Manufacturing

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.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

PTI moved to a new facility in Belgium that will house its headquarters and a R&D center for tablet dedusting, capsule polishing, and testing technology.

Fette Compacting and Glatt have joined forces to develop integrated solutions for the continuous manufacturing of oral solid-dosage drug forms.

Manufacturers and trading partners struggle to meet drug tracking requirements

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm’s sites to be equipped to supply serialized products to the United States.

Pharma trends translate into increased need for not only external partners, but those will capabilities that can help advance today’s drug development and manufacturing challenges.

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

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.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

A new facility type integrates next-generation mobile cleanroom systems.

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.

This article explores some of the challenges, services, and technologies that go into ensuring that vaccines are properly temperature controlled and maintain product integrity for delivery to patients.

The use of approved platform technologies can reduce the time and cost required to generate new vaccines.