Andrea Rabellino

Jan 16, 2025 | outsourcedpharma.com | Louis Garguilo |Andrea Rabellino |Pedro Morales

We’re ready to help usher your next drug into market! 2025’s first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry’s best and give you complimentary VIP access to the resources available to support your success.

Nov 26, 2024 | bioprocessonline.com | Steve Erb |Andrea Rabellino |Junwei Sun |Lucia Fernandez |Lucia Fernández

Webinar: Early Preclinical Development of mRNA/LNP projects - Setting Up Your Project for a Successful Transition to cGMP ManufacturingJoin us on December 2nd to explore mRNA construct development at Lonza, focusing on cGMP manufacturing, analytical advancements, and testing methods. Gain insights into the transition from research to manufacturing and the technologies shaping mRNA development for future projects. Click here to learn more.

Aug 23, 2024 | bioprocessonline.com | Tyler Menichiello |Andrea Rabellino |Jake Spies

AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.

Apr 15, 2024 | outsourcedpharma.com | Diane McCarthy |Li Jing |Andrea Rabellino |Apurv Puri |Louis Garguilo

Four Steps To Identifying The CDMO Proposal Worth SigningTransparency and communication are essential to the success of a manufacturing partnership. If a CDMO is unwilling to have frank conversations during the proposal phase, that’s likely a red flag. The right partner’s team will help you make educated choices while ensuring quality, reasonable costs, and timeline efficiency. When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis.

Mar 28, 2024 | outsourcedpharma.com | Louis Garguilo |Geoff Weiss |Andrea Rabellino

In biologic-based analytical CMC drug development, one of the most challenging obstacles in entering Phase II clinical trials is the cell-based potency assay. Common problems with CMC regulatory submissions include inadequate methods, lack of appropriate potency assays, or method description issues. The complexity of developing and validating a relative potency assay is often underestimated, given the need to balance MOA demonstration with minimizing variability.