The outlook for parenteral manufacturing is very good. Increasing demand for injectable biologics and after the "patent cliff" period most of the leading pharmaceutical products are parenterals.
This will remain the case in 2016 and towards 2020. Besides many of the small products (orphan drugs and others) are parenterals and we may face a challenging future where many parenterals are manufactured in quite small volumes - a "long tail of small products".
This has impact on parenteral facilities of the future. They need to be planned and designed with future needs in mind, both on flexibility and on agility.
In tablet manufacturing the new flexibility needs can be met by new technologies such as continuous manufacturing. But in parenteral manufacturing very few facilities have been thinking "out of the box" and few suppliers of equipment can provide the flexibility that will be needed in the future.
FDA has been promoting that the pharmaceutical industry should learn from other industries and there are many enablers for pharmaceutical agile technology for the facilities of the future. Some of these future enablers for agility and flexibility are presented.
Biotechnological/Biosimilar medicinal products are regulated in Turkey according to ‘The Regulation on the Registration of Medicinal Products for Human Use’ and ‘Biosimilar Medicinal Products Guideline.’ According to the Turkish Guideline on Biosimilar Medicinal Products a biosimilar drug is a medicinal product that shows similarity to a licensed biological reference product in terms of quality, safety and efficacy.
The active substance of a biosimilar product should show molecular and biological similarity to the active substance of the reference medicinal product. The pharmaceutical form, potency and route of administration must be same as of the reference biological product.
In order to show the similarity in terms of quality, validated state-of-the-art analytical tests should be performed that are sensitive enough to detect the possibilities of changes to the product.
Differences between the biosimilar and the reference product should be evaluated for their potential impact on safety and efficacy of the biosimilar.
The decreasing number of approved drugs produced by the pharmaceutical industry, which has been accompanied by increasing expenses for R&D, demands alternative approaches to increase pharmaceutical R&D productivity.
This situation has contributed to a revival of interest in peptides as potential drug candidates. The notable expansion of peptide therapeutics development in the late 1990s and the 2000s led to an unprecedented number of marketing approvals in 2012 and has provided a robust pipeline that should deliver numerous approvals during the remainder of the 2010s.
More than 20% of drugs belonging to the top 200 sales were based on peptides, proteins or antibodies, with sales reaching US$ 40 billion and, hence, approximately 10% of the overall figure for the pharmaceutical industry.
To date, hundreds of synthetic therapeutic peptides are in clinical development, and even more are in advanced stages of preclinical development in the pipeline of biotechnology and pharmaceutical companies.
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.
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.
Processing of biotech products in liquid form (Dirk Schuster - Groninger)
Processing liquid biotech products not only calls for highest precision but also for highest flexibility. Filling these often expensive bio products demands absolute highest precision when filling accuracy and any sort of product loss are concerned.
Biotech products are often filled in either cartridges, syringes or vials. Not seldom all three are processed on one production line, which requires highest flexibility.
In this presentation we will go into the technical details of these requirements and into the possible technologies meeting these requirements.
A new generation of automatic and semi-automatic visual inspection machines with continuous handling increases the Optrel portfolio for the next years.
New high speed and high resolution sensor technology in conjunction with more powerful real-time dedicated processing electronics open opportunities to increase the performances of the syringes inspection machines by implementing not only detection algorithm but also classification strategies in real-time.