Technology

Traditional manufacturing processes are poorly suited for formulating long-acting mAbs / proteins.

Localisation of protein within unwanted voids arising from traditional manufacturing processes often lead to loss of activity for the protein or monoclonal antibody due to the localised acidic environment. Traditional microsphere production processes also expose the protein to damaging liquid-liquid interfaces, high shear forces and heat, all of which contribute to drug degradation.

Biodexa Pharmaceuticals Q-Sphera™ platform is ideally positioned to address and overcome these limitations:

Our 3D printing process regulates the internal pH within microspheres and reduces the likelihood of protein degradation. The homogeneous structure contains no unwanted voids and demonstrates even drug distribution, whilst the open polymer microstructure allows easy fluid ingress and egress.

The Q-Sphera™ platform does not use surfactants, toxic solvents, biphasic mixtures, shear or heat forces and is flexible to allow for use with a wide range of solvents, bioresorbable polymers and stabilising excipients to finely tune product characteristics.