Sterile Injectables in Pharma

Sterile injectables in pharma are transforming the pharmaceutical industry. They enable patient-specific therapies such as vaccines, gene and cell therapies.

These therapies require strict storage, handling and distribution requirements. This makes a close collaboration between pharma development firms and contract manufacturing organizations essential. This cooperation is also vital to ensure a consistent global supply of sterile injectables for clinical trials.

Development of long-acting injectable formulations

The long-acting injectable (LAI) format is a promising way to deliver pharmacological therapies with long durations of action that require fewer injections. Unfortunately, the development of LAI formulations is challenging because of the difficulty in combining long durations of drug release with the ability to self-administer. Self-administration is possible only for formulations with low viscosities, which are difficult to achieve at the high concentrations required for long durations of release.

Most marketed ISFIs use polymer excipients to sustain long-term drug release and secure mechanical integrity, which substantially increases formulation viscosity at required concentrations. However, a high ratio of polymer to drug limits drug loading. The use of micro/nanoparticle drug suspensions circumvents this challenge and allows for significantly higher levels of poorly soluble drugs to be delivered at long durations. However, these formulations suffer from clogging and cannot be easily retrieved after administration, which is particularly problematic in situations where reversibility is required (e.g., contraceptive products).

The formulations described herein overcome these challenges by encapsulating proteins in aqueous lipid carriers. This method improves therapeutic indices by prolonging protein release and bypassing biological barriers. The resulting formulations can increase AUC/Cmax and Cmax/trough ratios relative to a conventional regular-release dosage form without causing ill effects in the subject. The lipid carriers also reduce the rate of drug degradation in vivo and protect against pH and temperature fluctuations, which are significant obstacles for the delivery of protein therapeutics.

Development of devices that allow patients to self-administer their therapy

Injection devices are a key piece of pharmaceutical products and allow patients to self-administer their therapy in a safer and more flexible way. This helps reduce costs by removing the need for patients to visit a doctor or hospital as often, and increases compliance and patient satisfaction by allowing them to control their own treatment regime.

Many of the new injectables being developed today are designed to be administered via a needle by the patient in their own home. This is a trend that initially came from diabetes treatments, but has now expanded to other therapeutic areas. The trend is being driven by a combination of factors, including a desire to lower costs and the desire for more flexible and convenient delivery systems.

The market for generic injectables is hot right now, particularly in oncology. This is because a number of cancer treatments that are delivered in injection form have recently gone off patent, such as Eli Lilly’s Gemzar (gemcitabine) and Sanofi-aventis’ Taxotere (docetaxel).

The demand for injection devices with advanced features has also been driving growth in the sector. For example, Bespak has seen strong interest in its VapourSoft(tm) powered Syrina(tm) range of self-administration devices, which can be used with a wide variety of drug formulations and volumes and is capable of detecting and addressing issues such as drug viscosity and flow.

Development of combination products with injection devices

Injection devices are increasingly becoming the focus of pharma companies’ attention. This has been triggered by the increased demand for combination products and the need to offer patients convenient, user-friendly devices to self-administer their therapies. In addition, pharma companies are looking to use injection devices as a strategic differentiation asset. This could be in terms of outer device design or the value proposition they provide to patients.

The development of injectable combinations requires thorough analysis and understanding of the drug and device interactions, including their impact on the product quality, safety and performance. This is particularly important because drug-device combinations are governed by different requirements and regulations in different regions. For example, the European Union’s new Medical Device Regulation (MDR) raises the bar for sterile injectable drug-device combinations, which will need to be assessed by a Notified Body to receive a certificate of conformity.

Moreover, the integration of software and electronics into drug-device combination products adds further complexity. This requires close collaboration between drug sponsor, CROs and CDMOs. It is also vital to identify the user and stakeholder needs and translate them into design input requirements at an engineering level. This will help ensure that the device and drug are compatible, minimize interactions, and reduce extractables/leachables. These issues will need to be documented in a risk management plan and addressed during the development phase.

Development of injection devices as a strategic differentiation asset

Injection devices are increasingly seen as a strategic differentiation asset for pharma products. This is because more and more treatments are being pushed into the home setting, where patients must be able to administer their own treatment. This trend has fueled demand for injection pen devices, which are easy to use and help reduce costs by eliminating the need for trained professionals.

This has also increased the need for devices that can handle higher dosages and viscosities. For example, the latest generation of biologic drugs are often injected into the bloodstream and must be administered at high concentrations or over an extended time period. Injection device manufacturers are addressing these challenges by developing systems that can hold higher volumes and deliver doses over longer periods of time.

These systems can also feature integrated actuation technology that allows for a smoother and more accurate dose delivery. They can also include a data collection system that automatically records each injection and sends this information to a remote server or an app. This can help monitor compliance, increase patient adherence and help improve healthcare outcomes.

Injection device manufacturers must continue to invest in research and development. This includes analyzing potential use error risks in the early design stages, conducting human factor and usability studies and optimizing primary packaging to ensure the safety of self-injection devices. In addition, it is important to develop innovative production technologies, such as tool-free changeover systems, that decrease production downtime and increase reliability.