Challenges & focus groups

The objective of the COBIOE project is to set up dynamic focus groups that will allow to jointly address identified priorities and challenges in a processus of collaboration, dialogue, exchange of good practices and development of related activities. Ultimately, joint activities will be build to further develop the collaborations and participate in other projects or initiatives supporting focus groups priorities, in line with the deployment of supporting activities.

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Bio-resources and biobanking
Identification of biotherapies
Drug design
Clinical validation
Production
Market access
1 Challenge: Research & innovation
Focus group: Personalized therapies & scaling complexity
Focus group: Cell therapy & vaccine development
Focus group: Technology transfer & commercialization
2 Challenge: Production capabilities
Focus group: Continuous bioprocessing & scaling up
Focus group: Flexible manufacturing platforms
Focus group: Process analytics & monitoring
Focus group: Supply chain and raw materials
Focus group: Downstream processing and purification
3 Challenge: Skills & talents
Focus group: Workforce development & training
Focus group: Talent attraction & retention
4 Challenge: Access to funding
Focus group: Innovation funding & collaboration
Focus group: Regulatory compliance & funding adaptation

1 Research & innovation challenges

Need to adapt the funding for the scaling up of innovation, and ensure to keep the talent

Need to explore new sources of cells and differentiation processes to create new cell therapies

Need to support the development & production capabilities of new therapeutic vaccines

Limited availability of standardized protocols and methods for biomanufacturing processes

Need for advanced process analytics and monitoring technologies to ensure product quality and consistency

Challenges in developing scalable and cost-effective continuous bioprocessing methods

Integration of advanced analytics and artificial intelligence for process optimization

Innovation in cell line development for improved protein expression and product yield

Focus groups

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Personalized therapies and scaling complexity

This group addresses the unique challenges of scaling up complex biomanufacturing processes for personalized therapies and explores innovative solutions to ensure reproducibility and product quality.

Cell therapy and vaccine development

This group focuses on advancing research and innovation in cell therapy and vaccine development, including exploring new sources of cells, differentiation processes, and production capabilities.

Technology transfer and commercialization

This focus group tackles the challenges of technology transfer from research to industrial-scale production and strategies for successful commercialization of biomanufactured products.

Want to join a focus group? Join COBIOE community!

2 Production capabilities challenges

Need to increase public-based investment on production capabilities

Need to adapt regulatory constraints

Need to secure biosourced resources supply chain

Need to support pre-industrial and industrial scaling-up

Complexity of scaling up complex biomanufacturing processes for personalized therapies

Challenges in ensuring consistent product quality and reproducibility at larger scales

Need for innovative solutions to address challenges in downstream processing and purification

Ensuring the availability and sustainability of raw materials and critical components

Developing flexible and modular manufacturing platforms to accommodate different types of biomedicines

Focus groups

Join a focus group

Production Analytics and monitoring

This focus group discusses the development and integration of advanced analytics, process monitoring technologies, and artificial intelligence to ensure consistent product quality and process optimization.

Continuous bioprocessing and scalling up

This group addresses the challenges of developing scalable and cost-effective continuous bioprocessing methods and strategies for successfully scaling up production to meet increasing demand.

Supply chain and raw materials

This group focuses on securing the biosourced resources supply chain, addressing challenges related to raw materials availability, and identifying strategies for ensuring sustainability.

Downstream Processing and Purification

This focus group discusses challenges in downstream processing, purification, and the development of efficient methods to extract, isolate, and purify biomedicines.

Flexible manufacturing platforms

This group focuses on developing modular and flexible manufacturing platforms that can accommodate various types of biomedicines and adapt to changing production needs.

Want to join a focus group? Join COBIOE community!

3 Skills & talents challenges

Need for more specialized training education programs

Talent development: stretch vs future demand

Upskilling and re-skilling of labor forces from other industry sectors

Talent chase and high competition to attract digitally skilled workforce (digital twins, simulators, virtual & augmented reality)

Need for more entrepreneurship skills

Shortage of skilled professionals with expertise in advanced bioprocessing techniques

Lack of cross-disciplinary training programs that combine biology, engineering, and data science

Difficulty in attracting and retaining diverse talent in the biomanufacturing workforce

Rapidly evolving technology landscape requiring continuous upskilling

Need for specialized training in regulatory compliance and quality control for biomanufacturing

Focus groups

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Workshop Development and Training

This focus group aims to develop strategies for enhancing specialized training programs, upskilling, and cross-disciplinary education to meet the evolving demands of the biomanufacturing workforce.

Talent attraction and retention

This group explores ways to attract, retain, and diversify the talent pool in biomanufacturing by addressing competition for skilled professionals and creating a conducive environment for career growth.

Want to join a focus group? Join COBIOE community!

4 Access to fundings challenges

Need to adapt the funding tools for the scaling up and growth of business

Need of larger investments from EU-based funds

Adaptation of regulatory constraints

No/few suppliers of equipment, consumables, and raw materials

Limited access to early-stage funding for biomanufacturing startups

Difficulty in securing venture capital investment due to the long development timelines of biomedicines

Need for more public-private partnerships to accelerate technology transfer and commercialization

Challenges in navigating complex regulatory pathways and obtaining funding for clinical trials

Lack of funding options for scaling up production facilities to meet increasing demand

Focus groups

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Innovation Funding and collaboration

This focus group delves into adapting funding tools, exploring new sources of funding, and establishing collaborations to support the scaling up of innovative biomanufacturing technologies and processes.

Regulatory Compliance and Funding Adaptation

This focus group navigates the complex landscape of regulatory constraints and explores ways to adapt funding tools to support biomanufacturing growth and commercialization.

Want to join a focus group? Join COBIOE community!

If you want more information about our focus groups and the COBIOE project, don’t hesitate to contact us.