PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
September 2020
TABLE OF CONTENTS
UNITED STATES
Thermo Fisher Scientific’s New Manufacturing
Facility, Lenexa, Kansas, USA
Merck’s ADC Manufacturing Facility Expansion,
Madison, Wisconsin, USA
Gx Biological Solutions Adds Two Innovation and
Technology Centers
Stevanato Group Opens Technology Excellence
Center in Boston
Arranta Bio Establishes Commercial-Ready
Manufacturing Facility
Piramal Opens Solid Oral Dosage Facility in
Sellersville, PA
Evergreen Theragnostics Breaks Ground for
Manufacturing Facility
REST OF WORLD
Sai Life Sciences’ New Research and Technology
Centre, Hyderabad
Bushu Pharmaceuticals’ Manufacturing
Facility Expansion, Misato, Japan
Gx Biological Solutions Adds Two Innovation and
Technology Centers
BioNTech to Acquire Novartis Mfg. Site for COVID-19 Vax
Production
BES Wins
Contract to Create New Quality Assurance Lab
Boulting Environmental Services has been
awarded a contract for the design and construction of a new Quality Assurance
Laboratory for a pharmaceutical blue-chip client.
Employed as principal designer and principal
contractor, the team will deliver this project on a full turnkey basis,
including civil and structural, architectural, HVAC and electrical services.
Based on extensive experience in designing
and building many similar laboratory facilities, BES were able to improve the
flow and spatial efficiency of the initial brief, providing a buildable solution
which meets current Good Laboratory Practice (GLP) requirements as well as the
client's own corporate standards.
In order to allow for much more accuracy and
precision while designing and building, BES generated realistic 3D renderings of
interior spaces, creating a complete overview of the design solution.
One of BES's senior planners has developed a
detailed schedule to ensure that the construction works are completed within a
challenging 22 week period.
A value engineering exercise to reconfigure
the mezzanine plantroom, generated significant savings for the Client and the
team are now focusing on the final design solution, which include control of
powders within the weighing room and maintaining close environmental conditions
to ensure stability of retained samples.
Thermo
Fisher Scientific’s New Manufacturing Facility, Lenexa, Kansas, USA
Thermo Fisher Scientific opened a new
manufacturing facility in Lenexa, Kansas to meet the increasing demand for viral
transport media (VTM) being used in Covid-19 testing in the US.
The new manufacturing facility was developed
with an estimated investment of $40m after the US government contracted the
company to provide highly specialized VTMs for COVID-19 sample collection in May
2020. Production was commenced in July 2020, while official inauguration was
held in August 2020.
The facility began operations with an initial
production rate of 50,000 VTM units a week. It currently manufactures more than
eight million units a week and is expected to deliver more than 150 million
units by the end of 2020.
The site can also be expanded to meet the
requirements for the rising COVID-19 testing demand in future. The facility will
subsequently focus on the new research and development activities related to
COVID-19.
Thermo Fisher Scientific created 300
full-time jobs for the local community through the new manufacturing plant.
Thermo Fisher Scientific’s new manufacturing
facility details…
The new manufacturing facility spans an area
of 120,000ft² and handles the production and quality control of VTM products for
COVID-19 sample collection.
VTM are plastic tubes used for the safe
collection and transportation of patient samples to laboratories for virus
detection.
The units help make sure that the sample
collected from a COVID-19 nose swab retains viability while being transported to
the laboratory for testing. VTM are manufactured and dispensed into tubes in an
aseptic condition to maintain the accuracy of COVID-19 test results.
The VTM products made at the new facility
will also be used to collect and sample flu and other viruses. The production
will be ramped up by utilizing the proven blueprint for high-quality production.
The VTM products will be distributed to the
US states, local testing centers, and the Strategic National Stockpile (SNS),
which is the national repository of critical medical supplies.
Thermo Fisher Scientific’s COVID-19 response…
Thermo Fisher has rapidly developed a new
multiplex real-time RT-PCR diagnostic kit named Applied Biosystems TaqPath for
rapid diagnosis of COVID-19, in response to the outbreak.
The company is partnering with its suppliers
to ensure supplies and prioritize shipments for those consumers specifically
involved in the efforts to control the COVID-19 outbreak. The partners include
first responders, healthcare professionals, and clients who support patient
safety and vaccine development.
Thermo Fisher generated revenue of
approximately $1.3bn by providing products and services related to COVID-19 in
the second quarter of 2020.
Marketing commentary on Thermo Fisher
Scientific:
Thermo Fisher Scientific is a biotechnology
company based in the US. It has a workforce of more than 75,000 employees
worldwide.
The company offers a mix of breakthrough
technology, convenient purchases, and pharmaceutical services via its brands,
including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific,
Unity Lab Services, and Patheon.
Thermo Fisher Scientific also provides custom
solutions, enterprise services, training, enterprise-level lab informatics
services, lab instruments and equipment services, finance or leasing plans,
product plans, product testing and inspection solutions, as well as CDMO and
clinical trial services.
It works internationally with government
agencies and researchers to ensure priority access to instruments, consumables,
safety supplies, and other items to resolve the epidemic particularly in virus
identification, diagnosis, and personal safety.
Merck’s ADC
Manufacturing Facility Expansion, Madison, Wisconsin, USA
Merck announced the expansion of its
high-potent active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate
(ADC) production capabilities and capacity at its facility in Madison,
Wisconsin, US, in September 2020.
With an estimated investment of $69m (€59m),
the expansion will facilitate large-scale production of increasingly potent
compounds for potential cancer treatment.
The Madison facility expansion will create
approximately 50 full-time jobs beginning in 2021, expected for completion by
mid-2022.
Merck will add a new 6,500m² (70,000ft²)
commercial building dedicated to the HPAPI manufacturing facilities in its
established Madison campus.
The new building will feature one of the
largest single-digit nanogram containment production facilities for the
manufacturing of HPAPIs. It will handle nanogram-single-digit occupational
exposure limit materials, allowing for a continuous flow of ADCs production.
Madison facility, the first commercial
facility in the US dedicated to the development of ADC, handles highly active
materials.
The addition of the new building will expand
the company’s ADC manufacturing capabilities together with the existing campus
in St Louis, Missouri, US, that specializes in ADC bio-conjugation, APIs,
excipient and adjuvants manufacturing.
ADCs are a new group of medications designed
as a targeted therapy for cancer treatment, developed by linking a cytotoxic
anticancer drug payload to a highly specific antibody via a biodegradable
linker.
The biochemical reaction between the antibody
and targeting antigen absorbs the ADC into the cancer cells where the cytotoxic
drug is released to destroy the cancer cells.
The production of ADC is complex and requires
a strict containment infrastructure. Its structural exceptionality involves
experience in various technologies for small and large molecules, as well as
analytical capability.
Just nine ADCs in the world currently hold
approval, with the ADC market projected to hit $15bn by 2030.
Details of the Merck’s ADC manufacturing
facility in Madison…
Merck’s existing manufacturing facility in
Madison handles HPAPIs, APIs, linkers, cytotoxic materials, payloads and
secondary metabolites.
Madison facility has a wide range of
manufacturing spaces and machinery. It has the requisite versatility for the
multi-step synthesis of complex and HPAPIs. It can support the development and
production of complex small molecules from pre-clinical to commercial scale.
Pilot and production-scale facilities and
equipment are certified for handling Safebridge® Cat IV materials and can
support HPAPI manufacturing. Most of the kilo labs are also Safebridge® Cat IV
qualified.
Some of the safety features of the facility
include differential room pressure designed for containment, airlocks, HEPA
filtered single-pass air and contaminants capturing with safe-change filters.
The company has two sites in Madison for
process development with process scale-up laboratories.
The Madison facility’s experience in linker
and payload technology manufacturing combines with the St Louis’ clinical and
commercial ADC facilities to provide comprehensive supply chain solutions.
The solutions include the company’s
end-to-end BioReliance® capabilities for process development and cGMP monoclonal
antibodies manufacturing for clinical supplies.
Marketing commentary on Merck:
Merck is a global pharmaceutical company
headquartered in the US. The company delivers vast expertise in both clinical
and commercial manufacturing. Furthermore, it has more than 35 years of
experience in the production and manufacture of small molecules, biologics, and
ADC technologies.
The company holds global rights to the Merck
brand except in the US, as well as Canada, where its business divisions operate
as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance
Materials.
Gx Biological Solutions Adds Two Innovation and
Technology Centers
Offers enhanced services for pharmaceutical primary packaging in the US and in
Europe.
The new centers are located in Bünde, Germany, and Vineland, New Jersey.
Gerresheimer has added essential laboratory and regulatory services to its broad
portfolio of products, solutions and services for biotech companies, with
innovation and technology centers in Bünde (Germany) and Vineland (New
Jersey/USA).
Gx Biological Solutions offers full service for biotech companies regarding
product development of primary packaging and drug delivery solutions, material
and functional testing as well as comprehensive regulatory support. The
partnership with Gerresheimer shortens the time to market for pharmaceutical
companies, minimizes risks, and saves resources.
"Our Glass Innovation and Technology Centers, with their new laboratory and
regulatory services, take a lot of the work off our customers on the long road
to regulatory approval," said Stefan Verheyden, global vice president of the Gx
Biological Solutions Team.
Glass Innovation and Technology Center,
Bünde (Germany)
The new center is located at the production site for glass syringes, injection
vials and cartridges in Bünde. The range of services includes laboratory and
regulatory services by regulatory experts for DMF III (Drug Master File) and the
new MDR (Medical Device Regulation). Product support is provided by the relevant
product and material experts. They take care of the correct specification and
can offer guidance regarding fill & finish questions.
