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
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
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
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