List view / Grid view
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
22 October 2015 | By John Carpenter, University of Colorado / Amber Haynes, Fradkin KBI Biopharma / Christina Vessely, Biologics Consulting Group Inc.
Quantifying and sizing subvisible particles in biopharmaceutical products are crucial aspects of formulation development, stability studies, process development, product release and extended characterisation of the final drug product.
22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen
Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…
16 October 2015 | By CHI
Largest European Event for Biologics Returns to Lisbon from 2-6 November...
During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug discovery.
CAMO Software, leaders in multivariate data analysis software, and Stat-Ease, Inc., a leading supplier of design of experiments (DOE) software and services, have released a software bundle for multivariate data analysis and design of experiments; The Unscrambler® X Design-Expert® Upgrade...
25 September 2015 | By Victoria White
The British Generic Manufacturers Association, the Association of the British Pharmaceutical Industry (ABPI), and the UK BioIndustry Association (BIA) have joined forces to welcome NHS England’s new publication “What is a biosimilar medicine?”.
24 September 2015 | By Victoria White
ABP 215 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb)...
17 September 2015 | By Victoria White
BioInject will be used to manufacture pre-filled syringes and devices for both Sandoz’s biosimilars and Novartis Pharma’s novel biologics...
15 September 2015 | By Victoria White
Data from secondary analyses of Phase III trials show Abasaglar (insulin glargine) demonstrated safety and efficacy outcomes similar to Lantus in diabetes...
In Issue #4 2015: NGS, Informatics, Spray Drying, Excipients, Rapid Methods, NIR, PAT, Regulatory Insight and much more...
3 September 2015 | By Benjamin K. Hodnett, Anita R. Maguire, Pat J. Guiry, Ake C. Rasmuson, Brian Glennon and Abina M. Crean - SSPC
The Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing, is funded by Science Foundation Ireland (SFI) and Industry, and represents a unique collaboration between 22 industry partners, nine research performing organisations and 12 international academic collaborators. It is a €42 million…
12 August 2015 | By Sartorius
Redesigned Sartobind® membrane adsorber capsules offer higher binding capacities, reduced void volumes, less buffer consumption and lower operational costs...
12 August 2015 | By Quotient Clinical
Quotient Clinical, the Translational Pharmaceutics® Company, has announced that Dr Peter Scholes, its Chief Scientific Officer, has been awarded an honorary professorship in the School of Pharmacy at the University of Nottingham...
27 July 2015 | By Victoria White
CPhI Korea, organised by UBM EMEA, will return to the COEX in Seoul, South Korea – 7 to 9 September 2015 – following a successful inaugural event last year...
