Whitepaper
23 Jul 2025
White Paper & Case Study: Fast Path to Market: Going from GMP1 to PPQ in Just 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...
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Rentschler Biopharma SE
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Country/Region:Germany
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On CPHI since:2024
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Certificates:3
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Employees:1000 - 4999
Company types
Primary activities
Other Content from Rentschler Biopharma SE (11)
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News Playbook: Houston we have a complex market
Taking off with the right CDMO -
Brochure Taking off with the right CDMO
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. -
News Rentschler Biopharma contributes to nearly 25% of FDA approved biopharmaceuticals in 2023
Exceptional capabilities in guiding therapies from early-stage development through to market based on over 50 years of biotech experience
In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals. Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.
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Video Interview: Enhancing CDMO Capabilities to Meet Evolving Client Needs
CDMOs play an increasingly vital role in the biopharmaceutical industry – evolving from simple capacity providers to strategic, integrated partners. As biopharma pipelines grow more complex and patient needs become more individualized, CDMOs like Rentschler Biopharma are continuously innovating to support clients in bringing life-changing therapies to market quickly, safely, and sustainably. Watch this interview with Benedikt von Braunmühl, our CEO, and learn more about: How CDMOs are shifting from service providers to strategic partners with deep expertise and integrated support for complex programs.
We are investing in infrastructure to achieve scalability and how targeted expansions help meet client needs from clinical to commercial production.
How our progress in sustainability create added value for clients, partners and patients. -
News Rentschler Biopharma Announces New State-of-the-Art Production Line in Massachusetts is Fully Operational
Largest expansion in company’s 150+-year history opens
Major client project already underway; new clients actively being onboarded
Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced that the company’s new state-of-the-art production line, formerly known as the Rentschler Biopharma Manufacturing Center (RBMC), in Milford, MA in the U.S. is now fully operational. The company has a major project underway at the new line, with several additional projects in the pipeline, and continues to welcome new projects and clients.
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Report Playbook: What It Takes to be First to Market
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.
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News Climate targets of Rentschler Biopharma successfully approved by SBTi
Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announces that the company's near-term climate targets have been officially approved by the Science Based Target initiative. -
News Rentschler Biopharma announces largest single investment at its headquarters in Germany
Construction of a new buffer media station in Laupheim
Largest investment in the German site; project duration of approx. three years
Continuous modernization, automation, and digitalization of the site
Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced the construction of a new state-of-the-art buffer media station at its company headquarters in Laupheim. The new facility aims to further increase production efficiency and modernize the site, ensuring that the evolving needs of clients and patients are anticipated and fully met, both now and in the future.
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Video Rentschler Biopharma Patrick Meyer at #BIO2025 Boston
It was great catch up with Patrick at BIO2025.
We talked about RentschlerBiopharma at NEW Rentschler Development Services, their US operations and why companies should work with them.
Learn more about Rentschler Biopharma here
Services: https://lnkd.in/eMniDBCS
DevelopmentServices: https://lnkd.in/e6kJDusX -
Report cGMP manufacturing at our site in Laupheim, Germany
Our state-of-the-art facilities provide flexibility from clinical to commercial needs
Flexible production set-up addressing dynamic nature of client projectscGMP production for clinical and commercial supplyHigh degree of flexibility enabled by multi-product facilitiesWide variety of bioreactor scales and technologiesMultiple seed train and upscale optionsFed-batch and continuous processes -
Video Reliability you can trust - Our Rentschler Biopharma manufacturing site in Milford, MA, USA
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.