SAN DIEGO, CA August 12, 2013 –The article titled “Biosimilars, Oxidative Damage, and Unwanted Immunogenicity” published in Bioprocess International is now available online and as a downloadable PDF.
The article highlights the fact that unwanted immunogenicity is an underlying cause of multiple deleterious effects for many protein-based therapeutics — including loss of efficacy, altered pharmacokinetics, and reduced stability — and it poses a major risk for product failures and recalls.
Failure to demonstrate equivalent or (ideally) lower immunogenicity for a biosimilar is both costly and risky. Development of an unsatisfactory or inconsistent immunogenicity profile during development — or much worse, during postmarket surveillance — may be economically disastrous, potentially leading to costly reformulation work and additional clinical studies.
The full article PDF may be accessed or downloaded from BioProcess International. View PDF
About Aegis Therapeutics
Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Our Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Our ProTek® excipients stabilize, prevent aggregation, and reduce unwanted immunogenicity of protein and peptide therapeutics while avoiding the oxidative damage caused by polysorbate surfactants currently found in most protein injectable drugs.
For more information about Aegis, please visit: http://www.aegisthera.com.