PHARMACEUTICAL & BIOTECHNOLOGY

INDUSTRY UPDATE

OCTOBER 2020

 McIlvaine Company

 

TABLE OF CONTENTS

 

UNITED STATES

 

REST OF WORLD

 

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UNITED STATES

 

SCA Pharma to Expand Production Facility for Compounded Sterile Medications

SCA Pharma, an FDA-registered outsourcing facility, plans to expand its sterile pharmaceutical manufacturing facility in Windsor by 40 percent.

SCA Pharma currently has two sterile pharmaceutical manufacturing facilities located in Windsor, CT, and Little Rock, AK. The planned expansion would increase the size of the Windsor facility to approximately 150,000 square feet with the ability to add state-of-the-art automation, compounding capability, and technical employees to manufacture critical medicines.

“Ensuring that hospitals have all of the readily available sterile injectable pharmaceuticals they need to properly treat and care for patients is more critical today than ever before,” said Milton Boyer, CEO of SCA Pharma. “The demand for SCA products continues to increase, and we are committed to meeting that need safely, efficiently and reliably. Our new construction will position us to expand our capacity and make products even more accessible to hospitals.”

Boyer said construction would take approximately nine months to complete.

 

Purolite Announces Expansion to Address the High-demand for Pharmaceutical Products

Purolite Corporation is expanding its manufacturing capabilities to address and fulfill the increasing global demand for its pharmaceutical and life science products. The new facility will include two new cleanrooms to manufacture active pharmaceutical ingredients (APIs) and excipients and an agarose manufacturing facility equipped with proprietary jetting technology for the capture and purification of (mAbs) monoclonal antibodies sold under the Praesto® brand.

The new location will be near its global headquarters in King of Prussia, PA, and construction is slated to begin in the first half of 2021. Currently, Purolite has four cleanrooms in Romania and an agarose manufacturing facility in Wales, UK. The addition will ensure a security of supply sourcing to support Purolite's increased market demand.

Purolite has more than four decades of experience producing active pharmaceutical ingredients APIs for hyperlipidemia and hyperkalemia. The Praesto agarose resins are utilized in the rapidly growing biologics market.

"Purolite is committed to expanding our manufacturing capabilities in these critical markets where the security of supply is essential," says Don Brodie, Purolite Executive Vice President. "Today, it's more important than ever to support the growing need for new medical applications and future drug development," shares Steve Brodie, Purolite President and CEO.

About Purolite Corporation:

Purolite Corporation is a leading manufacturer of life science products, ion exchange, catalyst, adsorbent and specialty resins for water and non-water applications. Headquartered in King of Prussia, Pennsylvania with 40 sales offices in more than 30 countries, the company has ISO 9001 certified manufacturing facilities in the USA, United Kingdom, China and Romania. It operates dedicated R&D centers in the USA, China, Romania, Russia and the UK.

 

MilliporeSigma Invests to Expand Antibody-Drug Conjugate Manufacturing

On Sept. 9, 2020, MilliporeSigma announced a $65-million investment in its facility near Madison, WI, to expand its manufacturing capabilities for high-potent active pharmaceutical ingredients (HPAPIs) and antibody-drug conjugates (ADCs). The investment will allow for the large-scale manufacture of increasingly potent compounds that have the potential to treat cancer.

The expansion, which includes a new 70,000-ft2 commercial building, is expected to be completed by mid-2022. The new facility will be dedicated to HPAPI manufacturing and will be specifically designed to handle single-digit nanogram occupational exposure limit materials, according to a company press release. The facility will also include containment areas where next-generation linker and payload materials for ADCs will be produced.

“ADCs have posted incredible growth over the last decade and regulatory agencies’ approvals in recent years demonstrate their promise as a targeted therapy,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma. “With more than 35 years of experience in this space, we have been a frontrunner in the development and manufacturing of biologics, conjugation processes, and small molecules. This investment underscores our commitment to working with innovators to bring new treatments to patients quickly and more efficiently.”