Chemical analyses help in finding the appropriate packaging system with regard
to material in direct contact to the drug formulation, such as glass, tungsten,
adhesives, silicone oil or polymers. Customer-specific developments and design
proposals are also developed and adapted to intelligent solutions as required.
Throughout the whole value chain of drug development, subsequent testing and
analyses can be conducted. Material and particle analysis, extractables and
leachables testing, container closure integrity investigations, drug container
interaction and aging tests, residual volume, fill & finish support and
orienting stability tests are just a couple of examples of the cutting-edge
services that Gerresheimer will offer.
Additionally, a sample stock will hold many frequently used possible container
formats for biopharmaceutical development enabling our customers to rapidly
respond to any urgent market requirements they might face. The Gx innovative
portfolio includes strengthened glass vials (both in non-sterile and
ready-to-fill format) silicone-free syringes, safety devices, also in already
assembled, sterilized and nested format (Gx RTF), and other intelligent primary
packaging solutions.
Glass Innovation and Technology Center, Vineland (NJ/USA)
Gerresheimer has also expanded the reach of the existing Glass Innovation and
Technology Center in Vineland (NJ/USA) with a comparable extended service
offering as specified for the Bünde site.
Next to the existing material science capabilities, an extensive offering of
functional testing will be added. The bundling of development capacities with
dedicated lab and regulatory services for primary packaging such as injection
vials and cartridges has clear advantages when it comes to significantly
reducing “time to market.” At Vineland, experts and engineers who specialize in
glass technology work in an environment that encourages collaboration through
open offices, project, laboratory, and meeting rooms. The environment also
enables interactive collaboration with customers on site.
The Innovation Center was the first of its kind for Gerresheimer's primary
packaging glass business and was built in 2019 next to the plant in Vineland. In
this way, the Innovation Center develops and tests new products and processes in
close proximity to a production site and can incorporate the operational
know-how of engineers from this plant. In addition, Gerresheimer's other
American production sites can also use the service. It comprises a detailed
analysis of the primary packaging material; for example, the material, surfaces
and functions of injection vials are tested and chemical analyses are carried
out. Gerresheimer also accompanies and supports its customers with regulatory
support, official documentation, and registration.
Stevanato Group Opens Technology Excellence Center in Boston
New center provides a full-service approach
to support biopharma companies across drug development to overcome
container-closure system hurdles.
Stevanato Group, a producer of pharmaceutical
glass containers and provider of integrated capabilities for drug delivery
systems, has officially inaugurated its Technology Excellence Center (TEC) in
Boston, Massachusetts.
The new center provides a full-service
approach to support biopharma companies along the drug development journey, from
early phase development to commercialization, helping them overcome
container-closure system hurdles. With growing demand for biologic therapies in
the US, the Boston-based laboratory is well positioned to offer integrated
development and analytical services to support local biopharma companies in
their drug development journey.
“We built on our analytical laboratory
experience in our headquarters in Italy, to create the first Technology
Excellence Center in Boston. We took this step also in the U.S. thanks to the
positive feedback received from our customers. They confirmed our capability to
work with them as true partners, integrating both our and their technical teams
and analytical competencies. As a result, they benefited from an optimized drug
development process, reduced time-to-market, increased flexibility, and reduced
total cost of ownership. U.S. TEC represents a unique business model that we
wish to replicate in other regions,” said Franco Stevanato, CEO.
Leveraging the Group’s knowledge in material
science of glass, plastics, and rubber, the U.S. TEC will cover one of the most
binding decisions for biopharma industry players: how to select the primary
container for a biopharmaceutical product.
“Massachusetts continues to attract life
sciences companies from across the globe, who come here to access our leading
academic and medical centers, diverse talent, a supportive government, and a
robust startup community,” said Robert K. Coughlin, president & CEO, MassBio.
“We are thrilled to welcome Stevanato Group to the #1 life sciences cluster in
the world and are confident their Technology Excellence Center will support the
diverse needs of biopharma companies as they seek to bring new therapies to
patients.”
The company has also strengthened its
offerings at the U.S. TEC through a network of strategic partnerships with
container closure integrity (CCI) testing provider , Pfeiffer Vacuum,
Extractables & Leachables testing with Nelson Labs, and small-scale fill
& finish with COLANAR.
Arranta
Bio Establishes Commercial-Ready Manufacturing Facility
Enables the CDMO to supply vital products to
patients in need.
Arranta Bio, a microbiome contract
development and manufacturing organization (CDMO), has announced the mechanical
completion of GMP suites at its Watertown, MA commercial-ready facility.
Arranta is investing more than $100 million
in 2020 to establish a multi-product, commercial-ready manufacturing facility
that will supply live biotherapeutic products (LBPs) to microbiome innovator
companies. The Watertown facility has been designed to the highest
specifications for advanced biologics production.
"We are grateful to the Arranta team and to
our construction management partner, DC Beane and Associates Construction
Company, who specializes in the construction and development of life science
facilities, and the numerous sub-contractors who have supported Arranta and
worked through the pandemic in a safe and efficient manner to keep our
commercial-ready manufacturing facility build-out on schedule. This is a
remarkable accomplishment that will enable Arranta to supply vital products to
patients in need and provide more than 200 new product development,
manufacturing and operations jobs," said Mark Bamforth, president and CEO of
Arranta Bio.
Arranta is also expanding process development
and GMP capacity at its early-clinical supply facility in Gainesville, FL.
Catalent Acquires New Biologics Facility
Catalent purchased the 23,000-square-foot
facility from AB BioTechnologies.
Catalent, a global provider of advanced
delivery technologies, development, and manufacturing solutions for drugs,
biologics, cell and gene therapies, and consumer health products, has acquired a
new manufacturing facility in Bloomington, IN, to create a North American center
of excellence for early-phase clinical biologics formulation development and
drug product fill/finish services. The $14 million investment includes the
acquisition, build-out, and qualification of the facility to begin supporting
customer programs starting January 2021.
The 23,000-square-foot facility, purchased
from AB BioTechnologies, Inc. and its affiliate, includes a new Vanrx SA25
aseptic flexible filling line capable of filling liquid and lyophilized vials,
syringes, or cartridges under barrier isolator technology, while also providing
rapid changeover for faster manufacture of clinical batches. The facility also
has formulation development capabilities, quality control laboratories, and
controlled temperature storage for biologic and sterile products. The site will
be fully integrated with Catalent Biologics’ main Bloomington facility located
nearby, where the company recently announced a $50 million investment to install
an additional high-speed vial filling line.
“The addition of this new small-scale filling
capability underlines Catalent’s commitment to our customers with early stage
programs looking to accelerate molecules into the clinic,” said Mike Riley,
Catalent’s Region President, Biologics, North America. “The filling line will
also be fully leveraged as part of our OneBio offering, an integrated solution
for drug substance and drug product development, manufacturing and clinical
supply, enabling faster development timelines to Phase 1 clinical trials and
beyond.”
This new line brings the drug product
fill/finish manufacturing capacity across both Bloomington facilities to three
high-speed vial lines, two high-speed syringe lines, one high-speed flexible
filling line, and one small-scale flexible filling line, all of which is
expected to be available by the end of 2021.
Catalent Biologics will now offer its
customers a center of excellence for clinical biologics formulation development
and drug product fill/finish services in both North America and Europe following
the recent announcement of a $30 million investment at its Limoges, France site.
Comar
Expands East Coast Footprint
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.
Aphena
Pharma Invests in Tennessee Expansion
Adds 258,000 sq. ft. to current Cookeville
footprint and represents expansion into biologics, cold chain storage and
third-party logistics distribution.
Aphena Pharma Solutions is investing $21
million to expand its Solid Dose Division in Cookeville, TN, with the
acquisition of a 500,000 sq. ft. property, purpose-built for FDA manufacturing
and packaging operations.
Aphena began renovations to transform the
property into a state-of-the-art pharmaceutical packaging and distribution
facility, which will also serve as Aphena’s corporate headquarters. The
renovations will be completed by Feb. 1, 2021.
This acquisition, which will add 258,000
square feet to Aphena’s current Cookeville footprint, also represents the
company’s expansion into biologics, cold chain storage and third-party logistics
distribution.
“This new facility will make Aphena a top
contender in the pharmaceutical contract service space, starting with over
12,000 pallets of cold chain storage capacity,” said Eric Allen, Aphena’s EVP of
Sales. “Being able to offer turnkey packaging and distribution services for
biologic products, plus expanding the current operations with newly innovated
bottling and packaging lines, will continue to attract key pharmaceutical
customers to the Middle Tennessee area.”
The expansion will allow Aphena to install 24
high-speed bottling lines and eight thermoform blister packaging lines. Also,
200,000-plus sq. ft. of warehouse space provides a strong foundation for a new,
third-party logistics program for current and future customers.
Aphena Pharma Solutions provides contract
manufacturing and packaging services for the pharma, biopharma, consumer health
and medical device markets. With two separate FDA- and DEA-registered locations
in the U.S., Aphena handles solid dose, liquids, gels, creams, ointments, foams,
suspensions and lotion-based products.
Frontida BioPharma Completes Facility Expansion
Frontida BioPharm Inc. has completed a
facility expansion to its oral solid dose manufacturing operations with the
commissioning of a Highly Potent Compound Contract Manufacturing Suite. This
addition features 1000 sq. ft. of readily available, hazard-certified production
space.
Key service equipment and set-ups include a
large-scale Roller Compactor, Milling Room, Bin Blender, Tablet Press, and
ingress and egress airlocks with enhanced personnel controls. Frontida will
utilize these capabilities to streamline clients' goals for the development of
flexible and scalable manufacturing processes for clinical trial materials
through commercial product operations.
