Our Expert Network
-
Achieving Flexibility In RNA Drug Manufacturing With Microfluidics
11/21/2023
RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.
-
Modular And Single-use Tech Driving The Future Of Biomanufacturing
11/14/2023
BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.
-
What We Need To Unlock Next-Generation mRNA Therapeutics
11/13/2023
mRNA is an incredibly nimble platform for drug discovery and development, but in order to truly unlock the next generation of mRNA therapeutics, we need to think outside the box (and we also need more funding).
-
What Regenerative Medicine Manufacturers Have Been Waiting For
11/9/2023
It's not revolutionary, say two FDA experts. However, the agency's new voluntary consensus standards program for regenerative medicine therapies responds to an industry clamoring for standardization. With standards that everyone agrees on, sponsors can save massive amounts of time designing protocols, and regulators can save time reviewing them.
-
New Developments In mRNA Vaccine Efficacy Show Promise
11/1/2023
Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more.
-
FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
10/25/2023
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
-
Global Market Trends For Oligonucleotide APIs
9/28/2023
Oligonucleotide APIs belong to a category of compounds that comprise short sequences of DNA or RNA. These compounds can be tailor-made to target an individual gene’s messenger RNAs. This article shares new market research, including a look at the drivers behind growing demand, different types of oligonucleotide APIs, and key players in the space.
-
The Regulatory Genome: “Digital Software” For Drug Development
9/22/2023
Next-generation sequencing (NGS) has allowed the industry to uncover all aspects of genomic activity, including the 98% of the traditionally unexplored genome, now known as the regulatory genome. Let's explore RNA as "digital software" for drug development, a look beyond NGS, and the role of long-coding RNAs in particular.
-
Guidelines For mRNA Drug Product Manufacturing And Quality Control
9/15/2023
The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.
-
How Strategically Partnering With Academia Supports Biotech R&D Goals
9/14/2023
For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.