Discerning growth opportunities (or business contractions) in the drug development and manufacturing outsourcing space is a challenging exercise. Among other things, it requires reading between the lines of various industry reports concentrating otherwise, for example on comparing commercial product sales and R&D pipelines. An “otherwise” focused report worth our attention is the EvaluatePharma World Preview 2017, Outlook to 2022.
As Robert Frost tells us in his classic poem Mending Wall, “Good fences make good neighbors.” This concept makes an apt analogy for the contracting process. I have discovered, through much trial and error, that relationships between product companies and CDMOs that are based on clear, detailed, and comprehensive contracts — i.e., “fences” — have better outcomes than similar collaborations that rely on handshakes and personal commitments.
The first installment in this two-part series examined rising costs associated with orphan drugs and two related case studies. This second part provides actionable suggestions for developers.
On June 12, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted.
Flavivirus vaccine development and production constitute many challenges and can be both space- and resource-consuming. This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production. Single-use production bioreactors and chromatography purification columns mitigate cross-contamination risk and support increased operator safety, while reducing time to market by eliminating costly and time-consuming cleaning operations.
Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.
What documentation and steps are required to clear a product shipment for entry into China? What is the ability for major airports in Brazil to store refrigerated products while they are awaiting customs clearance?
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
In this technical note, Henry’s Law is reviewed, and various types of dissolved oxygen sensors are described and the performances evaluated and summarized.
Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.
Manual buffer preparation for high-throughput process development (HTPD) requires a lot of effort as the number of different buffer conditions is large.
Good column packing is essential for any chromatographic process and plays a key role in the large-scale commercial manufacture of biopharmaceuticals. A bed packed too densely may crack, which can lead to channeling and early breakthrough. A bed packed too loosely can further compress, causing a liquid gap where mixing can occur. Either instance will lead to costly process disruptions and loss of valuable product. Proper packing eliminates such concerns and ensures a stable bed that performs according to expectations over many processing cycles.
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.
Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.
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.
Clinical trial protocol template can help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed. Read more!
In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”
Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.
Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
“Digital transformation” is a common buzzword across industries today, but is it more than just jargon? Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.
