• Cell Culture Dish Podcast

  • 著者： Brandy Sargent
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Cell Culture Dish Podcast

著者： Brandy Sargent
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  • The Cell Culture Dish (CCD) podcast covers areas important to the research, discovery, development, and manufacture of disease and biologic therapeutics. Key industry coverage areas include: drug discovery and development, stem cell research, cell and gene therapy, recombinant antibodies, vaccines, and emerging therapeutic modalities.
    Copyright 2024. All rights reserved.
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  • How AGC Biologics received approval from both US and European regulators for commercial manufacture of Lenmeldy – A cell-based gene therapy

    How AGC Biologics received approval from both US and European regulators for commercial manufacture of Lenmeldy – A cell-based gene therapy
    2024/06/05
    In this podcast, we spoke with Luca Alberici, Senior Vice President and General Manager, Milan Facility, AGC Biologics about the road to their recent EC and FDA approval to commercially manufacture Lenmeldy™ and their future plans in cell and gene therapy. What is Lenmeldy? We began the podcast by talking about AGC Biologics’ Milan site and their FDA approval to commercially manufacture Orchard Therapeutics’ Lenmeldy. Luca explained that Lenmeldy is a gene modified cell therapy product for the treatment of Metachromatic leukodystrophy (MLD), an ultra-rare hereditary disease characterized by accumulation of fats that causes neurodegenerative symptoms. It is a pediatric disease, and patients generally die by the age of five. With this therapy the patient’s stem cells are collected and modified through the use of a lentiviral vector to add a gene called ARSA that encodes for the right form of the enzyme that these patients are encoding wrong. These modified stem cells are then administered back to the patient so they can immune reconstitute not only the immune system, but the cells will also cross correct through secretion of the right form of the enzyme. After just a single shot of the therapy, there is an improvement in their condition and they develop normally, especially if treated in a pre-symptomatic phase. This is the power of gene therapy at its best. The Pathway to FDA Approval for Commercial Manufacture We then discussed the pathway for receiving approval to commercially manufacture this product and how the AGC Biologics Milan team navigated this process. Luca described that it was quite a long journey. AGC Biologics were manufacturing this product at preclinical and clinical phases dating back roughly 15 years. They worked with a series of different sponsors, it was developed by the San Rafaelle Telethon Institute for Gene Therapy in Milan Italy, then GSK continued the clinical development before it was acquired by Orchard Therapeutics. AGC Biologics remained the manufacturer during this time and in 2020 received approval for commercial manufacture of the product in Europe, but FDA requirements are different so over the last two years, they partnered with Orchard Therapeutics and worked to meet the FDA requirements for approval. Luca explained that approval required a great deal of work on the process, the analytics, the quality system, supply chain, and raw materials. One of the most transversal aspects of the validation of a product is getting it ready to be manufactured for the market and it was great to go this last mile with a strong partner like Orchard Therapeutics. He also credits the infrastructure of AGC Biologics, which is a multi-site global organization and provided the Milan site great support in terms of general quality, standards, procedures, and simply by having faced multiple FDA inspections before. The combination of all these factors was what carried them to the finish line, it required extensive teamwork, not only at the Milan site but also the entire organization. The Only Site to Receive EC and FDA Commercial Manufacture Approval I followed up by mentioning how with approval from the European Commission and the FDA, the AGC Biologics Milan facility is the only one in the cell and gene therapy industry to have commercial manufacturing authorization from both the FDA and the EC for LVV and cells. I asked Luca why there are so few CDMO's who have achieved this and what makes the FDA and EMA approval process so challenging? He explained that the Milan site was the first site to receive clinical manufacturing approval for an ex vivo gene therapy in 2003, 21 years ago, when cell and gene therapy was almost nonexistent at the time. They were the first facility to receive approval for commercial manufacturing in Europe for a marketed product in 2015/2016, 10 years ago. Now they are the only site who can do viral vector and cell therapy, both approved from the main authorities,
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    1分未満
  • How Real Time Titer Measurement And Monitoring Is Advancing Bioproduction Across Multiple Applications

