Manufacturing

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

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

Tablet Press with Fastest-in-Class Changeover

The root cause of drug shortages is mismanagement of variation.

Trends driving pharmaceutical packaging include product protection, productivity boosters, and patient adherence improvement.

USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.

The Intelli-Code Carton Coding and Inspection System connects to serialization data-management systems.

A combination of overt and covert features protects against counterfeiting.

New methods of encapsulation and filtering address scale-up challenges.

Manufacturers should plan ahead when implementing a serialization project to comply with the Falsified Medicines Directive.

Thirteen companies are accepted for participation in the supply chain program.

EMA releases an update on its flu vaccine guidance.

ProcessPro releases Premier 10.4 software.

EMD Millipore's new Drypour packaging system helps minimize caking of pharmaceutical raw materials.

High technology assessments are having an impact on biosimilars development in Europe.

CMOs may find opportunities in alternative expression services.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Advances in technology are improving the sensitivity and accuracy of mass spectrometry, increasing its use for the analysis of extractables and leachables.

Content Packages Accelerate MBR Creation

Advanced triple quadrupole technology for improved performance and ease of use.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

FactoryTalk Software Increases Flexibility

Simple and affordable mass detection for the chromatographer.

Work-in-Process Tracking Software