September 9th 2025
Data integrity and quality are paramount for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.
September 3rd 2025
The growing cell and gene therapy (CGT) market is driving demand for innovative, robust diagnostics to meet scaling, regulatory, and quality needs.
August 26th 2025
The agreement expands researcher access to backbone modifications that boost stability and delivery of RNA therapeutics across diverse applications.
August 7th 2025
The acquisitions include three testing laboratories that enhance Normec’s ability to serve key highly regulated sectors in the TICC industry.
August 5th 2025
At AAIC 2025, Roche presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios.
NGS abbreviates drug discovery timelines.
International Survey Uncovers Challenges in Laboratory Workflows
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
Sartorius’ New Flow Cytometer Offers Fully Automated Cell Processing
The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.
Automatic Pretreatment System for Cell Culture Media Analysis
Shimadzu’s C2MAP-2030 system can improve operational efficiency for optimizing and controlling the cell culturing process.
Portfolio of Tools to Advance Immunotherapy
Agilent’s updated portfolio of products for immunotherapy researchers provides cell-based tools for translational research and development.
From Data to Information
Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.
GLPs: Better Data Access Needed to Improve Compliance
Stuart Jones, regulatory quality assurance professional in good laboratory practice (RQAP-GLP) and director of quality assurance at PPD Laboratories’ Bioanalytical Laboratory shared GLP best practices with BioPharm International.
Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
Cleaning Chromatography Resin Residues from Surfaces
Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
Web-based Application Automates HT Experimentation at Pittcon 2019
Katalyst D2D from ACD/Labs enables the design, planning, execution, and analysis of high throughput (HT) experiments. The web-based application was introduced at Pittcon 2019 in Philadelphia, PA.
SSB, Novasep to Develop Membrane Chromatography Systems
Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
Test Methods and Quality Control for Prefilled Syringes
Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.
Affinity Chromatography Analysis Column for Antibody Drugs
The TSKgel FcR-IIIA-NPR HPLC column from Tosoh Bioscience is a FcRγ affinity chromatography analysis column suited for the analysis of immunoglobulin G glycoforms.
Andrew Alliance, Sartorius to Collaborate on Pipettes
The companies will develop a software-connected pipetting system for improved reproducibility and traceability in life-science laboratories.
Liquid Handlers for Automated Lab Workflows
Formulatrix’s FLO i8 and Flow Axial Seal Tip liquid handlers offer automated transferring.
Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
The Benefits of Combining UHPLC-UV and MS for Peptide Impurity Profiling
Determining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.
SGS Expands Testing Capabilities at Its Glasgow Facility
SGS announces expansion of cell bank and bulk harvest testing services.
Waters Launches SmartMS-Enabled LC–MS Biopharma System
The company has built a fit-for-purpose liquid chromatography–mass spectrometry (LC–MS) system to streamline analytical monitoring tests for biopharmaceuticals.
Matching Personal and Company Success
Compensation and professional challenges are key pieces to solving the biopharma employee satisfaction puzzle.
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
FDA Answers Data Integrity Questions
New FDA guidance developed to identify lapses in data integrity and promote best practices.
Microbial Identification Strategies for Bioburden Control
Microbial identity data can be critical for determining contamination sources.
Unprocessed Bulk Testing for Biopharmaceuticals
Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
NIST Fluorescence-Based Measurement Services
Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
Advanced Flow Cytometry System Breaks the Cost Barrier
Cytek Biosciences’ Northern Lights series of advanced flow cytometry systems brings reagent and application flexibility to more labs while enhancing performance.
Innovation and Industry Strength Recognized at CPhI
Survey results and record attendance may show positive signs for established and emerging biopharma regions.
Cobra Biologics and the University of Leeds Collaborate on Viral Vector Bioprocessing
A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.
Chip-Based Device May Transform Spectrometry
Research from Massachusetts Institute of Technology suggests that small chips could replace standard lab-scale spectrometry equipment for many applications.
Merck KGaA Adds New Packaging Center
The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.