm safety.”

By partnering USDA-NIFA and NSF with the US Department of Homeland’s Security Science and Technology Directorate, the US Department of Transportation’s Federal Highway Administration and US public research universities, the institutes aim to serve as hubs in a broader nationwide network determined to improve American competitiveness and transform key areas of society. The centers’ research hopes to improve the national capacity in critical areas such as extreme weather preparedness, K-12 education advancement, next-generation workforce development and agricultural resilience and sustainability.

The specific focus areas:

Integrating a holistic view of the food system with AI and bioinformatics to understand biological data and processes, addressing issues of molecular breeding to optimize traits for yield, crop quality, and pest/disease resistance, agricultural production, food processing and distribution, and nutrition

AI research in computer vision, machine learning, soft object manipulation and intuitive human-robot interaction to solve major agricultural challenges including labor shortages, efficiency and welfare in animal agriculture, environmental resilience of crops, and the need to safeguard soil health

AI, atmospheric and ocean science, and risk communication to develop user-driven trustworthy AI that addresses pressing environmental concerns

Theoretical challenges in AI, including next-generation algorithms for deep learning, neural architecture optimization and efficient robust statistics

AI that helps both students and teachers work and learn together more effectively, engagingly and equitably. The vision is to develop “AI partners” that will observe, participate in and facilitate collaborative learning conversations by interacting naturally through speech, gesture, gaze and facial expression in real-world classrooms

Development of new AI-enabled tools and serves as a training ground for the next generation of scientists with combined expertise in chemical synthesis and bioengineering

Workforce development, digital learning, outreach and knowledge transfer programs to advance physics knowledge – from the smallest building blocks of nature to the largest structures in the universe – and galvanize AI research innovation to broaden societal impacts.

“The AI institutes being awarded comprise large, multi-disciplinary, and multi-sector collaborations: they bring together consortia of dozens of universities and other organizations, ultimately spanning academia, government, and industry,” said Michael Kratsios, US Chief Technology Officer. “In effect, over the next five years, some of the best minds in the country will be tackling some of the grandest challenges that we face, both in terms of new AI techniques as well as breakthroughs in fields of science and engineering and sectors of our economy. And along the way, they will nurture the future American workforce in AI research and practice.”

 

Millstone Medical Completes New Facility

Millstone Medical Outsourcing has completed construction on its new Fall River, Massachusetts headquarters facility expansion. The expansion includes 60,000 square feet of warehouse and office space to expand capacity at the Fall River company headquarters to a total of 120,000 square feet of production space.

Begun in October 2019, the expansion adds 4,500 square feet of mechanical inspection, 31,000 square feet of warehouse area, and 6,000 square feet of kitting space to complement the existing 15,000 square feet of Class 10,000/ISO7-rated cleanroom space for medical device packaging operations. Expanded and upgraded office, conference, and meeting room areas are also complete.

“This building prepares Millstone to meet the growth we know is coming,” CEO Karl Neuberger said. “Since our founding 20 years ago, Millstone has been a high-growth company. As we have grown, we have seen the need for a new building to satisfy not only today’s market demands and administrative requirements, but what we anticipate over the next five to ten years.”

The new facility expansion also allows Millstone to provide a better work environment for its 250 on-site staff, from workers in the warehouse to administrative staff. Upgrades include more space for offices and cubicles in the administrative areas and the addition of several very large, modernized conference rooms, as well as more parking, electric vehicle charging stations, and bike racks. In addition, a solar rooftop system will generate 100% of the facility’s electricity needs.

“Creating a better workplace was a priority for us through the facility expansion,” Neuberger added. “We’ve sought to design and realize a facility that fit people’s expectations for comfort and productivity. This is reflected in how this expansion has transformed our facility with a campus feel.”

 

Thermo Fisher to Acquire Brammer Bio

Thermo Fisher Scientific has agreed to acquire Brammer Bio for $1.7 billion cash, the companies said, in a deal designed to increase the buyer’s presence in gene therapy with the viral vector contract development and manufacturing organization (CDMO).

Headquartered in Cambridge, MA, Brammer Bio employs nearly 600 people at primary locations in Massachusetts and Florida. Brammer Bio is projected to generate $250 million in revenue this year, and expects to continue to exceed the projected market growth rate of 25% over the mid-term, according to the companies.

Brammer Bio’s facilities include:

A 66,000-square-foot Phase III and commercial CGMP viral vector manufacturing site in Cambridge

A 49,000-square-foot warehouse and distribution center in Somerville, MA

An 80,000-square-foot early clinical campus in Alachua, FL, consisting of three buildings: a process development and analytical development facility, adjacent to its CGMP Phase I/II clinical manufacturing operation with a third warehouse and office building.

Brammer Bio says its CGMP facility is designed to accommodate spatially segregated viral vector processing in dedicated production suites to support early phase clinical trials.

This year, Brammer is expected to have operational an additional 50,000-square-foot Lexington, MA facility that includes commercial ready Grade B clean rooms for viral vector manufacturing.

“The combination of Brammer Bio’s viral vector capabilities with our GMP production expertise and proprietary bioprocessing and cell culture technologies uniquely positions us to partner with our customers to drive the evolution of this incredibly fast-growing market,” Thermo Fisher president and CEO Marc N. Casper said in a statement.

Casper noted that gene therapy is an area of increasing focus for Thermo Fisher’s customers: “The transaction is perfectly aligned with our mission to enable our customers to make the world healthier, cleaner, and safer.”

Thermo Fisher senior vice president and COO Mark Stevenson told GEN in a tweet that the acquisition will help the company address the longtime challenge of producing viral vectors at required scale, a challenge discussed last week at a panel talk during the Alliance for Regenerative Medicine’s Cell and Gene Therapy Investor Day.

The acquisition is expected to be completed by the end of the second quarter, subject to customary closing conditions that include regulatory approvals.

Added Brammer Bio co-founders Mark R. Bamforth, president and CEO, and Richard O. Snyder, PhD, CSO in a joint statement: “Brammer Bio has executed more than 100 projects to supply first-in-human gene therapy clinical trials and establish commercial-ready processes, and we’re excited to join Thermo Fisher to take our business to the next level.”

Upon completion of the deal, Brammer Bio will become part of Thermo Fisher’s pharma services business within its Laboratory Products and Services segment. That segment finished 2018 with revenue of $10.04 billion, a 28% jump from $7.83 billion in 2017, and an adjusted operating margin of 12.5%, versus 12.8% in 2017.

Thermo Fisher does not report results for Pharma Services or other businesses within Laboratory Products and Services. Until now, Pharma Services consisted solely of the legacy business of Patheon, which Thermo Fisher acquired in 2017 for $7.2 billion in a deal that expanded the buyer into the CDMO market.

