PTSM: Pharmaceutical Technology Sourcing and Management-06-08-2017

A case study presents important lessons for using average and individual results, as well as user requirements, when qualifying a laboratory refrigerator.

CMOs may be gaining as strategic partners to large bio/pharma companies, but compared to CROs, they face a tougher climb to capture a larger segment of the pharma manufacturing market.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

Increased capacity at PPD’s Richmond, VA laboratory are designed to support customers’ vaccine development programs.

Expanded storage capacity at the SGS laboratory in Mississauga, Canada increases stability testing capabilities.

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The company expanded its UK storage facility to meet increasing demand from its growing customer base.

The company installed the FlexFactory to support its biosimilar production.

The compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties.

The new storage and distribution facility provides PCI with additional space, complementing its existing footprint currently used for specialist clinical-trial logistics as well as packaging, labeling, and qualified person activities for investigational medicinal products.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

The company invested approximately $26 million to update its sterile pharmaceutical and development service suites.

The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.