Enhancing End-to-End Service Offering for Accelerated Development and Manufacturing of Antibody-Drug Conjugates (ADCs) as part of the scaling of its Development Services Business
PARSIPPANY, N.J., Oct. 07, 2024 (GLOBE NEWSWIRE) — Simtra BioPharma Solutions, a leading contract development and manufacturing organization (CDMO) specializing in sterile injectables, has announced a $14 million investment to expand its clinical-scale conjugation and purification capabilities for Antibody-Drug Conjugates (ADCs). Set to be operational by late 2025, this expansion is part of Simtra’s strategy to build a comprehensive end-to-end service offering, from development to clinical and commercial fill/finish, accelerating time to market for its customers.
The new clinical suite at Simtra’s Halle/Westfalen, Germany site will support ADC development by offering key capabilities, including:
- Conjugation mixing
- Single-use tangential flow filtration
- Diafiltration and buffer exchange
The Halle/Westfalen site currently offers clinical and commercial manufacturing services, with expertise in oncology and ADCs. Operating under SafeBridge classification and equipped to handle Category 4 drugs, the site will now provide a more comprehensive range of services for ADC development and manufacturing.
Strengthening Simtra’s Leadership in ADC Manufacturing
Franco Negron, CEO of Simtra, emphasized the strategic importance of this investment, stating, “This investment will further strengthen Simtra’s leadership in ADC manufacturing, a growing sector, by extending our capabilities in support of our customers and partners in the value chain.”
Lidia Serina, Head of Development Services at Simtra, added, “We are offering customers a true end-to-end solution, from early development to commercial production. This allows for more flexibility, reduces risk, and shortens timelines, ultimately saving our customers time and money.”
Simtra is moving to position itself as a strategic partner with a full spectrum of services, from early development—including formulation, material compatibility, container selection, lyophilization optimization, and analytical development—to clinical and commercial fill/finish.
With this investment, Simtra continues to build on its expertise and infrastructure to serve the evolving needs of the pharmaceutical industry, particularly in the rapidly advancing field of ADCs.
About Simtra BioPharma Solutions
As the premier, independently owned Contract Development Manufacturing Organization with more than 65 years of sterile injectable manufacturing expertise, Simtra BioPharma Solutions offers world-class cGMP sterile fill and finish, technical expertise, quality service, and a uniquely collaborative approach to support our customers’ strategic objectives.
Biotech and pharmaceutical companies partner with us when they need to take their molecule to market, whether launching an innovation globally, improving a formulation, or proactively mitigating risk to grow their business.
Our teams of tenured experts deliver tailored, flexible solutions to help our customers consistently fulfill their product goals at the highest quality, so they get in the hands of the patients who need them most.
For more information, visit www.simtra.com.
Contact info:
Rhonda Luniak, Director of Communications
Simtra BioPharma Solutions
rjluniak@simtra.com
303.406.8743
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