Sponsored Podcasts

The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data. Most notably, it signals a move to reduce or even eliminate comparative efficacy studies when robust analytics can provide equivalent insight, detecting subtle differences that clinical studies often miss. Biosimilar development will continue to require comprehensive analytical packages, with emphasis on orthogonal techniques. This session features Colette Quinn from Waters Corporation, who discusses how analytics support biosimilar development and help meet the FDA’s “totality-of-evidence” expectations.

Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.

In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.

Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.

The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.

In this podcast, we will explore the advantages of partnering with a Contract Development and Manufacturing Organization (CDMO) to navigate the journey from molecule conception to clinical trials, including the expertise, experience, and preparedness that a CDMO brings to the table. The audience will gain valuable insights into crucial questions such as the optimal stage in the development process to engage with a CDMO, the necessary preparations for a successful collaboration, and whether a finalized molecule is required to initiate discussions with a CDMO. Join Curia’s Director, Process Development Science, Scott Alderucci, who leads the process development group at Curia, a global CDMO offering CDMO expertise for biologics and small molecules.

Robust, scalable manufacturing of novel therapeutics requires partnering with a CDMO equipped to adapt to changes in the market and knowledgeable on the latest technologies used to support cell line development.

Bernhard Schlichtner, Chief Commercial Officer at Single Use Support, offers valuable insights into why adopting a holistic approach to process solutions is the key to successful fluid & cold chain management.

Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength and opportunities for collaborative growth. By working together, biopharma leaders, academia, and policymakers can create lasting improvements. Join Ludovic Brellier, President of Biotechnology Integrated Solutions and Business Operations Leader at Cytiva, as he delves into this year’s Index findings. Specifically, he’ll highlight where the industry should turn their focus to ensure that patients are continuing to get the essential life-changing therapies they need.

Creating a new therapeutic drug can take a decade or more to get to patients. Antibody production and discovery play an integral role in setting the stage for success at later stages of development. If a high affinity, functional antibody candidate is discovered early, the timeline to a finished targeted and effective therapeutic drug may be significantly reduced. In this podcast we will go through the untold tales of antibody production and discovery, as well as how Twist has optimized a process for antibody production and screening for potential therapeutics.

Adeno-associated virus (AAV) is a widely used viral vector for the delivery of genetic material in gene therapy. Vector development and production at an industrial scale requires an efficient method for accurate quantification of viral capsids. Unfortunately, traditional techniques such as ELISA, HPLC, and ddPCR are time consuming and labor-intensive. This podcast introduces a rapid, label-free method for the direct capture and quantitation of various AAV serotypes using the Octet® Bio-Layer Interferometry (BLI) platform with Octet® AAVX Biosensors. These biosensors deliver results in as little as 15 minutes and can be used to quantitate AAV capsids in both crude and purified samples.

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. And so is the importance of single-use systems. Single Use Support enables innovative process solutions around aseptic fluid management and improves aseptic liquid transfer in various manufacturing facilities. And yet there is hesitation.Dr. Lorenzo De Benedictis provides insights and outlook on the future of single-use systems in Biopharma.

When it comes to biotech, both the academic and industry settings are crucial in developing novel medicines. Dr Brent Cezairliyan has experienced both sides of biotech, first through an academic career exploring bacterial pathogenesis, and now in his administrative role at Octagon Therapeutics. The company, headquartered in Cambridge, Massachusetts, focuses on autoimmune disease treatments. By developing targeted approaches to the inflammatory nature of the immune system, they hope their advances in biotech help future scientists navigate the field for years to come.

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.

In this podcast, Richard Mirro, business manager at the Bioprocess Center of Eppendorf AG, explores how smart bioprocessing can help labs adapt to today’s demands, driving efficiency while making the development and production of next-generation molecules not only more economical, but also more reliable.

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.

After being diagnosed with Hodgkins lymphoma at age 15, Dr Joshua Schiffman was driven to pursue a career in medicine, starting as a pediatric oncologist, and was later drawn to the biotech side of the industry. Dr Schiffman was fascinated with a tidbit of knowledge: elephants almost never get cancer. He met Dr Avi Schroeder at a conference in Israel, and the two wondered how they could take this research about elephants’ cancer-fighting genes and apply it to humans. Together, they co-founded PEEL Therapeutics, the organization’s name meaning elephant in Hebrew, and currently work to bring together nature, medicine, and technology for the betterment of humankind. In this episode, Dr Schiffman provides a hopeful outlook on how nature and biotech can lead scientists to harness the power of evolution and create a bright future for medicine.

In this interview, we will talk about the advantages of changing from shake flasks to stirred-tank bioreactors, but also about the problems that can occur and things that have to be considered, in order to ensure proper cell growth.

While still considering himself a fundamental basic scientist, Samir Ounzain is embracing the biotech industry trend of merging academic research and biotechnological drug development. In this episode, Ounzain talks about his path from a dark theater as a kid watching Jurassic Park to the lab studying the dark matter of the human genome – and eventually to the founding of Haya Therapeutics, a biotech startup aiming to discover and develop safe and effective, tissue- and cell-selective, genome-based therapies for fibrotic diseases.

One of the harsher realities to balance in the biotechnology and life sciences industries is that success in the lab is not the same as success in business, and you have to run a successful business to keep the lab going. Kurt Gielen, co-founder and chief business officer of Medace, knew he didn’t belong in the lab but also that a career in the biotech business was his calling. Now he’s leveraging his 20 years of experience in the industry to help young companies strike that balance between business and science. Medace offers an innovative co-working environment where research and entrepreneurship meet – and grow. Kurt shares his path from the lab, across the globe, and eventually to this unique Belgium-based incubator committed to turning research into reality and discusses why he’s committed to making Medace’s resources and knowledge accessible to fledgling biotech companies all over the world.

Multi-column continuous chromatography (MCC) offers significant economic advantages over traditional batch methods for the purification of monoclonal antibodies (mAbs), including increased resin capacity utilization, smaller columns, reduced buffer consumption, and faster processing time. For mAb productivity, the Protein A capture step is a primary target to apply MCC due to its high cost, which is driven even higher as improvements in upstream processing have produced a steady increase in mAb titers. The multi-column continuous chromatography method has demonstrated that mAb productivity can be increased by 400 to 500% compared to batch-mode.

For years pharmaceutical and biopharmaceutical manufacturers have invested in rigid stainless-steel equipment for upstream bioprocessing. With new and innovative single-use products now on the market, manufacturers have access to flexible, safe solutions that offer a myriad of advantages over the traditional solutions. Single-use technology offers less risk of contamination, more operator safety, and less negative environmental impact than the stainless-steel alternatives. In this podcast, we will discuss the challenges associated with handling powders in upstream biopharm processes and how single-use technology can benefit manufacturers from an environmental, cost, and safety perspective.

This is the year in which manufacturers will have the courage to bet on data aggregation and AI solutions that help them grow their capacity, moving away from pilot mode and embedding those tools as foundational assets. These have become critical levers to support the expanded demand for drug manufacturing, especially exacerbated with the pandemic. Join John Vitalie, CEO at Aizon, as we discuss how Pharma 4.0 is transforming the pharma landscape to bring gains to manufacturers and to the patients they serve.

Fill finish (sterile filtration) operations are critical and often the only means to produce sterile liquid biopharmaceuticals as other means of sterilization will degrade the product(s). This complex packaging process has become more regulated and controlled in an effort to reduce the risks of contamination (with the greatest risk potential coming from cleanroom operators). This episode reviews current market trends and provides some characteristics expected of a top notch Fill Finish CMO, like Samsung Biologics in Incheon, South Korea.