PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
July 2020
TABLE OF CONTENTS
UNITED STATES
OncoGenerix & Alpha Capital to
Build Injectables Factory in the U.S.
Catalent’s Harmans Site Approved to Manufacture AveXis’
Gene Therapy
Pall Gets $4.9M DoD Contract to
Build Ventilator Filter Mfg. Line
Skender Completes Compounding
Pharmacy for Major Chicago Hospital
Novavax, FUJIFILM Initiate Large Scale
Mfg. of COVID-19 Vax Candidate
REST OF WORLD
Sandoz Partners with Austria to Boost Antibiotics Production
Sorrel
Medical’s New Manufacturing Facility, Netanya, Israel
Catalent’s Covid-19 Vaccine Manufacturing Facility, Anagni, Italy
Sanofi’s Evolutive Vaccine Facility (EVF), Neuville-sur-Saône, France
Also, Marken Doubles Capacity of Frankfurt Cold-Chain Facility
____________________________________________________________________________________________________________________
UNITED STATES
Alnylam’s
Manufacturing Facility, Norton, Massachusetts
Alnylam Pharmaceuticals is constructing a new
drug substance manufacturing and cGMP warehouse facility in Norton,
Massachusetts, US. The company broke ground on the $200m facility in April 2016.
The project is part of Alnylam’s expansion
plans aimed at increasing its manufacturing capacity. Fully-operational in 2018,
the facility produces the company’s RNAi therapeutics and to be a commercial
stage company.
Products manufactured at the Norton facility
will be sold across the world. The facility will initially generate 150 new full
time jobs at Norton, which is expected to increase to 300 in the future.
The cGMP manufacturing facility is expected
to be commercially operational in the second half of 2020.
The three-story plant will house several
production lines, GMP warehouse, as well as office space.
Alnylam’s new state-of-the-art Norton
facility will occupy an area of approximately 200,000ft² (18,580.6m²) on a
12-acre site. It will be responsible for developing innovative therapeutics
based on RNA interference.
RNAi therapeutics developed by Alnylam will
target a number of illnesses including TTR, hemophilia, hepatic porphyrias, beta
thalassemia, hypertension and liver infections.
Development of the facility involved various
levels of discussions with the contractors to develop a building plan, which met
Alnylam’s specifications. The company ensured that the plan appropriately
included machines used in its manufacturing process.
Machinery used by Alnylam is similar to that
used in the production of small molecules. RNA synthesis, which requires
advanced purification techniques, will be used to produce drugs at the facility.
An appropriate building plan was therefore required to meet this requirement.
The new facility will include a number of
green initiatives including the use of recycled water to reduce its
environmental footprint.
Alnylam surveyed a number of sites worldwide
before deciding on the Norton location. The proximity of the facility to its
headquarters in Cambridge will help the company to cut operational costs and
also enable its management to monitor the production process.
Locating in Massachusetts also enables
Alnylam to capitalize on the region’s innovative economic environment and
skilled workforce. Further, the Norton town council is providing Alnylam with a
$7m tax break over a period of 13 years for the project.
Alnylam has rented a small site in Cambridge
to initially produce its lead drug, Patisiran, which is used for the treatment
of a rare neurological disease. The company will also use third-party
manufacturers for back-up production capacity.
Alnylam’s remaining drugs will be produced at
the Norton facility. Having its own manufacturing facilities will enable the
company to establish a strategic supply chain for its products.
Jacobs Engineering Group was awarded the
engineering services and procurement contract for the project in August 2016.
Gilbane is serving as the construction
manager for the project.
A/Z was contracted to serve as the Building
Information Modeling (BIM) Coordinator during the construction of the facility.
Hereva is the project manager responsible for
supervising the design and engineering and supporting the environmental permit
process.
Albireo Energy won a contract to design and
install a customized building management system for the biopharmaceutical
manufacturing facility.
Marketing commentary on Alnylam
Pharmaceuticals:
Alnylam Pharmaceuticals is a global leader in
the development of novel therapeutics based on RNA interference and translation
of RNAi as a new class of medicines. The company was founded in 2002 to focus on
RNAi therapeutics for genetically defined targets to treat life-threatening
diseases.
RNAi therapeutics, which is a new approach
towards treating diseases, is a natural process of gene silencing that occurs in
plants and mammals. RNAi therapeutics use this natural process and inhibit the
creation of disease-causing proteins.
Alnylam has established investigational RNAi
therapeutics in major strategic therapeutic areas namely genetic medicine for
the treatment of rare diseases, cardiometabolic for liver expressed disease
targets in dyslipidemia, hypertension and type 2 diabetes, and hepatic infection
disease for infections such as hepatitis B and D virus infections.
The company aims to have ten such drugs in
the pipeline in various stages of clinical programs. It also has set the goal of
having at least three commercial products by 2020. It already has two drugs in
phase III trials.
Bionova’s
New GMP Manufacturing Centre
Bionova Scientific began the construction of
the new biologics manufacturing plant at its existing site in Fremont, CA in
July 2020.
Bionova Scientific is constructing its new
state-of-the-art manufacturing facility in California, US, for the production of
biologics.
The good manufacturing practices (GMP)
compliant facility will improve the company’s service offerings to the
biotherapeutics industry, while also supporting it to meet the increasing demand
for industrial biomanufacturing capacity.
The ground-breaking ceremony of the GMP
manufacturing center took place in July 2020. The company is anticipated to
complete the construction of the facility within ten months, starting operations
in the third quarter of 2021.
Bionova is currently in talks with customers
for production slots starting from 2021. The company’s move to build the
biologics manufacturing facility was in response to demand from clients to meet
their GMP production needs.
The manufacturing center is located within
Bionova Scientific’s 56,000ft² headquarters in Fremont, California, extending
across an area of approximately 36,000ft².
The production facility will use single-use
technology for all core unit activities. It will include two 2,000l mammalian
cell culture trains (XDR bioreactor trains), which will manufacture clinical and
commercial bulk drug substances.
It will add GMP manufacturing to Bionova’s
existing portfolio of services including cell line development, process
development, GLP material production, process characterization and analytics.
The plant will be equipped with Cytiva’s
FlexFactory bioprocess platform, designed to produce monoclonal antibodies and
other recombinant proteins.
The GMP center previously served as a
cleanroom facility. The company is reconfiguring the facility and installing
plug-and-play equipment and systems.
FlexFactory bioprocessing platform mainly
uses single-use technology and includes distinct unit operations connected by
single-use tubing sets. It provides the flexibility of installation in new or
current workspaces and can include several automation schemes.
It can be used to manufacture biologics
including monoclonal antibodies (mAbs) or vaccines. The technology also allows
scalability of capacity from pilot stage to commercial production.
A FlexFactory platform may usually have
bioreactor systems, AKTA chromatography systems for protein purification
operations, and Xcellerex XDUO and XDM Quad Mixing Systems for automation of the
mixing of buffers, media, and intermediates.
“The production facility will use single-use
technology for all core unit activities.”
Expansion of the company’s operations is
backed by a $22m equity commitment made by health care investment firm Great
Point Partners (GPP) in June 2019.
GPP provided $13.3m as of June 2019 and
intends to fund a further $9m by 2021.
The growth equity funding is intended to
support the construction of the Fremont GMP facility.
Bionova collaborated with DGA for design and
architect services and Dome Construction for engineering and construction.
Marketing commentary on Bionova Scientific
Bionova Scientific is a contract development
and manufacturing organization (CDMO) that specializes in protein production,
cell line development, process development and analytical science.
Founded in 2014, Bionova has experience in
terminal stage and commercial launch projects.
The company worked with more than 200
customers in the biopharmaceutical industry to support them in their drug
development efforts.
It assists in the management of different
stages of development and manufacturing of biologics, including initial research
material development, process development, and contract manufacturing.
In March 2020, Bionova announced that
companies involved in the development of treatments for Covid-19 would be
provided priority access to its lab capacity.
