Quality/GMPs

The authors describe considerations and best practices for meeting drug substance uniformity.

A series of advancements has changed the way bioprocesses are developed and optimized.

The authors developed a test for defects in filter membranes.

Courts and Congress seek to reshape policies and programs affecting drug costs and access.

Supply-chain analytics can lead to increased profitability.

New supply-chain challenges are forcing companies to act in different ways to secure product safety.

Executive management leadership is essential in the effective implementation of QbD.

US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals.

The authors present an approach for testing statistical equivalence of two stability profiles.

The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.

As drug shortages make headlines, FDA tests the Sentinel safety system and its effect on healthcare.

The authors review risk-assessment tools to evaluate product quality.

A successful QPS acts as a single point of contact for consistent product quality oversight.

FDA prepares for top-level changes while promoting transparency and product safety

An approach to reduce batch time, increase productivity, and decrease costs.

An approach to biopharmaceutical development that combines Quality by Design with a suite of visual informatics tools to reduce scale-up risks.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

To achieve manufacturing excellence, biopharma companies must adopt four key operating principles.

Apply a DoE strategy to test several formulations in parallel.

Changes on Capital Hill create uncertainty for healthcare reform, drug regulation, and biomedical research.

Evaluate and communicate risk to stakeholders.

Best practices to strengthen supplier quality management.

The pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?

Adequate characterization of materials protects product quality.

Comparative effectiveness poses challenges for drug manufacturers.