A total of 6 vendor seminars will be organised during the lunch breaks on Wendesday, October 12 and Thursday, October 13. Participation is free of charge but for organisational matters we kindly ask to sign up via your online registration.
Vendor Seminar 1 - Nouryon / Kromasil®
Chromatographic toolbox for Purification of GLP-1 Agonist and Advances in the Development of Stationary Phases and Purifications in Preparative Chromatography
Presenter: Fredrik Limé
During this informal vendor seminar, we will present the newly developed toolbox using state-of-the-art spherical silica for purification of GLP-1 agonists. A comprehensive screening was used where different Kromasil® stationary phases, mobile phase organic solvents and buffers were used. All these factors greatly affect the chromatographic efficiency in the preparative purification. By using what we call the GLP-1 agonist purification toolbox, we were able to systematically find ways to improve the purity from crude to 99.5%. The methodology of the toolbox was to choose methods that will target front or back impurities from the crude in a 2-step purification.
In addition to purification of GLP-1 agonist the presentation will also cover the Kromasil portfolio with stationary phases such as chemically stable EternityXT and fully wettable C18(w) phase for increased flexibility and show some of the latest solutions for purification of biotherapeutic.
Vendor seminar 2 - Osaka Soda Co., Ltd.
You need a COMPASS!
Presenter: Imre Sallay, Osaka Soda Co., Ltd. and members of the DAISOGEL TEAM
Peptide based API purification projects are reaching the highest numbers, the workload on purification process development people is increasing. To do a decent job developers are supposed to find the best stationary phase for the new specific purification job, but the number of projects is increasing, the number of candidate phases (columns to screen) is increasing and time is getting shorter.
If you feel lost and desperate like someone just dropped in the middle of a jungle you surely want one thing: find your way home quickly and easily. Find the best stationary phase. Do the perfect screening. We offer you the COMPASS to make it possible. The COMPASS concept will be explained and a great number of examples will shed light of the beauty of employing different separation principles to achieve your goal. Don’t miss our COMPASS to help you out of the jungle!
Key words: Peptide purification, API purification, HPLC stationary phases, Phase/column screening
Vendor seminar 3 - Sartorius
Chromatography challenges to purify Oligonucleotides and mRNA: how to deal with aggressive buffer and high temperature?
Presenter: Lisa Audoy
The design of Chromatography equipment must adapt new operating conditions such as buffer and solvent uses as well as high temperature required. The mobile phase used for this purification may contain water, high salt concentration and organic solvent. Bio contamination, stainless steel corrosion and explosive area constraints are gathered here. The need for high temperature up to 85°C requires a high level of expertise in the dimensioning of thermoregulation. Equipment design must address these challenges without impacting chromatography performance. The presentation will list technical challenges and test results that demonstrate the efficiency of implemented solutions.
Vendor seminar 4 - Tosoh Bioscience
Multi-column chromatography – A powerful tool to enhance productivity in downstream processing
Presenter: Sebastian Thuermann (Product Manager MCC)
Downstream processing of biotherapeutics frequently makes use of liquid chromatograpic methods. These purification steps however can become cost drivers for the intended drug. In the seminar, we will present how process economy significantly improves when preparative LC is transferred from classic batch to multi-column chromatography (MCC). We will present several case studies for the bench scale purification of antibody-type therapeutics such Protein A and Protein L-based capture steps, transfer of a salt tolerant ion exchange polishing step to MCC, and the execution of a two-step purification and polishing process. All studies were accomplished with an instrument capable of flexibly handling their different intrumental demands and make use of column hardware and resins specially optimized for continuous chromatography. Join us for an interactive discussion on MCC and how to further reduce production costs for biotherapeutic manufacturing!
Vendor seminar 5 - RotaChrom Technologies LLC
CPC Simulator – Accelerating Method Development in Centrifugal Partition Chromatography
Presenter: Gergö Dargó
The selection of an adequate biphasic solvent system (SS) in liquid-liquid chromatography is of utmost importance as it directly affects the efficiency of the separation. As the polarity range to cover can be quite wide, starting from the least polar SSs with no water content (e.g., alkane/methanol) to the most polar aqueous two-phase systems (ATPS), the selection process becomes laborious and time-consuming if done by the empirical trial-and-error method. If literature data is available for the family of compounds to be separated, the optimization process can be accelerated, however, the literature often lacks the necessary data, especially in the case of drug-like molecules.
To remedy this, several attempts have been made to establish simplified SS selection strategies and there is also an increasing trend for using computer-aided methods. Along these lines we developed a comprehensive prediction platform - called CPC Simulator - including an extensive database, a SS selection algorithm, and a visualization tool. In this vendor seminar, we intend to present the concept, components, validation, and operation of this brand-new software through some representative case studies.
Vendor seminar 6 - Thar Process & De Dietrich Process Systems
Sustainable API/Excipient Purification : After Years of Success in Discovery Laboratories, SFC is Finally Emerging as a Manufacturing Technique
Presenter: Isabelle François (Thar Process)
Chemists across the pharmaceutical industry have the tendency to revert back to the synthesis route in order to enhance the purity of an active pharmaceutical ingredient (API), intermediate or excipient. An attractive alternative is to combine synthesis with preparative supercritical fluid chromatography (SFC) which allows to obtain sufficient amounts of clinical material or intermediates quickly. Furthermore, the technology is available at scale to support the purification of products in development.
When compared to traditional liquid phase methodologies, SFC represents significant advantages, and has been widely used in the pharmaceutical industry for the separation of enantiomers. From a fundamental standpoint, SFC is characterized by high resolution and high separation speeds. Next to these benefits, SFC is highly versatile and tunable by a variety of parameters including stationary phase, flow rate, pressure, temperature, percentages and nature of modifier and the use of additives. Furthermore, the use of supercritical CO2 as the bulk of the mobile phase is highly environmental friendly and cost effective, which results in a 10-fold reduction of the process mass intensity (PMI) which is a reflection of the waste quantity generated by the purification procedure. After separation, CO2 spontaneously transforms into gaseous state, leaving the compound of interest concentrated in small quantities of co-solvent which significantly reduces evaporation time and energy.
The current contribution discusses the principles of the technology and is demonstrated with practical examples from the pharmaceutical industry including synthetic lipids widely used in the current COVID vaccines.