Podcasts

Inline dissolved CO2 measurement & monitoring during cell culture and fermentation scale up offers significant benefits for process control, impacting productivity and quality attributes. Real-time dCO2 measurement complements routine dissolved CO2 measurements with a BGA during pre-clinical and commercial operations. This podcast explains why dCO2 should be measured as a critical process parameter, what actions can be taken based on dCO2 measurements, and how to implement real-time dCO2 measurement.

In this podcast, we speak with Austin Mogen, Ph.D., Sr. Field Application Scientist and Cat Siler, Ph.D., Field Application Scientist both from Corning Life Sciences about the available platforms for adherent cell culture scale-up. These platforms offer the potential to reduce time and cost while delivering high efficiency for a variety of adherent applications.

Cell therapy market has been experiencing double digit growth in recent years stemming from the promising success of the first autologous CAR-T products. However, manufacturing these therapies at scale continues to be a challenge. This podcast will focus on the specialized needs of manufacturing cell therapies at scale and how Custom Manufacturing Organizations are stepping in to drive process efficiencies and standardization.

Infectious disease surveillance from wastewater and fecal samples has been recently adopted as a method for monitoring emergence and re-emergence of infectious diseases. This method allows public health agencies, universities, hospitals, cruise lines, and more to detect a pathogen and respond before there is a community outbreak. Thermo Fisher Scientific has partnered with many labs globally to implement new wastewater testing systems and optimization of existing wastewater monitoring processes. Listen in to learn about importance of wastewater.

Sue Marchant, director of product at MasterControl, will discuss how AI technology is helping pharmaceutical companies address CAPA and root cause investigations. The CAPA process has historically been more corrective than preventive, hard to track and implemented without context. During the podcast, we will be discussing the options available today to connect quality data and subsequently what problems can be solved using AI. These technologies will turn the tables making CAPA more preventive than corrective with the ability to track process in real time and understand the contributing factors and considerations surrounding an event. Additionally, Marchant will explain how AI combines and analyzes data, pinpoints relationships, and provides valuable process improvement. Companies should not be intimidated or hesitant about implementing AI technology. Today’s technology has AI capabilities embedded in the software to accelerate AI development. Companies no longer need specialists to get started and take advantage of the benefits.

In this interview we will discuss recent strategies for upstream bioprocess analytics and how a thorough process understanding can improve product quality and process efficiency.

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.

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.

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.

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.

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.

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.

BioPharm International interviewed Cloudleaf about trends in tracking vaccines through the supply chain.

In this interview, we will talk about the typical developmental process of new vaccines and how the current Covid-19 situation influences the global vaccine developmental landscape.

Learn Morewww.bio-rad.com/fluvaccine

BioPharm International interviews Tarja Mottram, CEO of Action for Results, on the marriage of science and business to ensure sustainable growth. Posted Feb. 2012.

Mike Ultee, chief scientific officer of Laureate Biopharmaceutical Services, discusses advances in separations technology, beginning with the 1988 publication of ?Separations Technology Outlook, Part II? by Nancy E. Pfund and Kathleen G. Charles.