The Challenge of Change - Managing Excipients Control
Colorcon
05-Sep-2011 - The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.
01-Sep-2011 - in-Pharmatechnologist.com presents a round-up of the latest regulatory developments, including a guide for GMP newbies from Health Canada, an internationally-flavoured revision of the EMA’s rules on batch certification and the EDQM’s latest thoughts membrane-based on WFI production.
31-Aug-2011 - Vivalis cut its operating loss after demand for its vaccine production cell line drove triple-digit revenue growth.
30-Aug-2011 - The FDA has toned down its support of QbD in final guidance on cutting residual drug in transdermal delivery systems following industry criticism.
30-Aug-2011 - The rise of tablet splitting has prompted the FDA to advise manufacturers on what data is needed to support applications for scored doses.
29-Aug-2011 - Batavia Bioservices has gained access to simulated moving bed (SMB) technology by collaborating with Xendo.
25-Aug-2011 - Emerson Process Management has released a dual-input liquid analyser with a high resolution colour screen.
24-Aug-2011 - US bioreactor maker PBS Biotech has bought medical device focused CMO Integrity CMI to expand its manufacturing capacity
23-Aug-2011 - Japanese drugmaker Takeda has been awarded JPY24bn ($313m) to develop and a cell culture influenza vaccine and establish a commercial-scale production facility.
23-Aug-2011 - The USP is strengthening ties to the Brazilian pharmaceutical sector to improve quality and drive harmonisation of standards.
22-Aug-2011 - AstraZeneca has adopted and scaled-up silica-based cartridges for removal of metal impurities at its pilot plant.
18-Aug-2011 - Repligen should consider selling its bioprocessing unit, which sells materials used in mAb production, to make best use of its assets, a shareholder suggests.
18-Aug-2011 - The FDA is prioritising development of technologies to compare biosimilars to innovator products in its plan to modernise regulatory science.
17-Aug-2011 - A study shows mAbs processed with fast acting dehydration show equivalent structural changes to freeze dried compounds after a year, EnWave claims.
10-Aug-2011 - Pfizer is “aggressively” moving toward real-time release (RTR) and believes return on investment can be realised in a year.
09-Aug-2011 - FDA scrutiny of the Burlington, MA sterile plant AMRI bought in 2010 has made the takeover a “money pit”, an analyst said.
08-Aug-2011 - Generic manufacturers can benefit from QbD but fears it will hinder companies in the race to be first-to-file are slowing progress, a VP at Teva said.
08-Aug-2011 - The EC has updated stability testing guidance to cover procedures for variations, such as change in batch size, to marketing authorisations.
04-Aug-2011 - HP has launched a global authentication service it says will help identify counterfeit and stolen pharmaceuticals.
02-Aug-2011 - Researchers have sequenced a Chinese hamster ovary (CHO) cell line to support improvements to biopharm protein production.
02-Aug-2011 - Protein engineering is an untapped method for limiting post-production aggregation that causes immunogenicity, academics say.
02-Aug-2011 - The pharma biobanking and compound management services sector welcomed its newest member last week with Brooks Automation’s acquisition of Nexus Biosystems.
01-Aug-2011 - Biosimilars should help Millipore achieve long-term growth but cancellation of an insulin contract and rising raw material costs hit second quarter results.
25-Jul-2011 - Sartorius Stedim Biotech (SSB) has revised its full year guidance after its range of single-use products drove revenue gains in the first half of 2011.
21-Jul-2011 - TAP Biosystems has inked deals with six distributors in South East Asia to extend sales support for its automated bioprocessing systems.