The updated draft guidance calls for fully validated bioanalytical methods for any pivotal studies used to obtain approval or labelling, though less validation may be sufficient for a sponsor’s internal decision making.
Biomanufacturing is offsetting a decline in Ireland's small molecule industry caused by the patent cliff and cheaper manufacturing options in the East say industry groups.
The global bioseparation systems market is projected to almost double in size from $3.25B in 2012 to $6B in 2018, at a compound annual growth rate of about 11%, according to a recent report on the market.
Quality concerns and high shipping costs mean BioPharmas currently prefer Western CMOs, but improving standards and market opportunities may soon make Chinese contractors more attractive, experts say.
With the Chinese NAP (nucleic acid purification) market expected to grow more than 8% over the next year and no clear market leaders, companies are looking to take control of the industry space.
Keeping up with the latest technology news is a must for biomanufacturers according to an MIT Professor who told BioPharma-Reporter.com new advances in microtechnologies could help address process development challenges.
The Brazilian Government is to fund a new facility to produce the Protalix-Pfizer Gaucher's disease drug Uplyso as part of a supply and tech transfer deal worth $280m (€212m).
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
Globalisation, outsourcing and a move towards biopharmaceuticals are leading innovation for pharma distribution companies, according to DHL Global Forwarding.
