PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
December 2019
TABLE OF CONTENTS
UNITED STATES
Tocci Begins Construction on Modular Pharmaceutical Building
for Amgen
Pharmadule Morimatsu Awarded Modular Biomanufacturing
Facility
China-Based Raybow Pharmaceuticals Expands CDMO Business
to USA
Iqvia and Quest Diagnostics Joint Venture Commits to US
Facility
REST OF WORLD
GE Healthcare Life Sciences and Pharmadule Morimatsu to
Expand KUBio
Novartis Opens Cell and Gene Therapy Facility Ahead of Time
___________________________________________________________________________________________________________________________________________________________________________________________
UNITED STATES
Tocci Begins Construction on Modular Pharmaceutical Building
for Amgen
Tocci, working with Jacobs and Pharmadule Morimatsu, is slated to start
construction on a new next generation biomanufacturing facility for Amgen’s West
Greenwich, RI manufacturing campus. The new plant is the first-of-its-kind in
the U.S. The building is a combination of traditional steel framed construction
and steel modular units which, once assembled, will create over 75,000 square
feet of lab, cleanroom and support spaces. This facility will be constructed
faster, more efficiently, and will ultimately reduce the building’s
environmental impact.
We’re excited to join a great team in Jacobs, Pharmadule and Morimatsu, and
Amgen – and we’re proud to be contributing to Amgen’s next-generation
biomanufacturing plant. Tocci is looking forward to working collaboratively with
this group to help bring a fantastic project to life in Rhode Island. – Bart
Tocci, BD Associate
About Tocci Building Corporation:
Tocci is a construction company and program manager rooted in hard work, driven
by innovation, and carried by smart team players who help their clients succeed.
Pharmadule Morimatsu Awarded Modular Biomanufacturing
Facility
Pharmadule Morimatsu has been awarded the contract for design, fabrication, site
installation and start-up of a state-of-the-art modular biomanufacturing plant
in the US. The basic design was
completed earlier this year and delivery and completion was scheduled for 2019.
The owner will leverage the off-site fabrication of modular construction and
complete site work in parallel to optimize the overall schedule and begin
qualification and production activities much earlier than can be achieved with
conventional stick-built construction.
This will allow the owner to more quickly gain a return on investment.
Pharmadule Morimatsu AB (Nacka,
Stockholm )is the Swedish-based global leader in the delivery of modular
facilities to the Life Sciences Industry.
Utilizing multidisciplinary expertise, including Process and Facility
Engineering, Pharmadule is able to provide turnkey solutions anywhere in the
world quickly, efficiently and cost effectively.
China-Based Raybow Pharmaceuticals Expands CDMO
Business to USA
Raybow has acquired PharmAgra Labs, a custom chemical research and development
company based in North Carolina.
Raybow Pharmaceutical, a global pharmaceutical chemistry services provider, has
acquired US-based PharmAgra Labs. The China-based company will use the
acquisition to expands its global footprint with the close proximity to the
company's growing US customer base.
PharmAgra is a custom chemical research and development company located in
Brevard, NC. The company’s current services include custom synthesis, process
development and optimization and analytical services.
As a result of the acquisition, PharmAgra’s Brevard facility will become the
headquarters and R&D center for RayBow’s North American operations. It will be
supported by sales and marketing offices in Los Angeles, Princeton, and
Copenhagen, Denmark.
"Raybow's European and US clients will appreciate the option for contract
services within the US,” said Bin Wang, Raybow CEO. “Coupled with existing
capacity ranging from grams to multi tons, we now have the flexibility to
accommodate all of our clients' phase-appropriate outsourcing activities on
multiple continents."
Raybow is also planning an expansion project at the PharmAgra site, adding
additional capacity and personnel in the Brevard area.
Iqvia and Quest Diagnostics Joint Venture Commits to US
Facility
Iqvia and Quest Diagnostics' joint venture commits $73m to North Carolina
expansion after securing financial incentives.
The creation of Q2 Solutions dates back to 2015 when Quintiles, now IQVIA, and
Quest Diagnostics teamed up to create a clinical trial laboratory services
business. News of the joint venture emerged shortly after Quest’s chief rival,
LabCorp, closed a deal to buy one of Quintiles’ main competitors, Covance.
By combining their assets, Quintiles and Quest created the world’s second
largest central laboratory services company, Q2. Now, Q2 has laid the
groundwork for further expansion.
