Workshop B (5th June 13.30 - 17.00) is titled "Critical Assessment of Lyophilised
Products Using Analytical, Visual and Mechanistic Approaches" led by Andrew Bright, Senior Scientist, Biopharma Process Systems.
Minimum numbers of ECAA lyophilised
plasmas for ISI calibration of CoaguChek and TAS point-of-care whole blood prothrombin time monitors.
The deoxyribose method for determining the scavenging effect of the lyophilised
infusion against hydroxyl radicals was performed according to a described procedure (Paya et al.
The British global leader in rare diseases said lyophilised
ONCASPAR had been approved as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and in adult patients.
Biopharmaceutical firm Shire plc (LON: SHP) has been given a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for lyophilised
ONCASPAR (pegaspargase), the company confirmed on Friday.
The company enrolled a total of 24 healthy male subjects in the single-centre, open-label, randomised, single dose cross-over Phase I trial that assessed the bioequivalence and tolerability of liquid and reconstituted lyophilised
formulations of caplacizumab administered subcutaneously.
Custom FusionPlex panels couple user-chosen primer design with a simple lyophilised
workflow, Anchored Multiplex PCR (AMP) technology and a sequence analysis platform to accurately detect and identify gene fusion events.
The sample prep kits contain lyophilised
reagent mixes and utilise Enzymatics' room temperature stable library technique.
In addition, APP currently markets the lyophilised
product, Oxaliplatin for Injection, 50 mg and 100 mg.