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Lonza Bioscience
Merck Boston
Ernie Desmarais 8/21/07
Lonza Bioscience Capabilities
slide 3
Table of Contents
Lonza Bioscience Overview
Research Products
Biotherapeutic Media Products
Rapid Microbial Detection
Cell Therapy Bioservices
slide 4
Lonza Bioscience Overview
Lonza Bioscience provides a variety of products and services for
life science research, quality control of pharmaceutical products for
injection, cell culture media for bioprocessing and cell therapy
services.
We Are Specialists In:
 Cell Culture
 Cell Biology
 Bioassays
 Electrophoresis
 Rapid Microbial Detection
slide 5
Bioscience is crucial to therapeutic innovation
slide 6
Lonza Bioscience Service & Support
Customer Service
 US: Customer Service in Walkersville, MD
and Rockland, ME
 Europe: Customer Service in Belgium,
Spain, Italy and England
 Phone Service M-F, 8:00am - 6:00pm
 E-Commerce, 24/7
Technical Services Group
 US and Europe
 Provide technical assistance and information
 Product experts
 Manage product testing, investigations and
Material Review Board
slide 7
Lonza Bioscience Quality Systems
Our entire staff is dedicated to maintaining the highest
compliance standards in the industry including:
All necessary requirements for cGMP compliance
QA review and approval of manufacturing documents
Comprehensive internal audit program
Raw materials release
Vendor audit and qualification programs
Reviewing and approving all product labeling and documents associated
with manufactured products based on FDA, EU and/or other current
applicable regulatory guidelines
Coordination of Corrective and Preventive Action Programs (CAPA)
Liaison to regulatory agencies and client
Regulatory support
slide 8
Research Products Overview
 Products and Services for Life Science Research
 Over 75 years of experience in cell culture:
 Primary Cells
 Classical Media & Sera
 Serum-Free Media
 Cell Therapy
 Integrated Platform of Cells, Media and BioAssays
 Over 40 years of experience in electrophoresis
 Agarose and Precast Gels
 Protein Precast Gels
 Basic manufacturer of >95% of offerings
slide 9
Research Products Overview (continued)
 Customers include:
 Academic and government institutions
 Research hospitals and medical schools
 Biotechnology companies
 Pharmaceutical companies
 Global presence
 Direct sales in 18 countries
 Distributors throughout the world
 Dedicated Technical Service
slide 10
Cell Biology Overview
Leader in primary cells and media systems
State-of-the-art cell isolation laboratory
Over 100 human and animal primary cell
types available
Proprietary growth and cryopreservation
protocols
Custom cell isolation capabilities
Extensive sources and experience in ethical
procurement of human and animal tissue
We offer performance and convenience:
We procure the tissue
We isolate and qualify the cells
We deliver the cells to you
slide 11
Primary Cells & Media
Clonetics®
Cells and Media Systems
Cells are non-immortalized, non-transformed and
produced from normal tissue
Advantages
Greater relevance – no species extrapolation, alternative to
animal testing, more relevant results
High quality – standardized isolation protocols and extensive
testing assure predictable results
Outstanding performance – optimized media systems drive
cell expansion yet maintain normal cell characteristics
Convenience – we procure the tissue and perform the
isolations under standardized, controlled conditions
Trusted source – ethical, documented tissue acquisition and
rigorous quality standards
slide 12
Primary Cells & Media (continued)
Available cyropreserved or as growing cultures
Specialized media optimized for superior
performance
Human cells tested for HIV, Hepatitis B and C as
well as for mycoplasma and sterility
Products are quality controlled and issued with a
certificate of analysis
slide 13
Primary Cell Systems Offered
Airway Cell Systems
Bladder Cell Systems
Endothelial Cell Systems
Fibroblast Cell Systems
Keratinocyte Cell Systems
Mammary Epithelial Cell
Systems
Smooth Muscle Cell Systems
Skeletal Muscle Cell Systems
Human and Animal Neural
Cell Systems
Prostate Cell Systems
Skeletal Cell Systems
Hepatocyte Cell Systems
Renal Epithelial Cell Model
Blood Brain Barrier Model
(Bovine)
slide 14
Stem Cell Systems
Poietics®
Stem Cells and Media
 Poietics®
products include a collection of adult stem cells
derived from the hematopoietic system and other tissues
 Fresh or cryopreserved cells are available from bone
marrow, G-CSF mobilized peripheral blood, cord blood, and
fetal liver
