CMC Biologics and IDT Biologika Announce a Strategic Collaboration
to Manufacture Antibody Drug Conjugates
Will provide an efficient end-to-end solution for development and manufacture of ADCs
Copenhagen, Denmark and Dessau, Germany, February 17, 2016. CMC Biologics A/S, a
global leader in clinical and commercial manufacturing of monoclonal antibodies and other
therapeutic proteins, and IDT Biologika GmbH, a privately-held life-science company with a 95
year history of expertise in research, development and manufacture of biologics for human and
animal health, announced the formation of a strategic collaboration to provide a complete and
efficient solution for the manufacture of antibody drug conjugates (ADCs).
Within this collaboration, CMC Biologics will perform process development and manufacture of
the bulk monoclonal antibody and IDT Biologika will perform services from conjugation of the
cytotoxic drug to the antibody substance through to the aseptic fill, finish and packaging of the
ADC final drug product. This joint manufacturing solution will provide speed, reliability, quality
ADC manufacturing and a simplified supply chain, from DNA to finished drug product, for
clinical trials and beyond through commercial manufacturing. Additional details will be provided
at the upcoming DCAT conference in March and initial services will become available to clients
in April 2016.
"The collaboration with CMC Biologics is an important step to provide full ADC manufacturing
services to meet the needs of ADC development and production in this rapidly growing field,"
said Dr. Ralf Pfirmann, Chief Executive Officer of IDT Biologika. "Our new collaboration permits
IDT Biologika to leverage its biologics and cytotoxics capabilities and facilities, and their unique
combination in the business, manufacturing and development portfolio at IDT´s Dessau
headquarter site, to provide ADC developers with a highly reliable and efficient solution for
early process development through clinical and commercial manufacturing based on our
capabilities and experience. We see this as an important undertaking to make a meaningful
difference in human health.”
"We are delighted to be working with IDT Biologika, one of the fastest growing and innovative
CMOs in Germany and now in North America,” said Gustavo Mahler, PhD, Chief Executive
Officer of CMC Biologics. “We share the common values with IDT Biologika with a constant
focus on manufacturing excellence and a dedication to customer service.”
About ADCs
Antibody Drug Conjugates are a class of therapeutic drugs consisting of a cytotoxic drug linked
to a monoclonal antibody that represents one of the fasting growing segments of the pharma
and biotech industry. Manufacture of ADCs poses unique and highly complex challenges,
requiring clean room biologic and high containment cytotoxic facilities, often involving multiple
vendors and providers. CMC Biologics and IDT Biologika will provide a unique complete
manufacturing solution for developers of ADCs.
About IDT Biologika
IDT Biologika is an innovative life science company headquartered in Dessau, Germany with
extensive expertise in research, development and manufacturing of vaccines, and in addition
providing fill, finish and packaging services for antibodies and proteins. It has expanded its
longstanding sought-after activity in vaccine development for Phase 1 and Phase 2 clinical
projects for the human vaccine market through its recently acquired Rockville, USA
facility. The company also operates vaccine development and manufacturing facilities in
Riems, Germany and Cambridge, Canada and sales offices for its own animal health vaccines
and biologics product portfolio in Denmark, the Netherlands, France, Spain and Canada. IDT
Biologika is a portfolio company of the Klocke Holding. The other Klocke portfolio companies
specialize in contract manufacturing and packaging of pharmaceuticals and cosmetic products.
Klocke Holding also owns a 50 percent stake in Oncotec Pharma Produktion GmbH, a
cytotoxics development and manufacturing facility, located and integrated in IDT´s Dessau site.
More information can be found at www.idt-biologika.com.
About CMC Biologics
CMC Biologics is leading the industry among CMOs in customer satisfaction, technical
excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the
Company provides fully integrated biopharmaceutical development and manufacturing
solutions to clients globally. The Company has proven expertise in delivering custom
solutions for the scale-up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials and commercial production. The Company’s wide range of integrated
services includes cell line development, bioprocess development, formulation and
comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary
CHEF1® expression system for mammalian production. More detailed information can be
found at www.cmcbiologics.com.
