Manufacturing

Innovations in the Manufacturing of Cell and Gene Therapies

by , and

Advancements in next-generation cell and gene therapies are fulfilling the promise of personalized medicine and attempting to cure and heal patients. Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. Developing innovative advanced therapies is one of the biopharmaceutical industry’s greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies is a contract testing, development, and manufacturing organization (CTDMO) that has launched several innovative world-class platforms. It offers integrated platforms to…

December 3, 2020

eBook: Drug Delivery —
Partnerships Are Key As Medical and Digital Worlds Converge

by

Drug delivery is advancing into a digital future. Information technology is changing aspects of every operation in the biopharmaceutical industry. Meanwhile, machine learning and cloud computing are not only finding their way into drug development, manufacturing, and distribution, but also into drug-product delivery devices themselves. As a result, many biopharmaceutical companies are seeking medical device expertise through strategic alliances and contract services. New delivery devices can help big companies extend patent protection on established marketed products, for example, and provide…

November 24, 2020

Making MAbs: Bioprocess Advancements Challenge Platform Assumptions

by

Still the largest sector of the industry, monoclonal antibodies (MAbs) have dominated the biopharmaceutical stage for over 30 years. Some observers might think there’s nothing new to say about these molecules; others point to antibody derivatives as a more exciting alternative. But MAbs are far from an outdated technology. From biosimilar developments to cell-free synthesis to yeast display, immunogenicity improvements, and fully human antibodies — as well as improvements in process efficiency and cost reductions, as discussed herein — the…

October 30, 2020

Tracking Therapeutic Antibody Development in a Pandemic

by

The COVID-19 pandemic has generated a significant and rapid response from scientists who aim to develop drugs and vaccines in the academic, government, and industrial sectors. Such interventions are essential to containing SARS-CoV-2, the coronavirus that causes the COVID-19 disease. To inform and educate the public about global efforts to develop targeted therapies such as monoclonal antibodies (MAbs), The Antibody Society (TAS) and the Chinese Antibody Society (CAS) have designed and implemented a freely available online database called the COVID-19…

October 30, 2020

G-Protein–Coupled Receptors: Promising Targets for Antibody–Drug Conjugates

by , , and

G-protein–coupled receptors (GPCRs) are a large and diverse family of seven-transmembrane–domain proteins expressed on the surface of human cells. These molecules respond to external stimuli by initiating signal-transduction pathways that affect the expression of a large family of genes — which, in turn, regulate a range of vital physiological processes and functions. Figure 1 illustrates the general pathways of GPCRs. Without these proteins, humans simply could not survive: Without β-adrenergic receptors, we could not regulate our blood sugar, for example;…

October 30, 2020

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies

by , , , , , , , and

Future biomanufacturing must address industry drivers, including the need for decreasing cost of goods (CoG), increasing market globalization, shortening development time for pipeline products, reducing risk to patient supply, and improving product quality. A CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies†took place on 16–17 July 2018 in Gaithersburg, MD, to address those opportunities. Advanced technologies include single-use bioreactors, alternating tangential-flow (ATF) systems used during fermentation, modular and closed process equipment,…

October 29, 2020

Run Rules with Autocorrelated Data for Continued Process Verification

by

Control charts can be used to assist in monitoring of biopharmaceutical product quality attributes as part of continued process verification activities. A number of tests known as run rules have been developed to assess whether biomanufacturing processes remain in statistical control. In practice, results for such attributes can be positively autocorrelated. Simulated data are used to assess the performance of run rules with autocorrelated data to assist in determining risk–reward profiles for process monitoring. Autocorrelated Data The tendency for data…

October 29, 2020

Technology to Transform AAV Manufacture

by

Adenoassociated virus (AAV) vectors are a popular choice for modern gene therapies because of their favorable safety profile, low immunogenicity, and the ease with which they can be transduced into different cell and tissue types. An AAV genome is a single strand of DNA comprising a replication (rep) gene, which encodes regulatory proteins involved in genome replication, and a capsid (cap) gene, which produces three capsid proteins. However, AAVs cannot replicate alone. In nature, AAV shares an exquisite relationship with…

October 29, 2020

eBook: Antibody–Drug Conjugates — Refining Product Designs for Improved Outcomes

by

Antibody–drug conjugates (ADCs) seek to partner the target specificity of antibodies with the cell-killing punch of chemotherapy drugs. Researchers identify antibodies that bind to proteins found predominantly or exclusively on the surfaces of cancer cells. The cells can absorb the ADC into their interiors, where the chemical environment or enzymes detach the drug from the antibody, freeing it to wreak havoc. Although nine ADCs have received US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval (and many…

October 22, 2020

eBook: Trends in Facility Design — In-House Manufacturing Considerations for Cell and Gene Therapy Production

by

Manufacturing and facility challenges facing cell and gene therapy companies are similar to but more complex than those encountered by companies that produce traditional biopharmaceuticals such as vaccines, monoclonal antibodies, and other therapeutic proteins. A single product can have multiple components, manufacturing of which may or may not be outsourced. Project timelines are short, production technologies are new and evolving, and clinical demands change rapidly. Increasing competition for contract manufacturing services requires reserving capacity far in advance, which in most…

September 28, 2020