Podcasts


Correct data is fundamental in a GxP quality system. This podcast will discuss what needs to be put in place to achieve data integrity and minimize the risk for an organization. We will discuss how to achieve data integrity and give real examples from FDA warning letters about the most frequent violations. To prevent violations, processes and systems should be designed to follow the ALCOA principles which will be explained in detail. We will review how a modern lab instrument can provide all the technical features which are needed to automate processes, ensuring that data integrity compliance issues are not created. As an example, we will present the functionalities of Cubis II, the 2nd generation premium laboratory balance from Sartorius. We will also discuss software applications for QC- or production-relevant applications like Tablet & Vial checker (Uniformity of dosage, USP chapter <905>), Loss on Drying (USP Chapter <731>), Standard preparation (USP Chapter <129>), Pharma Filling (Transfer of liquid products) or MYCAP CCX (Transfer of media and inoculum). The software applications safely guide operators through the workflow, automatically calculate the results and have conformity checks included.


Data Integrity and Digital Workflow Guidance for the Contemporary Pharma Lab

In this podcast, we will talk about advancing Cell & Gene Therapy expansion processes. A shift from traditional static and shaken cultivation conditions to a stirred controlled environment is taking place within this industry. Various applications will be discussed where the AppliFlex ST single-use bioreactor have enabled advances in process development.

Advancing Cell & Gene Therapy Expansion processes with the Appliflex ST Single-use Bioreactor

In the podcast series, Thermo Fisher Scientific’s Sr. Product Manager, Linas Pupelis, will discuss latest development of critical raw materials required to support the synthesis of mRNA for therapeutic development.  Today, mRNA therapies are one of the hottest drug classes and the development of an entirely new drug class is not without challenges.  A major issue in this industry is lack of high-quality raw material that meet clinical research and manufacturing regulations.  In this podcast, we will discuss how our TheraPure reagents, which is specifically designed and carefully manufactured following the principles of 21 CFR 210/211 and ICH Q7, can help build the solutions to today’s challenges.   

Advances in GMP-grade Raw Materials for mRNA Therapeutics

Since developing and patenting the single use aseptic fill finish isolator in 2017 Solo Containment have expanded their offering to accommodate small batch hand fill, semi-automated and high volume sterile isolator technologies that leverage the benefits of zero cleaning validation and rapid campaign change overs against the traditional stainless steel isolator. 

Disposable Aseptic Isolator Technology

Cell culture quality is critical to experimental success, but it can be time consuming and challenging to routinely record passages and confluency which effect cell physiology and phenotype.  In this podcast we’ll discuss the importance of cell culture quality control for cell based assays and ways to reduce the time required with new automated remote monitoring and quantification tools.

Get your time back. Quantitative Remote Monitoring for Cell Culture.

In this podcast series, Thermo Fisher Scientific’s Flow Cytometry Senior Product Manager, Jolene Bradford, will discuss innovations with instrumentation available for our BioTech customers using Flow Cytometry. Challenges facing BioTech customers using flow cytometry often involve obtaining reproducible results, reducing errors, and maximizing throughput to confidently reduce hands-on time. The need to move quickly and get it right the first time has driven development of new flow cytometry instrument solutions of interest in the BioTech field. In this podcast we will address how our instrument solutions are designed to meet these needs. 

Sponsored Podcasts