AAV 解析 QC サービス
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同一性、純度、力価、安全性の包括的試験
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規制要件に準拠したカスタム検証済みアッセイ
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GMPグレードの品質管理および出荷サポートによる迅速な対応
主な利点
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包括的な試験
純度（じゅんど）, 有効性（ゆうこうせい）, 安全性（あんぜんせい）, 不純物（ふじゅんぶつ） -
お客様のニーズに合わせたカスタムアッセイの開発
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規制遵守（きせいじゅんしゅ）
フェーズに適したリスクのための適格で検証されたアッセイ -
品質管理
GMPバッチのための事前定義された出荷基準 -
迅速な対応
迅速対応型ソリューション -
同定、純度、有効性、安全性に対する深堀りした分析サポート
サービスの詳細
PackGene offers comprehensive services for the development, optimization, validation, and implementation of quality control assays tailored to your specific project needs. Our assay services include:
- Development: We design assays to confirm critical quality attributes (CQA) based on Quality by Design (QbD) principles, determining necessary instrumentation, reagents, and performance parameters.
- Optimization: Experiments are conducted to confirm method parameters under various sample conditions, with data used to establish acceptance criteria for rapid service.
- Validation: We rigorously validate assay protocols, documenting performance in terms of accuracy, linearity, detection limits, specificity, precision, and suitability, with potential inter-laboratory comparisons.
Assays are re-evaluated regularly to ensure performance consistency, and methods are updated as technologies evolve or regulatory requirements change. For a quote or technical advice, please provide specific project details.
Contact us
PackGene provides a wide range of off-the-shelf characterization assays for immediate use, ensuring a quicker turnaround for your project.
| Assay | Methods |
|---|---|
| Titration & Genome Integrity | AAV Genome Titration -ddPCR |
| AAV Capsid Titration Infectious Titer -TCID50 | |
| AAV Genomic Integrity -CE | |
| AAV Genomic Sequencing -TGS | |
| AAV Identity by Sanger sequencing | |
| Alkaline Gel Electrophoresis | |
| Capsid characterization, purity, aggregation | AAV Empty Capsid Rate -AUC |
| TEM (5 pictures) +report | |
| DLS (Dynamic light scattering) | |
| AAV Capsid Peptide Mapping | |
| Capsid Protein Molecular Weight and Ratio | |
| Capsid purity Analysis -SDS-PAGE | |
| Capsid purity Analysis -CE-SDS | |
| Purity Analysis -AEC-HPLC | |
| Purity and Aggregation Analysis -SEC-HPLC | |
| Contamination | Residual Host HEK293 Cell DNA Quantification |
| Residual HEK293 Host Cell DNA | |
| Residual Plasmid DNA | |
| Residual E1A | |
| Residual Host Cell Protein | |
| Residual BSA | |
| Residual Nuclease | |
| Residual Affinity Ligands | |
| Residual PEI | |
| Residual Tween20 | |
| Residual Triton X100 | |
| Residual Iodixanol | |
| Residual Poloxamer 188 | |
| Residual Triton Analysis | |
| Safety | Endotoxin removal |
| Sterility test | |
| Mycoplasma detection | |
| Endotoxin test | |
| Quantitative Endotoxin test | |
| Bioburden Test | |
| Mycoplasma detection by qPCR | |
| Replication Competent AAV (rcAAV) Analysis |
見積もり依頼
PackGene による機密保持の約束：
ご提出いただいた情報は厳重に機密に保持されます。PackGene は、第三者または関係者に開示することは一切なく、提出者からの要請に基づき、機密保持条件下でプロジェクト評価や進捗レポートにのみ使用します。