Press Room

Webinar - Particle Engineering of Biopharmaceuticals

Start
Wednesday, December 09, 2020 - 16:00
End
Wednesday, December 09, 2020 - 16:00
Location: online
Biopharmaceuticals Spray Drying Inhalation Drug Product | Hovione

 

 

 

 

 

 

 

 

 

Wednesday, December 9th, 2020

4:00 pm GMT | 11:00 am EDT | 5:00 pm CEST

Registrations to the webinar are subject to approval

 

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Speakers

Diana Fernandes, MSc - Scientist, Particle Design & Formulation, R&D Drug Product Development
Paulo Lino, PhD - Scientist, Particle Design & Formulation, R&D Drug Product Development

 

 

Biopharmaceuticals represent the most promising and fastest growing field in the pharmaceutical area. These therapeutics show very high specificity and potency at relatively low concentrations and enable the treatment of otherwise untreatable diseases. Challenges in their delivery arise due to the inherent complex nature of large molecules which requires additional effort to improve bioavailability, shelf-life and patient-compliant delivery.

Freeze-drying has been the gold-standard in the isolation of large molecules in the solid form. Despite its prevalence and track record in the industry, presents several limitations that may be addressed by alternative technologies.

In this webinar we will discuss the advantages and disadvantages of the most promising alternatives to freeze drying with focus on particle engineering methods such as spray drying and spray freeze drying. Alternative methods pose many advantages in terms of costs, throughput and potential for alternate delivery routes. A series of case-studies will also be shown for each of the relevant technologies. Register Now!

 

What can you learn from this webinar?

Want to know how to spray dry your biologic? Our scientists will share their views and tell you how.

 

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Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024