Download - LakePharma General Technical Overview
GENERAL TECHNICAL OVERVIEW
Dec., 2016
CONFIDENTIAL
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Company mission is to provide industry-leading protein engineering and biomanufacturing services
Biologics company focusing on providing integrated solutions
Founded in 2009 and based in San Francisco Bay Area
Named as an Inc. 5000 Fastest Growing Companies in 2015 and 2016
Named on San Francisco Business Times’ list of 100 Fastest Growing Private Companies in the Bay Area in 2016
Acquired Blue Sky BioServices (Worcester, MA) in March 2016
~100 employees, 30% have PhDs
LakePharma is the largest US-based biologics CRO, with most complete capabilities
Introduction
CONFIDENTIAL
3LakePharma Bay Area Sites
UCB
UCSF
Stanford
21
3
1. Engineering SiteBelmont (15,000 sqft)
2. Development SiteSan Carlos (9,000 sqft)
3. Biomanufacturing Site Hayward (38,000 sqft)
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4LakePharma Worcester Site
Formerly Blue Sky BioServices
30+ employees
Clients include nearly every big pharma
Strong expertise in protein production in microbial and baculovirus expression systems
Major expansion of manufacturing operations planned for Massachusetts in 2018
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5Largest US Based Dedicated CRO Supporting Biologics R&D
Engineering Production Bioanalytical Bioactivity DevelopmentDiscovery
Molecular Engineering
BioExpression
BioProcessing
BioAnalytical
Protein Chemistry
BioFunction
Antibody Engineering
AntibodyDiscovery
Assay Services
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6Antibody Discovery
Custom immunogen preparation
UberCell™ immunizations for functional mAbs against
membrane targets displayed in native conformation
DNA based or rapid protein based RIMMS immunizations
Strategies for breaking tolerance enabling cross reactivity
and strong response to conserved targets
Proprietary myeloma line for high fusion efficiency
384 well screening of hybridomas
Incorporation of functional assays in screening cascade
Delivery of clonal, functional, purified mAbs along with V-
region sequences, hybridomas, and functional data
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7Antibody Engineering
High throughput gene synthesis and cloning
Antibody variable region cloning
Sequence liability analysis
Antibody reformatting
Custom library construction and screening
Immune library screening
Antibody humanization
Affinity maturation
Antibody affinity and functional assays
Thermostability engineering
de novo antibody sequencing
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8Molecular Engineering
Gene synthesis and molecular
cloning
High throughput cloning
Plasmid design & construction
Ligation cloning
PCR cloning
Site Mutagenesis
Gateway cloning
Custom cloning
DNA sequencing & analysis
Plasmid DNA production
Gene expression and copy
number analysis
Absolute and relative qPCR
SNP genotyping, genomic
sequencing
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9BioExpression
Multiple Expression Systems
Expression construct generation
Expression optimization
Endotoxin-free plasmid DNA scale up
Protein & Antibody production
Mammalian Expression
Baculovirus Expression
Yeast Expression
Bacterial Expression
Protein purification
Polishing and formulation Elution profile and CE-SDS
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10BioProcessing
Stable cell line generation
Process development
Optimization of cell culture and purification conditions
Scale up production
WAVE or single-use bioreactors
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11Protein Chemistry
Custom protein purification
Proteolytic cleavage and polishing
Biotinylation
Protein conjugation to beads
Protein conjugation to fluorophores
SDS-PAGE
kDa
190
15
115
25
80
30
50
70
10
NR R NR R
Un-cleaved Cleaved
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12BioFunction
Affinity measurement by Biacore
Affinity measurement by Octet
ELISA
Western (traditional and automated)
FACS
ADCC & CDC
Biochemical assays
Cell-based reporter gene assays
Cell proliferation assays
Octet
FACs
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13BioAnalytical
CE-SDS profiling
SEC-HPLC, RP-HPLC, IEX-HPLC profiling
Intact mass profiling
MS sequence confirmation and PTM analysis
de novo antibody sequencing
Glycosylation analysis
DLS, DSC & DSF
Stability analysis
Release assay development and validation
DSC
cIEF
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14Pharma Assay Development & Screening – East Coast
Cell-based Assays
Primary and Differentiated Cell Assays
High content screening
Small Molecule Cytotoxicity – HepG2
Cytokine Stimulation and Release
Flow Cytometry and FACS
Platforms
Meso Scale Discovery Sector S 600
BMG PHERAstar
Cellomics Cell Insight Reader
Standard data turnaround 5 days
Biochemical Assays
SPA-based Workflows
Radioligand binding
Fluorescence
FP, HTRF, FRET, TR-FRET
Luminescence
ELISA
qPCR
Fully Customized Assay Design and Development
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15LakePharma Provides Integrated Solutions
Our technical capabilities cover the entire spectrum of biologics development and analytics
We can take drug program from idea to lead to stable cell line to a formulated protein
construct optimization
Antibody engineering
Stable cell line generation
Cell killing assay
Affinity measurement
Cell culture process development
Purification process development
Research cell bank
Antigen engineering
FACS
Glyco-profling
Peptide map
Tm
SEC
Intact mass
Bispecific antibody
polishing
construct design
WAVE production
DNA cloning
cIEF
stability
formulation
AE AD
ME
PC
BEBF
BP
BA
Conjugation
Immunization
Hybridoma campaign
Transient production
ADCC, CDCReporter gene assay
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16Integrated Solutions Example
Bispecific antibody engineering program
Antibody engineering and production
Functional assays (cell binding, cell killing)
Biacore to observe dual binding
Stable cell line generation (RCB)
Bioanalytical characterization
Purification process development
Formulation and stability studies
Transfer to client or CMO
AE AD
ME
PC
BEBF
BP
BA
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17Track Records
Contributed to multiple IND filings
12 publications in peer-reviewed journals
>30,000 DNA plasmids constructed
>12,000 proteins produced
>500 CHO stable cell lines made
Our collaborators:
Harvard University Stanford UniversityU.S. Department of
Veterans Affairs
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18We take pride in our Client Services
Highlights
Integrated platforms support projects throughout the drug discovery process
Dedicated client services
Sophisticated software tracks and reports progress internally and externally
Clients are in control of their projects 24/7
Quality assurance and quality control steps in place
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19Our capabilities are YOUR capabilities. Our results are YOUR results.