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Biologics Characterization

Mitigate risk on your path to development

Characterization and monitoring of a biologics structure, specific activity, and maintenance of potency is critical during the drug discovery workflow to help minimize development risks.

In addition, the immune response to a biological entity is highly dynamic, involving multiple processes and components so characterization is required to unravel the interactions between innate and adaptive immunity and the effect of these processes.

Our analytical instrumentation and characterization assays serve to help you with your protein biologic, viral or nucleic acid vector characterization by mitigating risk through assessing potency, identity, and purity and impurity profiles. Whilst leveraging our advanced technology in immune functional assays to assess cytotoxicity, identify cytokine release and cell signaling, and observe cellular responses can help your understanding to develop effective and predictive treatments.

Bringing you solutions to help continue your development journey towards clinical trials.

For research use only. Not for use in diagnostic procedures.

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Biologics Characterization

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Biologics potency Biologics identity Biologics purity & impurity profile In vitro assay
Biologics potency

We can help deliver consistent evaluation of a biological drug’s critical quality attributes such as stability during development, and its impact on dosage and activity.

With relative potency of a biological drug product being determined by comparing the biological response with a control via determination of mode of action, we offer a range of bioassays to aid this assessment.

Our bioassays, including cell-based assays, help determine the potency and evaluate the reproducibility and stability of your drug product. While our assay platforms, automation, and bioanalytical solutions can offer high throughput workflows for you to establish reliable methods when determining potency during your late-stage drug discovery.

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HTRF

HTRF™ （Homogeneous Time Resolved Fluorescence）は、標準的なFRET技術と蛍光の時間分解測定を組み合わせた無洗浄技術で、短寿命のバックグラウンド蛍光を除去します。

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Alpha-ClassicAlphaLISA
Alphaアッセイ

定量ELISAアッセイやELISA試薬に代わる改良型Alphaテクノロジーを用いれば、事実上あらゆるターゲットを迅速かつ容易に測定することができます。

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Cell Counting and Image Cytometry

Revvity offers a leading portfolio of automated cell counters, image cytometry systems, and cell counting reagents and consumables.

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microplate readers
マイクロプレートリーダー

Revvityのプレートリーダー製品群は、今日のラボの多様なアッセイ要件に対応する最新の検出技術を備えています。

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マイクロ流体によるタンパク質特性評価

タンパク質は、そのサイズ、分子構造、物理化学的性質が互いに異なります。これらの違いにより、分離と同定によるタンパク質の分析と特性解析が可能になります。

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Fontus Liquid Handling Workstation-Revvity
リキッドハンドリングワークステーション

多様なアプリケーションのために設計された専用ワークステーションと、お客様のニーズに基づいて液体分注機ワークステーションをカスタマイズできる機能を備えた革新的な自動液体分注機ソリューションは、エラーを最小限に抑え、作業時間を短縮し、スループットと再現性を向上させます。

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customization services
Customization Services

Extend your lab’s capabilities with our experts in reagent and assay technologies and detection instrumentation.

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Biologics identity

Helping you test and confirm the identity of your large molecule drug with innovative integrated technologies and expertise so you can establish the specific type of therapeutic that’s being developed.

With a variety of techniques available to confirm the identity of the biological product (monoclonal antibody, recombinant protein, nucleic acid vectors or viral vectors), we can support to assist downstream characterization, scale up, purification, and compliant release of the final product.

We offer a wide array of molecular, biochemical, bioanalytical, and analytical solutions to help facilitate unambiguous detection of the large therapeutic molecule of interest and mitigate several of the challenges faced in the later stages of drug development.

Janus G3 Liquid Handling Workstation-Revvity
JANUS Workstations

The JANUS™ G3 automated liquid handling workstations offer flexible automated sample preparation solutions to meet your specific application needs.

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マイクロ流体によるタンパク質特性評価

タンパク質は、そのサイズ、分子構造、物理化学的性質が互いに異なります。これらの違いにより、分離と同定によるタンパク質の分析と特性解析が可能になります。

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microplate readers
マイクロプレートリーダー

Revvityのプレートリーダー製品群は、今日のラボの多様なアッセイ要件に対応する最新の検出技術を備えています。

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immunoassays
イムノアッセイ

1950年代にイムノアッセイが導入されて以来、イムノアッセイは研究や創薬に不可欠な要素となってきました。

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Biologics purity & impurity profile

Simplify the complexity of impurity profiling for the reliability of your drug product. We can help you gain an understanding of the potential host cell proteins, nucleic acids, and process related impurities and the acceptable limits.

