Manufacturing

Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

Micronization and other processes are used to obtain optimal particle characteristics for pulmonary and oral solid-dosage delivery.

The EdgeTRAC software Print, Apply, and Verify module from ROC IT Solutions can be used to implement serialization in manual packing operations.

Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.

A semi-automatic case packer from Omega Design and Brazil's Grupo Tecnor offers unit-level serialization capabilities.

Designed for ISO Class 4 compatibility, BioClean? 400mm (16?) gloves give 33% more coverage than the standard cleanroom glove providing exceptional comfort and offering extra personal and product protection.

Molecular Profiles has expanded its capsule filling capability following significant investment into new equipment at its clinical manufacturing site in the United Kingdom.

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses the use of interactive response technologies in investigational product expiry management.

FDA approved XTANDI for the treatment of metastatic castration-resistant prostate cancer.

The pharmaceutical industry has traditionally used glass as a primary material for containment systems due to a variety of characteristics that enable generally safe and efficient drug storage. However, there are many risks associated with glass.

Terra Universal introduced a floor-mount model of its BioSafe pass-through for cleanroom material transfer.

FDA gives NewLink Genetics approval to proceed to Phase 1 clinical studies of Ebola vaccine.

Meggle Group Wasserburg has been granted an EXCiPACT certificate.

Conventional tablets may no longer be the go-to solution.

Ultrasonic cleaning of solid-dosage tooling and other equipment, such as filling-machine valves and nozzles, is more effective than hand cleaning.

Experts from Baxter BioPharma Solutions provided the following commentary on trends in bio/pharmaceutical development outsourcing.

Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.

Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.

The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

Biopharma manufacturers must reduce risk in their complex supply chains and establish effective monitoring and control systems.

An expert discusses how companies should be preparing to meet the requirements of the Drug Supply Chain Security Act, which requires phase-in of requirements to prevent counterfeiting.

Manufacturers can identify and reduce waste using tools such as value-stream mapping.

PharmaChk, a portable device being developed to detect substandard medicines, receives $2-million grant.

Biopharma manufacturers must reduce the risk in their complex supply chains