Thermo Fisher Scientific

Articles

This compendium offers a resource to help tackle the common instrument challenges faced during method transfers to obtain consistent results and sustain regulatory compliance.

Successful and stress-free LC method transfers – application compendium

Granulation is a common process in pharmaceutical manufacturing to convert powder mixtures into agglomerated particles and is usually performed prior to tableting. Twin-screw granulation (TSG) has gained increased interest from the pharmaceutical industry for its potential within the development of oral dosage forms. It is a very flexible technology that can help to process a wide range of processed in a continuous manner. Twin-screw extruders offer excellent process control, can be equipped with high Process Analytical Tools (PAT), and processes can be optimized by using a Quality by Design (QbD) approach. All that leading to a high and stable product quality.

Within this webcast we review the basic concept of TSG, discuss the influence of process parameters on final product quality and give an insight into recent advances in TSG continuous manufacturing.

Review the principles of TSG and granulation mechanisms

Understand continuous TSG systems, including state of the art systems

Understand quality-by-design approaches and process analytical technology for TSG

Formulation scientists and engineers in the pharmaceutical industry Academics who want to learn more about the possibilities to use TSG for wet and melt granulation in R&D and manufacturing.


Professor in Pharmaceutical Technology and Process Engineering;
Director of Centre for Innovation in Process Engineering and Research


Professor Dennis Douroumis obtained a bachelor’s degree in chemistry and doctorate from the department of pharmacy at Patras University in Greece. He worked as a postdoctoral fellow (2004) at the Friedrich–Schiller University of Jena, Department of Pharmacy for the development of parenteral formulations of anti-epileptic drugs (Novartis Pharma, Basel). He also worked as a team leader (2005) in the development of nano-liposomal formulations and treatment of rheumatoid arthritis by applying photodynamic therapy (Biolitec Pharma GmbH.) Following this, he worked for Phoqus Pharmaceutical plc as a senior scientist at the product development department.

His research area focuses on the development of secondary continuous manufacturing by using hot-melt extrusion (HME) of extrusion granulation coupled with process analytical technology tools. His group is also involved in development of targeted anti-cancer drug delivery systems such as SLNs or NLCs produced by high-pressure homogenization. He is actively involved in ink-jetting and 3D-printing technologies for the development of medical devices (e.g. microneedles, stents) and personalized medicines.

Dr. Douroumis has published more than 80 research articles and seven book chapters, and edited two books on HME and the delivery of water-insoluble APIs. He has patented two proprietary technologies on the coating of transdermal microneedles and printing of drug eluting stents. Professor Douroumis has delivered keynote presentations at national and international conferences while his group has presented several poster presentations.

Webcasts

Friday, August 13, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST



Advances in Twin-Screw Granulation Technologies

http://www.pharmtech.com/pt_w/api_domains

	The distribution of API in a pharmaceutical tablet is a critical factor in developing drugs that are effective when consumed. What’s the best way to figure that out?

	The combination of Fourier-transform infrared (FTIR) and Raman spectroscopy with mapping is well-suited for identifying and sizing API domains. Both techniques provide excellent chemical and spatial information about the distribution and concentration of the API in a tablet.

		How to collect area data in FTIR and Raman imaging

		How to process and analyze a large mapping/imaging data set

		Understand and interpret the data to communicate to stakeholders

Mike Bradley, Product Manager, FTIR and FTIR Microscopy, Thermo Fisher Scientific

	Matthew Kole, Product Manager, Raman Spectroscopy, Thermo Fisher Scientific

Tuesday, Jul. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after final airing Jul. 21, 2021

Combining FTIR and Raman spectroscopy provides the insight needed to ensure appropriate distribution and concentration of APIs within tablets. Watch this webcast to learn more. 

Live: Tuesday, Jul. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing Jul. 21, 2021

Register free

Effective Imaging for Identification and Sizing API Domains

http://www.spectroscopyonline.com/spec_w/instrument_systems

	The ever-changing regulatory environment faced by manufacturers in pharmaceuticals and other regulated industries can cause confusion and doubts about compliance. Instrument systems designed to meet regulatory requirements can relieve the burden for manufacturers. How do they do it?

	Watch this webcast to see how two different instrument platforms-Fourier-transform infrared spectroscopy (FTIR) and microvolume ultraviolet-visible (UV-Vis)-help labs assure compliance in their processes. 

	The Thermo Scientific™ Nicolet™ Summit FTIR Spectrometer (for raw and finished material QA/QC) and the Thermo Scientific™ NanoDrop™ One Spectrophotometer (for DNA, RNA, and protein quantification) provide confidence when approaching your next audit.

) Part 11 is managed with innovative software controls

		The simplified workflows to create and deploy standard operating procedures 

		Why ongoing performance verification tests can give you peace of mind

		How to use workflows to ensure compliance from each analyst

		How to leverage built-in performance tests to consistently check instruments are fit for purpose

Matt Gundlach, Product Manager for FTIR Spectrometers, Thermo Fisher Scientific

	Patrick Brown, Product Marketing Specialist for Microvolume UV-Vis Spectrophotometers, Thermo Fisher Scientific

Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after final airing Jun. 23, 2021

Want to be sure your systems and processes are compliant? Learn how two enable 21 CFR Part 11 in the lab with compliant workflows and consistent testing. Be confident in your analyses!

Live: Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing Jun. 23, 2021

Register free

Instrument Systems Take on Burden of Compliance

http://www.pharmtech.com/pt_w/packaging_strategy


	Now that you are starting to see promising clinical results, the focus quickly shifts to commercialization and the many challenges that come from planning a pharmaceutical packaging strategy.  In order to be successful, it is critical to consider all packaging design and development requirements including the most cost-effective options regardless of annual product volumes.

		How to build a robust commercial pharmaceutical packaging strategy for successful commercialization of your product

		How to choose the right pharmaceutical packaging strategy for your project based on product size and growth path

		What the key technical considerations will be in your pharmaceutical packaging design and operational planning

Chris Howell, Director, Packaging Engineering, Thermo Fisher Scientific

	Brian Kunz, Director, Commercial Packaging, Thermo Fisher Scientific

Wednesday, Jun. 17, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after final airing Jun. 17, 2021

When planning for commercialization for your product, your pharmaceutical packaging strategy is critical to the success of your project.  Watch this webinar to learn how to build the right packaging strategy for your project based on product size and growth path.

Live: Wednesday, Jun. 17, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after final airing Jun. 17, 2021

Register free

Your Clinical Results Look Promising, but are You Ready for Launch?  How to Build a Robust Packaging Strategy for Rapid Commercialization

http://www.pharmtech.com/pt_w/ensuring_integrity


	After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy. 

	This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.

		Where along the drug development path can FTIR, NIR and Raman techniques be used and what knowledge is gained

		How to minimize the number of laborious steps in analytical method validation, verification, and transfer to QC and manufacturing  

		What to look for in a hardware-software platform to not only assure drug formulation integrity but also data integrity

Michael Bradley, Ph.D, Senior Manager, Global Training, Thermo Fisher Scientific

	Katherine Paulsen, Product Manager – Routine Spectroscopy, Thermo Fisher Scientific

	Mike Garry, Sr. Product Manager – NIR Spectroscopy, Thermo Fisher Scientific

Thursday, May 21, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST

	On demand available after final airing May 21, 2021

Learn how to reduce the number of steps and resources needed to assure chemical and structural integrity throughout drug development process. See where efficiencies can be gained in analytical methods development and transfer to QC and manufacturing while staying compliant with cGxP. 

Thursday, May 21, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST

On demand available after final airing May 21, 2021
Register free