Project Life Cycle - Case Study: Implementation of a Pre-filled Syringe (Markus Seitz, Vetter)
The presentation will give insight into Vetter’s project approach on implementing the manufacturing of new products at their manufacturing facilities and the services that can be offered. As an example the project of implementing a combination product will be described in more detail.
The different development phases within the project life cycle will be outlined including the selection of packaging material, first development trials on lab scale followed by scale-up trials and final GMP manufacturing and the handover to commercial manufacturing for continuous market supply.
The basic decision is first of all the handling of the substances within a multi-product facility. It is possible at Vetter to handle all kinds of protein-based substances like monoclonal antibodies, cytokines, hormones, or also suspensions and non-live vaccines.
The requested batch size and primary packaging material is then deciding on the manufacturing site as well as on the respective clean room at Vetter. On the basis of the combination product project an overview will then be given what kind of development approach was chosen to implement a robust process including the whole supply chain for commercial manufacturing in the end.
Practical Issues on PFS Sterilization: an Analysis of Critical Aspects (Maria Luisa Bernuzzi, Fedegari Group)
Over the last years, drug manufacturers have been facing an increasing sophistication on packaging mainly regarding to the use of variable volume containers.
Technical complexities about the sterilization of heat-sensitive materials, such as pre-filled syringes, constitute one of the major challenges in the parenteral drug industry. The heating phases of the sterilization cycle can be considered the most critical steps of the process.
In fact, when the pressure inside sealed containers increases and the liquid expands its volume the variation between internal and external pressure moves the syringe plungers.
This way, an excessive increase of internal pressure may cause syringe plunger displacement. In order to avoid mechanical or microbiological damages, a detailed understanding for developing the most appropriated sterilization cycle is required.
Glass containers are the primary packaging choice for drugs and vaccines in the pharmaceuticals market due to the intrinsic inert nature of glass Type I.
Essential requirements of the new biotech formulations are high hydrolytic resistance, high neutrality and chemical resistance of the inner surface to preserve drugs potential, increase shelf life and reduce rejection rate for leachable.
The “ready to fill” concept is gaining market shares not only for syringes but also for cartridges and vials and asserts the need of a new quality level based on highly controlled dimensional accuracy for automating processes and the highest cosmetic level to reduce more expensive end-of-line rejection rate and assuring market acceptability.
Injectable drug manufacturers are challenged to minimize risk, accelerate product development, ensure patient safety and improve ease of administration. At the same time, companies must differentiate their new products within therapeutic categories that are very competitive.
Prefillable syringes and cartridges offer many benefits as compared to vial formats including precise dose accuracy, less drug overfill for lower unit cost, and drug product differentiation.
Proper selection of primary elastomer components, used to package and deliver drugs in syringe or cartridge formats, is critical for patient safety and must be considered during development.
This workshop presentation is designed to educate participants, provide case study examples and includes content for: • Market trends driven by regulatory expectations • Matching component designs to meet user requirements • Component material selection and criteria • Considerations for functionality and container closure integrity • Ready-to-sterilize and ready-to-use components to meet fill-finish technology
Insight Into the Changing World of Auto Injectors: Trends, Partnerships and Key Learnings (Steven Kaufman, SHL Group)
The demand for self-injection devices, such as auto injectors, is increasing steadily. Now, biopharmaceutical companies are faced with the challenge of developing an effective device strategy to ensure that they can offer a range of solutions to address the needs of patients globally.
Drug delivery device companies are now working more closely than ever before with biopharmaceutical companies and key partners to prepare devices that can overcome a range of challenges from higher viscosity and injection volumes to human factors needs and increased regulatory scrutiny.
As such, it is vital that companies share more data and key learnings with one another about the newest biotech PFS, testing parameters, specialized primary containers, final assembly options and more.
Fill & Finish in Aseptic Environment for Ready-to-fill Glass Containers (Carsten Kern, Bausch + Stroebel)
Bausch + Ströbel, one of the world’s leading manufacturers of pharmaceutical equipment, will present their new concepts for fill and finish in aseptic environment for ready to fill glass containers.
Today’s principal topics will be the processing of different containers in nests under RABS and isolator. The high speed processing in nests comprises the steps: tub debagging, removal of foil lid and liner, filling and closing of syringes, vials and cartridges.
Further processing of containers consists of labelling, plunger rod insertion, assembly of safety devices and back stops.