12.04.25 -- 2025 Tariffs Barely Impact Europe's API Supply Chains

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

In collaboration with the Faculty of Medicine at Palacky University and supported by the Technology Agency of the Czech Republic, this project translated research into a medicinal product.

Safeguard your cell banks with secure, compliant storage and streamlined delivery solutions that keep manufacturing on schedule and therapies moving forward.

The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

The potential advantages that stable bulk cultures can offer a drug development paradigm are poised to accelerate and bolster biopharmaceutical clinical manufacturing.

Adhering to the rigorous standards set by the EMA's Annex 1 requires strategic, risk-based compliance for facility design and processes, all of which is key to patient safety and future innovation.

Review multiple studies utilizing the BxPC-3 human pancreatic cancer model in subcutaneous (SC) NSG and NSG-dKO mouse models, evaluating a range of standard agents, vehicles, and delivery methods.

As demand for capabilities and resources grows throughout a project, both become strained in-house and the scale-up process becomes a steeper hill to climb.

Unlock smoother, faster microbial manufacturing by tackling strain optimization, scalable fermentation, and predictable midstream development with an integrated, end-to-end approach.

To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

Uncover how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

Here, we observe how an advanced cell line development technology overcame production challenges related to the expression and scalability of complex biologics.

Partner with us as we deliver integrated services and capabilities to meet the needs of patients worldwide, improve the communities we all serve, and open doors to new possibilities.

Secure your supply chain with a trusted partner in sterile manufacturing. Discover a dual-site strategy that offers crucial redundancy, regulatory confidence, and a proven approach to tech transfer.

Transforming the CDMO experience means treating your molecule's journey from development to commercial supply with unmatched expertise, world-class facilities, and a quality-driven partnership.

We offer biopharma companies expert injectable drug development, rapid fill/finish services, and agile support, combining technical excellence with fast, reliable, and compliant project execution.

Pionyr Immunotherapeutics, a biotech with a pipeline of first-in-class clinical-stage cancer immunotherapies, needed a CDMO to help rapidly develop a third lead candidate from the start.