Pharma Prospects
March 4, 2021
·
Biogen to spend $200M on gene therapy plant in
North Carolina
·
Dover pumps in chromatography and sterile
filtration
·
GEA pump for vaccines and cell cultures
·
Oxular Limited
·
Forbion
·
Allied Cleanrooms supplies So Young
with 750 ft2 of ISO 7 3750 ft2 of ISO 8
·
Asgard
supplies G-Con pods with 3 month delivery
time
·
Asgard provides Regeneron with bulk biologics
facility
·
Other Asgard Cleanroom Projects
·
WHP builds large CGMP facility with 122 modules
in 2020
·
WHP
building cleanrooms for VMIC
·
WHP
supplied
cleanrooms for ADC.
·
WHP supplied cleanrooms to Oxford BioMedica
·
Wiskind supplying
modular cleanroom for Russian COVID
Vaccine
·
Wiskind provided modular cleanroom for the
largest Chinese vaccination plant
·
Chinese plants with 100 million dose capability
·
Inova vaccine phase III trials in Brazil in only
3 months with Wiskind Cleanroom
·
Connect 2 Cleanrooms builds temporary unit for
NHS Wales COVID response
·
Thermo Fisher announces major expansion plans
·
FDA gets in on the stimulus action from new
relief bill
·
Flowserve supplying pumps, valves for Pfizer
vaccine production
·
Little-known drug manufacturer, Phlow gets big
contract for COVID-19 response
·
SteriValves, Valves and Accessories for the
Pharmaceutical Industry
·
Merck Announces € 59 Million Antibody-Drug
Conjugate Manufacturing Expansion
Biogen to spend $200M on gene therapy plant in
North Carolina
Permission granted by Biogen
Kristin Jensen
March 4, 2021
Dive Brief:
·
Biogen plans to spend $200 million to build a
gene therapy manufacturing facility at its
Research Triangle Park campus in North Carolina
as the company invests further in the
fast-growing field of genetic medicine.
·
The
175,000-square-foot plant should be operational
by 2023 and employ about 90 people, Biogen said
Thursday. The company said it chose the location
because it's found the area attracts diverse and
"highly qualified and passionate employees."
·
Biogen didn't detail the types of therapies that
would be produced at the facility but said it
will have "differentiated, sustainable and
advanced manufacturing capabilities." The
company has primarily focused on gene therapies
for eye diseases, most notably through a roughly
$800 million buyout of Nightstar Therapeutics.
Dover pumps in chromatography and sterile
filtration
The QF2500 Quaternary Diaphragm Pump from
Quattroflow, part of PSG, a Dover company,
extends the company’s range of pumps. The pump
has a maximum flow rate of 2500 lph (660 gph) to
meet the needs of chromatography, tangential
flow filtration, virus filtration, sterile
filtration, and depth filtration applications.
GEA pump for vaccines and
cell cultures
The GEA Hilge Novatwin
hygienic, stainless-steel twin-screw pump, part
of the GEA Varipump line, is now available in
six sizes. GEA says the pump can be used for
pharmaceutical products including nutraceuticals,
blood products, vaccines, enzymes, and cell
cultures.
Oxular Limited ("Oxular"),
a leading retinal therapeutics development
company, today announced that it has completed
a $37 million (£27 million) financing led by Forbion. Proceeds
will fund planned further clinical development
of its lead asset, OXU-001, for the treatment of
diabetic macular edema (DME), as well as
accelerating development of its early-product
pipeline.
Forbion
is a dedicated European life sciences venture
capital firm that manages over €1.7 billion of
investments and works closely with entrepreneurs
to build life sciences companies that will
change the future of medicine. In the financing,
Forbion were joined by existing investors IP
Group, NeoMed, and V-Bio Ventures. Dr. Dmitrij
Hristodorov, Principal at Forbion, will join the
Oxular Board. Prior to joining Forbion in March 2020, Dr.
Hristodorov was Senior Director of Global
Business Development & Licensing at Bayer Pharma
where he was responsible for the Ophthalmology
and Cardiovascular Franchises.
The investment will fund
Phase 2 human clinical studies, commencing later
this year, to evaluate OXU-001 for the treatment
of DME, a serious retinal disease that affects
24 million people globally and is the leading
cause of blindness in young adults in developed
countries. A key challenge facing patients with
DME is the need for frequent clinic visits for
repeated treatment injections. To address this,
OXU-001, an innovative, sustained-release
formulation of dexamethasone, provides up to 12
months' treatment effects following a single
administration. Dexamethasone is a well-known,
safe and effective treatment for inflammatory
retinal diseases, including DME.
