BPI White Papers

Overcoming Challenges in Ophthalmic Formulations through Polymer Selection – A Closer Look at Polyvinyl Alcohol

Ophthalmic drug formulations are growing in importance due to the increased prevalence of eye-related disorders such as diabetic retinopathy and macular degeneration. However, ocular drug delivery is challenging due to unique anatomical and physiological barriers such as pre-corneal loss factors including tear turnover, nasolacrimal drainage with potential systemic absorption via the conjunctiva or nasal mucosa, transient residence time, and the relative impermeability of the corneal epithelial membrane. The low ocular bioavailability (<10%) of conventional ophthalmic formulations is driving the need…

Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts to a biopharmaceutical after administration. Pharmacokinetic studies (PK) measure the variations of drug levels in the body as a function of time and are an essential part of the drug development process. Properly designed PK studies…

Sterile Fill/Finish Manufacturing

The bio/pharmaceutical industry is rapidly changing with increased product complexity, shorter timelines, and a push from the FDA for less human intervention in aseptic processing. These changes can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art Vanrx Microcell Vial Filler…

Case Study – Merck Process Transfer and Scale-Up of Batch Chromatography to Multi-Column Platform

Traditional batch chromatography has high operating costs. Merck sought to evaluate the relative performance and costs of an MCC system. Learn how Merck achieved resin savings and productivity gains by implementing multi-column chromatography with the Sartorius BioSMB System. Key Learning Objectives: Learn how Merck achieved 3.5x higher productivity with MCC compared to batch mode See how the shift resulted in 80% reduction in chromatographic resin use Find out how Sartorius experts supported Merck’s process transfer Access this case study and…

Visit and work with the M Lab™ Collaboration Centers from the comfort of your own lab

Welcome to the M Lab™ Collaboration Centers where life science innovators come to explore big ideas, learn new techniques, and rapidly move from complex problems to just-right solutions–together. Using world-class remote technologies, you can do all this from the comfort of your own lab! We have expanded the walls of our labs by using the latest technology to bring you virtual visits or livestream trainings to support all areas of process development, implementation, and optimization. When you bring a problem…

Accelerating Antibody Discovery through Gator® BLI Biosensor Technology

The development of antibodies for diagnostics or therapeutics requires comprehensive characterization of affinity, specificity, and mechanism of action. Affinity measurements could screen different isolates of an antibody to identify those that are most effective at binding antigen. Also, measurements of the capacity of an antibody to bind other compounds that are structurally related to the original immunizing antigen can help establish the likelihood of whether an antibody will cross react non-specifically with other molecules that might accompany the antigen. Binding…

Transitioning from Quantitative PCR to Droplet Digital PCR for HEK293 Host Cell DNA Residual Testing

HEK293 cells are a dominant platform for cell and gene therapy production because they are highly effective at producing large amounts of recombinant viral vectors. However, it is critical to remove trace host cell contamination from therapeutic products to avoid endangering patients. To meet rigorous regulatory guidelines, biopharmaceutical manufacturers need a HEK293 detection method that delivers high-quality, quantitative data with a simple, reliable workflow. This white paper discusses the transition from quantitative PCR (qPCR) to Droplet Digital PCR (ddPCR™) for…

Converting an ELISA Assay into an Octet® BLI Quantitation Assay

Enzyme-linked immunosorbent assays (ELISA) are routinely used to quantitate molecules and despite their popularity, these assays are labor- and time-intensive. Quantitation assays on the Octet® platform can be considered automated forms of ELISA but allow a myriad of benefits compared to standard ELISA assays, notably the ability to detect lower affinity interactions and a reduced hands-on time for the scientist. As with ELISA, the signal reported in quantitation assays is either directly or inversely proportional to the amount of bound…

Increasing Dynamic Binding Capacity of Oligo(dT) for mRNA Purification: Experimental Results Using CIM 96-Well Plates

Messenger RNA (mRNA) emerged as a powerful therapeutic tool for treatments in gene therapy, oncology, and infectious diseases, as recently demonstrated by vaccines against Covid-19. mRNA is produced by an enzymatic reaction that can be rapidly designed and scaled-up, and the platform is highly adaptable to different targets. One of the greatest challenges in mRNA production is the removal of process-related impurities stemming from in vitro transcription (IVT) reaction, such as residual nucleotide triphosphates, DNA template, enzymes, abortive transcripts. Affinity-based…

Current Trends in Antibody Drug Conjugates (ADCs) Characterization: Expert Paper

We bring you a brand-new paper focused on Current Trends in Antibody Drug Conjugates Characterization, focusing on structure. Comprehensive structural, biophysical, and physico-chemical property characterization in alignment with Chemistry, Manufacturing and Controls (CMC) guidance is a requirement to achieve successful regulatory (IND) submissions. Multiple analytical technologies are required for ADC analysis with a focus on the drug’s critical quality attributes (CQA), with data interpretation conducted by experienced biopharmaceutical analytical scientists. In this review, we discuss the current trends in antibody…