FDA and Manufacturers Intensify Concerns about Data Integrity
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
Planning a Biologics Facility Start Up
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
Solid-Dosage Packaging Trends
Innovations protect product quality, improve productivity, enhance sustainability, and simplify usage for patients and caregivers.
Quality System for a Regulatory Affairs Department
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.
Data Integrity Challenges in Manufacturing
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
Bio/Pharma Funding Challenges Could Hurt CDMOs in 2017
CDMOs need to be aware that unfavorable public markets put emerging bio/pharma R&D spending at risk in 2017.
Cleaning Bioreactors and Fermenters with CIP Systems
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
Maximize Efficiency in Tooling Maintenance
A seven-step process may reduce many common tablet and tooling problems, resulting in a better quality end product.
Recognizing Pharma Industry Excellence
CPhI Pharma Awards seek nominations for excellence in development and manufacturing.
Expanding the Chiral Toolbox
Recent chiral advances demonstrate promise for API synthesis.
Modular Bioreactor Simplifies Process Development
The ambr 250 mini benchtop bioreactor system from Sartorius Stedim Biotech can be used for parallel fermentation and cell culture.
Data Integrity Solution Improves Quality and Compliance
The LabX from Mettler Toledo has the ability to connect different laboratory instruments to one management system.
Double Planetary Mixer for Deaeration of Viscous Formulations
The Double Planetary Mixer (DPM) from Ross, Charles & Son can be used for single-pot mixing and deaeration of viscous formulations such as thick pastes, putties, gels, and other semi-solid products.
Single-Use Bioreactor Reduces Turnaround Time
The BIOne single-use bioreactor from Distek is a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production.
Taking On Mission Insoluble with Polymers
Polymers have played a key role as solubilizing excipients. Industry experts explain why polymer structures and functionalities are important considerations in formulation development.
The importance of lipid screening in the development of lipid-based formulations
Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.
Exploring the Use of Aseptic Spray Drying in the Manufacture of Biopharmaceutical Injectables
Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.
Raplixa case study: Enabling an innovative drug presentation through aseptic spray drying
FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.
More inspections, and regulator collaboration, offshore
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
Ensuring Supply Chain Safety
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
Evaluating Practical Uses of Molecular Isotopic Engineering
The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
Pharmaceuticals in the Environment Spark Controversy
The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.
Pharmaceutical Technology, July 2016 Issue (PDF)
Click the title above to open the Pharmaceutical Technology July 2016 issue in an interactive PDF format.