Allied Cleanrooms supplies So Young
with 750 ft2 of ISO 7 3750 ft2 of ISO 8
California-based bioscience firm So Young
America, Inc. was experiencing growth of its
own. As an FDA-registered, GMP-ready/cGMP
manufacturing facility for food, beverages and
supplements, the organization looked to build
out within its existing warehouse to accommodate
its need for cleanroom space. The additions
would provide much-needed room for R&D work, an
organic chemistry lab and other labs devoted
specifically to food production, according to
Robert Tsai, President of So Young America.
The project also would include additional
warehouse storage as well as partitioning within
So Young’s front office entryway. The project
included a 750 sq. ft., class 10,000, ISO 7
standalone cleanroom on the main floor of the
warehouse with a second level mezzanine devoted
to storage. Allied Cleanrooms also installed a
3,750 sq. ft., Class 100,000, ISO 8 modular
cleanroom structure on the second floor of the
facility on top of an existing wood mezzanine.
Modular walls installed within the structure
provided So Young with six separate work-spaces
that varied in size. The project included all
necessary flooring, electrical, HEPA filters and
fire suppression and HVAC systems to maintain
the ISO requirements for these structures.
The result was two high-quality structures that
not only met specific cleanroom standards, but
also provided functional work and storage space
and an impressive, pristine aesthetic.
Allied Cleanrooms also installed a modular wall
and door with keypad lock in the lobby to
separate the entry from the hallway leading to
the work area. “We wanted that extra wall and
door so there wasn’t access to walk directly
into the work area,” Tsai explained, noting that
the new look is not only functional and flexible
but also attractive.
Asgard
supplies G-Con pods with 3 month delivery
time
G-CON Manufacturing, Inc.’s prefabricated,
turnkey cleanroom systems represent a
significant transition to forward thinking in
pharmaceutical and biopharmaceutical processing.
G-CON Manufacturing, the innovator of autonomous
cleanroom PODs, turned the challenges
experienced by the biopharmaceutical industry
into readily deployable, flexible, mobile and
scalable cleanroom solutions. PODs are ideal for
multi-product sites, rigorous containment needs,
and on demand scaling of production and
laboratory space.
Asgard Cleanroom Solutions are manufacturing
PODs in their new off-site manufacturing
facility in Castlecomer, Co. Kilkenny, Ireland
pursuant to G-CON’s quality system for their
EMEA customers.
G-CON now has a wide array of cleanroom PODs to
accommodate the increased demand from the
pharmaceutical, biopharmaceutical and cell
therapeutic industries. Moreover, G-CON’s patent
portfolio continues to grow which will
effectively preclude imitators from copying G-CON’s
initial and more recent innovations. G-CON will
continue to evolve and grow with the industry to
provide a comprehensive cleanroom solution that
truly is flexible, scalable and fast, all for a
fair and known price from the time the contract
is signed. G-CON has simplified the purchase pf
cleanrooms with their Standard Cleanroom PODs,
ready for delivery
in 3 months.
Asgard provides Regeneron with bulk biologics
facility
|
Bulk Biologics
–Limerick
|
|
Bulk Biologics
Facility
Limerick,
Ireland |
|
Completed In
2016 |
|
11,000 M2 of AES
Ceilings |
|
Engineer- Jacobs
Engineering |
|
Main contractor
PM Group |
|
AES Fully Flush
Panel system
|
Asgard provides Pfizer with 1300 m2 cleanroom in
Dublin
|
Project DSMPC |
|
Grange Castle
Dublin,
Ireland |
|
Project
Duration- 9
months |
|
Size 1300 M2 |
|
Engineer- Jacobs
Engineering |
|
Main contractor
Sisk
Group |
|
Project value
2.85 million
pounds |
|
1000 m2 fully
flush panel
system |
|
1300 m2 of walk
on ceilings |
|
1300 m2 of Mc
Dur Trowel
Flooring |
Other Asgard Cleanroom Projects
|
Name
|
Location
|
Size |
|
Eirgen Pharma, |
Limerick
|
1400 m2 |
|
BMS LSCC |
Bristol Myers
Squibb |
15,000 m2 |
|
Amgen Project
Hawk |
Dublin |
5,000 m2 |
|
MSD Project Lion
|
Cork |
1,700 m2 |
|
MSD Ballydine |
Tipperary
|
4,000 m2 |
|
Gilead Project
Rex
|
Cork
|
5,500 m2 |
|
Servier Packing
Hall
|
4,500 m2 |
|
|
Abbot
Diagnostics |
Longford |
1,800 m2 |
|
Biovail
|
Dublin
|
2,500 m2 |
|
Mainckrodt
|
Dublin |
1150 m2 |
|
Wyeth
|
Dublin |
22,000 m2 |
WHP builds large CGMP facility with 122 modules
in 2020
WHP was awarded its first contract to design and
build a fully modularised containment facility.