 Obtained through Institutional Review Board approved
donor programs
 Optimized media are available for growth and differentiation
 Highly purified populations from proprietary positive and
negative selection protocols
 All products are quality controlled and issued with a
certificate of analysis
slide 15
Stem Cell Systems (continued)
Preadipocyte Cell and Media Systems
Visceral Preadipocytes
Subcutaneous Preadipocytes
Osteoclast Precursors
Neural Progenitor Cells and Media
Human Bone Marrow
Mononuclear Cells from multiple sources
Hematopoietic Progenitors from multiple sources
Erythroid Progenitors
Mesenchymal Stem Cell System
Immune System Cells and Media
CD14+ Monocytes
Stromal Cells from Human Bone Marrow
Quadratox™ 4 Species Panel
slide 16
Custom Cell Isolation
Custom Cell Isolation Services
Extensive experience with multiple human and
animal cell types
Broad sourcing capabilities
Packaged to your unique specifications:
Cell count
Pre-seeded multi-well plates
Pre-seeded flasks
Cryopreserved
Customized treatments available:
Cell pellets
Specialized media
Customer specified cell treatment
slide 17
Cell Culture
Broadest range of cell culture applications
Bench research
High throughput screening
Production of biological therapeutics
Production of cell therapy products
Production of diagnostic tests
Cell culture products are manufactured under cGMP
protocols
Production is controlled from raw materials to
finished goods
All products are manufactured with WFI (water for
injection) quality water
Media is sterile filtered using pharmaceutical-grade
filters (USP or EP sterility)
Sold as BioWhittaker™ brand
slide 18
Specialty Media
Serum-free, protein-free, chemically
defined and NAO media
Advantages of specialty media
formulations
Increased lot-to-lot consistency
Simplified purification and
downstream processing
Better control over physiological
conditions of cultures
Ability to optimize formulations for
specific cell types
slide 19
Specialty Media (continued)
Media systems are available to optimize performance in:
CHO cells (PowerCHO™, ProCHO™, and UltraCHO™ media)
Immune cells (X-VIVO™ media)
Kidney cells (UltraMDCK™, Pro293™, and ProVero™ 1 media)
Insect cells (Insect-EXPRESS™ medium)
Hybridoma cells (HL-1™, UltraDOMA™, and ProDoma™ media)
ES Cells (X-VIVO™ media + growth factors)
General purpose serum-free media
UltraCULTURE™, PC-1™, and UltraMEM™ media
Other applications (available in Europe only)
Karyotyping, Cytogenetics, In-vitro fertilization
slide 20
Classical Media
Broad range of standard media used for
many cell culture applications
Manufactured with Tissue Culture
Association formulas
Manufactured under cGMP protocols
Prepared with WFI water
Available in liquid or powder formulations
Tests performed
Sterility
pH and Osmolality
Cell Growth Promotion on three cell
types (primary, diploid, heteroploid)
Endotoxin
slide 21
Cell Culture Reagents
Tissue culture grade products including
amino acids, antibiotics, buffers
Prepared with WFI water
Manufactured under cGMP protocols
Products include:
Buffers
Balanced salt solutions
Antibiotics
Cell harvesting reagents
slide 22
Animal & Human Sera
Animal sera is collected from USDA inspected abattoirs in the 48
contiguous states or from USDA certified sources outside of the
United States
US sourced sera are processed using dedicated tanks and
equipment
Human sera is obtained from donors who test negative for
hepatitis B and C, HIV 1 and 2
Sera products are manufactured with cGMP protocols
slide 23
Animal & Human Sera (continued)
Sera are tested for:
Mycoplasma
Adventitious virus (animal sera)
Sterility
Endotoxin
Hemoglobin (animal sera)
pH and Osmolality
Biochemical profile (animal sera)
Growth promotion (animal sera)
Products include:
 Fetal Bovine Serum
 Newborn calf serum
 Calf serum
 Donor calf serum
 Equine serum
 Human serum
slide 24
BioAssays
Cell health and cytotoxicity assays
Mycoplasma detection assays
Cell function assays
Cell analysis reagents
HTS (high throughput screening) assays
Enzyme assays
GPCRs
Conditionally immortalized cells
Unique, sensitive assays based on
luminescence and fluorescence…
slide 25
BioAssays (continued)
Cell health and cytotoxicity assays
ViaLight®
Cell Proliferation and
Cytotoxicity Bioassays
ToxiLight®
Non-Destructive
Cytotoxicity Bioassay
ApoGlow®
Rapid Apoptosis
Screening Kit
Mycoplasma Detection Assay
MycoAlert®
Mycoplasma Detection
Assay Kit - Unique 20 min assay for
mycoplasma contamination detection in
cell cultures
slide 26
BioAssays (continued)
Cell Function Assays
OsteoLyse™ Assay (Collagen)
OsteoAssay™ Human Bone Plate
