Aurigene Pharmaceutical Services Limited, a Global CRDMO, Announces the Opening of Its Biologics Facility Offering Process Development and Clinical Scale Manufacturing Capabilities
Aurigene Pharmaceutical Services, a subsidiary of Dr. Reddy’s Laboratories, has announced the opening of a new 70,000 sq.ft. biologics facility in Hyderabad, India. The facility offers process and analytical development, along with small-scale manufacturing of antibodies and recombinant proteins for preclinical and early phase clinical requirements. While the laboratories are now operational, the manufacturing capacity will be commissioned by 2024. This new facility aims to provide seamless transitions to larger commercial CGMP manufacturing, complementing Aurigene's current capabilities in recombinant proteins and antibody drug conjugates. The initiative aligns with Aurigene's strategic growth in biologics and small molecules, supported by recent collaborations and investments in AI/ML-led drug discovery.
- Opening of a new 70,000 sq.ft. biologics facility with state-of-the-art equipment.
- Operational process and analytical development laboratories.
- Facility designed for small-scale antibody and recombinant protein manufacturing.
- Complementary capabilities in recombinant proteins, mAbs, and immune-fusion molecules.
- End-to-end service from discovery to large-scale commercial manufacturing.
- Strategic growth initiatives, including AI/ML-led drug discovery.
- Recent collaboration with Vipergen for DNA-encoded library (DEL) technologies.
- Facility supports rapid clinical development for customers.
- Manufacturing capacity commissioning delayed until late 2024.
- Financial impact of investing in new facility not disclosed.
Aurigene Pharmaceutical Services Limited's new biologics facility in Hyderabad is a significant development for the company and the industry. The facility's focus on process and analytical development, as well as small-scale manufacturing of antibodies and recombinant proteins, addresses a important need for preclinical and early-phase clinical requirements. This expansion enhances Aurigene's end-to-end service offerings, potentially making it a more attractive partner for biotech firms looking to streamline their drug development processes.
From a market perspective, the addition of this facility positions Aurigene to capitalize on the growing demand for biologics. The biologics market has been expanding rapidly, driven by increasing approvals of biologic drugs and rising investments in biotech research. This new capability aligns with industry trends toward complex biologics, including monoclonal antibodies (mAbs) and antibody-drug conjugates, which require specialized infrastructure and expertise.
The timing is also strategic, with the manufacturing capacity set to come online in 2024, potentially allowing Aurigene to secure contracts and partnerships as biotech companies advance their pipelines. This could translate into a stronger revenue stream and improved market positioning in the long term, making it a positive development for stakeholders.
The financial implications of Aurigene's new biologics facility are noteworthy. The expansion represents a substantial investment, which indicates confidence in the future growth of their biologics business. This investment aligns with their strategy to extend their capabilities from discovery to commercial-scale manufacturing, potentially leading to higher revenue and profit margins as they capture more of the value chain.
However, the mention of the completion of manufacturing capacity in 2024 suggests that the financial benefits will be realized over the medium to long term. Investors should watch for operational updates and any new contract announcements, as these will provide clearer insights into the facility’s contribution to the company's bottom line.
In the short term, the company might experience increased capital expenditure and operational costs related to the facility's setup and initial operations. Yet, if successfully executed, the long-term benefits could outweigh these initial expenses, providing a stronger and more resilient revenue stream, particularly in the high-growth biologics sector.
From a medical research perspective, Aurigene's new facility is poised to play a pivotal role in the advancement of biologic drugs. The facility’s capabilities in developing robust cell lines and supporting analytical methods are essential for early-stage drug development. By offering process development solutions, the facility can help accelerate the timeline for biologic candidates to enter clinical trials, which is important for biotech companies that face significant pressures to deliver innovative therapies quickly.
The emphasis on state-of-the-art equipment and experienced talent pool underscores Aurigene's commitment to maintaining high standards of quality and compliance, which are critical in biologics manufacturing. These factors can reduce risks associated with regulatory approvals and improve the likelihood of successful clinical outcomes.
In summary, the facility stands to enhance the efficiency and effectiveness of drug development processes, potentially leading to more innovative medicines reaching the market faster. This could be beneficial not only for Aurigene and its clients but also for patients awaiting new treatments.
The state-of-the-art facility is equipped with best-in-class equipment and control systems, supported by an experienced talent pool that will ensure seamless transfer to large-scale commercial CGMP manufacturing facilities. The new facility is complementary to the company’s current discovery capabilities and infrastructure, which primarily focuses on recombinant proteins including mAbs, bi- and multi-specifics, immune-fusion molecules, antibody drug conjugates and other complex proteins.
Aurigene’s comprehensive end-to-end service offering now delivers solutions from, discovery through large-scale commercial manufacturing from three proximally located campuses (discovery, process development/clinical manufacture and large scale commercial manufacture) thus ensuring seamless delivery from “concept to commercial”. The newly opened Genome Valley facility will deliver robust, compliant and economically viable cell lines, process development solutions and supporting analytical methods in support of customers seeking to rapidly enter and progress through clinical development.
The opening of this latest facility is one of multiple strategic initiatives that Aurigene is implementing to support rapid growth in both the small molecule and biologics spaces, as illustrated by recent announcements related to AI/ML-led drug discovery in small molecules and a collaboration with Vipergen, a DNA-encoded library (DEL) technologies service provider.
Akhil Ravi, CEO, Aurigene, commented, “The journey started a year back when we decided to invest in creating the facility. It is great to see the facility operational and the addition of this capacity and capabilities shows our firm commitment to the continued expansion of our biologics business, building on 25 years of proven experience. The state-of-the-art facility will enable us to service our global customers efficiently and support in the development of innovative medicine.”
Dr. Roger Lias, Global Commercial Head – Biologics, Aurigene, added, “There are very few global CDMOs that can truly support customers ‘end-to-end’ from discovery services to large scale commercial manufacture of both Drug Substance and Drug Product. Our new facility further strengthens Aurigene’s capabilities and builds on our technical excellence, demonstrated global compliance and state-of-the-art facilities as companies from start-up biotechs to global multinationals continue to strengthen their supply chains and seek economically viable support for both their development portfolios and marketed products.”
About Aurigene:
Aurigene is a global contract research, development, and manufacturing organization (CRDMO) – a Dr. Reddy’s company – built on the legacy of accelerating innovation and backed by a vast experience in drug discovery, development, and manufacturing of biologics and small molecules. Aurigene offers integrated and standalone services for biotherapeutics discovery, discovery chemistry, discovery biology, development and manufacturing services for clinical phase I-III programs, regulatory submission batches and commercial manufacturing.
For more information log on to: https://www.aurigeneservices.com/ or email us at: ContactAPSL@aurigeneservices.com LinkedIn YouTube
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in
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Usha Iyer
Head of Corporate Communications
ushaiyer@drreddys.com
Richa Periwal
Head of Investor Relations
richaperiwal@drreddys.com
Source: Aurigene Pharmaceutical Services Ltd.
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