Antibody Drug Conjugates (ADCs)

38 Pages·2011·1.07 MB·English

Antibody Drug Conjugates (ADCs)
Agenda
 General Aspects & Organization

 Process R&D Capabilities

 Safety, Change Over and Cleaning

 Operations

 Quality Control
28-Oct-11 slide 2
What makes Lonza ADCs different?
 Leader in small molecule API and monoclonal antibody
(mAb) production and process development
(over 25 years of know-how)

 Dedicated high-quality ADC facilities, teams, standards
and safety procedures in place since 2004

 R&D labs, QC, and production all certified by
SafeBridge® Consultants

 Unparalleled expertise in product scale-up
28-Oct-11 slide 3
Our ADC investments have given us
leading-edge facilities and experience
Overview
 Location: Visp, Switzerland
 1st investment: 36m CHF (2006-08)
 2nd investment: 17m CHF (2008-10)
 1st start: 2006
 Large-scale: mid-2008 (cGMP)
Infrastructure
 Footprint: 750m2
 Total floors: Four
(1 production, 3 for
SafeBridge® Certification
utilities/infrastructure)
(Dec. 2008)
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Our broad manufacturing experience
equates to quality ADC production
Lonza has been involved in ADCs since 2004

 Long-term chemical and  Conjugation expertise from
biopharmaceutical multiple projects (e.g.
experience at lab and CIMZIA®)
commercial scale (2,500L)
 Experience with disulfide and
with highly potent active
amide coupling chemistry
ingredients
 Required infrastructure and
 Antibodies have been
support functions in place
manufactured at Lonza for
 First cGMP production start
over 25 years for our
mid-2007 (small-scale) and in
customers at pilot and
2008 (large-scale)
commercial scale (20,000L)
28-Oct-11 slide 5
Lonza has established the ADC teams
to deliver high-quality results
De dicated, experienced ADC teams

 Dedicated teams for R&D,  Same operators in entire
operations, quality control and development and scale-up
business development cycle
 Operators are well trained in  Familiar with facility:
cytotoxic handling procedures, Operators executed IQ and
biopharmaceutical operations OQ tests
and aseptic handling
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The R&D organization brings maximum
customer focus and effectiveness
LES R&D LES QC
Joe Pont Jens Donath
ADC R&D ADC Evaluation QC Conjugates/HAPI
Laurent Ducry Tom Rohrer Pamela Braun
ADC R&D Team 1 ADC R&D QC 1 PCP Support
Kai Meilert Dorothee Lay Torsten Meyer
Jeannine Michlig Philipp Meier Ulrike Wolf
Katja Williner Marlene Schnyder
Vera Escher
ADC R&D Team 2
Vera Schallbetter
ADC R&D QC 2
Bernhard Stump Robin Grichting
Paul Leiggener Thomas Grötsch
Andres Meyer
Désirée Schnidrig
ADC R&D Team 3
Miriam Hensgen
HAPI

Audrius Rimkus
Claudio Studer
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The manufacturing organization is
designed to ensure the highest quality
ADC Operations

Facilities Team Personnel Logistics Maintenance Support
ADC ADC Plant Qualification QC
Plant Engineering SHE
LBP Personnel
Cleaning Validation
Etc.
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Agenda
 General Aspects & Organization

 Process R&D Capabilities

 Safety, Change Over and Cleaning

 Operations

 Quality Control
28-Oct-11 slide 9
Procedures and laboratories for toxic
and nontoxic compounds are different
Non-toxic Compounds
 Standard R&D lab
 Purification of mAb/buffer exchange
 Modification reaction (linker
introduction or reduction of mAb)
 Purification of modified mAb
 Buffer preparation

Toxic Compounds
 Clean room (L-5000) for cytotoxic
ADC Laboratory Equipment
and ADC work
 Isolator to handle solid cytotoxic drug
 Room classification ISO 7
 WIBO hoods (push-pull ventilation) for
 OEL 40 ng/m3
conjugation reaction and ADC
 Air locks with separated material
purification
and personal flow
28-Oct-11 slide 10