Whitepapers

In this technical paper, Pete Makowenskyj, Sr. Director of Design Consulting at G-CON, explains how cleanroom facilities handling hazardous materials must balance patient safety, product sterility, and operator protection. The paper outlines the regulatory landscape, highlighting gaps between contamination-control guidance and containment requirements for high-risk agents such as ADCs, radiopharmaceuticals, and spore-forming organisms. It details key design considerations—including pressure schemes, HVAC zoning, filtration, and decontamination strategies—that ensure safe, compliant operations. The paper also emphasizes the value of prefabricated cleanroom solutions for achieving tighter environments, flexibility, and future-proofing.

The 503B outsourcing facility market operates under unique pressure: meeting FDA cGMP standards while maintaining agility, sterility assurance, and scalability to serve an ever-expanding network of hospitals, clinics, and health systems. As patient demand and regulatory oversight increase, traditional construction approaches struggle to keep pace. Prefabricated G-CON POD® Cleanrooms offer a transformative alternative—delivering speed, compliance, and future flexibility in a single integrated solution while also dramatically driving risk out of the project.

G-CON provided The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) with prefabricated POD® Cleanrooms to rapidly establish a GMP-like plasmid production facility within a renovated 50-year-old warehouse. The solution included prefabricated POD® Cleanrooms and all necessary utility systems, enabling parallel renovation and significantly accelerating the project timeline. The project was supported with funding from the National Institute of Standards and Technology in the Department of Commerce under 70NANB21H085.

Though we didn’t know it in the 17th century when a dog was injected using goose quills, we know it now: Bacteria and other contaminants can make patients very ill. That’s why the final aseptic filling step is so critical for making injectable drugs. How can we get better at protecting drug quality and patient safety? This e-book takes you on a journey to answer that question and others. Each chapter gives you practical insights: Dive into the “human factor” and why it continues to confound us. Discover why we need to go far beyond monitoring to keep contaminants at bay. Learn why regulators encourage the use of modern barrier technologies, such as gloveless isolators. Explore why airflow studies and computational fluid dynamics are key tools for qualifying aseptic filling processes. Learn how real-time tools for environmental monitoring can save batches and protect patients. Finally, get strategies for navigating complex regulations and see how innovation is helping companies deliver new therapies quickly and safely.

Perfusion-based upstream processing is redefining the production of biopharmaceuticals. By enabling continuous media exchange, perfusion systems maintain high cell density and cell health over longer periods, delivering higher productivity than traditional fed-batch approaches. The result is greater process efficiency, improved scalability, and broader access to affordable therapies. As Biopharma manufacturers face increasing pressure to accelerate timelines and reduce costs, perfusion technology offers a powerful path forward. This executive summary explores practical strategies for implementation, key process control insights, and real-world case studies demonstrating the advantages of perfusion-based production.

De novo assay development holds great promise for future drug discovery projects, potentially reducing costs, improving success rates, and ultimately benefiting patients by accelerating the development of safe and effective therapeutics. Learn what you need to know with regard to new biomarker assay development.

As the biopharmaceutical industry continues to prioritize precision and purity, material suppliers are adopting increasingly rigorous standards to combat particle contamination. Unwanted particulates in drug products, especially injectables, can lead to significant economic losses and, more importantly, pose serious risks to patient safety. Effective mitigation requires collaboration with partners who possess deep expertise in contamination control. Drawing on its heritage in the semiconductor industry, Entegris applies an exceptional level of sensitivity to purity and particle management, supported by robust quality systems, advanced contamination control technologies, and proprietary detection and sizing platforms. This paper examines the lifecycle of particle contamination in biomanufacturing and highlights practical strategies to mitigate its effects.

CDMS is reshaping the characterization of complex biotherapeutics by enabling precise analysis of large, heterogeneous biomolecular complexes and gene therapy vectors. This article explores how CDMS enhances resolution in quality assessments across biotherapeutic development and structural biology research—surpassing the capabilities of conventional analytical techniques.

Quantitative protein expression analysis is essential for advancing mRNA therapeutics, providing the data needed to confirm effective and targeted protein production. This article explores key assay development strategies, analytical challenges, and the application of advanced liquid chromatography-mass spectrometry (LC-MS) techniques to achieve precise and reproducible quantitation of proteins expressed from mRNA therapies.

Nitrosamine contamination in pharmaceuticals has become a major regulatory concern due to their potent carcinogenicity, requiring ultra-trace-level detection to ensure patient safety. Advanced LC-MS/MS workflows provide the necessary sensitivity, selectivity, and robustness to accurately quantify nitrosamine drug substance-related impurities (NDSRIs), even within complex pharmaceutical matrices. Case studies with betahistine, orphenadrine, and chloropyramine demonstrate how streamlined LC-MS/MS strategies can reliably detect and confirm nitrosamine impurities well below regulatory thresholds.

The first charged aerosol detector (CAD) was introduced in 2005. Nearly twenty years later, this near-universal detector has become an indispensable tool in the analytical chemist’s quantitative arsenal. This paper explores the CAD’s origin story, its adoption into everyday use by separation scientists, and its comparison to evaporative light scattering detector (ELSD). Technical highlights will include how parameters such as evaporation temperature influence application versatility, and how the power function impacts linearity and response behavior.

Optimized plasmids are vital for viral vector production. Catalent’s off-the-shelf plasmids help AAV gene therapy developers enhance efficiency, reduce costs, and improve consistency across development and manufacturing.

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions. Spray drying has emerged as a powerful and versatile manufacturing technology. It offers significant advantages for stabilizing complex and sensitive drug molecules while optimizing production processes. Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals. This session will cover the latest innovations in spray drying technology, and provide valuable insights into formulation development, process parameters optimization, and large-scale production. Attendees will also learn how to maintain molecular integrity during the spray drying process and leverage in-silico tools to streamline commercialization.

Pharmaceutical micronization plays a pivotal role in enhancing the efficacy and bioavailability of many active pharmaceutical ingredients and the need for robust, repeatable and precise particle size control is critical. This article provides an in-depth review of milling equipment, including jet, pin, hammer, conical and cryogenic mills. Each technique is influenced by material properties like hardness/brittleness, morphology, and moisture content, as well as milling parameters such as feed rate, grinding pressure, mill speed and temperature. By selecting the right milling equipment and optimizing its operation, pharmaceutical innovators can ensure that their products meet the highest standards of quality, efficacy, and safety.

Precise cold chain management is essential to safeguard biologics, but traditional ULT freezers can’t keep pace with the demands of modern drug development.

This infographic explores the benefits of Acoustic Ejection Mass Spectrometry (AEMS)- based workflows for efficient small and large molecule screening.

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.

Get a better understanding of pH measurement in Hamilton’s comprehensive pH Measurement Guide. This 68-page booklet is intended for anyone with an interest in pH sensor technology or anyone who needs to implement pH sensors in controlled environments such as laboratories and industrial plants.

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.

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.

As a leader responsible for metabolite identification in your organization, what keeps you awake at night? SCIEX can give you peace of mind by helping you . . .

We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created this solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options. This guide covers bio/pharmaceutical quantitative assays from discovery to QA/QC, for large and small molecules. Happy reading!

Explore how next-generation high-performance liquid chromatography (HPLC) systems are elevating biopharmaceutical analysis. This eBook showcases innovations in size-exclusion chromatography (SEC), method updates, and proven approaches to increase efficiency, consistency, and resolution in the lab.