09.13.24 -- BIOSECURE Act Passes House. How Will It Impact Your Outsourcing?

Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

No batch of medicinal product can be used for investigational purposes or sold commercially without certification from an EU Qualified Person. So who are these QPs? Who trains them? What exactly do they accomplish? Nollaig Buckley has the answers. She’s been an independent QP and consultant for 22 years.

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships?

When drug and API manufacturers decide to make the shift to bring production back to the U.S., they should be prepared with a well-designed quality system and a thorough tech transfer process.

An industry expert discusses pediatric patient compliance, regulations impacting pediatric trial access, excipients within pediatric formulations, and more.

Computer-aided synthesis planning (CASP) can mitigate the impact of rising complexity. We discuss the award-winning AI and vast data that propel a leading predictive retrosynthesis technology.

Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.

It is important to pursue a dualistic, longer term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.

With a network currently spanning 9 manufacturing sites in 5 countries, we can support discovery, preclinical, clinical and commercial programs for New Chemical Entities.

As a leader in small molecule manufacturing, we have over 40 years of experience providing high quality APIs and intermediates for companies throughout the world.