Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons.
Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits:
Protein-based therapeutics, specifically monoclonal antibodies (mAbs), have become the focus of pharmaceutical R&D over the last decade. While these biologics offer many possibilities when it comes to treating a variety of diseases, they also present considerable challenges during development.
All of these factors combined make manufacturing and delivery of protein-based therapeutics very difficult. If these drugs could be produced at lower viscosities, then a lower volume could be used, making subcutaneous delivery possible; this would also significantly reduce the risk of aggregates. Now, a treatment that typically requires an hour in a clinic could potentially become a simple injection at home.
This informative white paper by Althea covers the challenges of crystallization of proteins for therapeutic use and how to preserve efficiency during crystallization.
World Courier is transporting Zika diagnostic test kits to and from South America.
Companies trust us to transport and store time- and temperature-sensitive products, and the urgent and sensitive Zika diagnostic test kits are no exception! In the midst of concerns, especially for the well-being of athletes, World Courier’s capability and expertise are another reason to have peace of mind.
The Zika virus was a huge fear for the 2016 Olympic summer games in Rio de Janeiro, Brazil. In the white paper below, World Courrier explains the process and challenges of transporting Zika tests for the 2016 Olympic games to ensure the safety of the Olympic athletes and those attending.
Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey.
This article by World Courier delves into these relevant industry topics:
- Common considerations for shipping biopharmaceuticals;
- Temperature management in extreme climates;
- Recent advancements; and
- Looking ahead.
Medical device manufacturing has minimal tolerance for error—and quality is of the utmost importance. If your products don’t deliver what you promise, lives can be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make—or break—your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain.
This white paper by the Copley Consulting Group explains how you can make a commitment to lean processes while raising your quality standards, improving efficiency, and driving down costs. It’s important to create efficiencies in your manufacturing processes, but this often involves taking small incremental steps.
Find out more about educating your organization about these opportunities, driving down costs, and systematically removing waste and uneven workloads from your manufacturing processes below:
Medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reducing development costs, and improving patient safety and product quality.
In addition, SIMULIA provides medical device companies with the ability to more efficiently evaluate design alternatives, accelerate long-term stress life testing to predict product reliability, collaborate on projects and leverage computing resources for more efficient design analysis.
In today’s environment of strict regulation and reduction in spending for healthcare, life sciences companies are under pressure to reduce operational costs, increase efficiency and provide greater value to the system—and sales enablement is a crucial component to achieving all of the above.
In the eBook below, Seismic addresses some of the challenges that life sciences companies face and provides some solutions to these challenges.
Medical device organizations face a number of regulatory and compliance challenges ranging from design and development to commercialization. In preparation for the American Medical Device Summit 2016 we wanted to share the post below to introduce some of the challenges that can arise when life sciences messaging doesn’t meet FDA standards.
The Seismic blog post below discusses some common missteps life sciences marketers make when it comes to FDA compliant messaging, and the consequences to distributing non-compliant medical product promotional content. It also offers some simple solutions for avoiding those missteps.
Medical device developers are evolving and introducing new products and variants into the market. With this evolution comes a more complex and dynamic global supply chain. To help navigate this shifting terrain Dassault Systèmes generated the free webinar below to help guide developers through effective techniques to create an opportunity through traceability.
Check out the 35 minute free Qmed webinar on Making Traceability Work for the Business: Effective eDHR and UDI to discover:
- The role of integrated manufacturing software in eDHR and UDI compliance
- Approaches to consider for traceability program improvements
- Questions to raise as you assemble the diverse stakeholders for such a project