Speakers​​​​​​​​​​​​​​​​​​​​​​​​​​

Jeroen van de Laar

Ardent Biopharma

Sr. Process Development Engineer

Jeroen van de Laar has over 25 years of all-round experience and performance in biotech and pharma, including development, people management, upstream/downstream industrial processes, production organization, lean six sigma, quality and regulatory compliance and validation, audits, and connection with the markets. He can quickly oversee, optimize, organize and connect operations across manufacturing, quality, regulatory, process and product development, supply chain and customers, with a 360° overview and a strong focus on helping colleagues be productive in their role. Since 2018, he has worked as a freelancer, applying the know-how he gained to the organizations he serves.

Uniform information requirements for single use assemblies

Improving the selection process for both users and manufacturers

Ardent Biopharma

Advancing Affordable Biologics

Recent advancements in Continuous Manufacturing (CM), artificial intelligence and machine learning (AI/ML) and anticipated regulatory shifts—such as the potential waiver of Phase III clinical trials—have paved the way for a new biosimilar development and manufacturing company. Ardent Biopharma is seizing this opportunity to redefine cost efficiency in the production of monoclonal antibodies (mAbs) and other therapeutic proteins.

Leveraging these innovations, theyaim to deliver biosimilars below 20% of the originator price, significantly improving global affordability and accessibility to life-saving or life-enhancing biologic therapies. Ardent aspires to become a cost leader in the biosimilars industry. Both first and second wave biosimilars will be developed.

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Standardization effort aims to lower biologics manufacturing costs

Nowadays, the production of biological medicines mainly takes place using single-use components instead of stainless steel. According to Jeroen van de Laar of Ardent Biopharma, production could become cheaper if single-use parts were more comparable in quality. However, due to a lack of information, switching to equivalent alternatives is difficult because it is unclear whether the entire bioprocess would still meet the strict GMP requirements. Van de Laar is now contributing to the drafting of an international standard for SU components to address this information gap.

Partners of Single-Use Event Leiden 202​​​​6