INSIGHTS ON LIQUID DOSE MANUFACTURING

• Gene Therapy: Maintaining Sterility At Low Temperature Storage

  Bringing the first gene therapy for pediatric Spinal Muscular Atrophy to market in a leak and break resistant container which maintains sterility over product shelf life, through freeze and defrost cycles presented challenges. A combination of high-quality components created a proven system which ensured CCI over the product shelf life and low temperatures.

• GENiSYS® Lab Semi-Automatic Systems

  AST’s GENiSYS® Lab semi-automatic systems are ideal for drug product development and cGMP production applications. Each system automates the critical aseptic operations for vial, syringe and cartridge processing to reduce contamination risk and product variability. GENiSYS Lab offers a perfect balance between automated features, size and affordability without compromising quality, safety and ease of use.

• Optimizing Filling Technology To Minimize API Loss

  New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.

• 4 Reasons Blow/Fill/Seal Technology Should Be Considered For Aseptic Filling

  Drug manufacturers seeking alternative methods for a safe and reliable approach to drug delivery should consider blow-fill-seal technology, as it offers several benefits over traditional glass packaging.

• Aseptic Filling Of Dry Powder And Liquid In Dual Chamber Syringes

  The trend towards pre-filled disposable syringes whether of the single or dual chamber type is increasing. This webcast concentrates on the aseptic pharmaceutical packaging process challenges that need to be addressed in the final filling process of dual chamber syringes, where both liquid and powdery substances are mixed by the patient immediately prior to injection. This practice shows clear advantages as it can eliminate preservatives needs while enabling longer shelf lives.

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

  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.

• Freeze-Drying COVID-19 Diagnostics: Formulation & Process Development And Lyophilizer Selection

  Lyophilization may be considered a relatively gentle drying process, but there are still risks and pitfalls when applying it to biomolecular reagents in diagnostic tests that are different to the freeze-drying of general pharmaceuticals. Reagents typically used in ELISA and PCR based diagnostic kits for diseases, such as COVID-19 tend to contain labile  components, such as enzymes that need preserving for longevity in the supply chain or antibodies to test for a patients response to the virus, which can be challenging to stabilize for commercial use. This article summarizes a recent webinar exploring various aspects of formulation and cycle development in the lyophilization of diagnostic reagents, including those required for COVID-19 testing that may be different to regular diagnostics.

• Robotics, Isolators & Restricted Access Barrier Systems (RABS)

  The aim of advanced aseptic processing is the elimination and absolute control of all sources of contaminations - most importantly, human generated contamination. Robotics and isolator-barrier systems will be the core technologies in meeting this endeavor.

• Government Partnership Highlights Blow/Fill/Seal Advantages In Race For COVID-19 Vaccine

  Continued global efforts to incorporate BFS in the safe and efficient delivery of life-saving vaccines are proof the technology serves as a valuable tool in improving patient care across the world.