OncoGenerix
& Alpha Capital to Build Injectables Factory in the U.S.
Novel and generics pharma producer
OncoGenerix and Alpha Capital LLC have come to an agreement to build a new
injectable pharmaceutical factory in the U.S. The production facility will serve
as an affiliate factory, similar to the one that OncoGenerix already operates in
China.
Alpha Capital LLC is considering a Georgia
Opportunity Zone as the location for the new plant. The output capacity of the
project is expected to reach 20 million vials of injectable oncology products
and vaccines.
Earlier this year, Alpha Capital launched an
international capital raise to secure a substantial stake in OncoGenerix, which
recently completed a pharmaceuticals factory in Mudanjiang Province, China. The
offering is a digital investment opportunity - tokenized ownership of a
pharmaceutical facility. Alpha Capital is offering up to 500 million ONGX Tokens
at U.S. $0.12 per token and a U.S. onshore offering of shares in Alpha Capital's
special purpose vehicle. The ONGX Tokens are built on the ERC20 blockchain
protocol, serve as a SAFE (simple agreement for future equity), and will be
exchangeable at the option of the investor for equity-token securities.
“Our joint work with OncoGenerix is helping
to bring new pharma production capacity to U.S. soil. The planned facility will
be able to alleviate substantial shortages, as well as increase
injectable--liquids and vaccines--manufacturing capability. It has been hard in
the past for independent investors to enter the pharmaceutical industry as
building pharma production capacity takes substantial investments of financial
capital and time. Individual investors typically were only able to access this
vertical via publicly traded securities. The ONGX Token makes it possible for
individual investors to step in earlier, while reducing the investment ticket
size by orders of magnitude,” said Alpha Capital LLC’s co-founder and CEO Colin
Breeze. “We are excited to extend our manufacturing capacity to the United
States together with Alpha Capital and look forward to helping solve existing
oncology drug shortages to support the U.S. market,” said Oleksandr Zabudkin,
CEO of OncoGenerix.
OncoGenerix’s manufacturing services include
technical transfer, process development, scale-up, equipment and process
validation, formulation, filling, lyophilization, inspection, labeling, and
packaging. OncoGenerix combines sterile drug manufacturing to deliver compliant
and cost-effective drug production.
Catalent’s
Harmans Site Approved to Manufacture AveXis’ Gene Therapy
Catalent was approved by the U.S. FDA to
produce commercial drug substance intermediate for AveXis’ spinal muscular
atrophy (SMA) gene therapy at its manufacturing facility in Harmans, MD.
The approval follows an FDA inspection of the
Harmans commercial-scale gene therapy manufacturing center in June. Under
Catalent’s partnership with AveXis, a Novartis company, a dedicated suite space
has been prepared at the Harmans facility for the commercial manufacture of this
adeno-associated virus (AAV) gene therapy.
“This is a significant milestone for Catalent
and the gene therapy industry as a whole. Catalent is proud to be the first
contract development and manufacturing organization to be approved for
commercial gene therapy production,” commented Manja Boerman, Ph.D., President
of Catalent Cell & Gene Therapy. “This approval allows us to leverage our
now-licensed, state-of-the-art GMP commercial manufacturing facility, and our
deep AAV expertise, to support AveXis as it delivers a life-changing treatment
for patients.”
“Given the complexity and length of time
required to make gene therapies, manufacturing is critically important,” said
Dannielle Appelhans, Chief Technical Officer for AveXis. “This approval further
complements our internal manufacturing capacity and, over time, will allow us to
increase supply to meet growing patient needs.”
Catalent’s Harmans commercial manufacturing
facility, located near BWI airport, is equipped with single-use technology, and
houses over 200,000 sq.-ft. of late-stage clinical and commercial-stage gene
therapy production. The facility is one of Catalent’s five gene therapy
facilities in Maryland providing clinical through commercial scale services, and
houses multiple CGMP manufacturing suites, including fill/finish, central
services and testing labs, warehousing, and supply chain capabilities.
Pall Gets
$4.9M DoD Contract to Build Ventilator Filter Mfg. Line
New line set to open in fall 2021.
Pall's ventilator filter production capacity
will increase from 485,000 units per month to 650,000 units per month.
Pall Corporation, a global filtration,
separation and purification company, was selected by the U.S. Department of
Defense (DoD) to receive a $4.9 million contract to build a new breathing filter
manufacturing line within an existing U.S.-based Pall manufacturing facility to
increase ventilator filter production. When the new line opens in the fall 2021,
Pall's ventilator filter production capacity will increase from 485,000 units
per month to 650,000 units per month—allowing Pall to help meet the growing
demand in the U.S. for ventilator filters driven by COVID-19.
The grant is the result of a partnership
between the DoD and the Department of Health and Human Services (HHS) to
determine how to increase domestic ventilator critical component suppliers'
capacity.
"We are proud Pall was awarded this DoD
contract, which allows us to increase the production of ventilator filters to
help protect patients and give health care workers the equipment needed in a
pandemic situation," said Jennifer Honeycutt, president of Pall Corporation and
Danaher Group Executive.
In addition to Pall's efforts to produce
additional breathing filters for ventilators, Pall solutions play a major role
in global COVID-19 response efforts. The company's lab solutions are used in
COVID-19 research and Pall's expertise in scaling up vaccine manufacturing
processes is currently being applied by several drug makers. Notably, Pall is a
core member of the consortium led by The University of Oxford, which is
responsible for one of the front runners in the race to develop an effective
COVID-19 vaccine. AstraZeneca joined forces with the consortium and committed to
enabling global access to the vaccine, including low and middle-income
countries.
"From the start of the COVID-19 crisis, Pall
has drawn on the depth and breadth of our material science and engineering
expertise across a wide range of industries to devise trusted solutions that
support research, help patients heal and eliminate the spread of this disease,”
said Honeycutt. “It's through our innovation that we will continue to apply our
expertise in novel ways to protect people around the world.”
CoreRx
Fully Operational in New Product Development Center
CoreRx, Inc., a global contract development
and manufacturing services company opened its fourth new facility, on the ICOT
campus in Clearwater, FL in April 2020. The new Product Development Center
includes 9 R&D formulation development and R&D-scale manufacturing suites,
nearly 5,000 sq. ft. of analytical laboratory space as well as capacity for an
additional 35 employees to the Clearwater workforce over time.
The new 26,000 sq. ft. space expands the
capacity of CoreRx’s oral and topical dosage form development group, increasing
drug product volume through several formulation technologies that include:
blending, roller compaction, wet granulation, fluid bed drying, spray drying,
and extrusion spheronization. According to the company, the increased R&D
development capacity is in response to higher demand for expert contract
services. This expansion will assist its pharmaceutical chemists in the
development of robust, reliable dosage form options made available to our
clients.
This expansion gives CoreRx’s clients access
to over 150,000 sq. ft. of space at the ICOT center campus.
The new facility is designed to streamline
workflow and optimize product development efficiency, with analytical
development, pre-formulation, and formulation development teams all collocated
for optimal synergy.
“The establishment of our International
Center of Excellence on our Clearwater campus is both an indicator of our
continued growth and a commitment to our global and domestic customers,” said
Bill Reid, chief operating officer, CoreRx. “Investing in new facilities,
increasing development capacity, and expanding our capabilities help us to meet
the growing demand for our services and is also an important way of creating
jobs and supporting the communities where we operate.”
KBC Adding A
Cleanroom Suite
Kentucky BioProcessing is getting some
improvements.
AES Clean Technology picked up a building
permit last week for an $857,000 renovation and the creation of a cleanroom
suite.
Gemini Bio’s
New Manufacturing Facility
Cell culture solutions provider Gemini
Bioproducts (Gemini Bio) opened its new manufacturing facility in West
Sacramento, California, US, in June 2020.
