Whitepapers

In biologics development, a strong scientific idea is only the beginning. A molecule may show compelling biology in discovery, demonstrate good target engagement, and generate early excitement internally or with investors, but none of this guarantees that it can become a safe, manufacturable, and clinically viable therapeutic. That is the reality many early-stage companies face, and it is exactly why early development assessment matters. Early drug development is complex, multidisciplinary, and shaped by interdependent decisions. Data from discovery, drug substance, drug product, immunology, analytics, safety, and regulatory activities must ultimately come together in the first-in-human enabling package. Read this content piece to explore how at Lonza, these connected workstreams are assessed in a coordinated way, helping teams build a more complete and decision-ready foundation for development.

This custom eBook examines how advanced analytical characterization is changing biosimilar development following the FDA's October 2025 draft guidance. It covers modern SEC separations for biosimilar antibodies, LC-MS and MAM workflows for protein characterization and attribute monitoring, and the role of multi-angle light scattering (MALS) in biosimilar approval. A closing Q&A with Matthew A. Lauber, PhD, of Waters Corporation, explores how integrating these complementary techniques builds a more complete, regulatory-ready picture of biosimilarity.

This executive summary examines how FUJIFILM Biotechnologies' ShunzymeX™ platform addresses the purification challenges that make microbial expression systems slower and less predictable than monoclonal antibody workflows. Andrei Soliakov, PhD, a principal technical project lead of process development at FUJIFILM Biotechnologies, details the engineering of a scarless protease developed in partnership with the University of Edinburgh, along with proof-of-concept results across four structurally diverse model proteins. Readers will see how a standardized downstream workflow shortens the path from expression strain to GMP manufacturing.

Learn how key attributes such as encapsidation, aggregation, potency, purity, and genome integrity influence AAV quality and what analytical strategies are needed to characterize them with confidence.

See how CDMS accurately characterizes AAV reference materials and generates robust data to support development, comparability, and QC workflows.

Simultaneously measure aggregates, capsid titer, genome titer, molecular weight, size, and empty/full ratio from a single analysis.

Monitor AAV enrichment as it happens to improve process understanding, increase consistency, and reduce manufacturing risk.

Move beyond inferred measurements and gain direct insight into the viral vector quality attributes that drive efficacy, safety, and manufacturing confidence.

Discover how direct mass measurement reveals viral vector heterogeneity and provides a more complete understanding of capsid populations and product quality.

Comprehensive characterization of biotherapeutics requires advanced analytical strategies capable of detecting and identifying low-abundant product quality attributes (PQAs), including post-translational modifications, aggregates, sequence variants, and conjugation sites. This eBook presents three technical articles demonstrating advanced LC-MS workflows that achieve up to 10X improvement in MS sensitivity for trace-level detection and confident identification of these challenging attributes.

One workflow. More insight. Advanced LC-MS brings your data together

This Quality and Regulations eBook, presented by PharmTech, PharmTech Europe, and BioPharm International® is your guide to quality and compliance strategy, covering everything from ICH Q5A(R2)'s viral safety expectations to what a real FDA warning letter reveals about AI's limits in GMP documentation. Industry leaders discuss how risk-based quality frameworks are accelerating biopharma development, alongside a look at how USP's digital standards are modernizing quality control labs without sacrificing rigor. This eBook offers a practical roadmap for building quality systems ready for 2026's regulatory landscape and beyond.

Learn how cloud-based historian platforms can simplify bioprocess data management by centralizing process data, improving collaboration, and enabling secure, browser-based access. This white paper explores key considerations for evaluating cloud-native solutions, including security, compliance, scalability, and how modern data management can help scientists and engineers gain greater value from their process data.

Discover how accurate oxygen transfer rate (OTR) characterization supports microbial fermentation for high-quality plasmid DNA production. This white paper demonstrates the sulfite depletion method for measuring OTR in the Distek BIOne 2L Single-Use Fermentor and explains why it provides a more representative approach than traditional methods for process development and scale-up.

Delivering clinical supplies into the European Union and United Kingdom requires rigorous oversight from a QP to ensure every batch meets regulatory, GMP, and trial-specific requirements. Yet, many sponsors face preventable delays, often due to incomplete documentation, limited supply chain visibility, or late communication of changes. This paper breaks down the core responsibilities of the QP, explains how European Union and United Kingdom expectations differ, and share practical steps sponsors can take to streamline the certification process. Readers will learn how to prepare audit-ready documentation, avoid common pitfalls that extend release timelines, and build efficient collaborations with QPs to keep studies moving without interruption.