Highly potent compounds serve an increasingly
significant role in numerous R&D landscapes and pharmaceutical intensive medical
treatments; i.e. oncology, atrial fibrillation, osteoporosis. In order to
produce these products, a thorough process of product risk analysis is required
in order to maintain a consistent manufacturing balance between production
scale, market distribution and demand requirements. As a key step to utilize
this new suite, Frontida's manufacturing assessments will verify each highly
potent compound's level of toxicity, potential personnel and facility exposure
limitations.
"The addition of a highly potent suite at
Frontida Biopharm Inc. leverages the internal know-how and capabilities of our
existing product development and manufacturing teams. The expert personnel
leading this 'suite' new expansion contribute an average of 20 years practical
experience to every project. Each prioritizes the safety and well-being, OEL
guidelines, effluent containment practices, responsible air emissions, and
sanctioned waste removal needed in order to better serve our pharmaceutical
clients," commented Anthony Qu Ph.D, chief operating officer.
"This area will expand Frontida's
capabilities to our customers, further assuring that our culture of excellence
and production quality is maintained through high grade service options, and
top-of-the-line technological advantages," added Renard Jackson, executive vice
president of CMO Services.
MilliporeSigma Expands HPAPI and ADC Mfg.
Capabilities
MilliporeSigma is investing $65 million to
expand its facility near Madison, WI.
MilliporeSigma is investing $65 million to
expand its HPAPI and ADC manufacturing capabilities and capacity at its facility
near Madison, WI. The investment will allow large-scale manufacturing of
increasingly potent compounds that have the potential to treat cancer.
Completion is expected by mid-2022 and should add approximately 50 full-time
jobs starting in 2021.
The new 70,000-square-foot commercial
building will be one of the largest dedicated HPAPI manufacturing facilities
specifically designed to handle single-digit nanogram occupational exposure
limit materials. The project is in addition to the company's campus in St.
Louis, Missouri, which was the first commercial ADC facility in North America,
and which specializes in ADC bio-conjugation, active pharmaceutical ingredients,
excipient and adjuvants manufacturing.
ADCs are an emerging class of medicines
designed for high-specificity targeting and destruction of cancer cells, while
preserving healthy cells. There are now only nine ADCs approved globally.
However, the ADC industry is delivering strong growth and is expected to reach
$15 billion by 2030.
While ADCs can provide many benefits compared
with other therapeutic options, they also present a unique set of complex
challenges, necessitating stringent containment infrastructure, requiring
expertise in a number of different technologies for small and large molecules,
as well as analytical capabilities. Due to these challenges, a majority ADC
projects are outsourced to contract development and manufacturing organizations.
GigaGen Initiates Large-Scale Manufacturing of GIGA-2050
GigaGen Inc., a biotechnology company
advancing transformative antibody drugs for infectious diseases, transplant
rejection and checkpoint resistant cancers, has initiated large-scale
manufacturing of its recombinant hyperimmune drug for COVID-19, GIGA-2050, in
collaboration with two partners for Good Manufacturing Practice (GMP), Waisman
Biomanufacturing and Goodwin Biotechnology Inc.
Large scale production of GIGA-2050 will
support an Investigational New Drug application (IND) and Phase 1 studies in
COVID-19 patients. The GMP product will be subjected to nonclinical GLP
toxicology and pharmacokinetics studies in fall 2020 and the company expects to
reach the clinic in early 2021.
“Large-scale manufacturing of GIGA-2050 is a
crucial milestone for GigaGen for several reasons,” said David Johnson, Ph.D.,
co-founder and chief executive officer of GigaGen. “It not only puts us on track
towards initiation of first-in-human studies for COVID-19 in early 2021, but it
demonstrates our ability to execute on novel GMP manufacturing methods for
recombinant polyclonal antibody drugs. Polyclonal drugs have been used for years
to successfully treat a range of infectious disease and immunodeficiencies, but
until now they have only been produced directly from human and animal plasma.
Recombinant polyclonal drugs comprise thousands of different clones at very
particular ratios, unlike recombinant monoclonal drugs, which deal with one cell
clone. To manufacture recombinant polyclonals, we have developed new protocols
to optimize production yield, demonstrate consistency across batches and
generate a highly pure product. Our success with moving GIGA-2050 to large scale
GMP manufacturing in collaboration with our excellent partners paves the way for
other promising recombinant hyperimmunes in our pipeline in the future.”
About GIGA-2050
GIGA-2050 is a new class of drug designed to
provide passive immunity to COVID-19 patients or those at high risk. It can be
described as ‘recombinant convalescent serum,’ in that it has the consistency,
purity and potency of recombinant antibodies, while capturing and enhancing the
diversity of anti-coronavirus antibodies observed in convalescent serum.
Unlike current recombinant antibody therapies
in development for COVID-19 that comprise one or a few antibodies against
specific epitopes of the SARS CoV-2, GIGA-2050 comprises more than 12,000
antibodies with strong binding activity against natural SARS CoV-2 variants.
Additionally, GIGA-2050 is 100 times more potent than convalescent plasma, which
should result in a better therapeutic potential.
To produce GIGA-2050, GigaGen captured
millions-diverse antibody sequences from B cell repertoires of 16 convalescent
donors with exceptionally strong antibody responses to COVID-19. Thousands of
select libraries have been engineered into mammalian cell line clones to produce
the antibody product at large scale.
Carl Ross, director of Waisman
Biomanufacturing, added, “At WB, our mission is to support development of novel
therapeutics and we work collaboratively with companies to find ways to
manufacture their groundbreaking drugs. GIGA-2050 is one of the most exciting
manufacturing challenges we have encountered and exemplifies our ability to
actualize innovative manufacturing techniques. We look forward to continuing to
support GigaGen as they carry this potential treatment all the way to the clinic
and seeing the impact that GIGA-2050 can have as a treatment for COVID-19
patients.”
Sai Offers
Enhanced Lab Capabilities
Sai Life Sciences expands suite of cellular
analysis platforms in Cambridge, MA.
Sai Life Sciences, one of India's fastest
growing contract development and manufacturing organizations (CDMOs), has added
state-of-the-art cellular analysis platforms at its Discovery Biology facility
in Cambridge, MA.
Coinciding with its first anniversary in
Cambridge, the expanded suite of capabilities includes the Opera Phenix high
content screening platform, FACSCelesta flow cytometer and FACSMelody flow
sorter, enabling it to better serve start-up and biotech companies in the
region, especially in projects exploring novel biology in oncology, neuroscience
and rare diseases.
Over the past year, the lab has delivered a
range of projects including genetic and pharmacological target validation
studies, reagent validation, and developed a variety of assays for its clients,
such as cellular target engagement assays and in vitro biomarker assessments.
Located in the heart of the Cambridge/Boston
biotech ecosystem, Sai's 8,500 square feet lab in Kendall Square creates
opportunities for local biotechs to have frequent face-to-face collaboration
with Sai scientists, and to accelerate the pace of their externalized research
by reducing cycle-times. The exploratory focus of the lab allows clients to
externalize complex biology projects that necessitate more fluid experimental
design with real-time decision making. Complementing the team in Cambridge is a
larger biology team in India that works in tandem to present clients an optimal
solution in terms of speed, cost and talent.
"We are committed to helping our clients
successfully advance their internal discovery portfolios and are investing
considerable resources to provide world-class service in the Boston area,” said
Krishna Kanumuri, chief executive officer and managing directory, Sai Life
Sciences. “These new capability additions are just the latest in our strategic
growth plan with significant additional capabilities coming soon."
The Cambridge lab serves as a vital bridge,
enabling seamless integration with rest of the company's service offerings
across UK and India, spanning the drug discovery and development continuum
including medicinal chemistry, DMPK and toxicology, process chemistry and
analytical development, and commercial scale manufacturing.
Piramal
Opens Solid Oral Dosage Facility in Sellersville, PA
Site adds North American capability in
product and process development, manufacturing and packaging of solid oral
dosage forms, liquids, creams, and ointments.
Piramal Pharma Solutions’ Sellersville Grand
Opening. From left to right: Ken Yamashita, PPS; Jim Miller, West Rockhill
Township Board of Supervisors; John Fowler, PPS; Thomas Hufnagle, Sellersville
Borough Mayor; Robert Harvie, Vice Chair, Bucks County Commissioners; Stuart
Needleman, PPS.
Piramal Pharma Solutions (PPS), a Contract
Development and Manufacturing Organization (CDMO), held a grand opening event at
their recently acquired solid oral dosage drug product manufacturing facility in
Sellersville, PA.
Peter DeYoung, Chief Executive Officer,
Piramal Pharma Solutions, explained that this acquisition broadens the offering
of Piramal Pharma Solutions by adding solid oral dosage form capabilities
(tablets and capsules) in North America. He said, “This is a big day for us. We
are rapidly growing and we take pride in the fact that we let our customer’s
guide how and where we grow. The Sellersville facility is a great example of
this. It was acquired because it addresses a market need for solid oral dosage
form development and manufacturing in the United States. It also gives us new
capabilities in liquids, creams, and ointments. As a leading CDMO offering
end-to-end solutions across the drug life cycle, it’s vital that we provide our
customers with a complete suite of services in all major geographies.”
John Fowler, Chief Operating Officer, Piramal
Pharma Solutions, added, “Bringing the Sellersville site into the family
significantly helps us accomplish our goal of getting medicines to patients.
