Wednesday 19th March - Main Conference Day OneWednesday, 19 March 2025 - PT (Pacific Time, GMT-08:00)

This talk will delve into the intensification strategies being employed in mammalian cell culture to speed up the production process and improve yield. The session will cover techniques such as N-1 perfusion, seed culture optimization, and the use of larger flasks to reduce the number of bioreactors needed. Attendees will gain insights into how these strategies help overcome the physiological limitations of mammalian cell lines and reduce costs and risks associated with large-scale bioreactors.

• Understand the principles and benefits of process intensification.
• Explore different perfusion strategies and their applications.
• Learn about high seeding density techniques and their impact on productivity.
• Gain insights into media improvements for fed-batch and perfusion processes.

This session will look at both methods of biologic production and when, how and why to use them? What are the pros and cons to both and are they molecule dependent? Is there a clear winner and what will the future look like?

Poloxamer 188, a well-known surfactant, has a long history of use in pharmaceutical drugs across various dosage routes, including oral, topical, and parenteral administration. In the biomanufacturing space, the surfactant properties of poloxamer 188 have expanded its application in cell culture, serving as a crucial shield against shear stress during agitation in a bioreactor. The specific balance of the hydrophobic PPO chain flanked by two blocks of hydrophilic PEO in Poloxamer 188 is the key to its ability to prevent cell shear stress. However, impurities from the manufacturing process can compromise its performance, leading to detrimental effects on cell health and contributing to batch-batch inconsistency. In this presentation we will discuss about development of new Super Refined™ Poloxamer 188 optimized specifically for cell culture during upstream bioprocessing. The presentation will also highlight key physiochemical and cell culture data showing influence of quality of Poloxamer 188 on performance of CHO and HEK suspension cell lines, which are critical for biopharma industry.

• Case study

• During product development and the life cycle of commercial products, process changes are inevitable. Products manufactured using pre- and post- process changes are required to demonstrate comparability per ICH Q5E. A comparability study is a critical tool to ensure the “similarity” of product quality including efficacy, pharmacokinetics, safety and immunogenicity.
• In this presentation, a phase appropriate risk assessment of process change will be introduced, followed by comparability strategy based on the risk assessment. Analytical comparability study tools will be discussed including the analytical comparability plan, comparability criteria, execution, data analysis and presentation. Furthermore, non-clinical and clinical comparability will be briefly discussed if there is any analytical difference which may impact product quality. Two comparability case studies will be presented. The first study is to support a new bioprocess to improve product quality and to facilitate larger scale manufacturing. The second one is to support the use of an early process stability study for establishing commercial shelf-life by leveraging the comparability study for an accelerated program. The agency feedback from multiple markets for the case studies will also be discussed.

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

• A phase-appropriate process development strategy balances overall speed and quality

• Case studies of balancing speed and quality at different clinical phases are reviewed

• Product understanding drives development efficiency and effectiveness for bispecific antibodies

• Unique purification challenges associated with lentivirus and other emerging viral vectors (RLPs, AAV, etc.);
• Tailored purification strategies for different viral vector types;
• Developing efficient methods for the removal of empty/partial capsids;
• Strategies for dealing with post-translational modifications and heterogeneity in viral vectors.

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

• Spotlight on the complexities of CGT manufacturing;
• How do we address these complexities by standardizing the path to commercialization;
• What innovation and platforms exist to make CGTs more accessible now and in the future?

• How do manufacturers achieve scalability without compromising product quality?
• Increasing batch sizes and maintaining consistency to reduce costs;
• How early is too early to consider strategy for scaling up?
• Strategies to ensure reproducibility, robustness and cell product quality to uphold therapeutic efficacy;
• Harnessing rapid/integrated platforms and process improvements to broaden cell therapy impact;
• Accelerating delivery to patients and catering to increased demand at a clinical and commercial scale.

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

Cell culture media is arguably the most important and valuable component of a bioprocess. While use of commercially available basal and feed media is an option for some enterprises, biotherapeutic innovators must develop their own recipes for a variety of reasons including sourcing/supply chain and process control. While media development in the past has been focused on the application of fed-batch process, a workflow is also needed for designing media that can be used for intensified processes. A case study along with benefits and challenges that can be encountered with intensified bioprocess media development will be presented.

Cell culture process development is often limited by the turnaround time of spent media and of product quality analysis. Additionally, these methods are typically very complex requiring various SMEs to conduct the work. Here, we have assessed the Waters BioAccord instrument for its utility for streamlining these analyses to improve cell culture development timelines.

