Science Pool

This poster relates to enhancing dose selection in phase I cancer trials.

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This poster describes the rapid conversion of an intensified fed-batch antibody manufacturing process to an integrated continuous biomanufacturing process using the Just-Evotec Biologics platform, resulting in several key project accomplishments: 

• Mitigation of upstream IFB challenges
• Significant productivity increase
• Short development time
• Minimal risk from changes in product quality

These results demonstrate that the rapid conversion of fed-batch processes for monoclonal antibodies to an integrated continuous biomanufacturing process can be achieved with a robust ICB platform. This supports the biotherapeutics industry’s need to quickly adapt to changing clinical and business circumstances.

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Biologics manufacturing typically uses engineered Chinese Hamster Ovary (CHO) cells to produce folded and glycosylated antibodies. Determining the optimum conditions to grow and maintain cell culture often requires considerable time and effort.

A quantitative understanding of cell metabolism through an analysis of cell culture metabolites can enable optimization growth conditions for improved titles or increased perfusion duration. Mass spectrometry is the optimum tool for metabolite measurement, however, transforming raw data into accurate quantitative measurement requires both expertise and extensive sample preparation.

In this poster we demonstrate the ability of simple sample preparation using universal calibrators and a novel machine learning algorithm to rapidly provide biological insight into bioprocessing samples taken from perfusion cell cultures.

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High-throughput screening methodologies have accelerated downstream development for monoclonal antibodies by enabling parallelized evaluation of chromatographic resins across a range of conditions. However, scientists must now interpret results in a meaningful and consistent way.

Learn how Just - Evotec Biologics' Downstream Data Browser automates visualization of high-throughput datasets, fits response surface statistical models, standardizes report results from a high-throughput screening method and facilitates comparison across molecules allowing the accelerated development of continuous biomanufacturing processes.

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Endocrine disruptors, which can be either natural or man-made, interfere with the normal actions of hormones in the body. This can result in serious health issues such as cancer, birth defects and developmental disorders. Low cost screening models are needed to flag chemicals as potential endocrine disruptors at an early stage.

In this poster, we focus on:

• the development of a new high throughput screening panel for chemicals to detect potential endocrine disruptors
• the comparison between endocrine receptor activation assays expressing the human androgen receptor, the human estrogen receptor or the human thyroid receptor, and hormone receptor competitor binding assays using fluorescence polarisation.
• the relationship between the literature and the data generated in the assays.

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Enhancing Single-Pass TFF for Antibody Therapeutics Manufacturing

Single-Pass Tangential Flow Filtration (TFF) plays a pivotal role in enabling fully end-to-end continuous manufacturing of antibody therapeutics. In this poster, we delve into the study of two distinct SP-TFF membrane configurations to determine which one is most effective for clinical and commercial production.

Key Findings:

1.    Concentration Factor Achievement: Both tested configurations successfully achieved the required concentration factor without encountering fouling issues.
2.    Shear Forces Mitigation: Neither setup generated significant shear forces that could harm the antibody product.
3.    Operational Success at Low Feed Flux: Both configurations demonstrated successful operations even under low feed flux conditions, reinforcing their suitability for large-scale manufacturing.

Future Directions: Our team of scientists and engineers will continue their investigation, exploring various load challenges, system perturbations, and methods for in-line concentration measurements. These efforts aim to enhance the robustness and efficiency of our manufacturing processes.

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Food additive testing is essential to ensure human safety during consumption. Early stage genotoxicity screening is an efficient way of triaging additives to ensure only the safest additives are taken forward for more rigorous testing.

In this poster, we focus on:

• the development and validation of a new early stage genotoxicity approach for food additives
• the use of a panel of in vitro assays for detecting clastogens (pH2AX) and aneugens (pH3) as well as micronuclei formation (MNT)

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Prediction of drug-induced liver injury (DILI) is challenging. Translation from animals to humans is poor and manifestation of DILI can be complex mechanistically. 

In this poster, we focus on:

• transcriptomics analysis of 128 compounds form the FDA Liver Toxicity Knowledge Base (68 associated with DILI and 60 not associated with DILI)
• the use of machine learning in accurately predicting DILI and providing an insight into the mechanism of toxicity

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Evotec possesses a comprehensive drug discovery platform to support oligonucleotide-based drug discovery from in silico design to clinical translation. Oligonucleotides therapeutics have been emerging as novel therapeutic modality for a vast range of diseases constantly growing resulting in 15 drugs currently approved. Here, we show our ongoing effort to further expand this platform by employing the recently developed splintR-qPCR as a novel bio-analytical method for quantification of oligonucleotides in tissues and comparing it to LC/MS and bDNA in use in Evotec. Within an Evotec internal R&D proof of concept study, the splintR-qPCR was proven as valid and comparable method to bDNA and gold-standard LC/MS. The high sensitivity, throughput and low costs compared to LC/MS and bDNA assay place splintR-qPCR as pivotal method that will strengthen Evotec oligonucleotides expertise on PKPD modelling.

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The Twin Screw Wet Granulation (TSWG) is a manufacturing process gaining increased attention in the pharmaceutical industry due to its versatility, scalable nature, and seamless integration into continuous manufacturing lines. Especially advantageous in early pharmaceutical development, where API quantity is limited, TSWG accommodates small batch sizes, facilitating later large-scale campaigns using the same equipment. 
A DoE study was conducted in order to assess the influence of the main process parameters on the characteristics of granules and tablets. A leading formulation containing a soluble drug, namely Niacin, was used, and the factors evaluated in the DoE were the screw design, the screw speed, the Liquid/Solid ratio (L/S), the feed rate and the screen type. 
The responses evaluated were referring to the process (e.g. torque), the granules (e.g. particle size distribution (PSD), density and flowability) and the tablets (e.g. tensile strength, friability and disintegration time). This study provides critical insights into optimizing TSWG processes, ensuring efficient granule and tablet outcomes.

Download the poster, which was presented at AAPS PharmSci360 2023, for comprehensive details on the influential process parameters and their impact on granulation and tablet characteristics in TSWG.

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