Collaboration is key when it comes to success for clinical trial materials, especially when factors like Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) need to be accounted for. Thankfully, Ascendia Pharmaceutical Solutions, a specialty CDMO, has the expertise, along with flexible options to meet each client’s needs. Read on to learn just how Ascendia stands out from the competitors with its services.
Complete End-To-End Specialty Support
As a specialty CDMO, Ascendia can handle formulation development with different types of challenging compounds for both animal and human studies. Additionally, Ascendia has a Good Manufacturing Practice (GMP) facility to be able to manufacture clinical trial materials (CTMs). It can produce nonsterile clinical trial materials such as oral tablets, capsules, solutions, and suspensions as well it can manufacture sterile infusions, subcutaneous or intramuscular injections, or other routes of administration.
Not only can Ascendia supply the clinical trial materials, but it can also manufacture and supply the material for the toxicology studies in animal models that are needed for IND approval; a critical step necessary prior to clients being able to advance the formulations into human studies to commence the Phase I.
Once clinical trial materials have been manufactured, Ascendia can package them into the appropriate form, either in vials, pre-filled syringes, or cartridges. From there, the packaged material can be labeled by Ascendia and shipped to the client’s clinical trial site, or to the distribution center for further secondary packaging. The services offered by Ascendia are as complete as possible in the industry, for any sized client.
No Job Too Large or Too Small
Another aspect that makes Ascendia unique is its ability to accept any batch size that a client may need. Flexibility is a necessary component of any good assembly service, and Ascendia goes above and beyond the norm, and can handle the manufacturing of small batch sizes up to 20,000 or 30,000 unit per batche, which allows clients to maintain consistency between all stages of their trials.
Competitive Expertise From Top-Down
Founder and CEO Dr. Jim Huang has extensive experience in the realm of clinical trial materials, but he’s not the only one. Ascendia has industry-leading experts throughout its organization in regard to managing and manufacturing of clinical trial material in many different types of dosage forms. They’ve served many companies from preclinical trials, through their clinical trial phase of development, all the way through to late-stage development.
Unique opportunities for complex injectables
Arguably one of the most impressive services provided by Ascendia would be its complex injectable dosage forms by utilizing its enabling technologies including NanoSol®, EmuSol®, and LipidSol, all of which are unique to Ascendia and add value to its expertise.
In the past handful of years, Ascendia has vastly expanded its manufacturing capabilities, which has further bolstered its scope of producing clinical trial materials. Some of the expanded capabilities include sterile wet milling for suspensions, nano-suspension, and lipid nanoparticles using the microfluidizer or extrusion technologies. Additionally, there have been expanded capabilities for emulsion processes, including high-shear, high-pressure homogenizer or microfluidizer, as well as aseptic lipid nanoparticles and PLGA-based microspheres. Ascendia is continuously working to expand and increase its offerings to best serve the client’s unique needs.
Ascendia Can Do It All, at Any Scale, for Virtually Any Client
Ascendia not only offers superior clinical trial material service, but it also provides superior quality. It can offer a wide array of capabilities for many different types of clinical trial materials utilizing enabling technology platforms. The commercial GMP quality system is there to further support clients in their late-stage commercialization processes. Finally, Ascendia’s team is exceptional, dedicated to building long-term relationships with clients, and committed to the success of the client’s project.
Reach out to Ascendia today to see how they can support your individual needs, no matter what stage of development, or what scale, you might be working with!