Newsletter | November 13, 2025

11.13.25 -- Navigating The Complexities Of Small Molecule Production With The Right CDMO Partner

Handling Protocols: Key Considerations In The Highly Potent API Market

As oncology therapies become increasingly targeted, the use of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) and Antibody-Drug Conjugates (ADCs) is accelerating. Explore their growing role to highlight manufacturing challenges, safety protocols, and opportunities.

 

Sustainability By Design In API Manufacturing

Sustainability has become a critical focus in pharmaceutical manufacturing, especially in the production of APIs, which contribute significantly to global emissions. As the industry faces increasing scrutiny and regulatory demands, the need for more sustainable practices in small molecule API manufacturing has never been more urgent.

 

Integrating Phase-Appropriate Quality Standards

Incorporating phase-specific quality standards ensures compliance with GMP at all stages. This risk-based approach addresses late-stage quality needs to support overall development objectives. Discover how collaborating with an experienced CDMO offers valuable expertise in setting expectations and efficiently managing development timelines.

 

Overcoming Obstacles On The Journey To Commercialization

Examine the importance of a client-focused approach in the journey to commercialization with case studies that showcase the value of partnering with a CDMO for API and HPAPI development to overcome challenges in delivering new medicines to patients efficiently.

 

OPCU VIDEO FEATURE

Capacity Update July 2025: Small Molecule Drug Substance/API

Ensure the success of your Small Molecule program with a reliable and committed CDMO that meets your needs and navigates complexity with you. With 35+ years of experience, expert capabilities, and capacity, MilliporeSigma is the partner to support you every step of the way.

 

SOLUTIONS

 

Small Molecule Contract Development & Manufacturing Services

Whether your target is difficult to handle, synthesize, or source, you can rely on a committed CDMO partner to navigate complexity with expertise and care. With 35+ years of proven small molecule production, MilliporeSigma delivers trusted experience when it matters most. Offering phase-appropriate support, we work with you from preclinical to commercial, at every stage and every scale. Our global network of technical and regulatory experts is committed to safety, sustainability, quality, and delivery for your success.