Discussing Q4 and full-year 2018 results with analysts on the company’s quarterly conference call, senior vice president and CFO Stephen Williamson said the Patheon business “grew just about 10% for the year,” up from the mid-single-digits when Thermo Fisher bought the company, according to a transcript published by Seeking Alpha.

Williamson noted Thermo Fisher was expanding Pharma services operations. The company is underway with a $50 million expansion announced last year of its Center of Excellence (COE) for Biological Commercial Manufacturing site in St. Louis. And on March 18, Thermo Fisher disclosed plans for a $150 million expansion of capacity for sterile liquid and lyophilized product development and commercial manufacturing at sites in Monza and Ferentino, Italy, and Greenville, NC. Each site will be equipped with aseptic filling lines and isolator technology.

Pharma Services led all units within Laboratory Products and Services in generating 8% year-over-year revenue growth, to $2.60 billion, during the fourth quarter of 2018.

Pharma Services is Thermo Fisher’s business unit created to provide the entire spectrum of development, manufacturing, and clinical trials services for both small-molecule and large-molecule pharmaceuticals. Those services include development of a suitable formulation and manufacturing process for the active pharmaceutical ingredient (API) or biologic; technology transfer to scale up the manufacturing; labeling, packaging, distribution, and logistics for clinical trials; and commercial-scale manufacturing and packaging.

In its form 10-K annual report for 2018, Thermo Fisher valued Pharma Services at $3.37 billion of “goodwill,” an intangible asset associated with the purchase of a company. Pharma Services had an overall “carrying value” of $7.70 billion as of December 31, 2018, defined as the original cost of an asset, less the accumulated amount of any depreciation or amortization, less the accumulated amount of any asset impairments.

Thermo Fisher said it expects Brammer Bio to add to its adjusted earnings per share by $0.10 in the first full year of ownership. Thermo Fisher finished last year with adjusted earnings per share of $11.12, up 17% from $9.49 in 2017. For 2019, the company has offered guidance to investors that adjusted EPS is set to rise this year to between $12 and $12.20, an increase of 8% to 10% growth over 2018.

 

Cambrex Completes Biopharmaceutical Expansion at its Durham, NC Facility

Cambrex, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, announced it has completed an expansion of its biopharmaceutical analysis capabilities at the Durham, North Carolina site. Biopharmaceutical analysis services were initially launched at Durham in 2018 and have since been expanded through the purchase and implementation of various method development, validation, release and stability or endotoxin testing functions.

Following this expansion, the Durham site now features a range of new instruments, including particle analysis, imaging, qPCR, fluorescent/absorbance plate reader, immunoblotting, mass spectrometry and other compendial testing apparatus. The new capabilities are applicable to a broad variety of biopharmaceuticals, including bacteriophage/bacterial virus and mammalian viral infectious titer assays for intermediates, drug substances, and final drug products.

“The expansion began in response to a customer request to support a BioSafety Level 1 (BSL1) organism and grew from there based on broader customer response,” said Elliott Franco, Durham Site Director, Cambrex. “We remain committed to adopting the best-in-class technologies customers need access to. Our comprehensive expertise, coupled with a transparent, safety-driven approach to implementing the new equipment, allow the Cambrex team to better serve customers across the life of their processes.”

All new capabilities comply with current good manufacturing practice (cGMP) standards, as well as meeting International Conference on Harmonization (ICH) Q2 and United States Pharmacopeia (USP) guidelines for validating biological assays, and ICH Q6B test procedures for biological products. Existing safety and containment practices for BSL1 and BSL2, and some BSL2+, at the Durham site allow support for a wide range of active ingredients.

Ongoing assay additions are also planned at Durham, including impedance based orthogonal methods for existing and new cell-based potency assays, and protein-protein interaction/binding assays.

About Cambrex:

Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including oral solids, semi-solids and liquids and has the expertise to manufacture specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.

 

Emergent BioSolutions to Invest in Canton Site

Emergent BioSolutions acquired property adjacent to its Canton, Massachusetts live viral drug substance development and manufacturing facility to increase campus footprint and build out advanced therapy capability.

Advanced therapy CDMO drug substance manufacturing services is expected to be available beginning in 2023.

Expansion will enable molecule-to-market CDMO services in viral vector and gene therapy utilizing Emergent’s integrated network with development services and drug product manufacturing to be offered out of its Gaithersburg and Rockville, Maryland facilities, respectively  

Emergent BioSolutions in a press release announced that it will further strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. The company will invest $75 million in its Canton, Massachusetts facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.

“Emergent’s expansion into advanced therapy CDMO services is based on our biologics expertise and a strong understanding of our customers’ current and future needs,” said Sean Kirk, EVP, manufacturing and technical operations at Emergent BioSolutions. “We are investing in our people, plants, and products to meet the growing demand for precision treatments and to help get these therapies to patients.”

The investment will include a state-of-the-art, multi-suite operation up to 1000L scale. Emergent’s infrastructure and proven track record in development, manufacturing, and commercialization of solutions that address public health threats provide the foundation for differentiated services.

“We are energized by the continued growth of our CDMO offerings and this new focus on advanced therapies,” said Syed T. Husain, SVP and CDMO business unit head. “As a leading CDMO service provider, our goal is to support the needs of industry and fellow innovators in line with our mission – to protect and enhance life.”

The company plans to provide full molecule-to-market CDMO services for viral vector and gene therapy innovators, by offering development services out of its Gaithersburg location, drug substance manufacturing out of Canton, and drug product manufacturing at its Rockville location, which is in the midst of a recently announced significant expansion that is scheduled to be operational at the end of 2021.

Emergent’s CDMO business has the capability to work with five technology platforms – mammalian, microbial, live viral, advanced therapy, and plasma – across a network of nine development and manufacturing sites, to support the entire drug development life cycle.

Aligned with Emergent’s five-year growth plan, which was presented during the company’s 2019 Analyst and Investor Day, this investment supports the strategies of protecting the core business and building scalable capabilities. The addition of advanced therapy scale to the Canton facility will build upon its biologics platforms and will complement existing capabilities related to the company’s smallpox vaccine.

Through this strategic facility acquisition and expansion of the Canton site footprint, Emergent further secures the long-term supply chain of the only single-dose smallpox vaccine and broadens its advanced therapy capabilities increasing its overall CDMO service offerings.

About Emergent BioSolutions:

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what is most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.

 

Gemini Bio Opens New cGMP Facility

Gemini Bioproducts, LLC ("Gemini Bio"), a leading supplier of cell culture reagents and a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a New York-based healthcare private equity firm, announced the opening of a new, state-of-the-art manufacturing facility in West Sacramento, California.

Gemini Bio's new facility was built to support the production of cell culture media, sera, buffers, and other reagents with products that serve the cell and gene therapy market. The newly constructed 25,000-square-foot cGMP facility with cleanroom suites, cold storage, warehouse, and administrative space will quadruple production capacity and allow Gemini Bio to meet its rapidly growing customer demand.

