Ensuring Security of Supply for Biopharmaceutical Manufacturing

Today's complex and global supply chains require an end-to-end focus on risk management and planning to ensure agile business continuity.

Our multi-faceted and global approach includes:

• Business Continuity Planning and Disaster Recovery Planning
• Supplier Risk Management
• Supply Chain Mapping

Learn More:

• Article: Celebrate the Best and Fix the Rest

To ensure continuity of supply and to mitigate risk against disruptions, we continuously invest in improving the agility of supply network.

In-region for-region manufacturing backed by a global network of redundant manufacturing centers improves network agility and ensures business continuity. Globally harmonized manufacturing and quality governance standards ensures consistent performance.

Learn More:

• White Paper: Strengthening The Drug Manufacturing Supply Chain During Extraordinary Times
• White Paper: Global Expansion to meet the Growing Demands of Biopharma

Our quality and regulatory programs are grounded in our extensive industry experience and aligned with industry best practices. Our over 1700 global quality and regulatory professionals ensure compliance and quality for all our live science products.

Simplify regulatory approvals and de-risk process development with informed decisions on key components and raw materials that are fit for purpose and compliant with quality and regulatory standards.

Emprove^® Program provides Dossiers covering Material Qualification, quality management, and operational excellence to support regulatory submissions and compliance.

M-Clarity™ Program defines product quality levels and transparency to quality documentation and change notification supported for the majority of our life science products.

Change Notification Program based on validated change control processes and our M-Clarity program.

Dedicated global quality and regulatory teams provide regional market surveillance and support for regulatory changes and challenges.

Regulatory Expertise and support for Pharmaceutical and Biopharmaceutical manufacturers.

Learn More:

• Webinar: Regulatory Talks: USP <88>, Class VI Animal Bioreactivity Testing
• White Paper: Moving Forward Together: Industry Alignment to Eliminate USP <88> In Vivo Animal Bioreactivity Testing for Polymer Characterization in Pharma Manufacturing
• Webinar: How Updates to EU GMP Annex 1 Impact Sterilizing Filtration in Single Use Systems

Our commitment to sustainability is embedded in our values and our corporate strategy. We take a holistic life-cycle approach to sustainability that is closely tied to our ethical standards. Our global regulatory team, in close collaboration with our Supply Chain organization, is developing greener products for the biopharmaceutical industry and collaborating with our customers to ensure they navigate the changing regulations and the transition to a sustainable supply chain.

Our programs include:

• Sustainable Operations
• Greener Products and Solutions
• Biopharma Recycling

Learn more:

• The State of Plastics Recycling in BioPharma
• DCAT Sustainability Leaders