Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China.
Biologicals
; 52: 37-43, 2018 Mar.
Article
en En
| MEDLINE
| ID: mdl-29434001
ABSTRACT
There is a continuous need to improve the viral safety of plasma products, and we here report the development and optimization of a manufacturing-scale virus removal nanofiltration step for intravenous immunoglobulin (IVIG) using the recently introduced Planova™ BioEX filter. IVIG throughput was examined for various operating parameters transmembrane pressure, temperature, protein concentration, and prefiltration methods. The developed procedure was based on filtering undiluted process solution (50.0â¯g/l IVIG) under constant transmembrane pressure filtration at 294â¯kPa and 25⯰C following prefiltration with a 0.1⯵m MILLEX VV filter. The recovery of IgG was approximately 98%, and no substantial changes in biochemical characteristics were observed before and after nanofiltration in scaled-up production. A viral clearance validation study with parvovirus under worst-case conditions performed at the National Institutes for Food and Drug Control of China (NIFDC) showed PPV logarithmic reduction value (LRV)â¯>â¯4. Improved viral safety of IVIG can be assured by implementing a Planova BioEX nanofiltration step to ensure effective parvovirus clearance under conditions providing excellent protein recovery and no detectable impact on product biochemical properties. This plasma-derived IVIG product is the first to be certified for parvovirus safety by the NIFDC in China.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Inmunoglobulinas Intravenosas
/
Filtros Microporos
Tipo de estudio:
Sysrev_observational_studies
Límite:
Humans
Idioma:
En
Año:
2018
Tipo del documento:
Article