Analysis of mRNA Therapeutics and Vaccines
Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium Carboxymethylcellulose
In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
What’s Next for COVID-19 Vaccines and Variants?
Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.
Synthesis, Extraction, and Purification of Cannabinoids
Interest in natural phytochemicals or synthetic derivatives of cannabinoids has risen.
Accelerating Workforce Training on Single-Use Technologies
Training is crucial for supporting GMP operations in commercial-scale bioprocessing.
How to Effectively Implement Pharma 4.0 Technologies
Getting started with a PAT framework enables automation with digital technologies.
Serialization and Aggregation from a Manufacturing Perspective
For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.
Driving Consistency in Validation Management
With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.
Increased Data Output is a Double-Edged Sword in Drug Discovery and Manufacturing
Automated analytical workflows require advanced technologies to manage the higher volume of data output.
What’s in Your Quality Manual?
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.
The Data Relationship
As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
Global Vaccine Access Challenges FDA and Industry
The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.
Updated Guidance to the EU’s Digital Markets Act
The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.
The Price Debate
As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.
Celebrate the New
The process of reshaping inevitably leads to fresh insights.
Triple Shaft Mixer
The ROSS VersaMix Triple Shaft Mixers offer fine dispersion, deagglomeration, emulsification, temperature control, and degassing.
Rapid Mass Photometer
The SamuxMP enables routine quantification of empty/full AAV capsid ratios
High-Capacity Vacuum Filtration Units
Sartorius’ Sartolab RF|BT 150–1000 vacuum filtration units provide fast, high-capacity filtration.
Environmental Monitoring Plates
Thermo Fisher Scientific's Triple Wrap Plates possess a unique Vapour-phase Hydrogen Peroxide (VHP) indicator for enhanced sterility and complete clean room and isolator confidence.
A License to Innovate
Busy is good for business.
