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Next -Gen Biomanufacturing

Innovative manufacturing technologies and approaches for bringing biologics to market

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Conference Theme Sponsor

Oct 24th - Room 4.3

Oct  24th       11:00 - 11:15 (CET)    Room: 4.3, Conference Centre 4


Setting the scene for the biomanufacturing landscape

 

Sheila Ann Mikhail, Co-Founder and Former CEO, Asklepios BioPharmaceutical, Inc 

Oct  24th       11:15 - 11:35 (CET)    Room: 4.3, Conference Centre 4

  • Ensuring quality and compliance in biomanufacturing
  • Closing gaps in development data prior to the first GMP production
  • Adjusting manufacturing processes throughout the course of a site-to-site transfer
  • Fulfilling special requirements on container closure systems for biologics
  • Transferring analytical methods for drug products and drug substances

 

 

Speaker: Olaf Wegener, Head of Research & Development, Siegfried Hameln GmbH


Oct  24th       11:40 - 12:00 (CET)    Room: 4.3, Conference Centre 4

• The Covid-19 Pandemic forced us to learn new ways of collaborating and innovating to solve a global crisis - what can we learn and leverage from this experience as we adapt to a 'new normal'?

• Amazing scientific development and break-throughs are evolving faster than ever, with new advanced treatment options for patients being developed at unprecedented speed. All of us involved in manufacturing and supply need to rethink how we collaborate, deliver medicines and learn faster.

• No one company can solve this alone - requiring us to collaborate, innovate and learn in new ways. What does this change really mean for us?

 

Welcome to engage in a discussion, sharing case study data and recent insights in the middle of an industry learning journey.

 

Speaker: Magnus Blomberg, Global Supply Network Strategy Director, AstraZeneca


Oct  24th       11:05 - 12:25 (CET)    Room: 4.3, Conference Centre 4

The global contract research, development and manufacturing (CRDMO) industry is in its next phase of evolution. Increased investments due to the COVID-19 pandemic along with the looming energy crisis and the on-going supply chain issues have had a major impact on the pharmaceutical industry. To remain competitive, companies are implementing innovative manufacturing strategies and prioritizing manufacturing efficiency.

 

This is set to positively impact the CDMO industry wherein companies are employing differential service offerings and unique business models across drug discovery & development. This briefing charts the growth avenues for the CRDMO market in 2023 and beyond.

 

Speaker: Unmesh Lal, Director, Frost & Sullivan


Oct  24th       12:30 - 12:50 (CET)    Room: 4.3, Conference Centre 4

Though viral vectors are used extensively in cell and gene therapy, the challenges of manufacturing such complex biologics at industrial scale is still a limitation to its broader use. Dr. Ayuso will speak about how upstream and downstream process optimization using design of experiments (DOE), a platform approach and end-to- end capabilities can tackle manufacturing challenges and help to expedite drug development.

 

Speaker: Eduard Ayuso, Chief Executive Officer, Dinamiqs


Oct  24th       12:55 - 13:40 (CET)    Room: 4.3, Conference Centre 4

Manufacturers face unique quality challenges that can hinder progress. In this session, discover quality challenges in Cell and Gene Therapy (CGT) and learn common practices for overcoming them:

 

• Where are all the approvals? Understanding unique manufacturing challenges for Autologous Cell Therapies

• How does development by design, quality by design, and Cell Therapy COGs converge in this new space?

• Creating a Cell Therapy technology roadmap to address challenges and drive speed-to market

 

Moderator:
Eduard Ayuso
, Chief Executive Officer, Dinamiqs

Panelist:

Sheila Ann Mikhail, Co-Founder and Former CEO, Asklepios BioPharmaceutical, Inc

Unmesh Lal, Director, Frost & Sullivan

Magnus Blomberg, Global Supply Network Strategy Director, AstraZeneca

 


In person - day 2

Nov 2nd       10.45-11.15 AM    Stand 30J20, Hall 3.1

Nov 2nd       11.20-11.45 AM    Stand 30J20, Hall 3.1

Today, leading companies are not only centered on creating values, but they also focus on developing strategies to foster a company's longevity. Therefore, many companies have become more engaged in sustainable activities to make progress and are now joining the race. Acknowledging the importance of sustainable development, Biopharma CDMO companies are also finding ways to show their best performances in sustainability. In this session, we will discuss the importance of why pharmaceutical CDMO companies should make their transition with long-term sustainability in mind. Explaining how the pharmaceutical industry (and innovative initiatives) should put effort into improving outcomes for patients, employees, the environment, and the wider community. Learn how Samsung Biologics, as one of the leading CDMO companies, is committed to making a sustainable future by creating ESG values through climate change responses, entry into the carbon neutral society, and transparency in the governance structure.

Talk Sponsor

Nov 2nd       11.50-12.15 PM    

Indena is relentlessly working to generate a sustainable impact on its stakeholders, cultivating with care its own precious circle: Nature, Technology, and People. In terms of actual projects and actions, Indena's commitment in sustainability includes responsible supply chain management, a circular economy in product design, and very smart use of energy in its plants. As for energy use, which is linked to climate change, one of the most urgent global sustainability challenges, Indena has been working for years to reduce consumption, save energy, and achieve high levels of energy self-production. All the actions taken for sustainability allow Indena to be fully reliable in terms of business continuity and thus be a solid partner for all its clients.


Talk Sponsor

Nov 2nd     12.20-12.45 PM    Stand 30J20, Hall 3.1

Container closure integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug – device combination product development. Several methods exist with different advantages and limitations. During this session, we will address the following points:

- Probabilistic vs deterministic CCI Testing

- Presentation of the different deterministic CCI testing methods with applications and limitations

- What to consider when selecting CCI testing method.

At the end of the session, attendees should better understand the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activities based on the advantages and limitations of different techniques available on the market.

 


Talk Sponsor

1
In person - day 3

Nov 3rd     11.20-12.10 PM    Stand 30J20, Hall 3.1

Nov 3rd     11.20-12.10 PM    Stand 30J20, Hall 3.1

The complexity and risks found within the global pharma supply chain cannot be understated and key stakeholders from customers to regulators and investors are increasingly expecting the industry to both manage ESG risks and embed sustainability throughout the value chain. This can only be achieved through industry-wide collaboration that sets the standard for what a responsible supply chain looks like and provides support to suppliers to achieve these goals. The Pharmaceutical Supply Chain Initiative (PSCI) and our membership of 60+ pharma and healthcare companies are leading this collaboration to create harmonized approaches and standards for our value chains. Through our Principles for Responsible Supply Chain Management, shared audit program, and supplier maturity model, our members are putting ESG and sustainability into practice to create responsible supply chains.


Talk Sponsor

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