Testing Innovative Analytical Waters
Laboratories are focusing on more automated processes while also trying to maintain an efficient, safe, and personalized experience with each analytical test.
Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations
Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
Overcoming Challenges to Formulation Development for Pediatric Medicines
The biggest hurdle is developing palatable formulations that are efficacious and patient friendly.
An Intelligent Drug Development Paradigm
An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
Charting the Future of Vaccines
A comprehensive understanding of what makes mRNA vaccines tick is crucial in charting the future of the market.
Progressing Finished Product Inspection Through Automation
The industry is taking steps to automate the final product inspection process for complex therapeutics.
Staffing Shortages: Major Hurdle for Bioprocess Contract Manufacturing Services in 2023
More than a third of CMOs are struggling to keep skilled technical and production staff.
Ensuring OSD Quality and Safety
Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.
A Healthier Tomorrow?
Only a significant joint effort across the supply chain will help to make healthcare more sustainable and reduce the impact of climate change on global health.
Phasing Out COVID-19 Regulatory Flexibilities
What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?
Industry Challenges Medicare Price Negotiation Scheme
Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.
New Magic from mRNA
mRNA may be a modality whose chief advances are yet to come.
Sharing Critical Information for the Best Outcome
The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.
Supply Chain Securities
Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.
ROSS Multi-Agitator Low-to-Medium Viscosity Mixer
The ROSS Model CDA-200 is fitted with multiple agitators for semi-continuous operation.
Versatile Cell Line Platform
Sphere Fluidics’ Cyto-Mine is an automated cell line platform that is designed to enable screening of up to 40 million cells over the course of several hours.
Customizable mRNA Synthesis Service
Eurofins Genomics Blue Heron IVT mRNA synthesis service is designed to provide researchers a customizable solution.
Tumoroid Culture Medium Kit
Thermo Fisher Scientific’s Gibco OncePro Tumoroid Culture Medium Kit was specifically developed for the expansion of patient-derived tumoroids from multiple cancer indications.
