Ascendia Pharmaceuticals Expanding Injectable Manufacturing Capabilities in 2024

Ascendia Pharmaceuticals is all set to unveil its new injectables manufacturing opportunities with the launch of a state-of-the-art sterile cGMP production facility in March 2024.

This significant development opens doors to advanced capabilities in aseptic processing and fill & finish for vials, pre-filled syringe and cartridge, leveraging its cutting-edge pharmaceutical technologies in nanosuspension, nanoemulsion, and lipid nanoparticles. This expansion reenforces the continuous growth of Ascendia, as it rapidly becomes one of North America’s premier contract development and manufacturing organizations (CDMOs) over the past decade.

Responding Promptly to Meet Growing Demand

Ascendia attributes the creation of these new injectable manufacturing opportunities to an increasing demand from its customers. Many current clients have been supported by Ascendia from the preclinical discovery stage. Several of these projects have progressed into Phase One, Phase Two, and late-stage development.

The stated desires of several existing clients of Ascendia prompted the decision to expand its manufacturing capabilities. In short, our repeat customers were so pleased by the results they obtained with Ascendia that they became increasingly reluctant to take their late-stage development projects elsewhere.

Having diligently built up the aseptic process facility over the past year, Ascendia is poised to commission the facility in March.

This development marks a significant milestone in Ascendia’s decade-plus history. It will empower Ascendia to support late-stage and commercial fill and finish for vials, prefilled syringes, and cartridges. Additionally, this expansion enables Ascendia to manufacture various complex injectable dosage forms under aseptic conditions, including solution, suspension, nano-suspension, emulsion, lipid nanoparticles and others.

Providing a Seamless Transition for Existing Customers

Ascendia's ongoing commitment to maintaining a high level of quality and strong relationships with its customers led to the development of these new services and the construction of a new facility to support them, even though that level of responsiveness is only part of the story.

Existing customers, who have been supported by Ascendia through preclinical and early development phases, can seamlessly transition into late stage and commercial manufacturing without having to transfer to another CMO. This added capacity eliminates potential time, cost and logistical issues often associated with transferring projects to other facilities and/or companies.

Catering to Small-Batch Manufacturing Projects

Pharmaceutical development teams often encounter significant challenges when seeking to find a partner, who has facilities capable of manufacturing smaller batch sizes.

One primary difficulty is the limited availability of CDMO willing to specialize in smaller production runs. Many facilities are geared solely towards large-scale manufacturing. This can make it extremely challenging for drug developers with specific niche needs to find a suitable manufacturing partner.

The economies of scale typically associated with larger batches can result in lower costs per unit. This reality makes it financially attractive for manufacturers to focus on high-volume production. However, as a consequence, smaller batch sizes may be overlooked. This often leaves pharmaceutical developers struggling to find facilities willing to accommodate their unique requirements and budget restraints.

Manufacturing Niche Complex Injectables with a High Quality Standard

Developers often face the dilemma of finding a facility that not only caters to their complex injectable development needs but also maintains the highest standards of regulatory compliance.

The complex and stringent regulatory landscape governing pharmaceutical manufacturing often poses yet another hurdle. Meeting regulatory standards for niche complex injectables can be just as demanding as for larger quantities. This requires specialized formulation development and manufacturing expertise and adherence to all quality control measures.

Overcoming Commonplace Small-batch Snafus

Logistical challenges further compound the difficulties associated with small-batch manufacturing. Projects often involve more frequent changeovers. This process demands a higher level of flexibility and efficiency from manufacturing partners, many of whom are not equipped to handle the rapid transitions and customization required for smaller batches.

For small-batch customers, the logistical problems frequently bring with them the usual headaches, namely delays and increased production costs. Ascendia Pharmaceuticals, with its inherent emphasis on small batch accessibility, aims to address these industry-wide challenges.

Our new sterile manufacturing facility opening next month positions Ascendia as a unique CDMO in the field. We will be in the enviable position of being able to offer pharmaceutical developers the opportunity to overcome hurdles associated with finding a development and manufacturing partner for niche complex injectables. Ascendia is committed to minimizing waste and supporting batch sizes up to 25,000 units, becoming an ideal partner for those seeking tailored solutions in an industry dominated by large-scale manufacturing.

Leveraging Our Nanotechnology Expertise

Ascendia has gained industry-wide recognition for its nanotechnology platforms. LipidSol is one of four patented technology platforms that address challenges associated with lipid nanoparticles (LNPs) for drug delivery of small molecules and biologics.

The future of commercial development at Ascendia includes a full spectrum of LNP manufacturing, from research scale to cGMP clinical trial material and late-stage commercial production. This includes microfluidic mixing manufacturing equipment from Precision Nanosystems. Ascendia's precision nano system distinguishes it as a leading CDMO with the capability to support clients throughout the entire development process.

The other popular technology of Ascendia, NanoSol®, utilizing aseptic nanomilling processing, has been applied to manufacture sterile nanosuspension for use by IV, IM, SC, long acting injectables and topical routes. Ascendia’s newly expanded manufacturing facility also houses Netzsch’s wet media milling machine and mixing reactors that are equipped with in-line homogenizer and automatic CIP/SIP for cleaning and sterilization.

Dedicating to Diverse Client Needs

In the highly competitive world of pharmaceutical development, three key groups stand to benefit significantly from Ascendia's enhanced injectable manufacturing services:

• Existing customers can continue their projects with Ascendia from early development to late stage and commercial phases, ensuring consistent quality.

• Preclinical drug projects that seeks one stop service from discovery to cGMP manufacturing

• Drug development teams who have conducted early development services elsewhere can now turn to Ascendia for high-quality cGMP commercial manufacturing services.

Securing Adequate Production Capacity While You Can

The team at Ascendia Pharmaceuticals urges prospective clients to take immediate action. With the new production facility set to launch in March, securing project scheduling is crucial.

Waiting too long may result in Ascendia filling up its new production capacity. Whether you are initiating a new project or transferring an existing one, Ascendia now offers a “one-stop shop” with unparalleled development expertise. We pride ourselves on tirelessly working to ensure a smooth transition into late-stage commercial manufacturing.

Pharmaceutical developers are urged to act now. Our unique capability to handle smaller batch sizes, focusing on minimizing waste, makes Ascendia Pharmaceuticals the ideal partner for pharmaceutical development projects. Don't miss the opportunity to collaborate with Ascendia and benefit from our cutting-edge commercial manufacturing services.

Current and prospective clients are encouraged to reach out, initiate projects, and explore Ascendia's facilities.