The project comprised the design and manufacture
of 122 cGMP modules, making it one of the
largest modular cGMP facilities in Europe.
WHP has completed the fully modelled design
which included structural, M&E, architectural
and also the external envelope which included
staircases and security features. A bespoke
effluent discharge system was also designed by
the skilled in-house Engineering Team for this
project.
The modules were manufactured in WHP's dedicated
modular build facility in Tyne and Wear. They
were then packaged and shipped to site in Europe
where they are currently being installed, with
commissioning and validation to follow through
2021.
Despite the impact of COVID-19, the WHP team
pulled together to expedite the delivery of 122
modules before the end of the year. This
resulted in a 300% increase in WHP's export
sales from prior year, equating to 50% of the
company's 2020 annual turnover.
Conal Bovaird, Head of Modular Build Projects,
said: "This has been a fantastic achievement in
what has been extremely challenging times for
all of us. Full credit goes to the entire team
for their relentless efforts to ensure the
manufacturing phase has been completed safely
and successfully while meeting the client's
expectations. In addition, the team have
achieved 536 days without a lost time injury. I
look forward to successfully completing the site
installation and commissioning works in 2021."
WHP building cleanrooms for VMIC
WHP has been awarded a design contract for the
Vaccines Manufacturing Innovation Centre (VMIC),
which is set for construction in Oxford. The
contract will see WHP design an advanced array
of laboratory and production facilities within a
‘cleanroom wrap’ environment.
The contract was awarded to WHP as part of plans
for the specification of versatile new cGMP
suites and filling rooms for the VMIC.
These units will have the capacity to meet the
Department of Health and Social Care
requirements concerning the provision of
vaccines in an infectious disease emergency.
The centre, which has secured £66m of funding
from UK Research and Innovation, is being
developed through the UK Government’s Industrial
Strategy Challenge Fund (ISCF) Medicines
Manufacturing Challenge and is scheduled to open
in 2022.
WHP, which has already completed RIBA Plan of
Work 2 covering conceptual design, is utilising
3D BIM modelling to finalise the cleanroom
architecture, M&E components and process and
critical utility systems for a facility that is
set to become a national Centre of Excellence.
The project also features complex zoned HVAC
systems to maintain segregation, cleanliness,
air pressures and other environmental controls,
the new laboratory and production facilities
will be developed in compliance with MHRA
regulation
WHP supplied cleanrooms for ADC
Production of new anti-cancer drugs at ADC Bio’s
North Wales manufacturing plant has been boosted
following completion of a new cleanroom
facility. The project has been designed and
built by WHP.
The new GMP cleanroom is part of ADC Bio’s
construction of a bioconjugation facility at its
site in Deeside, North Wales (UK) for the
commercial production of antibody-drug
conjugates in response to global customer
demand.
“We are building a best-in-class facility to the
highest possible global standards," said Charlie
Johnson, CEO at ADC Bio. "We awarded the
contract to WHP on the back of its relevant
industry experience and reputation for
delivering cost-effective, single-source
cleanroom design and build packages," he added.
Project specs
Antibody-drug conjugates are a class of emerging
biotherapeutics that require a bespoke
infrastructure to ensure strict compliance with
the highest global regulatory standards.
The biotech company awarded the £5
million contract to WHP in December 2017.
The new facility sees drug manufacturing in a
stringently controlled environment. The site is
operated under cGMP regulations, and also
comprises support areas for washing,
depyrogenation, thawing and buffer preparation.
WHP’s scope of work covered the design and
build, including test and validation of a
state-of-the-art containment manufacturing
cleanroom within the existing 6,500 sqm hi-tech
facility, along with new quality control and
process development laboratories.
The infrastructure includes a Grade C cleanroom
on a 110 sqm area and a Grade D cleanroom on a
390 sqm area. The site also features four
complex zone HVAC system.
