Session Topics
Advances in Modalities with Chemical Transformations (peptides, oligos, ADC conjugations)
This session invites papers showcasing the latest advancements in the fundamental and applied aspects of product and process development for novel pharmaceutical modalities manufactured through chemical transformations. Examples of these modalities include oligonucleotides, peptides, antibody-drug conjugates (ADCs), gene therapies, and other emerging pharmaceutical innovations. We welcome contributions from scientists and engineers involved in development, processing, scale-up, and technology transfer.
Suggested topics include, but are not limited to:
- Scale-Up Challenges
- Novel Chemical Reactions
- Green Chemistry
- Automation
- Process Analytical Technology (PAT) and Process Control
- Process Modeling o Mechanistic (first-principles) or data-driven models
- Regulatory Strategies
- Addressing challenges in characterizing critical quality attributes (CQAs)
- Control and characterization of process impurities
Establishing product comparability under accelerated CMC development and clinical timelines Presentations in this session will emphasize novel therapeutic modalities, chemical transformations, and enabling technologies that address the complexities of modern pharmaceutical development.
Advances in Cellular Expression and Upstream Production
This session features presentations on the impact of host cells for novel biopharmaceutical products. Topics of interest include host cell transformation strategies, synthetic biology techniques to improve product titer and/or cell viability.
We are also interested in optimization by process intensification and host cell characterization by -omics technologies. The interactions between host cells and product quality are of high interest.
Although mammalian cells have played a dominant role in current biopharmaceutical manufacturing, we are open to contributions on alternative production hosts such as bacterial, yeast and plants, and even cell free technologies.
Finally, we are also encouraging contributions on regulatory aspects associated with host cell and product characterization.
Downstream Processing and Purification
The success of monoclonal antibody (mAb) therapeutics has driven exploration into designer biotherapeutic modalities capable of combinatorial and more targeted approaches. However these novel modalities present new and unique challenges in downstream bioprocessing.
This session calls for papers focused on the downstream processing of novel protein formats which may include, but are not limited to antibody based formats (fusion proteins, bispecific antibodies, proteins, single-chain variable fragments (scFv), antigen binding fragments (Fab), novel antibody structures, etc) and non-antibody based formats (protein conjugates, peptides, viral vectors, enzymatic proteins)
The scope may range from early/late stage process challenges, scale-up, and/or large-scale manufacturing, platform options, automation and high-throughput screening. Chromatographic and non-chromatographic stationary phases (resins, membranes, monoliths, precipitating agents) used in the processing of novel modalities are also welcomed.
Drug Product Formulation and Delivery Approaches
This session will explore the latest advancements and challenges in pharmaceutical formulation and delivery for novel modalities.
Topics include scale-up challenges, fill/finish considerations for novel modalities, regulatory strategies, and patient-centric device solutions.
Professionals and researchers will share insights on formulation and drug delivery platforms, such as permeation-enhancers for oral delivery of peptides, subcutaneous delivery of biologics, and nanoparticle delivery of oligonucleotides, and learn about the evolving control strategy and regulatory expectations for combination products.