SMART Chromatography™ - Feed Stream Clarification and Primary Purification in a Single Unit Operation

Presenter: Alistair Hurst

Since the COVID-19 pandemic, supply chain issues in the biomanufacturing sphere have meant that the traditional approach to the production of biologicals, for example monoclonal antibodies, has become considerably more expensive.  Optimisation of both the upstream and downstream operations requires a new approach.  Furthermore, with the advent of larger bioentities such as Adeno Associated Virus (AAV) and Lentivirus (LV) these traditional methods result in very low recovery of the target entity and, as a direct result, much higher production costs.

SMART Chromatography™ removes the necessity to clarify the target containing feed stream before application to the primary capture column.  The whole, undiluted, unmodified feed stream is passed through the column, thus combining the unit operations of clarification and primary purification into a single, linearly-scalable step.

How to Overcome Challenges in the Purification of Biomacromolecules with Cellufine and MLP Technologies

Presenters: Kenji Kadoi, Chigusa Mori, Malcolm G. Pluskal, and Shigeru Yamamoto

Explore Purification Strategies with Cellufine!

JNC offers a range of cellulose-based resins for preparative chromatography as Cellufine brand. We supply a broad selection of products for various chromatographic techniques, including affinity, ion-exchange, and hydrophobic interaction chromatography.

We are excited to present our Cellufine products and innovative MLP (Monolith Like Particle) technology. MLP consists of cellulose beads with pore diameters over 1 µm, enabling more effective processes for large biomolecules.  

This seminar will cover several topics.

• Cellufine product lineup and our latest applications for antibodies, viruses, and enzymes
• Super Edge, an empty minicolumn kit designed for rapid process development.
• Our next-generation MLP technology and its applications.

We look forward to meeting you at the seminar and discuss purification workflows.

Multi-Column Chromatography: A Solution for Modern Biomanufacturing Challenges

Presenter: Marissa Heino

In this talk, we dive into the world of downstream purification intensification. Tosoh addresses current biomanufacturing challenges with a holistic approach to downstream intensification using multi-column chromatography (MCC) on the Octave BIO (a benchtop MCC system for process development), the Octave PRO (a GMP-ready system for clinical and commercial manufacturing) and SkillPak pre-packed columns. MCC offers potential benefits such as increased productivity and resin utilization, decreased consumable costs and reduced clean room footprint. Through a collaborative case study with a CDMO, we show these concrete efficiency gains for Protein A chromatography.

Using BioSolve modeling software, we present a comparison of processing times, material costs, and non-material costs for purification platforms at varying titers, considering both pre-packed and self-packed columns. The results affirm that transitioning to MCC can effectively address current challenges in downstream purification and biomanufacturing.

Unlocking the Potential: Advancements and Strategies in Downstream Biomolecule Purification

Presenter: William H. Rushton, MS, Chromatography Support Scientist, Process Chromatography

Join our purification scientists at this complimentary lunch workshop to discuss these focus areas in downstream purification. We will explore the latest advancements in purification tools and share insights on how to optimize processes and overcome purification challenges.

• Explore chromatography tools to optimize viral vector purification and enhance yield
• Attain sustainability goals with a two-step mAb purification workflow
• Examine case studies for successful purification approaches for large biomolecules

Twenty Years of Supercritical Fluid Chromatography Expertise

Presenter: Gerard Rosse, Ph.D.

PIC Solution team will discuss the latest development in SFC instrumentation to tackle compounds separation at the analytical, preparative, and industrial scale for chiral, achiral and high-throughput applications. The benefits of our proven CO2 recycling technology and the combination of analytical, semi-prep and extraction in a single instrument will also be reviewed.

