The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
Filter Sizing for Process Optimization in Life Sciences Sterile Filtration
April 24th 2025Bench-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.
Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions
April 14th 2025Explore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance
April 14th 2025Cleanrooms 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.
GMP Validated Next Generation Sequencing Services: Viral Safety Testing & Genetic Characterization
March 26th 2025This 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.
Develop Potency Assays Early for ATMP Success
March 26th 2025Early 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.
Engage with Industry Leaders on Viral Clearance & Viral Safety at 2025 Summit
March 26th 2025Join 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.
Construction Efficiency with The floorlessPOD: A G-CON Prefabricated Cleanroom Solution
March 7th 2025G-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.
G-CON: The Benefits of G-CON Service Solutions
February 19th 2025Following 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.
Cleanroom Doors: Tailored Solutions for Seamless Integration and Compliance
February 19th 2025Learn 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 Next Generation of Prefabricated Cleanrooms: floorlessPOD
February 19th 2025G-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.
New Strategies for a Better Glycosylation Profile
January 22nd 2025Glycan 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.