The facility will allow Gemini Bio to satisfy
the demands of cell therapy and research markets while meeting the criteria of
global regulatory compliance.
Gemini Bio’s cGMP-compliant manufacturing
center will expand the company’s production capabilities, enabling it to serve
the needs of its pharmaceutical partners.
The ground-breaking ceremony of the
manufacturing facility was held in September 2019.
The new cGMP manufacturing facility is
located in West Sacramento, California in the US, extending over an area of
approximately 25,000ft².
Gemini Bio’s facility will support the
production of cell culture media, sera, cytokines (humans, mouse or rat), growth
factors, buffers and other supplement reagents with products for the cell
therapy and gene therapy.
It is equipped with cleanroom suites, cold
storage facilities, warehouses and administrative area. The additional
production will deliver a fourfold increase in the company’s production
capacity.
The facility will allow for rapid growth and
development while improving the quality level of Gemini Bio’s products.
Gemini Bio intends to be a center of
excellence supporting the requirements of customers in the cell and gene therapy
market.
It is relocating to the new facility from its
existing 12,000ft² location in West Sacramento.
MarketOne Builders, a design-build
contractor, and architecture firm DGA worked on the design and construction of
the new manufacturing facility in West Sacramento.
In June 2020, Gemini Bioproducts received a
contract worth $3.6m from the US government to deliver essential products to
boost Covid-19 testing efforts. The award is a part of the broader commitment of
Gemini Bio to support Covid-19 containment.
“CGMP-compliant manufacturing center will
expand the company’s production capabilities, enabling it to serve the needs of
its pharmaceutical partners.”
Gemini Bio will provide reagents in the
Phosphate Buffered Saline (PBS), Saline Solution and Viral Transport Media (VTM)
areas and will utilize its facility to support the initiative.
Development of media solutions is a primary
focus area of the firm. VTM is important to the coronavirus testing process and
the company will support measures to increase testing.
The company is mainly targeting the delivery
of its products and solutions in the areas of cell culture, viral harvesting and
transport, analytical instruments and research tools. Gemini Bio is complying
with the recommendations of the Centers for Disease Control and Prevention (CDC)
throughout its manufacturing processes.
Marketing commentary on Gemini Bioproducts:
Gemini Bioproducts provides cell culture
technologies to scientific organizations involved in cell and gene therapy,
biotechnology, biopharma and academic research.
The company also provides contract
manufacturing services and regulatory consultancy services to its clients. It
aims to offer holistic solutions for cell culture to facilitate the discovery
and manufacturing of therapies. The state-of-the-art facility will provide
services such as fill and finish, and the development of custom media.
BelHealth Investment Partners, a
healthcare-focused private equity company, invested in Gemini Bio in September
2018.
Founded in 1985, Gemini Bio is headquartered
in West Sacramento, California. Gemini has a global distribution network that
services cell culture laboratories across the world.
It purchased life sciences instrumentation
firm ORFLO Technologies in November 2019. The acquisition added Moxi Go and Moxi
Z products to Gemini Bio’s portfolio. The company also formed an exclusive
partnership with FroggaBio, under which the latter has the rights to distribute
the media and sera products of Gemini Bio across Canada.
Skender
Completes Compounding Pharmacy for Major Chicago Hospital
Skender, serving as general contractor,
recently completed interior construction of a 7,500-square-foot compounding
pharmacy at a large Chicago hospital. The project consolidates three existing
oncology pharmacies while expanding capacity to support projected growth.
The new sterile pharmacy allows for the safe
preparation, mixing and packaging of drugs to meet individual patient needs. It
features six compounding spaces that were constructed using cleanroom design to
keep airborne particles within specified limits. The project also includes 17
mixing hoods, refrigerated and non-refrigerated drug storage and an interlocked
anteroom with cleanroom doors that allow the opening of only one door at a time.
To comply with cleanroom specifications,
material selection included solid surface wall protection, Terra Universal
cleanroom doors, lab casework and extensive mechanical equipment to support
cleanroom functionality and standards. Skender worked with Kahler Slater and ESD
to successfully complete the new pharmacy.
The project took place within an active
hospital, requiring special logistics and safety measures, such as precise-sized
materials to fit elevators, extensive noise and vibration controls and
electrical and plumbing shutdown coordination. With space and access
constraints, a knockdown air handling unit was delivered in panelized sections,
assembled and installed on site over four weeks.
SCA to Expand
Operations in Little Rock
SCA Pharma to renovate an existing
42,000-square-foot facility at the Clinton National Airport and construct an
additional 20,000-square-foot facility.
SCA Pharma, an FDA-registered outsourcing
facility, is expanding its operations in Little Rock. SCA will be investing more
than $10 million and will create the opportunity to double its current Little
Rock workforce of 180 people.
Additionally, the investment will allow SCA
Pharma to renovate an existing 42,000-square-foot facility at the Clinton
National Airport and construct an additional 20,000-square-foot facility
adjacent to the existing facility. SCA also plans a 40 percent expansion of its
Windsor, Conn. facility.
Construction at Windsor will allow company to
add second cleanroom.
SCA Pharma, an FDA-registered outsourcing
facility, plans to expand its sterile pharmaceutical manufacturing facility in
Windsor, CT, by 40 percent. It currently operates two sterile pharmaceutical
manufacturing facilities located in Windsor and Little Rock, AK. The planned
expansion would increase the size of the Windsor facility to approximately
150,000 square feet with the ability to add state-of-the-art automation,
compounding capability, and technical employees to manufacture critical
medicines.
“Ensuring that hospitals have all of the
readily available sterile injectable pharmaceuticals they need to properly treat
and care for patients is more critical today than ever before,” said Milton
Boyer, chief executive officer, SCA Pharma. “The demand for SCA products
continues to increase, and we are committed to meeting that need safely,
efficiently and reliably. Our new construction will position us to expand our
capacity and make products even more accessible to hospitals.”
Boyer said construction would take
approximately nine months to complete.
“We are very pleased that as we continue our
geographical expansions in both Arkansas and Connecticut, we can partner with
the Arkansas Economic Development Commission (AEDC) and the Little Rock
Municipal Airport Commission to solidify and expand the operations of our legacy
operations,” said Milton Boyer, CEO of SCA Pharma. “Little Rock has been the
foundation that has allowed for our other expansion projects, and this project
will bolster that foundation for years to come.”
SCA says it has experienced significant
growth over the past five years and believes that creating an additional clean
room capacity will provide another avenue to increase supply.
“Arkansas is committed to nurturing its
homegrown companies from seed stage upward,” Gov. Asa Hutchinson said. “We are
proud to see the success that SCA Pharma is experiencing and look forward to the
products and services being developed here in central Arkansas that will
positively impact the lives of people around the country.”
The expansion of both locations will also
create the need for technical and highly skilled jobs for both areas.
“Even in these trying and turbulent times of
a global pandemic and its uncertainty, Little Rock is continuing to see
companies invest and create new jobs for our citizens,” said Mayor Frank Scott
Jr. “We are thrilled and grateful SCA Pharma is joining Little Rock’s momentum
and creating high-paying jobs that will have a lasting impact on our economy.”
Novavax,
FUJIFILM Initiate Large Scale Mfg. of COVID-19 Vax Candidate
FUJIFILM to manufacture bulk drug substance
for NVX-CoV2373 from its site in Morrisville, NC for Phase III trial.
Novavax, Inc. and FUJIFILM Diosynth
Biotechnologies (FDB), a contract development and manufacturing organization for
biologics, viral vaccines and gene therapies, entered an agreement to
manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine
candidate. FDB's site in Morrisville, NC has begun production of the first batch
of NVX-CoV2373.
This agreement falls under Novavax' recent
$1.6 billion award by the federal government as part of the Operation Warp Speed
(OWS) that aims to deliver millions of doses of a vaccine for COVID-19 to the
U.S. population. The OWS funding is being used by Novavax to complete late-stage
clinical development, including a Phase 3 clinical trial; establish large-scale
manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early
as late 2020.