Gemini Bio COO Robert Perry stated, "This new facility positions Gemini Bio to meet the needs of the growing cell therapy and research markets while addressing global regulatory compliance requirements. With our increased manufacturing capabilities, Gemini Bio will be able to deliver to our pharmaceutical partners the quantity and quality of product required as they advance through late-stage development and into commercialization."

Gemini Bio recently announced that it was awarded a $3.6 million federal government contract to supply critical products in support of the high demand for COVID-19 testing. Gemini Bio will be supplying reagents in the areas of Viral Transport Media (VTM), Phosphate Buffered Saline (PBS), and Saline Solution, and is leveraging its new facility to support the effort.

Gemini Bio CEO Dale Gordon added, "Completing this new facility is a major milestone for Gemini Bio and I am proud of the team who made it happen. I would also like to thank MarketOne for being a great partner throughout the project. Our facility expansion is intended to support our growth objectives by increasing capacity and allowing us to further strengthen our quality systems. With these added capabilities, we expect to be a center of excellence for our cell and gene therapy customers. Additionally, it has been incredible to see how the Gemini team has risen to the occasion to support the COVID testing efforts and has met its commitments by delivering on time."

MarketOne Builders, a design-build general contractor, partnered with DGA, a science and technology architectural firm, on the design and construction of the new facility. Gemini is relocating from its current West Sacramento facility, which has been its headquarters since 2006.

About Gemini Bio:

Founded in 1985, Gemini Bio is a leading manufacturer and supplier of cell culture media, sera, and other reagents to the scientific community across academic research and the biotechnology, cell and gene therapy, and biopharma industries. Service offerings include fill and finish and custom media development. Today, a national sales force and an international distribution network serve over 4,000 customers globally, including approximately 400 biotech companies.

About MarketOne Builders:

MarketOne Builders is a design-build commercial construction company headquartered in Sacramento, California. In business for over 23 years, MarketOne has delivered on some of the most demanding projects in Northern California, ranging from life science, mission critical facilities, urban renovations, commercial office, healthcare, hospitality, industrial, retail, and multi-family. Among the more notable projects to date include the state-of-the-art B Street Theatre at the Sofia, Downtown Commons (DOCO), the Sacramento Kings offices inside the Sawyer Hotel, Jackson Laboratories, EA Capital Games, Penumbra and the soon-to-open Fort Sutter Hotel.

About DGA:

DGA is a San Francisco Bay Area-based architectural firm recognized as a leader in facility design for the advancement of life sciences R&D and production (biologics, medical devices and diagnostics, pharmaceuticals), and active in the advanced technology, data centers and mission critical, healthcare and education sectors. DGA serves hospitals, science and research facilities including Agenus, Boehringer Ingelheim, Genentech, Gilead Sciences, Kaiser Permanente, Salk Institute, Scripps Research, Stanford University/Stanford Medicine, UC Davis/UC Davis Health and UCSF/UCSF Health.

 

Thermo Fisher Scientific Expands Viral Vector Mfg. Capacity

Thermo Fisher Scientific Inc. is investing $180 million to expand capacity for viral vector development and manufacturing services with a new commercial manufacturing site in Plainville, MA. The project will more than double the company's commercial viral vector capacity to support increasing demand for the development and manufacture of gene therapies and vaccines.

Construction of the new 290,000-sq.-ft. facility is expected to be completed in 2022. The project will add more than 200 jobs and complements recently expanded capacity in Lexington and Cambridge, MA, and Alachua, FL.

The Plainville site will offer a flexible and scalable configuration of lab and production suites co-located with adjacent warehousing and office space. An onsite engineering lab will help customers develop production platforms that enable rapid transition to commercial-scale operations. The facility will feature digital connectivity and capabilities that enable operational efficiencies, high quality, data visibility and advanced operator training.

"The Plainville expansion significantly enhances our 'start here, stay here' strategy, ensuring that customers have an uninterrupted pathway from development through commercialization," said Michel Lagarde, executive vice president of Thermo Fisher Scientific. "Between Plainville and our other expanded sites in the U.S., we're increasing viral vector production to accelerate cell and gene therapy innovation, giving hope to more patients everywhere."

 

Grand River Injectable Fill/Finish Facility Opens

U.S.-based CDMO completes aggressive expansion plan to serve the growing domestic pharmaceutical market

Grand River Aseptic Manufacturing (“GRAM”), an agile and modern parenteral contract development and manufacturing organization (CDMO), completed its major $60 million expansion project and recently took occupancy.

With the opening of its large-scale fill/finish facility GRAM more than tripled its existing footprint in Grand Rapids, MI to serve increased client demand in the aseptic fill/finish market. The added capacity, latest technologies, and state-of-the-art equipment provide flexible solutions to meet the needs of the most complex sterile injectables.

The new facility located on Butterworth Ave near downtown Grand Rapids, MI is part of the GRAM campus and is the third fill/finish facility for the company.  GRAM now has over 100,000 square feet dedicated to providing superior quality and service in the marketplace.  The Butterworth facility features industry-leading equipment and design, including:

Fully integrated, high-speed Bausch+Ströbel filling line;

SKAN isolators and an IMA lyophilizer auto-loader; and

Grade C cleanroom and formulation suites.

“Our customer-minded team and company culture make us unique, and this new facility – with its cutting-edge equipment and technology – further distinguishes GRAM at the top of the industry,” said Tom Ross, President and CEO of GRAM. “We look forward to bringing our technical expertise to new clients and continuing to serve our current partners with the highest regard for quality, safety and customer service. I am incredibly proud of how the team applied our culture of innovative thinking and hands-on approach to design this state-of-the-art facility.”

GRAM partnered with design and construction firm CRB to execute the project using CRB’s unique ONEsolution™ full-service project delivery method. The integrated team designed the building around the aseptic equipment hand-picked by GRAM experts and constructed the facility outward from its sterile core. This pioneering approach allowed for a concentrated focus on innovation and the ability to adapt to an ever-shifting regulatory landscape. Breaking ground in October 2018, this forward-thinking and unique approach resulted in the facility being built and completed in 20 months, saving months from the standard construction timeline, all while navigating challenging site constraints and without a single injury.

“GRAM has been a great partner and we thank them for entrusting CRB and our ONEsolution delivery team to design and construct their new state-of-the-art facility. Working closely with GRAM resulted in delivering this innovative project at a lower cost within a shorter delivery schedule, enabling their clients to bring patient therapies to market faster. All of us at CRB congratulate GRAM and are proud to be part of this industry-leading project,” said Lance Nordbak, CRB COO Construction Services Group.

 

Grand River Aseptic Manufacturing Expansion

When growing market demand moved the Michigan CDMO to expand, it opted for a novel design-construction approach to building bigger digs.

