In the May 2013 issue of Pharmaceutical Processing we profile Almac's new packaging services facility in Audubon, PA. Additional articles on contract services and outsourcing include a look at clinical trials technology and an update on fill/finish operations.
Download this new Application Note: "Matching Environmental Monitoring & Mapping to FDA/ICH Guidance for Better Stability Studies" and learn how to minimize the risk of data gaps. If your data is incomplete as a result of infrastructure failures during environmental mapping or monitoring applications, your testing may not comply with FDA/ICH guidelines. Learn how redundant monitoring devices reduce the risk of incomplete records. Get this PDF…
In the April INTERPHEX 2013 Show issue we profile Olympus Biotech, a biopharmaceutical contract manufacturer based in Lebanon, NH. Additional articles on contract services and outsourcing include a look at encapsulating services, and how to look beyond outsourcing for organizational success. We also highlight the six category winners in the 2013 Facility of the Year Awards.
This peer-reviewed paper (published in the Journal of Validation Technology) focuses on two sensors used in thermal mapping: thermocouples and thermistors, and describes advantages and disadvantages of both, concluding that thermistor-equipped data loggers can be used in regulated environments.
In the March issue we visit CDMO Cedarburg Hauser Pharmaceuticals’ API development and manufacturing facility in Grafton, WI. We also look at the narrowing cost of outsourced labor between the U.S., China and India. Our third article on contract services delves into the world of clinical trial outsourcing and how technology is changing how trials are done.
Learn how to evaluate your environmental monitoring applications to find the ideal connectivity to your network. There are times that wireless is a panacea, and times when a hybridized “wired-plus-wireless” system is a better solution. Read more…
In the January/February issue we profile Laureate Biopharma a Princeton, NJ based biopharmaceutical CMO. Other features include a look at single use technologies and their impact on vaccine manufacturing and our yearly outlook on the pharmaceutical industry and emerging trends in the CMO marketplace. Biosimilars and biosimilars and their collective impact on the CMO market is also featured. Additional articles include a look at blisterpackaging tips and techniques and how regulatory changes are affecting aseptic filling technologies.
In the ever competitive marketplace companies need to take advantage of the technologies that are available to them. Replacing dated technologies like the paper chart recorder with better more advanced technologies seems like a logical choice but many companies have been reluctant to change or simply not be aware of the cost savings involved. By using a modern humidity and temperature data logger users have the advantage of better accuracy, more functionality, less maintenance and an overall cost savings.
In the November/December 2012 issue we visit Anteco Pharma, a CMO that specializes in the lyophilization and related processing of pharmaceutical intermediates. We profile Merck's Vaccine Bulk Manufacturing Facility (VBF) Program of Projects, the overall winner of the 2012 Facility of the Year Awards. Our reader survey on selecting a CMO/CSO reveals what our readers look for in a service provider and what they view as a red flag.
This free white paper, 5 Must Have Strategies for Enterprise Quality, shows how quality can take a more prominent, enterprise-scale role.
A compelling read that at times is light hearted and funny, 7 Habits of Quality Obsessed Manufacturers is written for top performing quality professionals that want to give their company an edge.
Pharmaceutical and Biotechnology companies are under a great deal of pressure to comply with regulatory requirements from the inception of a product to its final destination. One such aspect of the regulatory process is stability testing. Stability testing allows drug manufactures to expose the product to conditions that might occur in the supply chain, as well as provide for stress testing for determination of shelf life. Stability testing relies on three important parameters:
In the October issue we profile OsoBio, an injectables CMO based in Albuquerque, NM. In addition we take a look at preclinical CROs and their contributions to pharmaceutical development. Our sourcing and operational strategies article looks at many of the other services companies can outsource to gain cost efficiencies.
Pharmaceutical Processing's September 2012 supplement Contract Manufacturing & Services: Best Practices and Selection Process focuses on the growing and diverse pharmaceutical CMO/CSO market. Featured editorial includes an overview of some of the industry's top CMOs/CSOs and a review of their best business practices and capabilities.
In the September issue we profile AAIPharma a comprehensive pharmaceutical development and manufacturing services company based in Wilmington, NC. In addition, we discuss the importance of validation service providers and examine the growth of biopharmaceutical testing services. The growing topic of single-use technologies is covered in three articles touching on several different aspects of single-use technologies and best practices.