A prefilled syringe (PFS) is a medical syringe that comes prefilled with a specific dosage of medication.
PFS have been around for more than two decades and represent one of the fastest-growing segments among the injectable drug delivery devices market. The advantages of PFS are their convenience, compliance, reliability, functionality, accuracy, sterility, and safety.
Transparency Market Research report says growth will be triggered by biologics and other potent injectable drugs as well as technical advances in PFS manufacturing and packaging.
For instance, PFS are used to package injectable drugs and diluents such as vaccines, blood stimulants, therapeutic proteins, erythroproteins, interferons, and rheumatoid arthritis.
In the past, metal or glass syringes were popular, but increasingly there has been a movement towards plastic and disposable syringes.
Therefore, the needle needs protected and cannot be re-used (prefilled disposable systems). While growth of PFS looks promising, there are some the key challenges that exist in the PFS market include interface incompatibilities (polymer, silicone oil, particles, adsorption losses, etc.), and physical and chemical instabilities due to leachables and poor barrier performances.
The integration of PFS with advanced delivery systems such as pen and autoinjectors will be one of the key drives for their adoption going forward.
Prefilled syringes are industry's choice of platform for further innovating your product and adding value.
With biological drug products being so complex, a huge amount of consideration needs to be taken regarding delivery method, design of primary packaging, device and analysis of product stability, safety and efficacy.
A system approach is needed because of the interaction between the biodrugs unique features (i.e. viscosity), drug delivery devices, such as autoinjectors, and syringes different geometries and elemental compositions.
All these are critical aspects that need to be carefully evaluated in order to guaranteed an effective, safe and painless injection to the patient.
This paper will highlight how to set critical parameters to fulfill these requirements.
Today’s pharmaceutical and biotechnology companies are increasingly under pressure due to a variety of factors including ever-rising drug development costs, highly competitive markets, and increasing regulatory demands.
Any competitive advantage that can be applied to the development process therefore is highly desirable.
One advantage is starting the development of a compound in a prefilled syringe earlier rather than later.
Syringe development is a promising alternative to vial only development, because a company having the insight into the potential of a product in syringe form earlier in the process may have to spend some more resources upfront, but the success and payoff for the company at later stages of the trial or at market launch can be significant.
As ‘patient and caregiver’ friendly administration systems continuously increase in demand, being able to offer solutions in this field can give a company a distinct advantage.
A discussion of the benefits resulting from development in a syringe will be reviewed and how development firms can work closely with the manufacturing organization to make it easier to start syringe work earlier in the development process is presented.
This presentation provides an overview of the many challenges faced by today's pharmaceutical and biotechnology companies during their drug development and examples of how companies can overcome some of these hurdles by including prefilled syringes earlier.
Key subjects involving time savings and an increase of the drug package´s attractiveness as well as issues to be considered within the development process are discussed, and possible conclusions reached.
The presentation also presents a case study of clinical development in syringe with typical development challenges and how to solve them.
This presentation provides an overview of key self-injection devices, such as auto injectors, and how they support the growing trend of injectable biologics coming to market.
The session starts with an introduction of different types of auto injectors and pen injectors, including some products that have helped to revolutionize the industry.
Trends such as the increased importance of human factors, regulatory changes, alternative materials for primary drug containers and speed to market demands related to an influx of generic injectable and biosimilars will be highlighted.
Based on the practical experience of working with leading biopharmaceutical companies to develop such devices, the speaker will provide advice on what to look for when identifying suitable partners to support these combination product programs.
The presentation will first very briefly go over some basic definitions of Extractables and Leachables, the importance of Extractable Leachable testing and the most important Regulatory Guidelines (US, EU) for container/closure systems for parenteral applications.
In a second part, the set-up of extractable studies for parenteral applications will be touched upon.
This will be illustrated examples of materials, used in the manufacture of containers and closures used for parenteral applications. It is therefore important to design the extractable study (with variables such as the type of solvents/extraction vehicles, use of drug product vehicle in extractable studies, material-to-solvent ratio, extraction times) in order to obtain correct and useful extractable information for further assessments.
Examples will be given of both well-designed and ill-designed extractables studies. Subsequently, the presentation will illustrate how the list of extractable compounds, obtained after a carefully designed extractable study, can be narrowed down to a list of target compounds that can be subject to a toxicological assessment or a targeted leachable study.
In a last part, the approach of how to design leachable studies for primary packaging of parenterals will be explained and illustrated.
Design and Application of a Single-Use Filling Needle for Aseptic Filling (Mona Steurenthaler, Pall)
Single-use components such as tubing, connectors, and filters have been widely used for many decades in bioprocess unit operations.
In more recent years, many other process components have been designed for disposability such as bioreactors, mixers, and chromatography and ultrafiltration systems.
Although such developments have raised the possibility of developing fully disposable multistage processes, some unit operations have not been easy to convert to single-use because of limitations on scalability, costs, performance, and/or the unavailability of single-use options.
One operation in which single-use technology is now becoming more widely adopted is formulation and final filling.
One major challenge in developing disposable systems for final formulation and filling is replacing the stainless steel, cleanable filling needles with a cost-effective, single-use alternative.
Pall has taken up this challenge and would like to present the design features and performance of their new Allegro single-use filling needle.