Cell line development matters
Cell line development plays an essential role in drug development. It is the bridge connecting drug discovery and development, more over a good cell line development service can always save your valuable time and lower your final cost.
GenScript ProCLD cell line development services will provide you the cell lines with accelerated timeline, high quality delivery and extensive understanding of drug development to help you get your own success.
Fig. Significance of Cell Line Development in Drug Development
GenScript helps you develop stable, high quality cell lines with accelerate timeline. Our traceable CHOK1-Gens is available for multiple use: monoclonal antibody development, bispecific antibody development, recombinant protein development, fusion protein development, etc.
Summary of our service features
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Key technology driver
- Proprietary CHOK1-GenS
- Royalty-free
- Path to comm ercialization
- Proprietary GenHT 1.0 expression vector
- High throughput clone selection: VIPS, Cellmetric, Cloneselect
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Accelerated timeline
- Gene synthesis to
Top 6 clones in
14 weeks - Gene synthesis to
Top 1 clones in
18 weeks
- Gene synthesis to
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High quality delivery
High Quality
- Productivity prior to cell culture, for mAb
- Guarantee: 3g/L
- Up to: 8g/L
- Excellent stability in 60-90 generations
Regulatory Compliance
- Traceable records for host cell and vectors
- Traceable records for cell line development
- Cell image to demonstrate monoclonality
- Productivity prior to cell culture, for mAb
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- >300 cell lines developed
- >80 projects for IND filing
- 2 in clinical stage
- 1 in clinical phase 1, 1 in clinical phase 2
ProCLD cell line development service has shown great performance both in stability and productivity , see below figures for more information.
Fig. Titer at day 13 in Fed-batch culture using platform feeding strategy, without optimization
Fig. GenScript's cell line perform well from 2L to 200L scale.
Cell pool evaluation
| Candidates | Cell pool Titer /mg/L |
|---|---|
| A | Middle |
| B | Middle |
| C | High |
Developability: Candidate C was chosen and finally succeed in CMC.
| Stability | Analytical methods | Changes from Tday0 and Tend | |||
|---|---|---|---|---|---|
| Candidate A | Candidate B | Candidate C | |||
| Free-thawn | Appereance | Remain the same | Remain the same | Remain the same | |
| Stressful (40℃ & 2 weeks) | Appereance | Remain the same | Remain the same | Remain the same | |
| CE-SDS-NR | Decrease ca.10% | Remain the same | Remain the same | ||
| SEC-HPLC | Remain the same | Remain the same | Remain the same | ||
| PTM by MS | ~ 10% deamidation (not CDR) | ~ 10% deamidation (not CDR) | ~ 5% Oxidation (not CDR) | ||
| cIEF | Acidic and basic increased | Main peak changed | Acidic and basic increased | ||
| Bioactivity | Remain the same | Remain the same | Remain the same | ||
| Acidic condtion (pH3.5 & 25°C & 4h) | Appereance | Remain the same | slight suspension | slight suspension | |
| SEC-HPLC | Decreased ca. 70% | Decrease ca.40% | Decrease ca.5% | ||
| PTM by MS | ~ 10% deamidation (not CDR) | ~ 20% Oxidation (CDR) | Remain the same | ||
| cIEF | Remain the same | Main peak changed | Remain the same | ||
| Bioactivity | Remain the same | Decreased | Remain the same | ||
PreCLD cell pool and developability assessment help to identify the potential developability risk and help to select the CMC candidates.
| PreCLD | ProCLD | ProCLD Plus | |
|---|---|---|---|
| Service details |
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|
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| Application scenario |
|
|
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| Titer for mAb | Guaranteed>1 g/L | Guaranteed >3g/L Up to 8g/L |
Guaranteed >4g/L Up to 8g/L |
| Turnaround time | 12 weeks | 14 weeks | 18 weeks |
PreCLD Cell Pool Package
| Service | Service Content | Deliverables | Timeline (week) |
|---|---|---|---|
| PreCLD Cell Pool Development | Gene synthesis & plasmid preparation |
|
12 |
| Cell pool screening | |||
| Cell cryopreservation | |||
| Basic Developability Assessment | 40℃ | Report: Tagg/onset, concentration, purity profiles | 6-8 |
| Low pH 3.5 | |||
| Premium Developability Assessment | 40℃ | Report: Tagg/onset, concentration, purity profiles, charge variant profiles | 6-8 |
| Low pH 3.5 | |||
| freeze-thaw |
ProCLD Cell Line Development Package
| Service Content | Deliverables | Timeline (week) | |
|---|---|---|---|
| ProCLD Cell Line Development | Gene synthesis & plasmid preparation |
|
14 |
| Cell pool screening | |||
| Cell clone screening | |||
| Fed-batch evaluation | |||
| PCB generation | |||
| PCB 60 generation stability study |
|
14-15 | |
| ProCLD plus Cell Line Development | Media & Feed screening & ambr 15 mini bioreactor clone evaluation |
|
4 |
Our customer service representatives are available 24 hours a day, Monday through Friday to assist you.