WHP supplied cleanrooms to Oxford BioMedica
WHP Engineering
secured the design, construction and
project management contract of a new viral
vector manufacturing centre for Oxford BioMedica.
New cleanroom facilities will enable the gene
and cell therapy company to expand its
bioprocessing operations and manufacturing
capabilities.
The new facility is being established in a
former Royal Mail sorting office in Oxford, UK.
Phases one and two of the expansion comprise the
specialist conversion of the building into GMP
cleanroom suites, fill and finish of the
production areas, as well as completion of
offices, warehousing and quality control
laboratories.
The multi-disciplinary engineering company is
responsible for both design and build, including
testing and validation, which encompasses WHP’s
integrated services. The design includes a full
3D building information model, including
cleanroom architecture, HVAC, monitoring and
evaluation systems, and process and critical
utilities systems.
The specialist areas have been designed in full
compliance with the Medicines and Healthcare
products Regulatory Agency and conform to ISO
cleanroom standards.
This includes the use of zoned HVAC systems to
maintain segregation, cleanliness, air pressures
and other environmental controls. CT understands
the cleanrooms will meet ISO 7 and 8
classification. The WHP team have finalised the
detailed design and is commencing construction
Oxford
BioMedica awarded WHP the contract for the
design and installation of the original pilot
plant for the LentiVector
delivery platform at its Yarnton premises in
2015.
As a result of the successful delivery and
operation of this initial project, WHP was then
appointed for this current, larger and more
complex project.
Wiskind supplying
modular cleanroom for Russian COVID
Vaccine
Wiskiind is building a modular cleanroom in
Moscow for
R-Pharm. Wiskind provided more than
40,000 square meters of rock wool cleanroom
panels, cleanroom doors and other cleanroom
enclosure products for the project.
The production base will produce the flagship
home vaccine "Sputnik V" developed by the
Epidemiology and Microbiology Centre. According
to this project, when the factory reaches full
capacity, it will produce up to 20 million doses
of vaccine every month. The total investment in
the project amounts to 8.6 billion rubles.
The R-Pharm enterprise started operations at the
end of December 2020, and the first batch of
Sputnik V vaccines was
produced in Moscow Technopolis in January
2021. The construction of the complex located on
the territory of the special economic zone "Technopolis
"Moscow" took place in record time, which is
necessary for the implementation of national and
urban vaccination programs. The area of the new
factory exceeds 20,000 sqm.
Wiskind provided modular cleanroom for the
largest Chinese vaccination plant
CNBG China built the world's largest new COVID
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. Wiskind provided the cleanroom.
The new
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 organised several rush meetings to
orderly schedule the procedures during the
construction process, which is particularly
critical in terms of material procurement and
construction plans.
Wiskind quickly provided all the materials
needed to build a cleanroom and was able to
provide a one-stop service.
For projects with tight turnarounds, Wiskind can
provide modular cleanrooms that are fast
assembly and standardised production.
By increasing the efficiency of cleanroom
material production and construction, Wiskind
was able to shorten the construction period by
20% to 40%, all the while improving the quality
of construction.
This enables the producer
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,
windows and wall panels.
Chinese plants with 100 million dose capability
China National Biotec Group (CNBG) in July
completed construction of a new plant for
coronavirus vaccines, doubling its capacity to
more than 200 million doses a year, as it
prepares late-stage trials of its potential
COVID-19 shots.
CNBG, a unit of the state-owned China National
Pharmaceutical Group (Sinopharm), has two
COVID-19 vaccine candidates in human trials and
plans a large-scale Phase 3 human testing in the
United Arab Emirates.
Its newly built plant in Wuhan, the epicentre of
China’s coronavirus outbreak that started last
year, has annual capacity of more than 100
million doses, and adds to its Beijing-based
facility whose construction was completed in
April.
Another Chinese vaccine developer Sinovac
started around end-March to build a coronavirus
vaccine plant with a 2020 completion target and
capable of making up to 100 million shots a
year.
Inova vaccine phase III trials in Brazil in only
3 months with Wiskind Cleanroom
Sinovac Life Sciences Co., Ltd., (or “Sinovac
LS”), previously known as Sinovac Research &
Development Co., Ltd., is a research-based
company incorporated in 2009 that conducts human
vaccine research, development, manufacturing,
and sales.
