Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.
Rebuilding 'problem' sterile manufacturing plants to modern specifications may be a better option than spending money trying to fix them according to an ex-GSK expert.
Pharma firms are returning to European and North American manufacturers as quality issues and rising costs have lost India and China some of its ‘Eastern promise,’ according to industry experts.
Critical Pharmaceuticals says its protein and peptide delivery technologies offer long acting injectables and greater compliance, saving money and easing patient administration.
With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.
Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).