Long acting (LA) formulations have become a game-changer in terms of bringing existing and new active pharmaceutical ingredients (APIs) in more cost-efficient and comfortable ways to patients, often directly impacting commercial viability of new products. However, existing technology platforms are only applicable to a limited part of the pharma portfolio and do not fully unlock all benefits linked to LA. LongActNow is a Marie Curie-Sklodowska International Training Network that will design novel platform technologies to develop LA suspensions of complex active pharmaceutical ingredients, involving innovative manipulation of API crystal formation and growth and solvent removal.
Call for PhD studentships/Early Stage Researchers (ESRs)
LongActNow invites applications from qualified candidates for five PhD studentships that will address major challenges in the manufacture, formulation and stability of LA aqueous drug suspensions. Successful candidates will benefit from the synergies leveraged across LongActNow’s four prominent international academic and industrial centres (University of Limerick, Trinity College Dublin, Technische Universität Dortmund and Janssen Pharmaceutica). As mobility is key to Marie Skłodowska-Curie actions, successful candidates will spend time in the different institutions listed including 18 months spent at Janssen Pharmaceutica in Belgium. Applicants must not have resided or carried out their main activity (e.g. work, studies) in the participating country where he or she has been recruited for more than 12 months in the 3 years immediately before the date of application.
Janssen hiring 1: The goal of this PhD is to produce an injectable suspension of an active pharmaceutical ingredient (API) via a crystallisation approach which can continue to release the API for a specific time (~ 6 months) and is biocompatible with the body.
Optimal process conditions and excipients will be selected to obtain a specific crystal size distribution using a high throughput screening approach. The objectives of this project are for the ESR to gain skills and generate data on the nucleation and crystal growth of the selected class of APIs during antisolvent precipitation. Molecular dynamics simulations on each active pharmaceutical ingredient (API) model system, excipient and solvent/antisolvent system will be conducted. In situ monitoring will support the proposed mechanisms by which the crystallization process is proceeding with control over the resultant polymorphic form demonstrated. API suspensions will also be produced with the same crystal size distributions using industrially accepted top down approaches. Controlled release kinetics, stability and bioactivity of the resulting suspensions in biorelevant media suitable for the target application of the relevant API will be compared.
Janssen hiring 2: The objective of this project is to validate the toolboxes and technologies developed by the other ESR’s in projects 1-4 and apply their findings and methodologies to optimally guide the selection of the most appropriate bottom-up technology and excipients to obtain suspensions with tailored properties for new types of APIs.
Based on the thermodynamic and kinetic properties of the complex systems, the ESR will identify and validate the attainable size ranges and limitations of the different processing routes and predictive in silico approaches for the relevant phenomena e.g. time constants for nucleation/growth kinetics and effective surface poisoning/affinity of the selected excipients resulting in nanosuspensions possessing different physical and chemical qualities and stabilities. ESR 5 will also explore more generic applicability of modelling and excipient selection tools across bottom-up and top-down manufacturing methods for nanosuspensions. A generalized experimental workflow and decision tree for technology platform and excipient selection for the development of aqueous suspensions will be developed. The derived methodology will be the result of the investigation of proprietary Janssen compounds in addition to the insights gained on model APIs by ESR 1-4.
Are you interested? Please apply through the website and upload a cover letter, transcripts of highest qualification and letters of recommendation.
Janssen Pharmaceutica N.V. (7555)