Manufacturing & Processing
PEER REVIEWED
The Opportunities and Obstacles of Filling and Packaging Pre-filled Syringes Pre-filled syringes (PFS) offer plenty of advantages for injectable drug formulations, but also have challenges ranging from sterile integrity requirements to packaging. Robert Fielders, Director, Engineering at Recipharm, presents the benefits that the PFS format gives the pharmaceutical industry and patients and provides advice to solve the common challenges associated with PFS filling and packaging.
The PFS format is increasingly being used for the administration of medicines, with benefits for dose accuracy, ease of use, and reduced patient risk. This is reflected in the rapid growth of the international PFS market, which is expected to be worth $6.5 billion by 2030, up from $3.6 billion in 2021.1 Multiple drivers are contributing to PFS market growth: Growing Demand for Injectable Biologics and Biosimilars The biologics market is set to be worth $900 billion by 2030.2 Demand for injectables has grown as a result of the rise in chronic conditions, such as autoimmune diseases or cancers. Biologics are often more selective than conventional medications in targeting the disease-modifying facets of human physiology. Many of these target the immune system, making them prime therapeutics to treat many immune-related chronic diseases. Biologics are often developed for parenteral administration to increase bioavailability as they are often broken down by oral administration. An injectable format that offers patient convenience benefits is highly desirable for treating chronic conditions, and can help therapies stand out in a competitive market. Planning for Future Pandemics The global COVID-19 vaccination programme to protect patients from potentially fatal virus symptoms required fast action from the pharmaceutical industry and from governments too. Although the vaccination campaign was highly successful, it flagged areas for improvement. At the time vaccine products needed to be manufactured and delivered efficiently and in high volume using vials to contain multiple doses. A disadvantage to this approach was the patient turnover time at vaccination centres. Each patient required a syringe to be prepared and filled from a vial, adding a cumulative time impact, which restricted the number of vaccinations that could be performed within a day. There are lessons to be learnt from COVID-19 for future outbreaks or for seasonal flu vaccination programmes. In particular, there needs to be better infrastructure in place to speed up the administration of vaccines to the general public. Learning from the pandemic is crucial and an injectable format that can simplify the vaccine administration process can significantly speed up the turnover of patients, allowing more 24 INTERNATIONAL BIOPHARMACEUTICAL INDUSTRY
people to be vaccinated each day. Ready-prepared injectables, like PFSs, also have the potential to enable self-administered vaccination for tourists against tropical diseases. Making Injectables Patient-friendly Traditional injectable therapeutics represent distinct challenges for patients and healthcare professionals (HCPs), which is why PFSs are becoming increasingly attractive to pharma companies. Possibly the biggest barrier to administration for injectables is that most require direct HCP interaction. HCP-administered injections are a major time burden for patients who have to schedule and travel to a clinic. This may cause patients of working age to lose income as they take time off work, and patients with mobility issues may struggle to travel for their treatment. The process also burdens healthcare systems as HCP resources are occupied while administering injections. Although self-administration of injectable therapeutics has the potential to ease burdens and enhance adherence, some barriers need to be overcome to see this become a reality. One of the reasons that injectables aren’t as easy to self-administer as other forms of medication is that there are complexities in preparing standard syringes for administration. This can be a large hurdle for patients with dexterity issues, poor eyesight, or many other useability issues that are often associated with age. The negative perception of needles and the practicalities of self-administering injectables in populations with these issues also serve to reduce patient adherence and a reluctance to take on injectable treatments. This has fuelled a movement from pharmaceutical companies to investigate ways that injectable therapeutics can be made into products that patients are confident to use at home, school, or in the workplace – removing the need for dependence on clinical settings. The use of a PFS format is viewed as a crucial step in allowing the self-administration of injectable drug products. The simplified preparation and precise drug concentration in every dose enable patients to have peace of mind when self-administering doses. The risk of administering an incorrect dose is minimised by the dosage being pre-determined at the filling stage. This avoids potentially ineffective doses or toxic doses that could be devastating to patient health. Empowering patients to use a PFS to administer their medication provides many advantages – including a significantly enhanced adherence to dosing and the subsequent effectiveness of the treatment. This allows the healthcare system to relieve pressure by taking HCPs away from routine injections. In short, the ease of use and confidence gained from using a PFS offer benefits for pharmaceutical companies looking to develop more supportive and patient-centric therapeutic approaches not just for vaccines but other applications. Spring 2023 Volume 6 Issue 1