バイオ医薬品の急成長分野は、タンパク質の生産に圧力をかけ、製造に課題をもたらしています。組換えタンパク質の抽出、精製、特性評価、定量化、アナリティクス分析には多大な労力を要し、複数のステップが必要です。従来の一時一事（OFAT）アプローチでは、複雑な相互作用を明らかにできず、最適化されていないプロセスが生じることがよくあります。最適化されたタンパク質プロセス開発ロードマップを策定すると、バイオ生産を合理化し、時間とコストを削減できます。Cambridge Healthtech Instituteの第8回年次会議「タンパク質プロセス開発」では、国際的な専門家が集まり、この普遍的なタスクを最適化するためのベストプラクティスと戦略を共有します。ワークフローを支える技術に重点を置き、業界の増大する需要に対応するために、どのように革新・刷新・改訂が行われているかについて紹介します。
Recommended Short Course*
Monday, 13 November, 14:00 - 17:00
SC4: The Use and Optimization of Eukaryotic Expression Systems to Support Therapeutic Generation and Structural Biology
*Separate registration required. See short courses page for details. All short courses take place in-person only.
Registration Open and Morning Coffee07:30
Protein Quality after the Release from Microparticles
Inclusion bodies (IBs) are protein microparticles produced by bacterial overexpression of recombinant proteins. Because of the protein functionality and secretion properties, IBs have been used in biotechnology and biomedicine. We have developed artificial IBs that preserve the features of natural versions but also have a controlled composition, ensuring biocompatibility. Our focus lies in pointing out the performance and functional improvement of the protein released from both IBs and artificial IBs.
Targeting Every Human Protein: Challenges and Prospects
Structural genomics has encouraged the development of systematic approaches to achieve the expression and purification of proteins that have not been previously studied. Such approaches are increasingly pertinent, as unbiased “omic” studies in many disease areas discover new possible targets for interventions, many of which have not been investigated at the protein and chemical level. Target2035 is an ambitious plan, aiming to generate chemical tools to all potential drug targets in the human genome. I will discuss how this could be done - and where innovative technologies as well as an international coordinated effort will be needed.
Sponsored Presentation (Opportunity Available)09:30
Coffee Break in the Exhibit Hall with Poster Viewing10:00
Rapid Purification of Multi-Specific Antibodies Enabled by Introduction of Engineered Mutations
We have designed and engineered a set of purification-enabling mutations into specific regions of multi-specific antibody chains that enables a highly effective, rapid and high-throughput, all affinity-based purification scheme for many different formats. This innovation can help accelerate the early identification of lead candidate molecules in research by allowing simple and fast isolation of highly pure material from mixtures of product-related impurities.
Enhancing Success Rates and Throughput of Protein Purification for Drug Discovery: A Medium-Scale Approach
Recombinant protein production is crucial in contemporary drug discovery, contributing to target identification, screening, selectivity, and structural biology studies. Swift and top-quality protein production is crucial for successful drug development, where efficient recombinant protein production becomes necessary. Our team is continuously improving technology, utilising a medium-scale recombinant protein purification platform to enhance sophistication, throughput, optimisation, and finally, reducing time and costs at the early stages of drug discovery.
KEYNOTE PRESENTATION: Protein Purification Strategies Must Consider Downstream Applications and Individual Biological Characteristics
Proteins are used as reagents in a broad range of scientific disciplines. The reliability and reproducibility of the obtained experimental data will largely depend on the quality of the (recombinant) proteins. Therefore, proper quality control is imperative. However, the specific features that need to be checked depend very much on both the biological characteristics of the protein and the intended downstream applications. Some proteins possess intrinsic properties (prone to aggregation, rich in cysteines, a high affinity for nucleic acids, etc.) that require certain precautions during the expression and purification process. For other proteins, the downstream application might demand specific conditions.
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:50
Dessert Break in the Exhibit Hall & Last Chance for Poster Viewing13:50
ROUNDTABLE BREAKOUT DISCUSSIONS
Breakout Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Breakout Discussions page on the conference website for a complete listing of topics and descriptions.
High-Throughput (HTP) Protein Production
- Benefits of testing multiple constructs in parallel. How can we produce the full length protein?
- How many and which expression systems should a lab set up to produce a variety of proteins (intracellular, secreted, membrane)?
- HTP expression screening in multiple hosts: What scale, tags, conditions, equipment, readout?
- Challenges of working in HTP: What conditions to test first to increase success?
Artificial Intelligence and Automation in Bioprocess Development
- Lab digitalisation - how far are we and where are the hurdles?
- How far can we go with automation of experimental approaches in R&D?
- How far can lab automation and model based approaches decrease the number of experiments and thus save time and costs?
- Where do you see the general opportunities and current limits of AI in bioprocess development?
- What do you think of the value of small scale high throughput experimental approaches for larger scale processes?
AUTOMATION AND PROCESS OPTIMIZATION
Expanding the Manufacturing Solution Space: Harnessing Gene Therapy Technology Innovation for Recombinant Protein Production
Gene therapy design and manufacturing platforms incorporate many technologies originally created for recombinant protein production. This talk will discuss how this technology flow is now moving in the opposite direction, driven by the innovation required to bring these complex product formats to market. Using recent examples from my academic and industry lab, I will present how we are harnessing our ATMP technological innovations to improve biomanufacturing of DTE protein products.
Development of an Integrated Messenger RNA Manufacturing Process Using Thermoreversible Aqueous Biphasic Systems
mRNA vaccines are in the spotlight, creating an opportunity to reinforce the expertise in mRNA manufacturing technologies. Built upon the tunable character of ionic liquids and able to achieve enhanced extractions and keep the stability of nucleic acids, these compounds are being investigated by a CICECO team (Augusto Pedro, Francisca Silva, Mara Freire, Maria Sousa, and Luis Silva) to integrate the production and clarification steps in the mRNA manufacturing process.
Sponsored Presentation (Opportunity Available)16:40
An Integrated Approach for the Process Development and Scale-Up of Recombinant Proteins
Utilising high-throughput systems and an ability to gain a holistic view of both product and process challenges is critical in the process development of modalities such as recombinant proteins. Approaching process development with molecular design, upstream production, downstream purification, and analytical characterisation in a single focused effort can allow for improvements in process understanding and expedite timelines in a product's journey from bench to clinic.
Using Machine-Learning to Transfer Learnings across Development Stages towards a Digital Platform Process
Quality by Design is cost-effective only when knowledge is transferred from one drug candidate to the next, from one scale to the other. In this contribution we show how transfer learning methods that originate from the area of machine-learning can be used to transfer knowledge between products and scale, allowing reduction of experimental effort and acceleration of process development.
FEATURED PRESENTATION: Automation and Closed Loop Optimization of Protein Development Processes
The combination of digital technologies with automation enables experimentation to enter an era - closing the loop of experimental design together with set up and analysis and resulting in the self-driving lab. This presentation will demonstrate both hardware and software solutions that have been used to make these physical manifestations of AI, real-world, and the useful application to protein centric development processes.
Close of PEGS Europe Summit18:40
- Antibody-Based Therapies
- Emerging Targets & Approaches
- Membrane Protein Targets
- Safety & Efficacy of Bispecifics
- Advancing Bispecifics
- Engineering Bispecifics
- Optimisation & Developability
- Analytical Characterisation
- Protein Stability & Formulation