ADC 製造
抗體-藥物結合 (ADC) 技術使用單株抗體 (mAbs) 將強效的高活性藥物成分 (HPAPI) 傳送至目標細胞。 然而,要發揮 ADC 技術的巨大潛力是極具挑戰性和複雜性的。先進的生產套件和專用設備是表徵分子並證明其純度、均勻性和穩定性的必要條件。有效地將獨特的腫瘤靶向 mAb 與強效的、殺死細胞的細胞毒性小分子藥物相結合,只是一個開始 - 要滿足 ADC 的製造需求,需要全面的產品組合,以及在小分子和大分子開發、製造和測試方面的廣泛專業知識。 |
相關技術文章
- ADCs are a fast-growing drug modality used as a cancer therapy. Learn more about the parts of an ADC, how bioconjugates work, and the ADC manufacturing process.
- Meta 描述:ADC 有效載體中間體,如 DOLCore ™、MAYCore ™ 和 PBDCore ™,可簡化最常用有效載體的有效載體合成:maytansine、dolastatin 和 PBD dimers。
- 查看殼寡糖 ChetoSensar™ 如何克服 ADC 溶解性挑戰的數據。
- 尋找在 ADC 製程中使用 Pellicon® Capsules 的最佳實務,以及在 ADC 製程中使用 Pellicon® Capsules 和 Pellicon® cassettes 的兩項研究資料。
相關產品資源
- Brochure: Biopharmaceutical and ADC Processing Portfolio
The document outlines the complexities of Antibody Drug Conjugate (ADC) development and emphasizes the expertise and integrated services offered to advance ADCs to market efficiently.
- White Paper: Know your ADC’s Critical Quality Attributes
The increased focus on cancer has led to the rapid development of antibody drug conjugates (ADCs), a highly effective class of oncology therapeutics with a projected global market value of $7.5 billion by 2025.
- White Paper: Commercializing Antibody-drug Conjugates: a CMO’s Journey
In this white paper, we outline how our organization used over 12 years of experience to establish commercial-scale ADC manufacturing capabilities.
- Poster: Efficacy Screening of Antibody-Drug-Conjugates by Surface Plasmon Resonance
The intro details the complexity and challenges in characterizing antibody-drug conjugates (ADCs) and the factors influencing their effectiveness, especially in tumor targeting. It also mentions a study that expands the investigation into linker and toxin variation and binding activities using Surface Plasmon Resonance (SPR).
- Poster: Novel Format Conjugates – Process and Analytical
Bioconjugation technology have greatly improved the efficacy of treatments for diseases previously difficult to address with traditional ADC therapies, leading to a demand for clinical supplies.
- PDF: ADC Express™ Services for Best Candidate Selection
As a leading CTDMO in the ADC space, we offer a rapid approach for developing ADC constructs and provide efficient bioconjugation capabilities for developers needing ADC library generation. Our ADC Express™ Service facilitates the transition to development and GMP manufacturing for candidates entering the clinic.
- White Paper: Benefits of Monodisperse and Activated PEGs in ADC Development
The whitepaper highlights the use of PEGs to enhance solubility in ADC development, emphasizing the importance of ADCs in delivering drugs directly to tumors while minimizing damage to healthy tissue.
- White Paper: Use of Payload Core Compounds to Accelerate ADC Clinical Development Timelines
ADCs treat diseases like cancer by targeting specific cells to minimize off-target toxicity. Eleven are approved, with hundreds in development.
- Technical Flyer: ADCore Payload Intermediates: Simplify Your Payload Synthesis
ADCore products are cGMP quality advanced intermediates that help accelerate drug development efforts by reducing the number of development and manufacturing steps needed to produce Maytansinoid, Dolastatin, or Pyrrolobenzodiazepine (PBD)payloads.
- Technical Flyer: ChetoSensar™
Our ChetoSensar™ Technology can help to improve the solubility of ADCs and provides access to highly hydrophobic novel payloads that might not be considered.
