BioPharm International April 2017

April 2017 | Volume 30, Issue 4
BioPharm International April 2017 Issue
Cover Story
Including next-gen antibodies in pharma pipelines is considered essential for future success.
Features
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
Downstream Processing
For cellular materials, new ultra scale-down devices inform large-scale downstream processing techniques.
Upstream Processing
OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.
Analytical Best Practices
Chromatography modeling can enhance bioprocessing efficiencies.
FTIR can successfully measure key characteristics of therapeutic proteins in a single step.
Regulatory Beat
Industry fears limited benefits as FDA readies voluntary data tracking program.
Perspectives on Outsourcing
New study shows China biopharma companies face staffing shortages.
Ask the Expert
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
From the Editor
Philadelphia plays host to the exhibits, conferences, and networking activities of CPhI North America on May 16-18, 2017.
Product Spotlight
By BioPharm International Editors
The Quantum Pump from Watson Marlow Fluid Technology Group is a peristaltic pump with patented ReNu single-use (SU) cartridge technology.
By BioPharm International Editors
The X500B QTOF System is the latest solution in SCIEX’s X-Series Quadrupole Time of Flight (QTOF) mass spectrometry (MS) platform.
By BioPharm International Editors
The Cannabis Analyzer for Potency from Shimadzu Scientific Instruments (SSI) is a high-performance liquid chromatograph (HPLC) specifically for quantitative determination of cannabinoid content.
By BioPharm International Editors
The Thinky PR-1 Nanoparticle Dispersion Machine from Intertronics is a desktop unit that can disperse carbon nanotubes (CNT), graphene, and other 2D nanomaterials within a closed container.
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