Biologics have experienced steady growth over the last 15 years. Similarly, pharma reports on orphan drugs are forecasting that by 2020, six of the ten best-selling global drug therapies will be biologic sterile injectable drugs.
The development of new parenteral targeted medicine for small patient populations and the rising trend for biologics entails big changes for the pharma and biopharma industries.
They will need to adopt flexible and versatile solutions to accommodate smaller batch sizes and, owing to the high value of these drugs, ensure minimal product loss.
Meeting this growing demand for targeted therapies for parenteral delivery, INJECTA is the winning move for a scalable and reliable “medium-to-low production batch” portfolio covering the fill-finish requirements for a wide range of Ready-To-Use disposable components.
INJECTA’s outstanding scalability ensures a unique production platform from the early phases of drug development and clinical trials up to full production scale.
#Scalability is Superior Agility in Aseptic Processing.
Manufacturing targeted biologics requires flexibility and an ability to handle small numbers of high-value batches at an increased frequency. It requires greater process flexibility, versatile equipment, and a more agile approach.
Scalability is what the market is in search of.
As biopharma pipelines grow, there is increasing demand to produce multiple therapies in parallel. All of this means that sterile injectable manufacturing capabilities have to meet the need for improved scalability. This enables flexible, multi-product, small batch production, minimizing product waste and cross-contamination between drugs.
#Scalability is Standardised Design for Container Handling.
INJECTA uses the same supports and transfer devices for all types of RTU components with a unique robotic pincer for material pick&place procedures. This means built-in scalability, high flexibility, simplicity and adaptability in product handling.
Design standardisation helps INJECTA conserve its agility.
Design standardisation helps INJECTA conserve its agility when switching from one container type to another (in nest or with de-nesting), overcoming the complexity and the difficulties of performing aseptic processing with high sterility assurance. INJECTA’s container handling system provides consistency and repeatability, simplifying set up and material transfer without any glass-to-glass contact.
#Scalability is the Same Identical Pattern Repeated for One, Two, Three and up to Ten Filling Pumps.
INJECTA’s robotic multi-format filling system design meets multiple requirements, ranging from small-scale clinical trial batches up to medium-high production levels. Its unique production platform, which implements any number of filling pumps between one and ten, performs the same identical filling, check-weighing and stoppering operations avoiding re-qualification of the production process.
INJECTA, performing the same operations without process re-qualification, enhances your production efficiency.
The filling system implemented on INJECTA relies upon a unique driving system for volumetric and peristaltic pumps and a filling nozzle approved for integration in single-use package forms. Similarly, its 100% check-weighing system can count upon the same HW components for the weighing cells, the same change over parts and the same SW process.
When handling syringes, stoppering operations are performed with the same deep tube and vacuum insertion. In the case of vial stoppering, all operational sequences are identical for both lyo & non-lyo stoppers. When it comes to handling the new integrated rubber & plastic caps, recently introduced on the market, INJECTA handles them in the same way.
The INJECTA family in all configurations ensures unique, standardised sterilisation, filling and stoppering performance, leading to improved product quality and superior manufacturing efficiency.