Forma Life Sciences, Inc. has officially launched as an independent, operator-owned contract development and manufacturing organization (CDMO) dedicated to oral solid dosage formulation development, clinical manufacturing, and commercial drug product production in the United States. Headquartered in Irvine, the company begins operations with a clear mandate: to deliver integrated, U.S.-based development and manufacturing solutions for pharmaceutical and biotechnology partners seeking quality, reliability, and long-term collaboration.
Forma Life Sciences was established following BioSelective Capital Investments’ acquisition of the U.S. drug product development and manufacturing operations of BioDuro, a global contract research and manufacturing organization. The transaction included two well-established GMP facilities in Irvine with a strong regulatory history supporting both clinical and commercial oral solid dosage programs. These facilities form the operational backbone of Forma’s newly launched platform.
Integrated U.S.-Based Oral Solid Dosage CDMO Platform
Forma operates two cGMP-compliant sites in Irvine encompassing more than 100,000 square feet of manufacturing and development space. Across the two locations, the company maintains 27 GMP manufacturing suites designed to support a broad range of pharmaceutical development and production activities.
The integrated platform supports:
- Oral solid dosage formulation development
- Clinical manufacturing for Phase I, II, and III programs
- Process scale-up and technical transfer
- Commercial drug product manufacturing
Collectively, the facilities have the capacity to produce more than two billion tablet and capsule units annually, positioning Forma to meet both mid-scale and large-scale commercial supply demands.
The company’s model is built around continuity from early-stage development through commercialization. By offering formulation development, clinical supply, process validation, and commercial manufacturing within a single U.S.-based network, Forma aims to reduce technology transfer risks, improve communication efficiency, and enhance overall program timelines for its partners.
Technical Expertise in Complex Oral Solid Dosage Forms
Forma Life Sciences brings deep scientific and manufacturing expertise to complex oral solid dosage forms. The company provides integrated services for tablets and capsules spanning early clinical development to full commercial production.
Among its core technical capabilities is spray-dried dispersion technology for amorphous solid dispersion (ASD) systems. This approach is widely used to enhance the bioavailability of poorly soluble drug compounds—an increasingly common challenge in modern pharmaceutical pipelines. By leveraging spray-dried dispersion processes, Forma can support formulation strategies that improve solubility and absorption while maintaining scalable manufacturing pathways.
In addition, the company offers commercial-scale fluid bed granulation and coating technologies. These capabilities support modified-release and multiparticulate dosage forms, including matrix-based controlled-release and delayed-release systems. Such technologies are critical for products requiring precise pharmacokinetic control, patient adherence optimization, or lifecycle management strategies.
The integration of advanced formulation science with scalable commercial manufacturing allows Forma to support products across their full lifecycle. From proof-of-concept batches to validated commercial campaigns, the company’s infrastructure is designed to ensure consistency, compliance, and operational discipline.
Established Regulatory Track Record
The two Irvine facilities included in the acquisition bring a long-standing regulatory track record supporting clinical and commercial oral solid dosage programs. With established quality systems and cGMP compliance frameworks in place, Forma enters the market with operational maturity rather than a startup footprint.
This history enables the company to provide immediate manufacturing support for ongoing and new development programs, while maintaining alignment with U.S. regulatory expectations. The emphasis on domestic production also reflects broader industry trends favoring supply chain resilience and geographically diversified manufacturing strategies.
Leadership with Proven Operating Experience
Forma Life Sciences is led by an experienced executive team with deep familiarity with the acquired operations. The company is headed by Cyrus K. Mirsaidi, Executive Chairman and Chief Executive Officer, who previously served as CEO of BioDuro from 2015 to 2021. Joining him is Armand Amin, President and Head of Business Operations at Forma, who formerly held a senior leadership role at BioDuro.
“For more than 30 years, this organization has supported the pharmaceutical supply chain,” said Cyrus Mirsaidi, Executive Chairman and CEO of Forma Life Sciences. “Forma was created to preserve that operating foundation while building a focused U.S.-based CDMO platform designed for disciplined execution and long-term partnership.”
Armand Amin emphasized the strategic timing of the launch: “Our industry is seeing renewed focus on domestic pharmaceutical manufacturing and supply chain resilience. Forma provides a durable, U.S.-based development and manufacturing platform that pharmaceutical and biotechnology partners can rely on from clinical development through commercial supply.”
Focused on Long-Term Partnership and Domestic Manufacturing
Forma began operating as an independent company in January 2026. As a U.S.-based, operator-led CDMO, the company is positioned to serve emerging biotech firms as well as established pharmaceutical organizations seeking a reliable domestic partner for oral solid dosage development and manufacturing.
By combining experienced leadership, established GMP infrastructure, advanced formulation capabilities, and large-scale production capacity, Forma Life Sciences enters the market with a clear focus: delivering integrated oral solid dosage solutions from early development through commercial supply, all within a resilient U.S. manufacturing framework.
With its headquarters and operational footprint in Irvine, California, Forma Life Sciences aims to build enduring partnerships grounded in technical expertise, regulatory compliance, and operational excellence across the pharmaceutical product lifecycle.
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