Manufacturing

The Endress+Hauser iTHERM TrustSens hygienic RTD self-calibrates to verify in-line that the sensor is working as designed

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

Oceasoft has updated its line of Bluetooth-enabled temperature data loggers for shipping and logistics applications.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

A survey by LNS Research and sponsored by Honeywell showed that industrial companies are not moving quickly to adopt cyber security; calls on CEOs to take action.

The company will expand two of its Ohio facilities, investing approximately $145 million to support manufacturing and warehouse operations.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Aero Pump’s preservative-free Multidose Eye Dropper System with SideActuationDevice received the CPhI Pharma Award for Excellence in Pharma: Packaging.

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.

Is pharma up to the task of developing knowledgeable, motivated employees?

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

The VERSA Telemanipulator from Central Research Laboratories (CRL), a Destaco company, is suited for remote-handling applications that involve specific customization requirements.

The Ross, Charles & Son Ross X-Series is a clean-in-place (CIP) ready ultra-high shear mixer for inline emulsification, particle size reduction, and homogenization.