Outlook On Next Generation Technologies And Strategy Considerations For Adc Process Development And Manufacturing
INNOVATIONS FOR NEXT-GENERATION ANTIBODY-DRUG CONJUGATES（2018）
摘要
In the chapter, we review new conjugation technologies from the standpoints of process development and manufacturability and identify potential process hotspots. We briefly review recent progress in conventional conjugation methods and assess, for instance, how new linkers impact process. We also consider antibody modeling and its untapped potential to help design ADCs. We address outsourcing options and trends and provide an overview of single use technologies. Finally, strategies for efficient early process development to ensure CMC consistency across clinical phases and manufacturing scales and ensure readiness for accelerated regulatory approval paths are discussed.
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关键词
ADC, Process development, Analytical development, Scale-up, Manufacturing, GMP, Drug substance, Drug product, Bulk drug substance, DS, DP, BDS, Conjugation technologies, Site specific, Bridging, Thiobridge, Conventional cysteine, Engineered cysteine, Lysine, Serine, Unnatural amino acid, Non-natural amino acid, Maleimide, Valine-citruline, Maleimidocaproyl, Thiosuccinimide, Haloacetamide, Click chemistry, Azide, Cyclooctyne, Glycan, Enzyme, Enzymatic ligation, Transglutaminase, Seleno mAb, AmbrX, Eucode, Xpress, THIOMAB, Glycoconnect, Fleximer, Hydraspace, Auristatin, Ozogamicin, Talirine, Maystantin, Quaternary amine, Glucuronide, Linker, Payload, Aggregate, Aggregation, Stability, Hydrophobicity, DAR, Drug antibody ratio, Modeling, Antibody, Probody, Extracellular, Bispecific, TFF, HIC, Chromatography, Tangential flow filtration, Regulatory approval, CMC, Accelerated approval, Single use, Outsourcing, CMO, CQA, Critical quality attribute, Toxicity, Cytotoxicity, MTD, MED, Therapeutic index, PK, PD
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