Manufacturing & Outsourcing

Tuesday 18 May

18 MAY 2021

Manufacturing & Outsourcing

LIVE PANEL - 15:00-16:00 CET

Navigating the CDMO Market: Hurdles, Transformation & Opportunities

After a tumultuous year, what are the key factors shaping the future of the CDMO market? This session will bring together industry stakeholders for an outlook on 2021 and beyond.

Discussion points:

CDMO market outlook, where do the most significant opportunities lie?
What does technology and innovation look like in a post-COVID-19 world? Is sector consolidation set to continue?
Manufacturing vaccines at scale – what are the concerns from the CDMO side?
Onshoring API Manufacturing – can we expect more manufacturers to expand operations on home turf?

Moderator: Rita Peters, Editorial Director, Pharmaceutical Technology and BioPharm International
Kevin Sharp, Head of Alliance Management, Samsung Biologics
Eric Langer, President and Managing Partner, Bioplan Associates, Inc.
Peter Shapiro, Senior Director and Editor-in-Chief of PharmSource, GlobalData Plc.

PRESENTATION - ON DEMAND

Drug Repurposing: A more Efficient Approach to Drug Development?

Drug repurposing has gained traction in the past year amidst the COVID-19 vaccine race - what are the challenges & potential benefits of drug repurposing, compared to the traditional drug development process?

Discussion Points

Benefits to drug repurposing
Examples from the COVID-19 toolkit
Who are the innovators in the drug repurposing space?
Re-purposing vs repositioning
What factors are likely to influence the evolution and future opportunities for this market?

Reenal Gandhi - Global Business Development Director, Aptar Pharma
Laura Kleiman, Founder and CEO, Reboot Rx

18 MAY 2021

PRESENTATION - ON DEMAND

Manufacturing Innovation: The Case for Continuous

Technologies with the potential to accelerate product development, reduce manufacturing costs and facilitate speed to market will be one of the leading change drivers for pharma manufacturing processes in coming years.

Continuous Manufacturing has been widely touted as an approach for creating efficiencies in pharma manufacturing and accelerating commercial success. While industry adoption has been slow, more and more facilities are choosing continuous manufacturing processes when introducing a new product.

Discussion points

What are some of the latest breakthrough technologies being implemented by pharmaceutical manufacturers?
Guidance for Industry: Quality Considerations for Continuous Manufacturing
Batch vs Continuous Manufacturing
Critical success factors and common pitfalls
Is the technology better suited to new products and facilities rather than existing ones?

Doug Hausner, Senior Manager, Business Development Continuous Manufacturing Thermo Fisher Scientific
Bikash Chatterjee, CEO, Pharmatech Associates

Sponsored by SAMSUNG BIOLOGICS

Sponsored by APTAR PHARMA

Sponsored by THERMO FISHER SCIENTIFIC

More and more facilities are choosing continuous manufacturing processes when introducing a new product

18 MAY 2021

CPHI WEBINAR SERIES - REPURPOSED CONTENT

Biomanufacturing Trends

Innovative biotherapeutics and novel technologies are currently being developed and commercialised at record levels providing practical treatments for patients with cancers and autoimmune diseases across the world. In 2019 the FDA approved 48 novel drugs, several of which represent advanced, first-in-class therapies. It comes as no surprise then to hear that venture capital funding into US-based biotech firms was $3.5 billion+ for each of the last eight quarters leading into 2020, according to Pitchbook data.

Today, in the fight against the novel COVID-19 virus all eyes are on the global scientific community who have come together to work on and produce various treatments and vaccines at record speed, and we are reminded just how important scientific innovation is.

Discussion Points:

Product pipeline - what's the latest overview? Which products post key manufacturing challenges?
Securing and sustaining the right talent pool to support growth
Innovation in manufacturing techniques - bioanalytical capabilities, cell line development, aseptic manufacturing, downstream/upstream
Continuous biomanufacturing - significant support for this in the small molecule space, what are the challenges and opportunities in the large molecule arena

Patti Seymour, Managing Director, BDO USA, BioProcess Technology Group
Killian O'Driscoll, Director of Projects, National Institute for Bioprocessing Research and Training
Eric Langer, President and Managing Partner, Bioplan Associates, Inc.

PRESENTATION - ON DEMAND

18 MAY 2021

PRESENTATION - ON DEMAND

Increasing Efficiencies in Bioprocess Development and Manufacturing Through Digital Process Development

Application of modeling tools to better understand and control bioprocess development and manufacturing became a hot topic within the last years. But what do we actually need?

Is it just about data and powerful modeling algorithms or might a shift in focus towards “why” rather than “how”, speed things further up?

Discussion points:

• The overall goal
• Experimental design concepts
• Different modeling approaches for different requirements
• Solutions to speed up both up- and downstream development
• Model transfer along scales
• Model usage for real time monitoring and control

Dr. Mark Dürkop, Chief Executive Officer, Novasign GmbH

IN PARTNERSHIP WITH BIOPRODUCTION

Application of advanced proteomic and mass spectrometry technologies to enhance the efficacy of production of biopharmaceuticals

Proteomics and mass spectrometry are a key technology to the understanding of biological systems. We are using proteomics to characterise recombinant mammalian cell lines (Chinese hamster ovary) in order to gain insights into improving the productivity of biopharmaceuticals.

Discussion points:

• Overview of advanced proteomic and mass spectrometry technologies
• How they can be utilised to enhance efficacy of production of biotherapeutics
• Potential application of proteomics and mass spectrometry in other industries to enhance research capabilities and to potentially improve production capabilities.

Paula Meleady, Associate Centre Director, National Institute for Cellular Biotechnology, DCU

18 MAY 2021

Navigating Decision Points to Fast-Track Commercialisation

Understanding the risks, requirements and challenges of bringing clinical products through validation and to the market are vital for the success of your large molecule project. Whether you are experiencing resource constraints or sturggling with the right level of technical expertise, navigating key decision points within early development can pose a lot of challenges. Optimizing your decision making can save time and costs by avoiding rework and delays.

Discussion points:

Strategies for formulation development vs. process development How to change presentation/dose and the appropriate timing
Selecting the right scale at each phase and for commercial launch
Limiting waste throughout your project
Readiness for validation
• Executing PPQ
Case studies: Small molecule lyo – large scale and Large molecule liquid – small scale

Christy Eatmon, Global SME, Sterile Drug Products, Thermo Fisher Scientific

Sponsored by THERMO FISHER SCIENTIFIC

Chemical Engineering in Pharmaceutical Manufacturing

• The role of engineering in the synthesis of organic compounds
• How to ensure smooth and effective scale-up from lab to plant?
• Controlling PSD through crystallization?
• Basic principles of solvent recovery systems.
• Process safety considerations
• Troubleshooting manufacturing processes

Hardev Nandepu, Chief Strategy Officer, Metrochem API Pvt Ltd

Trinadh Betanapalli, Process Development Engineer, Metrochem API Pvt Ltd

Sponsored by METROCHEM API PVT