8:30am | Morning Coffee & Networking

9:20 am Chair’s Opening Remarks

Tightening Your Process Control Strategies

9:30 am Exploring Solid Phase Synthesis of Oligos & Post-Synthesis Conjugation

Synopsis

  • Process development of modified oligo and post synthesis conjugation
  • Understanding the QC criteria relative to what you would need to support something in later stage, clinical development
  • How to adapt to the regulatory requirements that are much more stringent later in clinical development

10:00 am Roundtable Discussion: Sustainable Manufacturing & Novel Green Chemistry Approach

  • Oliver Thiel Executive Director Process Development, Drug Substance Technologies Pivotal & Commercial Synthetics , Amgen

Synopsis

With growing investment in new modalities such as peptides and oligonucleotides, it is increasingly important to tackle the challenges of waste, and sustainable manufacturing. Recognizing the ramifications of formulation and process development, now more than ever we need to turbocharge processes that are less environmentally stressful and move into green chemistry

10:45 am Exploring Attributes & Analytics

  • Bob Duff Senior Director, Medicine Chemistry , Switch Therapeutics

Synopsis

  • Gaining a keen understanding of your molecule’s attributes as the roadmap for analytical strategy
  • Understanding that analytical strategies must be precise, accurate and fit-for-purpose for in-process analysis and final Drug Substance and Drug Product

11:15am | Morning Break

11:45 am Emerging Technologies for Biopharma Manufacturing

Synopsis

  • Exploring formulation using new technologies – bioprinting and micro fluidics
  • Utilizing LNPs in the delivery of biologics
  • How using these technologies to encapsulate improves drug delivery or tissue engineering

12:15 pm Roundtable Discussion: Reducing the Waste in Oligo Synthesis

  • Tim Turner Senior Manager, Synthetic Process Development , Alexion Pharmaceuticals

Synopsis

  • Delving into Process Mass Intensity (PMI), the kilograms of waste generated per kilogram of API produced compared to small molecules
  • Raw material consumption and supply chain challenges
  • How to improve sustainability in the long term

1:00pm | Networking Lunch

Accelerate Scale-Up & Emerging Technologies Adoption

2:00 pm Successful Partnering in Tech Transfer to CROs & CDMOs

Synopsis

  • Exploring the options: one-stop shops versus specialty boutique firms
  • Understanding your partner: the challenges of multiple customers, multiple APIs, tight schedules, and the potential for bottlenecks
  • Assuring quality in early non-GxP development

2:30 pm Mass Spectrometry Characterization of siRNA-Antibody Conjugates

Synopsis

  • siRNA-Antibody has provided a novel approach to deliver siRNA to specific tissue or cells for therapeutic purposes
  • Analytical challenges inherent in the siRNA-Antibody conjugates
  • Mass spectrometry approaches for characterizing siRNA-Antibody conjugate, and identifying degradants and impurities

15:00 | Afternoon Break

3:30 pm Developing Analytical Control Strategies for Therapeutic Oligonucleotides

Synopsis

  • Outlining the analytical challenges in developing therapeutic oligonucleotides
  • Discussing how to identify and meet these challenges
  • Establishing the importance of platform knowledge and how an analytical control strategy can be developed during clinical development

REMOTE

4:00 pm Understanding Emerging Technology Development in Peptides

Synopsis

  • How to apply these processes at commercial scale
  • Outlining the nuances of applying PAT tools in the GMP environment

4:30pm | Chair’s Closing Remarks & End of Summit