This is the thirteenth facility in our global network and our first solid dose
facility in North America, giving us critical mass that matches local market
need.” Stuart Needleman, Chief Commercial Officer, Piramal Pharma Solutions,
added, “As a patient-centric organization, our mission is to help our customers
reduce the burden of disease on patients. It is the reason why we get up in the
morning. And the Sellersville site most definitely enhances our ability to do
that.”
Metrics Contract Services Begins Plant Expansion
Metrics Contract Services, a full-service
global contract development and manufacturing organization (CDMO), has begun
construction on the expansion of its novel oral solid dosage manufacturing
facility expansion in Greenville, NC.
The $10 million investment will add 3,760
square feet of production space to the current facility, providing added
flexibility and capacity to the CDMO and its clients.
The expansion consists of three new rooms:
one dispensing/flex room, one tablet press room and one flex room to accommodate
the company’s growing portfolio of commercial services following sustained
increase in demand from clients for high potent handling capabilities.
New equipment also forms part of the
investment and includes a Fette FE55 tablet press, a Bosch 720 encapsulator,
which both offer containment capabilities for the safe handling of potent
products, and a weigh and dispense isolator.
“The new equipment we’ve purchased is ideal
for the small batch size and high changeover products which our clients
require,” said John Ross, president at Mayne Pharma U.S and Metrics Contract
Services. “Our clients will see immediate benefits through higher yields and
improved potent handling. We recognized that customer’s commercial requirements
often demanded increased flexibility within production suites. This expansion
will cater for those needs because it creates more spaces where equipment trains
can be tailored to the applicable process.”
The expansion project which has been in
development over the last six months is expected to be complete and fully
operational by February 2021.
“This is a significant investment for the
business and reflects our commitment to increasing our novel oral solid
manufacturing capabilities and providing our clients with quality services from
initial concept through to global commercialization,” said Ross. “We are now
actively looking at the next phase of investment and how to maximize the
expanded facility even further with the potential addition of further packaging
and adjacent formulation technologies.”
Metrics Contract Services offers quality
pharmaceutical formulation development; clinical trial materials manufacturing
for all phases; analytical method development and validation services and
commercial scale manufacturing and specializes in highly potent, novel oral
solid dosage forms.
Evergreen Theragnostics Breaks Ground for
Manufacturing Facility
On September 23, Evergreen Theragnostics
Inc., a radiopharmaceutical Contract Development and Manufacturing Organization
(CDMO), broke ground for its new manufacturing facility in Springfield, New
Jersey.
The new 14,000 square foot facility is
designed from the ground up to meet global cGMP standards for
radiopharmaceutical manufacturing, including therapeutic and centrally
distributed diagnostic radiopharmaceuticals. It will feature four fully equipped
production suites, three additional customizable suites, research space,
multiple sterility lines, quality control, material storage, and packaging
space.
The location was chosen both for access to
the deep pharmaceutical talent pool in the area and for logistics advantages of
being in New Jersey. With proximity to major transportation hubs like Newark
Liberty International Airport in New Jersey and John F. Kennedy International
Airport in New York, the facility will be able to seamlessly manage both raw
material supply chains from Europe and the US, and delivery to North American
customers on a just-in-time basis.
Set to open next year, Evergreen will serve
the manufacturing needs of companies developing and commercializing
radiopharmaceuticals, from preclinical and early stage clinical trials to full
scale commercial manufacturing of approved products.
"We are excited to take one more step forward
in realizing our goal of providing high quality and high reliability
manufacturing of radiopharmaceuticals in North America. We are encouraged to see
companies in our industry developing so many exciting new drugs, and are eager
to provide a top-tier manufacturing service to support their efforts," said
James Cook, CEO of Evergreen.
G-CON
Expands for POD Manufacturing
G-CON continues its campus expansion to meet
the growing demand for prefabricated cleanrooms.
G-CON Manufacturing, the leader in off-site
built, pre-qualified cleanroom solutions, announced another facility expansion,
increasing its U.S. based cleanroom construction site from 189,000 sq. ft. to
245,000 sq. ft. The expansion boosts G-CON’s production capacity to 355 PODs per
year at its U.S. site, allowing the company to provide its growing client base
with the benefits of off-site cleanroom construction and eliminating bottlenecks
and interruptions often associated with onsite construction.
G-CON broke ground on the facility in July.
The structure will be complete in November and fully operational in the first
quarter of 2021.
“Ten years ago, we started with 12,000 square
feet of rented space and to see that grow into 245,000 square feet is truly
remarkable. We are very gratified to be a part of the pharma industry’s
acceptance of prefabricated cleanrooms for small, large and mission critical
projects that require quality and expedited timeframes for completion,” said Sid
Backstrom, Vice President, Business Management. “With this expansion, we further
ensure that we can reliably provide the cleanroom solutions that our clients
require in their production of life-saving therapies, thereby honoring our
‘BUILDING FOR LIFE’ purpose.”
Takeda
Opens Cell Therapy Manufacturing Facility
When Takeda unveiled its translational cell
therapy engine early last year, the Japanese pharma made it clear the crew,
under Novartis vet Stefan Wildt, is going all the way: clinical expertise,
bioengineering chops, world-class collaborations, plus chemistry, manufacturing
and control.
The final piece of the puzzle has now fallen
in place, with the opening of a 24,000 square-foot cell therapy manufacturing
facility at its R&D headquarters in Boston.
“In that early space, having it situated in
proximity to our teams is quite powerful,” said Chris Arendt, head of the
oncology therapeutic area unit. “When you think about it, the process defines
very much the medicine and the cell therapy space”
Designed to produce clinical-grade material
from discovery through pivotal Phase IIb trials, the site will support five
ongoing pacts. They include pluripotent stem cell work with Kyoto University
Nobel laureate Shinya Yamanaka, gamma delta T cell research with Adrian Hayday
and his biotech, armored CAR-Ts with Koji Tamada at Noile-Immune Biotech,
next-gen CARs with Memorial Sloan Kettering’s Michel Sadelain, and finally
CAR-NK with Katy Rezvani at MD Anderson.With three programs now in the clinic,
Takeda is now picking two more to test in humans in 2021, Arendt said. While
each research partnership has taken on its own bespoke approach to manufacturing
up to now, the new facility will provide a central spot to lock down the process
development as close to the final product as possible.
At the forefront are TAK-007, an allogeneic
CD19-targeted CAR-NK being tested in Phase I/II for relapsed or refractory
non-Hodgkin’s lymphoma; TAK-940, 19(T2)28z1xx CAR-T cells featuring a next-gen
signaling domain from MSK; and TAK-102, a cytokine and chemokine armored CAR-T
directed at GPC3-expressing previously treated solid tumors. The latter two are
in first-in-human trials.
Having a dedicated facility scales the
operations up so that the team can simultaneously advance multiple programs, he
added.
Before the Covid-19 pandemic sucked out all
the oxygen in the room, the booming cell therapy market’s demand for physical
infrastructure captured considerable attention. Gilead’s Kite constructed its
own viral vector manufacturing center in order to leave “no stone unturned.
Contract manufacturers like Catalent were snapping up space, and even Deerfield
got into the game with a splashy, $1.1 billion entrance.
The way he’s built the team — now grown to
well over 150 scientists — the learnings from any one program can be quickly
applied to the whole portfolio, Wildt noted.
“We wanted to place the engine team at that
sweet spot between late-stage discovery and rapidly putting forward innovative
ideas and concepts into clinical translation,” he said. “It was just a concept a
few years ago. And now we can partner with hospitals and patients and really see
hopefully we can be successful on their behalf.”
Mercy
Health Muskegon Medical Center - Muskegon, MI
Described as a “…world-class destination for
comprehensive health care,” the Mercy Health Muskegon Medical Center is a
$271-million, ten-story health care facility and the crown jewel of the Mercy
Campus in Muskegon, Michigan.
The building includes nearly 300 spacious,
private patient rooms and serves as the new home for the emergency department.
It also houses state-of-the-art surgical units.
The new building effectively doubles the
amount of floor space for medical staff to treat patients.
Well before the groundbreaking for the
impressive facility took place in 2016, planners knew they had a number of
mandates to meet as they began designing the building.
Among other key considerations, owners wanted
Mercy Health Muskegon to serve as a signature structure for the medical campus.
They also sought to potentially achieve LEED certification.
Products manufactured by CENTRIA were the
perfect prescription.
Accelerating the timeline for completion
became a key consideration, one that impacted decisions about the type of
insulation specified for the building.
Designers chose MetalWrap from CENTRIA, the
company’s insulated composite backup panels that serve as the ultimate backup
wall for nearly any type of exterior rainscreen system.
“Speed to market has become a critical
issue,” said Mike Andric, associate vice president and healthcare architect at
HGA Architects, who noted that the MetalWrap solution was easy to install by a
singular crew, saving time.
“You look at one trade coming in versus two
or three trades coming in to enclose the building, and obviously there’s going
to be a difference as far as coordination efforts go,” Andric added.
“Less coordination means more efficiency.”
Designed with CENTRIA's innovative advanced
thermal and moisture protection (ATMP) technology, MetalWrap consists of two
steel skins that are permanently bonded to a poured-in-place foam insulating
core. MetalWrap provides thermal, air, water and vapor barriers in a composite
assembly.
Crews installed nearly 100,000 square feet of
MetalWrap on the exterior wall of the high-rise facility.
Rather than designing what amounted to a
“white box” for the new healthcare facility, designers wanted to create visual
interest with the building’s exterior while also delivering versatility and
optimal performance.
The solution: Intercept from CENTRIA, which
was installed over the MetalWrap and became the face of the building, covering
almost all of the outer walls.
