Whitepapers

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.

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.

Discover the benefits of a global CDMO manufacturing strategy built for scale, speed and reliability

Biologics manufacturing is shifting toward integrated ecosystems that align clinical and commercial needs within a unified operational model. Learn how to deliver speed, flexibility, and lifecycle efficiency from early clinical supply to high-volume commercial production.

MaxiPure® Polysorbate 80 is a highly pure excipient designed for high-value injectable applications where control of particles, oxidative stress, and biological compatibility is essential. Fully compliant with Ph. Eur., USP-NF, JP and CP monographs, this non-ionic surfactant is characterized by an oleic acid content above 98%, exceptionally low impurity levels, and outstanding clarity. By combining regulatory excellence with functional performance, MaxiPure® Polysorbate 80 supports the development of stable and safe protein-based therapeutics, and ensures formulation reliability across the drug development lifecycle.

Scaling up a lyophilization process is one of the most technically demanding challenges in biomanufacturing, and even the smallest mistakes can lead to failed batches, delays, and extra costs. This white paper from Jubilant HollisterStier (JHS) shows how choosing the right partner can reduce risk, guarantee quality, and accelerate timelines and features a real-world case study of how JHS lead a successful Phase 3 oncology drug scale-up.

The biopharmaceutical landscape is undergoing a structural shift toward greater molecular complexity and formulation concentrations exceeding 100 mg/mL. High-concentration formulations, particularly those intended for subcutaneous administration, present a distinct set of technical challenges that conventional development approaches were not designed to address. Samsung Biologics’ proprietary S-HiCon™ platform provides an integrated, data-driven framework for navigating these challenges, encompassing early material generation, structured excipient screening, and advanced analytical characterization.

This practical guide sheds light on often underestimated risks in ADC fluid and cold chain management – including cytotoxic exposure, operator safety, precision filling, freeze thaw stress, bioprocess container breakages, and costs. It outlines how closed, automated, and controlled single use systems help reduce risk, improve process reliability, and preserve ADC quality across fluid handling and cold chain operations.

The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data. Most notably, it signals a move to reduce or even eliminate comparative efficacy studies when robust analytics can provide equivalent insight, detecting subtle differences that clinical studies often miss. Biosimilar development will continue to require comprehensive analytical packages, with emphasis on orthogonal techniques. This session features Colette Quinn from Waters Corporation, who discusses how analytics support biosimilar development and help meet the FDA’s “totality-of-evidence” expectations.

Shifting from reactive problem-solving to proactive quality management can be a critical differentiator in highly regulated industries such as biopharmaceuticals. This eBook offers practical guidance on strengthening customer–supplier collaboration, reducing particulate contamination risk, and building resilient supplier quality management systems to support product safety and regulatory compliance.