Biomedical engineering 2019-10-10T09:54:08+01:00

Biomedical engineering

We participate in all phases of engineering:

  • Technical and economic viability.

  • From the design phase to the sanitary certification.

  • Selection of suppliers.

  • Prototyping, packaging.

Custom formulations

I+Med has state-of-the-art facilities for polymer research, formulation development, analytical and manufacturing activities.

I+Med’s infrastructure enables support of partners not only during the first feasibility phase, but also during all subsequent product development phases, all the way up to manufacturing and supply of animal trial and clinical trial (GMP) batches and technology transfer if required. Regulatory support and quality assurance form an integral part of the product development services.

Over the past years, i+Med has gathered extensive pre-clinical (including animal trials) data, allowing for an efficient and fast product development track. This in turn helps us perform clinical trials in a timely manner.

ingeniería biomédica nanohidrogeles inteligentes

Development phases:

Design:

  • Analysis of the state-of-the-Art.

  • Define specifications.

  • Propose formulation strategies.

  • Define analytical and control methods.

Development:

  • Initial formulation development.

  • Define process conditions.

  • Optimize formulations.

  • Prototype development.

  • QC tests.

  • Characterization: physicochemical, microbiological, biological.

Scale Up:

  • Production of a batch under GLP conditions.

  • Analytical method optimization & validation.

  • QC tests.

Manufacture:

  • Process scale up to desired batch size.

  • Process optimization and validation.

  • Preparation of documentation.

  • Analytical method optimization & validation.

  • QC tests.

Support:

  • Technical, Regulatory and Quality.

  • Follow-up in all phases: reports, data transfer, etc.

  • Documentation preparation for notified bodies.

  • Quality requirements.

Custom encapsulation

We work as external R&D Unit in the development of new sustained release products in partnership with pharma, biotech, medical device, food, veterinary industries, etc. Our technology and experience allow us to offer different types of nanocarriers and functional molecules in order to select the optimal system for a desired application.

Technical requirements: To solubilize hydrophobic substances, Targeted delivery, sustained delivery, to minimize toxicity, to protect and stabilize molecules

Strategic development: Increased drug efficacy, Increased cost-effectiveness (less product – same or more efficacy), patient-friendly dosage forms, Extended products life cycle (new means of delivery)

Conjugation (functionalization)

It is imperative to control the interactions between biomaterials and living tissues to optimize their therapeutic effects.

Because most biomaterials do not have the perfect properties and functions, functionalization of polymers plays an important role to allow better adaptation to the physiological surroundings and deliver the required clinical performance.

Some of these functionalizations encompass adsorption, deposition, covalent binding of specific chemical groups, molecules, peptides, or targeting lingands.

ingeniería biomédica funcionalización