Five Common Challenges with Biopharmaceutical Process Analytical Testing

Jun 2, 2023 by IDEX Health & Science

Currently biopharma market is 50% of the total pharma market, which is about 1 trillion per year. The growth of biopharmaceuticals is predicted to trend upward for the foreseeable future and the increasing demand has created new challenges. From supply and demand issues to regulatory and operational scrutiny, IDEX Health & Science can tackle your biopharmaceutical analytical testing challenges and get you to market faster.

Our experts explain how our unique capabilities and expertise can turn your challenges into solutions to help you build your biopharmaceutical analytical testing platforms.

1. Time to market

The Covid-19 pandemic brought a renewed emphasis on speed-to-market as a top priority and business driver in the Biopharma market. While this remains a significant challenge for drug developers, there is increasing pressure to expedite research and alleviate delays in the manufacturing process.

Our Capabilities: Accelerating your time to market with expertise and testing

Equipped with a broad portfolio of fluidic devices and subassemblies, IDEX Health & Science engineers can accelerate your time to market, utilizing decades of experience and state-of-the-art design tools for advanced prototyping and fluidic simulation to optimize your biopharma testing applications. Our engineers provide instrument developers with an opportunity to analyze fluidic performance before committing to expensive prototypes, shortening the characterization of component functionality from months to weeks.

2. Regulatory and operational scrutiny

There are numerous risks and challenges associated with biopharmaceutical analytical testing. One critical roadblock is the need for metal-free / bioinert components designed to optimize the analysis and monitoring of Critical Quality Attributes (CQAs). Bioinert components minimize surface interactions, improve peak shapes, and increase analytical robustness to ensure drug efficacy and patient safety.

Our Capabilities: Suite of bioinert, metal-free products

Our bioinert components provide contamination-free fluidics essential for biopharmaceutical drug efficacy testing required to ensure patient safety. We design metal-free fluidic solutions for the most challenging protein, peptide, glycan, and other biological applications. Our portfolio of metal-free bioinert components minimizes adsorption and ensures the highest degree of analytical accuracy, precision, overall productivity, and compliance with Process Analytical Technology (PAT) workflows and CQAs.

3. Maintaining manufacturing costs and consistency

Due to the high cost of pharmaceutical drugs, there is increasing pressure to reduce the cost often starting with the manufacturing process. It is critical to put control strategies in place to increase batch-to-batch consistency. Biopharmaceuticals are sensitive to subtle changes during the manufacturing process and during storage, which can impact CQAs and the safety and efficacy of biopharmaceuticals. Controlling product variability is a central challenge for all biopharmaceutical manufacturers to ensure batch-to-batch consistency.

Our Capabilities: Advanced prototyping and reliable, consistent manufacturing processes

We help lower biomanufacturing workflow costs with our highly efficient, repeatable, and reliable world-class manufacturing processes. We provide advanced prototyping and simulation tools designed to eliminate multiple design iterations—saving you time and money while producing products manufactured to the highest quality standards. Our extensive portfolio of off-the-shelf components can also significantly reduce the cost of designing from scratch.

To ensure batch-to-batch consistency, we use purification and quality control systems. The systems include different types of chromatography columns that separate large volumes of material. Our processes also help eliminate system downtime, so developers can get to market faster.

4. The need for manufacturing flexibility

Biopharmaceutical analytical testing is primarily affected by the move towards smaller volume systems during biopharmaceutical manufacturing. The driving force behind this trend is a combination of process efficiencies—cost reduction and sterility assurance. This presents an opportunity for improved sampling and fluidic handling strategies.

Our Capabilities: Cost assurance and expertise

We are highly experienced at moving fluid volumes ranging from milliliters to microliters. We also have highly reliable rotary shear valve technology for fraction collection or sample selection operations and nano flow capabilities.

5. Supply and demand challenges

Supply and demand have been and remain a challenge in biopharmaceutical development.

Our Capabilities: Global reach and network

As a global organization, IDEX Health & Science has an international network of direct sales professionals and distribution partners in place to provide personal service to every customer, with experts available to visit your operation, assess your fluidic needs, and develop solutions for your challenging applications.

IDEX Health & Science is a global leader specializing in the development of engineered components and subsystems for analytical biopharmaceutical applications.

Learn more about our Biopharmaceutical Analytical Testing capabilities