Insights On Manufacturing Logistics
-
ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
3/11/2025
Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
-
FAQs On The Revised EU GMP Annex 1: Volume 2
3/5/2025
Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.
-
FAQs On The Revised EU GMP Annex 1: Volume 1
3/5/2025
The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.
-
Streamlining Compliance With Pre-Clinical Safety Tests
3/4/2025
As cell therapies advance, challenges in ensuring safe, scalable, and compliant production increase. Discover how to develop efficient strategies to maintain cell viability and functionality throughout the supply chain.
-
Meeting Annex 1: A Proactive Approach To Regulatory Compliance
3/4/2025
It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
-
Achieving EU GMP Annex 1 Compliance For Contamination Control
3/4/2025
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
-
Formulation Through Manufacturing Under One Roof
2/18/2025
Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.
-
Supply Chain Corrective Action Report Checklist
2/7/2025
Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.
-
The Leader In Pharmaceutical, Process, And Packaging Equipment
2/6/2025
Discover the leading source for used industrial equipment in pharma and processing. With a huge inventory and decades of expertise, find cost-effective machinery solutions that meet your needs.
-
Cell Culture Media Quality Control Strategies
2/5/2025
Cell culture media quality is key for lab success. Learn essential sourcing, storage, and handling strategies to prevent contamination and costly setbacks.