There are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In some cases, there is a need to identify a partner to support this next stage in a product’s life cycle. In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial manufacturing, understanding the operational, regulatory and quality connections is critical for successful filing and launch. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.
As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.
Chemical development is a time-consuming, expensive, and labor-intensive process. Traditionally, new chemicals are developed using batch processing, which fully relies on versatile and qualified equipment to perform different unit operations. To address these above challenges, continuous flow chemistry technology is currently emerging as an effective tool to conduct chemical synthesis, both at the micro and mesoscale, providing an improved product quality with safe and environmentally conducive process in comparison to traditional batch synthesis.
Sometimes your size exclusion chromatography (SEC) results don’t look like you want them to. Fix issues like poor resolution, peak tailing and fronting with the tips in this FAQ.
Need to find out how to calibrate your size exclusion chromatography (SEC) column? Or how different additives affect your results? Read these useful insights.
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.
Developability assessment or preformulation studies of small molecule is an important part the of drug discovery process leading to selection of New Chemical Entities (NCEs) for clinical studies. This white paper dives deeper into why we need developability assessment as well as its processes.
Droplet Digital PCR (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2-D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR Assays readily available through Bio‑Rad.
Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.
For over 15 years, GVK BIO has been supporting the chemistry needs of clients in the Pharma, Agrochem and material science space. These services are either provided as “Fee for Service” or “FTE” model. We cater to requirement of clients by providing them Medchem support, Library generation or simple plain Syntheses. Apart from designing small molecules and libraries, highly challenging syntheses and isolation of natural products, steroids, carbohydrates, peptides, macro cycles and nucleosides, is accomplished on a routine basis. The prime objective of our team is to accelerate research and development of our clients by providing them valuable scientific solutions with speed and quality.
Gibco BioProduction Services can support and partner with you no matter what your comfort level is with intellectual property. Our team of professionals will work with you to provide the best customized solution for your particular situation. You will receive exceptional customer service from start to finish.
The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.
The ZE5 Cell Analyzer is an innovative new flow cytometer with flexible configurations to meet a broad range of experimental complexities and throughput needs. Whether it’s a low-complexity, or a high-complexity experiment, the ZE5 Analyzer has up to 30 parameters and provides a truly expandable flow cytometer. This flexibility makes the ZE5 Analyzer accessible for novice flow cytometry users yet flexible enough for the most experienced flow cytometry professionals
Minimize errors, increase productivity and keep your laboratory’s resources focused on what matters most—positive patient outcomes—with the Thermo Scientific™ Arcos™ Block Management System.
Data-driven risk assessment enables smart decisions on development strategy.