Sinovac LS is a wholly-owned subsidiary of
Sinovac Biotech (Hong Kong) Limited. It develops
several human vaccines, including vaccines
against pneumonia, DTaP, Hib, hepatitis B
vaccines, and combo vaccines containing DTaP and
Hib. Sinovac LS was granted 12 patents in
vaccine technologies in China. Sinovac Life
Sciences is the developer of CoronaVac, an
inactivated COVID-19 vaccine candidate, and will
be the marketing authorization holder of
CoronaVac in China with a vaccine production
license from China National Medical Products
Administration (NMPA).The cleanroom
system of
this project is provided by Wiskind.
In May, Wiskind finished all the cleanroom
panels, doors, and windows, which were then
shipped to the site.
Connect 2 Cleanrooms builds temporary unit for
NHS Wales COVID response
09-Mar-2021 By Jenni Spinner
The temporary medicines unit built for the
agency's Central Intravenous Additive Service
can produce up to 2,600 syringes weekly to meet
growing demand.
Connect 2 Cleanrooms (C2C), a company that
specializes in the expedited design and build of
temporary life sciences facilities, constructed
a temporary medicines unit on behalf of the
National Health Services of Wales (NHS Wales).
The facility, constructed for the agency’s
Central Intravenous Additive Service (CIVAS), is
able to produce up to 2,600 syringes per week to
meet the growing demand for COVID-10 solutions.
Thermo Fisher announces major expansion plans
Mar 10, 2021
Bolstered by coronavirus-related contracts,
Thermo Fisher Scientific has announced expansion
plans that will more than double its
manufacturing capacity.
This week, the company said it plans to pump
$600 million into capital investments through
2022. The expansion plans, created to support
both short-term COVID-19 demands and long-term
development goals, will add more than 1,500 jobs
across 11 manufacturing sites around the world.
In particular, the company plans to grow its
prowess in three core areas:
Single-use technologies: Thermo will expand its
SUT capabilities at facilities in Utah,
Pennsylvania, California, Singapore, Cramlington,
UK and Suzhou, China.
Purification: The company will boost its resins
manufacturing at a site in Massachusetts and
reinforce its capabilities of process-scale
chromatography for vaccines, gene therapies and
other applications.
Cell culture media and process liquid: Sites in
New York, Florida and Scotland will increase
their production of Gibco cell culture media,
supplements and process liquids.
Thermo, which specializes in lab equipment and
diagnostics supplies, has experienced a major
sales boom during the pandemic. This year, the
company raked in an extra $2 billion in
coronavirus-related revenue from July to
September alone. And in its fourth quarter
earnings statement for 2020, the company
reported $10.5 billion in revenue — a 54 percent
increase year over year.
FDA gets in on the stimulus
action from new relief bill
Mar 09, 2021
President Biden’s $1.9
trillion COVID-19 relief bill is set to be
signed into law this week and will dole out a
host of benefits to the FDA and pharma industry.
Weeks
ago, The House Energy and Commerce Committee added a
nifty $500 million boost in funding for the FDA
to the bill, which has dealt with a major
increase its workload due to coronavirus-related
activities. Thus, the fresh funds will be
earmarked to support the development and
post-market surveillance of COVID-19 vaccines
and therapeutics. But the agency is also being
asked to tackle other long-standing goals with
the money, such as drug shortages and supporting
the development of continuous manufacturing.
And because the agency was
forced to delay and halt many inspections due to
the pandemic, the FDA will also be tasked with
using the funds to help clear its backlog of
inspections.
The
stimulus package will also set the stage for big
R&D investments in pharma with a whopping
$20 billion being
pegged for federal research on vaccines and
manufacturing for therapeutics, along with
another $3 billion allocated to increase the
national stockpile of vaccines.
In addition, states will
receive $8.75 billion to aid vaccine rollout.
The
one downside for the pharma industry in the bill
will be the removal
of a cap states
can collect in rebates for certain drugs for
Medicaid. The new provision, aimed at lowering
drug prices, will go into effect in 2023 and
impact Humira, some insulins and more.
Flowserve supplying pumps,
valves for Pfizer vaccine production
March 1 (Reuters) - Flowserve
Corp, an American supplier of industrial
machinery, said on Monday it was providing
pumps, valves and seals to Pfizer Inc to support
the production of its COVID-19 vaccine.
The company said it helped
the drugmaker replace a mechanical mixer seal on
its vaccine production line at a plant in
Kalamazoo, Michigan.
The vaccine is one of the
three authorized for emergency use in the United
States along with Moderna and Johnson & Johnson.