NVX-CoV2373 consists of a stable, prefusion
protein made using Novavax' nanoparticle technology and includes Novavax'
Matrix–M adjuvant. The batches
produced at the FDB site in North Carolina will be utilized in a future Phase 3
trial of up to 30,000 subjects, which is expected to begin in the fall of 2020.
Novavax expects preliminary immunogenicity
and safety results from a Phase 1/2 trial of NVX-CoV2373 in 130 healthy
participants 18 to 59 years of age during the first week of August. The Phase 2
portion to assess immunity, safety, and COVID-19 disease reduction is expected
to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by
an up-to $388 million funding arrangement with the Coalition for Epidemic
Preparedness Innovations (CEPI).
MedPharm
Expands U.S. Footprint
UK topical and transdermal firm invests in $4
million expansion of laboratory facility in Durham, NC.
MedPharm, a UK-based developer of topical and
transdermal products, recently unveiled a substantial expansion at its Center of
Excellence in Durham, NC. Supporting clients from discovery lead optimization to
GMP clinical batch supply, MedPharm has facilities in Guildford, UK, in addition
to the Durham site. The company’s expertise covers products to be applied to
and/or through the skin, nail, eye, airway or mucosal membranes. Contract Pharma
spoke with Jeremy Drummond, senior vice president of business development, about
the expansion and MedPharm’s plans for future growth on both sides of the
Atlantic.
Contract Pharma (CP): Could you please tell
me about the features of the Durham facility?
Jeremy Drummond (JD): MedPharm’s facility in
Durham, NC has recently been expanded to 25,000 square feet, tripling the area
of the existing footprint. The $4 million investment will predominantly provide
additional laboratory space and equipment.
Medpharm's Jeremy Drummond
In addition to the performance testing using
our proprietary in vitro models based on human tissue, MedPharm now can offer
pre-formulation/formulation development, histology and microbiology services out
of North Carolina. Importantly the facility will also encompass a dedicated
innovation laboratory to help solve unique problems presented by clients and
ensure that MedPharm stays at the forefront of technology.
This new facility will be able to accommodate
100 new highly skilled scientific personnel.
CP: Why was the expansion necessary—were you
looking to add capabilities in certain areas, capacity or both?
JD: The expansion has become necessary
because of the increased demand for MedPharm’s services across all sectors of
the pharmaceutical industry. There is increased demand, from biotech start-ups
to Big Pharma, to develop topical and transdermal products based on new chemical
entities. These companies recognize the inherent risks in topical formulation
development and increasingly appreciate how MedPharm’s specialist skills coupled
with its in-depth experience can de-risk their development plans and help them
to attract investors when they seek funding.
The increased demand is fueled by the growing
interest in developing new and repurposed drugs currently registered for oral or
IV delivery for indications which require delivery through the skin, direct to
the eye or into an airway. Another contributing factor has been MedPharm’s
pioneering expertise in the use of in vitro models based on human tissue to meet
the recently published FDA and EMEA guidance on demonstrating generic
equivalence for topical medicines.
MedPharm is now also attracting projects from
OTC companies who are keen to use its in vitro models to help educate their key
opinion leaders about their products and broaden the marketing claims of their
products with regulatory authorities.
This investment is just a first step in
MedPharm’s vision to expand its services in the future, particularly around
contract manufacturing.
CP: Could you tell me a little more about the
dedicated innovation laboratory—its features and capabilities?
JD: MedPharm’s Innovation Laboratory has a
wide-ranging remit to help customers resolve key questions to de-risk or
simplify their product development.
By example, recently the team has developed a
new model for assessing penetration through human nasal epithelia based on air
liquid interface tissue culture of primary human cells in the laboratory. This
allows clients to assess the performance of their products before they commit to
clinical trial decisions.
In a further step, MedPharm has expanded
these models based to support pharmaceutical development programs targeting
Coronavirus treatments. These models allow clients to assess therapeutic
effectiveness in nasal, airway (bronchial), and deep lung (alveolar) epithelia
against members of the Coronaviridae family. The work will help to de-risk
development programs and screen drugs for therapeutic effectiveness to
accelerate development prior to clinical trials.
Studies have shown that human tissue can vary
significantly from that of animals used in in vivo models and so this approach
provides the most realistic read out of how a topical drug product is going to
behave in the clinical environment.
In a similar way the innovation laboratory
has refined MedPharm’s whole eye model for monitoring penetration to encompass
the activity of formulations on key biochemical pathways and is extending the
viability of fresh skin kept in the laboratory from weeks to months to open the
opportunity for novel assays for monitoring wound healing and acne amongst
others.
REST OF WORLD
CMIC Group
Establishes Biopharma CDMO in Japan
CMIC Holdings has established CMIC Bio, a
fully-owned subsidiary that offers CDMO services for biopharmaceutical drug
substance.
CMIC Bio has a single-use facility in
Shizuoka, Japan for process development and GMP manufacturing of antibody drug
using mammalian cell line. The facility will be in full-scale operation from
October 2020.
In recent years, the
biopharmaceutical-related market has continued to expand, and companies from
other industries other than pharmaceutical companies have entered the market.
Each company emphasizes the speed to acquire POC in order to quickly identify
the development compound, and at the same time, the need for multi-product,
small-volume production is rising.
Given this situation, it is difficult to
produce all of the development products in-house, and an increasing number of
cases utilize outsourcing.
From April 2014 to September 2019, CMIC JSR
Biologics participated in the Japan Science and Technology Agency's Program
(NexTEP) (Project name: design and manufacturing technology of multispecific
antibodies). Research has been conducted in the fields of manufacturing and
quality control of biotechnology-derived pharmaceuticals, with a focus on the
manufacturing process development of bispecific antibodies.
"Based on these experiences, we establish
CMIC Bio and start the biopharmaceutical drug substances CDMO business. At CMIC
Bio, we have personnel with abundant experience at pharmaceutical companies and
have strengths in GMP API manufacturing bases in Japan to assist in accelerating
the development speed of biopharmaceuticals," said Hiroshi Kosaku, President of
CMIC Pharmaceutical Sciences.
"CMIC Group will provide end to end solutions
from non-clinical testing, running clinical trial, GMP manufacturing of
biopharmaceuticals to the commercialization and post market," Kosaku added.
Sandoz
Partners with Austria to Boost Antibiotics Production
Swiss pharmaceutical company Novartis unit
Sandoz has partnered with the Austrian Government to boost integrated
antibiotics production in Europe.
Sandoz plans to invest more than €150m over
the next five years to improve the long-term competitiveness of its antibiotic
manufacturing activities at Kundl.
The company will develop manufacturing
technology for active pharmaceutical ingredients (APIs) and finished dosage
forms (FDFs).
As part of the joint plan, the Austrian
government would provide or coordinate public funding worth about €50m towards
the total investment.
The government expects this initiative to
enhance the European-based manufacturing of essential medicines.
Novartis added that the joint plan is subject
to formal approvals by both parties, which expect a formal closing of the
agreement by the end of this year.
Sandoz CEO Richard Saynor said: “Antibiotics
are the backbone of modern medicine and our Kundl facility in Austria is the hub
and center of the last remaining integrated production chain for antibiotics in
the western world. This joint investment will help to keep it that way.”
Sorrel
Medical’s New Manufacturing Facility, Netanya, Israel
Wearable drug delivery devices manufacturer
Sorrel Medical opened a new manufacturing facility in Israel in July 2020.
The facility will develop and manufacture a
range of wearable drug delivery devices to boost clinical and commercial supply
capabilities. The company is looking to ramp up production of the wearable
devices as it prepares for upcoming clinical trials.
The manufacturing plant can assist Sorrel’s
partners in the pharmaceutical and biotechnology industry to bring advanced drug
delivery solutions to the market.
