05.07.26 -- FDA Letters Made Public Are Creating New Risks

Blending pharmaceuticals and medical devices into a single product offers immense potential for patient care, but manufacturing these combination products presents unique hurdles.

A critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered readiness in three months.

Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.

The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatments.

Discover how to transform logistical challenges into strategic advantages with flexible, forward-looking solutions designed for today’s dynamic clinical development landscape.

Bioprocess changes require robust comparability strategies that combine risk assessment, advanced analytics, and regulatory expectations to keep biologics safe, effective, and compliant.

Uncover a modern 293‑based expression system built for higher purity, controlled glycosylation, and improved activity, offering a new option for teams developing complex or next‑generation biologics.

Inhaled biologics are advancing as better formulations, particle design, and devices enable targeted delivery. Tracking key trends helps teams manage complexity and advance future therapies.

Leveraging cross-functional coordination between sites, harmonized tech transfers, one quality system, and synchronized team activities can streamline submissions and deliver commercial outcomes.

Find flexible scale-up from lab through commercial manufacturing, leveraging expertise. Gain technical insights for scalable, efficient development for advancing mRNA, saRNA, or circular RNA programs.

Explore how Annex 1 applies to low bioburden DS manufacturing and promotes a risk-based approach to contamination control that balances regulatory compliance with operational efficiency.

A thorough and adaptable analytical strategy is essential for navigating the complex mAb market. This approach boosts the likelihood of market approval and unlocks the full potential of these therapies.

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

Outlined are the benefits of prefilled syringes, their role in biologic and vaccine delivery, the surge in demand driven by SARS‑CoV‑2, and why partnering with a flexible CDMO is critical for success.

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.