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  • The importance of formulation in the successful lyophilization of influenza reference materials.

The importance of formulation in the successful lyophilization of influenza reference materials.

Biologicals : journal of the International Association of Biological Standardization (2015-01-24)
Chinwe Duru, Carolyn Swann, Una Dunleavy, Barbara Mulloy, Paul Matejtschuk
ABSTRACT

Lyophilized Influenza antigen reference reagents are a critical resource in the quality control of influenza vaccines. A standard formulation has been used successfully at NIBSC for many years however, following the unexpected occurrence of a collapsed appearance in a particular batch a study was carried out to establish the impact of the sugar concentration in the formulation using modulated differential scanning calorimetry (mDSC) and nuclear magnetic resonance spectroscopy (NMR). There was a correlation between the presence and size of the mDSC eutectic temperature events and the freeze dried appearance of the cakes, which became progressively worse with increasing amounts of sugar. NMR spectroscopy could be used to positively identify and quantify the sugars in the formulations. MDSC can rapidly predict if the freeze dried appearance will be acceptable so as to assure the successful lyophilization of influenza reference preparations.

MATERIALS
Product Number
Brand
Product Description

Supelco
Mannitol, Pharmaceutical Secondary Standard; Certified Reference Material
Mannitol, European Pharmacopoeia (EP) Reference Standard
Supelco
Acetone, Pharmaceutical Secondary Standard; Certified Reference Material
Trehalose dihydrate, European Pharmacopoeia (EP) Reference Standard
USP
Mannitol, United States Pharmacopeia (USP) Reference Standard
Supelco
D-Mannitol, ≥99.9999% (metals basis), for boron determination
Sigma-Aldrich
D-(+)-Trehalose dihydrate, ≥99% (HPLC), from starch
Sigma-Aldrich
Acetone, suitable for HPLC, ≥99.9%
Sigma-Aldrich
Acetone, natural, ≥97%
Millipore
D-(+)-Trehalose dihydrate, ≥99.0%, suitable for microbiology, composed of two α-glucose units that is used as a protectant, stabilizer and to support proper folding
Supelco
Acetone, analytical standard
Sigma-Aldrich
D-Mannitol, tested according to Ph. Eur.
Sigma-Aldrich
D-Mannitol, BioUltra, ≥99.0% (sum of enantiomers, HPLC)
Sigma-Aldrich
Acetone, ≥99%, meets FCC analytical specifications
Millipore
D-Mannitol, ACS reagent, ≥99.0%, suitable for microbiology
Sigma-Aldrich
D-(+)-Trehalose dihydrate, from Saccharomyces cerevisiae, powder, BioReagent, suitable for cell culture, suitable for insect cell culture, ≥99%
Sigma-Aldrich
D-(+)-Trehalose dihydrate, ≥99% (HPLC), from Saccharomyces cerevisiae
Sigma-Aldrich
D-Mannitol, BioXtra, ≥98% (HPLC)
Sigma-Aldrich
D-Mannitol, ≥98% (GC), suitable for plant cell culture
Sigma-Aldrich
D-Mannitol, ≥98% (GC)
Sigma-Aldrich
D-Mannitol, meets EP, FCC, USP testing specifications
Sigma-Aldrich
D-Mannitol, ACS reagent
Sigma-Aldrich
D-(+)-Trehalose dihydrate, ≥98.5% (HPLC), from Saccharomyces cerevisiae
USP
Acetone, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Acetone, histological grade, ≥99.5%
Sigma-Aldrich
Acetone, puriss. p.a., ACS reagent, reag. ISO, reag. Ph. Eur., ≥99.5% (GC)
Sigma-Aldrich
Acetone, ACS reagent, ≥99.5%
Sigma-Aldrich
Acetone, suitable for HPLC, ≥99.8%
Sigma-Aldrich
Acetone, suitable for HPLC, ≥99.9%
Sigma-Aldrich
Acetone, HPLC Plus, for HPLC, GC, and residue analysis, ≥99.9%