The CDMO and generic drug industry is growing and changing fast. COVID-19 and geopolitical issues such as reliance on China as a manufacturing resource has forced pharmaceutical firms to look for new, but reliable, supply chains, something most companies had taken for granted, for decades. 

Meanwhile the demand for more and more sophisticated drugs continues to accelerate. 

These changes present many challenges for pharma firms looking to keep up. But one key advantage continues to be the difference maker in pharmaceutical manufacturing—innovation. Because of the rapid growth of contract development and manufacturing organizations (CDMOs) and generics manufacturing, many new players have entered the industrial arena and many others are consolidating, adding more uncertainty in making the right choice of a manufacturing partner. 

Contract manufacturing and aseptic processing is not an easy process: supply chains, collective experience and expertise in development, manufacturing, delivery, regulatory compliance and cGMP are not created overnight. A seasoned partner that can embrace and develop innovations in a realistic manner is crucial to success.

One major innovation at Ritedose has been our adoption of, and improvements on, blow-fill-seal (BFS) technology. A key benefit of BFS is that it is closed and automated—a plastic container is formed within the equipment, filled with sterile solution, and sealed closed, with virtually no human intervention. Other benefits include efficient production of unit-dose containers at high volumes, ability to rapidly scale production for surge capacity, a consolidated materials supply chain, and a significantly reduced risk of contamination. While earlier challenges of BFS included the technology’s inability to handle more complex solutions, Ritedose has developed the capacity to handle oxygen- and temperature-sensitive products. 

Maintaining billions of doses of inhalation therapies made under aseptic processing conditions has required several innovations. Making sure processing remains aseptic requires more sophisticated factory floor instrument and safeguards, as well as exercises like validation and media fill “drills” to ensure safe processes, discover needs to improve in processing and develop ways to fix and improve how we manufacture these drugs. Artificial intelligence is also starting to play an important role, ranging from identifying inefficiencies to better managing what is only becoming more complex product and process data. AI is ushering in more digitization of processes, standard operating procedures, batch processing and QA/QC. 

Even the respiratory and ophthalmic drugs themselves come about due to innovation. 

The Ritedose team is a manufacturer for Verona Pharma’s newly approved drug Ohtuvayre (ensifentrine) for chronic obstructive pulmonary disease (COPD). It is the first inhaled product in 20 years to use a novel mechanism for maintenance treatment of the disease. It is a dual inhibitor of phosphodiesterase-3 and phosphodiesterase-4 that combines bronchodilator and non-steroidal anti-inflammatory effects in a single molecule—a first for respiratory treatments. Our manufacturing capacity has had to implement new methods to maintain levels of aseptic production high enough to safely and efficiently meet expected patient demand. 

A CDMO cannot ignore the “development” part of its business, of course. Transforming clinical trials into therapies is a data-intensive process, and requires scientific, operational and regulatory expertise to successfully turn these experiments into an FDA New Drug Application (NDA) and ultimately a new drug or vaccine. These new products almost always reflect newly gained knowledge of the science behind the disease, and innovative approaches to addressing illness. 

The professionals behind any CDMO and generic drug are key. Expertise and experience matter, for resolving daily issues on the line and developing new technologies to meet the constantly changing pharmaceutical landscape.