As we ramp up for the 2020 American Biomanufacturing Summit, we’re excited to share this exclusive e-book created for PHC Corporation of North America, one of our Silver Partners. In this e-book, we examine the long-term storage requirements and needs of biologicals. Here’s a key excerpt from our interview with PHC Corporation of North America: “As cell-based therapies and pharmaceuticals continue to proliferate in the market, the demand for precision cold storage will be vital to maintain medicinal efficacy and research sample viability. PHCbi refrigerators, freezers, and cryogenic products represent over fifty years of engineering excellence in temperature-controlled products. From the refrigeration platform to the control center and cabinet configuration, each model was purpose-built for the safety and viability of high-value pharmaceuticals and biologics.” Check out the full e-book here. Don’t miss out on PHCbi’s roundtable discussion at the American Biomanufacturing Summit (July 22nd @1:10PM EST) led by Carl Radosevich, Senior Manager of Scientific Applications and Collaborations. You can click here to view the full program.
Read More →Checklist for Establishing an Overseas CGT Operation
Cell and Gene Therapy (CGT) is a major breakthrough in medical science. Since penicillin, the world’s first antibiotic, was discovered in 1928, there has been measured progress in the development of new medicines. With the innovation inherent in being able to modify cells to treat or cure diseases, one of the biggest challenges today for U.S. biopharma companies during these early years for CGT is finding robust, repeatable and scalable ways to manufacture these life-saving products and test to ensure they are safe and effective therapies. Setting up a European operation can help American biopharma companies speed up their reach as a next step in medical care and get these advanced treatments to a wide patient population.
Read More →Reducing Cleaning and Cross-Contamination Risk in Single-Use Powder Handling
In June 2019, ILC Dover will join biopharmaceutical executives to discuss current trends, strategic insights, and best practices in manufacturing, outsourcing, capacity management, quality assurance, quality control, regulatory compliance, operational excellence, supply chain, and logistics at the American Biomanufacturing Summit 2019. On June 2018, ILC Dover will present the topics, “Reducing Cleaning and Cross-Contamination Risk in Single-Use Powder Handling”. Their case study presentation will focus on how cleaning validation is getting more difficult as the industry gets better at detecting dust and particles; enabling rapid turnover of campaigns to get to market faster; and how powder handling is a bigger challenge than liquid handling, and why it is often overlooked as a potential source of contamination. Ahead of the American Biomanufacturing Summit, Generis spoke with ILC Dover to discuss their upcoming session, key challenges in the pharma and biopharma industries, and why companies choose to work with ILC Dover. This is an excerpt from the Q&A we did with ILC Dover: “What evolving containment needs are the pharmaceutical and biopharmaceutical industries currently facing?
Read More →American Biomanufacturing Summit Gathers Executives to Discuss the Right Tools, Mindset and Culture Needed to Drive Productivity and Ingenuity
From June 18-19, biopharmaceutical executives and cutting-edge technology providers are meeting in San Fransisco to discuss industry challenges and opportunities, quality as a culture, supply chain management, and new technologies.
Read More →“The Future is Bright” – Reflections on the American Biomanufacturing Summit
Tawni Koutchesfahani, Director of Supply Chain at Relypsa, recently attended our 2018 American Biomanufacturing Summit. One of her key takeaways from the event was around how the paradigm of manufacturing and QA operations is changing and the ways in which it needs to change. We asked her to share her thoughts on the Generis blog. The Future is Bright By Tawni Koutchesfahani, Director of Supply Chain, Relypsa Let’s take a step back and think about where we were 38 years ago. In 1980, Martin Cline made the first attempt to modify human DNA. By 1989, National Institutes of Health approved the first nuclear gene transfer in humans. Since 1989, there have been over 2,000 clinical trials completed. If we fast forward to where we are now, gene therapy is now being viewed as the key to our future for many therapies. Last year, the industry hit some key milestones. Kite Pharma received its approval with Yescarta, and Novartis succeeded with Kymriah. Though these are significant highlights, the past addresses rare diseases. In turn, manufacturing of the gene therapy meets the market for a small population. As these therapies get approval for commercialization, the manufacturing models are not currently made for large scale, which poses a threat for the market. Thus, the whole notation of how we have been manufacturing has to change. How we have been producing in GMP environments has to change. How we have been implementing our quality systems …
Read More →Benchmarks and Best Practices for Next-Generation QMS
In a recent study conducted for Pilgrim, quality and compliance professionals from the top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape of their current quality management systems (QMS). This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
Read More →Addressing the Challenges Facing the Biomanufacturing Industry in the Next Five Years
Last year, at the American Biomanufacturing Summit, we sat down with some thought leaders from MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical and asked them: “What do the Next Five Years Look Like in the Biomanufacturing Industry?” Most agreed that it will be an exciting time with new product modalities improving patient care, but that these new product modalities will give rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. We asked them to go further and tell us what key challenges organizations need to overcome to be successful in this period of unprecedented change.
Read More →What Do the Next Five Years Look Like for the Biomanufacturing Industry?
Last year, at the American Biomanufacturing Summit, we sat down with some of our thought leaders to ask them where they see the industry going in the next five years. It was clear that major changes are on the horizon. It will be an exciting time, with new product modalities improving patient care, but giving rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. Read on for insights from thought leaders at MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical.
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 →Are You Forgetting Something In Your Single-Use Strategy?
In your experience, what has the outcome been like when an organization has taken the time to improve its’ single-use strategy? The first thing people sigh in relief about is that there is no danger of breathing in particles and that they are dispersing all over the manufacturing facility. Once the system is closed, there is no longer so much time spent on cleaning and validation. In addition, it helps speed up the process making it so there is one less bottleneck on the road to continuous manufacturing. To learn more about single-use strategy and make sure you are including everything you need, check out the full ebook by ILC Dover below!
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