Quality and speed are extremely important in early phase clinical trials.
When syringes or other more complex delivery systems are to be used in a clinical trial, transferring a product to a manufacturer is a complex process.
Choosing a manufacturing partner with the right capabilities and the expertise to support future drug product development is critical.
Planning and preparation for the clinical batches are extremely important.
About Vetter: Expertise in aseptic filling and packaging of complex products: Vetter’s facilities in Germany and the US to support biologics.
Market and development strategies: The growing need for syringes.
Outsourcing preparation: A checklist to consider for your project, including planning, product knowledge, primary packaging materials, excipients, shipment, analytics, process definition, documentation and fit with the CDMO.
Case study: Successful Transferring Technology to a CDMO: A project to transfer from vials to syringes during early phase clinical studies.
Pharmaceutical market requirements are increasing due to regulatory pressure for higher standard in safety and integrity of drugs and the rising of new drug delivery system.
This is affecting directly the existing glass prefillable syringes characteristics and functionality even if the request is to not introduce new materials of contact between the drug and the primary packaging.
This paper is illustrating a new generation of high performances syringes as outcome of a manufacturing process that guarantees optimized dimensions and tolerances for autoinjector compatibility, low tungsten level and high cosmetic quality.
These characteristics are taken to the next level thanks to the application of a specific silicone oil based internal coating, which leads to an extra low particle level, reduced extractable and leachable, limited pH drift and very good functional performances.
A methodical approach including a precise selection of rubber closures guarantees the creation of a full system able to answer to the need of low particles and best in class performances.
These characterization allows to define the best choice of syringes suitable for the new high-demanding drugs, avoiding issues related to the interaction between the product and the primary container, thus entering on the market in a definitely shorter time than usual.
The presentation will cover different processing solutions for ready to fill containers.
For laboratory use the latest generation of semi-automatic processing modules will be explained.
Furthermore, a highly-flexible and fully-automatic system for processing clinical trials and minor batch sizes will be described followed by a small scale processing platform with flexible production trolleys that are operated in a standard isolator system.
Our medium and high speed production machines will conclude the presentation. In addition a flexible filling machine for pre-sterilized container types such as syringes, vials and pre-capped cartridges will be explained in detail with the different available options and equipment.
The design of extractables and leachables studies for Pre-Filled Syringes depends on the intended application. Therefore, every specific case requires a tailor-made study set-up.
This presentation will initially discuss the basic definitions of extractables and leachables, before going over the most important regulatory guidelines, on to the actual design of the E/L studies.
It will focus on the most important variables to consider (type of extraction solvents, material-to-solvent ratio, temperature, extraction times…) and how to obtain correct and useful extractable information for further assessments.
Subsequently, it will demonstrate how the list of obtained extractable compounds can be narrowed down to a list of target compounds that can be subjected to a toxicological assessment or be used in a targeted leachable study.
In a last part, the set-up and time line of leachable studies for pre-filled syringes will be explained and illustrated.
A new generation of inspection machines for syringes now also with plunger rod already assembled.
Fast pre spinning turret for air bubbles elimination together with special inspection algorithms for air bubbles recognition will drastically reduce the false rejection rate.
New high speed and high resolution sensors, innovative technology in conjunction with more powerful real-time dedicated processing electronics, allowing to reach reliable results also for the top plunger inspection, an important cosmetic inspection now available among the innovative Optrel's inspection performances.