• 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.

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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.

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.