PA 800 Plus에서 치료 단백질의 정확한 특성 분석

규정에 따라 일관된 바이오치료제 특성 분석을 보다 신속하게 수행

바이오치료제의 변이는 환자 치료의 안전성과 효능뿐만 아니라 조직의 평판에 영향을 미칩니다. PA 800 Plus 의약품 분석 시스템을 사용하면 바이오로직스의 성공을 보장할 수 있습니다. 바이오의약품 실험실에서 사용하는 단일 시스템에서 여러 특성 분석을 실행하고, 정성 분석 및 정량 분석을 빠르고 정확하게 수행할 수 있습니다.

PA 800 Plus 의약품 분석 시스템은 치료 단백질의 개발 및 품질 관리를 위해 제품 순도, 전하 이질성 및 글리칸 분석의 특성 분석을 제공하는 우수한 성능의 분석 플랫폼입니다.

  • 이 모든 것을 PA 800 Plus에서 수행할 수 있습니다.
  • 단클론 항체
    • 표준 CE-SDS로 18분 안에 순도/이질성 확인
    • 수상 경력이 빛나는 고속 글리칸(Fas Glycan) 기술을 사용한 글리칸 분석
    • 간단하고 빠른 CZE로 또는 고분해능 cIEF로 전하 이질성 확인
  • mAbs를 넘어선 펩타이드와 단백질
  • 플라스미드 및 핵산 치료제 - 고분해능 정량 분석
  • 기타 바이오치료제
PA 800 Plus Pharmaceutical Analysis System
핵심 기능

단일 플랫폼에서 다양한 응용 분야

단일 시스템에서 여러 단백질 특성 분석을 실행할 수 있어 운영 효율성과 효과가 향상됩니다.

조작되지 않은 원시 데이터

조작되지 않은 원시 데이터와 제품 제출 및 상용화를 위해 실험실과 규제 기관 모두에 중요한 자신감을 가질 수 있습니다.

재현성

SCIEX만의 순환식 냉각수로 분리 온도를 정밀하게 제어하여 반복 가능한 결과를 얻을 수 있습니다.

이식성

이식성이 입증된 우수한 성능의 자동 분석법을 간편하게 이전할 수 있습니다. 전 세계의 다중 사용자, 다중 장비 환경에 적합합니다.

단일 플랫폼에서 다양한 바이오치료제 특성 분석

Biologics Characterization Results You Can Trust

Characterize molecules, large or small, with industry and regulatory compliant capillary electrophoresis (CE) technology. It’s why every biopharmaceutical company with therapeutic IgGs currently on the market uses SCIEX CE systems in their bioanalytical processes.

이전성

품질 관리 또는 규제 대상 환경에 적용 가능한 분석법을 개발하고 잠급니다. 이식성이 입증된 우수한 성능의 자동 분석법을 사용하여 간편하게 분석법을 이전할 수 있습니다. 전 세계의 다중 사용자 및 다중 장비 조직에 적합합니다.

EZ-CE 카트리지

편리한 EZ-CE 카트리지를 다양한 응용 분야에서 바로 사용할 수 있습니다. PA 800 Plus EZ-CE 카트리지로 데이터 일관성을 강화하고 직원 교육을 최소화하십시오.

신뢰할 수 있고 신속하고 정확한 바이오치료제 특성 분석

산업 규정 준수가 입증된 CE 기술

PA 800 Plus 의약품 분석 시스템은 우수한 성능의 분석 플랫폼이므로, 속도 저하 없이 데이터에 대한 확신을 가질 수 있습니다.

효율성 향상

단일 플랫폼에서 여러 분석을 실행하면 직원 교육이 간소화되고, ROI가 극대화되며, 실험실에 필요한 면적이 줄어듭니다.

신뢰할 수 있는 분석법

CE-SDS, cIEF, CZE 및 글리칸 분석을 포함한 SCIEX 모세관 전기영동 분석의 우수한 성능은 회사 간 광범위한 연구를 통해 입증되었습니다.

규정 준수 간소화

USP에는 모세관 전기영동을 통한 IgG 순도 및 이질성 분석에 대한 밸리데이션을 거친 절차 및 시스템 적합성 기준이 포함되어 있습니다.

