BPI White Papers

Transfection Reagents for Cell and Gene Therapy

Gene therapy is the transfer of genetically modified materials into a patient’s tissues or cells with the goal of correcting the abnormal gene contributing to a particular disease. In recent years, biotherapeutics have emerged as effective treatments for a broad spectrum of diseases as numerous genes connected to disease and cellular processes have been identified as potential targets for therapeutic approaches. It is estimated that every year hundreds of new biotherapeutic candidates are developed. Currently, one of the most critical…

FAQs: Challenging host cell protein assays for improved risk mitigation

Host cell proteins (HCP) are critical to quality control in biologics development. If left unremoved, they can cause immunogenic responses and reduce drug efficacy. In our last webinar we shared Cytiva’s strategy for designing a comprehensive HCP risk mitigation strategy. We discussed how to challenge your assays early to ensure accurate measurements, build confidence, and reduce the risk of unexpected HCP levels. Our HCP experts highlighted and responded to the most common questions raised around host cell protein assays. Want…

Fragment-Based Screening in Drug Discovery: How to Improve Hit Rates & Deliver Higher-Value Targets

Learn about the basics of fragment-based drug discovery (FBDD), one of the most valuable approaches to small molecule screening and now even more widely used today by pharma companies than high-throughput screening (HTS) HTS’s main limitations — low success rates for more challenging targets, high level of false positives, and the size of the compound libraries — are propelling the use of FBDD. This change is also driven by the rise in the number of explorative targets, which demands not…

Enabling Vaccine Production: Solving Challenges

Vaccine developers are in need of more efficient and cost-effective approaches to manufacturing. To achieve this, we actively collaborate with academia, researchers and manufacturers to develop and optimize innovative tools, processes and strategies to resolve bottlenecks and accelerate the availability of vaccines to the global population. This e-book contains a series of case studies highlighting our recent collaborations with organizations and thought leaders on the front lines of the battle against challenging pathogens. From proof-of-concept to full commercial-scale manufacturing, discover…

Single-Use Systems: Globalizing Best Practices and Technology Specifications

The challenges of multi-national bioprocessing operations are numerous. They include finding highly skilled experts for each site, lack of expertise with single-use systems, contamination risks and redundant efforts and resources—all of which can lead to higher costs. But these challenges also present opportunities for increasing speed to market, eliminating redundant work and overall cost savings. This white paper details the best practices used in global drug manufacturing. The key is global coordination. Best practices and specifications need to be identified…

Keep Your HCPs Under Control

When it comes to manufacturing biologics, managing host cell protein (HCP) levels is essential. A robust HCP strategy can help protect both your timeline and budget. Cytiva understands the challenges researchers face in HCP detection, quantification, and removal. We offer an end-to-end solution for HCP management, and our experts will work with you to find the right strategy tailored to your needs. To get started now, check out our knowledge center for expertise and advice on enhancing your HCP strategy.

Manufacturing Pluripotent Cell Therapeutics

Here we review strategies for gaining Food and Drug Administration (FDA) approval of allogeneic, pluripotent cell therapies. The crux of the discussion is that when developing a cell therapeutic, it is critical to look as much as a decade ahead to when FDA approval will be sought to commercialize the product through a biologics license application (BLA). While this discussion focuses on FDA approval of cell therapies, it is important to acknowledge the vast number of cell therapy clinical efforts…

Your Guide to Efficiently Develop Antibody-Based Therapeutics

This eBook presents various techniques used to measure the stability of antibody-based biotherapeutics. The authors address the ins-and-outs of monoclonal antibody (MAb) formulation, cover Investigational New Drug (IND) and New Drug Application (NDA) filing timelines, and explain how storage conditions affect MAb stability. Monoclonal antibodies have been used in therapeutics for more than 30 years. Efforts to further develop and optimize better MAb-based biotherapeutics are increasing as they have become increasingly popular for the treatment and prevention of many diseases…

Scalability of Lentiviral Production with the CTS LV-MAX Lentiviral Production System in Bioreactors

The Gibco™ CTS™ LV-MAX™ Lentiviral Production System provides a scalable and high-yield lentiviral vector (LV) production platform. It is based on a high-density suspension culture of HEK293F–derived Viral Production Cells that have been optimized for viral production in chemically defined LV-MAX Production Medium. Scalable LV production of greater than 1 x 10⁸ TU/mL LV (unconcentrated) can be achieved using our proprietary lipid nanoparticle transfection reagent in combination with an LV-specific enhancer and production supplement. All components work synergistically to help…

Technology Transfers – A Beginner’s Guide

Pharmaceutical developers are increasingly relying on external manufacturing partners for expertise to develop and commercialize their products. In fact, contract development and manufacturing organizations (CDMOs) now process and manufacture approximately 28 percent of the world’s prescription and non-prescription drugs. Innovation is coming from all corners of pharma including independent labs, scientific consortia, academia and government programs. These emerging sources of drug innovation often have excellent science but few resources and a lack of experience in commercializing formulations and drug product…