Increased production scale-up capability is
expected to support the needs of patients suffering from severe, high-burden
illnesses.
The new facility for the manufacturing and
commercialization of wearable drug delivery devices is located in the city of
Netanya in Israel. It includes an advanced production cleanroom to enable the
production of scalability of wearable drug delivery devices.
The 860 sq. ft. (80m²) cleanroom conforms to
the ISO class 7 environment standard, designed to minimize particulate pollution
in accordance with the standards of ISO 14664-1:2015 and EU GMP Annex 1 and
regulate other environmental variables including pressure, temperature and
humidity.
The company will leverage the Netanya site to
switch from initial design and development, with low-volume production, to
scalable high-quality production.
Sorrel Medical’s new manufacturing facility
will allow the firm to increase its production capacity to hundreds of thousands
of units a year. It also features an IQC laboratory and spaces to meet gowning,
washing, and warehousing requirements.
Sorrel’s pre-filled and pre-loaded wearable
drug delivery systems are used for self-administration of drugs with high
viscosities.
Flexible and fully connected on-body
injectors improve the patient experience and help pharmaceutical firms to
provide combination products for patients.
The devices feature a primary
container-agnostic configuration to handle a range of drug packages, UV LED
disinfection and smart sensing capabilities. The presence of multiple sensors
also allows for detection of cartridge placement and needle position, as well as
performing internal system checks.
The company’s devices incorporate
electromechanical pumping mechanism, while the flow rate is up to 3ml per
minute. Devices are equipped with Bluetooth low energy and near field
communication (NFC) enabled connectivity.
Wearable drug delivery devices, or wearable
injectors, are intended for the self-administration of injectable drugs. They
provide a solution for the drug administration of large volumes and high
viscosities into the subcutaneous tissue in a user-friendly drug delivery
system.
Drug delivery devices offered by Sorrel
Medical are available in multiple configurations including 2ml, 3ml and 10ml.
The features of the devices enable optimized usability and enhanced patient
safety.
Sorrel Medical is focused on the development
and commercial production of platform-based, pre-filled, and pre-assembled
wearable injectors.
The medical device firm was formed as a
spin-off from Israel-based company Q Core Medical and operates as a subsidiary
of Eitan Group.
Eitan Group is engaged in advanced infusion
therapy solutions and provides patient-centric connected, software-based
solutions to meet evolving drug delivery needs. In addition to wearable
solutions, the company offers systems for hospital care and ambulatory settings.
Sorrel leverages technology to simplify
processes for end-users and pharma companies. It aims to develop innovative
technology solutions to meet challenges in the drug delivery market.
The company supports its partners with its
expertise in technological flexibility, production scale-up, regulatory
compliance and marketing to reduce time and risk.
Sharp
Acquires Stake in Berkshire Sterile Manufacturing
Agreement will allow Sharp’s Clinical
division, via BSM, to offer sterile fill/finish services.
Sharp, part of UDG Healthcare plc, has
purchased a minority 25% ownership in Berkshire Sterile Manufacturing (BSM),
extending the existing preferred partner agreement that has been in place
between the two businesses since 2018.
BSM offers specialized isolator-based sterile
filling of vials, syringes, cartridges and containers, as well as Lyophilization
and terminal sterilization to small, medium and virtual pharma and biotech
companies.
The agreement will allow Sharp’s Clinical
division, via BSM, to offer sterile fill/finish and extend these services to
Sharp Packaging’s existing rare and orphan therapy biotech customers where
market demand is growing significantly.
“Starting in 2018, our partnership with BSM
has been incredibly successful for both parties, bringing a significant number
of new business leads to Sharp Clinical and enabling BSM to realize additional
sales,” commented Frank Lis, president of Sharp Clinical Services.
“Strengthening our relationship with a minority stake will be a great benefit to
our respective clients as BSM’s capabilities are a natural extension of the
existing services that Sharp offers.”
As part of the agreement Frank Lis and Kevin
Orfan, president of Sharp will join the BSM board.
“Having Frank and Kevin join the BSM board as
part of this deal will be greatly beneficial as the collaboration between our
companies grows in the years to come,” added Shawn Kinney, CEO of Berkshire
Sterile Manufacturing. “The agreement will also allow further collaboration in
Quality, Project Management, IT, Logistics, Storage and Distribution and will
enhance our respective integrated service offerings, reducing timelines and
ultimately optimizing the client experience.”
The deal follows BSM’s announcement of a $20
million investment into expanding its filling capacity and capabilities. This
expansion will double the company’s cleanroom and warehouse space, and bring an
isolator-based robotic flexible sterile filling line. With this new line, BSM
will be able to fill larger quantities of vials (RTU and bulk), cartridges,
syringes and custom containers.
Colorcon
Opens New Facility
The new center is in the award-winning
Caribbean Business Park in Australia.
Colorcon has opened a new technical center in
Melbourne, Australia. The facility provides customers in Australasia access to
pharmaceutical class development services such as tablet formulation and coating
as the region seeks to shorten supply chains and increase the capacity of its
pharmaceutical sector.
“Opening this facility demonstrates
Colorcon’s continued commitment to supporting the growing pharmaceutical and
nutritional markets in Australia, reducing our customer’s time to market during
product development. The investment reflects Colorcon’s dedication to providing
best-in-class products and services,” commented David Wei, general manager,
Colorcon South East Asia.
Tim Horwood, business development manager in
Australia, explained, “The new technical service center will provide both large
and small customers the opportunity to work directly with Colorcon and for the
first time in Australia to conduct laboratory-scale compression and coating
trials, using automated coating equipment, saving valuable development time and
cost.”
“The facility will also provide the
opportunity to extend the educational events offered through the Colorcon
Academy to our customers, with resources to conduct training programs to expand
their knowledge in formulation and coating; benefiting both companies and
individuals,” added Glenn Russell, technical director. “Colorcon’s continuous
investment in customer support is unmatched in the industry; this additional
facility brings the total number of Technical Service Laboratories around the
world to twenty-two and is the seventh within Southeast Asia.”
Sekisui
Invests in Biopharma CDMO Business
Sekisui has invested £14.4 million ($18.93
million) in its biopharma CDMO business aimed at cGMP microbial capacity
expansion at the existing site in Maidstone, Kent to be completed by the second
half of 2022.
This investment follows the investment of
$1.9 million in its new Bioprocess Innovation Center, completed in October 2019,
and is part of a long-term investment strategy to grow its share of the
microbial biopharma CDMO market.
Previously part of Genzyme Corporation,
Sekisui Diagnostics' Enzyme business launched its microbial biopharma CDMO
service offering, BioProduction by Sekisui, in 2017. The facility expansion and
cGMP upgrades will enable Sekisui to take on drug substance contract
manufacturing for programs entering the clinical trial phase. The new cGMP
certified microbial fermentation and purification suites will accommodate
production scales up to 1,000L, complementing its existing capabilities which
range from 20L to 5,000L fermentation scale.
Sekisui has wide experience with projects
from pre-clinical to commercialization, including but not limited to recombinant
systems such as E. coli and Pichia pastoris, and associated purification and
analytical technologies. Its main expertise lies in the production of enzymes;
however, its capabilities are also suitable for plasmids, antibody fragments,
and other protein production.
"This investment represents our commitment to
serve our Biopharma customers with much needed cGMP microbial CDMO production
capacity." said Robert Schruender, president & CEO of Sekisui Diagnostics and
Sekisui Medical board member. "Over many years we have built both a technical
and operational competency and expertise in enzyme production and microbial
fermentation. As the Biopharma CDMO market grows, we aim to further leverage
this capability to grow our share in this market."
Lonza
Expands Facility in Switzerland
Lonza is expanding its microbial
manufacturing facility in Visp, Switzerland. The new facility will provide
mid-scale commercial manufacturing to multiple customers and in particular,
serve the growing needs of Servier, an independent international pharmaceutical
company and long-term Lonza partner.