감도 극대화

모듈식 검출(UV, PDA, LIF)로 최소 불순물의 103 이상인 0.01% 미만의 불순물을 검출합니다.

PA 800 Plus에서 이 모든 것을 수행할 수 있습니다

바이오치료제의 자동 정량 분석

PA 800 Plus 자동 정량 분석 솔루션으로 재현성이 높은 데이터를 생성할 수 있습니다. SCIEX 엔지니어들은 바이오로직스 특성 분석에 경험을 가진 바이오의약품 개발 및 QC 그룹과 긴밀히 협력하여 분석 과제를 해결하는 분석법을 개발하고 있습니다.

단백질 순도 분석

SDS-Gel 모세관 전기영동을 사용한 정량 단백질 순도 분석

글리칸 분석

간소화된 시료 전처리, 신속한 고분해능 분리 및 자동 글리칸 동정을 통해 HILIC보다 최대 5배 빠른 속도로 글리칸을 분석할 수 있습니다.

전하 이질성

전하 이질성 분석을 위해 고급 모세관 등전 집중법(cIEF) 및 고속 모세관 영역 전기영동(CZE) 실행

펩타이드/단백질 특성 분석

mAbs를 벗어나 펩타이드 및 단백질 바이오치료제를 분석합니다.

플라스미드/핵산 분석

핵산 순도, 이질성 및 크기 확인 분석을 위한 효과적인 고감도 기술 포함

SCIEX Biopharma Symposium

Gain access to on-demand content that highlights beginning to advanced capabilities of the PA 800 Plus. Visit our Biopharma Symposium to learn more.

HILIC보다 최대 5배 빠르게 글리칸 분석

The PA 800 Plus – now compatible with Waters™ Empower 3 Enterprise Software.

With validated methods, integrating the PA 800 Plus into Empower 3 is quick and easy. Empower 3 allows you to manage raw data, applications, electronic signatures, records and appropriate system controls from a single software package, that can be deployed globally.

Read More

Windows 10 Upgrade

We Are Now Windows 10 Compatible! Upgrade Your SCIEX CE Instruments Today.

관련 제품

킷 기반 분석

매우 다양한 킷 기반 분석법 중 하나를 사용하여 실험을 실행하는 데 필요한 시약을 구하십시오.

EZ-CE 카트리지

편리한 EZ-CE 카트리지를 다양한 응용 분야에서 바로 사용할 수 있습니다.

질량 분석기에 연결

CE와 Electrospray 이온화(ESI)를 통합하고 CESI 8000 Plus가 있는 질량 분석기에 연결하십시오.

리소스

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Pre-Assembled Cartridge flyer

Low pH SDS sample buffer flyer (ZH)

CZE Rapid Charge Variant Analysis kit flyer (ZH)

CE Consumable Flyer

PA 800 Plus system start-up consumable groups flyer

PA 800 Plus system Empower driver notes de version (FR)

PA 800 Plus system Empower driver notas de la versión (ES)

PA 800 Plus system Empower driver 版本发布说明 (ZH)

PA 800 Plus system Empower driver リリースノート (JA)

PA 800 Plus system Empower driver note di rilascio (IT)

PA 800 Plus system Empower driver versionshinweise (DE)

PA 800 Plus system Empower driver release notes

PA 800 Plus system Empower driver user guide

PA 800 Plus system Empower driver user guide (DE)

PA 800 Plus system Empower driver user guide (ES)

PA 800 Plus system software validation guide

PA 800 Plus system Empower driver user guide (IT)

PA 800 Plus system Empower driver user guide (JA)

PA 800 Plus system Empower driver user guide (ZH)

PA 800 Plus system Empower driver user guide (FR)

PA 800 Plus system IgG Purity and Heterogeneity Assay kit application guide

PA 800 Plus system LIFluor™ EnhanCE dsDNA 1000 Dye application guide (JA)

PA 800 Plus system Fast Glycan Labeling and Analysis kit application guide

PA 800 Plus system IgG Purity and Heterogeneity Assay kit application guide (JA)