The design team used a customized program to
create a random pattern of colors for the exterior wall, which contributed
dramatically to the building’s curb appeal.
“We ended up going with three different
colors [for Intercept],” Andric noted. “They looked the same when you’re looking
at small samples, but in the field, you can really detect the difference between
the colors of the panels.”
Intercept is a modular metal wall panel
system that enables designers to create architecturally pleasing exterior
facades along with the protection afforded by a rainscreen. The solid metal
substrate is non-combustible and is compliant with NFPA 285.
Intercept also carries the Declare Label,
developed by the International Living Future Institute. The third-party
certification demonstrates how the product can contribute to the creation of a
building that boasts sustainability credentials.
The product achieved the label in 2020.
Intercept is 98.6% recyclable. It also has a
20-year finish warranty and can withstand the life span of the building when
following proper maintenance procedures.
Mercy Health Muskegon opened the new facility
in phases starting in late 2018 through 2019.
Architects, planners and the medical system
have submitted an application for the facility to be officially LEED-certified.
REST OF WORLD
Seqens
Launches HPAPI Manufacturing at 100-Year-Old Site
The global pharmaceutical ingredient producer
has opened a high-potency active pharmaceutical ingredient unit at its
century-old facility in France.
Seqens, a pharmaceutical ingredients
manufacturer with locations around the globe, has launched a specialty
production unit at its Villeneuve-La-Garenne, France site. The $35m (€30m)
facility (opened at a ceremony attended by French president Emmanuel Macron)
will tackle development and production of high-potency active pharmaceutical
ingredients (HPAPIs).
The project involves an investment of $35m
(€30ms) pharmaceutical synthesis. Called UPP30, the project constitutes a
partnership with Belgian biotech company Mithra, reportedly for the production
of a fifth generation contraceptive molecule.
JeanPhilippe Aubert, UPP30 project director,
said the company comes after years of research and labor. "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 knowhow and skills and thus
continue to maintain in France real competences in pharmaceutical synthesis,” he
said.
Seqens’s work comprises research, development
and commercialization of intermediates, APIs and HPAPIs.
The company reportedly is focused on
revitalizing its industrial footprint in three key areas:
Development of skills: the company reportedly
is looking at doubling the number of work-study students and setting up a
training program to build interest in pharmaceutical careers.
Innovation and R&D: the company employs 10%
of its workforce in developing new products and innovating processes
Production quality and performance: Seqens
reportedly prioritizes employee skills and continuous improvement at its 24
production sites.
Seqens CEO Pierre Luzeau said the company’s
focus on skills and innovation will help it succeed into the future.
"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 Luzeau.
Cambrex Completes Edinburgh Facility Expansion
The site currently has 50 employees, and the
expansion will add additional laboratory space to enable the recruitment of up
to 40 more scientists
Cambrex has announced the completion of an
expansion of its solid form screening and crystallization process development
facility in Edinburgh, Scotland. This major expansion project has seen the
facility's total footprint doubled to 15,000 sq.ft., with existing laboratory
space having been refurbished, and an additional 3,500 sq.ft. of laboratory
space added.
“We have seen an increase in demand for
services, and specifically for larger-scale crystallization projects, so this
expansion increases our efficiency and ability to respond to these requests,”
commented Tom Loewald, Chief Executive Officer of Cambrex. He added, “The work
we carry out at the Edinburgh site is one part of Cambrex’s integrated drug
substance offering, and the investment increases our flexibility to work on
projects at all stages of drug development.”
Cambrex’s Edinburgh site provides solid form
development services for drug substance and drug product. These include solid
state investigations such as salt, co-crystal, and polymorph screening, in
addition to crystallization process development and GMP analytical services. The
scientists at the site work on projects both as a standalone service to a range
of pharmaceutical innovators, as well as liaising with other Cambrex sites to
offer an integrated process development service.
The expansion has added an additional 13 fume
cupboards to the laboratory, including three that are ‘walk-in’, which will
allow the Edinburgh team to increase capacity and provide its clients with
larger process crystallization development, up to 20-liter scale.
Sai
Life Sciences’ New Research and Technology Centre, Hyderabad
Contract development and manufacturing
organization (CDMO) Sai Life Sciences inaugurated its new research and
technology (R&T) center in Hyderabad, India in August 2020.
The new R&T center increases Sai’s
capabilities to offer improved scientific solutions to global innovators in
pharmaceutical and biotech markets, serving as the hub for the company’s
integrated discovery and development services.
Inauguration of the facility marked the
completion of the first phase of a more than $150m investment plan between 2019
and 2023 under Sai Nxt, an organization-wide initiative designed to turn the
company into a new generation CDMO.
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.
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. Expected Completion is 2025
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
1,861480 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 609,900 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 tabletting 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 new
good 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).
Romark’s New
Manufacturing Facility, Manati
Romark has built a new manufacturing facility
in Manati, Puerto Rico, for the production of its diarrhea drug, Alinia® (nitazoxanide),
for the US market.
The facility can also support the
manufacturing and distribution of NT-300 (nitazoxanide extended-release
tablets), an investigational drug for the prevention and treatment of COVID-19
and other viral respiratory infections, if approved. The drug is currently
undergoing phase three clinical trials.
The Puerto Rico Industrial Development
Company (PRIDCO) announced the development of Romark’s new manufacturing
facility in Puerto Rico with an estimated investment of $110m in December 2014.
An old facility was repurposed with an
investment of $80m to develop the new facility. The plant was inaugurated in May
2019, while the US Food and Drug Administration (FDA) approval was granted in
August 2020.
The company’s Puerto Rico operations will
grow from the existing 100 employees to a total of about 400 employees over the
next three years.
Spanning an area of 35,000ft², the
state-of-the-art manufacturing facility produces 500mg Alinia tablets and
100mg/5ml Alinia oral suspension.
It is installed with suites and equipment to
manufacture pills, powders, and other types of oral solid dosage forms,
expanding Romark’s production and distribution capacity.
The company also acquired an analytical
laboratory in Puerto Rico in 2018.
Alinia is the only FDA-approved drug to treat
diarrhea caused by both Cryptosporidium parvum and Giardia lamblia in patients
aged one year and older. Oral suspension of Alinia is recommended for patients
between one and 11 years, while Alinia tablets are recommended for patients aged
12 years and older. The most frequent side effects identified for Alinia tablets
and oral suspension during clinical trials were stomach pain, chromaturia,
nausea, and headache.
Romark’s COVID-19 investigational candidate
NT-300 is being tested as a broad-spectrum antiviral medication for the
treatment and prevention of viral respiratory diseases caused by common, new,
and drug-resistant viruses.
Two phase three clinical trials of NT-300 are
underway for evaluating the drug’s potential in the prevention of COVID-19 and
management of respiratory diseases induced by rhino and other enteroviruses.
Romark initiated a new phase three clinical
study on NT-300 in up to 800 patients for the treatment of mild or moderate
COVID-19 in August 2020. The study will measure the recovery time in patients
administered with NT-300 compared to placebo.
Stonehenge Capital in partnership with
Capital One, Mid-City Community, Empowerment Reinvestment Fund, and HEDC
Emerging Markets invested $33m in New Markets Tax Credit (NMTC) financing to
complete Romark’s pharmaceutical manufacturing project in October 2018. The
investment from NMTC will facilitate the strategic expansion plans of Romark in
Puerto Rico.
In the previous phase, Romark invested $46m
to rehabilitate, renovate and equip 33,000ft² of vacant space for the
development of its products.
Urban Atlantic was responsible for the
restoration of the Puerto Rico pharmaceutical facility.
CMA Architects & Engineers, CIC Construction
Group, O’Neill & Borges, and Bermúdez-Longo-Díaaz-Masso were involved in the
design and construction of the facility.
Other contractors include BLDM, Pharma-Bio
Serv, and Pariter Wealth Management Group.
Marketing commentary on Romark:
Romark Laboratories is a vertically
integrated, multi-national pharmaceutical company based in Tampa, Florida. It
focusses on the discovery, development, manufacturing and marketing of new
medicines.
The company has presence in Puerto Rico,
Belgium, Luxembourg, and Australia. It conducts research and development and
handles commercialization of products worldwide.
Gx
Biological Solutions Adds Two Innovation and Technology Centers
Offers enhanced services for pharmaceutical
primary packaging in the US and in Europe.
The new centers are located in Bünde,
Germany, and Vineland, New Jersey.
Gerresheimer has added essential laboratory
and regulatory services to its broad portfolio of products, solutions and
services for biotech companies, with innovation and technology centers in Bünde
(Germany) and Vineland (New Jersey/USA).
Gx Biological Solutions offers full service
for biotech companies regarding product development of primary packaging and
drug delivery solutions, material and functional testing as well as
comprehensive regulatory support. The partnership with Gerresheimer shortens the
time to market for pharmaceutical companies, minimizes risks, and saves
resources.
"Our Glass Innovation and Technology Centers,
with their new laboratory and regulatory services, take a lot of the work off
our customers on the long road to regulatory approval," said Stefan Verheyden,
global vice president of the Gx Biological Solutions Team.
Glass Innovation and Technology Center, Bünde
(Germany) …
The new center is located at the production
site for glass syringes, injection vials and cartridges in Bünde. The range of
services includes laboratory and regulatory services by regulatory experts for
DMF III (Drug Master File) and the new MDR (Medical Device Regulation). Product
support is provided by the relevant product and material experts. They take care
of the correct specification and can offer guidance regarding fill & finish
questions.
Chemical analyses help in finding the
appropriate packaging system with regard to material in direct contact to the
drug formulation, such as glass, tungsten, adhesives, silicone oil or polymers.
