Articles

When university and industry researchers work in tandem to conquer big challenges in medicine, they can achieve much more together than they ever could apart. Sue Fletcher, a pioneer in RNA therapeutic and Chief Scientific Officer at PYC Therapeutics, know this firsthand. She has spent decades in the field and is the co-developer of some revolutionary genetic therapies for treating rare diseases. Here, Dr. Fletcher speaks with BioPharm International about her work in this field, her incredible career, and how she’s inspiring young scientists in this complex area.

Building Biotech Series with Sue Fletcher 

Podcasts

Changes in production scale required due to increasing product needs throughout clinical trials introduces risk to the product development timeline.  Both the process and the product can be dramatically impacted from scaling-up to larger production volumes.  Once in commercial manufacturing, sudden changes to product demand in either direction can have costly consequences if the scale of production chosen is not adequate to meet the changing material requirements.  Adapting a “scale-out” instead of “scale-up” strategy for clinical and commercial production can greatly minimize these risks. This podcast will review the scale-out biomanufacturing approach and the significant benefits of this production paradigm.

Scale-out Manufacturing – A Critical Risk Mitigation Strategy for Biologics Production

Cell and gene therapies may well be some of the most important recent advancements in modern medicine. The way they work, however, is very complex and completely different from any pill that simply addresses symptoms. So who are the pioneers in this field and what dares them to ask “what if”? In this episode of the Building Biotechs podcast series sponsored by Thermo Fisher Scientific, learn from Ainslie Little, senior vice president of corporate strategy at BlueRock Therapeutics, how her company’s cell & gene platform is breaking new ground in this important space.

Building Biotech Series with Ainslie Little

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.

Building Biotech Series with Tom Jarvie

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.

An 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.

Innovation in Sterilization Techniques for Parenteral Packaging

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. 

Developing Cost-effective, Accelerated Downstream Processes

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.


Building Biotech Series with Josh Arant

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. 

Lifesaving Logistics: Today's Cold Chain

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.  

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