Featured Articles

41. The Importance Of Defining A Practical Performance Test For Vial Washers 7/30/2020

    Different pharmaceutical companies have different preferences in test methods but it is important to define the expected results so they are achievable and evaluate the cleaning effectiveness of the important parts of the vial. This paper explains the pros and cons of different washer systems.

42. Minimizing Aseptic Pharmaceutical Manufacturing Risks With The Inclusion Of Depyrogenation Tunnels 7/29/2020

    Depyrogenation, as the name implies, is the process to remove pyrogens, including bacterial endotoxins from vial surfaces. The two most common methods for depyrogenation are batch ovens and depyrogenation tunnels, but there are different risk levels associated with these two processes. This paper discusses these risks and the opportunities for mitigation.

43. Factors That Influence Methods To Measure Product Resistance 7/29/2020

    Product resistance (R_p) is the resistance to vapor flow through the dried layer out of the vial during primary drying. With vial heat transfer coefficient (Kv), product resistance is a key determinant of temperature. 

44. Freeze-Drying COVID-19 Diagnostics: Formulation & Process Development And Lyophilizer Selection 7/29/2020

    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.

45. Equipment Capability Of Freeze-Dryers And Its Relevance To The Graphical Design Space For Primary Drying 7/29/2020

    The capabilities of a freeze dryer can change with differences in design. This is particularly important when users are transferring cycles from lab-scale to commercial-scale freeze dryers. Each freeze dryer has its own limitations and it is important to understand these limitations to avoid the risk of product failure when scaling-up the production. This article summarizes a recent webinar discussing how to measure and compare equipment capabilities of lab-scale and production scale freeze dryers in order to define optimal design space parameters.

46. 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.

47. Line Of Sight - Enabling Lyophilization Scale-Up From Formulation To Full Commercial Production 7/29/2020

    Line of Sight suite of freeze-drying equipment with scalable lyophilization technologies and process analytical technology (PAT) tools have been developed to provide the tools for a more successful scale-up of a lyophilization process from formulation through to full commercial production. This ensures superior product quality and uniformity and creates a data rich environment across all sizes of freeze-drying systems.

48. Enabling Lyophilization Scale-Up From Formulation To Full Commercial Production 7/29/2020

    Biologic drugs have shown great promise in curing many life changing diseases, even some that were once thought incurable. However, due to the sensitive nature of  biological material it requires specialized development and manufacturing processes. Stabilization by lyophilization is attractive to retain the product’s biological activity, structural integrity and homogenous quality, all of which are crucial to the success of the product. This white paper describes the challenges associated with lyophilization of biologic drug products.

49. Adoption Of Controlled Ice Nucleation Technology, ControLyo® - From R&D To Commercial Manufacturing 7/28/2020

    Stabilization by lyophilization is attractive to retain a drug product’s potency, structural integrity and homogeneity, all of which are crucial to the success of a pharmaceutical product. Lyophilization begins by lowering the temperature of the product to below its freezing point to form ice crystals (nucleation). However, this process is random and often results in heterogeneity and poor product reconstitution. This article describes various techniques used to control ice nucleation which have been widely used in research and development environments, and demonstrate its use in production manufacturing.

50. SP Industries Announces Partnership Agreement With Ecodyst To Distribute Single Sample Evaporation Systems 7/23/2020

    SP Industries (SP) CEO Brian Larkin has announced the signing of a partnership agreement with Ecodyst (NC, USA). In making the announcement Larkin stated, “This new partnership enables our SP Genevac brand to be the comprehensive, one-stop-shop for all evaporation solutions.