Founded in 2010 to fill an increasing need for outsourced sterile injectable manufacturing, Grand River Aseptic Manufacturing delivers high-quality fill and finish services for parenteral drug products. A sharp increase in demand motivated leadership to look at expansion options, and the company landed upon a unique approach to growing its Grand Rapids, Michigan facilities.

Rather than the traditional approach of doing design first and construction second, they worked in close collaboration with construction firm CRB in a more parallel way, designers staying several steps ahead of their construction colleagues.

The novel approach on the two-year greenfield expansion increased the company’s capacity by four times; features of the two-story include a high-speed Bausch+Ströbel filling line, SKAN isolators, IMA lyophilizer auto-loader, support equipment, and QC laboratory. Outsourcing-Pharma (OSP) spoke with representatives from Grand River Aseptic Manufacturing (GRAM) and CRB about the unique project.

OSP: Could you talk about the market demands and client needs that might have impacted GRAM’s growth?​

GRAM: Market demands and client needs have been the driving factor behind our rapid growth. With increased client demands, we understood we need to expand quickly while providing the same customer-minded service that has always set us apart. Client demands combined with a growing need for US-based facilities in the pharmaceutical market made us confident investing in our facility expansion.

With a decade of experience, our size has been an advantage allowing GRAM to stay flexible and agile. Our newly opened large-scale fill and finish facility incorporates flexible equipment that increases GRAM’s capabilities and capacity to serve a growing number of commercial clients.

OSP: Please tell us about the features of the new building, and how the specific features expand your services and/or add to your list of capabilities.​

GRAM: Designing and building a pharmaceutical manufacturing facility from the ground up gave GRAM the opportunity to incorporate top-of-the-line equipment that works seamlessly together. The combination of modern equipment, advanced technology and facility automation give us the flexibility to serve multiple clients on the best equipment in our industry.

GRAM has a decade of experience that is supported by talented staff. When you build a solid foundation and give experienced staff the ability to use their skillsets in a new facility like GRAM’s, it leaves the door open for future expansion; GRAM strategically left 14,000 square feet available in our facility for just that - expanding our capabilities to fill client needs. The design of the facility also took into consideration the utility requirements for future expansion.

OSP: Could you please tell us about the specialized considerations (structural, systems, etc.) that a specialized facility like GRAM’s new facility have that you wouldn’t have to think about on a more conventional building, such as an office complex, mixed-use retail, restaurant, etc.​

GRAM: The facility was designed around a unique footprint of land as well as a state-of-the-art filler/isolator system that had already been purchased by GRAM. The utilities were also designed to meet the needs of the specialized manufacturing processes at GRAM; these utilities that aren’t typical at most facilities are clean compressed air, clean room space air, nitrogen, water for injection and pure steam.

CRB: The facility includes several specialized components to support the pharmaceutical manufacturing systems, associated cleanroom spaces and quality assurance laboratories. Utility systems were designed and constructed to maintain reliability, highly stringent environmental parameters and flexibility in operations and future expansion. The structural systems and exterior envelope are constructed to provide enhanced stability and to minimize any potential disruption to the manufacturing systems.

OSP: The approach to design and construction on this structure also was innovative—could you talk a little bit about that?​

CRB: GRAM approached CRB with a very challenging project, including a tight timeline and difficult constraints. CRB’s ONEsolution approach enabled the project team to optimize the entire delivery and phasing of the project, allowing procurement, detailed planning and construction to begin months earlier than otherwise possible, yielding ultimately a lower cost and shorter delivery.

Additionally, through close collaboration and enhanced planning with the GRAM team, operational turn-over, validation and equipment start-up began months earlier than otherwise possible – allowing GRAM to bring the facility online quickly.

GRAM: Design and construction were completed in phases; for example, civil and structural design was completed and then construction began. While construction on civil and structural were ongoing we were finalizing design on mechanical, electrical, plumbing, and other phases.

This process was used through the entire project to start construction as soon as possible to meet the desired schedule. This also required dedicated resources from all vendors, CRB and GRAM to work together as a cohesive team to make decisions daily to meet long lead time purchases and construction schedule.

OSP: Aside from what makes a pharma-centric facility like this different, could you tell us what sets the GRAM expansion facility apart from other life-sciences buildings CRB might have worked on?​

CRB: The GRAM facility utilized many components and system common to the life sciences industry; however, the GRAM and CRB teams worked together to integrate these systems into a state-of-the-art and highly efficient design. GRAM was able to maximize the facility to the greatest extent, given some challenging constraints.

 

Catalent Invests in Bloomington Facility

The line is expected to be operational by April 2021 and will add capacity to support the growing pipeline of clinical programs and commercial launches at the site

Catalent is investing $50 million to install an additional high-speed vial filling line at its Bloomington, Indiana, facility.

It will provide capacity to produce up to 80 million vials annually under barrier isolator technology and a peristaltic pump filling mechanism, consistent with current good manufacturing practice (CGMP) regulations.

Catalent projects the Bloomington expansion will take approximately 10 months in total, including construction, procurement, installation, and CGMP qualification of the line.

This marks the third major investment in the last two years at the Bloomington site. By the end of 2021, the site will have high-speed filling capacity across three vial lines, two syringe lines, and a flexible line capable of filling vials, syringes, or cartridges.

The facility has expertise in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity, including primary and secondary packaging.

“The industry has seen an increased demand for vial filling of biologic drugs, which has been compounded by the accelerated development of vaccine and therapeutic candidates to address the COVID-19 pandemic,” said Mike Riley, Region President, Biologics, North America.

“Catalent’s continued investment in this capacity will allow us to remain flexible and continue to support the growth of our customers’ programs.”

 

Catalent Gene Therapy Facility Receives FDA Approval

Catalent announced that it has been approved by the U.S. Food and Drug Administration (FDA) to produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy (SMA) gene therapy at its manufacturing facility located in Harmans, Maryland.

The approval comes after an FDA inspection of the Harmans commercial-scale gene therapy manufacturing center in June 2020. Since Catalent’s partnership with AveXis, a Novartis company, was announced in July 2019, dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy.

“This is a significant milestone for Catalent and the gene therapy industry as a whole. Catalent is proud to be the first contract development and manufacturing organization to be approved for commercial gene therapy production,” said Manja Boerman, Ph.D., President of Catalent Cell & Gene Therapy. “This approval allows us to leverage our now-licensed, state-of-the-art GMP commercial manufacturing facility, and our deep AAV expertise, to support AveXis as it delivers a life-changing treatment for patients.”

“Given the complexity and length of time required to make gene therapies, manufacturing is critically important,” said Dannielle Appelhans, Chief Technical Officer for AveXis. “This approval further complements our internal manufacturing capacity and, over time, will allow us to increase supply to meet growing patient needs.”

