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In the intricate landscape of healthcare, ophthalmology stands out as a domain where innovation is not merely encouraged – it is imperative. As we delve into the realm of eye health, the question looms How can the pharma and medical device industry support patients journey? By exploring the vast unmet need in ophthalmology and focusing on developing advanced drug delivery systems, enhancing patient adherence through less invasive treatments, and improving biocompatibility and efficacy of ophthalmic devices, the industry can lead the way in this critical field and significantly ease patients’ journey.

For several years, the Food and Drug Administration (FDA) has required manufacturers of combination products, intended for drug delivery, to identify critical performance requirements that would be evaluated and controlled for the lifecycle of the combination product. Previously, these critical performance requirements were called “Essential Performance Requirements (EPRs),” however, a formal definition was never provided by the FDA. A long-awaited guidance was released by the FDA in June 2024 that establishes and defines new terminology and clarifies expectations from the agency related to establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements. Notably, the guidance does not address all required information for submission of drug/delivery devices but rather focuses on performance related outputs and adjacent processes.

In the realm of sterile pharmaceutical products, the pursuit of high-quality packaging components stands as the cornerstone of patient safety. The recent revision of the EU Good Manufacturing Practice (GMP) Annex 1, an integral guideline governing pharmaceutical manufacturing practices, has spotlighted the implementation of the Contamination Control Strategy.¹ This strategic framework meticulously controls the management and mitigation of contamination risks. Amidst these risks lies particulate matter – a challenge that underscores the need for meticulous scrutiny within sterile pharmaceutical product manufacturing processes.

Cell and gene therapies (CGTs) are becoming therapeutic modalities of choice for complex diseases like cancer, autoimmune and genetic disorders etc. In cell therapies, the cells are sourced either from the patient or a healthy donor and are genetically modified to fight diverse disease conditions within the body, whereas in gene therapies, malfunctioning genes in the cells are replaced with a working copy of the gene. With the advent of these advanced therapies, biopharma industry is facing many challenges not only in developing molecules against new hard to target conditions but also in the logistics of scaled up manufacturing. These therapies were in early stages during the past years and logistics of small batches that are often required for clinical trials were sorted out. As these therapies are becoming mainstream, scaling up or scaling out is becoming a challenge to reach more patients mostly due to intricacies of the manufacturing and fill/finish process that differs from conventional drugs. Gene therapy drug products are mostly filled in a traditional manner within an isolator in vials whereas for cell therapies closed processing and filling in either cryo-bags or vials is the current norm. However, as more therapies are getting approved along with the advent of allogenic cell therapies that will have relatively large batch sizes, more innovation, and new products are required for fast packaging needs as they tend to become less efficacious with increased processing times due to their sensitive nature.

The United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The scope of USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systemsⁱ introduces a paradigm shift away from testing elastomeric components individually by the supplier, as was done historically under USP <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systemsⁱⁱ, to a holistic evaluation of these components when assembled into drug product packaging and delivery systems. In addition, the testing is performed on the final packaging/delivery system as produced by the drug manufacturer, using product-filled systems or systems filled with a suitable proxy, where applicable. As such, the elastomeric component supplier cannot perform USP <382> testing without knowledge of the specific drug product/proxy or the complete packaging system that the drug manufacturer plans to use. Therefore, the responsibility for USP <382> testing shifts from the elastomeric component supplier to the drug manufacturer.

As pharmaceutical formulations become more complex, the need for precision and reliability in auto-injector technology has never been greater. Traditional plungers, once considered adequate for simpler drug formulations, are now facing limitations when it comes to delivering modern complex molecules. In this article, we will explore why traditional plungers may not be suitable for these advanced medications and outline key considerations for selecting plungers tailored to the needs of auto-injectors delivering complex molecules.