whitepaper
Application Note: The sterility of the ControLyo™ process: reducing freeze dried product batch time without compromise to system integrity
Controlled nucleation is the most significant new development in freeze drying in quite some time.
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Formulation
webinar
The Comet Assay – A valuable tool for Cancer Research
6 January 2016 | By Andor
This webinar presents real-world methods and examples of how to monitor and assess DNA damage in these cells using the Comet Assay and an insight into the software used to carry out this analysis...
article
Issue #6 2015 – Digital edition
In digital version of Issue #6 2015: Microbiology, Screening, PCR, Continuous Manufacturing, PAT, Regulation, and much more...
news
Real world study demonstrates effectiveness of biosimilar infliximab
6 January 2016 | By Victoria White
Newly presented data from the largest real world study to date demonstrate effectiveness of biosimilar infliximab in patients with inflammatory bowel diseases who have been switched from reference infliximab...
news
Quotient Clinical expands its formulation development services with the acquisition of Co-Formulate
16 December 2015 | By Quotient Clinical
Quotient Clinical, the Translational Pharmaceutics® company, has announced that it has acquired formulation development specialist Co-Formulate Limited...
news
EMA accepts MAA for Sandoz’s biosimilar etanercept
8 December 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
news
Amgen submits MAA for biosimilar ABP 501 to the EMA
4 December 2015 | By Victoria White
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...
news
Amgen submits Biologices License Application for biosimilar ABP 501 to the FDA
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
news
Personalised peptide vaccine increased bladder cancer survival in study
18 November 2015 | By Victoria White
The median overall survival for patients assigned personalised peptide vaccine and best-supportive care was almost twice as long as that for patients assigned best-supportive care...
news
BioOutsource Bioanalysis experts attending major Biosimilar Conferences November 16-19
Sartorius Stedim Biotech (SSB) BioOutsource today announced its expert technical staff will be speaking at and/or attending BIOLATAM, Biosimilars LATAM and Biosimilars and Biobetters conferences from November 16-19. This will provide developers of biosimilars with an excellent opportunity to discuss the optimum assay design for rapid and accurate biosimilar characterisation…
news
Investigational Enbrel biosimilar CHS-0214 meets primary endpoints
10 November 2015 | By Victoria White
CHS-0214 met its primary endpoints in a Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis...
news
Study demonstrates clinical equivalence of ABP 501 with adalimumab
10 November 2015 | By Victoria White
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases...
article
Issue #5 2015 – Digital edition
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
news
New UV-Vis Spectrophotometer simplifies sample quality decisions
Life scientists who work with DNA, RNA and proteins can make educated decisions about sample suitability in experiments using a standalone, microvolume spectrophotometer for accurate quantitation and purity measurements to ensure downstream application success.
article
Cyber security in pharmaceuticals
22 October 2015 | By Caroline Rivett and Dr Cornelius Namiluko at KPMG
Dr Cornelius Namiluko and Caroline Rivett discuss cyber security in the pharmaceutical industry and the approaches companies can take to address the risk of a cyber attack...
