{"title":"Thermo Fisher Pharma Analytic","description":"\u003csection\u003e\n\u003cp\u003e알앤디메이트는 Thermo Fisher의 Pharma Analytics 제품군을 통해 바이오의약품 생산 및 품질관리 환경에서 요구되는 \u003cstrong\u003e빠른 분석 속도, 높은 검출 민감도, 그리고 규제 대응을 고려한 QC workflow\u003c\/strong\u003e 구축을 지원합니다.\u003c\/p\u003e\n\u003chr\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eRapid testing workflow\u003c\/strong\u003e – 생산 일정과 QC 의사결정에 적합한 빠른 분석\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHigh sensitivity\u003c\/strong\u003e – contamination 및 impurity를 민감하게 검출\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eBiopharma-focused solutions\u003c\/strong\u003e – biologics, vaccine, cell therapy 제조 공정에 적합\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulatory readiness\u003c\/strong\u003e – 바이오의약품 품질관리 및 규제 대응 전략 수립에 유리\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntegrated platform\u003c\/strong\u003e – sample preparation, assay kits, instrument, software까지 연계 가능\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr\u003e\n\u003ch3\u003e1. Mycoplasma Detection\u003c\/h3\u003e\n\u003cp\u003eMycoplasma contamination은 cell culture, cell therapy, biologics production에서 가장 중요한 microbial risk 중 하나입니다. Thermo Fisher의 \u003cstrong\u003eMycoSEQ™\u003c\/strong\u003e portfolio는 qPCR 기반으로 \u003cstrong\u003e빠르고 민감한 mycoplasma detection\u003c\/strong\u003e을 지원합니다.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eMycoSEQ™ Plus Mycoplasma Detection Kits\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eMycoSEQ™ Mycoplasma Detection Kit\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eMycoSEQ™ Mycoplasma Detection System\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e특히 lot release testing, in-process monitoring, cell bank testing, raw material testing 등 다양한 biopharma QC workflow에 적용할 수 있습니다.\u003c\/p\u003e\n\u003cbr\u003e\u003chr\u003e\n\u003ch3\u003e2. Rapid Sterility Testing\u003c\/h3\u003e\n\u003cp\u003eSterility testing은 바이오의약품 제조에서 제품 안전성과 공정 신뢰성을 확인하는 핵심 단계입니다. Thermo Fisher의 \u003cstrong\u003eSteriSEQ™ Rapid Sterility Testing\u003c\/strong\u003e 솔루션은 bacteria 및 fungi contamination을 빠르게 확인할 수 있도록 설계되었습니다.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eSteriSEQ™ Rapid Sterility Testing Kit\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eSteriSEQ™ Rapid Sterility Testing System\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e기존 배양 기반 sterility test보다 더 빠른 QC 의사결정을 지원하며, cell therapy 및 advanced therapy manufacturing workflow에서 특히 유용합니다.\u003c\/p\u003e\n\u003cbr\u003e\u003chr\u003e\n\u003ch3\u003e3. Residual DNA Quantification\u003c\/h3\u003e\n\u003cp\u003eResidual host cell DNA는 biologics, vaccine, recombinant protein, cell \u0026amp; gene therapy 제조 공정에서 관리해야 하는 대표적인 process-related impurity입니다. \u003cstrong\u003eresDNASEQ™\u003c\/strong\u003e portfolio는 qPCR 및 dPCR 기반으로 residual host cell DNA를 정확하고 민감하게 정량할 수 있도록 설계되었습니다.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eresDNASEQ™ Residual Host Cell DNA Quantitation Kits\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eCHO, HEK293, Human, Vero, MDCK, NS0 등 다양한 host cell line 대응\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eqPCR \/ dPCR workflow 선택 가능\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eDownstream purification 성능 평가, process validation, lot release support, comparability assessment 등 다양한 QC 및 process development workflow에 활용할 수 있습니다.