Whitepapers

Advanced chromatographic and analytical approaches can help overcome the complex downstream purification challenges of therapeutic nucleic acids; these innovations include on-column DMT cleavage and real-time anion-exchange chromatography coupled with multi-angle light scattering (AEX MALS) integration. By exploring next-generation resin technologies and sustainable, solvent-free workflows, this article highlights how process scientists can enhance purity, yield, and scalability for complex drug manufacturing.

Pharmaceutical and biopharmaceutical companies are navigating tightening regulations, rising R&D costs, and intensifying competition, prompting a comprehensive reassessment of their production systems. By leveraging advanced analytics and modern technologies across the product lifecycle—from discovery through approval—organizations can enhance efficiency, strengthen quality and consistency, and enable more agile, data-driven manufacturing. This eBook examines how advanced analytical tools complement traditional methods to support faster, more confident decision-making within increasingly complex development and manufacturing environments.

Overcome common HPLC challenges. This eBook offers solutions to simplify routines, ensure reliable results, make smart investments, and create a sustainable lab.

Discover our comprehensive portfolio of analytical HPLC solutions, featuring the latest Agilent Infinity III LC Series, applications, and a selection guide.

Streamline your workflow with smart automation

How lab managers and analytical scientists can maximize ROI, minimize hidden costs, and drive sustainable profitability with smarter LC decisions

Explore key findings from LCGC user surveys on liquid chromatography—covering cost-performance, reliability, and evolving LC technology trends.

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client. Additionally, once the CRO has been awarded the project and now must create an executable plan for managing the study’s complex clinical supply needs, there are one or more key decision influencers who are critical to engage early on during the planning and project set up stage and several proactive steps to take to build a solid clinical supply plan.

Discover how pharmacy-led models in direct-to-patient clinical supply are pivotal in modernizing clinical trials, offering scalable, patient-centric solutions that align with regulatory guidance and industry trends. Strategic collaboration with pharmacy providers is the key to unlocking the full potential and benefits of decentralized clinical trials (DCTs).

In the era of seamless drug development, reducing time to the clinic and getting rapid regulatory approval has become the goal of nearly every early drug development sponsor. Handling drug development, manufacturing, and clinical supply efficiently can help sponsors save costs and provide maximum benefit for patients. To improve the efficiency of the drug development continuum, integrated solutions have become an effective option for sponsor companies to streamline the transition from early development to the clinic, in addition to providing timely clinical supplies to help keep study timelines and budgets on track. Along with a discussion, examples of real-life tactical and operational decisions involved in the integrated approach to drug development will be presented.

As biopharmaceutical pipelines diversify, laboratories must deliver reliable, high-quality data across increasingly complex sample types. Download this eBook to explore how next-generation liquid chromatography (LC) systems are enabling robust, flexible bioanalysis through real-world QC applications.

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.

Discover the future of microbial expression with a platform that optimizes strain selection, expression systems, and purification methods, providing actionable insights in just eleven weeks.

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