Cell Analysis Reagents
Fluorescent stains for cell organelles, cell structural
elements, and cell tracking
slide 27
BioAssays (continued)
Unique products for cell biology research
Transport™ Protein Delivery Reagent
HTS screening assays
PKLight®
HTS Protein Kinase Assay Kit
PDELight®
HTS cAMP Phosphodiesterase Assay Kit
G Protein-Coupled Receptors
Rapidly expanding list of newly de-orphanized
GPCRs
Clonetics®
Conditionally Immortalized Cells
Primary cell performance with telomerase
technology
slide 28
Molecular Biology Overview
Integrated platform gels, reagents and buffers for superior
separation of macromolecules
“Ready-to-use” products for protein and nucleic acid separation
Pre-cast gels for nucleic acid electrophoresis
Pre-cast gels for protein electrophoresis
Manufacturer of agarose and agarose derivatives for next
generation chromatography products and large scale protein
purification
World renowned brands in electrophoresis:
SeaKem®
LE Agarose
Reliant ®
Precast Gels
PAGEr®
Gold Gels
Long Ranger®
Sequencing Solutions
GelBond™ Film
slide 29
Nucleic Acid Electrophoresis
We provide:
The best known and most widely
cited agarose brands – SeaKem®
,
NuSieve®
and MetaPhor®
We are the inventor and the sole
innovator in agarose technology
for the past 40 years
We use the most stringent requirements in our manufacturing
– FDA and ISO 9001/2000 certifications
Precast Reliant®
and Latitude®
Gels
Precast RNA Gels
RNA & DNA markers and ladders
Nucleic acid stains
Electrophoresis Buffers
slide 30
Protein Gel Electrophoresis
High performance protein electrophoresis
products optimized to deliver sharp
resolution, superb sensitivity and fast,
convenient separations
We provide:
PAGEr®
Gold Precast Protein Gels
Protein stains
Protein markers
Electrophoresis buffers
slide 31
Sequencing
Superior sequencing performance matched with unique
packaging convenience
Long Ranger®
acrylamide gel solutions for longer
sequencing reads
Long Ranger®
Singel®
Packs – convenience and safety in
casting gels
MDE®
Mutation Detection gels
Sequencing Buffers
GelBond®
Film supports for agarose and acrylamide gels
Durable support for all gel processing steps
Available precut or in rolls
Thank You

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Lonza Bioscience Capabilities Overview

  • 3. slide 3 Table of Contents Lonza Bioscience Overview Research Products Biotherapeutic Media Products Rapid Microbial Detection Cell Therapy Bioservices
  • 4. slide 4 Lonza Bioscience Overview Lonza Bioscience provides a variety of products and services for life science research, quality control of pharmaceutical products for injection, cell culture media for bioprocessing and cell therapy services. We Are Specialists In:  Cell Culture  Cell Biology  Bioassays  Electrophoresis  Rapid Microbial Detection
  • 5. slide 5 Bioscience is crucial to therapeutic innovation
  • 6. slide 6 Lonza Bioscience Service & Support Customer Service  US: Customer Service in Walkersville, MD and Rockland, ME  Europe: Customer Service in Belgium, Spain, Italy and England  Phone Service M-F, 8:00am - 6:00pm  E-Commerce, 24/7 Technical Services Group  US and Europe  Provide technical assistance and information  Product experts  Manage product testing, investigations and Material Review Board
  • 7. slide 7 Lonza Bioscience Quality Systems Our entire staff is dedicated to maintaining the highest compliance standards in the industry including: All necessary requirements for cGMP compliance QA review and approval of manufacturing documents Comprehensive internal audit program Raw materials release Vendor audit and qualification programs Reviewing and approving all product labeling and documents associated with manufactured products based on FDA, EU and/or other current applicable regulatory guidelines Coordination of Corrective and Preventive Action Programs (CAPA) Liaison to regulatory agencies and client Regulatory support
  • 8. slide 8 Research Products Overview  Products and Services for Life Science Research  Over 75 years of experience in cell culture:  Primary Cells  Classical Media & Sera  Serum-Free Media  Cell Therapy  Integrated Platform of Cells, Media and BioAssays  Over 40 years of experience in electrophoresis  Agarose and Precast Gels  Protein Precast Gels  Basic manufacturer of >95% of offerings
  • 9. slide 9 Research Products Overview (continued)  Customers include:  Academic and government institutions  Research hospitals and medical schools  Biotechnology companies  Pharmaceutical companies  Global presence  Direct sales in 18 countries  Distributors throughout the world  Dedicated Technical Service
