The Earlier the Better for Formulation Strategies
Investing in formulation strategies earlier on in development will maximize the chance of success.
Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data
Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms.
Taking an Alternative Approach to Drug Delivery
Alternative drug delivery approaches are promising, but due to their complexity, they need to be sufficiently justified.
Computational Fluid Dynamics in Upstream Biopharma Manufacturing Processes
Advances in simulation and the development of digital twins.
GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 Pandemic
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
Visual Inspection: Seeing Room for Improvement?
Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.
Detecting and Determining Quantitation Limits for Impurities
Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.
Labeling Efficiently
Machine and material innovations yield more efficient, sustainable processes for pharmaceutical packaging, including vaccine vials.
Meeting Supply and Training Challenges
Best practices help mitigate generic drug shortages.
Pandemic Alters FDA Inspections and Quality Oversight
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Lipids for Self-Emulsifying Drug Delivery Systems
SEDDS and SMEDDS improve solubility and permeability while expanding efficacy and applicability.
Great Expectations for Excipients
Can We Agree on Conferences?
Making a Difference in European Bio/Pharma
Manufacturing capacity expansion is high on the agenda for many bio/pharma companies and service providers in Europe.
The Remote Audit–A Tongue-in-Cheek Memo
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
Wraparound Vial Labeling Machine
WL-1-RT Wraparound Vial Labeling Machine can label up to 600 vials per minute.
ADCC Expression Cell Line
The ADCC+ Cell Line is designed for rapid identification of clones expressing high levels of recombinant therapeutic proteins.
Liquid Pharmaceutical Checkweigher
The Mettler-Toledo StarWeigh checkweigher provides fill level measurements of products like glass and plastic bottles, vials, and ampules.
Pressure Feed Vessel
The ROSS Ribbon Blenders ensures even mix and consistent batches.
