SFF
Pre-filled syringes have become increasingly favoured across the healthcare industry due to the variety of benefits they provide. Offering a lower risk of misdosing at the point of care and ensuring accurate dosage administration, these syringes are primarily designed with the needs of the patient in mind.
However, there are several considerations pharmaceutical companies must make when selecting the right drug delivery format for their formulation. During DCAT Week, our Head of Sterile Fill & Finish Dr. Ulrike Lemke met with Grant Playter, Associate Editor at PharmTech, to discuss the current state of the market and the considerations for bringing the right therapies to patients.
The current market state
Expectations from regulatory authorities for enhanced patient safety have kept the industry vigilant in recent years. This has resulted in the introduction of the Annex 1 compliance framework, scheduled to come into effect in August 2023. The framework prompts the market to reconsider the handling of aseptic products and emphasises patient safety.
Naturally, meeting these requirements necessitates investments. Although these developments are positive, it is essential to ensure that the costs for patients do not skyrocket while continuing the strive to enhance the safety of these medicines.
Key considerations when deciding on a form of drug delivery
When determining the optimal delivery format for a drug product, there are a few key considerations to make:
- Consider the patient’s needs: Determine the optimal method of administration and dosage scheme for the patient. This involves considering whether the medicine will be self-administered or given in a hospital or point-of-care setting.
- Evaluate your target market: Assess the desired patient population, their maturity and the training status of their caregivers.
- Implement preventative measures to minimise formulation errors: Some drug product formulations, such as lyophillised products, require reconstitution back into a liquid form by the caregiver or patient themselves, making them susceptible to human error. Clear instructions and foolproof packaging should be provided to prevent such mistakes from occurring.
- Prioritise patient centricity: Address any patient-centric considerations such as supply chain logistics, caregiver training centres and patient convenience.
- Evaluate physical and chemical parameters: Examine the properties of the substance, including drug substance stability and bioavailability enhancement.
- Examine process efficiencies: Ensure the efficacy of the manufacturing process, API preservation, distribution logistics and cold chain management.
- Tailor the approach: Evaluate approaches to ensure they meet the diverse needs of pharmaceutical companies, biotechs and innovators for effective market service.
Looking ahead
It’s an exceptional time to be a part of the industry, with continuous growth and innovation in the field of biologics evolving at a rapid pace. Looking ahead, it is crucial to shift focus not only to patient-centric drug delivery and modality but also towards serving currently underserved markets, such as those in developing countries or regions.
Overall, it is imperative that we capitalise on the valuable lessons we have learned from the pandemic. From supply chain issues to cold chain logistics and drug administration challenges, many challenges were highlighted during this time, and we must continue our efforts to mitigate them. By doing so, we can proactively prevent future shortages, especially in medicines that play a vital role in preventing and combating any future pandemics.
Read the full piece with Dr Ulrike Lemke and Grant Playter discussing current industry trends and predictions for the future by clicking the button below.