ON-DEMAND WEBINARS

• Early Development To Clinic – De-Risking A Bioconjugate's Journey

  The journey of a novel bioconjugate into clinic is complex and uncertain. Explore the particular challenges when moving a bioconjugate candidate from early development into clinic.

• How To Safely Handle Your Antibody Drug Conjugate

  Internal specialized occupational toxicology and industrial hygiene knowledge can help solve the mystery of safe handling ADCs.

• IND Submissions In China: What's Different From Other Regions?

  The number of regulatory submissions in China is increasing. This webinar provides an overview of Chinese regulations with a specific focus on data and requirements for clinical trial applications.

• Embrace Molecule Complexity With Optimized Expression Technologies

  Explore the needs of more complex candidates, through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.

• Streamlined Selection Of In Vivo Predictive Dissolution Media

  Explore the design of dissolution media to support biopredictive dissolution testing and a method for selecting practical, physiologically relevant media based on drug, formulation, and GI fluid properties.

• Identifying And Mitigating Potential For Immunogenicity, Immunotoxicity

  Explore the challenges of assessing the immunosafety profile when moving a drug candidate to FIH studies, including key considerations and pitfalls to avoid along the way.

• Partner Perspectives To De-Risk Commercialization Of Combination Products

  Developing an effective drug-device combination product for self-administered biologics is a complex process. A well-executed strategy will help support integration with manufacturing operations and successful drug delivery.

• Accelerating Progress: Key Considerations For CDMOs To Maximize Productivity And Scalability

  Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.

• The Paradigm Shift To Continuous Flow Processes: A Holistic View

  A clear increase in continuous flow processes has emerged over the past decade, thanks to the commercialization of preparative flow reactor units.

• QP Release: Clinical, Commercial Expectations & Responsibilities

  Supplying into European countries requires planning, regulatory experience, GxP compliant facilities, robust processes, and, critically, a qualified person (QP) named on the license.

• FDC Development: Designing A Lifecycle Strategy With Agility And Speed

  Combining drugs that may have been shelved due to a variety of reasons with established, safe, and approved drugs has the potential to bring safer, effective therapies to patients.

• Local Delivery For Treatment Of Lung Cancer

  Explore two case studies where lung cancer therapies were delivered to the lung by dry powder inhaler in a rat model and evaluated for efficacy, confirming local delivery is a promising route to treat lung cancer.

• Orphan Drugs: Balancing Financial Incentives & Complex Challenges

  Whether your orphan drug is a small or large molecule, there are key strategies to enable a seamless transition from early development into commercial manufacturing, while also balancing your investment.

• Vaccine Development: Strategic Approach & Response During Pandemics

  In the wake of SARS-CoV-2, scientists and pharma companies are reinventing how to bring these life-saving vaccines to market faster without impacting product quality, safety, or efficacy.

• Shortening The Timeline To First In Human Clinical Dosage

  Lengthy early development timelines are common across new & emerging biotech companies. Strategies adopted for a rapid development of a simple yet flexible format prove beneficial.