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In response to ongoing customer feedback, Ascendia Pharmaceuticals® is expanding to take a lead in Phase 3 manufacturing of clinical trial materials and launching of commercial products. Current and future Ascendia® customers will no longer need to outsource their development projects to third-parties for manufacturing of clinical trial materials undergoing Phase 3 trials and beyond. The new development and manufacturing facility is scheduled to start production- as early as Q4 2023.
By Dr. Shaukat Ali - Sr. Director of Scientific Affairs and Technical Marketing
This major investment in manufacturing represents a natural evolution and logical progression of Ascendia's successful business model.
Customers impressed by Ascendia's ability to develop and deliver quality-controlled solutions will now be able to use the specialty CDMO as a one-stop shop for the entire product development cycle. Rolling out commercial product manufacturing services will enable Ascendia clients to keep moving expeditiously -their projects from development to manufacturing.
As clients have come to realize, Ascendia is bringing its trademark emphasis on quality control to the manufacturing process. The focus on tight quality assurance measures will enable customers to experience a smooth, seamless, comfortable launch process.
Additionally, a wide variety of customer development needs and products will be supported, including technology transfers or the transfer of later-stage projects. As a result, no matter the clinical trial material development process stage customers may sit, Ascendia can step in and move them to Phase 3 and on to cGMP manufacturing.
Quality Assurance: Ascendia's Non-Negotiable Focus for New Facilities
Ascendia's well-earned reputation for quality control during every step of the clinical trial material development process isn't an afterthought and bears its hallmarks. Rather, quality control (QC) is the linchpin. QC is intentionally "baked in" to everything the company does.
Facilities are clean and consistently exceed sterile lab requirements. Ascendia maintains a robust environmental monitoring program that includes regular cleaning and sanitizing procedures. The company's focus on details brings a greater level of assurance to customers looking to produce a clean, sterile product.
Strict quality assurance is the non-negotiable measuring line for successful development that informs everything Ascendia does. The relentless focus on QC remains consistent, even as the CDMO stays ahead of the curve and remains highly agile and responsive to shifting customer requirements. That level of commitment is one prime reason why Ascendia is well-known for its development of sterile injectables.
Ascendia’s People are Another Reason
As just one example, Ascendia's growth into Phase 3 and commercial product manufacturing is being spearheaded by Dr. Steve Goldner, head of quality assurance.
Goldner holds a Ph.D. from Rutgers and has over 40 years of experience in the pharmaceuticals industry, having had oversight on the full spectrum of products – over-the-counter (OTC), brand, and generic drugs. In addition to launching his own consulting business, Goldner's experience includes stints at Novartis, Warner-Lambert, Johnson & Johnson, and Pfizer. At one point, he was conducting 15 to 20 quality assurance audits annually in the vaccine research and development business.
"We are beyond excited to begin transitioning into Phase 3 and commercial product manufacturing," said Goldner. "That said, we are not allowing our enthusiasm, or that of our existing customers, to serve as any reason to let up in the slightest on the quality control measures that Ascendia customers have come to trust and value. Our clients need to know that we're engaging in this new expansion properly. I can honestly say in the three-and-a-half years that we've been building this program, we have had no microbial excursions at all from any kind of contamination."
Goldner is quick to point out that any pharmaceutical company is obliged to purchase the same type of equipment and adhere to the same environmental processes. Everyone must follow identical FDA regulations and must meet certain facility requirements. The criteria that set one pharmaceutical company apart from another is its ability to conduct implementation consistently. Ascendia's ability to maintain customer confidence through the progression of clinical trial material has proven effective for both short- and long-term trials.
"Now we're going where no other CDMO has gone before," quipped Goldner.
Current Ascendia Customers Already Lining Up
Well aware of Ascendia's ongoing investments in quality at every stage of the product development process, existing customers have already signed on for near-term Phase 3 development and manufacture. That vote of confidence speaks for itself.
It's one result of having experienced firsthand the difference that stringent quality control coupled with quality people makes. Ascendia has supported its customers in a wide variety of development projects, consistently delivering on robustness and an ability to validate its systems to be fully compliant with FDA and GMP manufacturing requirements. Customer confidence is further bolstered by past company successes with challenging formulation development projects employing its proprietary enabling nanoparticle technologies, such as NanoSol®, EmulSol®, AmorSol®, and LipidSol cross all modalities including orphan drugs and rare diseases.
Ascendia's well-trained, educated, highly-motivated personnel, coupled with state-of-the-art equipment and manufacturing facilities, assures the level of performance and results that have led Ascendia to be a Partner of Choice with many companies will continue in clinical trial development projects. The result is that biopharma and pharma companies will have their expectations met within full compliance with FDA regulations.
Interested in learning more? Contact your Ascendia rep today to schedule a consultation.
