There are a variety of challenges facing the small molecule drug sector, from U.S. tariff challenges and regulatory uncertainty to the demands of latest wave of complexity, meaning that CDMOs must act as proactive strategic partners.

The CDMO has completed the expansion of its Pessano facility in Milan, Italy, adding increased packaging and warehousing capacity that has already been authorized by the AIFA and is producing validation and commercial batches.

Primary packaging requirements are evolving in line with development trends; however, flexible and easily integrated ready-to-use solutions are beneficial options, highlight Dr. Robert Lindner and Christoph Zauner from SCHOTT Pharma.

For Jacob Werlinger from Bend Bioscience, turning innovative concepts into reality requires CDMOs to not just be service providers but more of a strategic scientific partner that can help advance the concept to commercialization using the right science tools.

Implementation of three-dimensional (3D) cell culture nanofiber systems in industrial vaccine production offers much higher viral vaccine titers, greater scalability and improved process economy, but it will require tight collaboration with the industry to help speed up their wide adoption, stresses Laura Chirica from Cellevate.  

As geopolitical factors are driving a greater focus on U.S. manufacturing, many companies are seeking ways to improve productivity while keeping their products affordable for patients, highlights Russel Miller from Enzene.

Innovation is driving OSD into new frontiers, from orally delivered biologics and enhanced solubility to sustainable manufacturing and AI-driven formulation development, asserts Shahrzad Missaghi from Colorcon.

For Timothy Compton from Alcami, there are numerous trends driving the surge in demand for U.S. based bio/pharma manufacturing, including the benefits of a greater quality culture and adaptability to batch size requirements.

CDMOs need to be more than just providers of capacity, they need to be integrated strategic solution partners, embedding flexibility, reliability, and sustainability into their business models, according to Dr. Max Lauwiner from Valsynthese.

Having a partner involved from the outset of a sterile fill/finish project to help plan and support at each stage, is a potentially beneficial approach for innovators, highlights Hanns-Christian Mahler from ten23 health.

Increasingly complex and moisture-sensitive ingredients require careful, considered, and connected approaches that ensure the integrity of the finished product is maintained, explains Christian Classen from Sanner Group.

This year’s show, taking place in Frankfurt, Germany, has grown further incorporating representation from the whole bio/pharma supply chain and providing networking opportunities for a global audience, reveals Tara Dougal, Event Director.

According to Kevin Li from BioDuro, bio/pharma partnerships are most successful when the parties involved are aligned, operating as one team with mutual trust and long-term vision.

It is possible to achieve longer-acting injectable drug products that also do not require aseptic fill/finish thanks to a new advanced drug delivery system, reveals Mårten Rooth from Nanexa.

While widespread adoption of 3D printing within the bio/pharma industry needs to overcome some key hurdles, its potential for the future is tremendous, emphasizes Tom Sellig from Adare Pharma Solutions.

Bio/pharma companies are turning their focus to Indian CDMOs to build resilience into their KSM and API supply chains and to help with complex payloads, according to Yann D’Hervé from Cohance.

In collaboration with A.forall and IMGA, Nanoform has formed a new subsidiary aimed at outlicensing Nanoencorafenib as an attractive patient-centric lifecycle management opportunity or value-added generic medicine opportunity.

Bio/pharma companies are adjusting their strategies to cope with a variety of industry trends and are seeking out partners that can not only provide them with capacity but also support them through their innovation journey.

The Big Pharma companies have voluntarily agreed to a range of measures to reduce the cost of medicines for American patients while also preserving the biopharmaceutical innovation ecosystem of the U.S.

Regeneron’s investigational gene therapy, DB-OTO, has been found to provide meaningful improvements in hearing for nearly all of the participants in the CHORD clinical trial.