  • 10. slide 10 Cell Biology Overview Leader in primary cells and media systems State-of-the-art cell isolation laboratory Over 100 human and animal primary cell types available Proprietary growth and cryopreservation protocols Custom cell isolation capabilities Extensive sources and experience in ethical procurement of human and animal tissue We offer performance and convenience: We procure the tissue We isolate and qualify the cells We deliver the cells to you
  • 11. slide 11 Primary Cells & Media Clonetics® Cells and Media Systems Cells are non-immortalized, non-transformed and produced from normal tissue Advantages Greater relevance – no species extrapolation, alternative to animal testing, more relevant results High quality – standardized isolation protocols and extensive testing assure predictable results Outstanding performance – optimized media systems drive cell expansion yet maintain normal cell characteristics Convenience – we procure the tissue and perform the isolations under standardized, controlled conditions Trusted source – ethical, documented tissue acquisition and rigorous quality standards
  • 12. slide 12 Primary Cells & Media (continued) Available cyropreserved or as growing cultures Specialized media optimized for superior performance Human cells tested for HIV, Hepatitis B and C as well as for mycoplasma and sterility Products are quality controlled and issued with a certificate of analysis
  • 13. slide 13 Primary Cell Systems Offered Airway Cell Systems Bladder Cell Systems Endothelial Cell Systems Fibroblast Cell Systems Keratinocyte Cell Systems Mammary Epithelial Cell Systems Smooth Muscle Cell Systems Skeletal Muscle Cell Systems Human and Animal Neural Cell Systems Prostate Cell Systems Skeletal Cell Systems Hepatocyte Cell Systems Renal Epithelial Cell Model Blood Brain Barrier Model (Bovine)
  • 14. slide 14 Stem Cell Systems Poietics® Stem Cells and Media  Poietics® products include a collection of adult stem cells derived from the hematopoietic system and other tissues  Fresh or cryopreserved cells are available from bone marrow, G-CSF mobilized peripheral blood, cord blood, and fetal liver  Obtained through Institutional Review Board approved donor programs  Optimized media are available for growth and differentiation  Highly purified populations from proprietary positive and negative selection protocols  All products are quality controlled and issued with a certificate of analysis
  • 15. slide 15 Stem Cell Systems (continued) Preadipocyte Cell and Media Systems Visceral Preadipocytes Subcutaneous Preadipocytes Osteoclast Precursors Neural Progenitor Cells and Media Human Bone Marrow Mononuclear Cells from multiple sources Hematopoietic Progenitors from multiple sources Erythroid Progenitors Mesenchymal Stem Cell System Immune System Cells and Media CD14+ Monocytes Stromal Cells from Human Bone Marrow Quadratox™ 4 Species Panel
  • 16. slide 16 Custom Cell Isolation Custom Cell Isolation Services Extensive experience with multiple human and animal cell types Broad sourcing capabilities Packaged to your unique specifications: Cell count Pre-seeded multi-well plates Pre-seeded flasks Cryopreserved Customized treatments available: Cell pellets Specialized media Customer specified cell treatment
  • 17. slide 17 Cell Culture Broadest range of cell culture applications Bench research High throughput screening Production of biological therapeutics Production of cell therapy products Production of diagnostic tests Cell culture products are manufactured under cGMP protocols Production is controlled from raw materials to finished goods All products are manufactured with WFI (water for injection) quality water Media is sterile filtered using pharmaceutical-grade filters (USP or EP sterility) Sold as BioWhittaker™ brand
  • 18. slide 18 Specialty Media Serum-free, protein-free, chemically defined and NAO media Advantages of specialty media formulations Increased lot-to-lot consistency Simplified purification and downstream processing Better control over physiological conditions of cultures Ability to optimize formulations for specific cell types
  • 19. slide 19 Specialty Media (continued) Media systems are available to optimize performance in: CHO cells (PowerCHO™, ProCHO™, and UltraCHO™ media) Immune cells (X-VIVO™ media) Kidney cells (UltraMDCK™, Pro293™, and ProVero™ 1 media) Insect cells (Insect-EXPRESS™ medium) Hybridoma cells (HL-1™, UltraDOMA™, and ProDoma™ media) ES Cells (X-VIVO™ media + growth factors) General purpose serum-free media UltraCULTURE™, PC-1™, and UltraMEM™ media Other applications (available in Europe only) Karyotyping, Cytogenetics, In-vitro fertilization
