Manufacturing

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

New identifiers and tracking requirements aim to block illegitimate products.

Methods of validating and assuring container closure integrity are crucial for quality assurance.

Arc View Handheld Mobile Sensor Enhances Measurements

CLARiSUITE Software Improves Accessibility and Productivity

Multirobot Offline Programming Software Allows 3-D Simulation

Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.

Advanced drug delivery technologies can increase efficacy and safety, extend patent lives, and provide competitive differentiation for biopharmaceuticals.

Catalent Pharma Solutions recently launched several new softgel product developments, all of which solve a delivery problem, while offering IP advantages to drug manufacturers.

Vetter launches new serialization process to support track-and-trace efforts.

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

Experts will examine continuous processing in solid-dosage and biopharmaceutical production.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Displays will include new products for anticounterfeiting, labeling, and compliance packaging and new equipment for filling, aggregating, and quality control.

Walker Barrier Systems builds eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

ASI Life Sciences introduced the DHX Disposable Heat Exchanger and the imPULSE MDS mixing, docking, and shipping system for single-use biopharmaceutical processes.

Plastic pump chamber is a cost-effective alternative for biopharmaceutical applications.

The DEPA DH next-generation double air-operated diaphragm pump from Crane features a new design.

Metering pump can be used with aggressive or corrosive liquids.

HHS plan makes progress in ensuring availability of safe vaccines.

Precalibrated instruments deliver accurate readings and withstand rigorous use.

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

Manufacturers are taking measures to comply with new package safety rules.

The extended-release performance of drug-loaded pellets manufactured by two methods, drug layering and direct pelletization, was compared.

Capsule filler

Bioprocessors should understand the key factors associated with implementing single-use components or platforms, which include materials of construction, components, system design, and vendor support.

Using best practices for manual or automatic inspection can improve the inspection process.

Tablet Press