Whitepapers

Ensure the stability, compliance, and success of your biologic with comprehensive CGMP cell banking and characterization services. Protect your process from start to finish with expert support and proven solutions.

This brochure will expand on our NGS testing services to biopharmaceutical and biotech companies, including viral contamination testing and genetic characterization of cell lines, bulk harvests, virus seeds, and raw materials used for production of biologics including cell and gene therapy products.

Early potency assay development and MOA understanding are critical for ATMP success. Delays can increase costs and risk failure, but recent advances highlight the need for timely, validated approaches to ensure regulatory and commercial success.

Join on June 3-4 in Cologne, Germany to gain insights from leading regulatory authorities, academics, and industry practitioners who define how biologics, vaccines, and advanced therapeutic medicinal products (ATMPs) are evaluated. Discover the latest technologies, learn best practices, and understand how to design an efficient manufacturing process.

Workflows to identify cancer biomarkers

G-CON’s floorlessPOD is a free-standing structure that provides direct integration with the host facility floor, eliminating the need for ramps, platforms and stairs typically required with prefabricated structures that have integrated floors. With fully integrated MEP, the floorlessPOD is an ideal solution when the cleanroom cannot be structurally supported by the host facility.

Following project close out, the G-CON Service Team will ensure that your PODs continue to function as intended. Service offerings include preventative maintenance plans, spare parts, NEBB certified TAB services (testing, adjusting, and balancing), and expedited support options. Additionally, the Service Team handles all warranty requests and manages data from these activities to drive continuous improvement in our products’ performance across all aspects.

Learn about the customization of cleanroom doors to meet specific operational and design requirements. This paper highlights GCS's ability to tailor door solutions, ensuring seamless integration with existing cleanroom infrastructure while maintaining efficiency, sterility, and compliance with industry standards. With a commitment to quality, compliance, and efficiency, GCS delivers door solutions designed to enhance cleanroom performance and meet the stringent demands of controlled environments.

The right cell line development technology can address production challenges associated with expression and scalability of complex biologics.

G-CON’s floorlessPOD is a free-standing structure that provides direct integration with the host facility floor, eliminating the need for ramps, platforms and stairs typically required with prefabricated structures that have integrated floors. With fully integrated MEP, the floorlessPOD is an ideal solution when the cleanroom cannot be structurally supported by the host facility.

The increasing demand for high-purity, regulatory-compliant guide RNA (gRNA) manufacturing in the CRISPR gene editing market underscores the need for advanced production capabilities.

Combining on- and off-site construction approaches reduces project risk while offering benefits to schedule, flexibility, and cost of ownership for new cleanroom construction.

Plasmid DNA (pDNA) is a critical starting material used to manufacture viral and nonviral cell and gene therapies (CGT).

Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.

Melting point determination using ultraviolet-visible (UV-Vis) spectrophotometry can be used as a sequence-specific method for identifying therapeutic oligonucleotides in pharmaceutical quality control. This method offers a simple, highly selective approach to differentiate between isomers and ensure the integrity of oligonucleotide active pharmaceutical ingredients (APIs) and drug products.

There are several advantages to using a novel capillary electrophoresis-mass spectrometry (CE-MS) device. The REBEL from 908 Devices offers a streamlined and efficient alternative to traditional liquid chromatography-mass spectrometry (LC-MS) for bioprocess monitoring. This paper highlights how this new technology can simplify media analysis, reduce method development time, and improve real-time data collection for biotherapeutic production.

Get a better understanding of dissolved oxygen (DO) measurement in Hamilton's comprehensive O2 Measurement Guide. This 72-page booklet is intended for anyone with an interest in DO sensor technology or anyone who needs to implement DO sensors in controlled environments such as laboratories and industrial plants.

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.

The eBook features must-see examples of real applications using Hamilton viable cell density monitoring (Incyte) and total cell density monitoring (Dencytee) and demonstrates how to leverage Viable Cell Density Monitoring in your processes.

Precision fermentation, a sustainable method for producing alternative food ingredients, faces significant technical challenges. This white paper explores the critical role of Process Analytical Technology (PAT) in overcoming these hurdles and ensuring product quality through a Quality-by-Design (QbD) approach. Through a comprehensive review of literature and case studies, key technical challenges are identified to demonstrate how PAT can enhance scalability and sustainability. This paper also highlights the transformative potential of PAT in advancing precision fermentation as a reliable solution for addressing nutritional deficiencies and fostering a circular economy.

Illuminating industry trends, challenges and sentiments