Catalent’s Harmans commercial manufacturing facility is equipped with single-use technology, and houses over 200,000 square feet of late-stage clinical and commercial-stage gene therapy production. The facility is one of Catalent’s five gene therapy facilities in Maryland providing clinical through commercial scale services, and houses multiple CGMP manufacturing suites, including fill/finish, central services and testing laboratories, warehousing, and supply chain capabilities.

 

Rockline to Double Disinfectant Wipes Capacity

Rockline Industries is installing a new state of the art $20 million disinfecting wipe production line that will nearly double the company’s production capacity. The new production line, known as the XC-105 Galaxy, when completed will be one of the largest production lines for disinfecting wipes in the private brands wet wipes industry.

“The COVID-19 pandemic has created a new level of awareness among the American people about the importance of proper surface disinfection,” says Randy Rudolph, president of Rockline Industries. “We are making a huge investment in the future by installing the Galaxy line to ensure that our customers will be able to meet consumers’ increasing demand for disinfecting wipes.”

The Galaxy line is being custom designed by Rockline’s Global Engineering Group and built in partnership with several of the world’s leading converting equipment manufacturers and is expected to be fully operational at Rockline’s Sheboygan, WI plant in mid-2021. The size of the line will require the company to relocate a number of existing production lines within the facility to accommodate the Galaxy. Rockline anticipates that it will increase its workforce as the line becomes operational and production volume increases though exact job numbers are not immediately available.

Rockline opened the Sheboygan plant in 1976 and since then it has grown to become one of the largest manufacturers of wet wipes and disinfecting wipes in the world with a reputation for developing some of the industry’s most innovative and sought-after products.

 

Bionova’s New GMP Manufacturing Centre

Bionova Scientific is constructing its new state-of-the-art manufacturing facility in Fremont, California, US, for the production of biologics.

The good manufacturing practices (GMP) compliant facility will improve the company’s service offerings to the biotherapeutics industry, while also supporting it to meet the increasing demand for industrial biomanufacturing capacity.

The ground-breaking ceremony of the GMP manufacturing center took place in July 2020. The company is anticipated to complete the construction of the facility within ten months, starting operations in the third quarter of 2021.

Bionova is currently in talks with customers for production slots starting from 2021. The company’s move to build the biologics manufacturing facility was in response to demand from clients to meet their GMP production needs.

The manufacturing center is located within Bionova Scientific’s 56,000ft² headquarters in Fremont, California, extending across an area of approximately 36,000ft².

The production facility will use single-use technology for all core unit activities. It will include two 2,000l mammalian cell culture trains (XDR bioreactor trains), which will manufacture clinical and commercial bulk drug substances.

It will add GMP manufacturing to Bionova’s existing portfolio of services including cell line development, process development, GLP material production, process characterization and analytics.

 

Comar Expands East Coast Footprint

Announces a new offsite location in Vineland, NJ

Comar, a healthcare plastic packaging, device and component supplier, has announced a major capacity expansion of its Buena plant operations by building a new offsite location in Vineland, NJ.

The new 159,000 sq.ft. facility in Vineland, only a 20-minute drive from the current facility, will be ISO 13485 certified, cGMP compliant and FDA registered, with house injection molding and assembly and finishing machines, as well as additional capacity to support long-term growth. The expansion, which is scheduled to be completed by March 2021, will also enable Coomar to refresh its Buena facility and increase capacity to better serve customers.

Linda Kershner, Buena plant manager at Comar, said, “In addition to better serving our customers by bringing additional production capacity, the expansion in Southern New Jersey will create a better experience for our employees who are central to delighting our customers. I am extremely excited about both our current Buena and new Vineland facilities. The new Vineland location allows us to create a best-in-class GMP compliant work environment right from the start and at the same time gives us the opportunity to refresh and optimize our Buena site.”

 According to Comar, the expansion effort will result in a range of benefits, including:

Increased space for injection molding, assembly and finishing operations;

Increased warehouse and storage space;

Improved facility layout with more dedicated product cells to drive speed-to-market;

Improved cGMP environment and quality lab; and

Improved design to enable better efficiency, safety, and employee experience.

Mike Ruggieri, chief executive officer, Comar, said, “This investment builds on our new West Coast facility – Rancho 2.0 – and represents another exciting milestone for our organization. Our Buena plant has provided the engine for much of our growth over the decades. This next critical step of adding footprint, infrastructure, and capacity, will ensure that we continue to delight our customers and drive our growth moving forward.”

In February, Comar announced it was building a custom facility in Rancho Cucamonga, CA to expand its West Coast footprint.

 

Eisai Plans to Relocate New Jersey Headquarters

Eisai Inc., an oncology- and neurology-focused pharmaceutical company and the U.S. subsidiary of Eisai Co., Ltd., based in Tokyo, Japan, has unveiled plans to relocate its New Jersey-based headquarters to the technologically-advanced and cutting-edge ON3 property in Nutley, NJ. The company plans to transfer up to 1,200 Eisai corporate staff and research and development functions from Woodcliff Lake to Nutley in late 2021.

"Eisai is a human health care company. This ON3 Eisai workplace will bring the Eisai community together in one place and drive a culture of new scientific horizons and entrepreneurial innovation," says Tatsuyuki Yasuno, president, Eisai Inc. "We draw inspiration from our patients and passion from our people. We break barriers every day. Our workplace will too."

The reinvigoration of the former Hoffmann-La Roche headquarters campus represents New Jersey's largest redevelopment project and has brought together a mix of pharmaceutical (Eisai Inc.), research and development (Hackensack Meridian Health Center for Discovery and Innovation), medical education (Hackensack-Meridian School of Medicine at Seton Hall University, and Seton Hall University's Graduate College of Nursing and School of Health and Medical Sciences), and diagnostics (Quest Diagnostics) companies all on one thriving life science campus, creating what is known as a Bio-ecosystem. In addition, massive expansion and creative urban planning integrates office, retail, fitness, restaurant, entertainment, residential, and lodging space to this new innovation hub.

Prism Capital Partners, owners Eugene Diaz and Edwin Cohen, is the real estate developer for the 116-acre ON3 site. Eisai will fully occupy 200 Metro Boulevard, the campus' flagship LEED Gold certified office tower.

"We are excited to welcome Eisai Inc. as the first biopharmaceutical company to this thriving center for healthcare," said Diaz.

Cohen added, "Eisai brings exceptional scientific and business expertise to this ever-expanding center for New Jersey and global business in a lease that has brought the campus to 100% occupancy."

The new, 15-story, ON3 Eisai Inc. location features significant space to offer a workplace-of-the-future for the existing employee population and allow for company expansion. This state of the art building and campus will ultimately bring all of Eisai's New Jersey-based employees together in one place.

