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The Bioinicia Group as a whole specialises in and focuses on the development and production of nano-structured and micro-structured materials, using electrospinning (production of fibre-based structures or nonwovens) and electrospraying techniques (particles, powder).

As well as developing electrospinning technology (equipment ranging from the laboratory range to pilot-scale production plants and industrial machines), Bioinicia works with its customers to develop their electrospun products or their electrosprayed products, in the performing of proof of concept and feasibility studies, process optimisation and, of course, the scale-up phase to ensure a scalable process so that a product can be manufactured in a consistent and reproducible manner at all times.

We can support and assist our customers from the initial design and conceptualisation phase of the product to its full development, and even in the industrialisation and manufacturing phase. We offer contract development and contract manufacturing services to provide a 360° comprehensive service to customers requiring as such.

Here are the development services we can help you with:

Proof of concept

Our customers sometimes have to perform a proof of concept using their materials or formulas before deciding whether to the purchase of electrospinning machine, so that they can assess the results obtained from processing with our Fluidnatek platforms.

This service consists of a series of initial tests so that they can consider the feasibility of the project and to meet the goals sought in subsequent phases. Of course, proof of concept does not guarantee the final goals of the project, but it is an interesting indicator to assess whether the project initially seems promising.

Bioinicia Fluidnatek has a team of application scientists with experience in electrospinning and electrospraying, who are capable of performing proof of concept and feasibility studies for our customers.

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Process scale up

The scaling of electrospinning processes is one of the most critical and complex phases, and requires the knowledge to be able to transfer the process from a laboratory electrospinning machine with relatively few emitters/nozzles to another continuous or semi-continuous manufacturing machine in an environment in which there might be hundreds or even thousands of emitters/nozzles (e.g. our Fluidnatek HT platform).

The difficulty in scaling an electrospinning process lies in the fact that the process dynamics change significantly when there are hundreds or thousands of emitters/nozzles compared with when there are only a few. This is because a large number of jets interact with each other and with the collector, the electrospinning process control must be more thorough, the incidence of process variables changes, the atmosphere in the manufacturing chamber changes because it often has to be inerted due to the large concentration of flammable solvents, etc.

Bioinicia provides its customers with a team of senior scientists with experience in electrospinning scaling and operating both pre-industrial (pilot-scale production plants) and industrial (electrospinning mass production) electrospinning equipment.

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Product development

We assist some of our customers in fully developing their electrospun products or electrosprayed products, starting from scratch and with a product ready and certified for marketing. This process is also known as “from Lab to Fab”.

In these cases, it is the team of senior scientists from Bioinicia, who are experts in electrospinning and electrospraying, who manage the entire development process: from the initial proof of concept to process optimisation at laboratory level and subsequent process scaling in an industrial electrospinning machine for manufacturing.

Bioinicia has certain analytical and test resources and instruments to analyse, test and assess the electrospun products developed. However, there may be another series of analyses and tests to be performed and for which Bioinicia does not have the appropriate resources or instruments, in which case either the customer itself performs these other analyses or Bioinicia outsources them through other specialist analytical laboratories.

The aim is to find a tandem between the customer and Bioinicia: our customer is most familiar with the application, what it wants to develop, and the technical features and specifications that the product should provide, whereas Bioinicia specialises in the electrospinning (or electrospraying) process used to attempt to obtain the characteristics and properties of the electrospun product required by the customer.

At Bioinicia, we have several examples of different electrospun products for various applications that have been developed from scratch and have been manufactured and launched onto the market.

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The Bioinicia Group is not only committed to the development and production of nano-structured and micro-structured materials but also provides comprehensive development services to its customers, including Performance Qualification (PQ) which entails a full validation of a specific process on a specific electrospinning equipment configuration. We specialize in electrospinning techniques and electrospraying methods, which we use in developing nano-structured materials and producing fibrous structures or nonwovens for different purposes.

Our development services extend beyond the mere production of materials. Bioinicia works hand-in-hand with its customers to develop their electrospun or electrosprayed products. We are involved from the early stages of proof of concept and feasibility studies, through process optimization, and to the scale-up phase to ensure a consistent and reproducible manufacturing process.

We understand the importance of a successful product launch. Therefore, we offer electrospinning development services to support and assist our customers from the initial product design and conceptualization phase all the way to full development. These development services also extend into the industrialization and manufacturing phase.

We offer contract development and contract manufacturing services to provide a 360° comprehensive service to customers. This holistic approach to electrospinning development services is designed to meet the needs of customers who require such comprehensive support.

