Outsourced Pharma App Notes & Case Studies

1. Particle Engineering For Inhalation Drug Delivery 10/6/2020

   Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe. Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs. This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.

2. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

   One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

3. Developing A Continuous Large-Scale Perfusion Cell Culture Process 9/25/2020

   The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality. 

4. Meeting Patient Needs Through Expedited Delivery Of Phase I Materials 7/17/2019

   To quickly deliver their product to patients in need, Reneo Pharma found a partner to provide both product development and clinical packaging services.

5. Operational Advantages Of Using Hot Melt Extrusion To Create Amorphous Solid Dispersions 11/5/2020

   The limited solubility of many modern drugs frequently translates to low bioavailability, making improved solubility a primary goal of oral dosage formulation development. Low aqueous solubility can be combated through preparation of an amorphous solid dispersion (ASD). This article explores spray drying and hot melt extrusion (HME) which are among the most widely applied technologies for producing ASDs.

6. Comparing Continuous And Batch Processing In Downstream Purification 6/10/2019

   Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

7. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

   Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

8. Zydis® Bio Technology, Grazax® & Grastek®: Revolutionizing Allergy Therapy 12/18/2019

   ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis Fast Dissolve Technology to their therapy, bringing a vastly superior product to market.

9. Ingenuity In Clinical Manufacturing Reduces Duration And Complexity For Phase III Trial 1/4/2019

   Sharp Clinical Services provided a solution for a pharma clients that required a new oral formulation of their product. Multiple active ingredients created a complex manufacturing process combined with a requirements of 8 different batches required expertise of Sharp's Analytical and Formulation Development teams.

10. Intelligent & Streamlined Drug Product Manufacturing: Assure Scalability, Overcome Regulatory Hurdles & Speed Time To Clinic 11/2/2020

    The speed and quantity at which novel vaccines, therapeutics, and candidates are currently entering into clinical development is unparalleled. Capacity for manufacturing these products is in high demand. Due to this ever-changing landscape, it is more important than ever to partner with a CDMO that is proactive with how they plan, resource, and execute programs.