INSIGHTS ON ENTERPRISE SOLUTIONS

• Accelerating A Complex Molecule From CLD To cGMP In 12 Months

  Learn how to mitigate technical risk, implement parallel process development, and design custom purification strategies for highly sensitive novel modalities to accelerate to cGMP material.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo

  In this episode of "Better Biopharma," Tyler Menichiello is joined by Patrick Bilbo, chief operating officer at Organogenesis, a regenerative medicine company developing and manufacturing advanced wound care products.

• Advancing Biologics Development With Next-Gen Cell Line Development

  11/17/2025

  Next-gen CLD utilizes transposase-mediated integration for speed and stability and employs an engineered cell line to enhance ADCC and a high-throughput assay for early glycosylation control.

• Using Digital Tools In Process Development

  11/17/2025

  Technology can transform the entire biopharma production process chain. Using integrated process models, machine learning, and genetic algorithms has made production faster and more efficient.

• Industry 5.0: Preparing For The Future Of Biotechnology

  11/14/2025

  Industry 5.0 represents the next generation of bioproduction—the Adaptive Plant—where human expertise is empowered by AI-enabled insights, autonomous systems, and strategic collaboration.

• Accelerating Early Phase Biologics From The Clinic To Commercialization

  11/13/2025

  Strategic planning in early-phase biologics accelerates clinical progress, reduces risk, and lays the groundwork for scalable, compliant manufacturing and successful commercialization.