Biologics

Biologics
Product Description

Why have we developed our bio nanoparticle technology?

The biologics industry is expanding rapidly as the potential of biological therapies grows in recognition. The field is also expected to become more versatile as it grows from antibody-focused production to gene and cell therapies, exosomes, fusion proteins and nanotechnology approaches. However, despite their success so far, biologics come with a number of challenges.

Among these is that the production cost of biologics is high. Despite this, increased opportunities for patient centricity exist, including better formulations and different modes of administration to aid drug delivery. Direct nanoforming of biologics is a promising new approach to allow more life-changing large-molecule drugs to reach the market, which was a key driving force behind the development of our proprietary biological technology.

Our technology

Our biological nanoforming technology can deliver large-molecule drug particles as small as 50 nm while retaining biological activity. It’s effectiveness has been demonstrated on proteins in the 6 kDa – 140 kDa range, and it is capable of engineering particle sizes to specific requirements. Our advanced technology can be applied across the biologics field to potentially:

Change delivery routes

Increase uptake

Enable new drug combinations

Tailor release profiles

Enhance drug loading capacity in formulations

Implement lighter infrastructures for drug logistics

Nanoform Finland Oy

  • FI
  • 2019
    On CPhI since
  • 1
    Certificates
  • 100 - 249
    Employees
Other

Nanoform Finland Oy

  • FI
  • 2019
    On CPhI since
  • 1
    Certificates
  • 100 - 249
    Employees
Other

More Products from Nanoform Finland Oy

  • AI Drug Candidate Screening

    Product AI Drug Candidate Screening

    Our STARMAP® 2.0 platform leverages cutting-edge sparse-data AI to pick winners among candidate molecules that are predicted to be best amenable to CESS®-powered nanoforming and that exhibit optimal production characteristics.

    When existing data alone is not sufficient for generating specific predictions, sparse-data AI comes to the rescue. Our STARMAP® 2.0 platform augments experimental results with detailed expert knowledge to allow sensible predictions to be made regarding drug development success. 

    Currently, we are launching a digital version of our CESS® technology that allows us to perform in silico experiments in large quantities and to create predictions of nanoformability. This is important since there are more potential drug molecules than particles in the known universe.

    Our game-changing CESS® technology lies at the heart of our operations and offers a unique opportunity to both bring failed assets back to life again and accelerate APIs to the clinic. The STARMAP® platform can have wide applicability in drug discovery and development as well as in lifecycle management for existing marketed drugs and 505b2 like product development strategies. 

    As CESS® has the potential to drastically improve several characteristics of APIs relative to other technology platforms, we recognize that it is vital to apply STARMAP® 2.0 widely to rapidly identify for our customers the APIs with the greatest potential for nanoforming success.   

    Additionally, past AI-based technologies were trained on old particle engineering techniques such as micronization, limiting prediction accuracy. This opens up the possibility that previously disregarded drug candidates can be revisited with the latest technology and transformed into a drug development success story. 

    Ultimately, the goal of STARMAP® 2.0 is to benefit as many patients as possible by making new and better drugs available faster than is possible with other technological platforms. 
  • Formulations

    Product Formulations

    We understand that speed is of the essence when working to deliver a life-changing drug to market. Our experienced clinical formulation development team can support formulation development across a vast range of dosage forms – including oral, ophthalmic and transdermal formulations, as well as injectables, inhaled therapies and more. Whether NCE or 505(b)(2), we can work with our partners to help you rapidly progress your drug from the preclinical stage through to commercial formulation development as part of an integrated process.

    Benefits of formulation development with Nanoform

    Our rigorous QbD approach to the formulation development of nanoformed drugs can open up new possibilities for drug delivery innovation. Reducing the API’s size down to the nanoscale can enable:

    Reproducibly fast dissolution

    High drug load

    Potential for a simple formulation with less excipients

    High physical suspension stability

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    Novel opportunities for exploring coformulations, in particular dual API formulations
  • Small Molecules

    Product Small Molecules

    Our multi-patented Controlled Expansion of Supercritical Solutions (CESS®) technology enables the creation of API nanoparticles directly from solution. The process can be applied to most small molecules, with a high success rate of 80-90%.

    CESS® is a bottom-up method of recrystallization that works by controlling the solubility of an API in supercritical carbon dioxide (scCO2). The use of scCO2 permits a green particle engineering process with pharmaceutical CO2 that is free from excipients and organic solvents. CESS® represents a significant improvement over previous supercritical technologies due to the employment of controlled mass transfer, flow and pressure reduction.

    Benefits of CESS®

    Controlled particle shape

    Our nanoforming process can control the shape of particles, leading to greater uniformity.


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    Our technology can produce nanoparticles as small as 10 nm. Smaller particles have greater active surface areas, which permits an increased rate of dissolution.


    Controlled polymorphism

    Polymorphic purity tests have shown that stable single polymorphs can be produced with defined process parameters enabling polymorphic control.

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