Whitepapers

This eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity. Part 1 covers the importance of selecting appropriate environmental monitoring locations and how a risk-based approach supports quality assurance efforts.

Learn about the role of environmental monitoring in a robust contamination control strategy to maintain product integrity and safeguard patient safety.

Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity. Part 2 of the series covers the importance of taking proactive measures based on environmental monitoring results to ensure consistent quality and mitigate potential risks to product safety and integrity.

Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.

In this case study, learn how TrueBinding leveraged G-CON’s prefabricated cleanroom PODs to achieve their mission critical goals.

In this webcast, we review industry drivers and risks for capital construction, with a focus on cleanroom infrastructure, and discuss the goals of using a hybrid approach while demonstrating its application and benefits using real-world examples.

Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.

Explore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.

Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.

Evolving therapeutic modalities increase bioanalytical complexity, making ion mobility spectrometry–mass spectrometry (IMS-MS) crucial for enhanced sensitivity and selectivity.

Explore top affinity resins for efficient downstream bioprocessing and lower costs.

Learn about new advancements for achieving increased component resolution, shorter run times and more consistent recoveries of HMWPs with outstanding reproducibility.

Automate your qPCR & dPCR workflows

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.

GCS manufactures cleanroom components designed for critical environments, prioritizing the use of sustainable and responsible materials, without compromising the quality and performance of our products. GCS, with its broad range of highly innovative products for the cleanroom infrastructure market, provides clients access to premium cleanroom materials such as modular wall and ceiling panels, cleanroom and specialty doors and other unique components.

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.