Customer-specific developments and design proposals are also developed and
adapted to intelligent solutions as required. Throughout the whole value chain
of drug development, subsequent testing and analyses can be conducted. Material
and particle analysis, extractables and leachables testing, container closure
integrity investigations, drug container interaction and aging tests, residual
volume, fill & finish support and orienting stability tests are just a couple of
examples of the cutting-edge services that Gerresheimer will offer.
Additionally, a sample stock will hold many
frequently used possible container formats for biopharmaceutical development
enabling our customers to rapidly respond to any urgent market requirements they
might face. The Gx innovative portfolio includes strengthened glass vials (both
in non-sterile and ready-to-fill format) silicone-free syringes, safety devices,
also in already assembled, sterilized and nested format (Gx RTF), and other
intelligent primary packaging solutions.
Glass Innovation and Technology Center,
Vineland (NJ/USA) …
Gerresheimer has also expanded the reach of
the existing Glass Innovation and Technology Center in Vineland (NJ/USA) with a
comparable extended service offering as specified for the Bünde site.
Next to the existing material science
capabilities, an extensive offering of functional testing will be added. The
bundling of development capacities with dedicated lab and regulatory services
for primary packaging such as injection vials and cartridges has clear
advantages when it comes to significantly reducing “time to market.” At
Vineland, experts and engineers who specialize in glass technology work in an
environment that encourages collaboration through open offices, project,
laboratory, and meeting rooms. The environment also enables interactive
collaboration with customers on site.
The Innovation Center was the first of its
kind for Gerresheimer's primary packaging glass business and was built in 2019
next to the plant in Vineland. In this way, the Innovation Center develops and
tests new products and processes in close proximity to a production site and can
incorporate the operational know-how of engineers from this plant. In addition,
Gerresheimer's other American production sites can also use the service. It
comprises a detailed analysis of the primary packaging material; for example,
the material, surfaces and functions of injection vials are tested and chemical
analyses are carried out. Gerresheimer also accompanies and supports its
customers with regulatory support, official documentation, and registration.
Algenex
Opens Facility in Spain
Algenex has opened its new facility in Tres
Cantos, Spain. The new facility allows Algenex to produce up to 3.5kg of
recombinant proteins, equivalent to around 100 million vaccine doses across
animal and human health.
The facility comprises around 9,684 sq. ft.
(900m2) of rearing and production areas, molecular laboratories and office
space. It also incorporates two small suites that will be dedicated to
commercial manufacturing. The first suite will be dedicated to the manufacturing
of Algenex’ Baculovirus-based proteins, while the second suite will be dedicated
to the inoculation of the Trichoplusia ni pupae, which are used as natural
bioreactors in the production of Algenex’ proteins. GMP certification for these
two suites is targeted for Q1 2021.
The new facility took five months to complete
and cost under EUR 2 million to build and is easily replicated to scale up
production as required. This is in contrast to traditional bioreactor
facilities, which require substantial capital expenditure and take two to three
years to put in place.
“We are pleased to inaugurate our new
facility, which enables Algenex to significantly increase its capacity to
provide protein production solutions to the healthcare industry across both
animal and human health applications,” said Claudia Jiménez, CEO of Algenex.
“The global COVID-19 pandemic has highlighted the urgent need for the rapid
production of large quantities of vaccine at an affordable cost and Algenex is
ready to put its technology and expertise to work to provide an efficient,
scalable and cost-effective manufacturing option that allows the implementation
of timely and global vaccination campaigns.”
NW
Bio Accelerating Sawston Plant Phase I Buildout
Northwest Biotherapeutics (NW Bio), a
biotechnology company developing DCVax personalized immune therapies for solid
tumor cancers, said it is pursuing an intensive program of manufacturing
preparations and planning as the company approaches top line data from its Phase
III trial of DCVax-L. A cornerstone of this expanding program is completion of
the Phase I buildout of the Sawston, UK manufacturing facility.
With construction crews working double shifts
to accelerate this completion, the company currently anticipates the Phase I
buildout will finish by mid-October of 2020.
This buildout is the culmination of several
years of design, development and preparatory activities, including clean room
suites, quarantined storage, quality control testing suites, controlled
cryostorage (freezing) facilities for the finished products, as well as
specialized systems. For example, for full air changes every 60 seconds in the
cleanroom suites, and precise monitoring of particle counts in the cleanroom
air.
This accelerated effort is being supported by
the company's recent financings and by a special purpose competitive loan of
~$1.77 million from the Department for Business, Energy & Industrial Strategy
which is administered locally in the Cambridge/Sawston region by the
Cambridgeshire & Peterborough Combined Authority. The project cost of this
accelerated construction project, initiated in June of this year, is
approximately ~$4.6 million.
Luina Bio, one of Australia’s most
experienced biopharmaceutical contract development and manufacturing (CDMO)
organizations, is expanding to meet the increasing demand in the microbiome and
recombinant biopharma markets.
The first stage of the expansion will see
Luina open an additional small scale (30L) GMP manufacturing suite in late 2020,
broadening he company’s service offering for new clinical projects that need
small scale GMP facilities. This facility will be available to customers in Q3
2020.
This will be followed by the opening of four
additional development laboratories in late 2020, allowing Luina to take
customer projects from the earliest development stage to a volume of 500L. This
opening formally introduces the company’s systems approach to facility design
and utilization, known as the Luina Flexible Manufacturing Platform (Luina FMP).
The Luina FMP environment is designed to deliver the speed and technical
excellence necessary to handle the development of technically advanced
microbiome & recombinant protein projects. It capitalizes on years of experience
Luina Bio has growing bacteria initially thought to be unable to be grown at
useful quantities for customers.
Les Tillack, CEO of Luina Bio commented,
“This new small-scale suite will allow us to respond to those customers that
need a smaller active dose for their initial clinical development, while also
giving them access to Luina’s proprietary FMP facility flexibility. Luina FMP
was developed from over three decades of contract manufacturing experience,
knowledge and expertise culminating in a unique manufacturing approach that
advantages Luina Bio’s customers.”
Currently in planning, the next stage will
see Luina develop a 107,600 sq. ft. (10,000m2) late phase clinical and
commercial production facility for commissioning in late 2021.
The new facility will have up to five
production lines in parallel, ensuring that multiple-strain live biotherapeutics
projects have compressed production times. Luina’s largest reactor (2,000L) will
allow it to deliver live biotherapeutics volumes compatible with the commercial
needs of those companies that have single-strain projects.
The facility will also boast new technologies
to decrease the downstream processing time of live biotherapeutics and bacterial
recombinant biotherapy projects dramatically.
“We aim to deliver the world’s most
technologically advanced live biotherapeutics manufacturing plant so that our
customers can be safe in the knowledge that their projects will be delivered on
specification and on budget. This quality-centric approach will start at the
earliest possible development stage and continue throughout the life of the
project,” said Tillack.
The new facility further expands Luina’s
capability for expanded capacity for bacterial and yeast recombinant projects
including vaccine manufacturing, particularly in light of COVID-19 vaccine
manufacturing demand.
Tillack further commented, “Luina Bio already
possesses the intricate cGMP capabilities needed to manufacture a COVID-19
vaccine and has the potential to cut down the time associated with this type of
infrastructure and advanced processes development by a number of years helping
Australia’s preparedness for COVID and other potential pandemic challenges.
Luina Bio’s location allows it to use
Australia’s scientific workforce for this expansion. Luina continues to work
with the Queensland government grant programs enabling new process engineering,
systems capability and jobs. The company will also be recruiting additional
technical and scientific staff further supporting and growing the biotechnology
industry in Queensland potentially up to a further 300 staff.
Tjoapack Invests in Automated Packaging Capabilities
Tjoapack, a global contract packaging
organization, is investing in its automated packaging capabilities to meet
growing customer demand for pre-filled syringes and vials.
The new fully automated packaging line for
vials will start operations in Q1 2021 and will increase its capacity to over 12
million vials per year. Its pre-filled syringes (PFS) capabilities are expected
to be fully operational by Q4 of 2021.
The fully automated PFS packaging line will
have an initial capacity for 7 million syringes per year and will be able to
assemble, automate insertion of plunger rods and back-stops, carry out inline
labelling and complete coding and vision control.
“At Tjoapack we’re committed to ensuring we
consistently bolster our offering and deliver the efficient and flexible
services that our clients expect. The investment from Ampersand allows us to
build on our strong foundations, expand our service offering, and ensure we
continue to meet customer demand,” commented Dexter Tjoa, CEO of Tjoapack. “Our
vision is to shape the pharmaceutical supply chain to be safer and more
efficient and, as a result enable our clients to make the world healthier by
facilitating their life sciences research, production and delivery of medicines
to patients across the globe.”
This latest addition to Tjoapack’s service
offering follows a recent investment by private equity firm and healthcare
specialists, Ampersand Capital Partners, and increased demand from existing and
new customers for pre-filled and vial packaging in line with the prevalence of
chronic diseases that require injectable therapies.
“As new therapies emerge to address unmet
patient needs for chronic ailments the demand for contract packaging
organization that can handle syringes and vials will continue to rise,” Tjoa
added. “Technological advancements, improving patient compliance, beneficial
reimbursement policies, and the rise of biologics in the pharmaceutical market
will also further propel the needs for service providers who can meet these
requirements.”
Based in North Brabant, Netherlands, Tjoapack
is a global contract packaging organization (CPO) dedicated to shaping the
future of the pharmaceutical supply chain to be safer and more reliable for
customers and patients.