MilliporeSigma is the life science business in the United States of Merck KGaA, Darmstadt, Germany, which holds the global rights to the name and trademark “Merck” internationally, except in the US, where the company operates as EMD Serono in the healthcare sector and EMD Performance Materials, in addition to MilliporeSigma in life science.

 

Catalent Invests to Expand Gene Therapy Manufacturing Capacity

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

On Sept. 9, 2020, Catalent announced that it is investing $130 million to expand manufacturing capacity at its gene therapy campus in Harmans, MD. The expansion, intended to support the gene therapy product pipeline and growing market demand, will include the addition of five Phase III through commercial-scale manufacturing suites.

The gene therapy campus has two facilities, and when expansion is completed, the campus will house a total of 15 gene therapy suites, each of which will be able to accommodate multiple bioreactors for commercial supply. FDA recently approved the first facility on the campus for commercial manufacturing, and the first facility is expected to have 10 current good manufacturing practices (cGMP) suites qualified and operational by the first quarter of 2021. The five new cGMP suites will be located in an adjacent building and are expected to come online in the first half of 2022. A second facility will offer cold storage warehousing and additional office space.

The campus is equipped with single-use manufacturing technology, including more than 200,000 ft2 (18,600 m2) of late-stage clinical and commercial-stage gene therapy production. When the second building is outfitted, the campus will encompass a total footprint of approximately 350,000 ft2.

“It is critical that we stay connected to the needs of our customers as they progress through the clinical pipeline. By increasing our late-stage manufacturing capacity at the Harmans campus, we will be able to meet demand through the medium term and take advantage of our shared resources, including the technical and manufacturing expertise that helped us reach the milestone of becoming an FDA-approved commercial partner,” said Manja Boerman, PhD, president, Cell & Gene Therapy, Catalent.

 

Stevanato Group Expands Fill-Finish Capabilities

Agreement with COLANAR adds fill-finish capabilities for ready-to-use glass primary packaging for small batches at US Technology Excellence Center in Boston.

The Modular Filling System FSM by COLANAR is developed for the filling and vacuum stopper placement of ready to use nested vials, cartridges, and syringes.

Italian-based Stevanato Group, a producer of glass primary packaging and provider of integrated capabilities for drug delivery systems, has signed an agreement with COLANAR, a global provider of small-batch pharma filling machines.

Stevanato Group's new US Technology Excellence Center (TEC) in Boston, MA will be equipped with COLANAR'S fill and finish machine to perform analytical characterization and determine critical factors impacting container closure systems.

The Modular Filling System FSM by COLANAR is developed for the filling and vacuum stopper placement of ready to use nested vials, cartridges, and syringes. This solution, built to the highest GMP quality standards, addresses flexibility, high accuracy, and short changeover requirements. These are essential factors when dealing with highly sensitive drugs such as biologics. The FSM will allow Stevanato Group's US TEC scientists to fill glass containers with buffers, placebos, and drug products and immediately test them. This will provide rapid data about the impact of the filling process on a formulation and container closure system helping biopharma companies to develop robust manufacturing processes and minimize challenges during scale-up and commercialization.

"The FSM machine is a key asset in our laboratory that will provide biopharma customers with an additional service for conducting stability testing on filled products,” said Abizer Harianawala, site leader, Stevanato Group TEC. “It will ensure our new US TEC provides robust data for critical fill & finish parameters for clinical batch manufacturing, facilitating scale-up and commercialization.”

Bernd Stroeter, president, COLANAR, said, "We are proud to partner with Stevanato Group at its US TEC complementing its offering with our proven and scalable F&F solution for biologics. The combination of our reliable equipment and the extensive testing methods supplied by Stevanato Group's US TEC will support biopharma companies selecting the best-suited container and drug handling, de-risking the entire manufacturing process, and improving the time to market".

