Date: February 28 - 29
Location: Dublin, Ireland
Attending
- Nigel Shipston, Senior Director Business Development Biologics at Just-Evotec Biologics
Date: February 28 - 29
Location: Dublin, Ireland
Attending
Tags: Events, Evotec, Just Evotec Biologics
Target identification is a fundamental first step in drug discovery, involving the discovery and validation of disease-associated molecular mechanism that can be modulated by a drug. In this whitepaper we introduce Evotec's PanOmics TargetID Framework developed by the Bioinformatics and Computational Biology teams. It is a modular system that uses computational tools coupled with expert assessments to identify and rank potential drug targets. Our framework delivers a comprehensive report with a list of disease-relevant targets, their scores, annotations, rankings, and detailed information on their druggability, biology, safety, competition, and efficacy..
Tags: Articles & Whitepapers, Proteomics, Metabolomics & Biomarkers
Cell line development at Just – Evotec Biologics is focused on lowering the cost of biologics development and manufacturing through the creation of highly productive engineered cell lines for our clients and partners. To achieve this, we leverage our own in-house GS knockout CHO host cell line, which has been shown to support cell densities up to 80 M cell/mL and productivities upwards of 5 g/L/day in our perfusion bioreactor platform. Additionally, we have implemented advanced instruments and liquid handling automation to increase the throughput of processes that are historically major bottlenecks. Examples of this include semi-automated, independent transfections of up to 32 different expression vectors or high throughput single-cell cloning/screening of up 1000 clones. Paired with our process development and manufacturing expertise, we continue to push the envelope on improving drug costs and have enabled many of our clients to file for INDs.
If you’d like to learn more about the benefits of a customized cell line development program, you can download our white paper here
Tags: Articles & Whitepapers, Biologics
Patients around the world have limited or restricted access to biopharmaceutical medicines. Reducing production costs while still maintaining high quality standards will help increase the affordability of biologics and ensure more patients benefit from these life-saving medicines.
Traditional biomanufacturing facilities have failed to deliver biopharmaceutical products with sufficiently low Cost of Goods Manufactured (COGM) to allow greater patient access. These facilities have been built with fixed capacity and a focus on large-scale fed-batch manufacturing. Scaling-up processes to large-scale fed-batch manufacturing facilities involves considerable risk, resource, and upfront costs. Such facilities often lack flexibility which limits the products that can be produced within them and can leave valuable production assets idle for periods of time.
Manufacturing costs link directly to capacity utilization and product demand. There is a historical precedent within the biopharmaceutical industry of operating with excess capacity but we must recognise this comes with a financial penalty. We must address this challenge if we are to respond to global healthcare emergencies, changes in the way healthcare systems are managed and greater demand for global access to biotherapeutics.
Continuous Bioprocessing Platforms and Modular Facility Designs
The industry needs new flexible biomanufacturing concepts to quickly react to market fluctuations and achieve a higher predictability of costs. Modern biopharmaceutical productions facilities use building and manufacturing technologies, such as modular construction, to minimize clean room space utilization and reduce footprints. They allow faster speed to market with a lower upfront capital investment and are readily expandable when product demand is better understood. Continuous manufacturing platforms can be integrated into these facilities for low-cost bioprocessing using mammalian cell hosts in perfusion bioreactors linked to continuous downstream trains. Production costs remain low irrespective of facility mass output, the product quality attributes are consistent and manufacturing footprints are minimized.
Just-Evotec Biologics has developed a low-cost manufacturing facility design utilizing modular cleanroom pod technology that we call J.POD®. The J.POD facility design features individual pre-fabricated cleanroom pods arranged in a controlled, non-classified ballroom to minimize the cleanroom footprint of operations that would have previously taken place in a large ballroom. Media and buffer preparations, cell expansion, upstream, downstream and post viral are all housed in separate pods. The design minimizes fixed utility infrastructure and instead relies on single-use continuous upstream and downstream operations.
Biomanufacturing Facility Cost Comparisons
We developed process models for a fed-batch process in a traditional stainless-steel facility, a fed-batch process in a single-use facility and three continuous processes in a J.POD facility. The models were created using the Biosolve software (Biopharm Software Ltd) to show the benefit of the J.POD facility design on the COGM of an antibody biologic. We used Net Present Cost (NPC) to compare scenarios. NPC estimates cash flows by computing operational costs and discounting over time using a capital parameter. It does not include revenues in the accounting of cash flows and assumes capital costs are sunk costs incurred at the beginning of the project.
