In the search for new and efficient ways to discover and develop new drug candidates, many big pharma companies have utilized external partners for R&D services.
This paper provides a recommendation for selection of long-term stability conditions for submission of room temperature storage drug products in Zone IV countries in the face of a confusing mixture of expectations from international regulatory bodies...
Thursday, September 01, 2011
In terms of differentiating from competitors through marketing, CROs and CMOs serving pharmaceutical and biopharmaceutical outsourcing markets need to recognize that data shows there’s a fundamental difference between black and white regulatory ...
The manufacture of a biopharmaceutical is a complex process with many steps and materials used throughout the operation. While we often view certain key materials, such as cell culture media, chromatography resin or filling vials, as critical ...
The purpose of this paper is to lay out the regulatory considerations related to the choice of starting materials and synthetic route for an API.
Tuesday, November 01, 2011
Thursday, September 01, 2011
Tuesday, November 01, 2011
Technology transfer includes analytical methods, process development, and manufacturing to support biologics. The most common practice in technology transfer is analytical methods.
Tuesday, November 01, 2011
Hiring problems, and finding experienced technical and production staff have biomanufacturers worried about production bottlenecks this year.
Tuesday, November 01, 2011
Like many industries, the Pharmaceutical sector is facing a number of major challenges over the next few years. The economic pressures are significant due to patent expirations, generic challenges, more stringent regulatory processes and pricing ...