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Synthetic Carbon Adsorbents for Host Cell Protein Removal in Monoclonal Antibody Purification

Demonstration of the excellent capability of Carboxen® synthetic carbon adsorbents to reduce host cell proteins (HCPs) and recover monoclonal antibodies (mAbs) using a post protein A pool step.

Value Drivers and Benefits of Closed Processing

Closed processing enables more streamlined, flexible, and cost-effective multi-product and multi-modal facilities, while ensuring the highest level of product quality and safety. Learn more about how contamination risk is mitigated and the additional value and benefits of closed processing.

One-Batch Calibration: A Process-, Instrument-, Scale- & Site-agnostic Method For Streamlining Raman Implementation

Challenges associated with Raman spectroscopy implementation in bioprocesses can be overcome by the innovative one-batch calibration approach. This streamlined process requires less time and resources compared to traditional approaches, unlocking Raman benefits for biopharmaceutical applications.

Operational and Financial Advantages of Cellicon^® Cell Retention Solution in an N-1 Perfusion Process

This page describes the financial and operational advantages offered by the Cellicon® Cell Retention Device in an N-1 perfusion process at the 2,000 L scale in comparison to a cell retention device from another supplier.

Cell Harvest, Lysis, Neutralization and Clarification of Plasmid DNA (pDNA) for mRNA, plasmid-based DNA Vaccines, and Viral Vector applications

An overview of the cell harvest, lysis, neutralization, and clarification steps used for pDNA purification along with case study and practical advice.

Chromatographic Purification of Plasmid DNA (pDNA) for mRNA, Plasmid-based DNA Vaccines, and Viral Vector Applications

See case study examples of how to optimize chromatographic purification of plasmid DNA for Biopharmaceutical Applications.

Plasmid DNA Purification Process

Free eBook outlines plasmid DNA manufacturing process and downstream purification challenges for various applications.

Performance Characteristics of the Mobius^® ADC Reactor for Conjugation

ADC production relies on conjugation to link the cytotoxic payload to the mAb. Explore the benefits of a single-use reactor for efficient conjugation.

Improving Efficiency and Control in Biopharma Manufacturing With Process Analytical Technology

Key considerations for process analytical technology (PAT) implementation in biopharma and its role in enabling the facility of the future.

Reproducible Scaling of a Cell Retention Filter Using the Cellicon^® Cell Retention Solution

This page describes the design attributes of the Cellicon® filter assembly for cell retention and how they simplify scale-up of intensified upstream processes.

Scalability and Performance of Mobius^® iFlex Bioreactors

This page summarizes several performance attributes and scalability data for Mobius® iFlex Bioreactors, single-use, stirred tank systems designed to support traditional and intensified fed-batch and perfusion cell culture applications.

Assay of Betamethasone Sodium Phosphate by HPTLC

Development of an HPTLC based method, using Silica Gel 60 F254 plate, to determine Betamethasone Sodium Phosphate over a concentration range of 1 to 7 µg/spot.

Assay of Doxepin Hydrochloride USP Monograph

The FPP Purospher® STAR RP-8e column offers a reliable and consistent assay with strong peak shapes and linearity, ensuring precise quantification.

Clozapine Assay HPLC Method acc to USP Monograph

An HPLC-UV method for the identification and quantification of clozapine in API samples and tablet formulations, following the USP monograph guidelines.

Determination of Baicalin, Chlorogenic acid and Forsythin

Analyze Shuanghuang Lian oral liquid using Discovery® HS C18 HPLC column per Chinese Pharmacopeia 2020. Quantify baicalin, chlorogenic acid, and forsythin with high accuracy.

Determination of Geniposide Forsythin in XiaoerChiqiaoQingre

Analyze Xiaoer Chiqiao Qingre granules for geniposide and forsythin using Discovery® HS C18 column and Supelclean™ LC-Alumina-N SPE.

Determination of Impurities in Clozapine API

HPLC-UV quantitative analysis of four clozapine-related substances in clozapine API as per Ph. Eur. Monograph using Purospher® Star RP-18 endcapped column.

Fatty Acid Methyl Ester analysis by Gas Chromatography

Development and validation of a fatty acid methyl esterification method, using methanolic HCl reagent, for FAME analysis by GC of vegetable oils and fats.

Fluticasone Propionate Assay by HPLC UV USP Monograph

Learn how the Purospher® STAR RP-18e Hibar® HPLC column meets the system suitability criteria outlined in the USP monograph for the fluticasone propionate assay.

Gabapentin Assay: Ph. Eur. Monograph

LC-MS/MS quantitative method analyzes highly polar 11 nucleotide activated sugars using Supel™ Carbon LC column.

Safinamide Impurity Profiling by HPLC Assay Methods

HPLC-DAD method on Ascentis® Express C8 column analyzes safinamide purity and related impurities meeting system suitability criteria.

HPLC Separation of Nitrosamines with Supel Carbon LC

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

Organic impurity profiling of Valacyclovir using TLC

Thin-layer chromatography method for detecting organic impurities in valacyclovir, an antiviral medication, following USP monograph guidelines.

Piroxicam Capsules-Assay and Organic Impurities Following United States Pharmacopoeia Pending Forum Method

A reversed-phase high-performance liquid chromatography (RP- HPLC) based quantitative assay and organic impurity analysis of Piroxicam in its capsule dosage form.

Protein Binding Determination Using Supel™ BioSPME C18 Pin Device as Part of the Manual Methodology With and Without Shaking

The application note describes a comparative analysis of plasma protein binding results for free/bound drugs using two different sample extraction steps, with and without agitation.

Quantitative Analysis of Nitrosamine Impurities by LC-MS Methods from the United States Pharmacopeia General Chapter <1469>

This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter .

Enhance Solubility With 3D Printing and Mesoporous Silica

Accelerate formulation of APIs with solubility challenges using additive manufacturing (3D printing) with mesoporous silica. Explore this case study!

API Solubility and Dissolution Enhancement Via Formulation

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

Active Pharmaceutical Ingredient (API) Stability in Solid Dose Formulation

This article describes the use of excipients to help address API stability issues.

Improving API Solubility with Mesoporous Silica

Discover how mesoporous silica enhances API solubility, unlocking the full potential of promising drugs with improved bioavailability.

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