PhD Position in Development of A Formulation Platform for The Colon Targeted Oral Delivery of Biologics

Catholic University of Leuven

 
The work will be performed at Eurofins Amatsigroup NV (Ghent, Belgium) in the Pharmaceutical Development department and Analytical department, under the direct supervision of Dr. Jody Voorspoels/ Dr. Lien Saerens/ Apr. Celine Van Vooren and the supervision of Prof. G. Van den Mooter (KULeuven). Eurofins Amatsigroup is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging). Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs: • Drug substance biological process and analytical method development and production, including GMP manufacturing. The principal technological expertise is production and purification of recombinant proteins derived from microbial and eukaryotic systems, for research purposes and toxicological studies as well as for clinical trials, including formulation development and stress stability studies. The company also has extensive expertise in the manufacturing of viruses and living cells for vaccine purposes and in-depth knowledge of working under pharmaceutical and GMP quality requirements. • Drug product development of new drug candidates focusing on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and GMP manufacturing of chemical and biologics drug candidates. Eurofins Amatsigroup NV develops and produces non-sterile and sterile biologics (drug substance and drug product) and chemicals (drug product) in preclinical and early clinical development phases.

Project

This project focuses on the development of a formulation platform for the colon targeted delivery of biologics (peptides, antibodies, enzymes,nucleic acids). First steps are taken in that direction for new biological entities (NBEs) that treat local gut disease states (Crohn’s diseases and irritable bowel syndrome), as systemic uptake is not required for these APIs.

In order to target the colon and to avoid degradation in the upper GI tract, a functional polymeric system is required, as a coating, or as a matrix system. The focus of this platform will be on the development of multiparticulate dosage forms (i.e. coated beads, mini-tablets, pellets) since these have numerous advantages over monolithic systems, such as predictable gastric emptying, no risk of dose dumping and less irritation.

The formulation of solid forms of biologics requires extra effort in view of the stabilization and dissolution. A (high-throughput) screening method will be developed to assess the solid state stability of biologics focusing on the excipient-API interaction. To obtain solid forms of the API, several drying techniques will be evaluated. Important parameters are the prevention of aggregation and chemical degradation of the biologics.

Since there is usually a low amount of material available for NBEs in early stage development, initial trials have to be performed at miniaturized scale. In this project, the development of a miniaturized coating process is investigated. Secondly, the influence of variations in process parameters onthe quality of the coating will be determined. Coating efficiency, coatingthickness, surface morphology and dissolution will be evaluated, as well as thestability and activity of the model compound in function of the process andformulation. Dissolution method screening and development are an integral part of this investigation.

Further down the line, the R&D formulation process can be transferred to GMP manufacturing at larger batch sizes, requiring upscaling trials and validation of the R&D analytical methods for release of the final drug product. Quality by Design (QbD) principles should be implemented during formulation and process development.

Profile

  • Profile: Master degree in Pharmaceutical Sciences
  • Research experience: Master thesis work and/or experience in pharmaceutical technology
  • Communication skills: Ability to work both independently and in a team, direct communication style. Fluency in spoken and written English is mandatory.

Offer

The project is funded by a European Union H2020-MSCA-ITN grant. It covers competitive salary, lab and conference expenses towards the completion of a PhD degree at the Faculty of Pharmaceutical Sciences of KULeuven.

We offer a fulltime PhD position for 2 years, extendable to 4 years after initial positive evaluation.

Interested?

For more information please contact Prof. dr. Guy Van den Mooter, tel.: +32 16 33 03 04, mail: guy.vandenmooter@kuleuven.be.

You can apply for this job no later than November 30, 2020 via the
KU Leuven seeks to foster an environment where all talents can flourish, regardless of gender, age, cultural background, nationality or impairments. If you have any questions relating to accessibility or support, please contact us at diversiteit.HR@kuleuven.be.
  • Employment percentage: Voltijds
  • Location: Leuven
  • Apply before: November 30, 2020
  • Tags: Farmaceutische en Farmacologische Wetenschappen