As pipelines shift toward complex, high-concentration, biological formulations, traditional manufacturing models are falling short, leading to a change in outsourcing strategies, notes Mark DaFonseca from Lifecore.

Ahead of BIO 2026, FUJIFILM Biotechnologies’ Toshi Iida outlines why the industry must pivot toward harmonized, modular facility networks to eliminate manufacturing bottlenecks and secure the global medicine supply.

As the drug development pipeline shifts toward complex biologics, traditional oral or frequent dosing regimens are being replaced by long-acting formulations, reveals David Westberg from Nanexa.

According to Sven Lee from Bionova, the era of predictable, plug-and-play bioprocessing platforms is coming to an end as novel advanced pipelines now require bespoke, early-stage intervention to ensure molecular quality.

Backed by USD 101 million in cumulative financing, Ethyreal Bio is targeting the shared pathogenic driver of Graves' disease and thyroid eye disease with a differentiated, long-acting subcutaneous antibody.

As the pharmaceutical supply chain digitizes, the unique human element of face-to-face networking remains fundamental, according to Sherma Ellis-Daal, Brand Director for CPHI Americas.

Ahead of CPHI Americas, Kent Payne from Wilmington PharmaTech reveals how shifting geopolitical regulations, private equity capital, and specialized technical expertise are driving domestic pharmaceutical manufacturing.

As the generic and biosimilar market enters a period of growth, developers are moving away from costly empirical testing and leveraging advanced technologies to overcome technical hurdles to formulation.

SPONSORED CONTENT: From AI-driven secondary packaging to enhanced business continuity, Timothy Compton outlines how Alcami is merging its legacy manufacturing excellence with new digital innovations to serve global markets.

Following the global launch of the Synchrony S1 PFS system, ten23 health has completed robustness testing to ensure the platform is ready for clients navigating the complexities of drug-device regulations.

With industry reaching the limits of traditional formulation techniques, to overcome solubility and bioavailability challenges, spray-drying is increasingly emerging as a primary development pillar.

As the industry pivots toward eco-design and green procurement, the whole value chain must align to bridge the gap between environmental targets and manufacturing reality.

As smaller batch products become more prominent within drug development, companies are being required to adopt more agile, modular approaches to ensure commercial viability is achievable.

Automation and living contamination control strategies are helping to answer some of industry’s most pressing sterile manufacturing challenges, explains Dr. Laura Moody from Syntegon.

Customized engineering and embedded sensors are helping to turn passive single-use assemblies into intelligent, data-rich assets, reveals Rich Jones from Phillips Medisize.

Automated and single-use technologies are offering companies the transparency and agility needed for the newer, more complex drugs in the pipeline, explains Mike D’Avanzo from Alcami.

While the benefits of continuous manufacturing have been well-documented, regulatory alignment and complex control systems remain barriers to universal adoption, notes Mike Fazio from L.B. Bohle.

The push for regionalized supply chains is having an impact on the CDMO landscape, with responsiveness and flexibility now considered equally important as efficiency and scale, notes Andrea Oro from ESTEVE CDMO.

As global volatility exposes the fragility of lean supply models, the industry is pivoting toward regionalized manufacturing and agile optionality to safeguard patient access.

In the current market, drug developers need to carefully balance sudden regulatory mandates with innovation while also managing costs and time efficiency, explains Meeta Kratz from Lonza Capsugel.