Figure 1 shows the expected costs from operating the different facility types and assumes their throughput increases at a rate of 250 kg/year up until a peak value. The range selected was representative of market demands for typical biopharmaceutical manufacturing facilities. Jumps in the NPC correspond to points when the capacity of a facility is reaches and new builds are needed.
We can draw the following conclusions from the results.
Driving Up Access to Biotherapeutic Medicines
We believe that modern biomanufacturing facilities must have smaller processing spaces, higher production throughputs and lower production costs. Modelling shows how our J.POD facilities have the lowest initial build and operating costs as well as the ability to control operating costs. These facilities are outperforming older manufacturing platforms in terms of cost and utilization. They are becoming an essential component of strategies for reducing costs and driving up access to biotherapeutic medicines.
Tags: Articles & Whitepapers, Blog, Biologics
Cardiotoxicity remains one of the most reported adverse drug reactions that lead to drug attrition during pre-clinical and clinical drug development. Drug-induced cardiotoxicity may develop as a functional change in cardiac electrophysiology (acute alteration of the mechanical function of the myocardium) and/or as a structural change, resulting in loss of viability and morphological damage to cardiac tissue.
Our latest work, published in Expert Opinion on Drug Metabolism & Toxicology, is now available to download.
Antimicrobial resistance (AMR) is one of the biggest health threats worldwide. Key to countering AMR is the development of novel anti-infective drugs. The limitations of animal models and clinical trial design have emphasised the importance of nonclinical pharmacokinetics/pharmacodynamics (PK/PD) platforms which provide a detailed understanding of the relationship between the fate of the antimicrobial compound in the body (PK) and the impact of exposure to the compound on the target microbes (PD). This allows us to optimise dosing regimens to maximise the efficacy of antimicrobial compounds (microbial killing) while minimising toxicity and the risk of the emergence of AMR.
What is the HFIM?
The HFIM is a system of pumps, tubing and microfibers that mimics the body, allowing in vitro assessment of anti-infective compounds under more relevant conditions. It consists of a central reservoir and tubing used as a circulating system, and a hollow fibre cartridge with thousands of permeable capillaries. The extra capillary space (ECS) outside the fibres within the cartridge contains the target organism. During operation, the drug-infused growth medium in the central reservoir is continuously pumped to the hollow fibre cartridge, rapidly passing through the capillaries into the ECS. This continuous flow ensures that nutrients, oxygen, and test compounds are continuously refreshed while waste products are removed. To simulate drug clearance, fresh medium is added to the central reservoir effectively diluting the drug from the system. Accordingly, this balance of drug supply/clearance can effectively simulate the drug’s PK profile.
Why choose the HFIM as PK/PD model?
It is the most capable in vitro system for PK/PD determination for anti-infective compounds, against bacteria and fungi. It is a dynamic model capable of simulating almost any given concentration-time profile for one or more compounds, even if they have very different half-lives.. The Hollow Fibre Infection Model is not limited by in vivo model availability, compatibility of PK profiles, dosing or sampling frequency, or study duration, which is extremely important for understanding PK/PD relationships and the risk of AMR over clinically relevant treatment times. Various cartridges with fibres manufactured from different materials are available to optimise the HFIM for microbial growth and compound performance.
In conclusion, the HFIM is a versatile in vitro PK/PD platform which can accelerate the development of antibacterial and antifungal compounds, contributing to the fight against AMR.
If you’d like to learn more about the uses of the Hollow Fibre Infection Model you can download our white paper here
Tags: pre-clinical development, infectious diseases, Articles & Whitepapers, Blog, In vitro Biology, Anti-Infectives
Date: December 6 - 8
Location: Edinburgh International Conference Centre
Our Senior Director • Business Development, Lynsey Haskayne, and Supervisor • ADQC / Inhalation Development, Fabio Russo, will attend DDL2023
Evotec excels in challenging oral inhalation and nasal product (OINDP) development, leveraging nanotechnology and therapeutic advantages. Our multidisciplinary teams drive inhaled product development for Phase I to late-stage clinical studies, offering tailored plans and robust strategies. Inhalation Analytics and Material Science ensure quality, supported by specific expertise and an integrated approach.
If you wish to discuss any inhalation development projects with Lynsey and Fabio, fill out the meeting form below or send an email to info@evotec.com
Date: November 12 - 15
Location: Rosen Shingle Creek Hotel in Orlando, Florida
Our team at EBF 16th Open Symposium
Booth Number: 330
Presentation
“Unleashing the science of toxicology along with formulation partners”
Presented by: Fabrizio Fina - Senior Scientist & Matteo Sartori - Senior Research Leader - Evotec
Date & Time: 12 November 2023 - 12:00 - 13:00
Location: Room E1
