Aragen Life Sciences Launches Integrated High-potency Development Platform in Hyderabad

Aragen Life Sciences Launches OneHP in Hyderabad

Aragen Life Sciences, recognized as one of India's leading Contract Research and Development Manufacturing Organizations (CRDMOs), has officially commenced operations at its state-of-the-art facility named OneHP, located in Nacharam, Hyderabad. This integrated development and manufacturing platform is pivotal for creating high-potency pharmaceuticals, especially those utilized in oncology treatments, marking a significant step forward in the company's expansive growth trajectory.

What is OneHP?

Aragen OneHP covers an impressive area of approximately 15,000 square feet and features a manufacturing line engineered to produce between 500 to 600 kg of active pharmaceutical ingredients (APIs) annually. This cutting-edge platform is designed specifically for supporting the development of highly potent compounds, including cytotoxic agents, thereby streamlining the pathway from initial discovery through clinical trials to commercial production.

A notable feature of the OneHP platform is its capacity to handle various stages of drug development. It provides services ranging from small-scale synthesis (up to 10 grams), non-GMP process development (up to 500 grams), to cGMP manufacturing for larger batches (from 500 grams to 5 kilograms). This wide range of capabilities greatly benefits clients by offering an integrated approach to drug manufacturing.

Advanced Manufacturing Capabilities

OneHP is equipped with advanced containment systems designed to manage substances with occupational exposure limits of up to 10 nanograms per cubic meter. These systems are crucial as they ensure a safe working environment while maintaining the integrity of potent compounds. Ongoing validations will be conducted to reinforce these safety standards as operations progress.

Global Clientele and Impact

In the fiscal year ending March 2026, Aragen's leadership in the industry is underscored by its impressive customer base, with nearly 95% of its revenue coming from international clients. The company proudly served 591 customers worldwide, including 16 of the top 20 global pharmaceutical firms. This reflects Aragen’s capability to meet the complex demands of the pharmaceutical industry not just domestically but also on an international scale.

Aragen operates six facilities globally, with five established in India and one located in Morgan Hill, California, which includes a biologics R&D facility. The launch of OneHP in Hyderabad further strengthens Aragen’s ability to cater to the growing international demand for efficient, high-quality drug development and manufacturing processes.

Statements from Leadership

Mr. Aniel Khubchandani, the Chief Executive Officer for Small Molecules-CDMO at Aragen Life Sciences, remarked, "With OneHP, we are bringing discovery, development, and cGMP manufacturing for highly potent molecules onto a more integrated platform. This can reduce handoffs between providers, while keeping process knowledge and programme context connected as a molecule moves from early development towards commercial supply."

The integration of these operations is expected to enhance customer collaboration and speed up the delivery of critical therapies to market. The establishment of OneHP emphasizes Aragen's commitment to innovation and quality, enabling it to further expand into advanced modalities such as antibody-drug conjugates and peptide-drug conjugates, thus keeping pace with the evolving pharmaceutical landscape.

Regulatory Accreditations

Aragen’s facilities, including those in Hyderabad, have received accreditations from several global regulatory bodies, including the USFDA, EDQM, PMDA, MFDS, ANVISA, WHO Geneva, and CDSCO. These certifications underscore the company’s dedication to maintaining high standards in its manufacturing processes, ensuring the delivery of safe and effective pharmaceutical solutions.

As Aragen Life Sciences embarks on this new chapter with OneHP, the organization is set to redefine therapeutic possibilities while continuing to prioritize the safety and efficacy of its products. The OneHP facility not only reflects technological advancement but also solidifies Aragen's position as a crucial player in the global pharmaceutical supply chain.