Displaying 1–25 of 45 results for Contract Manufacturing
In this eBook we explore issues surrounding how drug manufacturers and contract organizations have shared a mutually beneficial relationship for decades in the pharmaceutical industry and will no doubt continue to do so for years to come.
The Best of Pharmaceutical Manufacturing eBook is a collection of the most-read feature articles from 2016, chosen by the Pharmaceutical Manufacturing digital audience. Best of Pharmaceutical Manufacturing 2016 eBook.
Pharma’s Top CMOs are playing to their strengths, toning operations and flexing their technical muscles in an effort to compete.
Contract service companies are emerging as the industry's prime movers, tasked with providing the industry with a growing list of increasingly complex services, from early stage formulation to the heavy lifting of generic tablet manufacture.
As outsourced business models continue to pick up steam, updating strategies and technologies for managing quality and compliance is essential.
This eBook, the first in a series from WellSpring Pharma Services, will provide you with the knowledge to effectively choose a contract manufacturing facility, and to understand common regulatory matters that influence the manufacturing and packaging of your product.
Although the state of the pharmaceutical manufacturing union is strong, the continuing growth in the global demand for affordable prescription and over-the-counter drugs is challenging the industry in new ways to be able to manufacture enough safe, high quality drugs cost effectively and ...
This white paper outlines some of the elements that should be considered by a sponsor pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
This case study demonstrates how a commercial manufacturing partnership between a pharmaceutical contract manufacturer and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent Active Pharmaceutical Ingredients.
This white paper discusses the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage data, effective communications and ownership, and ways to improve metrics.
This case study provides an overview of the implementation of a framework that addressed both the usual technical challenges and also the business challenges in a recent real-world tech transfer involving the commercial manufacture of a solid oral dose product.
This white paper, first in a series of three, is to help executives and managers assigned to provide due-diligence of prospective contract manufacturing partners a framework in which to make a solid, objective evaluation of its overall operational excellence as it relates to quality.
Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
Case Study: A Successful Approach to Commercial Scale Final Dosage Manufacture of Drug Product Containing Highly Potent API
Case Study: Conducting a Joint Risk Assessment for Technical Transfer
Managing the Complexities of Global Pharmaceutical Sourcing
This white paper aims to provide a comprehensive overview of the CMC guidance by the U.S. Food and Drug Administration and present a streamlined approach for development and manufacture of nasal spray products. It will focus on the ability of the spray device to deliver reproducible plumes and ...
This case study demonstrates a large pharmaceutical contract manufacturing engagement in which there has been ﬁve years trouble free supply with OTIF (On-Time-InFull) consistently >95%.
This case study demonstrates the successful transfer of a low solubility compound into one of our manufacturing sites and achieving as a result, an OTIF (On-Time-InFull) consistently over 95%.
Outsourcing is no longer a tactical decision but rather a partner-driven strategic activity. This paper presents essential success factors in fostering and maintaining long-term partnerships in pharmaceutical outsourcing. After completing the registration form you will have access to download the...
Using empirical, or science-based, freeze-drying approaches versus trial and error can help you navigate potential commercialization roadblocks.