PA 800 Plus system IgG Purity and Heterogeneity Assay kit application guide (ZH)

PA 800 Plus system SDS-MW Analysis kit application guide

PA 800 Plus system ssDNA 100-R kit application guide (ZH)

PA 800 Plus system dsDNA 1000 kit application guide

PA 800 Plus system CZE Rapid Charge Variant Analysis kit application guide (ZH)

PA 800 Plus system dsDNA 1000 kit application guide (JA)

PA 800 Plus system Capillary Isoelectric Focusing (cIEF) Analysis kit application guide

PA 800 Plus system ssDNA 100-R kit application guide

PA 800 Plus system Capillary Isoelectric Focusing (cIEF) Analysis kit application guide (JA)

PA 800 Plus system SDS-MW Analysis kit application guide (JA)

PA 800 Plus system LIFluor™ EnhanCE dsDNA 1000 Dye application guide (ZH)

PA 800 Plus system CZE Rapid Charge Variant Analysis kit application guide

PA 800 Plus system SDS-MW Analysis kit application guide (ZH)

PA 800 Plus system LIFluor™ EnhanCE dsDNA 1000 Dye application guide

PA 800 Plus system ssDNA 100-R kit application guide (JA)

PA 800 Plus system Capillary Isoelectric Focusing (cIEF) Analysis kit application guide (ZH)

PA 800 Plus system CZE Rapid Charge Variant Analysis kit application guide (JA)

PA 800 Plus system RNA 9000 Purity and Integrity kit application guide

PA 800 Plus system dsDNA 1000 kit application guide (ZH)

CE Grade Water flyer

CE instrument maintenance flyer

PA 800 Plus system brochure (ES)

CE-SDS training flyer

CE Training Overview 2021

Capillary electrophoresis Windows 10 flyer

Empower Your PA 800 Plus with Waters Empower3 Enterprise Software

Fast Glycan labeling and analysis kit flyer

Fast Glycan Labeling and Analysis kit flyer

Capillary electrophoresis consulting flyer

Capillary Electrophoresis kit brochure

Low pH phosphate SDS sample buffer flyer (ZH)

LC-MS/MS 技术平台

Capillary electrophoresis solutions for DNA/mRNA vaccines flyer (ZH)

PA 800 Plus system Empower driver flyer (ZH)

SCIEX Capillary Electrophoresis Consumables flyer

Low pH SDS sample buffer flyer

SCIEX solutions for gene therapy and oligonucleotide compendium

CE Training Overview DE 2021

Capillary electrophoresis training course flyer

CZE Rapid Charge Variant Analysis kit flyer

A holistic approach to understanding cIEF poster

Fully automated sample preparation with ultrafast N-glycosylation analysis of therapeutic antibodies poster

Native state charge variant analysis of commercialized monoclonal antibodies poster

A sensitive and robust plasmid analysis method by capillary electrophoresis-laser induced fluorescence (Pfizer and SCIEX) poster

CZE Method

CZE Capillary Conditioning

CZE Shutdown

CZE Rapid Charge Variant Analysis kit methods

CZE Analysis

Low-level quantitation of impurities in bispecific proteins using CE-SDS with LIF detection

High-precision lentivirus titer determination and protein profiling

Size distribution analysis of residual host cell DNA fragments in lentivirus by CGE-LIF

Development of purity analysis methods for synthetic prime editing guide RNAs (pegRNAs) with high-level secondary structures for prime editing research applications

Rapid CZE analysis of erythropoietin variants

Sensitive impurity analysis of AAV capsid proteins by CE using Chromeo P503 fluorescent (ES)

Capillary electrophoresis in quality control: Part I: Application for therapeutic proteins

A Robust cIEF Method: Intermediate Precision

Assessing glycosimilarity of biotherapeutics

Simple, fast and robust method for plasmid purity testing and degradation monitoring

High efficiency evaporative fluorophore labeling of glycans

Achieving robust cIEF analysis of monoclonal antibodies while increasing capillary run-life and maintaining high resolution and reproducibility

Accurate analysis of double stranded DNA over an extended size range

Assay of IgG purity and heterogeneity using high-resolution sodium dodecyl sulfate capillary gel electrophoresis

