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Current Issue
BioPharm International, October 2018 Issue (PDF)
Click the title above to open the BioPharm International October 2018 issue in an interactive PDF format.
Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability
Non-destructive surface area measurement can improve stability testing.
Can QRM Transform Biopharmaceutical Operational and Quality Culture Excellence?
Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
Outsourcing
Outsourcing Development: Small-Scale to Commercial
Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
Biosimilars and Healthcare Policy: What China Can Learn from the EU and US
While food, shelter, and clothing are the primal essentials for life, hope—as embodied by modern medicine—has now become part of that human expectation.
Symbiosis Secures FDA Viral Vector Process Approval
The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.
Standards/Regulations
USP Proposes a New Chapter for Rapid Sterility Testing
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
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