Search results for "analytical"
Article
Essentials in Quality Risk Management
…hase during drug development and manufacturing and changes in drug-product formulation, definition, analytical method, and associated process changes are understood and managed to ensure patient safe…
Article
The Importance of Partnering for Bioanalytical Studies
By Feliza Mirasol
Bioanalytical studies are an important aspect in biologic drug development because data from these studies are needed to define the characteristics of potential new biologic …
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Advances in analytical instruments are one key part of the solution. Novel techniques including Raman spectroscopy and other advanced monitoring methods have the potential to reduce the reliance on di…
Article
Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
Article
Evaluating E&L Studies for Single-Use Systems
Analytical methods
In the three case studies, the following analytics were applied:
• Headspace sampling/gas chromatography/mass spectrometry (HS/GC/MS) and gas chromatography/mass…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The developed testing algorithm, which incorporates a combination of few relatively simple analytical methods such as osmolality, quantitation of glucose, and folic acid, provides specific identity co…
Article
Virus-like Particles as Therapeutic Moieties of the Future
In this 44th article in the “Elements of Biopharmaceutical Production” series, the authors review the status of VLPs as therapeutics as well as challenges associated with their analytical and function…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities and their consequence to the ultimate quality, safety, and efficacy of biopharmaceuticals--as well as improvements in analytical technology that provide…
Article
Witnessing Major Growth in Next-Generation Antibodies
Additional analytical and regulatory demands
Next-generation antibodies also have their own set of analytical and regulatory challenges. With respect to analytical methods, each format/target comb…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…