Application Notes & Case Studies

  1. QbD For Process Development, Scale-Up Of A Novel ALS Drug Product 8/4/2020

    A stepwise approach to Quality by Design (QbD), which drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

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

    There are several methods for validating the cleaning effectiveness of washers, but all include some sort of contamination and then an evaluation of the effectiveness of the removal of the contamination. 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.

  3. 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.

  4. 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.

  5. The Value Of A BD Integrated System For Combination Products 7/24/2020

    The growing complexity and regulatory rigour of combination products has called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers.

  6. Technology Selection To Enhance Bioavailability 7/23/2020

    Bioavailability challenges are among the toughest problems faced by today’s formulators. Most of the prospective drugs in pharmaceutical pipelines today have low solubility, which means the active therapeutic ingredients can’t be absorbed when patients take them orally. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

  7. In Vitro Test Methodologies To Characterize Bioavailability Enhancing Formulations 7/23/2020

    Some of the most important technologies available to formulators are those that enhance bioavailability, given the large percentage of low-solubility compounds in today’s pharmaceutical pipelines. Formulators have many choices in their toolkit when it comes to bioavailability enhancement, so the tough call becomes which one to use for a given compound. Lonza has developed a full complement of tools that accurately predict the performance of bioavailability-enhanced formulations.

  8. Container Closure Integrity Of Product Requiring Deep Cold Storage At -80°C 7/23/2020

    If CCI is lost during -80°C storage, non-sterile, cold, dense gas from the storage environment (i.e. air from a -80°C freezer or carbon dioxide from dry ice) can leak into the stored vial. It is therefore critical that robust development work is done to understand the CCI performance of any primary packaging components used for product needing deep cold storage and transport temperatures.

  9. Ensuring Container Closure Integrity Of A Gene Therapy Cancer Vaccine Needing Deep Cold Storage 7/22/2020

    A gene therapy clinical trial was halted due to CCI issues in deep cold storage. A CCI test method was developed that enabled non-destructive CCI testing of product vials at these cold temperatures. The capability to non-destructively test clinical product in deep cold storage enabled troubleshooting studies leading to corrective actions that assured good CCI.

  10. Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication 7/22/2020

    Armed with a promising idea and an urgency to help patients with Hereditary Hemorrhagic Telangiectasia, Cure HHT contacted Pii for assistance in developing a formulation and filing an Investigational New Drug (IND) application with FDA. The formulation, analytical and regulatory teams at Pii worked with a unity of effort and filed the IND fourteen days after starting the project.