Merck Plug & Play Upstream Development Service

Merck has launched its Plug & Play Upstream Development Service to help emerging biotech and start-up companies advance their molecules to the clinical stage.

Eliminating the need to work with multiple vendors for upstream development, the service is designed to reduce bottlenecks, lowering time to clinic by two months. It includes cell line development, utilising CHO cell lines or Merck’s CHOZN licence; standard analytics and early material from stable pools; and stability study and clone selection.

In the early stages of upstream development, cell line development and analytical development occur in parallel, allowing molecules to progress quickly. For users looking to progress at an even faster speed, Merck offers its fast-track process by running process development and clone development steps in parallel, balancing speed and risk without sacrificing quality. The company’s robust and automated mini-pool approach allows it to more efficiently generate early material for process development, reducing the timeline by 10 weeks for the first pharmacodynamic experiment at the preclinical stage.

Customers are supported by a dedicated project manager and Merck expertise including risk assessment and regulatory expertise. Monoclonality and stability validation is fully documented based on regulatory expectations and a statistical approach. There are no royalty fees and users have the freedom to technology transfer at any stage.

Optional, add-on plug and play services are available, including off-the-shelf media and feed screening; analytical method development; complete analytics; GMP master cell bank (MCB) and cell bank characterisation; and MCB storage. Users also have the option for Merck’s BioReliance Product Characterization team to synthesise data from multiple analytical and bioanalytical methods to help reveal the true identity of the product, ensuring the biotherapy’s safety, purity and potency with off-the-shelf mAb-based assay packages or a custom assay tailored for the biologic.