Articles

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.

Ep 1: Bioprocess for Beginners - From Shaker to Bioreactor

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.

Building Biotech Series with Samir Ounzain 

Podcasts

An Expert Overview of Drug Lifecycle Management 

Labeling Genes and Genetically Modified Organisms with DNA Watermarks

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.

Building Biotech Series with Kurt Gielen

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.



Increase Downstream Productivity and Decrease Costs with Multi-column Continuous Chromatography

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.

Smart Manufacturing: Growing from Pilot to Production

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.

Key Considerations in Aseptic Fill Finish CMO Facilities

It is the bottleneck in pharmaceutical manufacturing: Lead times. 
Which are the approaches that may secure business continuity? What are ways to overcome dependencies on vendors’ supply?
Barbara Fischer gives insights on how single-use system providers tackle this industry-wide challenge in supply chain.  


SUS –  an Acronym for “Single Use Systems” or “Supply Under Shortage”?

Lipid-based formulations are gaining global awareness, notably with lipid nanoparticles (LNPs) being a key component in several current COVID-19 and mRNA vaccines. Lipid-based formulations, including liposomes and LNPs, are an effective drug delivery system for a variety of active pharmaceutical ingredients (APIs), notably for complex parenteral drug products including cancer, viral, and gene therapeutics. In this podcast, we discuss how Emergent has been involved in the manufacturing of lipid-based formulations over the past two decades, along with factors to consider when partnering with a CDMO for lipid-based formulation manufacturing.

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