Biological product pipelines become more and more diverse with regards to quantities, fluctuations, and molecule types. Biomanufacturing facilities must be adapted and be able to cope with these demands. Multiple intensified upstream and downstream process scenarios are being developed by the Bioprocess industry to fulfill their requirements and other market drivers.

Implementing the processes, biopharmaceutical companies should also minimize the risks associated with intensified processing and put themselves in the best position to decrease time to market while ensuring the highest product quality.

This presentation defines intensified processing needs and provides solutions using a decision criteria matrix to choose the optimal upstream and downstream intensified strategy. Data Analytics is pivotal to support the industry trends towards implementation of process intensification. Its role of providing robust process control by incorporating into the product lifecycle will be also highlighted in this webinar.

Speaker:

Dr. Susanne Deckers
Market Entry Strategy Manager
Segment Marketing Protein-Based Therapeutics
Sartorius

The need for more knowledge on the approach to business prioritization, process design and experimental setup is often evident when dealing in the area of connected processes. Mid to late-adopters who haven’t yet invested significantly in this space seek starting points and deep insights into the fundamental considerations and learnings from those who have gone before them. This presentation deals with these concepts in depth and provides useful results for biomanufacturers who are considering the value of connected processes. We will show results from a closed and connected process starting at the N-1 step going all the way to the purified product. Furthermore, we will give insights and share knowledge about process design considerations, risks analysis, resource planning, buffer management, and process automation.

Speaker:

Thomas Falkman
Senior Scientist
Cytiva

This presentation will review the current status of PAT deployment in EMD Serono Vevey in frame of biotherapeutics continuous manufacturing, including:

• Transition to continuous manufacturing drive our PAT implementation strategy
• Raman to deploy feedback loop control
• Autosampler implementation to allow at-line analytics

Speaker:

Tiziano Brogna
Assistant Scientist
Biotech Process Sciences
EMD Serono

The mAb production process of smaller footprint and shorter operation time with the higher reduction of impurities and virus clearance will provide greater convenience for the future purification process. This presentation will illustrate the total flow-through

Speaker:

Hironobu Shirataki Ph.D.
Senior Consultant, Scientific Affairs
Global Marketing Dept., Bioprocess Division
Asahi Kasei Medical

The accelerated rate of advancement in downstream bioprocessing is largely driven by the increased need for improved biotherapeutics. Continuous bioprocessing, specifically, is becoming more widely adopted in biomanufacturing, and companies are exploring various ways the implementation of this technology can help them efficiently produce high quality products. As continuous manufacturing leads to changes in processes, facilities and equipment, these factors need to be considered within the virus filter design space. It may be reassuring to know that an already established technology, one that has been used to ensure the safety of biologic products for years, can be tailored to fit into and function within a continuous downstream process.

In this session, attendees will learn about the feasibility of small-scale long-term virus filtration. The studies presented will show the impact of extended process times and dynamic product streams present in continuous manufacturing on Planova 20N and BioEX filters. Proof-of-concept long-term PP7-spiked filtrations, performed for up to 4 days, showed that both virus filter types were capable of effectively removing bacteriophage PP7 (>4 log). Additionally, a mock chromatography step elution peak having increased protein, salt and bacteriophage concentrations was successfully processed on both virus filter types. Finally, MVM-spiked continuous virus filtrations were successfully imlemeted for up to 6 days at low flux. The impacts of low flux and process pauses were evaluated under these conditions.

The work presented demonstrates that small-scale viral clearance studies can be designed to model a continuous VF step with specific process parameters. The integration of continuous VF into continuous biomanufacturing processes is therefore applicable and adaptable, although it remains largely process-dependent. The ability to implement continuous VF as part of “facilities of the future” can help companies reduce footprint while achieving desired product throughputs

Speaker:

Julie Kozaili, PhD
Senior Scientist, Science & Technology
Asahi Kasei Bioprocess America

• Regulatory guidance and standards are currently being written for continuous processing
• Quality by Design(QbD) principles can be applied to continuous bioprocessing
• While the guidance is being written, flexibility exists to adopt best practices tailored to the new continuous unit operations

Speaker:

Kurt Brorson, Ph.D.
Vice President, Technical
Parexel International

• The setup of robust control strategies is of utmost importance for robust tech transfer, process validation and smooth manufacturing. For continuous bioprocessing, we need to have a more timely defined control strategy, compared to batch processing, where we only are looking at the integrality of quality of the process volume.
• The control strategy is mainly the knowledge, which range critical process parameters need to adjusted to reach the product quality. This contribution will focus on how PAT, data science and digital twins can contribute to develop those control strategies efficiently and how those three disciplines are interacting fruitfully.
• We show case studies demonstrating how digital twins allow redefining the PAT requirements, how data science can replace PAT and how integrated process model define intermediate acceptance criteria (IACs) of CQAs and robust Proven Acceptable Ranges (PARs).

Speaker:

Christoph Herwig
Professor, Head Research Area
Biochemical Engineering
TU Wien

YMC Thought Leader Panel: Continuing Gains in Continuous Processing

Introduction: Barry Walsh, Senior Conference Producer, Informa Connect & J Preston Ph.D. Director, Separations Science and a Senior Subject Matter Expert, YMC

9am EDT / 2pm BST / 3pm CEST

First Session: Continuous Integrated Production of Therapeutic Proteins: The Role of Digitalization

The important role of digitization for advancing the implementation of continuous processing to the production of therapeutic proteins will be outlined by Prof Morbidelli

Speaker

Professor Massimo Morbidelli
Politecnico Milano

Second Session: Continuous Chromatography of Peptides: A CMO Perspective

The current modus operandi for the downstream processing of synthetic peptides is reversed phase chromatography performed in batch mode. Continuous chromatography is expected to be a disruptive technology for this very cost intensive part of synthetic peptide manufacturing. Results from a proof of principle study will be presented and compared to traditional batch chromatography

Speaker:

Dr. Ralf Eisenhuth
Process Manager Chromatography and Technology Transfer
Bachem

Third Session: How Certain Resins Further Accelerate MCC Gains

Speaker:

Dr. Hans Johansson
Global Application Director
Purolite Life Sciences.

Fourth Session: UV Based in Line Control of Twin-Column Continuous Countercurrent Chromatography; AutoPeak and AutomAb

The in-line control during the application of twin-column continuous countercurrent chromatography is crucial to optimize the yield during extended / continuous runs. Changing conditions such as degradation of Protein A resin (fouling) and / or titer of feedstock must be accounted for in the control scheme of multi-column chromatography. A patented in-line UV arrangement applied to either LPLC or HPLC versions of a twin-column system can automatically adjust operation “on-the-fly” without intimate operator intervention based on the user applied risk tolerance.

Speaker:

Thomas Müller-Späth, Ph.D
Chief Technical Officer
YMC ChromaCon AG

Panel Discussion: Continuing Gains in Continuous Processing

Moderator:

Gerard Gach

YMC

Panelists:

Professor Massimo Morbidelli
Politecnico Milano

Dr. Ralf Eisenhuth
Process Manager Chromatography and Technology Transfer
Bachem

Thomas Müller-Späth, Ph.D
Chief Technical Officer
YMC ChromaCon AG

• Insights through case studies for developing a fully integrated mAb manufacturing process
• Integrating upstream perfusion with a connected downstream process
• Implementing the continuous process in GMP

Speaker:

Himanshu Gadgil, Ph.D.
CSO and Whole-Time Director
Enzene Biosciences LTD.