Agenda

Breakfast will be served in the Longmont Canteen as we gear up for our first speaker session.

Biopharmaceutical companies deliver highly sophisticated molecules that save many lives. This is clearly a high-tech industry, but the methodologies used to develop, operate or optimize processes must be quantitatively improved. These factors are creating greater interest in alternatives like single-use systems, continuous processes, and of course, digitalization.

Regulatory authorities are increasingly requesting and focusing on orthogonal data for Host Cell Protein (HCP) characterization and documentation. Dr. Thomas Kofoed will discuss the benefits and applications of quantitative HCP analysis using reproducible mass spectrometry (LC-MS), which is now available under GMP guidelines and has been utilized in more than 300 projects. 

The bioTRAK database tracks mammalian and microbial supply and demand. You’ll hear about trends in production technologies and production capacity.

Learn how to reach phase I in a faster and cost-effective manner, and get more flexibility for commercial production. 

Marijana Golubovic will moderate a panel of our speakers from day 1, allowing for open conversation and questions from the audience.

Lunch will be served in the Longmont Canteen as we prepare for a tour of AGC Biologics Boulder.

Our Boulder Facility offers a significantly larger production scale for mammalian-based projects. The site houses two massive stainless steel cell bioreactors, and its size, automation, and cost-effective capabilities make it well-suited for high-volume commercial production and high-titer antibody processes.

Breakfast will be served in the Longmont Canteen as we head into day 2. 

Marijana Golubovic will provide a recap of the day 1 activities, and lead us into a productive and inspiring day 2. 

Providing general considerations and background information on the field of mRNA therapeutics and vaccines, insights into the process complexity, approaches to the manufacturing of (pDNA and) mRNA - leveraging flexible single-use technology platform elements, microfluidics for the encapsulation and off-the-shelf technology for aseptic filling of the drug product.

In only 11 months, BioNTech and Pfizer developed BNT162b2 as a highly effective Covid vaccine. However, in addition to infectious diseases, we see the potential of mRNA in many areas and indications. At BioNTech, we will use the technical and regulatory learnings in our other therapeutic areas, such as immuno-oncology and protein replacement. The presentation will give an overview of different aspects of the chances and challenges.

Cell therapy processes are highly variable in terms of cell type, length, volumes, reagents, equipment and testing. A CDMO willing to compete in this highly complex and variable environment needs to have flexibility in each critical step, from basic technical capabilities, equipment base, facility design, and analytical platforms to reduce the time to GMP and optimize throughput and costs.

As AAVs are increasingly used to target more common indications, it is important that appropriate consideration be placed on designing a robust manufacturing process.  This talk will describe the use of Quality by Design (QbD) principles to build a manufacturing process for AAVs with an emphasis on process design, instead of relying solely on final quality testing.  We will show how the process can be applied to specific unit operations and how the use of stable cell lines can drive greater process consistency.

This session gives a snapshot of the industry and what factors are impacting the advanced therapies market, including manufacturing bottlenecks, global regulations, and more. 

Product developers are increasingly harnessing mesenchymal stem/stromal cells (MSCs) and extracellular vesicles/exosomes to develop new classes of advanced therapies. Developments in genetic engineering, upstream and downstream processing, and analytics technologies are enabling these groundbreaking therapies to get to patients faster while maintaining CQA and COGS targets. 

The rapid development of mRNA vaccines was paradigm-shifting, not only for public health but for the biotech industry, regulatory agencies and RNA therapeutics companies. As the current mRNA conversation expands beyond the vaccination realm, there are several scientific, regulatory, manufacturing, and business-centric conversations taking shape that hint at where the biggest challenges and opportunities lie for the mRNA industry in the upcoming year(s). 

We'll wrap up our 2022 speaker series with a panel of our day 2 speakers, moderated by Marijana Golubovic.

Lunch will be served in the Longmont Canteen. Eat up and get ready for a tour of our incredible Longmont campus! 

Longmont is AGC Biologics' North American Hub for cell and gene therapy services. The site's capabilities include viral vector development, characterization, and manufacturing in adherent and suspension environments, along with cell culture and modification development and manufacturing using the latest industry technologies and methodologies.