INSIGHTS ON REGULATORY COMPLIANCE

• Putting The “Process” Into Process Characterization

  Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.

• Collaboration In Biopharma: Harness Cloud-based Technologies

  Although biopharma has been slower than some other industries to adopt cloud-based technologies, the field is increasingly relying on the cloud to advance scientific knowledge.

• How To Avoid Last Minute CMC Roadblocks To Approval

  Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

• Using A CMO To Streamline Process Characterization

  While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

• Webinar: Navigating EU Product Launch Milestones

  Throughout this webinar we will share our knowledge and experience of various EU regulatory filing options focusing primarily on the centralized procedure. This webinar will help you navigate the various EU regulatory filing options to allow you to plan ahead and save time in what can be a lengthy and complicated process.

• Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

  Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.

• 6 Regulatory Changes Affecting Bioprocessing In China

  This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

• Critical Considerations About The Future Of Global Cell Culture Bioprocessing

  In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

• New Guidelines For Container Closure Integrity Testing

  Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.