Matt Boag, Biopharmaceutical Product Marketing Manager at Phenomenex, discusses the transformative innovations shaping plasmid DNA, mRNA, and peptide purification processes. From cutting-edge chromatography solutions to sustainability-focused advancements, Phenomenex is enabling efficient and precise biotherapeutic development while addressing global regulatory and environmental demands. Explore how Phenomenex is setting new benchmarks in biopharma purification and paving the way for groundbreaking therapies in 2025 and beyond.

The Role of Chromatography in Biotherapeutic Development

Since its early 20th-century origins, chromatography has become indispensable in pharmaceutical development, evolving alongside drug complexity. The biopharmaceutical sector’s rise over the past few decades has driven the need for advanced chromatography techniques to address the complexity of biotherapeutics, such as proteins, peptides, and cell and gene therapies. Innovations like high-performance liquid chromatography (HPLC) and size-exclusion chromatography with multi-angle light scattering (SEC-MALS) are now critical, enabling detailed molecular profiling without denaturation—a core requirement for biologics.

Innovation Trends in Chromatography for Biotherapeutics

With the emergence of novel therapeutics, such as mRNA and gene therapies, chromatography methods must keep pace with demanding purity and quality standards. Current trends shaping the field include:

  Growth of mRNA Therapeutics: The success of mRNA COVID-19 vaccines has sparked further exploration into developing mRNA-based therapies for cancer, genetic disorders and infectious diseases. Purifying these molecules requires highly specialized chromatography solutions, capable of distinguishing minute molecular variations to ensure safety and efficacy.

  Gene Therapies and Viral Vectors: Gene therapies often use viral vectors such as Adeno-Associated Viruses (AAV) or Lipid Nanoparticles (LNPs) as delivery mechanisms. These vectors have stringent purification requirements to separate full, empty, or partially filled capsids, an area where size-exclusion and ion-exchange chromatography have become particularly valuable.

  Growing Demand for Small Peptide Therapeutics: Small peptides, like GLP-1 receptor agonists, are widely used in treating conditions such as type 2 diabetes and obesity. The growth of peptide therapeutics emphasizes the need for high-resolution and selective chromatographic techniques, like ion-exchange and reverse-phase columns, to ensure accurate separation and characterization, which are crucial for maintaining safety and efficacy.

  Increased Demand for High-Throughput and Continuous Manufacturing: With a shift toward automation, chromatography is evolving to deliver faster, scalable purification that maintains high purity and quality. Real-time monitoring now enables quality control at every stage, with integrated data analysis to detect impurities and quality variations instantly, minimizing downtime and ensuring regulatory compliance.

Phenomenex’s Vision and Innovations

Phenomenex is responding to increasing regulatory demands by investing in sustainable technologies and methodologies that align with rigorous global standards. Agencies such as the FDA, USP, and ICH are intensifying requirements for impurity detection and solvent reduction, emphasizing both environmental impact and therapeutic safety. To meet these benchmarks, Phenomenex is pioneering advancements that reduce analysis times while ensuring the precision needed for high-performance molecular profiling. For more information about Phenomenex’s quality initiatives, please visit here.

For instance, Phenomenex’s SEC and reversed phase chromatography solutions are designed to detect impurities down to trace levels, supporting ICH Q3D impurity profiling recommendations. Additionally, Phenomenex's latest bio-inert columns and solvent-reduction technologies provide green solutions that decrease hazardous waste. By enabling labs to cut down solvent consumption by up to 30%, these columns support sustainability while maintaining high analytical performance.

In supporting development of these advanced chromatography technologies, Phenomenex aims to streamline purification processes and reduce environmental impact—benefiting both manufacturers and the broader healthcare ecosystem. This approach allows Phenomenex to lead in sustainable solutions for a sector increasingly focused on responsible biotherapeutic development.

Anticipated Breakthroughs in Chromatography for 2025 

Phenomenex’s upcoming product portfolio is designed to address major challenges in biotherapeutic purification with a focus on efficiency, selectivity, and bio-compatibility. Key anticipated offerings include:

• Biozen Analytical Columns: As biotherapeutics become more complex, effective separation and sensitivity to subtle molecular differences is essential. With several unique fit-for-purpose chemistries targeting sensitivity and bio-inertness through the use of biotitanium hardware and modern surface chemistries, Biozen columns optimize analyte recovery with minimal sample loss. These columns provide tailored pore sizes across different chromatographic techniques to accommodate large biomolecules, such as monoclonal antibodies (mAbs) and gene therapy vectors.
  
  
• Clarity Purification Solutions: Clarity technologies address critical challenges in oligonucleotide purification, particularly the need for precise removal of impurities to maintain high purity, selectivity, and reproducibility at scale. As demand for oligonucleotide therapeutics increases, high-efficiency purification solutions help minimize sample loss and streamline workflows, supporting diverse oligonucleotide formats and simplifying the purification process.
  
  
• Axia Preparative LC Columns: Scaling up from analytical methods to bulk production often reveals bottlenecks in column capacity and durability. Traditional preparatory columns struggle with the demands of continuous bioprocessing, especially in high-throughput applications. Axia columns integrate Phenomenex’s advanced packing technology, which uses precise axial compression to deliver uniform media density and maintain structural integrity even under high pressure. This innovation in addition to the resolution and throughput improvements from its core-shell particle technology are especially beneficial for high-value biotherapeutics, such as small peptide molecules like GLP-1 agonists, where sample purity and yield are critical.

Innovating for Tomorrow’s Therapeutics

As the biopharmaceutical landscape evolves, Phenomenex’s innovations in chromatography and purification are poised to streamline biotherapeutic development, supporting the industry’s shift towards efficient, scalable solutions. By focusing on the specific needs of complex therapies, Phenomenex is solidifying its role as a pivotal partner in global healthcare advancement.

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