8:00 am Registration & Morning Refreshments

8:45 am Chair’s Opening Remarks

Where is Continuous Manufacturing Today?

9:00 am Key Opinion Leaders Panel: Emerging Technology to Maturing Capability, Where is Continuous in the Technology Adoption Life Cycle?

Synopsis

• As the ETT sees its first graduation with Continuous Direct Compression (CDC) technology, we reassess where continuous manufacturing stands on the technology adoption cycle. Is

this still a technology for innovators and early adopters, or are we making the steady move towards the early majority?

• How does this differ between small molecules, traditional mAbs and newer modalities?

• Top-down or bottom-up: which approaches for continuous processing adoption has produced the most impactful results in pharma?

9:45 am Why Continuous? One Company’s Journey for Continuous Processing Adoption In-House

  • Raymond Knox Chief Manufacturing & Engineering Officer, Lyndra Therapeutics

Synopsis

• Changing attitudes from ‘why continuous’ to ‘why not continuous’?

• Stakeholder engagement to operator training, where are the pinch points for a top-down vs bottom-up approach?

• Technical vs strategic challenges – where is the biggest gap in industry capability today?

• Case study with timelines for bringing in-house continuous manufacturing (CM) line online

10:15 am
Speed Networking & Coffee

Small Molecules Track

Drug Substance Automation for Next-Gen Control

11:30 am Keeping a Flow Profile: Progress in the Automation & Optimization of Flow Chemistry

Synopsis

• Lab-scale flow process development is differentiated in

the ability to handle challenging chemistries and

scale robustly

• Combining automation with microfluidics enables

transformational optimization opportunities with minimal

material requirement

• Application of data-driven algorithms supports selfoptimization

methods with minimal human-in-the-loop

intervention

12:00 pm Bright Path Laboratories – AI-Enabled Continuous Flow Manufacturing Platform Greener, Faster, Safer

Synopsis

• Bright Path Labs is disrupting the Pharma industry by

domestically manufacturing safe and affordable medicine.

• The current state of drug manufacturing in the US and

worldwide and the looming supply chain crisis.

• AI-enabled technology has a significant part to play in

solving the global pharmaceutical supply chain and safety

problems.

• The future of pharma has already arrived, and Bright Path

Labs is ahead of the curve.

12:30 pm Closed Loop Control in Continuous Drug Substance Manufacturing

Synopsis

• The goal: optimal operation in the face of disturbances

without manual attendance

• Use of PAT as well as online sampling and non-PAT

techniques (LC) in closed loop system

• Robustness is key: ensuring your closed loop control setup

is robust to measurement errors/artifacts and stable

across all visitable scenarios

1:00 pm SK pharmteco needs to be added to talk ‘Flow Chemistry Platforms to Integrate Multiple Processes Using Flexible Systems – CDMO Perspective’

Biologics Track

Bioprocessing 4.0 for Upstream Innovation

11:30 am Opportunistic Continuous Bioprocessing: Small Volume, High Potency Applications

Synopsis

• Where is continuous adding value to bioprocessing across

biologic portfolios?

• Program specific applications to maximize opportunities

for continuous bioprocessing

• Ensuring platforms and processes are in place to enable

adoption of continuous bioprocessing where appropriate

12:00 pm What is ‘Success’ for PAT in Continuous Bioprocessing?

  • Sarwat Khattak Head of Cell Culture Development Proteins, Biogen Idec

Synopsis

• What areas of bioprocessing benefit from continuous unit

operations with PAT application?

• How useful is Process analytical technology (PAT) for

process ‘success’ from:

a) A regulatory point of view

b) A manufacturing point of view

• Raman probe and other analytical techniques that

drive value

12:30 pm End-to-End Continuous Biomanufacturing for Exosomes & Bionanoparticles

Synopsis

The supply of advanced medicinal therapies such as viral

vectors and exosomes has been constrained by inadequate

process and production technology. Over the years, Codiak

has focused on process intensification and debottlenecking

the production of exosomes to enable ample clinical supply

while reducing cost of goods.

Through case studies based on successful process

development, CODIAK Bio will describe the evolution

of exosome manufacturing technology from batch

to continuous and highlight further opportunities for

integrated, continuous bioprocessing.

1:00 pm Advancing End-to-End Continuous Manufacturing for Biologics & Biosimilars 

Synopsis

  • CM implementation hurdles when moving from development to phase III manufacturing 
  • Regulatory assessment of CM
  • CoGs is the driver for CM of Biosimilars & Biologics

Regulatory CMC Track

Regulatory Harmonization for Global Adoption

11:30 am Has the Publication of ICH Q13 Delivered the Global Regulatory Harmonization the Industry So Desperately Needs?

Synopsis

• Overview of regulatory and industry view

• Plans for Implementation training

• What are the next steps to ensure global harmonization,

and what opportunities would this mean for the

continuous manufacturing community?

12:00 pm Overview of the Regulatory Industry for Continuous Manufacturing

  • Moheb Nasr Principal, NPRC, Independent Consultant

Synopsis

• Industry perspective on the implementation of continuous

manufacturing & related regulatory guidelines

• How does regulatory adoption and harmonization differ

globally?

• What are the remaining challenges or regulatory gaps for

both small molecule & biologic continuous manufacturing?

12:30 pm Control Strategy: Telling the Story

  • Ciby Abraham Senior Director and Group Manager, Project and Product Leadership, AstraZeneca

Synopsis

• Clearly communicating the control strategy utilization of raw material specifications, in-process tests, process monitoring and controls, and end-product testing

• What is must-include, and how to translate into a meaningful story?

