Among the many things that the COVID-19 pandemic brought to light, life science organizations were faced with the immediate need to improve the reliability, safety, scalability, and speed to market of their offerings. This much is clear: Gone are the days of using inefficient, cumbersome paper procedures and disconnected systems. Today’s complex manufacturing organizations are under great pressure to simultaneously speed up their processes while ensuring top quality. In order to meet today’s demands, the adoption of intelligent technology and remote collaboration platforms is crucial—empowering organizations to efficiently connect their people, processes, and environments. Through leveraging intelligent technology and Pharma 4.0 connected systems, organizations are able to: Connect, monitor, and support their various teams in real-time Significantly improve batch yield Effectively manage resources Utilize guided workflow assistance Gather, query, and store the critical data needed to improve efficiency, reliability, compliance, and speed Learn more in this exclusive Apprentice e-book:
Read More →Examining Long-Term Storage Requirements & Needs of Biologicals
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 →US Medtech Industry Looking at Ireland as a Resource
While the American medtech industry is thriving, it still must deal with challenges that include higher production costs, finding skilled staff and the ongoing issues innate to a highly regulated sector. Then there are global concerns such as competition, funding and the high cost of research. With Europe and the United States being the key markets, many U.S. medtech firms have located some of their operations in Ireland in order to take advantage of an established, flourishing life sciences sector, strong governmental support and easy access to the lucrative European market. Among the more than 300 companies with Irish facilities are Boston Scientific, Abbott, Vistakon, Medtronic, Teleflex, Stryker, Cook Medical, Zimmer Biomet, DePuy Synthes, Hollister, and BD. The medtech field in Ireland employs more than 32,000 people, which is the highest per capita in Europe. One-quarter of the world’s diabetics — 30 million people — rely on an injectable device manufactured in Ireland, while half of all ventilators used by acute hospitals worldwide are also made there. Meanwhile, three-quarters of global orthopedic knee products were produced in Ireland. There are several important reasons why American medtech companies have been choosing Ireland as their European base of operations, benefiting from Ireland’s manufacturing expertise, R&D facilities, pool of trained workers, data analysis skills, collaboration between companies, financial advantages, and regulatory advantages.
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 →GDP for APIs New Regulations
The Shift to Monitoring BioPharma Product Quality Throughout Their Lifecycle For years, pharmaceutical manufacturers have talked about the last mile. With mail order pharmacies, direct to pharmacy/patient channels, and things like orphan drug clinical trials, the last mile can be complex yet largely unregulated. The other end of the pharmaceutical supply chain, the inbound supply of ingredients, has received more solid guidance from regulators. In 2000, major markets including the EU and US supported the ICH Q7 initiative by publishing their own guidelines specifically for GMP for APIs. Although GMP guides have included some elements on storage and distribution, the only GDP focused guide was the WHO Guide on GTDP for Pharmaceutical Starting Materials until recently.
Read More →Choosing the Right Writer for Your Documentation Project
Pharmaceutical technical writers are a broad collection of technical people including engineers, biologics, chemists, microbiologists, and even a few liberal arts majors. Nearly all writers share a passion for accuracy, completeness, robustness, compliance, and clarity. But what pharmaceutical companies need from their writers differs across projects, products, departments, and maturity. Some companies need document processors to manage redlines and facilitate approvals. Other companies need an expert to identify and address compliance or procedural gaps. Some companies need writers to compile, analyze, and summarize data for reports. And others need authors who can leverage data to tell a story, inform and instruct readers, or present a scientific perspective for a submission. Matching writer skills to project objectives is an important first step. Why?
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