Whitepapers

Dr. Luca Mantilli, an R&D chemist at Valsynthese, shares his insights into the company’s journey with phosgene, an exceptionally versatile reagent that offers various synthetic possibilities.

Consistent quantification using qPCR and dPCR technology is essential for obtaining accurate and precise viral vector titers.

Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully selecting fill formulations during the early stages of drug development, it is possible to meet the specific requirements for bioavailability and stability for clinical trial and supply.

Various impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.

Knowing the right time to introduce cGMP raw materials when scaling up mAbs manufacturing avoids production process redevelopment, delays and increased costs. Using cGMP grade reagents earlier makes for a seamless transition while maintaining quality and viability. Learn key considerations for a seamless scale up process in our GMP fact sheet.

Buffers are used in great quantities when producing monoclonal antibodies (mAbs), and many biopharmaceutical companies — even large ones — do not have the processing capacity or infrastructure in-house to handle these large volumes. Whether it’s providing quality, pre-weighed, GMP-compliant raw materials or the entire buffer preparation step, there are options available to optimize your process.

As the most expensive stage of monoclonal antibody production, downstream processing presents numerous opportunities to increase efficiency and raw material performance. This article discusses advances in purification process materials, as well as emerging technologies to aggregate and analyze data, as possible solutions to these challenges.

Lipid-based formulations can improve the oral bioavailability of some molecules. However, a poor understanding of the technology and complexities limit their use.

It is essential to have access to the right tools and expertise to support process development for biologic therapies, from the clinical trial phase to commercialization.

Experic’s latest article looks at new initiatives aimed at fostering the development of biologics delivered via inhalation, an emerging field. While manufacturing technologies have advanced to support this sector, several challenges remain, including an unclear regulatory pathway.

When you’re partnering with a design firm to support your product development and manufacturing needs through automation, it’s important to decide whether you should work with a systems integrator or an automation design engineering firm.

When establishing or expanding services to support new drug development, pharmaceutical and biotech companies find that automating their processes increases efficiency, maximizes capital, reduces costs, and expedites time-to-market.

Automation systems can increase efficiency, reduce time to market, and improve facility and operational performance. Support from a life sciences-focused design firm with experience in cGMP requirements will help you tailor your system to your specific process, facility, and operational needs.

Eurofins BioPharma Product Testing (EBPT) in the US is a leading entity in the analytical testing of Cell and Gene Therapy, with its involvement dating back to 2010 at the Eurofins BPT Lancaster, PA location. Over the past decade, EBPT has developed a comprehensive business strategy catering to the analytical industry's needs, covering Raw Materials, Cell Banks, Plasmids, Viral Vectors, Genetically Modified Cells, CAR-T drug products, and iPSCs. The company has actively supported the growth of Cell and Gene Therapy through strategic investments, including the adoption of innovative technologies like droplet digital PCR, Analytical Ultracentrifugation , and Transmission Electron Microscope testing. These investments also involve dedicated facilities at various locations across the US.

Helium has been the preferred carrier gas for gas chromatography (GC) testing, but its finite supply, environmental impact, and recent supply chain issues have prompted Eurofins Lancaster BioPharmaceutical Chemistry teams to actively seek alternatives and reduce helium usage in laboratories. Conservation efforts include evaluating gas chromatography methods, checking for helium leaks during audits, and avoiding idle periods between analytical runs. Nitrogen and hydrogen are explored as alternatives, with challenges noted. Eurofins is committed to developing strategies to conserve or eliminate helium usage, recognizing the importance of reducing reliance on this non-renewable resource in the industry.

Eurofins acknowledges the significance of Cell and Gene Therapies, particularly Autologous Cell Therapies , in the healthcare industry. Recognizing the urgency associated with short shelf-life products, Eurofins BioPharma Product Testing has developed a comprehensive set of services to address the need for swift and reliable testing. This suite of services positions Eurofins as a one-stop-shop for rapid and facility testing requirements. Clients can benefit from guaranteed short turnaround times while maintaining the highest quality standards for tests crucial in ensuring the safety of Cell and Gene Therapies for patient administration.