The SG US TEC will provide end to end key services to support biopharma customers along the entire drug development journey, from the early stage through commercialization of the final drug product. The SG US TEC can support the full life cycle management and therefore reduce the risk and time required to bring products to the market.

 

GRAM Opens Fill-Finish Facility

Grand River Aseptic Manufacturing (GRAM) has marked the grand opening of its newest fill/finish facility.

Located near Grand Rapids, the 60,000 sq. ft. large-scale filling facility completes GRAM's $60 million expansion project and triples the company's manufacturing capacity.

Though the facility has been operational since April, the formal celebration was hosted in partnership with the Grand Rapids Area Chamber of Commerce and attended by Grand Rapids Mayor Rosalynn Bliss, Kent County Commissioner Carol Hennessy, and a handful of other guests. Mayor Bliss and GRAM President and CEO, Tom Ross, both gave celebratory remarks reflecting on GRAM's community-minded culture and how far they have come in the 10 years since their inception. GRAM's VP of Operations, Steve Nole, then gave a brief tour of the state-of-the-art facility.

The large-scale aseptic fill-finish facility is equipped with industry leading technologies that support projects using high-speed, state-of-the-art manufacturing and packaging equipment. This aseptic processing facility expansion more than doubles existing square footage to over 100,000 sq. ft. providing access to top-quality parenteral drug manufacturing for all batch sizes.

"The new large-scale, fill-finish facility - within sight of our primary location - will accommodate customer and industry-wide demand for cGMP parenteral drug manufacturing, analytical testing, and regulatory filing services," GRAM said.

The breakdown of the new facility:

State-of-the-art isolator technology

Grade C formulation suites

Grade C cleanroom

Filling suites

Laboratories

Walk-in cold and frozen storage

Future capacity for new technologies

Dedicated personal airlocks (PALs) and material airlocks (MALs)

Jacketed tanks for heating or cooling

Customer viewing rooms

Over 60,000 square feet

CAPABILITIES:

Biologics and small molecule manufacturing

Controlled substance manufacturing

Formulation volumes up to 1,000 L

Aseptic processing

High-speed filling

2R to 50R vial sizes

200 vials/minute

Commercial-scale lyophilization

Chamber capacity up to 68,000

Single-use-systems, or product dedicated process equipment

EQUIPMENT:

Fully integrated, high-speed Bausch+Ströbel filling line

IMA LyoMax 17 Lyophilizer

SKAN Isolators for filling line and IMA lyophilizer auto-loader

BMT Autoclaves

Semi-automated Dabrico inspection system

End-to-end single-use systems for formulation and filling

High-speed Marchesini packaging line

With top-of-the-line equipment, advanced technologies and space for future growth, the new facility significantly increases GRAM's capacity to support the growing demand for US-based pharmaceutical manufacturing.

 

Bio-Techne Announces Grand Opening of GMP Manufacturing Facility

Bio-Techne Corporation (NASDAQ: TECH)  announced the grand opening of its approximately 61,000 square foot state-of-the-art GMP (Good Manufacturing Practices) manufacturing facility. Located in St. Paul, MN, the new facility is dedicated to supporting large-scale production of GMP-grade materials, including E. coli-derived recombinant proteins, which are an essential component for many immuno-oncology and regenerative medicine cell and gene-modified therapy workflows. The advent of both chimeric antigen receptor T cell therapies (CAR T) and stem cell therapies has significantly increased the demand for GMP grade recombinant proteins. The opening of this facility positions Bio-Techne to meet current and future demand for the GMP-grade reagents necessary to support the rapidly growing cell therapy market.

Bio-Techne invested approximately $50 million to build the new facility and equip it with the advanced manufacturing and quality control technologies needed to produce products for cell and gene therapies. The process of culturing cells for therapeutic use requires precise amounts of specific biological proteins to support cell growth and development. Bio-Techne has decades of experience in manufacturing these proteins. With multiple fermenters and purification suites, this new facility will now allow Bio-Techne to manufacture the large quantities of proteins under the GMP quality conditions required for use in the manufacturing of cells for therapeutic applications. Following extensive quality validation procedures, the facility is expected to begin production in early 2021.