 

REST OF WORLD

Autolus Expands Operations at CGT Catapult Manufacturing Centre

Autolus Therapeutics are further expanding their operations at the Cell and Gene Therapy Catapult (CGT Catapult) manufacturing center, and are collaborating with CGT Catapult to achieve licensure for the commercial manufacture of their CAR-T cell therapies. This collaboration facilitates the company’s plans to manufacture CAR-T cell therapies for both clinical and commercial supply and the CGT Catapult and associated UK supply chain will gain new capability and expertise, adding to the favorable cell and gene therapy ecosystem in the UK.

Autolus are a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer. They are one of five collaborators to have established their large-scale manufacturing operations at the CGT Catapult manufacturing center in Stevenage, UK.

The facility, which has recently doubled in capacity, provides infrastructure, expertise and a surrounding cell and gene therapy ecosystem which is favorable for the growth of companies moving towards clinical adoption. Autolus are expanding within the facility to utilize additional cleanroom space in the newly operational modules, supporting the manufacture of materials for their pipeline products.

“We are proud to undertake this collaboration with Autolus, a pioneering company that has been showing tremendous progress with their pipeline products for oncology. We look forward to working with Autolus to meet all of the standards required for commercial CAR-T cell therapy manufacturing,” Matthew Durdy, CEO, Cell and Gene Therapy Catapult said. “With its unique operating model, the Manufacturing Centre is well suited as an international base for manufacturing innovation at scale and, having recently expanded, has the capacity to support new and existing collaborating companies as they grow.”

 

Bushu Pharmaceuticals’ Manufacturing Facility Expansion, Misato, Japan

Bushu Pharmaceuticals unveiled a new expansion program for its pharmaceutical manufacturing facility in Misato, Japan, in August 2020.

With the estimated investment of $100m, the new capital program will expand the company’s footprint, capability, and range of services to the clients. The program will be implemented over the next five years.

The additional capacity and inspection lines in the facility will facilitate the entry of greater volume of bulk goods into the country, making the clients’ logistics and supply chain processes competent.

Established by Eisai in 1981, the Bushu Pharma’s Misato facility is located in Misato-machi, Kodama-gun, in Saitama prefecture.

The site covers an area of approximately 1,861,480 sq. ft. (173,000m²), divided into a pharmaceuticals manufacturing area and welfare facilities area, including a gymnasium and park.

 The facility has a floor area of approximately 613,320 sq. ft. (57,000m²), encompassing a solid dosage manufacturing building, an injectables building, a warehouse, and a quality control (QC) space.

The expansion program of the manufacturing facility includes the addition of a new cold chain warehouse facility spanning 41,964 sq. ft. (3,900m²). It will be utilized to store temperature-controlled sterile drugs and biologics for export to the market in Japan.

The ground-breaking ceremony of the new cold chain center was held in September 2019.

The center was recognized as an advanced and productive business plan, under the Regional Future Investment Promotion Law, and obtained specific privileges and funding from the Ministry of Economy, Trade, and Industry and Saitama prefecture in May 2020. The facility will be commissioned and validated by the end of September 2020.

The new earthquake-resistant facility is crucial to the company’s ‘Asia hub’ initiative. The initiative helps foreign pharmaceutical firms in Japan to import bulk products for quality inspection, labelling, packaging, and marketing across Japan and other Asian countries.

A total of 26 inspection stations will also be added to the facility to improve the inspection capability, of which 23 will be equipped with cameras. The inspection stations will include 12 stations for pre-filled syringes, seven for liquid vials and seven for lyophilized vials.

Bushu will also add eight new packaging lines, including one pre-filled packaging line and a water-for-injection line to strengthen its sterile manufacturing filling suite at the facility.

The company will also update the production automation infrastructure and the laboratory information management system (LIMS) as part of its long-term information technology (IT) master plan.

Bushu’s collaboration with several pharmaceutical companies globally has underpinned the establishment of the company’s international technical transfer team.

The extended team will promote the transfer of analytical methods and allow the validation of foreign drugs into the two manufacturing facilities of the company.

The existing facility features a large area for manufacturing and packaging of solid dosage, which is double the size of the company’s Kawagoe facility.

Manufacturing Building 1 and the N1 Workroom in the solid dosage manufacturing area are utilized for the production and packaging of the sugar-coated, film-coated and plain tablets. The tableting and coating machines in the building are run primarily during the night for enhanced output.

The packaging area for solid dosage contains a filling space, primarily for packaging, and a packaging space for secondary packaging.

Manufacturing Building 2 includes an area for manufacturing and packaging injectables, with extended capability for ampoules, vial, pre-filled syringe, and freeze-dried pharmaceuticals.

It has an integrated system for the processing, filling, and sterilization of liquid pharmaceuticals (except aseptic packaging).

It contains three sterile ampoule lines, one vial line, one pre-filled syringe line, and one freeze-dried pharmaceutical line.

A structure called J Centre supports manufacturing at the facility. All the raw materials, packing materials, and goods move into the warehouse for dispatch. J Centre has large-scale automated racks to hold 3,860 pallets.

Marketing commentary on Bushu Pharmaceuticals:

Founded in August 1988, Bushu Pharmaceuticals is a pharmaceuticals contract development and manufacturing organization (CDMO) based in Japan.

Bushu undertakes contract manufacturing and packaging of clinical trials and commercial products in compliance with the good new manufacturing practice (GMP) guidelines.

The Misato manufacturing facility of Bushu Pharma has received GMP certification in Japan, the US, Europe, as well as in other regions, including South America and Africa. Its production business is capable of processing a range of over-the-counter (OTC) medicines and prescription medicines (anticancer medications, orphan medicines, regenerative medicines).

 

Seqens Opens New HPAPI Unit

Seqens recently inaugurated a new HPAPI unit for the production of highly active ingredients at its Villeneuve-La-Garenne site, in the presence of Emmanuel Macron, president of the French Republic, and Bruno Lemaire, minister of economy, finance and recovery.

This investment of $35 million in one of the three leading technologies in pharmaceutical synthesis, demonstrates the Seqens group's ability to design, develop and industrialize complex molecules while maintaining a high level of performance in terms of quality, safety and respect for the environment.

This project, called UPP30, has been carried out in partnership with the Belgian biotech company Mithra for the production of a fifth-generation contraceptive molecule with a superior safety profile for women and with a very high level of biodegradability, giving it a major environmental interest. It demonstrates the interest for both major pharmaceutical laboratories and biotech companies to rely on local and perennial skills for the development and industrialization of their molecules.

"Today, I am proud and happy to inaugurate the fruit of many years of work and to see that the Seqens group continues to invest massively in the latest cutting-edge technologies to maintain and develop more than a hundred years of know-how and skills and thus continue to maintain in France real competences in pharmaceutical synthesis. It is the key to keep our health sovereignty over the long term," said JeanPhilippe Aubert, Seqens’ UPP30 project director.

As an integrated player in the drug production chain, from the production of intermediates to the production of active pharmaceutical ingredients and from research and development to industrialization, Seqens has the technical and industrial capacities to relocate and increase the production capacity of essential and critical molecules.

