Harnessing Technology to Ensure Drug Safety
The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.
Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms
This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.
Excipients Impact Stability in mRNA-LNP Formulations
Lipids aren’t the only important ingredients influencing stability and in vivo performance.
Influencing Change in Drug Delivery
Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.
Frontrunner in Microbiome Therapeutics
EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.
Implementing Process Analytical Technology
PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs.
Automated Inspection of Pre-filled Syringes and Biologics During Fill/Finish
Shifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
Taking Steps Toward Supply Chain Continuity
Stockpiling excess inventory is no longer enough to respond to supply chain volatility.
Keeping Europe’s Medicines Stocked
Technological advances will help ease pressure on pharma supply chains, allowing for greater visibility and less uncertainty.
The Logistics of Outsourcing Biologics
The trends shaping the growth of the biologics outsourcing industry demand attention.
Vaccine Development Builds on COVID-19 Breakthroughs
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.
EMA Guidance on Paediatric Investigation Plans
Stepwise paediatric investigation plans aim to boost the development of medicines for children.
Outsourcing Still Vital
The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.
Feeling the Pinch
Soaring energy costs are compounding the challenges currently being faced by the European bio/pharma industry.
Securing the Supply Chain with Good Distribution Practices
Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.
Planetary Dual Dispersers for Highly Viscous Batches
The ROSS PDDM Planetary Dual Disperser offers flexibility in the form of removable disperser shafts.
Enhanced Filter Blowback System
Fluid Air’s Enhanced Magnaflo filter blowback system is designed to increase powder yield in PolarDry Models 001 and 004.
Single-Cell Picker
The IsoPick from iotaSciences is designed to expand handling solutions for cell biology and gene therapy applications.
CHO-Based Assay Kit
Charles River’s HCP-ELISA kit is designed to increase the efficiency and efficacy of HCP assay development.
Subsurface Currents
That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.