Contract research services (CRO) - Bioinicia
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CRO Contract research services

Developing micro or nanostructured materials to provide optimal performance benefits in your application requires both suitable equipment and a strong knowledge of the electrospinning and/or electrospraying process.

Through our contract research services, our customers can take advantage of the wealth of knowledge and experience of Bioinicia’s R&D team in the development of such materials for a wide range of applications including bioactive encapsulation, controlled drug delivery, wound healing, tissue engineering scaffolds and implants, functional coatings, and many more.

Some benefits of using Bioinicia CRO services are:

  • Save cost and time in your developments.
  • Leverage materials and process expertise of Bioinicia’s R&D team.
  • Develop IP rights: you own the materials-related IP created in your product.
  • Bioinicia has necessary EHDA and characterisation equipment in-house.
  • Possibility of scaling-up to industrial production.
  • Focus on your core-business: bringing products to market.
  • Bioinicia does not develop its own products so does not compete with its customers.

Testimonials

Reference example

Rivelin® oral patch (pharma product)

Rivelin® is a nanofiber-based drug delivery platform developed for our customer DERMTREAT.

What did the customer want to develop?

  • A patch to improve the healing of ulcers and other type of lesions in the mouth.
  • The patch should effectively adhere to the oral mucosa for a limited time period.
  • The active pharmaceutical ingredient (API) should be delivered in a controlled manner over a predetermined time period (e.g. 2 hours).

What did Bioinicia develop?

  • A bioadhesive nanofiber-based material consisting of 2 layers: a hydrophilic layer and a hydrophobic layer.
  • The hydrophilic layer:
  • Incorporates the API and is placed in contact with the oral mucosa,
  • Provides adhesion to the mucosa and allows the adhesion time to be controlled.
  • The hydrophobic layer:
  • Acts as a barrier to ensure that the API is delivered only to the area of application, preventing release elsewhere in the mouth.
  • Allows for easy handling of the patch.
  • Both layers are effectively bonded to form a simple-to-apply patch
  • Patches remain in place for over 2 hours and can then be swallowed or disposed of.
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Production Process

CRO Concept

1. Concept development

Any new product development project starts with a concept – an idea about what performance enhancement you want to achieve in your application and how this can be achieved. If needed, Bioinicia can work with you to develop your concept by helping you to understand how nano or micro-structured materials can be integrated into your product to provide performance and commercial advantages.

CMO Record keeping

2. Validation criteria

Once you have a clear concept, it is important to define a set of criteria against which the materials developed during the R&D project will be assessed. This ensures that the best material is selected for scale-up. If needed, Bioinicia can assist you in selecting appropriate criteria for your application. These criteria will be agreed between you and Bioinicia at the start of the project, or after preliminary trials.

CRO Validation

3. Lab Scale development

Once a customer’s application and concept are understood, a material development project typically begins with series of lab-scale trials using Bioinicia’s single-emitter Fluidnatek® apparatus, to select the most appropriate formulation for electrospinning or electrospraying. This step involves: 1.Selection of material (e.g. polymer, protein etc) to provide the required product performance 2. Selection of solvent system to enable the processing of the selected material by electrospinning / electrospraying. 3.Optimisation of the solution properties (viscosity, surface tension, conductivity, volatility etc.) to achieve stable processing conditions<br /> In parallel with formulation optimisation, the key processing parameters (solution flow rate, applied voltages, processing distance, temperature & humidity) are also optimised in order to generate the required nano and micro-structured morphologies. 4. Samples of the materials are produced and characterized for comparison with the validation criteria. This iterative process continues until the required material properties are obtained. All of the information obtained is then used in transferring the process to Bioinicia’s pilot-scale multi-emitter electrospinning / electrospraying equipment for scale-up of fiber or particle production.

CRO Scale up

4. Scale up

All the previous stages are carried out at lab-scale, typically using a single-emitter.<br /> If the customer requires larger volumes of material, Bioinicia has the option to use either its pilot-production plant (Fluidnatek® LE-500 machine) for small batches or its industrial manufacturing plant if required. In both cases the electrospinning or electrospraying process uses multi-emitter heads in order to achieve higher throughputs. The behaviour of the process changes when working at larger scale, so further optimisation of processing parameters is often required to maximise throughput and achieve the desired material properties. Once the process is optimised using Bioinicia’s pilot-scale equipment, large samples are typically provided to our customers for thorough application performance testing. This can then lead to further iterations of development, or progression to industrial-scale manufacturing.

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