Manufacturing

Manufacture and Regulation of Cell, Gene, and Tissue Therapies, Part 1: Chemistry, Manufacturing, and Control Challenges

Cell, gene, and tissue (CGT) therapies and other advanced-therapy medicinal products (ATMPs) have made tremendous progress over the past decade. They are different from other biologics and small molecules because of their inherent complexity and variability. Although many unknowns remain about the development of these products, their clinical success has enabled the CGT therapy and ATMP fields to advance rapidly. We are seeing an increase in the number of marketing authorization applications (MAAs) filed in the European Union and new…

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics

Part 1 of this article focused on the first two sessions of a CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies,” which took place on 16–17 July 2018 in Gaithersburg, MD. Those sessions focused on upstream and downstream process technologies and strategies (1). Part 2 highlights the final two conference sessions on process modeling, control, and analytics. Process Modeling and Control The third conference session was “Modeling and Control Strategies.” Advancements in…

Practical Considerations for Statistical Analyses in Continued Process Verification

Several statistical techniques can be used to assist in monitoring biopharmaceutical product quality attributes as part of continued process verification (CPV) activities. These include run charts, control charts, and capability analyses. Below, I provide an overview and recommendations on statistical strategies when developing a CPV program, considering the expected behavior of manufacturing results in the biopharmaceutical industry. Presence of Autocorrelated Data In a previous study, I highlighted the tendency for data to be positively autocorrelated (values are closely related to…

Evolving Business Models to Meet the Future of Healthcare

Yourway provides integrated supply-chain solutions for the global pharmaceutical and biotechnology industries. We exceed traditional offerings to provide customized support that includes warehousing and packaging, project management, planning and optimization guidance, comparator sourcing, ancillary-supply sourcing, forecasting, and returns/reconciliation management. Our single–specialized-provider approach offers clients a high level of convenience and efficiency that translates into quality, speed, and operational improvements. A Growing Global Footprint As we introduce new added-value solutions, expand our global footprint, and continue investing in infrastructure, technology, training,…

Case Study for a Facility-Fit Driven Process Development

Time to clinic and time to market are the key drivers for client success in the biopharmaceutical industry. Facility fit is becoming key to understanding process constraints and which aspects of the process have the largest impact on enabling facility fit. Process development with facility-fit constraints in mind will ensure a smooth technology transfer and shorten the timeline of current good manufacturing practice (CGMP) product delivery to clients. Fill out the form below to read this Special Report and learn…

Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues

Reliable access to high-quality starting material is a primary challenge in cell therapy manufacturing. Freshly isolated leukopak starting materials depend on donor availability and are vulnerable to cell losses from scheduling changes and other unforeseen circumstances. Flexibility often is required for cell therapy manufacturing. Therefore, relying solely on freshly isolated starting material is impractical, particularly when cell therapy logistics involve global shipping and distribution. Donor sourcing is among the most critical factors shaping cell and gene therapy (CGT) supply chains.…

Innovations in the Manufacturing of Cell and Gene Therapies

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…

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

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…

Making MAbs: Bioprocess Advancements Challenge Platform Assumptions

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…

Tracking Therapeutic Antibody Development in a Pandemic

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…