View
229
Download
0
Category
Preview:
Citation preview
Sartorius Stedim CellcaCustom Cell Line & Process Development for Pharmaceutical Purposes May 2017
Overview of Contents
2
Cellca History
Overview: Cellca Technology Platform
3
4
Products & Services
2
Key Parameters: Why Cellca?
1
5 Contact Information
Cellca History
3
2012-2015
20152005-2010
2010-2012
• Founded by Dr. Cayli• Focus: R&D,
integrate molecular& cellular biologywith process know-how
• ProductDevelopment
• Building Infrastructure
• First technologytransfer
• Growing thecompany & customer base
• Completed 48 projects
• Improving theplatform & performance
• Growinginternationally asa part ofSartorius group
Overview: Cellca Technology Platform
4
Host cellline
Expression Vector
UpstreamProcess Design
Media System
Host Cell Line: CHO DG44 growth in suspension, 18 h doubling time, long term stability
Expression Vector: DHFR selection system, low DHFR expression, S/MAR elements, optimal signal peptide
Media System: Optimized, chemically defined, free of animal components, proteins & peptones, high cell densities, viabilities & productivity
Upstream Process Design: robust, easy to scale, provenperformance in various bioreactor systems
Cellca
Cell Line Development
Process Transfer
GMP Production
Downstream Processing
Fill & Finish
Process Development
CMO/Client
Products & Services
5
FEE FOR SERVICE
Our service is divided into individual work packages starting from DNA synthesis to RCB generation, stability studies, or process confirmation in lab-scale bioreactors.
TECHNOLOGY PLATFORM LICENSING
Technology transfer to enable in-house generation of high producing cell lines
MEDIA SUPPLY All parts of the media system are completely chemically defined and optimized for the different stages. They are commercially available.
Key Parameters: Why Cellca?
6
Speed
Performance Customer Focus
Track Record
Scalability
7
From DNA to RCB within 4-5 months.
No need for media and process development. Save up to 3 months by omitting scalability studies!
Speed
Vector Cloning Transfection and Pool Generation Single Cell Cloning Clone Evaluation RCB Preparation
From DNA to RCB in 4 to 5 months
8
Scalability
Cellca technology platform was developed from scratch specifically for the industrial production
Focused development at Cellca lead to a process providing:
Direct and robust scale-up to production scale
No need for scalability studies
9
Scalability
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
0
50
100
150
200
250
0 1 2 3 4 5 6 7 8 9 10 11 12
Pro
du
ct co
nc. [
g/L
]
Via
ble
Ce
llC
on
c. [ 1
05/m
L]
Via
bili
ty[%
]
Time [ d ]
Comparison VCC, Viability, Product conc. - 25-mL, 5-L & 1000-L
SF 25-mL VCC BIR 5-L VCCSUB 1000-L Xcellerex VCC SF 25-mL ViabilityBIR 5-L Viability SUB 1000-L Xcellerex ViabilitySF 25-mL Product BIR 5-L ProductSUB 1000-L Xcellerex Product
VCCViability
Viability
10
Performance: Titer
Efficient cost reduction by achieving steadily productivities of 3g/L or more
Cost reduced by 50% by omitting media and process optimization
0
100
200
300
400
500
600
700
800
900
1 2 3 4 5 6 7 8 9 10
Cost of Goods €/gClone distribution Cellca*95%; ≥ 3 g/L
11
Performance: Quality
Targeted modification of quality attributes (e.g. glycosylation pattern)
Application for biosimilars
Scalability of modifications
Cellca Track Record (March 2016)
12
>40 cell lines built to date Small, Medium and
Big Pharma US, EU, Asia
Customers 60% returning
customers
95% express 3 g/L or more
Monoclonal Antibodies (IgG1, IgG4, IgG2)
Fusion Proteins
Fab-related products
Bispecifics
Biosimilars
Applications:
NBE
Biosimilar projects
Replacement E. coli
Productivity Improvement
Track Record
2 g/L 3 g/L 4 g/L 5 g/L 6 g/L
Pre-clinic &Phase 1 4 21 9 4 2
Phase 2 1 1 - - 1
Phase 3 1 - - - -
Market Approval - - - - -
13
DetailedDiscussions
F2F, TCs
Agreement by both
sides
Final proposal SLA
PROJECT:Committed project team & close contactwith Customer Order Manager:
Renate WestnerAlexander PietschmannHeike Mayer (Head of Team)
Customer Focus
Kick Off Data Packages Regular TCs
Scopechangespossible
Final report
PROPOSAL:Direct service and support byProduct Management Team:
Adelheid BurkhardtDr. Lucia Rieger
Benefits of Cellca Technology Platform
SPEED From DNA to high-titre RCB in 4-6 months. Save up to 3 monthsby omitting the need for scalability studies.
SCALABILITY Processes can be easily transferred and scaled-up to a range of bioreactors up to 1000L.
PERFORMANCE 95 % of our developed cell lines deliver protein titres exceeding 3 g/Lin a 12-14 day standard fed-batch process.
TRACK RECORD More than 40 successfully completed projects using the CellcaCHO Expression Platform.
CUSTOMER FOCUS Committed project teams and dedicated client manager’s make it their purpose to deliver service excellence and meet our clients requirements.
For more information on Sartorius Stedim Cellca’sCell Line Development services:
Contact us at www.biooutsource.com/contact-us/
Recommended