The development of sterile injectable drug products requires unparalleled precision, specialized expertise, and a deep understanding of stringent regulatory requirements.
Our sterile injectable services cover every stage of the process, leveraging a high-speed production line at our state-of-the-art facility to ensure rapid, reliable, and compliant manufacturing.
With a proven track record in developing a diverse range of injectable therapies, we are committed to accelerating your product’s journey from concept to market.
Comprehensive Sterile Injectable Product Development
Aenova’s sterile injectable manufacturing capabilities cover a wide range of parenteral formulations, including:
- Intravenous (IV) Solutions: For direct administration into the bloodstream, ensuring rapid drug absorption
- Subcutaneous (SC) Injections: Designed for precise delivery under the skin for sustained release
- Intramuscular (IM) Injections: Formulated for deep tissue administration for enhanced bioavailability
Handling Complex and Sensitive Formulations
We understand the intricate requirements of modern biopharmaceuticals and have the expertise to manufacture highly specialized drug products.
This includes the handling of compounds up to OEB Class 3, with specialized containment measures to ensure safety and compliance.
In-House Microbiological Testing & Quality Control
Ensuring the sterility and safety of GMP sterile pharmaceutical products is our top priority. Our in-house microbiological testing capabilities include sterility testing to verify that products are free from microbial contamination.
We conduct endotoxin and bioburden testing to ensure compliance with stringent pharmaceutical sterility standards. Additionally, our particulate matter analysis maintains the highest level of purity for injectable drug products, safeguarding quality and patient safety.
Diverse Sterile Injectable Dosage Forms
We offer a variety of sterile drug product dosage forms to meet the needs of pharmaceutical and biotech companies worldwide:
Liquid Injectables
- Aqueous and Non-Aqueous Solutions – Ready-to-use sterile liquids for parenteral administration.
- Suspensions – Particulate dispersions for controlled drug release.
Powder Injectables:
- Aseptic Powder Filling – Ensuring sterility for reconstitution prior to administration.
Regulatory Compliance & Commitment to Quality
Aenova’s sterile pharmaceutical manufacturing processes comply with global regulatory requirements, including:
- EU GMP Guidelines – Ensuring compliance with European regulatory standards.
- U.S. FDA cGMP Compliance – Meeting the stringent requirements of the U.S. market.
- ICH Guidelines – Following international best practices for drug development.
Why Choose Aenova for Your Sterile Injectable Development?
With extensive expertise in sterile injectable drug product development, our comprehensive services cover every stage of the process, including formulation development, aseptic processing, sterile fill-finish, and regulatory support.
With flexible and scalable solutions through our global network of GMP-certified manufacturing sites, our facilities are equipped to handle the development of complex formulations.
By partnering with Aenova, you gain access to industry-leading expertise, state-of-the-art aseptic technology, and a commitment to the highest quality standards. Whether you require support for sterile injectables, pre-filled syringes, or other advanced parenteral products, our proven methodology ensures regulatory compliance, product integrity, and accelerated time to market.
Additional Development & Technology Services
At Aenova, we provide a wide range of development and technology services for pharmaceutical companies.
Contact Us
Ready to partner with Aenova for sterile injectable development and manufacturing?
Get in touch with our team today to discuss your sterile drug product needs and discover how our cutting-edge aseptic solutions can support your project.
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