At Ascendia Pharmaceutical Solutions, we take pride in providing seamless, end-to-end clinical trial material manufacturing services tailored to support Phase I, II, and III trials. Our commitment to quality, innovation, and customer-centric solutions has made us a trusted partner in the pharmaceutical industry. In this article, I will highlight the key aspects of our clinical trial materials and what distinguishes Ascendia apart from other CDMOs (Contract Development and Manufacturing Organizations).
Ascendia strictly follows Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards for clinical manufacturing, ensuring the highest level of quality throughout the clinical trials supply process. Our facilities are designed to meet the stringent requirements for development and cGMP manufacturing of Phase I, II, and III clinical trials, making us uniquely positioned to handle a wide range of client needs, from small-scale projects to large-scale manufacturing of injectables (IV, IM, SC), liquid and solid oral products.
To meet growing demand, we’ve expanded into two advanced facilities for injectables: Aseptic Area 1 and Aseptic Area 2. These facilities are well equipped to support different phases of clinical trials with precision, safety, and scalability, particularly in complex injectable manufacturing in nanosuspensions, nanoemulsions, and lipid nanoparticles
- Aseptic Area 1: Primarily supports Phase I projects, catering to small-scale batches of up to 5,000 vials. This facility is ideal for early-stage clinical trials where flexibility and speed are critical.
- Aseptic Area 2: Focuses on Phase II and Phase III trials, with capabilities for production of up to 30,000 vials, prefilled syringes, and cartridges. This expansion reflects our ability to scale operations to meet the needs of clinical trials targeting late-stage and commercial manufacturing.
Non-Aseptic GMP for oral manufacturing of liquid and solid dosages: In order to meet the needs of a variety of poorly oral bioavailable therapeutic modalities, Ascendia’s non-sterile facility provides formulation development and manufacturing of clinical materials in liquid filled capsules, liquid solution, nanosuspension, spray drying, nanomilling, and oral tablets at scales up to 100,000 units.
In an industry with numerous CDMOs, Ascendia stands out for several reasons:
We provide a one-stop shop for clinical trial material services. From formulation development and analytical testing to aseptic manufacturing and packaging, all critical processes are conducted in-house. This eliminates the need for clients to coordinate with multiple service providers, saving time and reducing complexity.
Unlike larger CDMOs that often focus solely on high-volume projects, Ascendia caters to companies of all sizes. Whether you need a small batch of 100 vials for a Phase I trial or a larger batch of 30,000 vials for a Phase II trial, our facilities and team are equipped to meet your needs. We’re proud to support small biotech startups, virtual companies, and large pharmaceutical firms alike.
Our team includes highly skilled scientists and manufacturing professionals with extensive experience in aseptic manufacturing and complex formulations. We’re known for our agility and ability to rapidly adapt to client needs, delivering high-quality products on time and on budget. This level of responsiveness builds trust and fosters long-term partnerships.
At Ascendia, we prioritize clear and consistent communication. Each client is assigned a dedicated project team to ensure alignment and progress throughout the project lifecycle. Weekly updates and progress reports are standard, providing transparency and peace of mind.
Our advanced facilities are equipped with state-of-the-art technologies, including lyophilization (freeze-drying) capabilities for stabilizing injectable drug products. This is especially critical for drugs that require enhanced stability during storage and transport.
One of our core strengths is the ability to support clients through every stage of the clinical trial process:
- Formulation Development: Our R&D team develops robust formulations tailored to meet the unique needs of each product.
- Manufacturing: We ensure the sterility and safety of drug products by adhering to rigorous cGMP manufacturing practices.
- Analytical Services: Our in-house analytical capabilities include QC release testing, stability testing, impurity analysis, QC micro, and method development and validation to ensure product quality.
- Scale-Up and Tech Transfer: We facilitate smooth transitions from small-scale to large-scale production, providing scalable solutions for every phase.
Trust is at the heart of everything we do. Our ability to deliver high-quality clinical trial materials on time has earned us the loyalty of clients across the pharmaceutical industry. Whether working with small startups or global pharmaceutical giants, we approach every project with the same dedication to excellence.
Recently, we successfully completed a Phase I clinical trial project for a leading pharmaceutical company. The client was impressed by our efficiency, flexibility, and transparency, resulting in additional projects being awarded to Ascendia. This reflects the growing confidence in our capabilities and the value we bring to our partners.
In today’s fast-paced pharmaceutical landscape, having a reliable partner for clinical trial material services is essential. Ascendia’s unique combination of expertise, flexibility, and state-of-the-art facilities makes us the ideal choice for clients seeking high-quality solutions for Phase I, II, and III clinical trials.
Whether you’re a biotech startup needing small-scale production or a global pharmaceutical company preparing for large-scale trials, Ascendia is here to support you every step of the way.
If you’d like to learn more about our clinical trial material services, let’s work together to bring your innovative therapies to patients around the world. Contact us today!