Servier and Lonza have recently signed a
long-term extension to the manufacturing agreement for L-asparaginase, produced
at Lonza since 2009. The extension and expansion of the collaboration will
provide Servier with the additional capacity required to provide treatment to
many more patients with acute lymphoblastic leukemia (ALL), a cancer of the
white blood cells. Servier intends to expand access to asparaginase-based
multi-agent chemotherapeutic regimens.
The new facility will be the sixth to be
housed in Lonza’s new biopark in Visp, Switzerland, currently under
construction. Lonza launched Ibex Solutions in 2018 to offer custom-tailored
manufacturing solutions across a broad range of technologies while minimizing
time to market with pre-built shells and infrastructure. The new mid-scale
(3,000L) microbial facility will tap into existing central utilities and labs
and will complement the existing small-scale (1,000L) and large-scale (15,000L)
assets in Visp.
The facility is expected to be operational in
the second half of 2022 and Lonza expects to add 100 new staff to the existing,
highly-experienced microbial team.
Catalent’s Covid-19 Vaccine Manufacturing Facility, Anagni, Italy
Catalent Biologics’ manufacturing facility in
Anagni, Italy will serve as the launch facility for the large-scale production
and supply of the University of Oxford’s Covid-19 vaccine candidate, AZD1222.
The company signed an agreement with
AstraZeneca, which is working with Oxford University on the development and
production of AZD1222, in June 2020. The agreement will support the scale-up of
capacity for the manufacturing of AZD1222.
The facility will provide vial filling and
packaging capabilities to AstraZeneca. It will be ready for production by August
2020 and the company aims to deliver hundreds of millions of doses of the
potential vaccine. The production of the adenovirus vector-based vaccine will
continue until March 2022, subject to the approval by regulatory authorities.
It will also accelerate the launches of
customers’ biologics and oral drug products and broaden Catalent’s network in
Europe. Catalent plans to invest further in the facility for its growth.
The 301,280 sq. ft. (28,000m²) facility is a
state-of-the-art pharmaceutical manufacturing facility located in an industrial
area approximately 100km south-east of Rome. With a floor space of 207,668 sq.
ft. (19,300m²), the facility lies on a 34ha site.
Biologics fill-finish and oral solid dose
product manufacturing and packaging center was acquired from Bristol-Myers
Squibb in January 2020.
Bristol-Myers Squibb used the facility for
technology transfers and accelerated launch of its various flagship products
including Opdivo® (nivolumab), Yervoy® (ipilimumab), Sprycel® (dasatinib) and
Reyataz® (atazanavir). The facility continues to manufacture Bristol-Myers
Squibb’s products.
The manufacturing facility specializes in
filling aseptic liquid, and powder of biologics and sterile products in
different vial sizes, as well as primary and secondary commercial packaging
solutions with blister and bottling capabilities for product launches.
Other capabilities of the facility include
automated warehousing, serialization and a service that provides shipping of
packaging solution within 48 hours after order placement.
The facility is approved by several agencies
including the US Food and Drug Administration (FDA), the Italian Medicines
Agency (AIFA), Brazil National Health Surveillance Agency (ANVISA), and Ministry
of Health, Labour and Welfare of Japan.
Developed by the Jenner Institute at the
University of Oxford and the Oxford Vaccine Group, the recombinant adenovirus
vaccine technology-based AZD1222 is backed by the US government.
AZD1222 utilizes a replication-deficient
chimpanzee viral vector derived from a weakened version of a common cold
adenovirus that infects chimpanzees. The vaccine contains SARS-CoV2 spike
protein genetic material.
Vaccination will produce the surface spike
protein and prepare the immune system of the patient to attack coronavirus if
the body gets infected by it later. It will be a single dose vaccine to create a
strong immune response in individuals. Vaccinated individuals will not suffer
from ongoing infection as it does not replicate.
The drug is currently in clinical studies. It
entered Phase I / II clinical trial to evaluate the safety, immunogenicity, and
efficacy of the drug in more than 1,000 healthy individuals aged between 18 and
55 years in southern England in April 2020.
US Biomedical Advanced Research and
Development Authority (BARDA) is supporting the vaccine development and
production project with an investment of over $1bn.
The US Department of Health and Human
Services (HHS) formed a partnership with AstraZeneca, under Operation Warp
Speed, to deliver at least 300 million doses of Covid-19 vaccine AZD1222 by
January 2021. First doses of the vaccine are expected to be available from
October 2020. Phase 3 clinical studies of AZD1222 in Summer 2020 involve 30,000
volunteers in the US.
Marketing commentary on Catalent:
Catalent Biologics is a business division of
Catalent, a pharmaceutical company based in New Jersey, US, focused on providing
advanced delivery technologies and development solutions for biologics, drugs,
and gene and cell therapies. The company operates a network of facilities in
Europe including Brussels, Belgium, and Limoges, France, as well as other
facilities in the US.
Catalent has more than 13,000 employees,
including 2,400 scientists and technicians. In May 2020, it signed an agreement
with Arcturus Therapeutics to manufacture the LUNAR-COV19 vaccine candidate at
its biomanufacturing facility in Madison, Wisconsin, US.
Sanofi’s Evolutive Vaccine Facility (EVF), Neuville-sur-Saône, France
Sanofi is planning to build a new Evolutive
vaccine facility (EVF) for the manufacturing of vaccines in Neuville-sur-Saône
in the eastern part of France.
EVF facility will allow Sanofi Pasteur,
Sanofi’s global vaccine company, to supply vaccines in case of new pandemics.
The investment will boost the company’s
capability to further research and mass production of new innovative vaccines.
The project will involve an investment of
€490m ($552.4m) over five years and create 200 new job opportunities.
Sanofi’s Evolutive vaccine manufacturing
facility will be located in the Neuville-sur-Saône commune of France.
The Neuville-sur-Saône site is located close
to the company’s facility in Marcy-l’Etoile, and Sanofi Pasteur’s global
headquarters, as well as the Genzyme production site of Sanofi, situated in the
center of the Sanofi Biotechnology Hub in the city of Lyon.
The company’s existing operations at the
facility in Neuville-sur-Saône primarily include biotechnological manufacturing
of vaccines. The Neuville-sur-Saône site represents the first dengue vaccine
production center in the world.
In addition, the site includes a research and
development (R&D) laboratory devoted to analytical sciences. The plant has
high-tech facilities and an innovative structure that enables new vaccines to be
developed in collaboration with R&D.
The state-of-the-art manufacturing facility
will incorporate the latest advanced technologies for the manufacturing of
vaccines.
EVF is a facility built around a central unit
that includes completely digital production modules. The modern factory will be
able to produce three to four vaccines at the same time, compared to only one in
the existing sites.
Customization and modular design will enable
the development of a specific vaccine on priority and in a more reasonable time
frame depending on public health concerns.
Sanofi will work with the European Union (EU)
and the French Government to create an additional vaccine or monoclonal antibody
(installation of cell culture tanks and start-up projects) manufacturing
capabilities for the EU and pharmaceutical firms in case of any healthcare
emergency.
Marketing commentary on Sanofi:
Sanofi is a major healthcare company
delivering solutions and services in more than 170 countries around the world.
It plays an instrumental part in meeting customers’ healthcare demands and
improving health services.
Through its global vaccines’ division Sanofi
Pasteur, Sanofi is involved in the development and manufacturing of vaccines.
The multinational company’s vaccine portfolio includes products to treat
patients from infectious diseases, influenza and endemic diseases.
Sanofi Pasteur employs 16,000 personnel and
operates 12 vaccine manufacturing sites, including three in France.
It supplies over 200 vaccines, medicines and
healthcare-related drug products in France. It has 33 sites in France including
22 industrial sites.
