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 days |
|
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 |
Sample Name | main peak % | LMW % | Total % |
---|---|---|---|
Positive control | 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 |
Sample Name | main peak % | LMW % | HMW % | Total % |
---|---|---|---|---|
Positive control | 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 |
Sample Name | Acidic component % | Main component % | Basic component % | Total % |
---|---|---|---|---|
Positive control | 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 |
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 |
Chinese hamster ovary (CHO) cell lines are derived from the ovary of adult, female Chinese hamsters. CHO cells were first established in 1957 by T. Puck, and were subsequently multiplied and optimized in vitro, allowing it to be cultured indefinitely. The CHO-K1 cell line was derived as a subclone from that parental CHO cell line. They are typically the preferred host expression system for recombinant antibodies due to their advantages in producing complex therapeutics and manufacturing adaptability.1
One of the key advantages of CHO cells is their ability to produce complex proteins that are human-compatible, with post-translational modifications, such as glycosylation. This feature increases therapeutic efficacy, protein longevity, and reduces safety concerns. Furthermore, CHO cells are highly stable, having a high tolerance for fluctuations in temperature, acidity (pH), oxygen, and cell density. This adaptability makes them suitable for large-scale manufacturing, and the product can be delivered in up to several grams per liter.2
Stable expression involves the integration of the gene of interest into the genome of the host cell line, allowing for long-term, heritable expression. This is typically achieved by using viral vectors or plasmids containing the gene of interest and a selectable marker (e.g., antibiotic resistance gene) to facilitate the selection and isolation of cells that have successfully integrated the gene.
Transient expression involves the direct introduction of the gene of interest into the host cells without integration into the genome. This is usually achieved through methods like transfection or electroporation.
The use of either depends on your research goals. Typically, for long-term studies or consistent gene expression across multiple experiments, stable expression is preferred. But for quick screening or short-term experiments, transient expression can be more suitable.
There is an increasing number of recombinant antibodies being developed as therapeutic agents, with about 40 new antibody molecules undergoing clinical trials every year, most of which are produced from CHO cells.3,4 For instance, TZ mAb is a therapeutic antibody that was expressed by CHO cells and is specific for the human epidermal growth factor receptor 2 (HER2).