Choosing the right CDMO for Long-Term Stability

Taking off with the right CDMO

In the biotechnology industry, choosing the right contract development and manufacturing organization (CDMO) is essential for the success of drug development projects. Dr. Patrick Meyer, Global Head of Business Development at Rentschler Biopharma, outlines the deciding factors biotechs should consider when selecting a CDMO partner. 

Henning Gerschewski, our VP of Manufacturing Science and Technology, and Patrick Cushing, our VP Operations, spoke with Megan Manzano of BioPharm International, about how Rentschler Biopharma leverages a highly coordinated dual site model to streamline tech transfer between sites. Central to this approach is early-stage planning, timeline alignment, and a deep understanding of process robustness. Risk mitigation, too, plays a huge role in identifying differences in equipment, scale, and processes, while defining critical parameters to enable a smooth and reliable transfer. Ultimately, strong communication, experienced project teams, and a commitment to quality and compliance allows us to accelerate timelines while delivering both efficiency and confidence to clients.

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Our cell line development expert Sebastian Schwamb, Senior Director Process Science Upstream, gives instighs into our Cell Line Development and how we unleash the Power of the Pool.
Developing cell lines is a vital component of biopharmaceutical manufacturing. High productivity already at non-clonal pool stage, comparability of product quality between non-clonal pools & clonally derived cell lines and a robust & scalable USP platform process which is suitable for non-clonal pools and equally clonally derived cell lines, are crucial for reducing CMC timelines from the start of development to Drug Substance.

In the biopharmaceutical industry, companies face a complexjourney as they strive to transform groundbreaking ideas intolife-saving therapeutics. The process is fraught with challenges,also driven by current geopolitical changes, that demand for asuitable and reliable Contract Development and ManufacturingOrganization (CDMO) partner.

As the biopharma industry grows ever more competitive, with multiple companies developing therapies for the same indications, being first to market carries a significant advantage.  
However, few drug developers have the internal resources to streamline process development, scaling and manufacturing, all while maintaining regulatory excellence. And developers increasingly look outside their organizations for the support they need to bring novel therapies to market.  
Against this backdrop, contract development and manufacturing organizations (CDMOs) play a key role in successful launches – and finding the right partner is essential to hit key development milestones, including successful process performance qualification (PPQ).  
Here, we’ll discuss how Rentschler Biopharma helped its client beat rival companies to become first to market, condensing GMP1 to PPQ development into an “impossible” 12 months.  

This white paper details a landmark project and case study undertaken jointly at Rentschler Biopharma’s Milford, Massachusetts and Laupheim, Germany, facilities, where the company successfully compressed the typical biopharmaceutical development timeline to achieve process performance qualification (PPQ) from good manufacturing practice (GMP) initiation in just 12 months — a process that conventionally takes 15 to 18 months. This achievement not only highlights Rentschler Biopharma's expertise in rapid biopharmaceutical development but also underscores its strategic capability to meet aggressive market demands, and is further notable given that this was the first PPQ project undertaken at the Milford facility. 

Facing direct competition, a client needed to expedite the development and approval of a groundbreaking therapy. The urgency to be first to market required a development and manufacturing partner that could navigate complex regulatory landscapes efficient...

At our licensed, multi-product manufacturing site in Milford, MA, USA, we are dedicated to full-service solutions along the biopharmaceutical value chain. Under the leadership of Tom Roberts and a commitment to excellence, we offer reliability you can trust. Our state-of-the-art facility and highly experienced team are poised to tackle the most complex challenges in bioprocess development and cGMP manufacturing. To meet growing demand and enhance our capabilities, we've expanded our capacities at Milford. The video gives you first-hand insights into our new and active state-of-the-art manufacturing suite, which houses four 2,000-liter single-use bioreactors and added manufacturing cleanroom space. Join us as we continue to innovate, expand, and make a difference in the lives of patients by advancing medicine to save lives, worldwide.