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.
Chalmers Researchers Develop Fluorescence Method to Track RNA
Chalmers University researchers have developed a method to label and track mRNA molecules.
Thermo Fisher Scientific’s Clinic Solution Aims to Accelerate Biologic Drug Development
Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.
Sphere Fluidics and ClexBio Introduce CYTRIX Microfluidic Hydrogel Kit
The CYTRIX Microfluidic Hydrogel Kit is the first in Sphere Fluidics’ new range of 3D cell culture kits in partnership with ClexBio.
Development Strategies for Cell and Gene Therapy Methods
The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
PPD Opens Multipurpose Clinical Research Laboratory in China
PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.
PerkinElmer Expands Cell Biology Capabilities with Nexcelom Bioscience Acquisition
The acquisition gives PerkinElmer access to Nexcelom Bioscience’s complementary cell counting and analysis capabilities and enhances its QA/QC capabilities.
CDMO Landscape Seeing Changes as Consolidation Continues
The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.
Challenges When Outsourcing Viral Safety Services
Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
Evolving Analytical Technology Unravels Protein Characteristics
Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.
Pipette Tip Shortage Hinders Bio/Pharmaceutical Development and Testing
A shortage of pipette tips has been attributed to several factors, including the COVID-19 pandemic.
Stability Testing of Protein Therapeutics Using DLS
Dynamic light scattering presents a good analytical technique for testing protein stability.
Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing
The need for real-time monitoring and control has spurred the development of new analytical tools.
Toxicology: Ensuring Drugs are Safe for People
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
Roche and Cambridge Quantum Computing Use Algorithms for Early Alzheimer's Drug Research
The companies intend to design and implement algorithms for the early stages of research for drug discovery and development of drug candidates to treat Alzheimer’s disease.
SPT Labtech Strengthens Automation Services with BioMicroLab Acquisition
The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.
Nexelis Expands Bioanalytical Services with Bioanalytical Lab Acquisition
Nexelis’ recent acquisition of GSK’s Marburg, Germany-based vaccines clinical bioanalytical laboratory expands its bioanalytical capabilities.
Almac Invests in Expanding Global Biologics Testing Solutions
The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.
Talent-Driven Market for Laboratory Technicians
Demand for specific advanced laboratory skills creates a positive employment market.
rBIO Hits Key Lab Milestone with Synthetic Production of Insulin
Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.
Biopharma Gets Back to “New Normal” Business
After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.
Compensation Does Not Necessarily Align with Job Satisfaction
Essential bio/pharma employees show hard work and dedication can pay off, for patients.
Using Protein Characterization to Support Regulatory Submissions
Clear understanding of what exactly the biomolecule entails is essential.
BioSkryb Discusses First Data Demonstrating Improved Accuracy in Single Cell Analyses
A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
Dolomite Microfluidics Partners with MilliporeSigma for Microfluidic Device Kits
Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.
Charles River and PathoQuest Establish US Subsidiary for NGS-based Testing Lab
The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.
Single-Use Sensors Increase Process Understanding
The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.
Complex Modalities Require More Sensitive Adventitious Agent Testing
Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.
Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?
Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging
Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.