For Seqens, revitalizing its industrial footprint will be based on three pillars:

The development of skills: SEQENS is committed to doubling the number of its work-study students and apprentices, and achieved that by early 2020. In 2021, more than 150 young people will be welcomed to its sites to learn its businesses. Similarly, Seqens has set up a training program to offer a qualifying career path and radical career changes to people who want to discover the world of industry.

Innovation and R&D: Ten percent of the group's employees work on the development of new products and innovative processes, always more efficient and respectful of the environment.

The quality and performance of productions: Seqens is above all an industrial group that relies on the high skills of its employees to continue to offer its customers quality products in compliance with the strictest quality, environmental and safety standards.

"Our sustainability will depend on the ability of our companies to innovate and boost productive investment in our territories. Seqens is ready to take up the challenge by relying on innovation, R&D and the skills of our teams on our production sites," said Pierre Luzeau, CEO of Seqens.

 

TriRx Acquires MSD Animal Health Manufacturing Site in France

TriRx has finalized an agreement with MSD Sante Animale, a division of Merck & Co., to acquire the operations and ownership of its manufacturing site located in Segré, France

The integrated facility has dedicated office, production, sampling and warehouse areas and delivers products to all major global markets. The agreement has officially been executed with all customary regulatory, regional and local approvals.

Timothy C. Tyson, Chairman and CEO of TriRx said: “We are excited to welcome the Segre team to the TriRx family and to partner with MSD Animal Health to continue to provide important products to the market. This transaction allows us to continue our expansion as a global CDMO while assuring continuity of supply of animal health products from the Segré site.

“The site’s history of exceptional performance and the world class knowledge and experience of the site staff expand TriRx service offerings into sterile suspensions and liquids and non-sterile ointments and liquids.” The site currently manufactures a range of veterinary products and has over ninety employees.

“This site will transition to a worldwide center of contract manufacturing excellence in the fast growing, animal health market. It will continue to be a significant contributor to the local economy”, Tyson added.

 

Samsung Biologics to Build Fourth Manufacturing Plant

South Korea-based biomedicine maker Samsung Biologics has unveiled plans to build its fourth plant this year to boost its manufacturing capabilities.

Once complete, the 256kl plant in Incheon will increase the company’s total capacity to 620kl. Manufacturing operations are expected to start in the second half of 2022.

Samsung Biologics will design the plant by incorporating unique features of the three previous plants to enable multi-scale manufacturing services at the site.

Plant 4 will comprise a total floor area of 256 million sq. ft. (23.8 million square meters).

Samsung Biologics CEO Dr Tae Han Kim said: “In this continuously evolving climate, we are strategically positioning ourselves to respond to the needs of our global clients who are producing new medicines that are more complex and diverse and deliver superior client satisfaction.

“With the production of Plant 4, our ‘Super Plant,’ Samsung Biologics is investing in a total line refinement and addition of new mid-scale and small-scale facilities to ensure production efficiency and provide top-notch services to raise the bar even further to establish ourselves as the leading global standard.”

The company also announced that it entered negotiations with Incheon Free Economic Zone (IFEZ) authorities to acquire additional land for its second bio complex.

 

Sorrel Medical’s New Manufacturing Facility, Netanya, Israel

Wearable drug delivery devices manufacturer Sorrel Medical opened a new manufacturing facility in Israel in July 2020.

The facility will develop and manufacture a range of wearable drug delivery devices to boost clinical and commercial supply capabilities. The company is looking to ramp up production of the wearable devices as it prepares for upcoming clinical trials.

The manufacturing plant can assist Sorrel’s partners in the pharmaceutical and biotechnology industry to bring advanced drug delivery solutions to the market.

Increased production scale-up capability is expected to support the needs of patients suffering from severe, high-burden illnesses.

The new facility for the manufacturing and commercialization of wearable drug delivery devices is located in the city of Netanya in Israel.

It includes an advanced production cleanroom to enable the production of scalability of wearable drug delivery devices.

The 861 sq. ft. (80m²) cleanroom conforms to the ISO class 7 environment standard, designed to minimize particulate pollution in accordance with the standards of ISO 14664-1:2015 and EU GMP Annex 1 and regulate other environmental variables including pressure, temperature and humidity.

 

CDMO Sai Life Sciences Opens New Facility

State-of-the-art research and technology center is located in Hyderabad, India and completes first phase in $150 million investment.

Sai Life Sciences, one of India's fastest growing contract development and manufacturing organizations (CDMOs), has inaugurated its new Research and Technology (R&T) Center in Hyderabad, India.

Built with an aspiration to achieve the best global benchmarks in lab infrastructure, the new R&T facility features several unique aspects such as intelligent and ergonomic lab design to enhance safety and productivity, advanced automation for seamless data capture during process development, lean and 5S approach to enhance productivity and collaborative workspaces for engendering innovation.

"Our philosophy behind building this new facility was to go beyond what the norm is in India and to create what our global innovator partners expect from their in-house capabilities," said Krishna Kanumuri, chief executive officer and managing director. Sai Life Sciences. "We are an example of what is possible in Hyderabad's rich life sciences ecosystem. Today, as we build world class R&D capabilities and invest in nurturing talent with deep domain expertise, I can unhesitatingly say, Hyderabad is truly a city where pharma dreams are made."

The new 83,000 square foot facility houses state-of-the-art research capabilities and advanced technology platforms, augmenting the company's capabilities in providing scientific solutions to its pharma and biotech innovator customers globally. It has 24 chemistry labs with 250 fume hoods, analytical labs, fully equipped technology suite and a dedicated process safety lab.

Sai Life Sciences began a process of organizational transformation in 2019 reinventing itself as a new generation global CDMO. Through this initiative, named Sai Nxt, the company is investing over $150 million to expand and upgrade its R&D and manufacturing facilities, induct top-notch global scientific and leadership talent, strengthen automation and data systems, and above all raise the bar for safety, quality and customer focus.

Sai Nxt focuses on upgrading the company’s R&D and manufacturing facilities, boost automation and data systems and improve safety and quality levels.

In January 2020, Sai started hiring more than 300 scientists with expertise in synthetic organic or analytical chemistry and experience in pharma R&D. The roles being filled through the recruitment are in areas of process R&D, analytical R&D, biology, DMPK, and toxicology.

Spanning 83,000ft², the new research and technology center is located adjacent to Sai’s current R&D facility in Genome Valley, Hyderabad, in the state of Telangana. Life science is a major focus area of the Telangana state government.

Sai Life Sciences’ new research and technology (R&T) center is designed as an innovation corridor, with the arterial corridor running through the building providing the space for collaboration between different cross-functional teams.

The facility features an aesthetic environment developed with green spaces to allow scientists to work in a comfortable setting.

The workspaces are designed to consolidate work areas, and comfortable meeting spaces to create an atmosphere suitable for research.

