Anapharm Bioanalytics (formerly: Anapharm Europe)
本記事では、豊富な経験を有するチームと先端技術を備えたラボを保有するAnapharm Bioanalyticsを紹介しています。同社が対応している非臨床試験の特徴や強み、これまでの事例などについて調査してまとめています。
Anapharm Bioanalyticsが請け負う非臨床試験
技術力と豊富な分析メソッド
Anapharm Bioanalyticsは、LC-MS/MS機器をはじめとする充実した設備を備えており、低分子から高分子まで幅広い生体試料分析を提供しています。30年以上の経験を持つ同社では、前臨床からフェーズ3、生物学的同等性試験までワンストップでの対応が可能となっています。また、ピコグラム未満の高感度アッセイなど複雑な分析に強みを持ち、多数の検証済みメソッドを保有する技術力を提供しています。
国際基準を満たす厳格な品質保証
品質を非常に重視しているAnapharm Bioanalyticsでは、GLP（優良試験所基準）およびGCP（医薬品の臨床試験の実施の基準）に準拠した試験を実施しています。同社の品質保証ユニットは業界で豊富な経験を有するディレクターが率いており、ガイドラインの厳格な遵守に加え、継続的なモニタリングやプロセスの改善、スタッフの研修を行うことにより、研究データの品質を確保しています。
顧客との透明性の高いコミュニケーションを重視
Anapharm Bioanalyticsは「顧客第一主義」を掲げており、透明性が高く効果的なコミュニケーションを大切にしている点が特徴です。各プロジェクトには専任の試験責任者（Study Director）が配置されています。迅速な支援と定期的な進捗報告を提供しており、それぞれのプロジェクトを通じ、顧客の要件を満たしています。
Anapharm Bioanalyticsが保有する病態モデル一例
生体試料の分析を実施
Anapharm Bioanalyticsは、生体試料分析に特化した分析CROであることから、特定の動物病態モデルの販売や提供は行っていません。顧客より依頼のあった血液などの生体試料を受け取った上で、自社で保有するラボにて直接分析を行う形で非臨床開発をサポートしています。
Anapharm Bioanalyticsの非臨床試験事例
設立から20年以上にわたる長年の実績
Anapharm Bioanalyticsは長年の実績がある点が特徴といえます。スポンサーの機密保持のため具体的な化合物名は公開されていませんが、設立から20年以上にわたって新規の低分子・高分子医薬品の非臨床TK（トキシコキネティクス）試験や、バイオマーカー測定における分子メソッド開発・バリデーションを成功させてきた豊富な実績を持っています。
Anapharm Bioanalyticsの企業情報
| Address |
Encuny 22, 2nd floor, 08038 Barcelona, Spain |
| Tel |
+34 93 223 86 36 |
| Website |
https://www.anapharmbioanalytics.com/ |
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