BioTalk US- Biological Manufacturing Excellence
7th – 8th May 2024, Boston, US
BioTalk is a leading annual meeting that brings together some of the most influential senior executives across the world’s Pharma & Bio-pharmaceutical Manufacturing community. The Talk will look at how companies and leaders are driving change within the industry to achieve manufacturing excellence through a series of keynotes, workshops, discussions, and debates.
Industry Leaders will be able to engage with fellow peers through a ‘closed door’ and ‘invitation only’ networking environment and discuss some of the industry’s key challenges in an intimate setting.
For more information, contact kamran.yousaf@gmstrats.com
DAY ONE
JJP-1212 as example for the “SMART GOOSE” story
Autoantigen-specific IgA autoantibodies closely correlate with symptoms severity in a subgroup of patients in multiple autoimmune diseases. Beyond the value of these IgA autoantibodies as biomarkers, the presence of excessive IgA/autoantigen immune complexes results in continuous CD89 (Fc?RI)-mediated activation of myeloid cells, leading to severe tissue damage. Activation of myeloid cells – especially of neutrophils – is a highly underappreciated and untargeted hallmark of autoimmune diseases. Enabling a personalized medicine approach, high autoantigen-specific IgA serum levels will serve as companion diagnostic to stratify patients for personalized treatment with our antagonist humanized anti-CD89 antibody (JJP-1212). Interfering with the IgA/CD89 axis by JJP-1212, resolves IgA/autoantigen-induced inflammation and subsequent tissue damage in a variety of autoimmune diseases.
Louis Boon, CSO, JJP Biologics
Acceleration of downstream process development of both platform and non-platform molecules by adopting a HTS (High Throughput Screening) DoE approach using an automated 96-well HTS platform
- HTS can be used to rapidly develop downstream processes for molecules with a poor platform or no platform fit so that we can choose the best molecule rather than eliminate it due to platform fit considerations.
- With the right types of controls, yield and some impurity data from 96well separations can be closely approximated to what is observed in traditional scale-down packed chromatography.
- Regeneron’s HTS platform greatly accelerates the development of early-stage clinical processes allowing for a “speed-to-clinic” approach.
- HTS screening can be used to accelerate mechanistic model development to potentially replace scaled-down packed DoE’s
James Reilly, Associate Director, Downstream Process Development, Regeneron
Transforming traditional cell culture process development with insilico solutions
- Establishing a generic insilico model for cell culture processes.
- The impact of generic models on cell culture productivity and quality over multiple programs.
- Can Insilico modelling significantly improve process development over traditional approaches?
- What gains can we achieve by applying insilico modelling to early or late-stage programs
Dr. Sarwat Khattak, Head of Cell Culture and Cell Line Development, Biogen
Next Generation Manufacturing and Continuous Bioprocessing: application of rapid bioburden testing
- In this work we focus on the evaluation and testing of a rapid bioburden technology and its implementation for Intensified and continuous bioprocessing (ICB) microbial control.
- This technology allows detect contamination in hours instead of several days – a limitation of compendial methods.
- The speed of detection is crucial to identify contamination and still have time to decide on material diversion for a continuous process.
- In collaboration with NIIMBL colleagues, the strategy on how to use early detection of bioburden contamination, in a few ICB locations, informs how GMP facilities and their Quality Management System will need to include new mitigation strategies for product diversion and consequently batch release.
- A case-study developed at AstraZeneca will be presented, where sampling strategy and real-time data analysis was crucial to inform bioburden levels for all process intermediates throughout the run.
Irina Ramos, Director Downstream Continuous Manufacturing, Bioprocess Engineering & Technology Group, AstraZeneca
Process Intensification technologies using In-line concentrators for High Titer mAb process
- As mAb titers are increasing, it is straining downstream purification manufacturing technologies. One of the issues facing manufacturing is the ever-increasing in-process volumes, due to increasing titers.
- A look at the comparative evaluation of Single Pass Tangential flow filtration (SPTFF) or In-line product concentrator technologies for the management of in-process volumes for downstream process fit.
- Comparative evaluation of SPTFF technologies on in-process volume controls including process robustness and controlling parameters, product quality impact, manufacturing scalability, and implementation
Lihua Yang, Principal Research Scientist II, AbbVie
Application of Digital Modelling in New Product Introduction (NPI) into Commercial FacilityDigital modeling has been used to de-risk and facilitate successful NPI activities
- Case studies of using CFD and cell culture digital twin modeling will be presented.
- Modeling provides recommendations on equipment and control strategies.
- This helps to reduce at-scale tests and achieve the right first time tech transfer/scale up.
-
Yuanyuan Cui, Principal Engineer, Sanofi
Request Full Agenda
This is my first BioTalk and I got the opportunity to share some of the sessions here, it has been a very intense two days, very short and compact, and brings a lot of subject matter experts on very relevant topics, my experience at BioTalk has been nice.
I think it was great! How many opportunities do we get in a year to get together with our peers and talk to them about the experiences they share. Overall, I believe that this is a great platform where we come together and share our experiences