This application note describes a UPLC-MSE analysis of monoclonal antibody (mAb) disulfide bond. This study demonstrates that UNIFI-a compliance-ready software-is designed to support biopharmaceutical laboratories in performing fast peptide mapping and monitoring of mAb disulfide linkages.
This whitepaper provides a summary of the impact of PIC/S, and compliance with the PIC/S document PE 009-12 “Guide to Good Manufacturing Practice for Medicinal Products Annexes“ Annex 11 Computerised Systems. It includes a high-level foundation to understand how pharmaceutical manufacturing companies are being regulated, what PIC/S means for common requirements across different countries, and how these requirements relate to expectations for data from computerised systems/electronic records.
Historically, UV detection has been favored in many laboratories for its ease of use, robustness, and reliability. However, some of the inherent challenges include analytes that do not have a response in a UV channel, coelutions, and unknowns, any of which can require an orthogonal approach such as mass detection. While mass detection offers a number of benefits when used in tandem with UV detection, incorporating it into an existing UV workflow can be time-consuming and laborious.
The objective of this application note is to demonstrate that the ACQUITY QDa Detector provides a simple and cost-effective solution for detecting oligonucleotides across a wide molecular weight range and can be readily integrated into existing UV-based workflows.
The validation process of an analytical method is a complex and demanding activity, consisting of many time-consuming steps. Empower® 3 Method Validation Manager (MVM) automates the method validation workflow within a single software environment, reducing time and ensuring conformance to the validation requirements and acceptance criteria defined in the protocol. This application note demonstrates validation of a UPLC® method for metoclopramide HCl and related substances using Empower 3 MVM.
Insulin was the first recombinant pharmaceutical produced. Currently, one of the critical quality control attributes of therapeutic insulin in the US and European Pharmacopoeia (USP and EP) monograph is the level of covalent high molecular weight (HMW) insulin as determined by HPLC size-exclusion chromatography.
The migration to chromatographic methods utilizing smaller particle sizes has been well demonstrated to increase productivity through faster, more efficient separations.
For the analysis of biotherapeutics, size-exclusion and ion-exchange chromatography are typically conducted under native separation conditions, requiring high ionic strength, 100% aqueous eluents.
Fast, flexible platforms for peptide quantification are needed, particularly for a discovery setting. This type of methodology would be especially advantageous in the case of amyloid beta (a?) peptides.
In the past decade, supercritical fluid chromatography (SFC) has been established as a cost-effective, sustainable, and green purification technology for pharmaceutical and related industries.
Morphine is an effective pain-relieving drug that is primarily metabolized into morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G). The highly potent M6G may have adverse effects, such as respiratory depression and renal failure, if accumulated in the body. As morphine abuse continues to affect modern society, an effective method must be established to analyse morphine and its structurally related compounds in biological fluid samples. In this work, a UPLC–MS-MS method was developed to separate six morphine-related compounds on a 2.1 Ã- 100 mm, 1.8 μm ACQUITY UPLC HSS T3 column in a single run using an ACQUITY UPLC system connected to a fast-scanning triple-quadrupole MS detector (TQD). The method achieved adequate retention of these very polar compounds by reversed-phase (RP) chromatography in an 8-min total run time.
