Researchers involved in biopharmaceutical studies face various demands when developing therapeutic proteins, peptides, and RNA.
Image Credit: Yokogawa Fluence Analytics
This article explores the critical challenges and advancements in biopharmaceutical formulation development.
Stability and solubility
Solubility is fundamental in successfully developing all classes of therapeutic biopolymers. Contact with stressors related to mechanical stirring or changes in buffer conditions may cause destabilization and permanent aggregation or degradation.
Approaches aiding in situ and real-time monitoring of solution stability under diverse conditions can enable appropriate screening and deliver critical insights into enhancing and accelerating development.
Drug delivery systems
Effective and stable delivery systems are essential, especially for RNA-based therapies due to degradation. Tools capable of modeling bioprocessing stresses related to temperature or shear stress offer crucial insights into improving solution conditions necessary to maintain stability.
Scalability
It is often challenging to upscale without compromising stability or purity. Tools that can analyze multiple samples together can accelerate scaling, allowing rapid screening and optimization of formulations to guarantee scalability.
Regulatory compliance
Complying with international regulatory requirements for safety, efficacy, and quality is essential, often demanding extensive testing and documentation. Tools that improve the understanding of solution behavior under variable conditions and offer comprehensive stability environments can support these efforts, easing compliance.
Immunogenicity
Protein, peptide, and RNA therapeutic instability may cause immunogenicity. Advanced investigative equipment that offers insights into propensities for aggregation or degradation can alleviate these instabilities.
Technologies with sophisticated analytical capabilities, such as in situ and real-time stability observation under different stressors and fast parallel analysis, are crucial for meeting these demands.
These instruments enhance formulation development efficiency while improving the ability to meet regulatory requirements and effectively manage scalability and immunogenicity concerns.
Image Credit: Yokogawa Fluence Analytics
ARGEN is a versatile static light scattering instrument developed for in situ and real-time stability and viability assessments of all classes of biologics. Patented on simultaneous multiple-sample light scattering, ARGEN can analyze up to 16 samples together.
Each sample cell has dedicated optics. This allows independent control of experimental parameters like temperature and stirring rate and enables a comprehensive stability assessment for different biologic classes.
Some of ARGEN’s features include:
- In situ and real-time stability monitoring: Solution stability under variable stress conditions is key for successful biologic development. ARGEN permits in situ and real-time stability monitoring for all biologics, allowing rapid screening and optimized solution conditions to improve solubility and stability.
- Kinetics of oligomeric state transitions: ARGEN reacts to even small changes in molecular weight and enables observation of oligomeric state transitions (aggregation and degradation). It is ideal for quick screening and ranking of formulation stability.
- Bioprocessing stress modeling: Perturbations from stirring stress during bioprocessing can cause instability and aggregation. ARGEN’s unique capability to observe stability under stirring stress helps to accelerate formulation development.
- Parallel analysis: ARGEN can analyze several samples together under various conditions, considerably accelerating development. This feature coordinates with higher throughput screening methodologies, facilitating rapid screening and formulation optimization.
- Low-temperature stability assessment (shelf-life): Verifying shelf-life is key for all biologic formulations to maintain safety and effectiveness. ARGEN can track temporal stability at low temperatures down to 3 °C over extended periods. Researchers can optimize concentration and storage conditions for optimal results by examining multiple samples.
Integrating technologies like ARGEN into biopharmaceutical formulation development addresses specific technical demands, going beyond what can be achieved when developing innovative treatments.
ARGEN and comparable tools are critical for bringing innovative, effective, and safe therapies to market faster by improving formulation stability, scalability, and regulatory compliance.
About Yokogawa Fluence Analytics
Yokogawa Fluence Analytics, which was named as a Top 50 global advanced manufacturing startup by CB Insights, provides patented process analytics and control solutions to polymer and biopharmaceutical customers worldwide. Yokogawa Electric Corporation acquired Fluence Analytics in January 2023.
Yokogawa Fluence Analytics is a global leader in real-time polymer reaction monitoring and control, and its industry-leading ACOMP product is the only commercially available smart manufacturing system that continuously monitors and measures polymerization reactions.
The company’s biopharmaceutical product line includes a high-throughput static light scattering instrument called ARGEN. ARGEN can independently measure the stability of biopolymers under thermal, chemical, and mechanical (physical) stress, while also performing shelf-life stability studies at low temperatures.
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