1:00 pm Roundtable Discussion: Does ICH Q13 Leave Any Unanswered Questions?

Synopsis

Roundtables are moderator-led audience discussions, where the audience can share their questions, feedback and experiences on a set topic, following a short introduction to the topic from the moderators.

1:30 pm Lunch & Networking

Small Molecules Track

Innovations in Continuous Drug Product for Efficient Workflows

2:30 pm Predictive Tools in Tablet Coating: Current and Future Development

Synopsis

• Understanding tablet motion with particle simulations

• Case study: Optimising pan load for of film coating

batches

• Transferring film coating from pilot to commercial scale

coaters

• Leveraging digital tools to increase process efficiency and

capability, improve product quality, reduce

3:00 pm Digital Solutions to Facilitate Adoption of Continuous Manufacturing

  • Katie Baumer Pharmaceutical Continuous Manufacturing Community Engagement Manager,, U.S. Pharmacopeia

Synopsis

  • Supporting the innovation of CM through funding from US FDA and National Institute of Pharmaceutical Technology (NIPTE) by addressing barriers to CM adoption via a digital platform designed for industry, academia, and regulators 
  • Providing a user-friendly online space to discuss, comment, and collaborate on research and best practices and solve collective problems
  • Enabling aspiring adopters to engage with experienced practitioners and find curated and contextualized research, news, and events in one location
  • Creating a knowledge solution to increase efficiency and harness the collective expertise of CM professionals

3:15 pm Continuous Personalized Drug Product Manufacturing using Drop-on-Demand Dropwise Additive Manufacturing

Synopsis

• Novel modular 3D printing platform using drop-on demand(DoD) technology for continuous manufacturing of various formulations is presented

• Specially designed PAT and control system enables reduced within dose and between dose variations

• A combined process and product design framework for the DoD system using machine learning is presented

• Integration with upstream drug substance process, and application to personalized and distributed drug product manufacturing is discussed

Biologics Track

Emerging Technologies for Downstream Innovation

2:30 pm Scaling-Up Continuous Purification

Synopsis

• Continuous processing has made enormous strides in the biopharmaceutical industry over the past decade. In PAK’s own journey, technologies have moved from messy laboratory setups to out-of-the box, fully automated commercial offerings that run an end-to-end continuous biopharmaceutical process. As we look ahead, the company plans to scale up its systems to enable the manufacture of volumes not previously seen in the industry

• With these systems and facilities, we aim to be able to provide the world with biopharmaceutical products at rates that would enable vaccine inoculation of the world population in less than three months

• In this talk, we will explore the technologies that will enable this as well as the bottlenecks to global implementation of this network

2:45 pm Introduction to NIST, NIIMBL & Leveraging Private- Public Partnerships

  • Kelley Rogers Director & Chief Of Biosciences, Technical Program, Operations Division & Federal Program Manager, National Institute of Standards & Technology - NIST

Synopsis

• What is the NIST strategy to ensure the biopharma industry can adopt emerging technologies in a timely manner with quality and cost in mind?

• Overview of how the government advancing continuous processing in pharma/biopharma industry, the role and model of NIIMBL and what successes and challenges have been seen on the journey so far? Roundtable Discussion. Audience to discuss:

1. How to ensure collaboration, connection and communication between quality and process development teams, why is this important?

2. How aware are you of the private-public partnerships in the US that can help your organization advance continuous?

3. What modalities still need more support? How can partnerships continue to help commercialize emerging technologies? e.g. Real time release

Regulatory CMC Track

Collaboration & Communication for Commercial Success

2:30 pm Regulatory Reflections on Batch to Continuous Conversion

Synopsis

-Case study on batch to continuous conversion when were regulatory teams engaged and what challenges were presented

-How to ensure proper communication and collaboration between development, commercial, internal, and external regulatory teams

-Integration of real time release testing; what are the implications from regulatory perspective?

3:00 pm Panel Discussion:Quicker Speed to Approval, Speed to Market and Improved Product Quality – Too Good to Be True or a Reality Ready to be Adopted?

  • Ganapathy Mohan Executive Director, Merck & Co
  • Moheb Nasr Principal, NPRC, Independent Consultant
  • Ciby Abraham Senior Director and Group Manager, Project and Product Leadership, AstraZeneca

Synopsis

A recent audit by the FDA shows applications that used continuous manufacturing were approved in a shorter time than the comparator batch applications, and the products using continuous manufacturing entered the market twelve months faster on average after regulatory submission, and three months faster after approval when compared to the batch applications:

• Is this due to increased communication with emerging technology team (ETT) prior to submission or genuine

faster approval?

• What are the regulatory concerns for companies new to the commercial manufacturing commercial space?

3:45 pm Poster Session

Synopsis

Submit a poster to show case your latest work, and potentially get the opportunity to present your work onstage amongst the expert

speaker faculty. See the website for more details on submitting a poster.

4:15 pm SMART Cycling and Advances in Protein A Chromatography Resins

Synopsis

• Jetting Technology

• Sustainability in Jetting

• Advances in Protein A Offerings: increased pH Elution

Is End-to-End the Be All & End All?

4:45 pm From Unit Operation Implementation to End-to-End Strategy

Synopsis

• Strategic and technical evaluation of end-to-end vs hybrid/unit operation approach for small molecule continuous manufacturing

• Where does each application bring the most value for the process and business?

• Our approach for integrated continuous trains and data from recent projects

5:15 pm Chair’s Closing Remarks & End of Day 1

5:30 pm Continuous Cocktail Hour