Whitepapers

Download our White Paper and learn about quality attributes, critical process parameters, and key performance indicators at the bioreactor. Our White Paper provides a comprehensive, but accessible, overview of requirements and recommendations related to the FDA's Process Analytical Technology (PAT) initiative for the biopharmaceutical industry.

This white paper provides an overview of key units in the DSP skid train, including chromatography, ultrafiltration/diafiltration, viral inactivation, and optional operations like centrifugation and refolding. Critical process parameters (CPPs) associated with each operation are discussed, along with the analytical process sensors used to monitor them.

From method concept to routine QC, analytical scientists must balance innovation with scalability, compliance, and reproducibility. This eBook explores how next-generation liquid chromatography (LC) systems are helping bridge that gap. Through three real-world examples you’ll see how modern LC platforms support confident decision-making across the entire analytical lifecycle.

Collect more actionable data and optimize yield with real-time bioprocess adjustments. Learn how cell density monitoring works for your process in our comprehensive eBook. Discover must-see examples of real applications using in-line sensors for real-time viable cell density and total cell density monitoring.

This white paper explains the benefits and challenges of microbial-based fermentation for biologics, highlighting why processes often need to be custom-built for each molecule. Outlining a streamlined, cost-effective path that accelerates development from strain selection through tox material and early GMP, to reach IND and first-in-human trials faster.

GlucoSense introduces real-time, in-situ optical glucose measurement to improve consistency, viability, and productivity in bioprocesses. Designed for easy integration and built on Hamilton’s proven Arc technology, the sensor provides continuous, calibration-light monitoring without external spectrometers or complex workflows. With glucose recognized as a critical process parameter for maintaining optimal metabolism and product quality, GlucoSense delivers a robust, ready-to-use solution that supports modern PAT strategies and accelerates bioprocess development.

This white paper offers concise, practical guidance for biopharma teams outsourcing Process Characterization (PC) to strengthen CMC packages and accelerate commercialization.

Discover how a robust platform enables fast, high-quality bispecific antibody production by optimizing gene ratios, CLD, and analytics for purity and yield.

Case study showcasing accelerated PPQ for an E. coli–expressed orphan therapy, achieving three PPQ batches in 18 months through high-compliance manufacturing.

By allowing developers to bypass comparative efficacy studies when advanced analytics are successful substitutes, the FDA draft guidance avoids one of the most expensive steps, potentially cutting years from timelines and expanding patient access. For developers though, the burden doesn’t disappear; it shifts directly from clinical trials to analytical testing.

The development of biologics, from initial molecule selection to commercial product, presents complex challenges related to stability, manufacturability, and immunogenicity. Skipping essential risk assessments can lead to costly consequences, including reformulation, reduced shelf life, additional testing, regulatory delays, or even project termination. Download this article to learn more about how a structured, data-driven developability workflow can de-risk biologics during early stages of development.

Catalent’s GPEx® Lightning platform now integrates HEK cell line development, delivering faster timelines, higher titers, and consistent product quality for complex biologics. By combining precise genome engineering with high-throughput screening, the system accelerates cell line creation from months to just four, even for difficult-to-express proteins. This paper expands on the platform’s proven CHO capabilities, offering developers a robust, scalable solution for next-generation therapeutics from discovery to GMP manufacturing.

Protein A resin is an essential tool used to purify monoclonal antibodies (mAb); however, it can also be the costliest step in downstream bioprocessing. To prolong the lifetime of your protein A resin and therefore reduce operating costs, this performance study showcases a novel protein A resin’s ability to withstand extensive cleaning before experiencing a loss of binding capacity.

Each additional step in monoclonal antibody (mAb) downstream bioprocessing increases operating expenses and reduces the recovery of precious product. This Application Note, demonstrates how Multi-Column Chromatography (MCC), an integral part of continuous biomanufacturing, reduces operating time, buffer consumption, and resin usage, thereby decreasing operating expenses.

Now more than ever, researchers are leveraging the power of monoclonal antibodies (mAbs) to fight life-threatening diseases. To support scientists worldwide in their purification efforts, this Application Note details an example workflow to optimizing purification steps for mAb capture, the most critical step in downstream bioprocessing, using a novel protein A resin.

This eBook presents compelling examples of how the powerful Pro iQ Plus mass detector can significantly elevate analysis and QC in biopharma.