Contract manufacturing services (CMO) - Bioinicia
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CMO Contract manufacturing services

Bioinicia uses its electrohydrodynamic & aerodynamic processes to produce industrial volumes of micro or nanostructured materials on behalf of its customers (outsourced manufacturing).

We can process a wide variety of materials in order to achieve a range of properties, making products suitable for multiple applications, including encapsulation of active components. Bioinicia has particular expertise in the fields of pharma, biomedical, cosmetics and nutraceutical food ingredients.

Bioinicia has two in-house industrial setups:

Electrospinning plant – intended for pharma and biomedical products. This site is GMP (pharma) and ISO 13485 (medical devices) certified and incorporates ISO 7 Class C cleanroom facilities.

Encapsulation plant – intended for room-temperature encapsulation of thermo-sensitive materials (actives, bioactives, biological materials…) into dry particles/powders.

Benefits of using our CMO services:

  • Minimize your investment in manufacturing.
  • Focus on your core business: bringing solutions to the market.
  • Leverage process expertise of Bioinicia’s manufacturing team to scale your process to the required quantities.
  • Bioinicia can take responsibility for the whole manufacturing process, including packing if required.

Production Process

1. Scale up to industrial production

Bioinicia can either develop your product for you, through its Contract Research & Development services, or take your previously developed material and then scale-up its manufacturing to the required volumes to enable commercialisation. The behaviour of the process often changes when working at larger scale with multi-emitter spinning heads, so further optimisation of processing parameters is usually 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 for thorough application performance testing. This can then lead to further iterations of development, or progression to industrial-scale manufacturing.

2. Validation data

Before completion of the scale-up phase, it is important that the customer defines, with Bioinicia, the specific criteria against which the electrospun or electrosprayed product will be assessed and either accepted or rejected. This ensures that clear targets are set for manufacturing. The scale-up process will only be complete once these criteria are successfully fulfilled, at which point the process can continue to the production phase.

3. Production

Depending on your volume requirements, Bioinicia has the option to use either its pilot-production plant (Fluidnatek® LE-500 machine) for small batches or its industrial manufacturing plant for larger volumes. The production facilities at Bioinicia include GMP and ISO 13485 certified manufacturing lines housed within its own ISO 7 Class C cleanroom, enabling the production of pharmaceutical products and medical devices.

4. QA / QC

Running in parallel with manufacturing, quality assurance procedures take place in the mixing phase, the weighing and manufacturing devices, the packing… The quality control procedures are applied to all products: parameters of the solution, on the resulting electrospun/electrosprayed products… The products are characterized to ensure they are within the required parameters. The final resulting products are checked according to the previously established validation criteria.

5. Regulatory requirements

All processes can be carried out in accordance with international standards & regulations as required by our customers, including the possibility of manufacturing under GMP (for pharma products) or ISO 13485 (for medical devices) conditions. Responsibilities relating to product registration with the corresponding national authorities and taking the products to market lies with our customers.

6. Record keeping

Running in parallel with manufacturing, quality assurance procedures take place in the mixing phase, the weighing and manufacturing devices, the packing… The quality control procedures are applied to all products: parameters of the solution, on the resulting electrospun/electrosprayed products… The products are characterized to ensure they are within the required parameters. The final resulting products are checked according to the previously established validation criteria.

Do you want to know all what we can do for you?