\u003c\/p\u003e\n\u003cbr\u003e\u003chr\u003e\n\u003ch3\u003e4. Viral Safety Testing\u003c\/h3\u003e\n\u003cp\u003eAdventitious virus contamination은 바이오의약품 제조에서 매우 중요한 safety risk입니다. Thermo Fisher의 \u003cstrong\u003eViralSEQ™\u003c\/strong\u003e 솔루션은 특정 바이러스에 대한 PCR 기반 검출 workflow를 통해 생산 공정의 viral safety monitoring을 지원합니다.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eViralSEQ™ Mouse Minute Virus (MMV) Detection\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eViralSEQ™ Vesivirus Detection\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eSf-rhabdovirus testing workflow\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eViral safety testing은 특히 vaccine, recombinant protein, cell substrate 기반 생산 공정에서 품질 및 안전성 확보를 위해 중요한 영역입니다.\u003c\/p\u003e\n\u003cbr\u003e\u003chr\u003e\n\u003ch3\u003eRecommended For\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eBiopharma manufacturers\u003c\/li\u003e\n\u003cli\u003eCell therapy developers\u003c\/li\u003e\n\u003cli\u003eVaccine manufacturers\u003c\/li\u003e\n\u003cli\u003eCDMO \/ CMO facilities\u003c\/li\u003e\n\u003cli\u003eQC microbiology laboratories\u003c\/li\u003e\n\u003cli\u003eProcess development and manufacturing science teams\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr\u003e\n\u003ch3\u003eR\u0026amp;D Mate Biopharma Quality Control Solution\u003c\/h3\u003e\n\u003cp\u003e알앤디메이트는 Thermo Fisher Pharma Analytics 제품군과 함께 Precision Systems의 osmometer calibration standards, Ricca의 conductivity \/ pH standards 등 biopharma manufacturing에 필요한 핵심 QC 솔루션을 함께 제공합니다.\u003c\/p\u003e\n\u003cp\u003e이를 통해 고객은 \u003cstrong\u003emicrobial detection, residual impurity analysis, osmolality verification, process QC workflow\u003c\/strong\u003e를 하나의 통합된 관점에서 검토할 수 있습니다.\u003c\/p\u003e\n\u003cp\u003e제품 선택, 적용 workflow 검토, 관련 QC 솔루션 구성에 대해 R\u0026amp;D Mate로 문의해 주세요.\u003c\/p\u003e\n\u003c\/section\u003e","products":[{"product_id":"mycoseq™-plus-mycoplasma-detection-kits","title":"MycoSEQ™ Plus Mycoplasma Detection Kits","description":"\u003cp\u003e\u003cstrong\u003eMycoSEQ™ Plus Mycoplasma Detection Kits\u003c\/strong\u003e는 \u003cstrong\u003eThermo Fisher Scientific\u003c\/strong\u003e BioProduction에서 제공하는 \u003cstrong\u003erapid qPCR-based mycoplasma detection solution\u003c\/strong\u003e으로, cell therapy, vaccine, monoclonal antibody 및 다양한 biopharmaceutical production 공정에서 \u003cstrong\u003emycoplasma contamination을 빠르고 민감하게 검출\u003c\/strong\u003e하도록 설계되었습니다.\u003c\/p\u003e\n\u003cp\u003e바이오의약품 제조에서 mycoplasma contamination은 생산 중단, batch 폐기, 규제 문제로 이어질 수 있는 가장 중요한 microbial risk 중 하나입니다. MycoSEQ™ Plus는 이러한 위험을 최소화하기 위해 \u003cstrong\u003esame-day 수준의 빠른 결과\u003c\/strong\u003e와 \u003cstrong\u003e높은 검출 민감도\u003c\/strong\u003e를 제공합니다.\u003c\/p\u003e\n\u003chr\u003e\n\u003ch3\u003eWhy MycoSEQ™ Plus?