Innovations in biotechnology and recombinant techniques have led to a large increase in
the number of macromolecule drugs developed over the last several years. These …

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there
were only 19 biotechology medicines on the market. Currently there are more than 100, with …

Abstract Formulation often has a dramatic effect on degradation of proteins during the freeze-
drying process as well as impacting on the “shelf-life” stability of the freeze-dried product …

The unique nature of recombinant technology and the biotherapeutic production process
means that regulatory agencies around the world not only require extensive characterization …

Due to the advances in genetic engineering and biotechnology, peptides/proteins have
become very important therapeutic agents. The clinical applications extend to the …

A discussion of the factors influencing peptide stability illustrates the challenges of
formulation and shelf‐life prediction which face biotechnologists. The activation energies of …

The chemical stability of an Asp-hexapeptide (Val-Tyr-Pro-Asp-Gly-Ala) in lyophilized
formulations was evaluated as a function of multiple formulation variables–specifically pH of …

The physical and chemical integrity of a biopharmaceutical must be maintained not only
during long-term storage but also during administration. Specifically for the intravenous (iv) …

The kinetics of enzyme inactivation in aqueous solution of neutral pH were studied for α-
chymotrypsin, bromelain, and kallikrein. Inactivation of α-chymotrypsin and bromelain …

The effects of amphiphilic additives on inactivation of β-galactosidase during freeze-drying
were studied in comparison with those of sugars and amino acids. The activity loss was …