We also understand that scaling up electrospinning processes can be a challenging phase. That’s why our development services include a team of senior scientists with experience in electrospinning scaling and operating both pre-industrial and industrial electrospinning equipment.

Our electrospinning development services have resulted in several successful real-life cases, from filter media to pharmaceutical, cosmetic or medical products. This demonstrates the effectiveness of our comprehensive development services to meet our customers’ goals.

At Bioinicia, we are committed to providing highly professional development services to help our customers achieve their nanostructured materials using electrospinning or electrospraying.

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Real cases

Here are some of the real cases that prove our experience in electrospinning scale-up:

Scale-up of electrospinning process to produce air filter media

Bioinicia develops and produces the range of filter media materials under the trademark PROVEIL®. This air filter media is mainly used for breathing face masks, although it could also be used in other products/applications. The range of PROVEIL® electrospun products are based on the synthetic polymer PVDF and must have a certain fibrous structure and morphology for the purpose for which they have been developed. This is how Bioinicia conducts the phases of the scaling process:

The R&D phase was conducted on a Fluidnatek LE-100 platform. The initial proof of concept was performed using an injector with just one emitter before switching to a spinning injector with 5 emitters/nozzles (needle-based technology) to optimise the process at laboratory scale and in a multi-jet environment, albeit with a small number of emitters/nozzles. We used a rotating drum as the test collector to obtain samples that were somewhat larger than A4 format. However, this phase is very important because it provides an insight into the process from the start up to its industralisation. From the outset, we are aware that the ultimate goal is to scale the electrospinning process and be able to consistently manufacture the electrospun product sought with the specifications and requirements needed. The duration of this R&D phase depends on each project, but usually takes between 2 to 4 weeks.

As a result of the previous process and the three phases described, Bioinicia obtained a productivity of around 1,250 m2/h of PROVEIL® filter media in a Fluidnatek HT industrial machine using over 1,500 emitters/nozzles (considering that the nanofibre layer produced by electrospinning has a grammage of less than 1 gsm).

Scale-up of electrospinning process to produce pharmaceutical oral patches

Our customer Afyx Therapeutics (www.afyxtx.com) approached Bioinicia with the idea of developing an electrospun medical device that consisted of a patch to cover and help heal ulcers and other lesions that occur in the oral mucosa. The idea was that this electrospun medical device would deliver a controlled release of a drug (corticosteroid) according to a certain release profile, once the patch had been placed over the oral lesion in the patient’s mouth. Afyx Therapeutics wanted to scale the electrospinning process, working under GMP certification for pharma. In this case, Afyx Therapeutics had also conducted prior proof of concept on a Fluidnatek LE-10
lab-scale machine, so we were not starting entirely from scratch in this project.

First, we re-optimised the electrospinning process on the Fluidnatek LE-100, which is a Fluidnatek platform for advanced R&D. Both the formula and the process parameters were modified to ensure everything was re-optimised. During this phase, we worked with a spinning injector with up to 5 emitters/nozzles. As a result, stable and scalable processes were obtained for the hydrophilic electrospun layer and the hydrophobic electrospun layer.

However, one of the first things we believed we had to do was to modify the initial formula that had been provided, as it did not use Class III solvents for pharma, among others. Therefore, the formula had to be changed and re-optimised.

In this case, this electrospun medical device consists of a patch formed by two electrospun layers: one hydrophilic layer consisting of the mixture of various biopolymers and whose nanofibres are charged with the active ingredient (drug); and a hydrophobic backing layer consisting basically of polycaprolactone – PCL, which ensures the active ingredient is released in one direction to the oral lesion the patch is covering. Both layers are processed and manufactured separately. Overall, this electrospun product exceeds 100 gsm.

Scale-up of electrospinning process to produce a membrane for selective filtration of high-value substances in liquid medium

One of our industrial customers developed a proprietary process at laboratory level using a bilayared process (two electrospun materials processed simultaneously), both layers of which were synthetic polymers, to generate an electrospun membrane of several dozen gsm for the extensive, selective purification of substances immersed in physiological fluids. This type of applications is increasingly in demand as novel cell and gene therapies are developed by medical science.

In an initial phase, we used the process developed by our customer at laboratory level in a Fluidnatek LE-500 electrospinning machine with around 50 emitters/nozzles, processing both polymers at the same time. We produced samples that were around 8-10 meters in length and about 40 cm in width for customer assessment and feedback. Due to the notable thickness of the required electrospun membrane, each sample had required several days of manufacturing. Over a dozen samples were produced over several months to achieve a structure and properties of the electrospun material manufactured that were in line with the product specifications and results required by the customer.

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