Dalton adds formulation service to manufacturing offering
The new unit will provide formulation development for liquid, solid, semi-solid and lyophilised versions of small-molecules, proteins, monoclonal antibodies and potent active pharmaceutical ingredients (APIs).
Pekos said that the Canadian contract manufacturing organisation (CMO) has “also expanded our Analytical Services to serve our formulation development experts and as a result now offer dissolution testing and particle size distribution testing.”
Dalton did not respond to Outsourcing-pharma’s request for additional information.
Formulation development market
All the forecasts are that drug industry demand for this type of service will increase markedly over the next few years as pharma firms race to extend the lifecycles of lucrative products by developing new patentable formulations.
For example, a recent survey by industry analysts Espicom predicted that $15bn (€10.5bn) worth of controlled release (CR) medicines are due to go off-patent in the medium-term.
The Espicom survey also suggested that pharma firms are “[looking] at CR delivery earlier in the product life-cycle” and, in some cases, launch CR versions ahead of patent expiry.
The authors also predicted that business from generic drugmakers will also drive the formulation development market as companies seek ways of differentiating their products as market competition increases.
Such shifts in the drug industry’s approach to life-cycle management is likely to benefit contract manufacturing organisations (CMO) capable of rising to the technical challenges associated with formulation development.