LSNE
Expands Aseptic Fill Finish Capabilities in Europe
LSNE-León receives approval from AEMPS to
manufacture biotechnology-based therapeutic products.
LSNE Contract Manufacturing said that the
Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the
manufacturing of clinical stage biotechnology-based therapeutic products at its
aseptic fill finish facility in León, Spain. This approval builds upon LSNE's
well-established capabilities in providing aseptic fill finish of biologic
products for clients at its U.S. facilities. These products include monoclonal
antibodies, fusion proteins, replacement enzymes, plasmids, capsids, and
oligonucleotides.
"The authorization of biologic manufacturing
for clinical drug product in both vial and pre-filled syringe (PFS)
presentations is a vital step to our maturation of drug product manufacturing at
our facility in Spain," said Shawn Cain, chief operating officer, LSNE. "This
will provide the global market with more access to LSNE facilities for the
manufacture of these high-value biologics, including monoclonal antibodies and
other recombinant proteins."
Jaime Del Campo, site head at LSNE-León,
said, "We are thrilled with this most recent milestone and our ongoing
partnership with AEMPS. This is another big step forward supported by our
industry leading quality and operations teams. We anticipate this authorization
will have an immediate impact in our ability to support our client's varied
clinical programs and ensures long-term benefits to their future commercial
supply."
Vetter
Pharma Invests in Ravensburg Training Facility
The center opened on September 14, with a
small celebration held for management, training management and trainees.
Vetter trainees have started learning and
working in the company's new training center, located in Ravensburg, Germany.
The building, which was specially converted
for trainees and students, houses various workshops where the trainees can build
their technical skills. They will also learn about methods such as 3D printing
and computer-aided 3D construction.
An electrical workshop and a robotics work
area round off the diverse range of learning areas. Vetter invested around $4.1m
(€3.5m) in the center and in the training itself.
With more than 100 trainees, Vetter says it
has one of the largest training programs in the region. In September 2020, 39
trainees and students started with the company.
BioNTech
to Acquire Novartis Mfg. Site for COVID-19 Vax Production
Will accelerate BioNTech’s efforts to
scale-up commercial manufacturing capacity for its mRNA COVID-19 vaccine
candidate BNT162.
BioNTech SE has signed a share purchase
agreement with Novartis AG, to acquire their GMP certified manufacturing
facility in Marburg, Germany. The manufacturing site will expand BioNTech’s
COVID-19 vaccine production capacity by up to 750 million doses per year, or
over 60 million doses per month, once fully operational. The transaction is
expected to close in the 4Q20. BioNTech plans to produce up to 250 million doses
of BNT162b2 in 1H21, with the established team and drug substance and drug
product manufacturing capabilities at the site.
The Marburg production site is a
state-of-the-art, multi-platform GMP certified manufacturing facility that
currently employs approximately 300 people. It is fully equipped for the
production of recombinant proteins as well as cell and gene therapies, and has
cell culture labs and viral vector production capabilities, with further
potential growth and expansion.
The acquisition will accelerate BioNTech’s
efforts to scale-up its commercial manufacturing capacity to produce its mRNA
COVID-19 vaccine candidate BNT162. The BNT162 program includes five mRNA vaccine
candidates currently in clinical testing in the United States, Europe, South
America, and China. BioNTech and Pfizer are evaluating the lead candidate,
BNT162b2, in a global Phase 3 trial.
The Marburg facility is expected to start the
production of mRNA and the LNP formulation for a COVID-19 vaccine in 1H21,
pending regulatory approval. BioNTech plans to manufacture additional
therapeutic and vaccine drug candidates at the plant as well as to contribute to
the production of the COVID-19 vaccine for global supply, subject to regulatory
authorization or approval.
Valneva to
Create Vaccine Facility
Valneva SE has announced a vaccine
partnership with the UK Government for its inactivated COVID-19 vaccine,
covering up to 190 million doses.
Under the agreement announced, Valneva is set
to supply the UK with 60 million doses at €470m ($558.8m) in the second half of
2021; with options for another 130 million doses between 2022 and 2025. This
would take the total value of the 5-year deal up to €1.4bn ($1.66bn).
The UK government will also invest in
Valneva’s Scottish manufacturing facility in Livingston to increase capabilities
and hire new staff, as well as co-fund ongoing clinical trials for the vaccine
candidate.
The vaccine is expected to enter the clinic
by December 2020 and – if successful – hopes to gain regulatory approval in H2
2021.
Valneva’s vaccine candidate, VLA2001, uses
the French company’s existing Japanese encephalitis vaccine manufacturing
platform (the vaccine, Ixiaro, was approved in 2009 in the US and is also EMA
approved).
The inactivated, adjuvanted, two-dose
SARS-COV-2 vaccine candidate uses Valneva’s platform with the Dynavax CpG 1018
adjuvant.
Valneva is preparing to increase
manufacturing capability in Scotland, with the UK Government also contributing
upfront to this work (with its investment being recouped against the vaccine
supply under the partnership).
“The Livingston site currently employs more
than 100 people, with a quarter working directly with the virus, and the number
of researchers working on the vaccine’s manufacture is expected to increase by a
further 75 once production starts,” said David Lawrence, CFO, Valneva.
“Upping manufacturing capacity will include a
combination of expanding the existing facility and building a new one
at the Livingston site. Valneva will build a
total of five production lines equipped with modern, disposable cell-culture
systems of about 500 L.”
Valneva will arrange COVID-19 vaccine
production around its existing vaccines.
“We currently have one production line
available for COVID-19 in our existing facility where we also manufacture
Japanese encephalitis and Chikungunya: we are then adding two other production
lines for COVID-19 in a second facility that we just acquired. This new facility
will multiply our COVID-19 capacity by four to five times; from around 50
million doses per annum to over 200 million doses per annum.”
In May Pfizer partnered with Valneva to
progress its vaccine candidate for Lyme disease. Valneva’s chikungunya vaccine,
meanwhile, commenced Phase 3 clinical studies last week.
BES
Completes Phase 1 Of Hospital Aseptic Suite Project
BES, the specialist in complex facilities for
the healthcare and pharmaceutical sectors, has completed the first phase of a
project to design and construct a new pharmacy and aseptic suite at Weston Park
Hospital in Sheffield.
The project includes clinical trial and ATMP
(Advanced Therapy Medicinal Products) facilities that will enable the hospital
to provide gene therapy treatments on site.
The project is BES's first for Sheffield
Teaching Hospitals NHS Foundation Trust. It is being delivered in two
meticulously-coordinated phases to allow the existing pharmacy to remain
operational while the new one is delivered.
As principal designer and principal
contractor for the project, BES is responsible for all design, engineering and
construction of the new facilities, which are located on the hospital's sixth
and seventh floors.
During the design phase, the BES team was
able to offer improvements to the client's proposed layout to improve the flow
and reconfigure the rooms. Phase 1 has involved strip out and refurbishment of
redundant office space to create the new pharmacy, which includes Grade C and
Grade D cleanrooms, with all contingent building services, including specialist
air handling requirements and air locks.
Amongst the inherent challenges of completing
the project on the sixth floor of a live hospital, the BES team had to consider
the existing live services to ensure that any additions and modifications to
services in the area did not interrupt supply in the existing pharmacy or other
locations in the hospital. The logistics of the project have also proved
challenging, with all materials and equipment having to be lifted to the sixth
and seventh floor via an external hoist.
With construction for phase I now completed,
the hospital's pharmacy team will be moved across to its new location and BES
will refurbish the existing pharmacy as a new clinical trial and ATMP (Advanced
Therapy Medicinal Products) aseptic suite. Phase 2 will also involve complex
engineering to deliver controlled isolator cleanrooms and avoid any risk of
contamination.
BES has worked collaboratively with us
throughout the design phase to understand our requirements and create a tailored
pharmacy and aseptic suite.
Jonathan Morton, Engineering Director at BES
said: "BES is responsible for designing and delivering some of the most advanced
cleanroom and laboratory environments in the UK for hospitals, pharmaceutical
companies and high-tech industries, such as the compound semi-conductor sector."
"Our team has the expertise to support
clients like Sheffield Teaching Hospitals NHS Foundation Trust in bringing
advanced new technologies into play," Morton added. "The project at Weston Park
Hospital will enable the preparation of tailored, targeted cancer treatments and
we expect this to be a growing requirement for UK hospitals in which BES has the
proven expertise to take a leading role."
BES Completes Viral Vector Suite For Cobra Biologics
BES has completed a viral vector suite
facility for Cobra Biologics; a biologics specialist involved in COVID-19
vaccine scale-up and manufacturing.
Located within Keele University campus, Cobra
has invested in upgrading part of its existing development and production
facility with 3 viral vector suites to enable the company to expand its clinical
and commercial viral vector services as a Contract Development and Manufacturing
Organization (CDMO). The time-critical project is a pivotal element of the
company's commercial strategy and BES has delivered the project four weeks ahead
of schedule, despite the social distancing and supply chain challenges of the
COVID-19 pandemic.
Compliant to ACDP Hazard Group and US
BioSafety Level 2, along with FDA, EMA and MHRA standards, the new facilities
will allow Cobra to work with customers to develop gene therapy treatments for a
range of life-limiting and life-threatening conditions.
Working closely with the Cobra team, BES was
responsible for providing design development of the Cobra's concept around their
user requirements, leveraging the company's multi-disciplinary team across all
mechanical and electrical engineering, architectural design, construction and
project management requirements. BES provided a consistent team and an
accountable critical path throughout the design and construction phases of the
project with clarity on costs and timescales from the outset.
