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ProCLD Cell Line Development Services

Gene to Top 6 clones in 14 weeks

Gene to Top 1 clone in 18 weeks

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 ProBio 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

Get to Know GenScript ProBio ProCLD Cell Line Development Services

GenScript ProBio 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

Key technology driver
- Proprietary CHOK1-GenS
- Proprietary GenHT 1.0 expression vector
- High throughput clone selection: VIPS, Cellmetric, Cloneselect
Accelerated timeline
- Gene synthesis to
  Top 6 clones in
  14 weeks
- Gene synthesis to
  Top 1 clones in
  18 weeks
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
- >300 cell lines developed
- >80 projects for IND filing
- 3 in clinical stage
  - 2 in clinical phase 1, 1 in clinical phase 2

GenScript Probio Has Rich Experience in Cell Line Development

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 ProBio's cell line perform well from 2L to 200L scale.

Case Study: Developability Assessment

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 T_day0 and T_end
Stability	Analytical methods	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.

ProCLD Cell Line Development Service Offerings

	PreCLD	ProCLD	ProCLD Plus
Service details	Cell pool development & deveopability assessment	Cell line development PCB & PCB stability	Cell line development Feed & medium selection Bioreactor performance evaluation
Application scenario	Generate materials for animal studies in the same host cell and vector system as CMC Evaluate the developability of drug candidates	Preclinical CMC development
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	pUC57 plasmidCryopreserved cells (3 cell pools) Delivery to client or stored in GenScript ProBio Cell pool development report	12
	Cell pool screening
	Cell cryopreservation
Basic Developability Assessment	40℃	Report: Tagg/onset, concentration, purity profiles	6-8
Basic Developability Assessment	Low pH 3.5	Report: Tagg/onset, concentration, purity profiles	6-8
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	Plasmid construct map; Stable cell line development final report; 6 PCB	14
	Cell pool screening
	Cell clone screening
	Fed-batch evaluation
	PCB generation
	PCB 60 generation stability study	Report of stability study	14-15
ProCLD plus Cell Line Development	Media & Feed screening & ambr 15 mini bioreactor clone evaluation	Top 1 clone and a back-up clone Report	4

ProCLD Cell Line Development Workflow

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