Process development has evolved considerably to support the biopharma shift towards newer drug modalities and accelerated development pathways. But the software applications available to process development teams remain a siloed array of rigid point solutions, legacy ELN and LIMS applications, custom integrations, and internally-built systems. All of these software applications contribute to siloed data, poor user experience, and high cost of ownership. A new digital approach is required for process teams to thrive in the modern era of biopharmaceutical development. In this session, you will learn key digital strategies to improve process design for cutting-edge therapies, plan better experiments, unify your process data, and simplify technology transfer.

Learning objectives

• Discuss challenges faced by process development teams.
• Understand key digital strategies to improve process development.
• Learn about the value unlocked from these digital strategies

Speakers:

Areef Jetha
Market Strategy Lead - Development
Benchling

Justin De La Cruz
Solution Excellence Consultant
Benchling

Attendees will learn how the HaLCon protein analyzer can be used to provide insight into how product concentration is changing during their production bioreactor processes. The HaLCon was shown to be a useful tool to monitor different monoclonal antibodies with different extinction coefficients, using a generic curve approach that is critical to its use at a CDMO. Attendees will come away with knowledge on how the HaLCon can be used to monitor molecules with minimal a priori information, identify adverse experimental conditions, and how the HaLCon be used to measure the concentration of a wide variety of different Fc-containing protein molecules. 

Moderator:

David Sloan
VP Applications and Product Management 
RedShiftBio

Speaker:

Roger Connolly
Senior Scientist
Lonza Biologics 

Today, process efficiency and scale-up are the most common bottlenecks for viral vector manufacturers. The CellBRx-IST (Integrated Seed Trail) platform is a series of closed-loop end-to-end fully integrated and automated variable scale bioreactors ranging from 1L to 200L (from 1 m2 to 1500 m2 surface area for cell attachment and growth) serving as a perfect platform for vaccine and viral vector manufacturing. The CellBRx®️ Single-use Bioreactors are developed upon the concept of Dynamic-bed reactor technology, which ensures nutritional & gaseous homogeneity across the cell carrier bed resulting in ultra-high-density cell culture and multifold increase in the harvest titres compared to the traditional technologies. The CellBRx bioreactors are specifically developed to provide linear scalability, and ultimate process efficiency and to reduce the batch to batch variability to minimizing process failures at large-scale operations.

Speaker:

Jiten Pant, PhD
CEO and CSO
OmniBRx Biotechnologies Inc. USA

1. Overview the progress of mRNA technology development. What’s the key differences between mRNA vaccines and therapeutics development.
2. Discussing the key quality attributes for plasmid DNA, RNA and LNP.
3. Overcoming CMC challenges to make mRNA therapeutics effective, safe, and stable.
4. Implementing proper analytical control strategy for the control of process impurities
5. Innoforce RNA platform provides one-stop CDMO service that accelerates mRNA therapeutics and vaccines from preclinical stage, clinical to commercialization.  

Speaker:

James Fang Ph. D.
Head of RNA Center of Excellence
Innoforce Pharmaceuticals

• Filtration plays a critical role in both upstream and downstream continuous processing and presents unique challenges compared to traditional batch manufacturing.
• Perfusion cell culture requires optimized filtration operations to ensure a high degree of product recovery while maintaining high throughput and cell viability.
• Microza™ microfilters operated in tangential flow filtration (TFF) mode demonstrate excellent protein sieving performance for perfusion cell culture operations and provide the scalability needed for commercial manufacturing.
• Continuous virus filtration (VF) is performed at a lower flux and higher throughput than most batch operations, presenting challenges for both filter fouling and viral clearance.
• Planova™ filters can provide robust continuous VF performance but understanding specific mAb characteristics may be critical in ensuring success.

Speaker:

Daniel Strauss, Ph.D.
Director of Research and Development
Asahi Kasei Bioprocess America, Inc.

During this presentation, Andrew Sinclair, MD at Biopharm Services Ltd. gives an overview of process modelling approaches and an introduction to Biosolve and its capabilities. Also, 3M’s Dr. Hani El Sabbahy explores a case study examining the impact of advanced single use technologies on sustainability parameters, compared to more traditional approaches.

