BioPharm International November 2017

November 2017 | Volume 30, Issue 11
BioPharm International November 2017
Cover Story
Siliconization is a key process step in the manufacturing of prefilled syringe systems.
Features
Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
Upstream Processing
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
Downstream Processing
Connectors are a critical element in the process optimization of single-use bioprocessing systems.
The use of external retainers to enhance the seal between connectors and tubing is an essential component in single-use manufacturing systems.
Manufacturing
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
Regulatory Beat
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Perspectives on Outsourcing
Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.
Ask the Expert
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
From the Editor
CPhI Pharma Awards honor companies and individuals driving the pharma industry forward.
Product Spotlight
By BioPharm International Editors
Qosina's Y connectors are manufactured from plastisol and produced through a dip-molding process.
By BioPharm International Editors
An updated version of Shimadzu’s LabSolutions analytical data system features an operating environment for complete data management and security in networked laboratories.
By BioPharm International Editors
The Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is compliant with good distribution practices and comes in three models.
By BioPharm International Editors
Cole Parmer's Masterflex L/S Cytoflow pump head is suited for use in biopharma and microbiology applications.
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