Q2 plans to invest $73m (€66m) in a new facility in Durham, North Carolina,
creating 749 jobs in the process. The project will see Q2 move its headquarters
from Morrisville to the neighboring city of Durham.
With Q2 headquartered in Morrisville and its parent company, Iqvia, based in
Durham, North Carolina was a likely location for the new facility. However, in
keeping with modern interstate competition for new facilities, North Carolina
offered incentives to Q2 to secure the facility.
North Carolina has signed off on two Job Development Investment Grants (JDIGs)
worth $4.3m and $5.3m. The second, larger payment covers the second phase of the
project, which is due to start in 2023. Both payments will be spread over 12
years.
The state’s willingness to put up the money reflects calculations that the
project will add more than $1bn to the economy of North Carolina and create jobs
with starting salaries well above the $69,000 average for Durham County.
North Carolina may withhold some of the payments if Q2 fails to uphold its end
of the bargain. Both payments are contingent upon Q2 meeting incremental job
creation and investment targets. Through that caveat, North Carolina thinks it
can ensure the JDIG projects are a net positive for tax revenues.
The JDIG agreements also cover plans to move $3.2m into a fund designed to help
rural communities invest in the infrastructure upgrades needed to attract future
business.
Q2 framed the investment in North Carolina as supporting its efforts to meet
“explosive demand for regulatory compliant genomic testing in clinical trials”
and provide translational services.
Q2 CEO Brian O’Dwyer said, “The market for genomic testing in clinical trials
has expanded rapidly over the past five years and, with the increased
information provided to clinical development programs from genomic data, we are
expanding our capacity and offerings in North Carolina. To complement the
expansion in genomics, we are also creating a dedicated Translational Science
and Innovation Laboratory.”
Amgen Leased New R&D Facility
Amgen has signed a lease on a 240,000-square-foot facility in South San
Francisco, positioning it to join AbbVie in a new campus. The nine-story
building will house Amgen’s Bay Area employees when it opens early in 2022.
Amgen leases seven buildings covering 684,000 square feet in the Bay Area,
although some of this space is subleased to third parties. With those leases due
to end between December 2021 and December 2023, Amgen has put in place new deals
to secure its future in the Bay Area, modifying the terms of its current
arrangement while forming an agreement with BioMed Realty for new space.
The BioMed Realty deal will give Amgen a long-term lease on 240,000 square feet
of space that is under construction at the Gateway of Pacific campus at Oyster
Point. Amgen expects to move its Bay Area cardiometabolic, inflammation and
oncology researchers into the digs in 2022. The scientists will work out of a
site that has “modular green wet labs and green molecular lab design.”
Amgen is the second big biopharma company to commit to the Gateway of Pacific
campus. AbbVie snapped up 94% of the 509,000 square feet of space BioMed Realty
is creating in the first phase of the project. Amgen’s 240,000-square-foot
facility will take up the north tower of the second phase of the project, which
will provide 440,000 square feet of space in total. Construction of a third
phase of the project, which will add a further 350,000 square feet of space,
began recently.
In conjunction with the deal for new space, Amgen has revised the terms of its
existing leases with Healthpeak Properties. The lease on three buildings on
Veterans Boulevard, which was due to expire in two years, is now due to run
until the end of 2029. However, Amgen can terminate the lease on the 257,000
square feet of space in two tranches in 2022 and 2024.
“With this amendment, Amgen retains flexible rights to continued occupancy at
several important research and development facilities, while providing
Healthpeak the clarity needed to advance discussions with prospective tenants
looking for space at this irreplaceable campus,” Healthpeak Chief Financial
Officer Pete Scott said in a statement.
REST OF WORLD
GE Healthcare Life Sciences and Pharmadule Morimatsu
to Expand KUBio
The KUBio “factory in a box” is expanding to accelerate the accessibility of
biotherapeutics on a global scale. Additional modular platforms will be
introduced in 2020 allowing biopharma manufacturers to quickly scale up
vaccines, viral vector-based therapies, and other novel modalities.
To do so, GE Healthcare Life Sciences will work closely with Pharmadule
Morimatsu, a company specializing in the design and manufacture of modular
facilities. Pharmadule will provide engineering design, construction,
installation, and validation services, based on GE Healthcare Life Sciences’
proprietary design.