The Importance of Chromatography in the Advanced Therapy Landscape – A Case Study of Plasmid DNA and Viral Vector Manufacturing

Presenter: John Bowen

As multiple cell and gene therapies enter the clinic and become commercially approved products, there is a large effort to use platform manufacturing processes to enable speed and agility.  SK Pharmteco utilizes multiple chromatography methods to provide a “flexible tool kit” for viral vector gene therapy manufacturing.  In addition, our plasmid DNA platform provides customers with a 2-column plug-and-play process to accommodate a variety of plasmid sizes and complexities.  Multiple purification strategies such as ion exchange, hydrophobic interaction and affinity-based methods are utilized in large scale cell and gene therapy production.  Our presentation will review a variety of viral vector serotypes and the purification strategies utilized by SK Pharmteco to provide consistent, high-quality vector at multiple scales.  Also, we will review our plasmid DNA flexible platform and demonstrate its versatility to a variety of plasmid types and sizes.  In addition to industry-standard release analytics, SK Pharmteco also uses Next Generation Sequencing (NGS) to ensure the high level of product quality.  In summary, SK Pharmteco will demonstrate its impact in the Advanced Therapy landscape given its technical expertise in cell and gene therapy manufacturing.

Innovation in resin technology: purification of biomolecules by means of combined chromatography technologies applied to Food, Pharma and medical devices.

Presenters: Dr. Alessandra Basso and Dr. Fred Ghanem

Sunresin have been a pioneer in the field of separation, purification and extraction technologies for over 20 years. Dr. Alessandra Basso discusses the development process from R&D to commercial launch of different resins for the purification of peptides, oligonucleotides, proteins, and mAbs.

This seminar will cover:

• Strategies for purification of peptides and oligonucleotides using IEX monosized resins from analytical and preparative scale
• Purification of lactoferrin, a protein used for human nutrition, using IEX agarose and polymeric media. Comparison among the approaches used for purification of lactoferrin from Milk, whey and precision fermentation
• Purification of mAbs using in-house developed proprietary recombinant Protein A ligand and agarose base matrix. In this section we will cover the different steps used for manufacture the rProtein A and its effect on mAb purification. From Initial production of the alkaline-stable recombinant Protein A, through fermentation in E. coli and subsequent purification steps, to the development of a highly cross-linked, dextran-grafted agarose base matrix and finally to the coupling of the Protein A ligand to the agarose bead. Case studies will be presented on purification performance following the Affinity purification step and Purity, Yield and HCP clearance following platform purification in combination with Cation and Anion Exchange chromatography steps

An Overview of Twin-Column Prep Chromatography Techniques

Please join us for a technical presentation on the proprietary twin-column prep chromatography techniques from YMC America that enable higher manufacturing efficiency with continuous or semi-continuous operation. All of these techniques, are scalable from R&D to process development with the goal of implementation in GMP manufacturing.  The presentation will focus on the MCSGP technique and describe how N-Rich is related to it.  How the twin-column technology is used to implement the integrated batch technique will be described and the capture SMB technique will also be explained.

• MCSGP : Higher yield in chromatographic polishing steps, without compromising purity. Ideal for difficult purification tasks where yield matters.
• N-Rich : A tool for enrichment and isolation of minor compounds from complex mixtures. Ideal for accumulating difficult to isolate compounds in an automated way.
• Integrated Batch Chromatography : Integrated 2-step purification allowing orthogonal chromatographic steps to be combined on one platform.
• CaptureSMB : Higher resin utilization and productivity, lower buffer consumption. Ideal for affinity/capture chromatography steps, where resin costs are very high and manufacturing footprint matters.

Purification of Bispecific Antibodies and Fragments Using the VH3 Interaction

Protein A affinity chromatography is the main technique for capturing antibodies and is commonly used in purification platforms. Bispecific antibodies are increasing as a format, which creates new challenges for the purification procedure. A new resin has been developed. It has a good advantage in the purification of bispecific antibodies where homodimers can be easily removed in the capturing step using the VH3 interaction.

Journey to Develop Preparative SFC, a Story of Bridging Collaboration to Innovation

Presenter: Brian Domanski, Strategic Collaborations Scientist - Pharmaceuticals

In this talk, Brian will discuss the collaborative process that progressed from the introduction of Shimadzu's Nexera UC analytical SFC systems to the Pharma-focused creation and launch of the Nexera UC Prep semi­ preparative SFC systems.

Case Studies with Hydrophobic Interaction and Mixed-Mode Chromatography: Flow-Through Technologies for mAb Polishing.

