Lonza Bioscience

Merck Boston

Ernie Desmarais 8/21/07

Lonza Bioscience Capabilities

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Table of Contents

Lonza Bioscience Overview Research Products Biotherapeutic Media Products Rapid Microbial Detection Cell Therapy Bioservices

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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

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Bioscience is crucial to therapeutic innovation

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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 onluminescence and fluorescence…

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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

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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

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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

KitG Protein-Coupled Receptors

Rapidly expanding list of newly de-orphanized GPCRs

Clonetics® Conditionally Immortalized Cells Primary cell performance with telomerase

technology

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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

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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

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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

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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