Phase 2 - Research

The AMPTEC Cluster will take advantage of Phase 2 to promote an experimental cross border Centre of Excellence in “Advanced Technologies on Continuous Manufacturing of Solid Dispersions and Process Analytical Tools” by launching a pilot research work with cross border teams.

The AMPTEC teams will conduct the following studies:

2.1 Research on continuous processing of solid dispersions and cocrystals

The aim is the optimization of continuous manufacturing processes for pharmaceutical companies due to the increased market demand in this area. Currently, only few companies use continuous processing while there is a lack of expertise worldwide for such projects. These studies will help industries to reduce cost, increase profit, improve product quality and improve patients’ life.

Teams will work jointly to develop continuous processing for the development of amorphous solid dispersions and cocrystals. A range of different techniques (HME, spray-drying, freeze-drying, milling, chemical synthesis) will be explored. These technologies have attracted industrial interest and the partners are highly qualified to develop commercial products for regional industry.

2.2 Research on continuous development of medical devices

The aim is to optimize the manufacturing of medical devices (stents) as the current processes are time consuming, generate drug/polymer losses and difficult to scale-up. There are also concerns about the safety and efficacy of some of the marketed products. New approaches are required that will be robust, reproducible, accurate with improved quality (drug release, new designs). The next generation of stents should be biocompatible and biodegradable without side effects.

Teams will work together for the development of novel medical devices by exploring new biomaterials with advanced properties (biodegradable, biocompatible, controlled release). The partners will also develop a sustainable manufacturing process that will be attractive for biomedical companies (cost efficient, robust and commercial)

2.3 Application of Process Analytical Tools (PAT) for process monitoring

The goal is to employ novel analytical techniques to analyze the solid dispersions and determine if they are in crystalline or amorphous state. The use of novel approaches (NIR, Raman, DSC, molecular modeling) will provide process control and subsequently will lead to the product optimization. The partners have excellent experience of such applications due to their strong industrial collaborations.

Teams will heavily be involved in the development of various analytical techniques (PXRD, TEM, DSC, HSM, NIR, particle sizing etc.) for the characterization of the manufactured dosage forms in order to identify the drug state (e.g. amorphous) and the effect of the processing parameters of the used technologies. The techniques will help to control the production and ensure the quality of the final product.

2.4 Test of the in vitro/in vivo cytotoxicity of biomaterials

The aim is to investigate the biological properties of the used materials and prove their safety. It is very important to provide evidence that especially humans can safely use biomaterials and to determine the appropriate drug levels after administration in order to induce a pharmacological effect.

Teams will work together to investigate the safety (biocompatibility, toxicity) of various polymers, produced drug dosage forms and implanted medical devices prepared through continuous processing. Bioavailability studies will also be determined whether the active dose has a pharmacological impact or not.

Training and Research seminars - June 25th 2015 Villeneuve d'Ascq (France)

Training  and Research seminars will be organized to present AMPTEC activities. The seminars will be opened to scientits and technical staffs from academia and from industry and general scientfically interested public. They will particularly focus on manipulations of the physical states of pharmaceuticals, continuous processing of solid dispersions and cocrystals, Application of Process Analytical Tools, continuous development of medical devices and in vitro/in vivo tests of cytotoxicity of biomaterials.


The flyer of the event is available here (pdf)(external link)

 

The “Fédération des biomatériaux” (FED 4123, Resp.: F. HILDEBRAND, Lille, France) is now included in the AMPTEC cluster as associated partner (AP6). Activities of the “Fédération des biomatériaux” are based in the field of biomaterials functionalized with a real opening to the biological and clinical applications. AMPTEC will benefit from the network of the “Fédération des biomatériaux” with industries and academic laboratories.

 

 

 

 

 

 

 


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