The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.
FDA conducted a general inspection of operations and quality systems of Albany Molecular Research Inc (AMRI) in Burlington, Mass.
Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.
New cartridges designed specifically for use on high-speed filling lines increase efficiency.
Equipment and Processing Report
Presenters at a pharmaceutical extrusion seminar discussed formulating drugs produced using hot-melt extrusion.
Equipment and Processing Report
Containers, components, and quality control equipment help safeguard product quality and patient safety.
The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.
Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.
The new ink takes less a second to dry and is four times more fade resistant than inks that are typically used in retail packaging.
PTSM: Pharmaceutical Technology Sourcing and Management
The US and EU move forward with measures to fortify the pharmaceutical supply chain.
Report outlines recommended practices for control and evaluation of operations.
Novartis and Biological E, a biopharmaceutical company based in India, have entered into an agreement that aims to deliver affordable and accessible vaccines for typhoid and paratyphoid A fevers to developing countries and thereby address the unmet medical need in endemic regions.
Compounding, tracking legislation moves forward
Risk management guides decisions in facility design and operation for highly potent drugs.
A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.
Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.
The author presents best practices for extractables and leachables.
GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.
The US and EU move forward with measures to fortify the pharmaceutical supply chain.
Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.
The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.
Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.
Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week.
Equipment and Processing Report
Model-predictive design is applied to solid-dosage processes.
Equipment and Processing Report
Solid-dosage forms and parenteral products benefit from next-generation packaging machines.
