Sponsored Podcasts

One of the greatest unexplored spaces of the world is the microbiome, a bustling network of trillions of microorganisms living inside each of us. If we could learn more about them, the advancements we’d make in healthcare and other fields would be incredible. This line of thinking is what spurred Tom Jarvie and Mark Driscoll to found Shoreline Biome, maker of the most complete end-to-end microbiome sample prep kits on the market. Hear their incredible story in this Building Biotechs podcast.

The past few years have been filled with seminars discussing viruses, with COVID-19 stealing most of the headlines. Not all viruses are created equal; some are actually beneficial for human health and biotherapeutics delivery. Adeno-associated virus (also referred to as AAV) vectors fall into this category. AAVs are “hot” right now, as they are currently one of the most promising systems for human gene therapy. There are many types of AAVs and purification and analysis of these types of viruses can present challenges. In this dedicated dialogue, we will discuss the most efficient workflow for AAV purification and analysis.

Choosing the right sterilization technique for your drug product and its packaging is not always a simple decision. While most packaged drug products have specific requirements, newer sterilization techniques offer innovative ways of ensuring sterility that may be more suitable than standard sterilization processes. In this dedicated dialogue, the audience will learn about standard sterilization processes, be introduced to newer techniques, and understand how these techniques have been applied to parenteral packaging components.

Astrea Bioseparations joins Biopharm International for a discussion about the evolving challenges of downstream processing for advanced therapies, and what the future might hold. We talk about the company’s evolution over the last three decades, including the Discover. Develop. Deliver. approach to customer alignment. The latest industry trends are reviewed, along with considerations to keep in mind during the selection of off the shelf or customized downstream solutions.

In just a few years, MAKO Medical has become a thriving healthcare disruptor by nimbly navigating the lab diagnostics waters with creativity and heart—helping patients and bringing joy to the communities it serves. In this episode of the Building Biotech podcast series from BioPharm International (sponsored by Thermo Fisher Scientific), hear the inspiring story of how founders Josh Arant and Chad Price turned their dream into a reality.

The entire clinical supply chain — from manufacturer to shipper to clinician to patient — is united in its reliance on cold chain solutions to consistently deliver quality of life and potentially lifesaving treatments. Learn more about how to navigate a vast array of temperature-controlled shipping options across five specific temperature ranges while ensuring product integrity and patient safety.

In this podcast, Catalent Biologics regulatory expert, Kelly Davis shares her insights on why companies choose to repurpose drugs, what the main considerations are when doing so, how companies can overcome the challenges they face, and how Catalent supports companies going through this process.

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.