The refurbishment project involved design and
delivery of three grade C processing suites, each specified to contain a Class 2
Microbiological Safety Cabinet (MBSC), which will allow biological manipulations
to be carried out in a grade A environment. Scientists will enter the new
facilities via a primary change area to gain access to a grade C change area.
Processing suites will be accessed via a clean corridor and exited into a
'dirty' corridor that leads back to the primary change area.
The scope of works also included a new
extension to the existing building to upgrade the reception lobby. BES
implemented a temporary entrance and reception to enable the company to operate
as usual while this was constructed.
Amongst the challenging elements of the
project was the need to co-ordinate works in order to minimize the risk of
business interruption. BES worked closely with Cobra and the university to
co-ordinate the relocation of existing cryogenically frozen preparations stored
within the area of the building re-purposed as the new viral vector suites. A
new secure compound was established for the liquid nitrogen and the BES team
meticulously planned and implemented the relocation of these assets to ensure
any risk to existing product stocks. Similarly, the new High Voltage (HV)
connection needed to accommodate the upgraded facilities was carried out over a
weekend to overcome any downtime.
BES has now carried out a successful OQ
(Operational Qualification), including particles, pressures, Dispersed Oil
Particulate (DOP) tests and clean up rates. Cobra will now carry out final
validation and PQ (Performance Qualification) to enable full production to begin
for new and existing customers.
Peter Coleman, CEO of Cobra, said: "From the
outset, the BES team understood our commercial and operational requirements and
worked with us to design and program the project around those needs."
"The company's experience in the
pharmaceutical industry makes them ideally placed to deliver complex projects
like this for the gene cell therapy sector," Coleman added. "Their
multi-disciplinary team not only worked collaboratively with us, but seamlessly
with each other, for a joined-up and efficient approach. This was particularly
important during a period when we are involved in development and manufacturing
work of international importance for COVID-19 response. It's extraordinary that,
despite the challenges of the lockdown, BES has completed the project to such a
high standard ahead of schedule."
Samsung Biologics Plans 'Super Plant' for Biomanufacturing
Samsung Biologics has announced plans to
break ground for a fourth plant in South Korea within this year. This is part of
its long-term strategy to maximize its operational efficiency and scale up its
development and manufacturing capabilities in response to growing
biomanufacturing demands.
The company also said that it is in
negotiations with the authorities at IFEZ (Incheon Free Economic Zone) to
purchase additional land for its second bio complex.
Upon finalization of the terms under
negotiation, the total size of the two investments is expected to be over 2
trillion Korean won (roughly $2 billion) and over the total amount invested in
the company's previous three plants combined throughout its nine-year history.
Plant 4
Adding 256KL capacity to its site, Plant 4 is
scheduled to commence manufacturing activities in the second half of 2022, and
further advance the company's standing as the world's largest manufacturing
facility at a single location - holding a 620KL total capacity upon completion.
Samsung Biologics is taking an innovative
approach in the design strategy of its new plant: by incorporating the unique
advantages from Plant 1, 2, and 3, it will offer multi-scale manufacturing
services to support the diversifying needs of new and existing clients.
Construction will begin on an existing site
with the plant comprising of 256 million sq. ft. (23.8 million sqm) in total
floor area - the equivalent to the combined floor area of its existing three
plants. In an effort to maximize operational efficiency, Plant 4 will introduce
real-time production schedule simulation through automation and latest
biomanufacturing technologies as well as optimization of utility supply based on
data collected from its current plants.
Samsung Biologics is also investing heavily
in offsetting its facilities' environmental impact. Newly advanced technologies
such as streamlined application, smart disposal of high-concentration
wastewater, and improvement of nitric acid emissions will strengthen the
environment of the workplace and community.
The land under negotiation for Samsung
Biologics' second bio complex is closely located to the company's current
complex, and is slightly larger at 3,550,800 sq. ft. (330,000 sq.meters). Once
the terms are finalized, the company plans to create an Open Innovation center
to foster biotech companies and build a global R&D facility in addition to
securing space for future plants within the new complex.
"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," said Dr Tae Han Kim, CEO of Samsung
Biologics. "With the production of Plant 4, our 'Super Plant,' Samsung Biologics
is investing in a total line refinement and addition of new mid- 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."
Owing to its quality competitiveness,
state-of-the-art technology, and active response to demand for outsourced
manufacturing of products including COVID-19 treatment candidates, Samsung
Biologics has signed over 1.8 trillion Korean won in orders, about 2.5 times
last year's total revenue, in the first half of 2020 alone.
Ajinomoto Expands Small Molecule Manufacturing in India
Ajinomoto Bio-Pharma Services, a provider of
biopharmaceutical CDMO services, has announced a major expansion of small
molecule manufacturing capabilities with the addition of a new production
facility in Visakhapatnam, India.
Construction of the 91,460 sq. ft. (8,500
sqm) facility began at the end of July 2020 and is expected to be completed
mid-2022.
To meet the current and future needs of
customers, the new small molecule manufacturing 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. Further, the site has completed renovations on existing laboratory
space to support additional R&D activities. It is estimated that the expansion
will create at least 60 new jobs at the site.
The US 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, has successfully supported a number of the world's leading
biopharmaceutical companies since its formation in 2011 and continues to win
awards for sustainability and quality standards.
"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 of Ajinomoto Bio-Pharma India.
"This expansion exemplifies our commitment to our vision statement of being a
leading, trusted, innovative partner to our clients and our people."
"The increased manufacturing capacity at Aji
Bio-Pharma India offers a significant advantage for our small molecule
customers, who now have a variety of options to meet their manufacturing needs,"
said Peter Stuyck, Sr VP and Head of European Operations at Ajinomoto Bio-Pharma
Services. "This expansion optimizes capacity across all locations and further
enhances Aji Bio-Pharma's commitment in being a leading global and
quality-driven CDMO with comprehensive service offerings."
How quickly
can China Build a New Crown Vaccine Laboratory?
Wiskind details how it facilitated in the
speedy build of a new crown vaccine laboratory, with an annual production
capacity of 100 million vaccines…
China built the world's largest new crown
vaccine production plant with a mass production annual capacity of 100 million
vaccines, to meet the scale-up production requirements of emergency and routine
vaccinations.
The new crown vaccine production plant had
stringent systems and tight schedules to meet, which created difficulties in the
project.
To successfully complete construction on
time, the team organized several rush meetings to orderly schedule the
procedures during the construction process, which is particularly critical in
terms of material procurement and construction plans.
New Crown COVID-19 Vaccine Description
New Crown COVID-19 is an inactivated vaccine
that is made of virus particles that are grown in culture and lack
disease-producing capability.
This SARS-CoV-2 strain (WIV04 strain and
GenBank accession number MN996528) was isolated from a patient in the Jinyintan
Hospital, Wuhan, China. The virus was cultivated in a qualified Vero cell line
for propagation, and the supernatant of the infected cells was inactivated with
β-propiolactone (1:4000 vol/vol at 2 to 8 °C) for 48 hours. Following
clarification of cell debris and ultrafiltration, the second β-propiolactone
inactivation was performed in the same conditions as the first inactivation.
The vaccine candidate was adsorbed to 0.5-mg
alum and packed into prefilled syringes in 0.5-mL sterile phosphate-buffered
saline without preservative.
This vaccine candidate was developed by
Sinopharm’s Wuhan Institute of Biological Products Co. and the Chinese Center
for Disease Control and Prevention (CDC).
On August 13, 2020, JAMA published a study
that concluded saying 'In this interim report of phase 1 and phase 2 trials of
an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions
and demonstrated immunogenicity; the study is ongoing. This inactivated COVID-19
vaccine reported a low rate of adverse reactions and demonstrated
immunogenicity, but a longer-term assessment of safety and efficacy will require
phase 3 trials.'
In the phase 1 trial, 96 participants were
assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and aluminum
hydroxide (alum) adjuvant–only group (n = 24 in each group), and received 3
intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults
were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14
[n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only
[n = 28]).
China National Pharmaceutical Group Co., Ltd.
(Sinopharm) is a large healthcare group directly under the State-owned Assets
Supervision and Administration Commission of the State Council, with 128,000
employees and a full chain in the industry covering R&D, manufacturing,
logistics and distribution, retail chains, healthcare, engineering services,
exhibitions and conferences, international business and financial services.
Marketing statement:
At Wiskind, we can quickly provide all the
materials needed to build a cleanroom and we are able to provide a one-stop
service.
For projects with tight turnarounds, we can
provide modular cleanrooms that are fast assembly and standardized production.
By increasing the efficiency of cleanroom
material production and construction, we were able to shorten the construction
period by 20% to 40%, all the while improving the quality of construction.
This enables the team to start using its new
facilities as soon as possible, thereby greatly reducing work delays and
promoting the industry's profitability.
Modular cleanroom includes cleanroom doors,
cleanroom windows and cleanroom panels.
The high flexibility of modular cleanroom
design means that you can choose additional cleanroom equipment to maintain
stricter environment control.
The modular cleanroom has great advantages
over the brick and mortar cleanroom structure. For example, you can solve any
damage to the cleanroom wall by replacing a single clean wall panel without
having to consider replacing entire structure.
Furthermore, the experts at Wiskind invented
a removable sandwich wall panel, through the development of removable
accessories to connect the panel, which can removed part of the wall.
As a global supplier, we are able to learn
from our customers and make the most of this opportunity to develop better
modular cleanrooms. We can suggest what suitable for your organization.
McIlvaine Company
Northfield, IL 60093-2743
Tel:
847-784-0012; Fax:
847-784-0061
E-mail:
editor@mcilvainecompany.com
Web site: www.mcilvainecompany.com