Olivier Loeillot, General Manager BioProcess at GE Healthcare Life Science,
says: “We are combining our decades-long expertise in biomanufacturing with
Pharmadule’s proven excellence in modular construction to support the growth of
the biopharmaceutical industry. What biomanufacturers need is fast access to
reliable technologies, cost-effective investments, and speed to market. KUBio
offers all this, while continuing to extend and adapt to the dynamics of the
market.”
Helen Zhang, CEO of Pharmadule, says: “Joining expertise with GE Healthcare Life
Sciences is an important milestone. Through this collaboration, we will leverage
our capacity to execute effective projects from conceptual design to a qualified
modular facility and support the expansion of the KUBio biomanufacturing
facility offering. This fits very well with our modular concept, which includes
global turn-key delivery, from early design through fabrication and installation
up to operational qualification on site.”
Biopharmaceuticals are the fastest-growing class of medicines, used in the
treatment of a wide range of diseases, including rheumatoid arthritis, certain
cancers, and diabetes. The biopharmaceutical market grows at a compound annual
growth rate (CAGR) of 13.8% from 2018 to 2025 and is forecasted to reach $526
billion by 2025(1).
GE Healthcare Life Sciences launched the first off-the-shelf KUBio modular
facility in 2012 for the biomanufacturing of monoclonal antibodies. The KUBio
portfolio has expanded over the years to support the production of vaccines and
viral vectors. GE Healthcare Life Sciences has provided KUBio facilities to JHL,
Pfizer, and BeiGene. In collaboration with Pharmadule, GE Healthcare Life
Sciences is currently deploying a KUBio facility in Guangzhou, China.
About GE Healthcare Life Sciences:
GE Healthcare Life Sciences helps therapy innovators, researchers, and
healthcare providers accelerate how precision diagnostics and therapies are
invented, made, and used. Our products enable biological analysis, research,
development, and the manufacture of advanced therapies and vaccines. Life
Sciences is part of the $19.8 billion healthcare business of GE. With over 100
years of experience in the healthcare industry and more than 50,000 employees
globally, GE Healthcare helps efficiently improve outcomes for patients,
healthcare providers, researchers, and life sciences companies around the world.
About Pharmadule Morimatsu:
Pharmadule was founded in 1986 and has from the start provided its expertise in
modular construction technology to various industries. Today, Pharmadule
Morimatsu AB enjoys a strong global position as an authority in designing,
constructing and delivering state-of-the-art modular manufacturing facilities
for the pharmaceutical & biopharmaceutical industries. More than 70 projects
have been delivered using Pharmadule's modular concept and both multinational
and local companies have benefited from our delivery method.
Novartis Opens Cell and Gene Therapy Facility Ahead of
Time
The Swiss manufacturing facility will be responsible for the manufacture of cell
and gene therapies, including Kymriah.
When the facility was originally announced, in August 2018, it was projected to
be completed in early 2020, but the company has managed to ready the CHF 90m
(€79m) facility earlier than this timeline.
According to the company, the first clinical production of a cell and gene
therapy batch was completed in September 2019, at the newly opened Stein,
Switzerland facility.
After the European approval for Kymriah (tisagenlecleucel), the company has
focused on building out capacity to meet demand in the region.
This includes acquiring its former manufacturing partner for Kymriah, when it
purchased CellforCure. At the time of the announcement, Novartis revealed that
production of Kymriah would begin by mid-2019 after the deal had been completed.
The Stein facility will also focus on the production of chimeric antigen
receptor (CAR)-T therapies, with commercial production expected to be completed
in the first quarter of 2020, subject to regulatory approval.
At present, the facility has created 185 positions in cell and gene therapy,
with a further 265 expected to be added over the next few years.
Producing Kymriah has not been without its difficulties for the Swiss company,
with it previously telling investors that it had struggled with meeting product
specifications.
As a result, the company pledged to invest into its cell therapy manufacturing
network and to speed up the process of digitization, whilst also moving
investment away from traditional production technologies.
In third quarter financials, Kymriah was able to repay some of this investment
with strong growth, after making $79m (€71m) in the third quarter – representing
growth of 295% over the previous year’s results, though these were released
shortly after the product gained European approval.
In addition to the investment in cell and gene manufacture and announcing that
it was looking away from traditional processing, Novartis also stated that the
new facility would hold capabilities to produce solid dosage forms, including
tablets and capsules.
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