Presenter: Jett Appel, Purification Staff Scientist, Field Applications

Advancements in the engineering of monoclonal antibodies (mAbs) have led to additional challenges in the purification of these modalities including high levels of aggregates. Ion exchange chromatography is often not sufficient to achieve the purity targets, so hydrophobic interaction chromatography (HIC) as well as mixed-mode resins are needed as orthogonal tools. These technologies can be implemented in flow-through mode allowing for high loadings and fast processing times, making them well-suited for large-scale implementation.

This presentation reviews case studies using POROS Benzyl Ultra (HIC) and POROS Caprylate (mixed-mode cation exchange).  First, a mAb with high starting levels of aggregates was purified effectively utilizing flow-through HIC chromatography while also achieving robust retrovirus clearance.  Secondly, a novel antibody format utilizing synthetic amino acids intended for site-specific drug linker conjugation presented unique purification challenges with aggregates and host cell proteins (HCPs).  Flow-through HIC achieved the desired reduction of these impurities along with effective clearance of model retro- and parvoviruses.  Lastly, the aggregate levels were significantly reduced from a mAb using POROS Caprylate in flow through mode.  Some critical and challenging HCPs were also removed with this technology.

These case studies illustrate how novel chromatographic tools can improve the purification processes for complex therapeutics.

Practical Approaches to Purification of Oligonucléotides and Peptides Using High-Performance Liquid Chromatography

Presenter: Sandeep Kondaveeti, Biopharma Account Manager

A crucial step in any pharmaceutical production is the purification of the Product The purification of Bio therapeutics such as oligonucleotides (ONs) can be particularly challenging because of the high similarity of target and impurities. Therefore, high-performance liquid chromatography (HPLC) is the method of choice if high-purity products are desired. Preparative separations become an economic decision as we balance the cost of solvents, adsorbents and time. In this presentation, the focus will be on the most common purification challenges today; that of oligonucleotides, peptides and the high throughput method development.  Optimal analysis relies on LC System with precise gradient mixing, even at high flow rates, pump heads that are compatible with a wide pH range and salt concentration, and choosing the correct trigger ion of the desired compound which will lead to better fraction collections resulting in higher final products.  We will discuss the best workflow solution needed to achieve ideal purification.

Key Learning Objectives :

• Analytical to preparative chromatography workflow
• About strategies to efficiently develop methods for purification success.

• Column technology and method optimation for purification of Peptides and oligonucleotides sample modalities

Purification of Active Ingredients - Scaling Up to Process Scale

Presenter: Jordan Ho

At Gilson, we offer customizable SKID systems for pilot to process scale chromatography applications to address any customer’s needs, using HPLC or CPC columns.

We strive to give our customers complete satisfaction and peace of mind and offer global solution including contract servicing to help our user’s meet their purification goals in a safe manner that adheres to any and all safety and regulatory requirements.

Come hear about our wide range of capabilities in process chromatography and see how we have already helped many customers across the globe.

You could be next!

Kromasil Circle of Value: Purification of Peptides using Reversed Phase Preparative Chromatography

Presenter: Fredrik Limé

During this informal vendor seminar, we will present and discuss key aspects of using state-of-the-art spherical silica for purification of peptide APIs. This topic includes an overview of what benefits can be obtained by using silica, for example, increased efficiency and high loadability to reduce production cost. Other features such as scalability, both in terms of increased column volume and particle size with the same selectivity will be addressed. We will also share examples of best practice regeneration of the column for increased column lifetime. Finally, we will share the latest findings from our comprehensive screening of Kromasil phases for purification of GLP-1 agonists. The methodology is based on systematic removal of impurities from the crude in a 2-step purification. We will demonstrate the extensive Kromasil portfolio of stationary phases such as the chemically stable Kromasil EternityXT and the fully wettable Kromasil C18(w) phase for increased flexibility.

Sartobind® Rapid A: Economical and Technical Considerations of Multi-Batch Use

Presenter: Ana-Raquel Fortuna

Although compatible with single-use processes, the investment on affinity media for capture of mAbs can be difficult to justify for one single batch, especially in early phases of the process development. In this presentation, we want to highlight how sanitization and cleaning-in-place protocols allow Sartobind® Rapid A to be re-used for several batches and how multi-batch use impacts the purification performance and total cost of ownership. Optimally we will present a customer use-case (pending approval) and the economic analysis will compare different scenarios using a comprehensive Sartorius tool, used in customer consulting context.