Speakers:

Andrew Sinclair, MSc, CEng, FIChemE, FREng
Managing Director
BioPharm Services

Hani El-Sabbahy, PhD
Advanced Application Engineering Specialist
3M

Launched in 1989, Planova™, the world’s first virus removal filter, has emerged as a significant technological advancement in assuring robust viral safety in biopharmaceutical production. The Planova 20N filter, which employs cuprammonium regenerated cellulose hollow fiber membranes, is highly valued by the industry for its stable protein filterability over a wide range of solution conditions. Given the need to continually improve operational efficiency to meet current and future demands, the Planova S20N filter has been developed using emerging technology. By utilizing superior cuprammonium regenerated cellulose, it withstands higher operating pressure requires simple leakage test to demonstrate post-use integrity. Planova S20N shows robust virus removal capability, higher throughput, and stable protein filterability at higher operating pressures over a wider range of solution conditions and molecules (e.g. multi-specific antibodies). We will present the characteristics and results of customer-led and internal evaluations on Planova S20N filters, including studies related to continuous processing. We will show how Planova S20N is up to the challenge of providing viral safety in virtually any biologic manufacturing process.

Speaker:

Ray Lillie
Planova Product Manager
Asahi Kasei Bioprocess America, Inc.

The number of new single use assemblies (SUA) introduced as part of a single use biologics GMP facility startup can be in the order of hundreds. Most SUAs are novel custom assemblies designed based on facility’s preliminary design. Rarely do these assemblies come from single supplier – both due to supplier capability and for risk mitigation reasons. During operations, numerous single use leaks and defects are inevitably encountered. The challenge then is to properly categorize and address the defects while keeping the facility startup timelines on track. Additional challenge for a company with multiple manufacturing sites is to ensure that the information about the SU defects and the resolutions put in place at a site is communicated and implemented across the network. This presentation describes the type of defects encountered, defect tracking and resolution processes developed, supplier engagements experiences, and the overall lessons learnt from Genentech’s new 2K scale single use clinical manufacturing facility in South San Francisco, CA.

Speaker:

Roshan Shrestha
Single Use Expert (CSC) and DS Tech Team Lead (Global)
Genentech

Meissner will discuss how enhancements in filter membranes translate into manufacturing benefits for bioprocessing applications. Dr. Thomas Lazzara, PhD, Director of Research & Development, will present an enhanced method of characterizing ultrafiltration and microfiltration membranes to improve lot to lot consistency and remove risk associated with hollow fiber filter performance variability in manufacturing applications. Anabel Cho, Product Manager, will introduce Meissner’s new barrier filter (Zebragard™) that features a uniquely patterned sterilizing grade PVDF membrane having dual hydrophilic and hydrophobic characteristics to enable passage of both liquids and gases. This filter facilitates in-line pre-use, post sterilization integrity testing (PUPSIT) of single or redundant sterile process filter systems.

Speaker:

Dr. Thomas Lazzara, PhD
Director of Research & Development
Meissner Corporation

Anabel Cho
Product Manager
Meissner Corporation

In the process of manufacturing biopharmaceutical products, it is of high importance to measure the concentration of excipients and protein titer. However, there is a lack of accurate and user-friendly at-line technologies for obtaining this information in downstream bioprocessing. Nirrin’s NXT system fills this gap by combining near-infrared (NIR) spectroscopy with the latest high precision tunable laser source technology. This combination provides superior signal-to-noise benefits and is well-suited to a wide range of downstream bioprocessing application needs.

The NXT system can deliver quantitative measurements of excipient and protein concentrations from an aliquot of just 15µL in 30 seconds while eliminating the need for sample dilution. This immediate analysis of excipients ensures the presence of the correct formulation components in the right concentrations during process development. In this upcoming presentation, Lonza Biologics’ R&D team will showcase their ability to detect five excipients in solutions with varying concentrations of a monoclonal antibody (mAb).

Speaker:

Bryan Hassell, PhD
Founder and CTO
Nirrin Technologies

Courtney Hazelton-Harrington, MS
Senior Scientist
Lonza Biologics

This talk will focus on biopharmaceutical process development using microbial systems, such as bacteria and yeast. The discussion will cover key aspects such as optimization of expression for the target proteins, downstream process development, and high throughput approaches for rapid parameter screening. The talk will emphasize the innovative SMART Process Design platform, which assists in streamlining workflows and considering capacity limitations during process development. Automation, parallelization, and integrated process models will be highlighted for their role in enhancing efficiency, facilitating data-driven decision-making, and identifying optimization opportunities. Boehringer Ingelheim RCV's commitment to advanced technologies and data-driven strategies in delivering innovative bioprocess solutions for the digital transformation of the biopharmaceutical industry will be emphasized throughout the presentation.

Speaker:

Cécile Brocard
Director Downstream Development, Biopharma Process Science
Boehringer Ingelheim RCV GmbH & Co KG