Press Room

News / Aug 09, 2021

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Count on our multidisciplinary teams to exchange knowledge, ideas, and experience to develop and improve your project. As a specialist integrated CDMO we are dedicated to helping you bring new and off-patent drugs to market faster.

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Did you miss the articles on Pharmaceutical Technology, Drug Development & Delivery, On-Drug Delivery or Chemistry Today? You are still in time to read them. Access them here: 
 

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Moving Beyond
Particle Size Control

Contributors:
João Henriques (Group Leader,
R&D Drug Product Development)
Mafalda Paiva (Group Leader, Analytical Development)


 
Improving Bioavailability
& Solubility: Each Molecule
Is Unique - Emerging Platforms
Address Extreme Compounds

Contributor: João Henriques
(Group Leader, R&D
Drug Product Development)


 
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Semi-Automation in
Inhaler Testing - Exploring
the Potential & Practicalities

Discussion with João Pereira
(Team Leader, R&D Analytical Development)
Raquel Borda d' Água
(Associate Analytical Chemist, R&D Analytical Development; Copley) 


 
Where Continuous Flow
can help in today’s
Pharmaceutical Industry

Panel Discussion with
Rudi Oliveira
(Scientist, R&D Process
Engineering and Scale-up)

 

 

 

 

 

 

 

Did you miss our presentations at DDF, RDD, DDL or AIChE?
You are still in time to join. Access them here:

 

 

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Technology & Innovation

Performance Enhancement Strategies for
Low Solubility APIs – do more with less

Authors: Mafalda Paiva &
João Henriques
 

Workshop Presentation

Fully Integrated
DPI Development
From API To Device

Authors: João Pereira,
Beatriz Noriega Fernandes

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Predictive Scale-Up/Scale-Down for Production of Pharmaceuticals

Reaction Kinetic Model
Application to Speed up Development

Author: Filipe Ataíde
 

Presentation
and Paper

Spray-dried composite
formulation for lung
sustained release

Author: Beatriz Noriega Fernandes

 

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