Contacts:
Peter Kellner
Corporate Communications
IDT Biologika
[email protected]
+ 49 34901 885 5681
Robert Broeze, PhD
SVP, Global Business Development
CMC Biologics
[email protected]
+1 609 273 3414
CMC Biologics and IDT Biologika:
Comprehensive, One-Stop ADC Manufacturing
A one-source solution for the development and manufacturing of your antibody drug
conjugates — from DNA to clinical trials to commercialization
Our Solution Simplifies Your Supply Chain
and Shortens Time-to-Market
It’s challenging for ADC developers to find a CMO partner
who can 1) efficiently support clinical and commercial
scale, and 2) accelerate the entire developmental and
manufacturing process. We are offering this onesource solution via a collaboration between two CMO
industry leaders, CMC Biologics and IDT Biologika.
“Ultimately the evolution of
CMOs (contract manufacturing
organizations) with integrated, endto-end solutions is what is needed.”
­— World ADC Industry Outlook 20151
Together, we now offer the industry’s first end-to-end
solution for the development and manufacture of ADCs,
from DNA to the finished drug product. For the first
time, drug developers can take advantage of a fully
Antibody Drug Conjugates Industry Outlook 2015. World ADC.
1
integrated ADC supply chain that:
• Consistently applies the same best practice
protocols at each stage of development
• Has scientists and professionals working together
to expedite the process
• Executes seamless technology transfers
• Provides strong analytical capabilities to
characterize the complex ADC molecules
• Leverages the extensive resources of two
international CMO leaders dedicated to
manufacturing excellence and customer service
As a global leader in the clinical and commercial
manufacture of monoclonal antibodies and other
therapeutic proteins, CMC Biologics will perform
process development and manufacture the bulk
monoclonal antibody. With nearly a century
of experience in researching, developing and
manufacturing biologics, IDT will be responsible
for conjugating the cytotoxic drug to the antibody
through the aseptic fill, finish and packaging of the
ADC product.
ADC Manufacturing from A to Z
CMC Biologics
MAb development
and manufacturing
GMP QP released
MAb-bulk drug
intermediate
IDT Biologika
MAb conjugation,
ADC F&F
Clinical or
commercial
packaged, released
drug product
• Antibody development and production
• Filling, labeling, packaging and storage
• Cell line, upstream, downstream, formulation and
process development
• Quality control and product release
• Conjugation of antibodies with linkers and toxins
• Analytical method development, stability studies
and testing
Five Global cGMP Facilities for All of
Your ADC Manufacturing Needs
CMC Biologics and IDT have five facilities (located
in the U.S., Germany and Denmark) that are fully
compliant with global regulatory standards and
designed to optimize capacity and technological
flexibility. Our combined upstream and downstream
capabilities, credentials and expertise include:
• EMA and FDA certification for commercial production
• Six mammalian cell culture lines
• First-in-market Bioreactor 6Pack™ single-use cell
culture line
• Parenteral aseptic cytotoxic fill finish
A Single Choice
Selecting multiple CMOs for your ADC development
and manufacturing is an overwhelming decision
and commitment of your time and resources for
project planning, management, CMO coordination,
troubleshooting, etc.
• Validation of analytical methods and
manufacturing processes
• Project management and regulatory support
Now you have a better option: our integrated, endto-end manufacturing solution provides unmatched
speed, reliability and efficiency in delivering
high-quality, customized services that drive the
performance of your end products.
Together, we now offer the
industry’s first end-to-end
solution for the development and
manufacture of ADCs from DNA
to the finished drug product.
In a business where a one-day delay can cost your
company $1 million or more, let us be your preferred
one-stop shop for your ADC supply chain needs.
Please contact Robert Broeze (+1 609-273-3414, [email protected]) at CMC Biologics
or José Ochoa (+1 703-303-8892, [email protected]) at IDT Biologika to learn
more about the CMC/IDT joint manufacturing solution.
MARCH 2016