Eurofins CDMO Presentations and Webinars

New Strategies to Enhance Physicochemical Characteristics of Active Pharmaceutical Ingredients

September 9, 2021

Presented by Bahareh Khalili, PhD

Eurofins CDMO Alphora

This webinar discusses new techniques on solid form screening that aims to enhance physicochemical characteristics of active pharmaceutical ingredients. These new strategies will be discussed in comparison to common techniques used in drug product development.

Technical aspects of the screening will be discussed along with process to characterize and develop discovered new API solid forms. Aspects of Intellectual property and regulatory guidelines regarding these strategies will also be described. In this webinar you’ll learn about API polymorph landscape, salts, and co-crystals screening. You will also hear about new solid form developments and regulatory guidelines around it.

To watch the video: click on the picture below

The benefits of combining formulation and purification activities during process development

June 3, 2021

Presented by Geraldine Buysschaert, Fons Bosman and Jo Vercammen

Eurofins CDMO

This webinar focuses on the benefits of including formulation development early in biologics process development. We took as case study our contribution to the Hookvac project, a EU-funded project to develop a vaccine against hookworm infection. A cost-effective vaccine would be the answer on the poor results obtained today with small drugs. The ultimate goal of this project was to develop a bivalent vaccine, based on two candidate antigens APR (a protease) and GST (a glutathione S transferase). For GST, we optimized the production process and did the GMP manufacturing of the Ph I clinical batch. For APR, we developed a new expression strain based on E.coli, developed a production process (USP+DSP), and produced an MCB. Unfortunately the detergent needed in the formulation of APR was not compatible with GST. By formulation screening we were able to identify another detergent that did not negatively impact the structure of both proteins. This finding led to an adaptation of the purification process of the APR protein and paved the way towards the development of the bivalent vaccine.

To watch the video: click on the picture below

C&EN Webinar - A Scientific Journey of a Niche API Achieving Breakthrough Status by the FDA for a Lifesaving Drug for Infants

February 17, 2021

Presented by Peter Duspara, Ph.D., Bahareh Khalili Ph.D., Graham McGowan, Ph.D. & Yan Rodriguez-Evora, Ph.D.

Eurofins CDMO Alphora

A case study illustrating how to overcome technical challenges of an orphan drug that received FDA breakthrough status, while ensuring fast-track development milestones and stringent timelines.

We will take a deep dive into the program, with a focus on:

• Optimization of the synthetic process
• Physicochemical characterization of the API molecule
• Analytical controls and specifications development
• Technology transfer to manufacture
• Process performance qualification (i.e. process validation)
• Establishing a phase and product-appropriate regulatory concept and dossier

To watch the video: click on the picture below

Highway to Clinic – Formulation Strategies for Improved Bioavailability

June 30, 2020

• How to deal with poorly soluble compounds
• Which techniques can be used for drug product development in the short term
• How Eurofins CDMO can assist in developing and manufacturing your drug product

Peptide and Protein Formulation Strategies

July 16, 2019

Joe Page, Ph.D. - President, Eurofins Advantar Laboratories
Daniel E. Beidler - Project Director, Eurofins Advantar Laboratories

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