PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
OCTOBER 2020
TABLE OF CONTENTS
UNITED STATES
SCA Pharma
to Expand Production Facility for Compounded Sterile Medications
Purolite Announces Expansion to Address the High-demand for Pharmaceutical
Products
MilliporeSigma Invests to Expand Antibody-Drug Conjugate Manufacturing
Catalent Invests to Expand Gene Therapy Manufacturing Capacity
Bio-Techne
Announces Grand Opening of GMP Manufacturing Facility
REST OF WORLD
_________________________________________________________________
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:
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Web site: www.mcilvainecompany.com