Navigating Tech Transfer in Biologics Manufacturing

Effective viral clearance processes during biologics manufacturing are the final shield to ensure product and patient safety. One of the classical methods for viral inactivation (VI) is the detergent treatment step in manufacturing of various drug modalities, including antibodies, plasma-derived products and AAV. In this presentation, we will discuss the application of an environmentally safe and sustainable alternative for Triton X-100 to enhance VI while maintaining compliance with regulations. An extensive study with different model viruses demonstrated its capability of providing >6.5 Log of viral inactivation and high virus killing kinetics independent of operational temperatures (4 ⁰C to RT) will be shown. Health-based exposure information will be presented for use in determining operator and patient safety. Other benefits of using this detergent include no impact on product stability over typical operating durations and sensitive molecules such as bi-specifics or on process performance. This detergent can easily be removed from the process by typical chromatography techniques and be detected by a simple analytical assay.

Join our panel of experts as we delve into the latest innovations and advancements in academia, exploring how these developments can benefit the biologics industry.

Join our Pharma Awards Winner as we Recognise their achievements in accelerating innovation and improving patient outcomes across healthcare

What does the publication process look like? How to prepare a manuscript Ethical considerations during the publication process Identifying the target journal Peer review do’s and don’ts How we can help you enhance your research through our services

Biosimilars are delivering on their cost-saving potential, reducing biologic medication costs and expanding treatment options. However, there are hurdles that hinder optimal biosimilar use, potentially jeopardizing their long-term viability in the healthcare system. Examining these challenges through real-world examples and case studies is essential to ensure biosimilars continue to play a significant role in overall healthcare affordability and access.

Oncology has always been a powerhouse of innovation in healthcare, and with ground-breaking new technologies on the horizon, its impact is only set to continue. This dynamic session will go deep into growth areas within Oncology and evaluate the future pipeline and its implications in: Elevating patient outcomes to new heights Successfully launching medicines Starting up clinical trials Expanding manufacturing capabilities Navigating off-patent opportunities Join us for an overview of Oncology's competitive landscape to gain a deeper understanding of the growth drivers in this fast-paced therapy area.

Cell-cultured meat production is increasing, predicting to reach $1.1 billion in value by 2034. Though not the usual modality, various companies in the life science industry have expanded their interest and activity to cell-cultured meat research and manufacturing because of the similarity in equipment and expertise required. Exploring existing biomanufacturing facilities setup and the possibility to adapt cultivated meat production Comparing the regulatory frameworks for biologics and cultivated meat, highlighting key differences and potential challenges. Assessing the possibility of using cultivated meat technology to manufacture specific proteins or biomaterials for therapeutic purposes. Looking at the potential opportunities and challenges of scaling cultivated meat production to meet market demands compared to smaller-scale biopharmaceutical production.

Discover how single-use technologies are driving advancements in biopharmaceutical manufacturing. Exploring the advantages: Delve into the benefits of utilizing single-use technologies in biologics manufacturing, including increased flexibility, reduced contamination risks, and enhanced scalability. Case studies and insights: Gain valuable insights from real-world case studies showcasing successful integration of single-use systems with biologic production processes. Future outlook: Gain a glimpse into the future as we discuss emerging trends and developments shaping the ongoing evolution of the biologics-single-use partnership.

Biopharmaceutical development and production requires the investment of significant time and resources. Manufacturing procedures must be efficient, robust and productive to minimize failure risk and ensure targets are met. With increasing product titers, greater volumes of process buffer are required to meet processing demand. Increased buffer volumes place additional pressure on buffer hold and storage area constraints, particularly for companies that prefer to prepare their buffers in advance. Complex scheduling of staff and equipment is necessary to ensure there is an adequate quantity of QC-released process buffers prepared and ready for an entire batch. These logistical challenges increase in plants producing multiple products due to the need for different buffer solutions for different process applications. Furthermore, continuous manufacturing requires different considerations, as it requires constant supply of process buffers. Identifying the right buffer preparation strategy for a given facility and operation is key. While holding larger buffer quantities might be suitable for a fed-batch processes, in-line dilution or conditioning deserves careful evaluation for continuous manufacturing. Operational modifications in buffer management allow manufacturers to maximize their output without significantly altering their production approach. This can enhance several measures of efficiency, including faster drug product release, increased productivity of GMP manufacturing, reduced footprint, enhanced flexibility and improved quality. In this presentation, we will take a holistic approach to buffer management, discuss the known and unknown challenges, and consider different options of buffer preparation, weighing the merits of in-house vs. outsourcing. Conceptual design scenarios in both existing and new facilities will be shared to assist with the economics and logistics of the buffer journey. And finally, we will show how the best buffer management approaches come together to deliver significant operational benefits —allowing biologics manufacturers, including CDMOs, to remain nimble and competitive.

Looking at examples of challenges and bottlenecks in cell therapy applications and what can be done to overcome them Assess automation and process optimization tools and its role in scaling up cell therapy production

Digital transformation is becoming an essential part of biopharma manufacturing as it helps improve product quality and robustness. Join our panel of experts where we Exploring the power of digital technologies for real-time monitoring and quality enhancement in manufacturing Unveiling AI's expanding role in manufacturing and predictive maintenance Addressing challenges in upskilling and regulation to help maintain high standards across manufacturing

Understand the potential of the microbiome in shaping the future of therapeutics. Dive into the latest technological innovations propelling microbiome research forward, uncovering new insights and possibilities. Discover the latest research findings with the microbiome Exploring microbiome influence in alternative therapeutic areas such as Neurology and Oncology

Bio-manufacturing is rapidly evolving with increased outsourcing, new modalities, and M&A opportunities shaping the landscape. Join our panel of experts and explore the latest in outsourcing trends, partnership models, and the M&A activity that is fostering growth, capacity and capabilities.. The outlook for outsourcing New modalities Partnership models M&A opportunities

Delve into the future of vaccination technology as market experts Moderna unveil the potential of mRNA vaccines to revolutionise healthcare. Don't miss this opportunity to explore the forefront of medical innovation and discover how these next-generation vaccines are reshaping the landscape of disease prevention.

The European Commission published a communication launching the EU Biotech and Biomanufacturing Initiative to enhance competitiveness and industrial modernization. These efforts seek to foster innovation, facilitate investment, and position the EU as a leading hub for biotechnology and biomanufacturing. The initiative proposes eight key actions, including most notably: Launching a study to support the simplification and streamlining of the EU regulatory framework for biotech (potentially leading to an EU Biotech Act) Establishing an EU Biotech Hub to support navigation of the regulatory framework and scale up Setting up several mechanisms to increase funding and investment in EU biotech and biomanufacturing Reviewing the EU Bioeconomy Strategy These actions have significant implications for stakeholders within the EU life sciences ecosystem—especially in the context of the ongoing Pharma Package

Join us on day 2, into the potential of biosimilars to expand access to critical treatments for patients. We'll explore how these medications can play a significant role in healthcare, while also discussing the opportunities and challenges associated with their wider adoption.