サービス概要
細胞株の生成は、医薬品開発プロセスにおいて重要な役割を果たします。産業の要求を満たすリコンビナントタンパク質や抗体のための細胞株を効率的に生産することは、貴重な時間を節約し、総合的なコストを削減することができます。
Biointronでは、ECACCライセンスの付与を受けたCHO-K1細胞を用い、専門的な細胞株開発サービスを提供しています。経験豊富なチームが、高収量の細胞株を迅速に作成し、お客様の後工程のCMC開発ニーズに合わせてカスタマイズします。
細胞株の生成は、医薬品開発プロセスにおいて重要な役割を果たします。産業の要求を満たすリコンビナントタンパク質や抗体のための細胞株を効率的に生産することは、貴重な時間を節約し、総合的なコストを削減することができます。
Biointronでは、ECACCライセンスの付与を受けたCHO-K1細胞を用い、専門的な細胞株開発サービスを提供しています。経験豊富なチームが、高収量の細胞株を迅速に作成し、お客様の後工程のCMC開発ニーズに合わせてカスタマイズします。
| ステップ | 詳細 | 作業時間 | 納品 | |
|---|---|---|---|---|
| 細胞株開発 | ||||
| 遺伝子合成と一過性発現 |
|
2-3週間 |
|
|
| 安定細胞プールを作成 |
|
8-9週間 | ||
| シグナルクローンの選択とスクリーニング |
|
8-9週間 |
|
|
| プライマリー細胞バンクの作成 |
|
～3ヵ月 |
|
|
| CHO-K1細胞レポート |
|
N/A |
|
|
| CHO-K1細胞サブライセンスサービス | ||||
| CHO-K1細胞サブライセンス |
|
3-5日 |
|
|
Single cell image system is applied to confirm the monoclonality. The yield of the final obtained clone A is 2.31 g/L.
The stability of clone A is also tested by assessing the doubling time of the cells, cell density and yield.
Three single clones were selected, and their yield was assessed using three different commercial media. The results are as follows:
| Subclone | Medium A (g/L) | Medium B (g/L) | Medium C (g/L) |
|---|---|---|---|
| 414203-N42-6-N1 | 3.19 | 5.5 | 2.63 |
| 414203-N42-7-N1 | 6.48 | 2.78 | 1.9 |
| 414209-N10-6-N1 | 7.82 | 9.02 | 7.72 |
Both reducing and non-reducing CE-SDS analyses were performed to assess the purity of these three clones after one step of affinity purification. The results indicated >97% purity.
R-CE-SDS
| Sample Name | main peak % | LMW % | Total % |
|---|---|---|---|
| Positive control (Pembrolizumab) | 99.1 | 0.9 | 100.0 |
| B414203-N42-6-N1 | 98.8 | 1.3 | 100.0 |
| B414203-N42-7-N1 | 98.5 | 1.5 | 100.0 |
| B414209-N10-6-N1 | 97.8 | 2.2 | 100.0 |
NR-CE-SDS
| Sample Name | main peak % | LMW % | HMW % | Total % |
|---|---|---|---|---|
| Positive control (Pembrolizumab) | 98.3 | 1.7 | 0.0 | 100.0 |
| B414203-N42-6-N1 | 94.6 | 5.4 | 0.0 | 100.0 |
| B414203-N42-7-N1 | 94.1 | 5.9 | 0.0 | 100.0 |
| B414209-N10-6-N1 | 93.3 | 6.4 | 0.3 | 100.0 |
CEX-HPLC analyses were performed to assess the charge of these three clones. The results indicated a similar main component% compared to the positive control for the first two clones. Additionally, the first clone (B414203-N42-6-N1) shows the most similar basic component%.
CEX-HPLC
| Sample Name | Acidic component % | Main component % | Basic component % | Total % |
|---|---|---|---|---|
| Positive control (Pembrolizumab) | 19.5 | 64.1 | 16.4 | 100.0 |
| B414203-N42-6-N1 | 16.0 | 69.7 | 14.3 | 100.0 |
| B414203-N42-7-N1 | 17.4 | 69.2 | 13.4 | 100.0 |
| B414209-N10-6-N1 | 18.1 | 44.6 | 37.3 | 100.0 |
Currently, we have sublicensed the CHOK1BN cell line to dozens of customers, and the status of some customers' projects is as follows:
| Customer | Type | CLD | PD | Pilot | Nonclinical | IND | Phase I | Phase II | |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Customer A | ADC | |||||||
| 2 | Customer G | R-vaccines | |||||||
| 3 | Customer H | Mab | |||||||
| 4 | Customer B | Mab | |||||||
| 5 | Customer C | Fab | |||||||
| 6 | Customer J | R-vaccines | |||||||
| 7 | Customer F | R-glycoprotein | |||||||
The development process typically takes approximately 3 months, encompassing gene synthesis, transient expression, stable pool generation, single clone selection, and primary cell bank generation.
Clients need to provide the gene sequence of the target protein or antibody. If the sequence is unavailable, Biointron offers gene synthesis services to obtain it.
Biointron utilizes ECACC-licensed CHO-K1 cells, known for their high productivity and stability, to develop stable cell lines tailored to client's specific needs.
Biointron employs rigorous quality control protocols, including clone screening, productivity assessment, and stability testing, to ensure the cell lines meet the highest standards.
Yes, Biointron can develop stable cell lines for a range of applications, including recombinant protein production, antibody production, and other therapeutic protein expressions.
Clients receive the developed stable cell line, along with detailed reports on development processes, quality control results, and any relevant assay data.
Yes, CHO-K1 stable cell lines are widely used in therapeutic protein and antibody production due to their proven regulatory compliance and scalability for commercial manufacturing.
Yes, Biointron uses advanced screening and optimization techniques to develop cell lines with high productivity, stability, and consistency, tailored to meet the demands of large-scale production.
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