Whitepapers

Get ahead of cyber-attacks by keeping pace with the speed of IIoT innovation

Gene therapy products require extensive experience in bioassay development, optimization, phase appropriate method validation/transfer, as well as assay maintenance to support routine lot release and stability testing. Learn how Eurofins BioPharma Product Testing can support your gene therapy products.

Cybersecurity with Clarity and Rockwell Automation

Eurofins BioPharma Product Testing supports the development of cell and gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation.

Eurofins BioPharma Product Testing’s dedicated Biologics Raw Materials testing team has vast experience in cell and gene therapy manufacturing from early clinical, through process validation, product optimization, and marketed release. Work with the team that has over 20 years of biopharmaceutical experience for your raw materials program.

Mycobacterium has been a concern in the vaccine industry for many years and now for the gene therapy industry. At the speed the industry is moving, faster and alternative approaches are needed to address speed of results as well as quantity of material needed. The Eurofins Mycobacterium complex PCR detection method can issue a COA in 10 days, requiring only 1-2mL of sample.

Through advanced technology, deep industry knowledge and an unwaveringly collaborative approach, our proven capabilities help life sciences companies succeed in a highly competitive and complex marketplace from targeted biologics to cybersecurity.

The rapid development of gene therapies and high demand for therapeutic proteins pose considerable challenges for biomanufacturing. Complex production processes, product changeover, managing supply chains, and staying ahead of the curve, to name just a few. To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. The solution could be a comprehensive approach for screening and characterizing molecular interactions such as protein-protein or protein-drug interactions. It enables a huge variety of applications performed at various stages of biologics development — from early selection to validation to manufacturing. Based on Bio-Layer Interferometry (BLI), it enables real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Download this eBook to learn how the Octet® BLI platform can streamline workflows, reduce time-to-results, and costs saving on broad range of analytical applications in bioprocessing.

Read a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.

A 2-step platform to purify Pertuzumab is developed, using 1 mL and 5 mL pre-packed columns. Then, scale-up is demonstrated using 50 and 200 mL pre-packed columns.

Octet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.

This eBook highlights key considerations for navigating the supply chain as newer biotherapeutic molecules drive growth and support the innovation and manufacture of newer biologics.

Lipid-based nanoparticles (LNPs) are effective non-viral vectors for delivering messenger RNA products (mRNA), most notably used for vaccine production against the recent SARS-CoV-2 pandemic. In this executive summary, you will discover a robust and high-throughput kit-based analysis of nucleic acids extracted from different mRNA-LNP samples.

Partnering with a single CDMO can increase speed to market, ensure production capacity and avoid costly-time consuming tech transfers. Learn more inside this eBook.

Scorpius BioManufacturing discusses the importance of selecting the right CDMO for your next clinical biologic campaign. They cover what attributes are needed through evaluating analytical integration as well as new technologies to look for that will mitigate risk and speed your drug’s manufacturing timelines,

This white paper summarizes information around chromatography resin variability, providing support for developing robust purification bioprocesses.

Automated filling of drug substance into single-use bags help optimize fluid management in terms of accuracy, scalability, flexibility, speed and more.

This application note examines the suitability of BioBLU® 0.3c Single-Use Bioreactors and the DASbox Mini Bioreactor System in the long-term expansion of CD4+ T cells.

Given the risks and opportunities inherent in drug development, choosing the right late-phase strategy to optimize timelines and capacity, while remaining flexible enough for changing market conditions, presents a significant challenge to companies developing and commercializing biopharmaceutical products. This piece highlights new technologies and strategies to reduce risk and execute consistently.

This note outlines the benefits of PFS transfer and the key engineering processes required to successfully carry out this process.

Obtain more data without the ambiguity of traditional chromatographic and electrophoretic assays. This notebook compiles app notes generated by the Biopharmaceutical Scientific Operations Team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.