Discover how scalable 3D suspension culture can improve human induced pluripotent stem cell (iPSC) expansion compared to traditional 2D methods. This poster demonstrates process development within a BIOne 2L single-use bioreactor, highlighting aggregate size control, cell viability, expansion performance, and cost efficiency while achieving a 60-fold expansion over five days using Defined Bioscience HiDef® S8™ medium.

The regulatory landscape for life sciences manufacturers is evolving faster than ever.

Want to know what it really takes to protect a drug substance process's scientific integrity when it moves to a new manufacturing site? This executive summary, featuring the insights of Danielle Wittenwyler, PhD, Associate Director of Process Development, Drug Substance Lifecycle at Catalent, examines how late phase tech transfer can preserve process characterization (PC) as active scientific knowledge rather than static documentation. It outlines the common sources of transfer risk and describes a risk-based approach to bridging studies. The piece explains how preserved process knowledge supports more meaningful process validation (PV) and continued process verification (CPV) throughout the product lifecycle

This application note highlights strategies to optimize existing facility capacity and cold chain workflows while maintaining cold chain integrity for biologics.

BioPharm International speaks with David Cetlin, Cygnus Technologies, about MockV®, a non-infectious virus-like particle (VLP) technology designed to streamline viral clearance testing in biopharmaceutical manufacturing. Cetlin explains how the BSL-1 based approach allows companies to perform these assessments in-house, replacing reliance on costly, CRO-run live viral spiking studies with easy-to-use. The conversation also covers data comparability to the XMuLV gold standard, regulatory traction, and which internal teams are best positioned to lead adoption.

ILC Dover’s WFI Quality Water is a high-purity solution manufactured in a cGMP-compliant USA facility and designed for pharmaceutical and biopharmaceutical applications.

Meet the soloLAB containment isolator. Perfect for providing operator protection from hazardous materials or creating inert gas environments at laboratory scale. With its instant “pop up”deployment the soloLAB is ready for use in minutes.

ILC Dover’s custom plastic solutions are engineered for pharmaceutical, biopharma, and medical environments. Manufactured from hygienic, medical- and pharmagrade polymer that meets USP Class VI and FDA standards, with smooth, non-porous surfaces designed for easy cleaning and cleanroom compliance.

As the demand for monoclonal antibodies (mAbs) continues to grow across therapeutic, diagnostic, and industrial applications, biomanufacturers face mounting pressure to achieve higher productivity, increased process robustness, and improved scalability. Upstream and downstream operations, particularly media and buffer preparation, ingredient dissolution, and process homogeneity, play a critical role in ensuring consistent performance and maximizing overall yield. However, traditional mixing technologies often struggle to meet the evolving needs of intensified and flexible bioprocessing strategies while keeping operators safe and protecting the products from contamination risks.

The landscape of host cell protein (HCP) analytics has undergone a dramatic transformation over the past 25 years, and the pace of change is only accelerating. From the strengths and limitations of traditional ELISA testing to cutting-edge antibody affinity extraction and quantitative liquid chromatography-mass spectrometry (LC-MS) approaches, this content delivers a comprehensive look at the integrated impurity detection strategies shaping biologics development today.

Sequence variant analysis is essential for characterizing biotherapeutic proteins, but high rates of false positives can slow development. Subtle yet potentially profound changes to a protein's amino acid sequence can dramatically alter its function and impact patient safety. This paper reveals how low-level posttranslational modifications introduced during protein digestion can be misidentified as sequence variants. By implementing time-course digestion during method development, it can effectively distinguish true variants from artifacts, significantly reducing data analysis time. Case studies also show how to integrate time-course digestion into a workflow.

ICH Q5A(R2) is the key regulatory guidance document for the viral safety evaluation of cell lines used in the manufacture of biologics. This guideline now specifically references Next Generation Sequencing (NGS) as an advanced virus testing tool and an ethical replacement for virus assays in animal models. In collaboration with Charles River Laboratories, Pathoquest has generated data which underscores the superiority of their GMP validated iDTECT® Transcriptome assay over MAP/HAP/RAP in the characterization of rodent cell lines. This assay harnesses the power of NGS to screen cell lines for any replicating viral contaminants and allows the replacement of two mandatory animal-based assays: in vivo adventitious virus and MAP/HAP/RAP testing.

See how early supply chain engagement and continuous improvement reduce risk, accelerate tech transfer and time-to-market, and ensure reliable supply for customers and patients—download the white paper to learn more.