The company has around 5,000 scientists and
researchers engaged in therapy areas, with a focus on immuno-oncology, vaccine
development, oncology and rare diseases. It is also planning to spend €120m
($135.3m) to set up a new research and development facility in France at Sanofi
Pasteur’s Marcy-l’Etoile site to produce possible future vaccines.
The proposed advanced digital facility in
Marcy-l’Etoile will be equipped with specialized laboratories for vaccine
development against emerging diseases and pandemic hazards.
Sanofi aims to transform its French
operations into a center of excellence in the areas of vaccine research and
manufacturing.
The company is also supporting global efforts
to combat the Covid-19 pandemic disease. It joined forces with GSK to explore
the use of recombinant DNA technology to produce a potential Covid-19 vaccine.
Its research efforts, in partnership with TranslateBio, are focused on
developing a vaccine using messenger RNA technology.
Marken
Expands Global Footprint
Marken, the clinical supply chain subsidiary
of UPS Healthcare, is adding a GMP-compliant depot in Los Angeles, CA, and a new
GMP-compliant depot in Kiev, Ukraine. In addition, two GDP-compliant logistics
branches will be added in Dublin, Ireland and Amsterdam, the Netherlands. These
newest additions to Marken's global network add increased capacity and enables
Marken to continue to offer superior supply chain services to its clients, their
investigator sites and patients.
The Amsterdam facility will include a
cryogenic filling station to meet the growing need of Marken's cell and gene
therapy clients. An additional LN2 service station has been added to Marken's
network in Geneva, Switzerland.
"The infrastructure investments we have made
in all of our facilities globally serve a single purpose," said Ariette van
Strien, president, Marken. "Since 2011, we have made investments which meet
client demands where they need us. Marken will always strive to offer the very
best service, reliability and security for our clients."
By early Q4, Marken will have 12 fully
operational GMP-compliant depot locations, complemented by more than 10 million
square feet of GMP-validated commercial warehouse space in 56 UPS Healthcare
distribution centers. This extensive global network provides an exceptional
degree of flexibility and efficiency, whether it involves coordinating supplies
from a central or regional location based on trial enrollment activity or
implementing innovative strategies that are built for future demand.
Wes Wheeler, president, UPS Healthcare, said,
"Marken continues to lead as our clinical trial logistics subsidiary with unique
new services and a very broad reach. We will continue to invest in Marken as the
industry moves into new regions of the world, becomes more virtual, and demands
a greater degree of control and visibility. We are also using their unique
knowledge in clinical trials to influence our strategic investments in
healthcare."
Also, Marken Doubles Capacity of Frankfurt Cold-Chain Facility
The company has expanded the footprint of the
location to accommodate an anticipated increase in the need for COVID-19 vaccine
and storage needs.
By increasing the size of its Frankfurt,
Germany, facility (slated to go online in October) to more than 40,000 square
feet, Marken is increasing its frozen-room storage capabilities and
accommodating more clients looking to transport and store cell and gene therapy
solutions. Outsourcing-Pharma (OSP) recently spoke with Marken president Ariette
van Strien (AVS) about the GMP-certified facility, the industry’s evolving
cold-storage demands and how COVID-19 is impacting the business.
OSP: Could you please share the history of
the Marken GMP network – when was it launched, storage/logistics capabilities
there, how it’s evolved over the years, etc.
AVS: Marken has built and operated a fully
GMP compliant owned network of 10 depots for the last decade, and these are also
supplemented by select partner depots in other key locations around the world.
This network continues to grow with plans to open Los Angeles (USA) and
Kiev (Ukraine) in the coming months.
Each depot is built after an extensive
analysis of client demands as well as geographical needs, allowing clinical
trials to be conducted in a cost efficient and optimized manner. These central
depots allow us to serve our clients with comprehensive and efficient global
distribution services for their clinical drug products and ancillary services;
they are built to pharmaceutical manufacturing standards and are fully GMP
compliant.
Depots are usually co-located with our
logistics hubs in order to take advantage of well-established customer service,
operations import /export and administrative support. Each of Marken’s depots
are connected through the Solo platform, a global state-of-the-art, 21 CFR part
11 validated, cloud-based inventory management system which can interface with
IRT for improved inventory reconciliation.
OSP: Could you please talk about the market
conditions and client needs that helped drive Marken’s decision to expand its
frozen-room storage capabilities there? Was the company eyeing this opportunity
before COVID-19 hit?
AVS: The expansion of cryogenic (liquid
nitrogen) service locations facilitates global cell and gene therapy trials.
The combination of our expanded locations and packaging assets allows
Marken to meet client demands in a rapidly growing industry.
Ultra-low temperature transportation has
become an increasingly important supply chain requirement for cell, gene or
immunotherapy-based medicines and those plans were in place well before the
pandemic. We continue to see an increase in the demand for cell and gene therapy
trial shipments.
We are committed to building the largest
cryogenic service network in the clinical logistics industry to safely connect
patients in all corners of the world with their required therapy.
OSP: In the announcement about the Frankfurt
facility, you talk about cell and gene therapies being a particular focus for
Marken—could you provide a little more detail about how industry work
on/interest in this area has evolved in recent years, and how Marken is working
to fulfill these associated needs?
Ariette Van Strien, president, Marken
AVS: Advances in cell, gene and immunotherapy
therapies continue to grow at a rapid rate and the clinical trial supply chain
is evolving to provide personalized solutions for these life-changing therapies.
One of the more recent changes has been the
development and issue of a new ISO standard that covers the transportation of
cells for therapeutic use. Based on ISO9001, a panel of experts from the
industry and ISO standards body worked together to develop ISO21973, which was
released at the end of June.
This new standard points to the important
considerations for those involved in this sensitive and essential work. Marken
subject matter experts provided expertise early in the development of the new
standard, with the ultimate goal to minimize variation, improve reporting and
communications, and to achieve better quality of services for clients and
patients.
Marken’s expanded cryogenic network of liquid
nitrogen service locations and specialized fleet of packaging, allows our
clients to recruit and treat patients from a greater number of countries around
the world. Six Marken branches became Cell and Gene Centers of Excellence in
2019; in addition, a full-time, global team was appointed to develop and support
the products and services required to handle cell, gene and immunotherapy
materials and products.
The products and services have been designed
to assure quality, chain of identity, data privacy and include a combination of
best in class technology, facilities, processes and measurements. A central
control center is now established at our headquarters in North Carolina; this
team includes project management specialists, technology SMEs and logistics
operations staff who are dedicated to cell and gene services on a full-time
basis.
As an important part of many cell, gene and
immunotherapies, cryogenic transportation at -150 degrees C are supported by
Marken’s liquid nitrogen shipping fleet, which are serviced at 14 geographically
distributed locations. Marken has been chosen as a key provider for global cell
and gene trials and commercial supply shipments around the world.
OSP: Could you talk about how the COVID-19
pandemic has impacted Marken’s offerings in the clinical trial supply chain
service realm? Please feel free to talk about offerings in general, as well as
this facility in specific. I love this straight-forward quote: “Fewer handoffs
mean fewer variables, less risk and an unbroken chain of custody.” Could you
please elaborate on why shortening the chain (so to speak) is desirable for your
clients, and ways in which your company helps make that happen?
AVS: COVID-19 has impacted Marken in many
ways including how we onboard clients, expansion of the number of countries in
which we were able to provide direct-to-patient (DTP) services, greater
deployment of single use packaging, and a myriad of other evolutions in our day
to day business.
For instance, working closely with our
clients, we have onboarded DTP trials in as little as a few days, as opposed to
a more typical timeline of several weeks. Our teams have worked together to
quickly procure and coordinate the appropriate temperature-controlled packaging
solutions and temperature monitors into all countries.
We shifted our forecasting to add in more
single use packaging rather than reusable because of quarantining policies in
many areas and to help ensure the safety of our team members and clients.
We procured PPE equipment for our branches globally and ensured adequate
supplies for all of our drivers and workers.