    How Real Time Titer Measurement And Monitoring Is Advancing Bioproduction Across Multiple Applications
    2024/02/29
    This panel discussion was originally published in the eBook “ Monoclonal Antibody Manufacturing Trends, Challenges, and Analytical Solutions to Eliminate Bioprocessing Bottlenecks” You can download all the articles in the series, by downloading the eBook. Panel discussion members: Carrie Mason - Associate Director, R&D at Lonza Biologics Laura Madia - Independent Industry Consultant Alan Opper – Director of HaLCon Sales at RedShiftBio David Sloan, PhD – Senior Vice President, Life Sciences at RedShiftBio Brandy Sargent, Editor in-chief, Cell Culture Dish and Downstream Column (Moderator) In this panel discussion, we talked with industry experts about antibody process development and manufacturing. Specifically focusing on current antibody titer expectations, analytical challenges and how real time titer measurement is a game changer for bioproduction moving forward. Where is the industry at today with titer expectations and what are the best practices for measuring titer? Laura Madia With respect to expectations regarding titer over the years, what we’ve seen is a need for increased titer within the upstream development of a drug. As an industry, we have moved from the 80s where titers were closer to .2 to .5 grams per liter to the early 2000s where concentrations of titer production rose to 3 to 5 grams per liter. What we see today is a continued increase in titer concentrations, which creates a challenge to make sure that you have technologies that can accurately measure titer concentration without introducing any errors. The other thing that we have seen within the industry is the need for more data to not only understand what is happening in the tank, but also to be able to make decisions about the product as the process is running or shortly after. Lastly, it is important to consider people and resources. It has been exacerbated by COVID, but it is difficult to find people to work within the industry and there are fewer people within a production suite. This has helped to drive the need for online and remote monitoring and automation to make it easier to get the necessary measurements. David Sloan To follow up on the lack of workers, one of the things that we constantly hear from the customers we are working with is that training employees can be a real challenge and a very time-intensive process. Technologies that are easier to use and require less expertise help get people up and running and minimize errors amongst new users of a technology. Laura Madia As for the current best practices for measuring titer, HPLC is the gold standard. But HPLC presents some challenges including training and HPLC requires a highly skilled person to get accurate results. There is a need for something that is simple and easy to use when it comes to measuring titer. You will still need HPLC results for approval and decisions at the end, but to be able to monitor titer throughout the process is important. What are the challenges associated with the way that titer is measured today and what can we do as an industry to improve? Laura Madia One of the challenges is that most of the assays available today are batch processes, so that lends itself to providing a retrospective look and means that most people don’t run samples throughout the process. This is because most people save these tests until the end when they can run a batch and make it more cost effective, and it is typically a long time to result so running it during the process isn’t helpful. Systems today are more for batch process and are not set up for at-line measurement, unless you are lucky enough to be able to have an HPLC that’s dedicated to that tank. Another challenge is speed and accuracy. Many of the techniques that are offline today are longer assays because they’re running as a batch. You must wait for the entire batch, which is a long time to first result.
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    41 分
  • Advancements in Buffer Management and Single Use Inline Buffer Formulation

    Advancements in Buffer Management and Single Use Inline Buffer Formulation
    2024/02/15
    In this podcast, we spoke with Nainesh Shah, Senior Application Engineer at Asahi Kasei Bioprocess about buffer management including the benefits of inline buffer formulation, and single use inline buffer formulation systems. Buffer Management We started the podcast by talking about how critical buffer management is to bioprocessing. Mr. Shah discussed how buffers are required in large quantities during the biomanufacturing process and that traditionally buffers were made in large tanks, stored, and used as needed. However, now real estate in the bioprocessing industry is at a premium and companies are looking to utilize new technologies that can reduce facility footprint. For buffer management, it makes sense to create buffer on demand to reduce the footprint dedicated to buffer production in the past. Inline buffer formulation is a hot topic with companies who require a large quantity of buffer because it provides a way to create buffer on demand in a much smaller footprint. The interesting thing is that it is now also a hot topic among small R&D scale buffer users as well. Inline buffer formulation systems are ideal for users who need 200 to 500 liters of buffer at a time. The system takes the concentrate and adds clean water to provide just the right amount of buffer on demand. Another benefit of inline buffer formulation is that you can achieve a quick process changeover and move on to the next buffer formulation without spending valuable time cleaning the tank, taking samples, and readjusting the critical parameters. Recently, any new manufacturer, whether it's a large scale or small scale tends to move into this field of buffer management and operates one or two Inline Buffer Formulation (IBF) systems like the MOTIV™. They then use these systems to make all sorts of buffers needed for their various processes. The MOTIV Family of Inline Buffer Formulation Systems Next, I asked Nainesh if he could talk a bit more about the MOTIV family of inline buffer formulation and fluid management systems that Asahi Kasei Bioprocess America (AKBA) offers. He explained how the award-winning MOTIV family has evolved into a series of inline buffer formulation systems designed to help companies move past downstream bottlenecks by driving buffer productivity. The product family includes 3-pump, 5-pump, and custom IBF configurations that can fit most any space, cost, or performance requirements. The MOTIV is a leader in buffer production with a range of scale from 4,500 liters per hour to 10 liters per minute to fit an entire range of volume requirements. He went on to say that they have added a new feature where MOTIV can fill up bags with buffer and monitor the quantity in the bag to make buffer on demand even easier. MOTIV SU Then we talked about the new MOTIV SU, a single use inline buffer formulation system, built to produce complex buffers on-demand effectively and efficiently, all from one pump head, and without the need for CIP/SIP procedures between batches. The innovative design modulates flow through control valves while simultaneously integrating buffer solutions and mixing. As with all the MOTIV systems, OCELOT System Control ensures precise blends every time, controlled by pH and conductivity feedback or flow. The MOTIV SU is perfect for a biomanufacturer who does not want to spend time with cleaning and validation. It is great for one time use as it does not require time spent in cleaning, validation, and making sure that it is free of all the contaminants and all the buffers which may be harmful for the next process. Another benefit would be if a biomanufacturer used a buffer which had a chemical or ingredient which would be problematic for other processes, and they wanted to eliminate any risk of contamination. Since the MOTIV SU has replaceable parts, which come as a pre-built unit, it is easy to replace the components and then the system is ready to run again.
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    16 分

あらすじ・解説

The Cell Culture Dish (CCD) podcast covers areas important to the research, discovery, development, and manufacture of disease and biologic therapeutics. Key industry coverage areas include: drug discovery and development, stem cell research, cell and gene therapy, recombinant antibodies, vaccines, and emerging therapeutic modalities.
Copyright 2024. All rights reserved.
身体的病い・疾患 衛生・健康的な生活 博物学 生物科学
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