eBooks

Messenger RNA Drugs: Engaging the Machinery of Patients’ Cells to Therapeutic Effect

Although most of the bioprocess industry has focused on process development for large-molecule formulations (e.g., protein drugs), a growing segment of the industry has been concentrated on other types of biotherapeutics to leverage advances in understanding of immunology and genetic engineering. Such technologies may emerge both as tools for drug manufacturing and at some point, as biopharmaceuticals, biotherapeutics, vaccines, and cell and gene therapies,  themselves. What brings mRNA research to BioProcess International’s attention is the increasing interest turned toward therapeutic…

Biopharmaceutical Characterization,
Part 1: Biological Assays —
A Conference Report

In late October 2018, KNect365 brought together more than 250 analytical specialists to discuss characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies, including BPI editorial advisor Nadine Ritter (president and analytical advisor of Global Biotech Experts). She began the final day moderating a special town-hall session where audience members could pose their regulatory questions to a panel of FDA reviewers, and she ended…

eBook: Using Modern In Situ Analytics and PAT for Automated Feedback Control of Critical Process Parameters

Simply put, the best way to control a critical process parameter (CPP) is to measure that specific parameter, integrate the live signal into your control system, and apply a smart feedback algorithm for an automated control loop. The challenge in doing this for bioprocesses has been due, in part, to the complex, highly dynamic, and variable nature of the process along with the lack of robust, scalable, and multiformat (single-use or multiuse) technologies that can monitor in real time such…

Partnerships in Immunotherapy: Working Together to Take Cancer Treatment to the Next Level

Biopharmaceuticals are a particularly complex expression of medicine — and immunotherapies perhaps even more so. As treatments, these products themselves often also need “partners” of a kind: e.g., radiation/radiotherapies, traditional MAbs, and chemotherapies. Just as this field of endeavor requires the input and expertise of many different disciplines — from medical researchers to process engineers, clinicians to business leaders, and market experts to policy makers — this discussion of the topic of partnerships in immunotherapy brings together different experts in…

Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant

Triton X-100 detergent makes an interesting case study in bioprocess sustainability strategy. Also known as octylphenol ethoxylate (OPE), this nonionic surfactant has many uses in biopharmaceutical research and development. Among other laboratory applications, it is used to lyse cells and DNA in research, to solubilize membrane proteins and decellularize animal-derived tissues, to reduce the surface tension of aqueous solutions during immunostaining, and to remove sodium dodecyl sulfate (SDS) from polyacrylamide gel electrophoresis (PAGE) gels for analysis. It also serves as…

BioProcess International Conference and Exhibition 2018 Postevent Report: Key Insights, Highlights, and Take-Away Messages

From the global shift in demographics to increased efficiencies in chromatography media, change is constant within the bioprocessing industry and a major reason delegates flock to the annual BPI Conference and Exhibition. As a place to get an overview of the hot topics affecting this industry, the meeting brings together key aspects of bioprocessing — therapeutic modalities, cells, expression systems, upstream production, downstream processing, development, and manufacturing — with digital integration and the increasing importance of analytics. Add in macrobusiness…

Cell Culture Media: An Active Pharmaceutical Ingredient or Ancillary Material?

Cell-based therapies are used to treat diseases that require the replacement of diseased, dysfunctional, and injured cells (1). To produce these therapies, a wide range of reagents and materials such as antibodies, growth factors, and enzymes are used in their manufacturing processes. Such necessary materials are administered through a cell culture medium. Active pharmaceutical ingredients (APIs) are the main ingredients that make products therapeutic. Ancillary materials (AMs) and raw materials (RMs) are essential components used during production but are not…

Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities

New technologies bring new regulatory challenges. The biopharmaceutical industry must be cautious in its implementation of new scientific ideas and technology platforms — no matter how promising those might be. Regulators will look skeptically on any claim that isn’t backed up by good data, and with no solid history of successful use to build on, a company must have all the answers itself. How do compliance professionals anticipate what kinds of questions reviewers will ask when the time comes —…

eBook: Scalable Cell-Based Immunotherapy Manufacture: A Comparison of Single-Use Agitated and Static Expansion Technologies

Early clinical results indicate that personalized autologous immunotherapies could revolutionize cancer treatment (1). However, challenges lie in the realization of cost-driven, scalable cell therapy (CT) manufacturing strategies (2) for generating sufficient therapies to treat a populace, thereby limiting their translation to public health (3). Primary challenges involve complex needle-to-needle logistics, complexities in closed processing, and high variability in starting cell materials that define the autologous nature of such therapies. Despite barriers in industrial-scale manufacture, public health management already has engaged…

eBook: Biopharmaceutical Training – Train Your Team to Meet Evolving Industry Needs

Welcome to this year’s focus on industry training programs. In the past three years we’ve brought this information to you in several forms: as a full supplement issue (2016), a featured report (2017) – and now this ebook. Each program that we’ve profiled offers its unique approach to training present and future biotechnologists. The best of the programs offer hands-on training with current equipment provided by supplier partners and with up-to-date approaches to documentation and regulatory requirements. Many university- and…