01.31.25 -- Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data

Chief Editor Louis Garguilo doesn't recall a time of more collective concern over development and manufacturing outsourcing than exhibited during last year's news of Novo Holdings’ purchase of Catalent, and the sale of certain Catalent facilities to Novo Nordisk. That angst was aggravated by the simultaneous drama known as the BIOSECURE Act. Will we have a calmer 2025?

Explore examples of visible particle identification and the root cause investigation, along with a discussion of the performance of additional troubleshooting using advanced and innovative technologies.

Learn how spatial bioanalysis can provide answers regarding molecule function and form that can improve the quantity and quality of information obtainable in drug development studies.

Discover the importance of drug product formulation and manufacture for FIH trials, and how they can determine if the correct dosage is safely provided and, ultimately, gain regulatory approval.

Consider the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.

By partnering with a reputable CDMO, biotech and pharmaceutical companies can leverage their expertise and resources to expedite the development and manufacturing of life-saving medications.

How can pharma companies secure the supply of vital APIs and intermediates and maintain consistent manufacturing costs? These steps minimize supply chain insecurity in a rapidly changing market.

Partner with us to successfully tackle your solid dosage challenges globally with our holistic, science-driven solutions for common tableting issues like capping, lamination, picking, and sticking.

Watch for an overview of taste-masking solutions that can elevate your oral dosage forms, drive the success of your business, and address the needs of multiple, large patient populations.

The 132M HC sets the standard for performance, precision, and reliability. This wrap-around labeler applies labels to cylindrical products with the utmost accuracy at the highest performance.

Our injectables CDMO expertise can support your molecule, with a team skilled in complex formulations, over 20 commercial products, a 40+ year regulatory history, and a new isolator filler capacity.