We adjusted our Standard Operating Procedures (SOPs) including DTP driver
No Touch protocols and processes to safeguard everyone involved to meet the high
demand to deliver treatments to thousands of patients in need.
Risk mitigation is a multi-step process and
requires planning, foresight, technology, and experience.
Reducing the number of handoffs eliminates potential weak points in the
supply chain, which benefits clients because it means that their critical and
high value shipments of medicine or treatment reach the patient.
Through decades of experience, Marken's team
of experts can critically assess any shipping lane and immediately identify
points of potential risk. Mitigation
steps can be taken early on to avoid as many potential pitfalls as possible.
Communication is critical, amongst our teams and to our clients, to ensure
success.
When clinical sites and hospitals needed to
refocus on COVID-related treatments and testing, Marken was ready with services
that allowed patients to continue with their trials through home visits. Direct
to/from Patient (DTP/DFP) and home healthcare (HHC) services provide solutions
to keep clinical trials going, while maintaining patient safety, by shipping
treatments directly to participant’s homes.
Through DFP services, biological samples can
be retrieved from a patient’s home and sent to laboratories for testing.
Combining DTP services with HHC services allows patients to respect the
confinement guidelines of their location while continuing to participate in
their clinical trial.
Prior to the pandemic, Marken was operating
DTP in 57 countries. Now, that service has been provided in over 80 countries.
After sponsors secure permission to include
DTP services into their protocols, Marken successfully coordinates logistics and
delivery of thousands of clinical drug products directly to patients
participating in trials throughout Asia, Europe, the US and Latin America. All
Marken staff and selected partners are trained to provide DTP services after the
personnel perform careful risk assessments to ensure time and temperature
control will be maintained for each shipment.
Further, Marken is adding cold storage space
across our GMP network for vaccine storage. We have already procured an
additional supply of -80C freezers with the option to double the volume as
needed.
Early on, we assessed our availability for
+2C to +8C and -20C storage needs in order to be ready for vaccine storage and
are also in the feasibility stage of adding further capacity within Marken and
the UPS fully owned GMP network. We are also closely working with our sister
company, Polar Speed, a UPS subsidiary, to build out a large cold chain storage
hub in the UK.
OSP: I understand you have additional
facilities planned in various parts of the world—can you share any additional
detail about that?
AVS: In addition to the GMP-compliant
facilities being added in Los Angeles, California and a new GMP-compliant depot
in Kiev, Ukraine, two GDP-compliant logistics branches will be added in Dublin,
Ireland and Amsterdam, the Netherlands. These newest additions to Marken’s
global network add increased capacity and enables Marken to continue to offer
superior supply chain services to its clients, their investigator sites and
patients.
The Amsterdam facility will include a
cryogenic filling station to meet the growing need of Marken’s cell and gene
therapy clients. An additional LN2 service station has been added to Marken’s
network in Geneva, Switzerland.
UK Invests
to Scale Up Covid-19 Vaccine Manufacturing
The Government of UK has announced an
investment of £100m ($127m) to scale up manufacturing of Covid-19 vaccine and
gene therapy in the country.
The investment will support the new Cell and
Gene Therapy Catapult Manufacturing Innovation Centre for expediting the mass
production of a successful Covid-19 vaccine.
Schedule to open in December next year, the
Centre will have the capacity to manufacture millions of doses per month.
In Braintree, Essex, England, the investment
will help upgrade an existing facility into a fully-licensed manufacturing
center. This is intended to boost the country’s capability to respond to
diseases such as Covid-19, as well as any other future pandemics.
This will also create new jobs to support
economic recovery.
The new center will support the Vaccines
Manufacturing and Innovation Centre (VMIC), which is being built in Oxfordshire
with a £93m government investment.
Following its completion next year, the
facility will be equipped to generate enough vaccine doses to cater to the UK
population at scale.
Eurofins
CDMO Expands Drug Product Facilities
Eurofins CDMO announces the strategic
expansion of its existing Drug Product operation capabilities with the
completion of new Drug Product development and cGMP manufacturing facility
located in Mississauga, Canada.
The expansion of Eurofins’ Drug Product
operations spans 14,500 sq. ft. The assets include fully equipped
state-of-the-art pre-formulation and formulation development laboratories, a
development suite, multiple GMP manufacturing suites, clinical packaging, and
warehousing. With the expansion, Eurofins CDMO can support development and
clinical manufacturing of oral solid dosage forms, including Highly Potent
API’s. The integration of Drug Product operations compliments Eurofins CDMO
existing API development and manufacturing services by providing an enhanced
Quick-to-Clinic drug product strategy designed to meet clients’ needs for phase
I and II products.
“Our complement of services offers
science-driven strategies which enhance the Drug Product performance of API’s,
from IND enabling through to late stage programs.” notes Kevin Rosenthal,
Business Head of Drug Product Operations at Eurofins CDMO Canada.
The new drug product facility allows Eurofins
CDMO to offer all drug development services under one roof, achieving enhanced
science faster.
Samsung Biologics Expands Manufacturing Facility in Incheon
Samsung Biologics will expand its Drug
Product (DP) capability in line with increasing market demand and to ensure
flexible production capabilities for new and existing clients.
Samsung Biologics has been providing aseptic
filling and lyophilization services since 2013 and has 25 product approvals from
global regulatory bodies, including the FDA and EMA. In response to the
forecasted increase in demand for aseptic filling, the company is making a
strategic investment on its global capacity by building a flexible filling line
and two additional lyophilizer units with 41.2 m2 chambers.
The flexible filling line is expected to
commence GMP operations in the second half of 2021, and the expanded
lyophilization line will become operational in the first half of 2022. Through
this expansion, Samsung Biologics will add small-scale cartridge and syringe
filling to its DP product offerings, and increase the total lyophilization
capacity by 246% of the current capacity. The company expects to demonstrate its
ongoing commitment to reliability and quality-oriented services for its clients
and strengthen existing partnerships in addition to procuring new orders.
"We are committed to meeting every market
demand from our clients, especially during this global climate," said Dr. Tae
Han Kim, CEO of Samsung Biologics. "Samsung Biologics continues to work
rigorously to accommodate our clients with world-class services, and through
this investment, we hope to offer more flexibility and demonstrate our extensive
manufacturing capabilities with the largest production capacity in the
industry."
GenScript Expands CDMO Capabilities
The inaugural GenScript Cell and Gene Therapy
Industry Development & Cooperation Forum concluded in Shanghai on July 17, at
which more than 700 researchers and corporate leaders shared insights on the
future growth of the cell and gene industry.
At the event, GenScript unveiled the
integration and upgrading of the original CDMO platform and the release of its
latest brand, GenScript ProBio. The new brand is dedicated to providing
end-to-end service from discovery to commercialization.
For the past 16 years, since 2004, GenScript
has gradually expanded its reach in the antibody drug discovery segment and
established its capabilities in process development, helping many customers with
their IND approvals during the period.
In 2019, GenScript opened the Biologics
Development Business Unit (BDBU), the predecessor of GenScript ProBio, and
appointed Brian Min, senior vice president at Samsung Bioepis, to join as chief
executive officer and form a management team. The core members of the team each
have more than 15 years working experience at recognized international firms
across the sector, including Roche, Pfizer, Henlius and Innovent, among others.
"The GenScript CDMO platform has established
strong antibody capabilities within just 18 months since launch and has
accumulated considerable experience in cell and gene therapy," said Dr. Min at
the launch of the brand. "GenScript ProBio's one-stop antibody drug development
solutions will proactively provide clients with end to end service from target
to commercialization. Looking beyond China and the Asia Pacific region, many
large multinational companies in the U.S. and Europe have also established
productive partnerships with us. Operating under the principle of 'Innovation
through Collaboration', we fully expect to drive the development and progress of
the whole industry together with our customers."
McIlvaine Company
Northfield, IL 60093-2743
Tel:
847-784-0012; Fax:
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E-mail:
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