Bacterial or fungal burdens need to be determined per USP/EP guidelines through microbial testing, whilst viruses are detected with several in vitro and in vivo assays. In addition, for viral vector development such as Adeno-Associated Virus (AAV), viral capsid characterization is assessed for varying degrees of encapsidation – empty, partial, and full genome capsids.

We offer innovative which are designed to help streamline impurity profile workflows and maintain GMP compliance in drug discovery and development.

Photo CHO HCP Kit
HTRF CHO HCP Detection Kit, 500 Assay Points
The CHO Host Cell Protein (HCP) kit measures contaminants originating from the CHO cells used to manufacture therapeutic antibodies. The kit can be used for the quantification of CHO HCP proteins in routine bioprocess operations, from the completely raw harvest material to the final product. The simple and robust procedure benefits from increased throughput compared to ELISA.
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AlphaLISA Sandwich Anti-analyte Conjugated Acceptor Bead image
AlphaLISA CHO HCP Detection Kit, 100 Assay Points
CHO cells are widely used expression hosts for recombinant proteins and are utilized for the generation of monoclonal antibodies. The CHO Host Cell Proteins (HCP) kit is designed to measure contaminants originating from the CHO cells used to manufacture therapeutic antibodies. This kit can be utilized to quantify CHO HCP proteins at various stages, from routine bioprocess operations to crude harvest materials to final products. Our simple procedure and robust assay offer increased throughput compared to ELISA. Formats: <ul> <li>Our 100 assay point kit allows you to run 100 wells in 96-well format, using a 50 µL reaction volume (5 µL of sample).</li> <li>Our 500 assay point kit allows you to run 500 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).</li> <li>Our 5,000 assay point kit allows you to run 5,000 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).</li> </ul> Features: <ul> <li>No-wash steps, no separation steps</li> <li>ELISA alternative technology</li> <li>Sensitive detection</li> <li>Broad sample compatibility</li> <li>Small sample volume</li> <li>Results in less than 3 hours</li> <li>Half the time of an ELISA assay</li> </ul> AlphaLISA technology allows the detection of molecules of interest in a no-wash, highly sensitive, quantitative assay. In an AlphaLISA assay, a biotinylated anti-analyte antibody binds to the Streptavidin-coated Donor beads while another anti-analyte antibody is conjugated to AlphaLISA Acceptor beads. In the presence of the analyte, the beads come into close proximity. The excitation of the Donor beads causes the release of singlet oxygen molecules that triggers a cascade of energy transfer in the Acceptor beads, resulting in a sharp peak of light emission at 615 nm.
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AlphaLISA Sandwich Anti-analyte Conjugated Acceptor Bead image
AlphaLISA HEK 293 HCP Detection Kit, 100 Assay Points
Human Embryonic Kidney (HEK) 293 is a cell line commonly used for research and biopharmaceutical production. The HEK Host Cell Proteins (HCP) kit is designed to measure contaminants originating from the HEK cells used to manufacture therapeutic antibodies. This kit can be utilized to quantify HEK HCP proteins at various stages, from routine bioprocess operations to crude harvest materials to final products. Our simple procedure and robust assay offer increased throughput compared to ELISA. Formats <ul> <li>Our 100 assay point kit allows you to run 100 wells in 96-well format, using a 50 µL reaction volume (5 µL of sample).</li> <li>Our 500 assay point kit allows you to run 500 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).</li> <li>Our 5,000 assay point kit allows you to run 5,000 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).</li> </ul> Features <ul> <li>No-wash steps, no separation steps</li> <li>ELISA alternative technology</li> <li>Sensitive detection</li> <li>Broad sample compatibility</li> <li>Small sample volume</li> <li>Results in less than 4 hours</li> <li>Half the time of an ELISA assay</li> </ul> AlphaLISA technology allows the detection of molecules of interest in a no-wash, highly sensitive, quantitative assay. In an AlphaLISA assay, a biotinylated anti-analyte antibody binds to the Streptavidin-coated Donor beads while another anti-analyte antibody is conjugated to AlphaLISA Acceptor beads. In the presence of the analyte, the beads come into close proximity. The excitation of the Donor beads causes the release of singlet oxygen molecules that triggers a cascade of energy transfer in the Acceptor beads, resulting in a sharp peak of light emission at 615 nm.
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AlphaLISA Sandwich Anti-analyte Conjugated Acceptor Bead image
AlphaLISA Host Cell Residual DNA Detection Kit, 500 Assay Points
Formats: <ul> <li>Our HV (100 assay point) kits allow you to run 100 wells in 96-well format, using a 100 µL reaction volume (10 µL of sample).</li> <li>Our 500 assay point kit allows you to run 500 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).</li> <li>Our 5,000 assay point kit allows you to run 5,000 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).</li> </ul> Features: <ul> <li>No-wash steps, no separation steps</li> <li>ELISA alternative technology</li> <li>Sensitive detection</li> <li>Broad sample compatibility</li> <li>Small sample volume</li> <li>Results in less than 3 hours</li> <li>Half the time of an ELISA assay</li> </ul> Biologics can be impacted negatively by contamination with DNA introduced during fermentation and purification processes. While the use of serum-free media in the manufacturing process significantly improved the success rate on preventing DNA impurities, other routes of contamination, such as microbial contamination, still remain a concern. It is thus critical to remove and monitor DNA impurities at each step in the purification process. This kit is designed to quantify the levels of DNA (from different hosts, either double- or single-stranded and of varying fragment sizes) in cell culture supernatants. AlphaLISA technology allows the detection of molecules of interest in a no-wash, highly sensitive, quantitative assay. In an AlphaLISA assay, a biotinylated anti-analyte antibody binds to the Streptavidin-coated Donor beads while another anti-analyte antibody is conjugated to AlphaLISA Acceptor beads. In the presence of the analyte, the beads come into close proximity. The excitation of the Donor beads causes the release of singlet oxygen molecules that triggers a cascade of energy transfer in the Acceptor beads, resulting in a sharp peak of light emission at 615 nm.
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マイクロ流体核酸分析