Cell and gene therapies are rapidly growing fields of medicine that introduce natural or genetically modified cells into patients' bodies to treat disease or repair damaged tissues, representing the next paradigm in treating difficult clinical indications. Initial successes in immuno-oncology have propelled the market forward, enabling many commercial and research institutions to develop novel cell therapeutic modalities, creating a rich pipeline of potential therapies. These cell and gene therapies provide new hope to patients where traditional therapies were previously unavailable or failed over time.     

"Bio-Techne is the global leader in manufacturing research-grade proteins, with our R&D Systems brand widely recognized for the highest level of purity, bioreactivity and lot-to-lot consistency," commented Chuck Kummeth, Bio-Techne's President and Chief Executive Officer. "GMP proteins are an essential ingredient for the production of cell and gene therapies. With over 1,000 cell and gene therapies in various phases of clinical trials globally, we anticipate demand for GMP-grade proteins to dramatically increase going forward, representing a potential bottleneck in the cell and gene therapy workflow. Bio-Techne's global recognition combined with our state of the art GMP manufacturing facility positions us to meet global demand and further solidify our protein leadership position." 

 

REST OF WORLD

 

Lonza Expands Its Capsule Manufacturing Capacity

Lonza announced a CHF85m ($93m) investment in its Capsules and Health Ingredients (CHI) Division, a dosage form delivery partner to the biopharma and health nutrition industry. The investment will enable the company to expand its overall production capacity of capsules within CHI's Capsugel® portfolio by 30 billion capsules annually while maintaining the high-quality standards with Lonza's Sigma Series. Production capacity will be increased across Lonza's global manufacturing and supply chain network. The investment will allow a 15% increase in CHI's current capsule production capacity.

The addition of manufacturing capacity for a further 30 billion capsules will address the high growth across CHI's gelatin, vegetarian, and specialty polymers portfolio as well as the liquid-filled hard capsules sold under the Licaps® brand. This investment will be made over two fiscal years, 2020 and 2021, across eight global Lonza manufacturing sites, including Bornem (BE), Colmar (FR), Greenwood (USA), Haryana (IN), Jakarta (ID), Puebla (MX), Sagamihara (JP), and Suzhou, (CN).

"We continue to see strong demand for our products across all markets, as consumers and patients alike take a more active interest in their health. Therefore, we felt it is critical that we make this commitment to expand the manufacturing capacity of our network, not only addressing supply needs in the near term but also supply availability over the long term," Claude Dartiguelongue, President Capsules & Health Ingredients, Lonza said.

"Dosage form technologies have evolved rapidly over the past ten years. As the leader in the industry, we are committed to innovation and helping our customers successfully deliver next-generation drugs and nutritional supplements," Quote from Stef Vanquickenborne, Head of Capsules & Health Ingredients Research and Development, Lonza said.

 

MilliporeSigma Invests in New Switzerland Laboratory

MilliporeSigma has announced plans to build a new, $20 million laboratory facility in Buchs, Switzerland to support its growing reference materials business. MilliporeSigma anticipates that about two dozen jobs will be created.

"Researchers in testing labs around the world use MilliporeSigma’s reference materials every day to help generate accurate, reliable analytical results in pharmaceutical, environmental and food and beverage analysis,” said Jean-Charles Wirth, head of Applied Solutions at MilliporeSigma. “This new laboratory will allow us to continue to drive innovation in diagnostics and testing and expand our research and development of analytical standards.”

Completion of the three-story, 12,000-square-foot Buchs building is scheduled for December 2021 and the move is planned for early 2022. The modern, flexible workplace design, to include laboratory and office space, is aimed at fostering a collaborative environment for its 40 employees, some of whom will move from the existing, heavily utilized building. The new facility will offer a more efficient way of working for current and future employees in research and development, analytical production and quality control. The laboratory area can be adapted to new requirements in the future, including increased site capacity.

