10.13.25 -- The FDA 483 Heard Round The World

The updated E2500-25 standard transforms pharmaceutical manufacturing with a proactive, risk-based approach, enhancing compliance and accelerating the delivery of therapies to patients.

BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

Collaborating with an experienced CMO that combines transparency, expertise, and a shared commitment can help advance complex biologics from preclinical research to clinical success.

Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

Examine a high-throughput approach that streamlines LogD measurements, offering faster and more accurate insight into compound lipophilicity to support better decision-making in early drug discovery.

Lyophilization is a common method for stabilizing parenteral drugs with poor solution stability. Ensure the success and stability of your lyophilized products by choosing the right container-closure system.

A robust contamination control strategy using a plan-do-study-act framework promotes compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

Review the challenges and consider solutions in high-concentration monoclonal antibody manufacturing, including practical strategies for maximizing product recovery and optimizing processes.

Learn about an integrated drug substance/drug product offering for your IND program and beyond, with a holistic approach to ensure process robustness at every stage.

Improve your cell line development and achieve high productivity, rapid timelines, low risk development, and robust genetic stability with an innovative platform.

Uncover how comprehensive drug product fill and finish services streamline the journey from formulation development to commercialization, ensuring quality, efficiency, and compliance at every stage.

Access a comprehensive suite of biologics testing services meeting cGMP standards, covering characterization, biosafety, and quality control release testing.

As your product transitions from clinical phases to commercial launch, flexible, globally compliant facilities stand ready to adapt to your evolving needs.