INSIGHTS ON REGULATORY COMPLIANCE

• An Executive’s Checklist For CDMO Selection

  C-level executives must take an early and active role in vetting potential partners using a deeper understanding of the capabilities and characteristics a CDMO should have to successfully bring a product to market.

• Strategies For Startups — How To Structure Milestones For Successful Outcomes

  Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

• Process Characterization And Validation For Biologic Processes

  Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.

• Top 5 Risks That Can Compromise Your Life Sciences Data

  Keeping the clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, we’ve created a list of five common ways that trial data puts us in jeopardy, and approaches you can take to avoid these risks.

• Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions

  11/11/2020

  When it comes to APIs and advanced intermediates, there are few pharmaceutical companies that have successfully utilized continuous manufacturing for more than a single process step. In addition, very few have been able to scale-up beyond the kilogram range under cGMP conditions. In this interview with Dr. Andreas Meudt, Head of Exclusive Synthesis for Evonik, the challenges and opportunities for the use of continuous manufacturing for APIs and intermediates are reviewed.

• How To Ensure Chemical Inventory Safety And Compliance With Regulations

  4/21/2021

  When federal, state and local safety regulations regulations concern chemicals, it is vital that the organization deploy efficient processes and systems that enable laboratory and Environmental, Health and Safety (EHS) personnel to easily comply with the regulations, ensure safe chemical management and produce accurate chemical inventory reports. This white paper discusses the obstacles organizations face ensuring chemical compliance and how different organizations have solved the compliance challenge.

• Achieving Business Continuity In Pharma During COVID-19 Restrictions

  3/4/2021

  To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

• Automating Cell Therapy Manufacturing For GMP Compliance And Consistency

  11/1/2019

  Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.

• Upstream Considerations For Biosimilar Development

  1/11/2021

  Understanding upstream challenges during biosimilar development and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.