Altasciences
True One-Stop-Shop for Sponsors’ Early-Phase Drug Development Needs

A forward-thinking contract research organization (CRO) and contract drug manufacturing organization (CDMO), Altasciences, is a trusted name in the drug development space.

What differentiates Altasciences from most CROs is its fully integrated, end-to-end CRO and CDMO solution, and how it can treat drug development as a continuum instead of a series of steps, for a more efficient and seamless outsourcing experience.

The company’s CDMO services are particularly notable for their breadth and depth. Altasciences offers comprehensive drug development and manufacturing capabilities, including:

•Formulation Development: Creating optimal formulations tailored to the unique properties of each drug.

•Discovery through Phase I to Large Scale Commercial Manufacturing: Supporting every phase of drug development from initial discovery through commercial production.

•On-Site ICH Stability Storage and Testing: Providing stability testing and storage that meets International Council for Harmonisation (ICH) guidelines.

•Analytical Method Development, Qualification, and Validation: Developing and validating precise analytical methods to ensure drug safety and efficacy.

•Finished Product and Release Testing: Conducting rigorous testing to ensure that the final product meets all regulatory standards before release.

Altasciences has formulated, tested, and/or manufactured nearly every available dosage form on the market. Furthermore, Altasciences can handle highly potent APIs and controlled substances, including their transport from site to site, with a DEA License for Drug Schedule I to V, including pallet positions for Schedule III to V and vaults for Schedule I to II.

With Altasciences, clients can benefit from an integrated preclinical and CDMO solution. Once a drug product is formulated, their in-house preclinical team evaluates its safety profile. At the same time, the CDMO team also develops a reproducible and scalable manufacturing process, detailing the appropriate equipment and establishing relevant parameters.

“Having our own preclinical research team that works hand in hand with our formulation scientists offers numerous advantages for a client, including streamlined development, optimized formulation, early risk identification, enhanced product quality, and cost efficiency,” states Ben Reed, Executive General Manager of CDMO Services at Altasciences.

Once safety testing is completed and before clinical trials begin, Altasciences’ regulatory team will compile a client’s preclinical data, clinical trial protocols, and information about the manufacturing process, which will be included in their IND application. Next, its experts will efficiently optimize the manufacturing process to prepare the drug product for clinical conduct followed by commercialization.

Altasciences’ unique strength to transition clients smoothly from the preclinical phase to clinical manufacturing and then to commercial manufacturing within the same facility eliminates the need for technology transfers, a process that often introduces delays due to the necessary hand-offs between different teams and facilities. By using the same operators and equipment throughout the manufacturing lifecycle, Altasciences ensures consistency, helps reduce production costs, minimizes batch-to-batch variability, and enhances manufacturing while accelerating timelines.

“Our integrated approach enables our scientists and managers to proactively address short- and long-term challenges,” says Reed. Altasciences offers formulation development and manufacturing of a drug substance from the early stages through commercialization. Its in-house analytical testing capabilities enable scientists to optimize a client’s drug formulation and ensure the efficacy and safety of the drug substance being evaluated in preclinical studies. They can contribute to the translational success of the drug candidate into the clinical phases—whether these preclinical and clinical studies are occurring at Altasciences or with an external partner.

Over the years, Altasciences has assisted many clients in attaining their desired level of outcome. For example, a long-term client contracted Altasciences to manufacture a nano-milled suspension of a loteprednol etabonate intermediate for ophthalmic application. Loteprednol etabonate is classified as a corticosteroid and requires HPAPI safety procedures, handling and operator protection protocols. The design and implementation of the HPAPI safety program followed traditional industrial hygiene protocols. Altasciences’ experts anticipated hazards, recognized and evaluated all events with potential drug exposure, and ensured all exposure events were controlled.

What differentiates Altasciences from other CDMOs is that, in addition to our formulation development, manufacturing, and analytical services, we offer fully integrated CRO services, making us a true one-stop-shop for sponsors in the early phases of their R&D

Once the occupational exposure band (OEB) was established and the safety hazards recognized, Altasciences’ experts identified all instances where potential exposure could occur, from pre-formulation work to commercial manufacturing. The highest risk of exposure for loteprednol etabonate was determined to be during the dispensing and addition of the API to the vehicle. Altasciences also accounted for the disposal of potent materials and used the best approach for cleaning or disposing of contaminated containers. All generated waste was properly documented and sent to a regulated chemical treatment plant.

“Many clients come to Altasciences with an API and an end goal in mind but are not sure how to get there. But we can take them and guide them all the way through the process—not just formulation and manufacturing, but also entering clinical studies and through the tail end into commercialization,” says Reed.

With nine strategically located sites, Altasciences offers an extensive array of services that span the entire early-phase drug development lifecycle. This integrated approach ensures that clients receive customized solutions tailored to their specific study requirements, enhancing efficiency and effectiveness at every stage of their projects.