Outsourced Pharma

By 2034, only 10% of 2024 biopharma revenues will come from drugs still under patent, down from a historical average of 23%. That compression is arriving alongside pricing reform, tightening regulatory requirements, and geopolitical pressure on supply chains, leaving little room for ad hoc portfolio decisions. For executives managing mature product portfolios, the core question is no longer whether to outsource but how to do it in a way that fits your organization's actual operating model.

By Lynette Nazabal and Riley Welch, Clarkston Consulting As the life sciences industry moves beyond the disruption caused by the COVID-19 pandemic, manufacturers are facing a different set of pressures. Geopolitical uncertainty, tighter investment funding, and growing demand for flexible U.S.-based capacity are reshaping how companies plan for clinical development and build more resilient supply networks. Cell and gene therapy (CGT) companies are feeling this pressure acutely.

By Louis Garguilo, Chief Editor, Outsourced Pharma Much has been written about China’s biotech-innovation growth. My explanation among others: Where CDMOs flourish, biotech innovation follows. Another example is South Korea, where the latest indications of which arrived in March: Lilly signed a memorandum of understanding (MOU) with the South Korean government indicating the U.S. pharma giant will invest $500 million in the clinical trial ecosystem and biopharma industry in that country.

Webinar: When High-Stakes ADC Decisions Can't Wait for More Material or Better Data Learn how a streamlined analytical workflow can simplify early ADC development by enabling accurate concentration and drug-to-antibody ratio (DAR) measurements with minimal material.

Video | Adare Pharma Solutions Tailored drug release is rapidly evolving from a standard formulation tactic into a precision therapy strategy, optimizing timing, site, and rate of delivery to significantly improve patient outcomes. Video | AGC Biologics What does it take to ensure performance and compliance in GMP manufacturing? We optimize single-use systems across upstream and downstream processes, ensuring they perform under GMP conditions.

JUNE'S FEATURED EDITORIAL BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore For sponsors rethinking China-exposed supply chains, BIOSECURE is less a warning label than a stress test for redundancy, oversight, data control, and operational resilience. A CMC Playbook For Leadership And Hiring Would you like a shortcut to failure in regulatory CMC? Hire extensively based on what candidates already know.

Balancing in vivo potency and safety Achieve targeted, durable CAR expression while limiting off-target toxicity and immune reactions Complex formulation and conjugation Combine genetic payloads with delivery systems deliver precise control Expanded analytical requirements Advanced bioanalytical methods are used to characterize both vector and formulation attributes Cross-modality GMP scale-up End-to-end solutions manage viral vector or RNA-LNP production, formulation, and fill/finish New...

If you're developing an antibody-drug conjugate (ADC) or antibody-oligonucleotide conjugate (AOC), the science may be the easiest part. The harder work is building a development program that actually holds up under clinical and regulatory scrutiny. Regulatory and bioconjugation specialists Jeffrey Mocny and Nicolas Camper lay out where programs most often run into trouble, and it's almost always earlier than developers expect.

As sterile manufacturing demands evolve, facility design is under increasing pressure to deliver speed, flexibility, and consistent quality. Rising complexity — from biologics and GLP-1 therapies to varied batch sizes and accelerated tech transfers — has exposed the limitations of legacy fill-finish operations. Modern approaches emphasize purpose-built environments that integrate contamination control, independent manufacturing suites, and optimized material and personnel flows from the outset.

Guest Column | July 10, 2026 By Ian Glassford, VP of Bioconjugation Development & Technical Excellence Antibody-oligonucleotide conjugates (AOCs) combine the targeting precision of antibodies with the gene-modulating power of oligonucleotides, short nucleic acids that can silence, splice, or redirect gene expression.