- Technical Flyer: Maytansinoid GMP Quality Payloads for Your Drug Conjugate Programs
Our maytansinoid products aim to expedite your journey to the clinic. Offerings include GMP quality DM1-Mertansine for drug conjugate programs and MAYCore™ intermediate for simplified payload synthesis. These products feature high purity, free samples, and regulatory filing support, suitable for phase I clinical studies with valid processes.
- Brochure: Biopharmaceutical and ADC Process Application Guide
Developing an Antibody Drug Conjugate (ADC) demands expertise in small and large molecule development, manufacturing, formulation, and testing.
- Data Sheet: Eshmuno® CMX mix-mode chromatography resin
- Case Study: Complete Single-use ADC technology, from development to scale-up
The global antibody-drug conjugate (ADC) market is rapidly expanding, with an estimated 22% compound annual growth rate (CAGR) from 2017 to 2022.
- Application Note: Compatibility of a Mobius® Single-use Solution for ADC Processing
ADCs, a fast-growing biomolecule class in oncology therapeutics, include a monoclonal antibody (mAb), linker, and cytotoxic payload, all contributing to therapeutic efficacy
- Poster: Mobius® Single-use ADC Technology Supporting ADC Processing
Our Mobius® line provides a comprehensive single-use bioprocessing portfolio, featuring mixers, chromatography, and tangential flow filtration systems ideal for antibody drug conjugate production.
- Application Note: Pellicon® Capsules for Ultrafiltration/Diafiltration of ADCs
Tangential flow filtration (TFF) is crucial in antibody drug conjugate (ADC) manufacturing. Ultrafiltration (UF) concentrates the protein product, while diafiltration (DF) exchanges buffer and removes impurities.
- White Paper: ChetoSensar™- Overcoming the Solubility Challenges of Antibody-drug Conjugates
The St. Louis (USA) manufacturing site offers over 35 years of experience in bioconjugation, APIs, excipients, and adjuvants manufacturing. With extensive analytical capabilities, dedicated compliance resources, and innovative manufacturing capabilities, the site assists customers worldwide in accelerating their drug development programs.
- Brochure: Process Development and Drug Manufacturing
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
強大 ADC 合作關鍵從基因序列到最終藥物產品的穩定性測試的無縫供應鏈,可以將開發和製造的複雜性降到最低,從而縮短產品上市時間。
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工作流程
為您的有效負載供應尋找缺失的一環
高活性的有效載體和藥物連結劑與 mAb 相匹配,最終結合成抗體藥物。
單分散和活化的 PEG 或 Chetosensar™ 技術可以解決藥物發現和開發過程中的溶解性挑戰。適用於最常見有效載體類別的先進有效載體中間體有助於縮短開發時程。
利用共轭服务连接点
在結合和/或生物結合過程中,細胞株、抗體、有效載體和連結劑等已開發的元件會結合在一起。
ADC 大量藥品 (BDS) 測試服務
BDS以及最終藥品會接受廣泛的分析測試,包括穩定性和釋放測試。
與細胞毒性分子結合
抗體與高活性有效負載之間的連結是 ADC 的關鍵組成部分,需要廣泛的產品和化學品。
層析 (選購)
可選的色譜步驟可用於去除高分子量物質,如抗體聚集物和游離藥物殘留物,同時支持藥物-抗體比值 (DAR) 的優化和多分散性的控制。
Eshmuno® CMX 樹脂專為高選擇性混合模式色譜而設計。
超濾/反過濾
在製備具有所需濃度和緩衝的最終配方之前,必須先去除結合後的殘留溶劑和游離藥物。
Pellicon® Capsule 是同類產品中的第一款--真正的一次性 TFF 裝置,可在幾分鐘內完成 ADC 的處理。
無菌過濾
滅菌級過濾受到監管機構越來越嚴格的審查,需要高度的無菌保證。
ADC BDS 最終填充和配方
BDS是為最終的獨特配方而製備的。以凍乾劑型為佳,通常包含緩衝劑、穩定劑 (如曲哈糖或蔗糖) 及表面活躍劑。
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