Whitepaper: BPOG extractables data in single-use systems adoption
Posted: 12 November 2020 | Merck Emprove® | No comments yet
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
Single-use systems are increasingly popular in biomanufacturing. For patient safety, biomanufacturers must systematically assess and mitigate risks posed by extractables and leachables (E&L) in these systems. In the absence of official E&L guidance, manufacturers are fulfilling regulatory expectations by following the BPOG protocol. Readily available extractables data helps manufacturers using single-use technology to accelerate product qualifications, risk assessments and process optimisation.
Related content from this organisation
- Antibody-immunotherapy treatment shows benefit in serious endometrial cancer
- First-in-class biologic approved for rare lung disease
- Mycoplasma testing market expected to value nearly $2 million by 2031
- Pharmaceutical suspension market to witness accelerated growth
- Immunotherapy drug achieves trial-first in fifty years
Related topics
Biopharmaceuticals, Bioprocessing, Data integrity, Good Manufacturing Practice (GMP), Manufacturing, Medical Devices, QA/QC, Regulation & Legislation, Research & Development (R&D)