Determination of full, partial and empty capsid ratios for adeno-associated virus (AAV) analysis

Sensitive AAV capsid protein impurity analysis by CE using P503 dye

Preparation scale-up of complex biological samples for deep N-glycomic analysis by CE-LIF and CESI-MS

IgG purity/heterogeneity and SDS-MW assays with 96-well plate adaption

Purity analysis of adeno-associated virus (AAV) capsid proteins using CE-SDS method

Native state charge variant analysis of commercialized monoclonal antibodies in minutes

Genome sizing methodology for genome integrity analysis of adeno-associated viruses (AAV)

Automation of CE-SDS for IgG purity/heterogeniety

Comparative characterization of the Fc domain N-glycosylation in monoclonal antibody and fusion protein therapeutics

Ultrafast Analysis of Human Milk Oligosaccharides (HMOs)

Capillary electrophoresis in quality control: Part II: CE-SDS: Method development and robustness

Separation of recombinant human erythropoietin (rhEPO) using the European Pharmacopoeia method on the PA 800 plus system

Simplifying CE-SDS data processing with mineral oil

Velocity-corrected area calculation: SCEX PA 800 plus system Empower driver version 1.3 vs. 32 Karat software

Identification of System Parameters Critical for High-Performance cIEF

Fast glycan sequencing using a fully automated carbohydrate sequencer

Purity analysis of adeno-associated virus (AAV) capsid proteins using CE-LIF technology

Evaluation of the glycosimilarity of biotherapeutics (ES)

Optimize non-reduced CE-SDS analysis with the SCIEX low pH SDS sample buffer

SDS-MW calibration and molecular weight estimation using the SCIEX PA 800 Plus Empower driver version 1.3

Optimization of a robust and sensitive capillary electrophoresis laser induced flourescence method for monitoring plasmid stability and purity

High-Resolution cIEF of Therapeutic Monoclonal Antibodies

A Series of Collaborations Between Various Pharmaceutical Companies and Regulatory Authorities Using CE

A single analytical platform for glycan analysis, charge heterogeneity, and purity determination of the NIST mAb

Rapid CZE analysis of erythropoietin variants (ZH)

Heterogeneity analysis of cysteine-linked antibody-drug conjugate by CE method (ZH)

Analyzing the average degree of substitution of betadex sulfobutyl ether sodium by capillary electrophoresis (ZH)

Analysis of purity and isoelectric points of HPV by capillary electrophoresis (ZH)

Purity analysis of CircRNA vaccine by CGE-LIF method (ZH)

Analysis of capping efficiency of MRNA by capillary gel electrophoresis (ZH)

Study on the stability of RNA Analysis by neutral capillary combined with RNA 9000 Kit (ZH)

Analysis of Purity and Integrity of mRNA Vaccine by Capillary Gel Electrophoresis (ZH)

Size analysis of residual host cell DNA in Lentivirus by CGE-LIF

Highly sensitive CE-SDS-LIF purity analysis of T7 RNA polymerase (ZH)

Purity analysis of oligonucleotides by capillary gel electrophoresis (ZH)

Analysis of Poly A tail distribution of mRNA by capillary gel electrophoresis (ZH)

High Throughput Detection of IgG Purity by Using Quick Rinse CE-SDS Separation Method

Purity analysis of SgRNA by capillary gel electrophoresis (ZH)

Identification and quantitative analysis of impurity E in glutathione by capillary electrophoresis (ZH)

Rapid purity analysis of plasmid using neutral coated capillary in CGE-LIF method (ZH)

Analysis of size variants and isoelectric point of recombinant human serum albumin by capillary electrophoresis (ZH)

Size analysis of residual host cell DNA in Recombinant protein vaccine by CGE-LIF (ZH)

Determination of free carrier proteins in polysaccharideprotein conjugate vaccines by capillary micellar electrokinetic chromatography (ZH)

Purity analysis of monoclonal antibodies (5-TAMRA labeling) by CE-SDS-LIF (ZH)

SCIEX CE solutions in China Pharmacopoeia (ZH)

Determination of P-carboxybenzaldehyde and P-methyl benzoic acid in P-terephthalic acid by capillary electrophoresis (ZH)

