- Blood plasma fractionation
- Antibody and protein harvesting and clarification
- Process development (lab scale to commercialization)
- High purity pharmaceutical grade diatomite
- USP-NF compliance
- Produced in accordance with cGMP manufacturing practices
Specially treated diatomite, high-purity filter aids (HPFA) are used for solid/liquid separation in biotechnology and pharmaceutical applications. Imerys Celpure® diatomite is an HPFA specifically designed for blood plasma fractionation and for harvesting and clarifying antibodies and proteins.
Celpure® is produced at Imerys’ stand-alone, state-of-the-art Lompoc plant in California, US according to a patented manufacturing process. The process generates a media that surpasses conventional diatomite filter aids in terms of purity, performance and finished product consistency.
Harnessing the properties of diatomite
Diatomite is powdery, porous and non-metallic making it ideal for the high-specification needs of the pharmaceutical and biotech sector. It offers enhanced purity and filtration speed over conventional filter aids and enables the removal of microscopically small solids.
Celpure® diatomite is now the HPFA of choice in biotechnology and bio-pharmaceutical applications, including blood plasma fractionation and as a filtration-boosting process aid for harvesting and clarifying antibodies and proteins.
Celpure® provides superior and consistent quality and is available in USP-NF grade for use in cGMP processes.
Only Celpure® and USP-NF grade filter aids meet EMEA Guideline 410/01 Rev 2 and come with BSE / TSE free certification.
Celpure® USP-NF grade filter media is used to reduce endotoxin content in a microbial lysate in a lentiviral plasmid recovery process
Imerys high purity pharmaceutical filter aids are produced with the most extensive quality system in the filter aid industry.
Production is structured to meet the requirements of ISO 9001 as well as the appropriate cGMPs and guidance documents.
These quality programs have been audited and accepted by both traditional pharmaceutical and biotechnology-based pharmaceutical producers.
This program enables the support of customer requirements for:
- Process control
- Change control
- Certificate of analysis
When appropriate, compendial testing is documented on the certificate of analysis.
Our Regulatory Support Packages are updated to align with cGMP requirements, guidance recommendations, and customer requirements.
The documents include information on:
- Quality policies
- Identity testing
- Specifications and test methods
Imerys High Purity filter aids come in a variety of packaging configurations, including non-bulk and semi-bulk.
We offer a full range of custom formulation and technical and process support services to help you match the right mineral grade to your application requirement.