Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigation.
This meeting was successful in achieving its main goals: (1) summarize currently available information on the origin, detection, quantification and characterization of sub-visible particulates in protein products, available information on their clinical importance, and potential strategies for evaluating and mitigating risk to product quality, and (2) foster communication among academic, industry, and regulatory scientists to define the capabilities of current analytical methods, to promote the development of improved methods, and to stimulate investigations into the impact of large protein aggregates on immunogenicity. There was a general consensus that a considerable amount of interesting scientific information was presented and many stimulating conversations were begun. It is clear that this aspect of protein characterization is in its initial stages. As the development of these new methods progress, it is hoped that they will shed light on the role of protein particulates on product quality, safety, and efficacy. A topic which seemed appropriate for short term follow up was to hold further discussions concerning the development and preparation of one or more standard preparations of protein particulates. This would be generally useful to facilitate comparison of results among different studies, methods, and laboratories, and to foster further development of a common understanding among laboratories and health authorities which is essential to making further progress in this emerging field.
Carpenter
John
J
University of Colorado, Boulder, CO, USA.
Cherney
Barry
B
Lubinecki
Anthony
A
Ma
Stacey
S
Marszal
Ewa
E
Mire-Sluis
Anthony
A
Nikolai
Thomas
T
Novak
Jeanne
J
Ragheb
Jack
J
Simak
Jan
J
D056704:Adaptive Immunity / Q000187:drug effects / Q000502:physiology; D000818:Animals; D001688:Biological Products / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology / Q000627:therapeutic use; D011232:Chemical Precipitation; D002626:Chemistry, Pharmaceutical / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D010316:Particle Size; D052638:Particulate Matter / Q000009:adverse effects* / Q000276:immunology*; D011506:Proteins / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology* / Q000627:therapeutic use*; D011786:Quality Control; D018570:Risk Assessment; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use
D001688:Biological Products; D052638:Particulate Matter; D011506:Proteins; D014614:Vaccines, Synthetic