BCG therapy and its complications
BCG has been the standard treatment for non-muscle-invasive, BCG-resistant bladder cancer. However, it’s often ineffective for patients who develop resistance – with the historical fallback being radical cystectomy. Also known as bladder removal, it’s an invasive, life-changing surgery that significantly reduces quality of life.
"It's either a treatment like this one, or it's a bladder being removed. It's not even a comparison," explained a member of Ferring's supply chain team, underscoring the life-changing impact their new treatment brings.
Ferring’s innovative alternative
The company’s pioneering drug offers patients the potential for remission without resorting to surgery. Crucially, it allows individuals to maintain independence, dignity, and overall well-being.
The patient impact is profound. One team member shared the story of a patient who had undergone bladder removal, only to later discover that this new alternative treatment had become available. "The emotional weight of that was heavy. That’s why this matters so much," they reflected.
The treatment not only spares patients from invasive surgery but also avoids the burdens of lifelong catheterization and its associated challenges. That includes frequently self-inserting a catheter—sometimes up to three times a day.
From a clinical perspective, this new drug addresses an overlooked population segment—people who have suffered with limited options for too long. Patients with BCG-resistant, non-muscle-invasive bladder cancer faced two main choices: second-line treatments with limited success, or surgery.
This new option provides a non-surgical path, improving not only survival outcomes but also quality of life. That’s especially true for older populations where surgical recovery is particularly difficult.
About the project
Beyond the patient story, the project’s success hinged on seamless cross-functional collaboration. "Even people not directly involved had to adjust their workloads to give space to those working on this full-time," the team noted. The approval process required not only clinical success but also operational excellence and cross-departmental support.
A critical factor in this journey was the partnership with Adelphi Healthcare Packaging. Ferring relied on Adelphi to supply high-quality sterile vials, and closures that met strict regulatory and operational requirements. “Adelphi’s timely delivery and technical support enabled Ferring to meet demanding project timelines without compromising on quality.”
The team also chose to work with the most up-to-date manufacturing systems to support the delivery of this advanced therapy. The adoption of the automated VanRx filling system introduced new levels of precision, efficiency, and product protection.
"When the machine runs well, it delivers exceptional consistency and quality, helping us meet the highest standards for sterile manufacturing," shared one team member. The system's advanced capabilities, combined with carefully selected packaging components, play a key role in ensuring the safe and efficient production of this innovative treatment.
Regulatory success
Ferring’s regulatory journey was also key to the progression of this project. The team managed the FDA application with meticulous attention to documentation and supplier qualification – earning praise from regulators. “The FDA specifically said our vendor qualification process was very well executed,” the supply chain professional proudly shared.
This success was built in part on Adelphi’s responsiveness and technical expertise in providing necessary validation materials and certificates. “One thing I can gladly say is this – I know when we ask for detailed product information from Adelphi, not only will we get it quickly but I can also trust the information we get is of the highest standard. I can’t say this for all suppliers I have worked with”
With future regulatory changes such as the EU Annex 1 guidelines for the manufacture of sterile medicinal products, Ferring is already working proactively to ensure ongoing compliance. Annex 1 places a strong emphasis on contamination control, cleanroom integrity, and process validation – factors that are closely tied to both packaging choices and manufacturing precision.
By collaborating with trusted partners like Adelphi, Ferring is well-positioned to meet these heightened expectations and maintain the highest levels of product quality and patient safety.
Building a long-term strategy
Looking ahead, this partnership and the adoption of cutting-edge manufacturing technology represent not just a one-time achievement. They’re part of a long-term strategy for bringing advanced therapies to market. Together with Adelphi’s packaging expertise, Ferring is committed to continuous improvement, regulatory readiness, and delivering treatments that transform patients’ lives worldwide.