\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eRapid Detection\u003c\/strong\u003e – 기존 culture 기반 테스트(최대 28일) 대신 \u003cstrong\u003e1일 이내 결과\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHigh Sensitivity\u003c\/strong\u003e – 다양한 Mycoplasma species에 대해 높은 검출 민감도\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eqPCR Technology\u003c\/strong\u003e – TaqMan™ probe 기반 real-time PCR detection\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDesigned for Bioproduction Samples\u003c\/strong\u003e – complex biologics samples 대응\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDiscriminatory Positive Control\u003c\/strong\u003e – 실제 contamination과 cross-contamination 구분\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulatory Alignment\u003c\/strong\u003e – USP, EP 등 compendial mycoplasma testing strategy 지원\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr\u003e\n\u003ch3\u003eKey Benefits for Biopharma Manufacturing\u003c\/h3\u003e\n\u003cp\u003eMycoSEQ™ Plus는 특히 다음과 같은 환경에서 강력한 성능을 제공합니다.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eCell therapy manufacturing\u003c\/li\u003e\n\u003cli\u003eBiologics production QC\u003c\/li\u003e\n\u003cli\u003eVaccine manufacturing\u003c\/li\u003e\n\u003cli\u003eCDMO \/ CMO production facilities\u003c\/li\u003e\n\u003cli\u003eUpstream bioprocess monitoring\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e빠른 detection capability는 contamination risk를 조기에 확인할 수 있어 \u003cstrong\u003eproduction downtime과 batch loss 위험을 줄이는 데 매우 중요합니다.\u003c\/strong\u003e\u003c\/p\u003e\n\u003chr\u003e\n\u003ch3\u003eTypical Applications\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eCell bank testing (MCB \/ WCB)\u003c\/li\u003e\n\u003cli\u003eIn-process bioreactor monitoring\u003c\/li\u003e\n\u003cli\u003eRaw material testing\u003c\/li\u003e\n\u003cli\u003eLot release testing\u003c\/li\u003e\n\u003cli\u003eCell therapy manufacturing QC\u003c\/li\u003e\n\u003cli\u003eBiopharmaceutical process development\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr\u003e\n\u003ch3\u003eWorkflow Overview\u003c\/h3\u003e\n\u003col\u003e\n\u003cli\u003eSample collection from cell culture or production workflow\u003c\/li\u003e\n\u003cli\u003eNucleic acid extraction\u003c\/li\u003e\n\u003cli\u003eqPCR reaction setup\u003c\/li\u003e\n\u003cli\u003eReal-time PCR detection\u003c\/li\u003e\n\u003cli\u003eData interpretation and QC decision\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003cp\u003e\u003cstrong\u003eTotal assay time: 약 5시간\u003c\/strong\u003e\u003c\/p\u003e\n\u003chr\u003e\n\u003ch3\u003eAvailable Configurations\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eA55124\u003c\/strong\u003e – MycoSEQ™ Plus Mycoplasma Detection Kit\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA57925\u003c\/strong\u003e – Detection Kit + PrepSEQ™ 1-2-3 Nucleic Acid Extraction Kit\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA57926\u003c\/strong\u003e – Detection Kit + PrepSEQ™ Express Extraction Kit\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr\u003e\n\u003ch3\u003eRecommended Instruments\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eQuantStudio™ Real-Time PCR Systems\u003c\/li\u003e\n\u003cli\u003eApplied Biosystems™ Real-Time PCR platforms\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr\u003e\n\u003ch3\u003eR\u0026amp;D Mate Biopharma QC Solution\u003c\/h3\u003e\n\u003cp\u003e알앤디메이트는 biopharmaceutical manufacturing을 위한 \u003cstrong\u003eQuality Control (QC) 솔루션 포트폴리오\u003c\/strong\u003e를 제공합니다.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eRapid Mycoplasma Detection\u003c\/li\u003e\n\u003cli\u003eOsmometer Calibration Standards\u003c\/li\u003e\n\u003cli\u003eConductivity \u0026amp; 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