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Setting the scene for the biomanufacturing landscape
Sheila Ann Mikhail, Co-Founder and Former CEO, Asklepios BioPharmaceutical, Inc
• Facilitating speed to market for biologics
• Assessing potential risks and solutions when scaling up development
• Considerations for developing a robust and scalable manufacturing process
• Machine learning applications for improving current manufacturing protocols
Biologic manufacturing can be a complex and timely process when producing therapeutic proteins, antibodies, vaccines, and other biologic drugs. Listen and gain insight to acceleration. strategies for biologics manufacturing and to meet the growing demand for biologics in a timely manner
• Reviewing time-saving strategies to improve early-stage development processes
• Assessing current upstream and downstream toolkits and how to best utilize them to drive efficiencies
• Why defining your regulatory strategy can help improve manufacturing timelines
Speaker: Reserved - Magnus Blomberg, Global Supply Network Strategy Director, AstraZeneca
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
Advancing standards in biosimilar engineering encompass ongoing efforts to establish rigorous criteria and guidelines for the development, characterization, and manufacturing of biosimilars. Join and learn what can be done to improve engineering standards in biosimilars
• Why clearer regulations from both the FDA and EMEA can help progress manufacturing outcomes
• Why having clear communication lines with patient organizations can help improve clinical outcomes
• Reviewing cost measures to increase scalable manufacturing operations
Speaker: Anders Wallstron, Head of Manufacturing and supply chain, Xbrane Biopharma AB
• 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
Anders Wallstron, Head of Manufacturing and supply chain, Xbrane Biopharma AB
Unmesh Lal, Director, Frost & Sullivan
Magnus Blomberg, Global Supply Network Strategy Director, AstraZeneca
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.
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.
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.
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.