The R&T center houses state-of-the-art research capabilities and advanced platforms.

It includes 24 chemistry labs with 250 fume hoods, analytical laboratories, a fully configured technology suite, and a dedicated in-house process safety lab.

Each lab is designed with intelligent and ergonomic lab design with logical workflows and is self-sufficient with dedicated analytical support and compliant storage capacity. The customized fume cupboards enable the labs to conduct specific chemistries while maintaining global safety requirements.

Intelligent features are intended to increase safety and productivity and support Sai in expediting the delivery of complex chemical synthesis to its clients.

All process R&D labs at the facility are equipped with advanced automation to allow seamless online data collection during process development.

The data is used as the basis for accelerated and precise scale-up using software such as DynoChem and Aspen.

The center employs a lean approach, using the 5S (sort, set in order, shine, standardize, sustain) technique and other methods to increase productivity in labs and reduce the wastage of time and resources. The initiative also helped achieve other improvements such as better planning of drills, standardized labware storage, and timely delivery of process development milestones.

An analytical laboratory is co-located as part of each process chemistry lab under the ‘Satellite Analytical Lab’ concept, which supports greater chemical-analyst interactions and online analytical assistance for ongoing experiments.

Platform technologies at the new R&T center include flow reactors, bio and chemo catalyst screening, molecular distillation, particle engineering tools, separation technologies, continuous extraction, and photochemical reactors.

Innovative technologies help to improve the product development quality in many applications including ensuring safety and scalability of hazardous processes, enhancing API bioavailability, as well as developing greener and selective processes.

Marketing commentary on Sai Life Sciences:

Sai Life Sciences is one of India’s fastest-growing, full-service CDMOs. It aims to assist the launch of 25 new medicines by 2025.

It partners with global pharmaceutical and biotech firms, providing support for the discovery, development, and production of complex small molecules.

The company served more than 100 molecules of drugs across various clinical phases, including 18 molecules in commercial stage and nine in Phase III trials.

Its manufacturing and R&D facilities successfully passed USFDA and PMDA inspections.

Over the last few months, Sai Life Sciences increased its cGMP API and intermediate manufacturing capacity by 172KL. The company already opened a biology lab in Cambridge, Massachusetts, US, and is establishing a process R&D lab in Manchester, UK.

 

Liveo Research Expands Pharma Packaging Business

Announces capacity expansion for coated barrier films in Germany.

Switzerland-based Liveo Research Group, a manufacturer of high-performance barrier films used for blister packaging in the pharmaceutical industry, has announced a 20,000 ton capacity expansion to its existing coating capabilities in Boetzingen, Germany.

With this investment, Liveo will underpin its market position in high barrier products. Its three production-lines, based in Germany and Singapore, will enable Liveo Research to provide enhanced security of supply to its customers in the Pharmaceutical industry.

The high capacity new line will include proprietary coating technology that will allow Liveo Research to produce very high-quality products, extremely efficiently. Following expected commissioning in Q3 2021, the total capacity will reach over 50,000 tons.

The investment will also include a new building equipped to meet the pharmaceutical industry’s highest hygiene standards. Liveo Research had already commissioned a new slitter in June, and the addition of two more slitters will provide even more flexibility to address customer needs and reduce lead times.

Andreas Pfefferle, head of Liveo’s Pharma Packaging Innovations business unit, said, “We have been growing this market very successfully over the last couple of years in response to our valued customers’ demand to get the very best balance of performance and cost. With supply levels already stretched to meet the global demand, this expansion is absolutely the right step to enable us to provide our customers with superior quality, excellent service and shorter lead times. It will be a key enabler to continue our growth story.”

Dr. Carsten Heldmann, CEO of Liveo Research, added, “I’m really excited about this important step as it will propel Liveo to the next level of growth and support our customers with an even higher security of supply, high quality and innovative products.”

 

Aji Bio-Pharma Expands Small Molecule Mfg. Capabilities

Ajinomoto Bio-Pharma Services is significantly expanding its small molecule manufacturing capabilities with the addition of a new production facility in Visakhapatnam, India. Construction of the 91,460 sq. ft. (8,500 square meter) facility began at the end of July 2020 and is expected to be completed mid-2022.

The facility doubles the production capacity at the site to 310 m3 for active pharmaceutical ingredients (API) and intermediates and has dedicated equipment to manage OEB 4 high potency ingredients. The site has also completed renovations on existing lab space to support additional R&D activities. It is estimated that the expansion will create at least 60 new jobs at the site.

The U.S. FDA approved Ajinomoto Bio-Pharma Services India manufacturing site, which was designed, constructed and is managed based on the Aji Bio-Pharma Belgian sites’ GMP operating standards and quality systems.

“We are very excited to be investing in this additional production capacity to continue delivering high quality, cost-effective small molecule manufacturing services for our customers,” said K.V.V. Raju, Head of Site Operations and CEO, Ajinomoto Bio-Pharma India Pvt. Ltd. “This expansion exemplifies our commitment to

 

Lonza Expands Facility in Switzerland

New facility will provide mid-scale commercial manufacturing to multiple customers and in particular, serve the growing needs of Servier.

Lonza is expanding its microbial manufacturing facility in Visp, Switzerland. The new facility will provide mid-scale commercial manufacturing to multiple customers and in particular, serve the growing needs of Servier, an independent international pharmaceutical company and long-term Lonza partner.

Servier and Lonza have recently signed a long-term extension to the manufacturing agreement for L-asparaginase, produced at Lonza since 2009. The extension and expansion of the collaboration will provide Servier with the additional capacity required to provide treatment to many more patients with acute lymphoblastic leukemia (ALL), a cancer of the white blood cells. Servier intends to expand access to asparaginase-based multi-agent chemotherapeutic regimens.

The new facility will be the sixth to be housed in Lonza’s new biopark in Visp, Switzerland, currently under construction. Lonza launched Ibex Solutions in 2018 to offer custom-tailored manufacturing solutions across a broad range of technologies while minimizing time to market with pre-built shells and infrastructure. The new mid-scale (3,000L) microbial facility will tap into existing central utilities and labs and will complement the existing small-scale (1,000L) and large-scale (15,000L) assets in Visp.

The facility is expected to be operational in the second half of 2022 and Lonza expects to add 100 new staff to the existing, highly-experienced microbial team.

 

Construction at Punjab Biotechnology Incubator

Punjab chief minister Captain Amarinder Singh announced the inauguration of a 66 KV substation and the construction of the building of Punjab Biotechnology Incubator.

He made the announcements while addressing the state-level Independence Day function in Mohali.

The 66KV sub-station will be set up at Sector 82 in IT City, Mohali, while the Punjab Biotechnology Incubator building is being built at a cost of Rs 31 crore in Knowledge City, Sector 81.

The construction of the incubator building was started recently by PWD (B&R), and work is in progress on the basement.

 

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