Laboratory Data Integrity Benefits from Electronic Systems
IDBS described benefits and best practices for laboratory electronic data systems.
Do You Listen to What Your Data are Telling You?
This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
Matching Tools to Biophysical Analysis Demands
Method choice is crucial to when seeking answers to biosimilar characterization questions.
Tale of Two Financial Trends
New reports address biopharma’s leading concerns: funding for drug development and pricing of finished drugs.
Inspections: The Value of the Opening Presentation
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Deviation Investigation Format and Content: A Guide for Inspection Success
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Balancing Protocols for Leachables
While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
Biosafety Concerns of Single-Use Components
Single-use bags containing toxic or hazardous materials required special handling.
FDA Continues to Promote Quality Drug Production
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Contract Manufacturing Through the Years
How has the bio/pharmaceutical contract manufacturing industry evolved and changed over the years and what does the future hold?
Intensification of a Chromatography Platform
The authors present a shift toward more integrated purification processes.
Going from Fed-Batch to Perfusion
Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.
Platform for Integrated Continuous Bioprocessing
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
STR Profiling: Authentication of Human Cell Lines and Beyond
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
BioPharm International, July 2017 Issue (PDF)
Click the title above to open the BioPharm International July 2017 issue in an interactive PDF format.
