PRODUCT TYPES – Page 29

Biosimilar residual HCP / DNA OOS during BLA/MAA review: bridging study planning and regulatory communication strategy

Identifying symptoms signaling potential OOS results is crucial in promptly addressing issues related to biosimilar product quality. Symptoms may manifest in several forms:Click to read the full article.

Half-life deviation during radiopharma production: regulatory deviation handling

The first indicators of a half-life deviation often arise from unexpected test results or observations during production. Symptoms may include:Click to read the full article.

Biosimilar aggregate level increase after manufacturing site change: how to build a defensible similarity narrative with data integrity controls

When aggregate levels in biosimilars increase following a site change, several telltale signs may emerge on the production floor or within lab settings. Symptoms often include:Click to read the full…

Radiochemical purity OOS during dispensing: regulatory deviation handling

The first step in addressing any deviation is understanding the symptoms or signals that indicate an issue. In the case of radiochemical purity OOS during dispensing, these symptoms may manifest…

Biosimilar aggregate level increase after downstream resin change: CAPA strategy to restore similarity and prevent regulatory delays

During routine quality control (QC) assessments, several signals may indicate a problem with biosimilar aggregate levels. These include:Click to read the full article.

Transport time excursion during inspection readiness: regulatory deviation handling

The initial step in any investigation is to identify the symptoms or signals that indicate a potential transport time excursion. In the context of radiopharmaceutical manufacturing, these symptoms may include:Click…

Biosimilar reference standard qualification gap during stability pull comparisons: inspection-ready evidence pack for comparability and lifecycle management

The initial step in addressing a potential qualification gap in biosimilar reference standards is identifying the symptoms and signals that indicate a problem. Signs of issues may include:Click to read…

Sterility assurance gap during transport to clinic: patient safety assessment

Assessing Sterility Assurance Gaps in Transport to Clinics for Radiopharmaceuticals In the pharmaceutical manufacturing sector, particularly concerning radiopharmaceuticals, ensuring sterility during transport is critical to maintaining patient safety. A gap…

Biosimilar stability comparability failure after downstream resin change: bridging study planning and regulatory communication strategy

The first step in any investigation is identifying the signals indicating a potential stability comparability failure. This can manifest through:Click to read the full article.

Radiochemical purity OOS during radiopharma production: patient safety assessment

When radiochemical purity fails to meet specified standards, various signals may manifest on the production floor or in laboratory settings:Click to read the full article.

Biosimilar reference standard qualification gap during stability pull comparisons: bridging study planning and regulatory communication strategy

Symptoms indicative of a biosimilar reference standard qualification gap can manifest in various forms within both laboratory and production environments. These can include:Click to read the full article.

Radiochemical purity OOS during transport to clinic: regulatory deviation handling

Identifying symptoms or signals that indicate a potential OOS scenario is crucial for initiating an effective investigation. Symptoms related to radiochemical purity deviations may not always be immediately apparent; however,…