従来のゲル分離を簡略化し、わずかな時間でデータの再現性を向上させることができます。LabChip™自動マイクロ流体キャピラリー電気泳動技術を利用した分離では、ゲノムサンプルを数十秒で分析できます。

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In vitro assay

Leverage reliable in vitro assays to help better understand the interactions of the innate and adaptive immune response for your discovery and development of immunotherapies

We offer a range of assays for characterizing cytokine response, screening biologics, measuring signalling events, determining mechanism of action, and understanding the antibody-dependent cellular cytotoxicity (ADCC) of the biologic.

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Luminescence Assays

Luciferase assays allow for the study of transcriptional gene expression, virus life cycles, and cell viability.

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放射性物質の検出

放射性物質検出は、薬物経路の分析、研究室の環境保護、環境汚染の評価、食品の安全性のモニタリングなど、多くの科学的用途で研究者に使用されてきたゴールドスタンダードであり、現在もその地位を維持しています。

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Radionuclides

Radionuclides provide a highly specific and sensitive labeling option for proteins, cells, and tissues.

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Immune Cell Screening

Preclinical screening services using primary human immune cells to address biologically relevant questions for target identification and lead optimization

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immunoassays
イムノアッセイ

1950年代にイムノアッセイが導入されて以来、イムノアッセイは研究や創薬に不可欠な要素となってきました。

Learn more
microplate readers
マイクロプレートリーダー

Revvityのプレートリーダー製品群は、今日のラボの多様なアッセイ要件に対応する最新の検出技術を備えています。

Learn more

Featured resources

White paper

Achieving higher throughput for the bioanalysis of advanced biotherapeutics

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Brochure

Potency detection assays and solutions

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Application Note

Alpha technology: a fast and sensitive orthogonal approach to cell-based potency assays

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Application Note

Advantages of using our automatable and no-wash HTRF and AlphaLISA kits for CHO HCP detection

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Application Note

Streamline the HEK 293 HCP impurity quantification workflow with new, no-wash AlphaLISA HEK 293 Host Cell Protein Kit

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