Get $mart: 1 Year Out From Phase 1 Injectable Trials, Avoid 3 Expensive Mistakes

Transitioning from early-stage drug development to Phase 1 injectable trials requires careful planning, particularly when scaling up from small bench batches to clinical-scale production. This webinar, hosted by Singota Solutions, highlights three costly mistakes to avoid during this critical phase. Experts Ryan Memmer and Dr. Robert Sleiman provide insights into overcoming key challenges such as cold chain management, analytical method development, and maintaining strategic alignment with a CDMO.

One major challenge is ensuring that assumptions made in early-scale production hold true at clinical scale. The webinar covers best practices for scaling up while maintaining product integrity and regulatory compliance. Another crucial aspect is developing a robust analytical method to demonstrate critical quality attributes. Singota’s team applies investigative approaches honed through years of experience with emerging biopharma products to streamline this process.

Selecting the right CDMO partner is also vital. Offshore and large-scale CDMOs may not align with smaller companies' strategic timelines or IP protection concerns. Singota emphasizes the importance of choosing a partner that respects a company's development goals while delivering quality and value on time.

Through a case study, the webinar illustrates how Singota helps clients anticipate and navigate common pitfalls in the scale-up process. Whether addressing long-term stability requirements or overcoming technical hurdles, Singota’s expertise ensures a smooth transition to clinical trials. Join this on-demand session to learn from industry veterans and make informed decisions for your drug development journey.