Remarkably, all the noise swirling around the Pfizer-Allergan deal has knocked off the national stage (at least for the moment) the one specific question that has so occupied health care news throughout 2015: the price of drugs. “Will this move by Pfizer help to lower drug prices?” If so, who’d care so much where Pfizer makes its corporate bed?
Manufacturing facilities in the pharma industry may set the bar high for complexity and capital density when compared to the wider industrial community. At the very beginning of the design process, however, where the initial concepts are developed and decided upon, all too often a sense of urgency overtakes, leading to shortcuts in the process. However, two factors seem poised to change this pattern.
For many, GMP training is an event where attendees are herded into a room and are read the contents of the regulations or asked to watch a video. This video is often the same slides or video year after year. Then, after this nice little break, everyone goes back to their jobs, forgetting about it until the next time the necessary evil called “GMP training” is required.
A growing number of people are managing long-term chronic conditions with medication, driving increased demand for drug delivery options that put control in the hands of patients while keeping doctors in the loop. Satisfying the challenges created by that demand will generate opportunities for device developers well into the future.
I consider myself to be a fan of the pharmaceutical industry. This is not simply because I write for a media group that covers the pharma industry. I feel like I was a fan even before taking on my current job. It may have started a few years ago when an ailment of old age (I’m 52) began to inconvenience me and disrupt my sleep. One little white pill taken once per day has now relieved me of that issue. So, while there are many industries that bring happiness and efficiencies into my life, only one of those industries has the potential to save the lives of patients with life threatening illnesses, and ease the suffering of others. That is the pharmaceutical industry.
Viral clearance studies are done to evaluate a purification process’s capability, or to remove/neutralize viruses that can contaminate a starting material in regulatory submissions in clinical trials. The complexity of these studies means that they typically require significant financial and scientific expertise to perform. Because of this, if a viral clearance study isn’t done right the first time, costly delays are all but inevitable.
When a pharmaceutical company has a drug product and is in search of a contract manufacturing site to make its product, it usually puts out a request for proposals (RFP) to gather information regarding time, cost and the organization. While this might sound routine, the truth is that a mediocre, poorly organized RFP has the potential to slow the process of selecting the right manufacturer, drive up technology transfer and commercial product costs and also negatively impact the relationship between the sponsor and the manufacturer.
If you look at the CDMO market holistically, it is clear that continued growth within the sector market remains strong. At the same time, the market is becoming more competitive, with pharma customers looking for a smaller number of best fit CDMOs that offer high value services that will help them satisfy a range of industry challenges.
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.
People expect options in most areas of their lives, so why should their medication be any different?
Swallowing tablets or capsules is difficult for many, and size is just one of the problems.
This paper identifies the challenges of temperature-sensitive drug transportation and evaluates systems available to help reduce variability in order to preserve product quality and improve business efficiencies.
A full-service contract manufacturing organization (CMO) encounters many compounds at different phases of development and varying customer requirements. From fully developed large scale manufacturing to a single development batch, the CMO must be prepared to handle multiple compounds in the same facility.
The desire to create more targeted, effective therapeutics with fewer side effects has driven drug formulators to expand into more technically demanding areas over the past decade. Microtablets are one result of this burst of creativity and engineering expertise. Going small opens up numerous new delivery options, but also creates additional challenges for drug formulators and manufacturers.
Since it was founded in 1976, Ropack has become much more than a remarkable and efficient packaging service provider. Every effort is constantly made to make Ropack an extension of your company, a strategic partner that provides turnkey production services and avant-garde solutions.
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.
WellSpring provides peace of mind to pharmaceutical companies for their contract manufacturing and packaging needs. When you work with WellSpring, you'll have a whole team of professionals backing your project. Our team will oversee the entire operation; while a project manager will help you plan all stages. You'll also have a dedicated technical team to manage all aspects of the project. All this at one convenient location, offering everything from clinical to commercial manufacturing, packaging and analytical testing services for virtually all non-sterile dosage form products including, tablets, capsules, creams, lotions, ointments, gels and oral liquids.
With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.
Phillips-Medisize is a global contract manufacturer with 1.7 million square feet of manufacturing space designed to meet demands associated with drug delivery devices and pharmaceutical packaging needs. Our dedicated specialists understand the complexities of product development, and offer a full range of product development services through commercialization with a constant focus on quality.
Pfanstiehl is the premier manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of “pharma grade” ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7 compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
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The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.