Routes of Administration Supported
Agno Pharma is a leading solutions provider for long-acting implantables (LAIs) and has extensive expertise in the development and cGMP manufacture of LAIs for a wide range of routes of administrations.
Experienced with a range of polymers and APIs
Whether you are looking to design a novel drug product, create a generic (ANDA) or 505(b)(2), or add a drug to an existing medical device to improve performance, we are here to help.
Agno Pharma is equipped with the technologies and expertise to handle the design, formulation, and production of long-acting drug delivery systems, including those that contain highly potent APIs (hormones, steroids, cytotoxics), controlled substances (Schedule I-V), and large molecules (proteins, peptides, nucleotides).
We understand the importance of polymer control and have established strong relationships with the world’s leading suppliers of biodurable and biodegradable polymers. Agno Pharma can assist in polymer evaluation and selection of the proper grade to support the target drug implant product.
A breadth of formulation and manufacturing capabilities
Long-acting implantables systems are complex products that can take several forms. Agno Pharma utilizes various techniques to design formulations that meet our customers’ target product profiles. Whatever the goal of a long-acting implantable system is, the drug incorporation method, material selection, and product performance are optimized by our experienced team to achieve the desired drug release rate. Our in-house formulation and manufacturing teams have successfully supported programs for a broad range of LAI products, including:
- Implants (Ophthalmic)
- Implants (Other Routes of Administration)
- Vaginal Rings
- Vaginal Pessary
- Films
- Tubing
Taking your long-acting implantable system from concept to commercialization
Complex drug product manufacturing is performed in on-site clinical and commercial cGMP manufacturing suites, including dedicated cleanroom space for processing highly potent APIs. Agno Pharma are experts in bringing processes into a cGMP environment, whether through a technology transfer or as part of a larger development project.
Our formulation and manufacturing efforts are supported by a full suite of analytical services and staff that specializes in method development, validation and focuses on critical quality attributes such as in vitro drug elution and chemical stability. Our analytical staff also supports our accelerated and long-term ICH stability programs.
