02.08.25 -- Outsourced Pharma Best Of January

In 2023, Chief Editor Louis Garguilo proclaimed it was "the year of oligonucleotides," and 2024 would be an incredible growth year for oligos. How are those proclamations panning out? He takes a detailed look, including the important role in the expected growth played by CDMOs.

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?

Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.

Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

Explore key considerations for ensuring accuracy and efficiency in your process, from robust control systems to diverse printing options and comprehensive qualifications.

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.