Manufacturing

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

Software Expands Plant-Specific Analysis

Although software and the overall warehouse management solution (WMS) are crucial tools, common problems include failure to put in place an efficient warehouse layout best suited to the products being handled, lack of knowledge of the inventory on hand, and inadequate preparation and training of personnel.

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

Geographic location, customs and drug-development regulations knowledge, and transportation infrastructure were factors in Catalent Pharma Solutions' selection of Shanghai for its clinical-trials supply facility.

A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.

PharmaCell enters an agreement purchase TiGenix therapy production facility.

I Holland announces service that predicts solutions for tablet sticking problems.