Date: April 10
Location: Boston, MA
Date: April 05-10
Location: San Diego, CA
Attending:
Evotec will be exhibiting and showcasing their science at the American Association for Cancer Research (AACR) Annual Meeting this April in San Diego, CA.
Join our scientific specialists at booth #1149 and don’t forget to add our poster presentations to your AACR itinerary.
Contact Us to Arrange a Meeting
If you wish to meet with us in San Diego, get in touch via the form below, we will be happy to arrange a meeting.
Children under the age of 5 years account for more than 75% of deaths attributable to malaria. The World Health Organization (WHO) has recommended the vaccine Morsquirix for paediatric use, but it has modest efficacy. Monoclonal antibodies and other complementary strategies are critically important in efforts to eradicate this disease.
A multi-disciplinary team of scientists from multiple organizations collaborated on a project to select and engineer a potent and long-lasting antibody drug with anti-malaria activity. Key to this mission was to develop an antibody with developability properties amenable for cost-effective manufacturing and dosing in paediatric populations.
Scientists from Just – Evotec Biologics played a crucial role in the project. They helped with the lead candidate selection by ranking a panel of human-derived potential antibody candidates for developability using Just - Evotec Biologics’ in silico Abacus tool. Abacus is a component of our J.MDTM Molecular Design suite of tools for antibody research and development. Once the team had selected a lead and backup candidates, Just - Evotec Biologics scientists designed optimized variants of the candidate antibodies with greatly improved developability properties informed by stability violations found with the Abacus tool.
Scientists used stable pools to express the optimized designs and generate material for biophysical characterization and activity assays. This enabled the final lead selection of AB000224 and AB007088 for advancement as a clinical lead and backup. The team engineered the variable domains of both antibodies to enable low-cost manufacturing at scale for distribution to paediatric populations.
Just-Evotec Biologics scientists identified the best-producing clonal cell line, expressing the candidate molecule in continuous-perfusion bioreactors at twice the original titre. They advanced the candidate into production following good manufacturing practices. The material generated from this production run is being used to support studies for clinical development of an antimalaria drug suitable for use in paediatric populations living in Low to Middle Income Countries.
Learn more in the following article published in the prestigious journal, Nature Medicine.
Tags: Blog, Biologics, Anti-Infectives
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.
Tags: Posters, Formulation & CMC, IND Enabling Studies/Preclinical Development
This text underscores the significance of Orally Dispersible Tablets (ODTs) for enhancing treatment compliance, particularly for patients with swallowing difficulties. Co-processed excipients for fast-disintegrating tablets (CPE-ODT) offer a convenient solution, combining a soluble filler and superdisintegrant. These can be efficiently blended with active ingredients, lubricants, and compressed into tablets, streamlining the development process. Investigating the relationships among compaction stress, compact solid fraction, and mechanical strength is crucial for optimizing tablet composition and speeding up development. Striking a balance between inter-particle bonding strength and porosity is especially vital for ODTs, ensuring rapid disintegration with sufficient mechanical resistance for downstream processes. The study aims to establish a general pre-formulation screening method by generating compressibility, compactibility, and tablettability profiles of CPE-ODTs blended with varying drug amounts. These data offer valuable insights into the impact of drug load on compression behavior and key properties, such as friability and disintegration time, facilitating the efficient development of ODTs.
Download this poster presented at AAPS PharmSci360 2023 for comprehensive details on this formulation screening approach.
Tags: Posters, Formulation & CMC, IND Enabling Studies/Preclinical Development
This poster discusses the development of oral enteric dosage forms as a solution to bypass the acidic stomach environment. Coated hard-shell capsules are more time and cost-efficient in early pharmaceutical development than enteric tablets and pellets. The current study assesses acid-resistance and dissolution rate of not-banded gelatin and HPMC capsules, filled at two weights, and coated with an enteric polymer at four levels. The goal is to determine the minimum enteric polymer needed for gastro-resistance, compare gelatin and HPMC shells in the coating process, and examine the impact of filling level and curing step on dissolution profiles, with fixed coating parameters. This research is important for optimizing the coating process and advancing the understanding of factors influencing gastro-resistance in oral enteric dosage forms.
Download our poster presented at AAPS PharmSci360 2023 for in-depth insights into this critical aspect of pharmaceutical development.
Feel free to make questions to our experts!
Tags: Posters, Formulation & CMC, IND Enabling Studies/Preclinical Development
While simple combinations of dosage forms expedite access to First-in-human (FIH) studies, the demand for robust formulations and processes challenges quick development, particularly for tablet production. Early clinical phases face hurdles like dose uncertainty and limited active pharmaceutical ingredient availability. The study addresses these challenges by proposing a compressibility assessment method using small-scale experiments. The aim is to establish a pre-formulation screening approach based on compressibility data for active ingredients, utilizing round punches of varying diameters. By employing the smallest tooling, the study achieves a remarkable 75% reduction in the amount of active ingredient required for compressibility analysis.
Download our poster presented at AAPS PharmSci360 2023 to learn more
Tags: Posters, Formulation & CMC, IND Enabling Studies/Preclinical Development
Check out Evotec's infographic to learn more about our expertise with ASAP as well as with all-type stability studies.
Tags: Infographics, Formulation & CMC, IND Enabling Studies/Preclinical Development
Check out Evotec's infographic on Aerodynamic Particle Size Distribution and learn how our dedicated team of scientists has the right experience in analytical inhalation to ensure accuracy and reliability.
Tags: Infographics, Formulation & CMC, IND Enabling Studies/Preclinical Development
Date: April 09-12
Location: Vienna, Austria
Attending: Nigel Shipston, Associate Vice President, Business Development at Just–Evotec Biologics
Use the link below to request a meeting.
Contact Us to Arrange a Meeting
Presentation title: Enabling lowest COGS Through the Latest GMP-Scale Continuous Manufacturing Technology
Presenter: Nigel Shipston, Associate Vice President, Business Development at Just–Evotec Biologics
Where: Recovery & Purification track
When: Thursday, 11 April, 11:30-12:00
Tags: Events, Evotec, Just Evotec Biologics