 

Arcinova Installs Robotic Capsule Filler

Arcinova, a multi-service Contract Development and Manufacturing Organization (CDMO) based in Alnwick, Northumberland, has recently taken delivery and commissioned the award-winning R1000 Robotic Capsule Filler from life-sciences automation company 3P innovation, as part of the ‘Fill-Inova’ project.

The R1000 includes 3P’s patented Fill2Weight micro-dosing technology, which directly supports the optimization of drug substance through direct filling into capsules. Thanks to its capability of handling challenging powders with very poor flow properties, Fill2Weight enables formulators to bypass the need for excipients, with the associated benefit of avoiding the need for excipient compatibility tests. The result is a significantly faster route through clinical trials and lower overall costs.  

“By combining our well-established expertise in drug substance manufacture and solid form optimization with the advantages offered by the R1000, we are now ideally placed to address the growing demand for pharmaceutical products in clinical trials, ranging from simple capsules to inhaler devices.  It is an absolute pleasure to be offering such advanced services to clients around the world with real patient benefits,” commented Stephen Byard, head of Drug Product, Arcinova.

Arcinova’s previous manufacturing method for patient specific drug products involved a non-automated procedure with a production rate limited to 200 units per hour. The installation and commissioning of the new robotic machine from 3P Innovation increases production to 1000 units per hour, while maintaining the same level of operator labor. This fully-automated capsule filler has been designed to provide Arcinova with an agile manufacturing solution with traceable weight recordings for each individual capsule.

“As the pharmaceutical industry is under increasing pressure to develop new drugs faster, it is important that manufacturers seek the most advanced technologies. The R1000 is a versatile and powerful production machine, capable of handling the most challenging and specialist powders from pure API’s and blends to delicate spray-dried powders and micro-pellets,” added Simon Strothers, business development director, 3P.

The Fill-Inova Project is part of Arcinova’s multi-million-pound investment in the Alnwick site and aims to create a more responsive ‘economy-of-scope’ approach to producing complex medicines in smaller volumes. By employing digital technologies with automation and machine learning, Arcinova is able to produce on-demand, specific therapies for small patient populations. This will increase the UK’s capacity to manufacture small-molecule and high potency medicines, with patients set to benefit from accelerated access to targeted drug therapies.

 

Dräger Sets Up Respiratory Mask Production Facility in the UK

Germany-based Dräger has received an order from the British government to deliver respiratory protection masks (FFP3)

In connection with the COVID 19 pandemic, Dräger has received an order from the British government to deliver respiratory protection masks (FFP3). The delivery of the order will start in 2020 and will stretch until the end of 2021. The expected net sales are roughly EUR 100 million.

For this purpose, a mask production facility will be set up in the UK, in the Blyth area of Northumberland. There, Dräger has had a development and production site for respiratory protection technology for firefighters and industry for over 50 years.

This is in addition to the existing production network in Sweden and South Africa and the recently decided new production sites in France and the US. The investment in the expansion of production capacities across all five production sites will require a mid-double-digit million euro amount in the 2020 financial year.

Rainer Klug, Chief Officer of Safety Division at Dräger: "We are very pleased about the major order from the British government. It gives us the opportunity to expand our international production network for FFP masks."

"With this additional production unit, Dräger will increase volumes quickly and flexibly," Klug said. "Our international production network enables us to react very quickly and specifically to national or local requirements on the one hand, and to cover international requirements in a closely networked and flexible manner on the other. Dräger thus operates a highly responsive manufacturing system for certified FFP respiratory protection masks, with a product design originating from our own development in Germany."

 

 

McIlvaine Company

Northfield, IL 60093-2743

Tel:  847-784-0012; Fax:  847-784-0061

E-mail:  editor@mcilvainecompany.com

Web site:  www.mcilvainecompany.com