Reaction Biology
Reaction Biologyは、創薬研究から非臨床開発まで幅広く対応する米国発のグローバルCROです。キナーゼをはじめとする生化学的アッセイ、細胞試験、薬理、毒性、バイオアッセイなどを自社施設で受託しています。
Reaction Biologyの非臨床試験の受託サービスの特徴
豊富なキナーゼアッセイで候補化合物を評価
Reaction Biologyは、キナーゼ創薬に強みを持つCROです。ヒトキノームを対象とした広範なパネルを用いて、候補化合物の活性や選択性を評価できます。単一ターゲットのIC50測定から複数キナーゼを対象としたプロファイリング、ライブラリースクリーニングまで対応。HotSpot™や³³PanQinase™などの放射性アッセイを利用し、キナーゼの触媒活性を直接測定しています。
GLP対応の毒性試験とGMPバイオアッセイ
GLPに対応した非臨床毒性評価にも対応しており、ドイツ・ハイデルベルクの施設ではGLP toxicologyやOECDガイドラインに基づく試験を実施しています。また、同施設ではGMP potency assayやfunctional bioassayも提供。GLP/GMP Certificateを取得した施設で、バイオ医薬品の有効性・安全性評価や品質管理を支援しています。
創薬初期からIND申請を見据えた評価まで対応
生化学的アッセイだけでなく、細胞ベースアッセイ、in vivo薬理、PK/PD、安全性薬理などを組み合わせた非臨床評価が可能です。米国とドイツに複数の研究拠点を持ち、IND申請につながった研究実績も蓄積しています。GLP/GMP対応サービスに加え、IND/CTAを見据えた分析サポートも提供しており、候補化合物の選定から開発段階への移行まで支援できる点が特徴です。
Reaction Biologyが保有する病態モデル一例
Reaction Biologyでは、がん領域を中心としたin vivo薬効評価モデルを保有しています。Hershey施設では、xenograft、syngeneic、orthotopicなどの腫瘍モデルに対応。Freiburg施設でもin vivo efficacyやimmuno-oncologyモデルを用いた評価を行っています。
Reaction Biologyの非臨床試験事例
MEK阻害薬の3D細胞パネル評価
Reaction Biologyでは、3D ProLiFiler™ Spheroid Cancer Cell Panelを用いてMEK阻害剤を評価した事例を公開しています。2D培養と3Dスフェロイドで薬剤の作用を比較したところ、3D環境では臨床で使用されるMEK阻害剤の活性が高く示されました。細胞の立体的な環境を考慮した候補化合物評価の一例です。
Reaction Biologyの企業情報
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise
In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
- SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
- From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.
- With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
- Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
- The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
- Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
- PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
- With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
- The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
Japanese