INSIGHTS ON LIQUID DOSE MANUFACTURING

• Take Your Drug From Concept To Clinical To Commercial

  Sterile Parenteral, Aseptic Fill-Finish: The GENiSYS® R aseptic filling and closure system is a fully robotic, automated line providing accurate precision-filling and eliminating the loss of costly drug product.

• Determining Performance Improvements in NovaPure® Plungers for Syringes in Autoinjector Systems

  NovaPure 1-3 mL plungers were developed for use in pre-filled syringes - especially those coupled with autoinjectors. This poster presents a 1-year study examining performance with placebos of different viscosities (1, 8, 15 cps) in a laboratory configuration that replicates an autoinjector.

• GENiSYS R: Aseptic Filling Of Liquid Pharmaceuticals

  The AST GENiSYS R provides ultimate flexibility for the aseptic filling of liquid pharmaceuticals. Designed with the specific challenges of small-batch production in mind, the GENiSYS R can be built to meet the needs of your facility today and for years to come. Learn more in our latest video.

• The API Process Development System For Personnel And Product Protection

  The API Process Development System was designed to provide personnel and product protection when working with powder and liquid substances. Read more about this solution that offers easy operator access for cleaning purposes, inlet HEPA filtration, bag-in/bag-out filtration with dual HEPA filters, and LED lighting and acrylic viewing panels maximized lighting across the workspace.

• Freeze Drying Of Vaccines – Challenges And Concepts In Formulation And Process Development

  7/29/2020

  Vaccination prevents millions of deaths from infectious diseases per year; however, there are still millions of people who die from these diseases due to weak thermostability demanding cold chains, long-term stability issues and distribution challenges. All these limitations can be overcome by creating a dry product through lyophilization. With the urgency to develop a coronavirus vaccine, it is a crucial time to discuss the process of freeze-drying vaccines. This article summarizes a recent webinar that discussed the suitability of freeze-drying vaccines to increase their thermostability.

• Container Closure Integrity: A Risk-Based Approach To Ensure Drug Product Quality

  8/4/2021

  Container closure integrity is essential to protect the drug product through shelf life and to demonstrate an integral system to regulatory agencies. A proper risk-based approach enables creation of a robust data file that can assist in the timely approval of regulatory applications.

• Aseptic Fill Services

  4/7/2020

  First to the market is always key in the pharma industry. "Right first time" is also a key slogan often heard in the pharma industry. With the creative sterile filling solutions that we have to offer, you can learn how Pii, quick to act and your very own personalized CDMO, can help bring your concept to clinic in a nimble fashion, right first time.

• Zeta Potential Studies On The Surface Treatment Of Prefilled Syringe Barrels

  4/14/2020

  Plastic and disposable prefilled syringes are getting more and more common. The major challenges in this industry for the manufacturers include the interaction of the material of the prefilled syringe with the drug. SurPASS 3 and its dedicated measuring cell for prefilled syringes offers the possibility to investigate the inner syringe surface of the different barrel materials.

• Partner Perspectives To De-Risk Commercialization Of Combination Products

  7/27/2021

  Developing an effective drug-device combination product for self-administered biologics is a complex process. A well-executed strategy will help support integration with manufacturing operations and successful drug delivery.