The global pharmaceutical market sale had reached nearly one trillion U.S. dollars.
North America is responsible for the largest portion, generating more than 40 percent of the sale. The global pharmaceutical market could be worth nearly $1.6 trillion by 2020.
Demand for medicines is rising rapidly in the growth markets (China, Brazil, Russia, India, Mexico, Turkey, Poland, Venezuela, Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam). In the past 10 years, over 300 medicines have been approved.
Taiwan's pharmaceutical industry generated total revenues of NT$83.2billion in 2014.
To ensure a smooth transition to a knowledge-intensive economic model, the Biotech and New Pharmaceutical Development Act was legislated on July 6, 2007 to promote the development of knowledge-intensive industries such as new drugs investigation and high-level medical devices development, and to drive the transformation of Taiwan’s economy.
ISO 11040-4:2015 Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling tubing-glass barrels (single-chamber design) for injection preparations, and sterilized subassembled syringes ready for filling.
It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040 4:2015.
ISO 11040-7:2015 Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling.
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.
Commercializing drug products has become more challenging, especially when launching complex drugs in a vial or prefilled container.
Component design and material selection during development must take into account the drug stability during storage, robustness of the container closure system, and intended user requirements to ensure safety and effectiveness of the medicine.
In this talk, we will review component selection strategies being applied by leading companies for multiple container formats.
It is essential that components used to store and deliver drug products be of the highest quality and designed to support combination product needs.
This presentation will provide an overview of the development, scope and content of the PDA technical report 73.
Written by industry experts, the report showcases the current state-of-the-art for 1 ml long syringes used for biotechnological products, and is designed to help pharmaceutical companies develop their own user requirements for their products.
By attending this presentation, the audience will have gained an understanding of the key issues that must to be considered when developing such a delivery system. The presenter, as both author and co-author of several chapters, will answer questions from attendees.
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 implementation of single-use technologies in the final filling process is steadily increasing. Single-use technologies can effectively meet the stringent requirements for this final process step with proper assembly design and integration.
This presentation will discuss single-use assembly design considerations and practical applications for these assemblies in the final filling process.
Particular attention will be given to the topics of flow path sterility and integrity as well as operational safety and efficiency.
The pharmaceutical demands on machine manufacturers are steadily increasing. In the recent past, clean room classifications (RABS / isolators) and sterilization processes (UV / H2O2 / Plasma / e-beam) were the main focus.
Today dosing systems (rotary piston pump, time pressure, peristaltic pump) and stoppering are of great importance. Another trend of prime importance is the demand for automatic and 100% IPC. Nested syringe machines must thereby provide a wide variety of performance options.
Established syringe manufacturers are now offering nested cartridges and vials.
Machine manufacturers need to act on such trends with sophisticated and flexible solutions.
Multi use filling machines for ready-to-use components are the new trend in the pharma industry. Today smaller batch size and higher value products are used compared to previous larger batch sizes.
Optima pharma has realized the demands and has established a high flexibility to process ready-to-use components on one machine (Multi use filling machines).