While pharmaceutical companies are ultimately responsible for assuring the control and review of outsourced activities and the quality of purchased materials, many struggle with supply chain visibility due to the complexity of multi-tiered supply chains, inadequate IT systems, limited experience, and resource constraints. The supply chain has gotten increasingly complicated over the past decade. The complexity arises from the entrance of vendors from many countries into the marketplace; vendors that previously played a small or limited role. Mergers and acquisitions have also complicated the supply chain, particularly around quality.
Read More →The 2017 Pharma Outsourcing Summit: Closing Chair Remarks by Mark Fromhold (Ph.D., Director, Biologics Outsourcing, Gilead Sciences)
Check out Mark Fromhold’s closing chair remarks at the 2017 American Pharma Outsourcing Summit: “It’s been an absolute pleasure moderating the American Pharma Outsourcing Summit. There’s been a tremendous amount of discussion on topics ranging from QA, legal, tech transfer, to building internal and external partnerships to supply chain security. From this broad range of topics, common themes that stick out from the two days of presentations include the need to collaborate, communicate and have a common passion for what we’re trying to do, which is treating patients and helping improve people’s lives. At Gilead Sciences, “We are inspired by the opportunity to meet unmet medical needs of patients living with life-threatening diseases around the world, and I believe that everyone at this event shares this same passion and appreciates that increased collaboration will be required for us to continue to being successful moving forward.” In industry, we are seeing new paradigms evolving with the continuing consolidation of contract development and manufacturing organizations. We’re also seeing new manufacturing paradigms, such as disposables for biologics, continuous processing, as well as niche and personalized medicines moving forward. The continuing evolution of the outsourcing market and development of more personalized therapeutic strategies will require us as an industry to find ways to collaborate more seamlessly to effectively address manufacturing challenges and cost- of-goods associated with these new opportunities. These are just a few examples of the many areas that need to be discussed to …
Read More →Eurofins Lancaster Laboratories PSS Insourcing Solutions
Eurofins Lancaster Laboratories PSS Insourcing Solutions is a program that places a team of experts in the client’s laboratories with access to their quality systems in order to execute a project in the client’s scope of work. By adopting this insourcing approach, organizations are able to benefit from the expertise of an experienced laboratory testing provider, while reducing costs as they continue to keep projects, methods and analytical techniques in-house. With more than a 55-year track record of scientific and laboratory operations expertise, PSS ensures that each team of experts are top quality and selectively chosen for the appropriate project. This in-house approach is preferred by pharmaceutical and biopharmaceutical companies as opposed to hiring temporary staff. Temporary staff solutions result in valuable resources being used for recruitment, training, and managerial purposes, which could be redistributed to another area. Temporary staff also often result in conflicts with long-term needs, European regulations, and strict IRS guidelines. Benefits of insourcing include lower headcount, avoiding high turnover, condensing product development cycles, flexibility and more. PSS’s Insourcing Solutions has grown exponentially, currently, employing more than 1,500 employees, as well as serving clients in 15 countries at more than 70 different sites worldwide. You can find more information on the PSS’s Insourcing solutions in their ebook here. For more information on Eurofins, visit their website here.
Read More →Managing Complex Pharma Projects
As the pharmaceutical landscape is evolving to adjust to external effects, the demand for efficiency within the internal pharma industry is at a high. Praxis Life Sciences, who is reputable for analyzing challenges within an industry workforce and creating solutions based on quantitative and qualitative research has just released a new beneficial case study to the pharma industry. Their consultation within the life sciences field has a track record of proven results, and their most recent study, Managing Complex Pharma Projects, is no exception to this. The challenge that most pharma companies are currently facing is the inefficiency created by having a large project team with “disparate decision makers.” Praxis Life Sciences has analyzed this problem, and created solutions ensuring that ” decisions and progress are made in a timely fashion.” To learn more about the results of their case study, click here.
Read More →Cost-Effective Range of 48-Hour Pre-Qualified Temperature Controlled Shippers
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. To learn more about qualified temperature controlled shippers, check out this article by Sonoco!
Read More →Smart Outsourcing: Strategic Alignment, Risk Management, and New Relationships
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: To learn more about smart outsourcing and what the operational and business benefits are, check out this white paper by OQSIE
Read More →Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation
In your experience, when an organization has invested in proper documentation, what have the results been like? The results have been tremendous! We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements. In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients. To learn more about GMP documentation, check out the ebook by Bulletproof below!
Read More →Managing Your Cold Supply Chain to Ensure Your Vaccinations Get to Where They’re Needed Most
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. Take a look at the full white paper below!
Read More →Optimizing Temperature Control for Biopharmaceuticals
This article first appeared in BioPharm International, October 1, Caroline Hroncich 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. Learn more about optimizing temperature control for biopharmaceuticals in the article below!
Read More →The Serialization Challenge
Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights. The eBook explores and explains: The Current Regulatory Landscape The Serialization Challenge Best Practices in Serialization Operationalizing a Serialization Program Check out the eBook below! eBook, The Serialization Challenge To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!
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