A Flowserve's facility in
Tennessee will supply Pfizer with more than 200
ball valves that can handle the cold temperature
requirements needed to support the mass
production of the vaccine, the company said.
The Irving, Texas-based
company said it was also providing pumps to
Pfizer for both their North American and
European vaccine production.
Little-known drug
manufacturer gets big contract for COVID-19
response
May 19, 2020
Dive Brief:
·
Phlow, a Richmond,
Virginia-based corporation that describes itself
as a public benefit drug manufacturer, announced
Tuesday the
federal government will pay it hundreds of
millions of dollars to make essential medicines
that are at risk of shortage, including
medicines used to respond to the coronavirus
pandemic.
·
The money comes from
BARDA, or the Biomedical Advanced Research and
Development Authority, which is part of the U.S.
Department of Health and Human Services. The
contract starts with a four-year award of $354
million, which can be extended to a 10-year
award worth $812 million total.
·
Phlow said BARDA's money
has already allowed it to manufacture 1.6
million doses of five essential generic
medicines used to treat COVID-19 patients. The
medicines, which include a sedative, a pain
management drug, and an antibiotic, were
delivered to the U.S. Strategic National
Stockpile, Phlow said. The corporation is
working in partnership with Civica Rx, AMPAC
Fine Chemicals and Virginia Commonwealth
University's Medicines for All Institute.
https://www.biopharmadive.com/news/phlow-barda-funding-us-drug-manufacturing/578224/
SteriValves, Valves and Accessories for the
Pharmaceutical Industry
SteriValves offers high-quality products and
services to the pharmaceutical industry.
We design and manufacture valves and accessories
to adhere to the most applicable standards, with
close cooperation of machine manufacturers and
end-users.
Our core business is provided by interception
butterfly valves and flow regulation rotary
valves while remaining highly committed to
developing innovative solutions and designing
products such as SteriSplit, now at the point of
reference for safe powder handling.
Containment is a critical issue throughout the
pharmaceutical industry; it is crucial to
preserve the safety of the operator, as well as
the quality of the product. For this, Sterisplit
is the solution.
Merck Announces € 59 Million
Antibody-Drug Conjugate Manufacturing Expansion
- Creates one of the largest
single-digit nanogram containment manufacturing
facilities for high-potent active pharmaceutical
ingredient (HPAPI) production
- Allows continuous flow
manufacturing for antibody-drug conjugates
(ADCs)
- Approximately 50 full-time
jobs to be added
Sept. 9, 2020 /PRNewswire/
-- Merck, a leading science and technology
company, today announced a € 59 million
expansion of its HPAPI and ADC manufacturing
capabilities and capacity at its facility near Madison,
Wisconsin, USA. This investment will
allow large-scale manufacturing of increasingly
potent compounds for therapies that have the
potential to treat cancer. Completion is
expected by mid-2022 and should add
approximately 50 full-time jobs starting in
2021.
Merck is expanding its ADC manufacturing
capabilities. ADCs are an emerging class of
medicines designed for high-specificity
targeting and destruction of cancer cells, while
preserving healthy ones.
"ADCs have posted incredible
growth over the last decade, and regulatory
agencies' approval in recent years demonstrate
their promise as a targeted therapy," said Andrew
Bulpin, head of Process Solutions, Life
Science, at Merck. "With more than 35 years of
experience in this space, we have been a
frontrunner in the development and manufacturing
of biologics, conjugation processes and small
molecules. This investment underscores our
commitment to working with innovators to bring
new treatments to patients quickly and more
efficiently."
Merck's new
6,500-square-meter 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 an addition to
the company's Madison campus,
which was the first commercial ADC facility in North
America designed to handle highly active
materials. The new building will join Merck's
established campus in St.
Louis, Missouri, USA, 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 € 13 billion by
20301.
While
ADCs can provide many benefits compared with
other therapeutic options, they also present a
unique set of challenges. Their development is
complex, necessitating stringent containment
infrastructure, and their structural
exceptionality requires expertise in a number of
different technologies for small and large
molecules, as well as analytical capabilities.
Due to these challenges, more than 70 percent of
ADC projects are outsourced to contract
development and manufacturing organizations2.
With more than 35 years of
experience in the development and manufacturing
of small molecules, biologics and ADC
technologies, Merck offers extensive experience
in both clinical and commercial manufacturing.
The company's comprehensive service portfolio
combines the steps of drug development and
production — from pre-clinical to commercial
— from a single source. This consolidation helps
reduce risk and streamlines the process of
getting therapies to patients faster.