Quality control of raw materials of diagnostic reagent in vitro by capillary electrophoresis (ZH)

Quantification of whey protein content in infant formula by CE-SDS (ZH)

Multi-laboratory validation for the purity analysis of protein products in CE-SDS method using CESI 8000 Plus (ZH)

The determination of α-lactalbumin and β-lactoglobulin in dairy by capillary zone electrophoresis (ZH)

Purity analysis of MRNA vaccine by using CGE-LIF (ZH)

Comparation the N-Glycan of different sources recombinant human erythropoietin by using capillary electrophoresis with laser-induced fluorescence detector (ZH)

The determination of lactoferrin in dairy by capillary zone electrophoresis (ZH)

Isoelectric points analysis of LNP encapsulated mRNA by cIEF (ZH)

ruo-mkt-07-14191-a-rna-kit-flyer_V1_08-23

十六烷基磺酸钠-毛细管凝胶电泳法用于双抗的纯度分析

CGE-LIF方法分析不同工艺阶段狂犬疫苗中宿主残留DNA的片段大小分布

PA 800 Plus System Overview Guide (EN)

CE consumables and reagents catalog

PA 800 Plus system RNA 9000 Purity & Integrityキット アプリケーションガイド

PA 800 Plus Pharmaceutical Analysis System - System Administration Guide

PA 800 Plus system RNA 9000 Purity & Integrity 试剂盒 应用指南

Challenges with CE-SDS?

RNA Analysis for CRISPR by capillary electrophoresis with laser-induced fluorescence detection

SCIEX solutions for LNP-based genetic medicines brochure

PA 800 Plus system system maintenance guide (EN)

Breaking through boundarieswith CRISPR gene editing

사양 
A66528 PA 800 Plus Pharmaceutical Analysis SystemIncludes separation module with UV, photodiode array and LIF detection; system controller with PA 800 Plus software; system startup kit and reagents
A66527 PA 800S Plus Pharmaceutical Analysis SystemIncludes separation module with photodiode array detection; system controller with PA 800 Plus software; system startup kit and reagents
DimensionsHeight: 29.2 in (74.2 cm)
Door Open: 38.8 in (98.6 cm)
Width: 25 in (63.5 cm)
Depth: 28.4 in (72.1 cm)
Weight (uncrated)188 lbs (85.3 kg) (includes photodiode array detection)
Electrical RequirementsVoltage: 100 - 240 V; 50/60 Hz
Voltage Range1 to 30 kV programmable at 0.1 kV increments
Current Range3 to 300 μA programmable at 0.1 μA increments
Pressure Delivery Range-5 to +100 psi
Sample Temperature Control4 - 60°C
Capillary Temperature Control15 - 60°C
Sample Trays: 2 x 96-well plates2 x 48 universal vials 2 x 48 0.2 mL microvials
Buffer Tray2 x 36 universal vials
Detection CapabilityUV/Vis
200, 214, 254, 280 nm standard filter
190 - 600 nm (custom filter option)
Diode Array
190 - 600 nm (programmable)
0.5 - 32 Hz scan collection frequency (programmable)
Laser Induced Fluorescence (LIF)
300 - 700 nm excitation range
350 - 750 nm emission range
0 - 1000 RFU
Source Lasers with 3 mW Power Output488 nm solid-state laser (included in A66528)
리소스 및 지원 
Installing the LIF Aperture and Probe Guide/Stabilizer Step-by-Step Video GuideWatch
Cartridge Removal, Rebuild and Reinstallation Step-by-Step Video GuideWatch
Change the Coolant Tubing Step-by-Step Video GuideWatch
Change a Detector Step-by-Step Video GuideWatch
Capillary Removal Step-by-Step Video GuideWatch
Capillary Storage Step-by-Step Video GuideWatch
CE-SDS MW Application GuideDownload
Glycan Analysis Application GuideDownload
Fast Glycan SoftwareDownload
Sample Preparation for the Fast Glycan Technology on the PA 800 PlusWatch
Fast Glycan Sequencing Using a Fully Automated Carbohydrate SequencerDownload