  • 20. slide 20 Classical Media Broad range of standard media used for many cell culture applications Manufactured with Tissue Culture Association formulas Manufactured under cGMP protocols Prepared with WFI water Available in liquid or powder formulations Tests performed Sterility pH and Osmolality Cell Growth Promotion on three cell types (primary, diploid, heteroploid) Endotoxin
  • 21. slide 21 Cell Culture Reagents Tissue culture grade products including amino acids, antibiotics, buffers Prepared with WFI water Manufactured under cGMP protocols Products include: Buffers Balanced salt solutions Antibiotics Cell harvesting reagents
  • 22. slide 22 Animal & Human Sera Animal sera is collected from USDA inspected abattoirs in the 48 contiguous states or from USDA certified sources outside of the United States US sourced sera are processed using dedicated tanks and equipment Human sera is obtained from donors who test negative for hepatitis B and C, HIV 1 and 2 Sera products are manufactured with cGMP protocols
  • 23. slide 23 Animal & Human Sera (continued) Sera are tested for: Mycoplasma Adventitious virus (animal sera) Sterility Endotoxin Hemoglobin (animal sera) pH and Osmolality Biochemical profile (animal sera) Growth promotion (animal sera) Products include:  Fetal Bovine Serum  Newborn calf serum  Calf serum  Donor calf serum  Equine serum  Human serum
  • 24. slide 24 BioAssays Cell health and cytotoxicity assays Mycoplasma detection assays Cell function assays Cell analysis reagents HTS (high throughput screening) assays Enzyme assays GPCRs Conditionally immortalized cells Unique, sensitive assays based on luminescence and fluorescence…
  • 25. slide 25 BioAssays (continued) Cell health and cytotoxicity assays ViaLight® Cell Proliferation and Cytotoxicity Bioassays ToxiLight® Non-Destructive Cytotoxicity Bioassay ApoGlow® Rapid Apoptosis Screening Kit Mycoplasma Detection Assay MycoAlert® Mycoplasma Detection Assay Kit - Unique 20 min assay for mycoplasma contamination detection in cell cultures
  • 26. slide 26 BioAssays (continued) Cell Function Assays OsteoLyse™ Assay (Collagen) OsteoAssay™ Human Bone Plate Cell Analysis Reagents Fluorescent stains for cell organelles, cell structural elements, and cell tracking
  • 27. slide 27 BioAssays (continued) Unique products for cell biology research Transport™ Protein Delivery Reagent HTS screening assays PKLight® HTS Protein Kinase Assay Kit PDELight® HTS cAMP Phosphodiesterase Assay Kit G Protein-Coupled Receptors Rapidly expanding list of newly de-orphanized GPCRs Clonetics® Conditionally Immortalized Cells Primary cell performance with telomerase technology
  • 28. slide 28 Molecular Biology Overview Integrated platform gels, reagents and buffers for superior separation of macromolecules “Ready-to-use” products for protein and nucleic acid separation Pre-cast gels for nucleic acid electrophoresis Pre-cast gels for protein electrophoresis Manufacturer of agarose and agarose derivatives for next generation chromatography products and large scale protein purification World renowned brands in electrophoresis: SeaKem® LE Agarose Reliant ® Precast Gels PAGEr® Gold Gels Long Ranger® Sequencing Solutions GelBond™ Film
  • 29. slide 29 Nucleic Acid Electrophoresis We provide: The best known and most widely cited agarose brands – SeaKem® , NuSieve® and MetaPhor® We are the inventor and the sole innovator in agarose technology for the past 40 years We use the most stringent requirements in our manufacturing – FDA and ISO 9001/2000 certifications Precast Reliant® and Latitude® Gels Precast RNA Gels RNA & DNA markers and ladders Nucleic acid stains Electrophoresis Buffers
  • 30. slide 30 Protein Gel Electrophoresis High performance protein electrophoresis products optimized to deliver sharp resolution, superb sensitivity and fast, convenient separations We provide: PAGEr® Gold Precast Protein Gels Protein stains Protein markers Electrophoresis buffers
  • 31. slide 31 Sequencing Superior sequencing performance matched with unique packaging convenience Long Ranger® acrylamide gel solutions for longer sequencing reads Long Ranger® Singel® Packs – convenience and safety in casting gels MDE® Mutation Detection gels Sequencing Buffers GelBond® Film supports for agarose and acrylamide gels Durable support for all gel processing steps Available precut or in rolls