In the dynamic landscape of pharmaceuticals, the surge in demand for drug substance development and cGMP manufacturing services has become more palpable than ever. Over the past few years, a remarkable interest increase from Biotech companies seeking reliable partners for drug substance supply, preferably located in Europe, has reshaped the industry narrative.

Fueling the Momentum: Polpharma’s Strategic Approach
At the forefront of this transformative wave is Polpharma, dynamically responding to the evolving needs of the industry. Recognizing the pivotal role of drug substance development, we’ve orchestrated a strategic expansion in our Contract Development and Manufacturing Organization (CDMO) segment. This undertaking involves not just the recruitment of top-tier talent in R&D but also significant investments in state-of-the-art production equipment. Our commitment extends to a comprehensive overhaul of ways of working and processes, ensuring we are primed to meet the demands of high-impact CDMO collaborations.

What Sets Polpharma Apart? A Glimpse into Our Distinctive Edge
In a market teeming with seasoned CDMOs, Polpharma, with its over 70 years of experience stands out as an exceptional partner. We attribute this distinction to a multifaceted approach that sets us apart:

Regulatory Prowess: Polpharma boasts a sterling track record of regulatory approvals, particularly with a focus on experience in navigating the intricate processes of filing with the FDA. Our commitment to transparency is evident through our Quality Management System, which offers clients a crystal-clear view of meticulously defined procedures.

Project Management Excellence: While many companies claim to offer project management, Polpharma elevates this standard by ensuring that every Project Manager possesses substantial technical expertise in API development and manufacturing. This expertise allows us to be agile and responsive, promptly addressing customer needs right first time. Our Project Management Office ensures standards and tools for frequent, transparent reporting, providing clients full control over project progress and timely, within-budget delivery.

Navigating the Potency Challenge: Polpharma’s Investment in Cutting-Edge Facilities
As the industry witnesses a surge in projects involving high potency levels, such as OEB 5 or even 6, Polpharma has risen to the challenge. We’ve invested significantly in a state-of-the-art facility that handles Highly Potent Active Pharmaceutical Ingredients (HPAPIs). This facility encompasses process and analytical R&D, small-scale cGMP manufacturing suites, and QC labs, enabling us to handle compounds with OEL values as low as 10 ng/m³ (OEB6).

Versatility redefined: Polpharma’s CDMO Project Spectrum
Drawing from decades of experience in drug substance development, regulatory filing, and commercial cGMP manufacturing, Polpharma offers comprehensive support across various phases of NCE development. From initial clinical supplies to validation, launch, and routine commercial supplies, we stand ready to meet diverse project needs.

Connect with Polpharma: Your Partner in Pharma Advancement
For more information and to explore how Polpharma can be your strategic ally in drug substance development and manufacturing, contact us at cdmo@polpharma.com. Let’s embark on a journey of innovation and excellence together.

Author:
Dawid Ignatowicz
Head of Key Account Management, CDMO
Polpharma API