• How CDMOs have evolved in the last 5 years and what to expect in the coming years;
• Geopolitical uncertainty and its impact on outsourced manufacturing;
• Collaboration to understand the changing needs of pharma and biotech.

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

Host-cell proteins (HCPs) can compromise biopharmaceutical products by persisting through purification, leading to polysorbate degradation and reduced stability. This presentation summarizes literature on HCP challenges, provides case studies, and highlights advanced techniques like LC-MS/MS and size-exclusion chromatography. The goal is to develop strategies to control HCP persistence and ensure the stability and safety of biotherapeutic products.

Ultrafiltration/Diafiltration has been the hallmark for concentration and buffer exchange of protein and peptide-based therapeutics for years. With the emergence of nucleic acid-based therapeutics, UF/DF is often being used to process these new modalities. We examine the capabilities and limitations of UF/DF membranes to process oligonucleotides using antisense oligonucleotides (ASOs) as a model. This presentation will share our experiences with oligonucleotide process development around the use of UF/DF, as well as the development of the oligonucleotide purification platform.

Over the past 3 years the joining of cell and gene therapy material quality with the joint auditing model has proven to not only increase safety but also decrease money spent. The joint audit model can partner confidentially C&G organizations together to audit material suppliers, which in turn provides a much more robust audit, and return. This presentation will dive into the joint auditing model and provide case examples on best practices as well as guidance.

• Pointers for evaluating academic/early stage programs before technology transfer to a commercial CDMO;
• Choosing and interacting with an optimal CDMO for streamlining manufacturing protocol development;
• Practical tips to avoid time and cost in early manufacturing planning.

• Innovations in HEK293 suspension cell cultures;
• Strategies to maximize AAV production yield;
• Regulatory considerations for CQAs in gene therapy;
• Overcoming challenges in process scale-up and technology transfer.

This talk will explore the critical challenge of optimizing the empty to full capsid ratio in AAV production. By examining various techniques such as plasmid engineering and feed studies, the session will provide insights into improving viral yield and product quality. The discussion will also cover innovative tools and analytical methods for early detection of capsid ratios in crude harvest materials, aiming to streamline the purification process and enhance overall efficiency.

• Identifying and mitigating project, technical, and operational risks
• Ensure consistent product quality and robust processing across manufacturing sites through global integration
• Digitalization of tech transfer workflows and knowledge management

In today’s fast-paced tech landscape, expediting the licensing of innovative technologies is crucial for success. However, many organizations struggle to effectively communicate their offerings to potential licensees. This presentation explores the often-overlooked question: Are we using the right technology to get the word out? We will analyze various outreach methods—from traditional networking to modern digital platforms—and their effectiveness in reaching target audiences. By examining case studies and best practices, we will identify key strategies for leveraging the latest communication tools to enhance visibility and engagement. Attendees will leave with actionable insights on optimizing their technology outreach efforts, ultimately accelerating the licensing process and driving innovation forward. Join us to discover how to align your messaging with the most effective channels to ensure your technology gets the attention it deserves.

Novel modalities propose unique challenges for their purification and removal of impurities - how can purification processes be optimized for these novel modalities?

Roundtable groups discussing:

Emerging technologies and approaches utilized for DNA/RNA/mRNA downstream processing

• Scaling these technologies for growth;
• Unique purification challenges and solutions for viral vectors and mRNA;
• Challenges when transitioning from membranes for viral vector/mRNA based therapeutics.

Addressing challenges related to ADC degradation and impurity clearance

• Developing analytical methods for monitoring ADC stability and purity;
• Optimizing conjugation processes to prevent downstream bottlenecks;
• Strategies for managing heterogeneity in ADC products;
• The impact of ADC instability on downstream processing and product quality.

Overcoming issues for purification for Radiopharmaceuticals

• Unique challenges associated with handling and purifying radio-labelled compounds;
• Ensuring the safety and efficacy of radiopharmaceuticals through effective purification;
• Regulatory considerations for the purification of radiopharmaceuticals;
• The role of automation and robotics in radiopharmaceutical purification.

Achieving optimal downstream purity during vaccine development

• Specific purification challenges associated with different vaccine types (e.g., viral, bacterial, subunit);
• Strategies for removing impurities and contaminants from vaccine products;
• The importance of maintaining vaccine stability and potency throughout purification;
• Regulatory requirements for vaccine purity and quality.

30 minute roundtable discussions, 30 mins feedback to group and key takeaways.

• Ensuring the commercial sustainability of cell & gene therapies;
• Tackling barriers and identifying opportunities for commercialization;
• Innovative payment models in the US and globally;
• Strategies for attracting investment to ensure smooth transition from bench to bedside.