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“But the GMP manufacturing standards criteria are very strict.” Moving from a non-GMP process to a GMP process late in development can be a challenge, he adds, especially for companies with ...

STOCKHOLM, Feb. 7, 2024 /PRNewswire/ -- SmartCella, through its business unit ProCella, has been approved by the Swedish Medicinal Product Agency for manufacturing and quality control testing of ...

Stay updated on the latest Good Manufacturing Practices (GMP) and quality compliance standards in the digital era with our comprehensive guide. ... (PQC) combines advanced process control ...

By compressing the chemistry, manufacturing, and control (CMC) steps into 11 months, ... That includes conducting a small pilot process alongside its GMP operations.

Clarity and conciseness: Alert messages should identify the precise problem, where it stands in the manufacturing process and the suggested next step. Communications should be easy to read, succinct ...

- Enables streamlined stability testing and release of higher quality AAV-based gene therapy products. - Provides much needed European capacity for AAV characterization and release. ROCKVILLE, Md ...

Pharma makers get a year for GMP implementation, Mandaviya warns action on defaults The Union Health Minister said the observations from the ongoing Risk-Based Inspections by regulators ...

Niklas Prager, CEO of SmartCella, continues: “The approval of our GMP facility is a key milestone for SmartCella. We now have capabilities across the entire life cycle of product development, from ...