Manufacturing

eBook: Cell Therapy — Lessons Learned from Working with Vectors and Cells

Gene-modified cell therapies hold much promise for cancer treatment. Currently, the most popular approach leverages T cells expressing chimeric antigen receptors (CARs), which give immune cells the specificity needed to bind with and destroy malignancies. Despite rapid progress in drug discovery and development, the biopharmaceutical industry still has much to learn about manufacturing CAR T-cell therapies in commercially feasible ways. In this eBook, BPI’s managing editor speaks with subject-matter experts from VIVEbiotech, Castle Creek Biosciences, and Bristol Myers Squibb (BMS)…

The Talent Enigma in Digital Biomanufacturing

Demand for talent in the biopharmaceutical industry already had been climbing before the COVID-19 pandemic, showing an increase of 26% from 2018 to 2020. By the end of 2021, a further 32% surge was observed in the United States and Europe, against a 10% rise in the supply of expertise. Bolstered at first by the need to manufacture SARS-CoV-2 vaccines and therapeutics and now by the threat of new pandemics, current market drivers include increases in investment, initial public offerings…

eBook: mRNA — Negotiating New Manufacturing Hurdles

The emergency authorization, regulatory approval, and successful commercialization of Pfizer–BioNTech’s and Moderna’s respective mRNA vaccines for SARS-CoV-2 have ignited considerable interest in the modality across the biopharmaceutical industry — and for good reasons. Establishing a platform process for mRNA production could facilitate and accelerate several aspects of vaccine development and manufacturing. Drug makers also intend to leverage benefits associated with cell-free bioprocessing. But as the contributors to this eBook show, mRNA remains a nascent modality, and companies must surmount new…

Cell Therapy — Supply Chain Discussions

The 2017 approval of Kymriah (tisagenlecleucel) has paved the way for other cell therapy products to reach the patients who need them. Each passing year promises to open the regulatory floodgates to more product approvals, but technical and manufacturing issues continue to keep initially high expectations from being realized. One barrier is supply chain complexity, especially for the subset of autologous cell therapies. This eBook features expert commentary from Be The Match BioTherapies, a company providing more than 50 product…

Improving Scalability of AAV and Lentivirus Production: Tailored Transfection Reagents Enable Large-Scale Manufacturing

Scientific advances have increased the safety and efficacy of recombinant viral-vector technology for cell and gene therapies. In this special report, we will discuss how tailored transfection reagents improve the scalability of AAV and lentivirus production. We will also focus on the challenges of scaling up viral vector production platforms and the importance of selecting the right transfection reagent for this process to increase the titer and quality of viral production to generate more therapeutic doses per run. Fill out…

Using Synthetic Biology To Develop Novel Biotherapeutics

A multidisciplinary area of research, synthetic biology involves the use of genetic engineering to create new biological parts, devices, and systems, with potential applications in industries such as healthcare, agriculture, energy, and environmental science. As early as the 1960s, researchers combined advanced techniques in precision genetic engineering with rational drug development and explored approaches in synthetic biology to support development of innovative drug products. Later research shed new light on how molecular networks regulate cellular function and how gene expression…

Container Materials for Biopharmaceuticals: A Comparative Small-Scale Case Study of Stainless Steel and a Proprietary Nickel-Based Alloy

Evaluating compatibility of a drug substance with all surfaces that it might come into contact with during drug product manufacturing is essential to ensure product quality. Proteins can adsorb to contact surfaces, form aggregates, and desorb into a drug-substance solution. Proteins also can degrade in presence of leachables generated from contact surfaces during manufacturing. Containers and vessels used during manufacturing are single-use disposable components or metal tanks, primarily either 316L stainless steel (SS) or C-276 Hastelloy nickel-based alloy (HLY). Researchers…

Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications

Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals. Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce…

Purity by Design

After launching Nereus LentiHERO, a game changing fit-for-purpose solution for lentiviral vector purification in 2022, Astrea Bioseparations present this end of year report with a selection of interviews, application notes, and articles. Identifying the gaps in lentiviral purification, they discuss how to increase processing efficiency, purity, and recovery of LVV particles. They also look towards the future to bring a radical change in bioprocessing for cell and gene therapies. The Nereus LentiHERO spin column is the first product in a…

Cell-Free Synthesis of Highly Potent Recombinant Neurotoxins: A Process Economic Feasibility Study

Since its inception four decades ago, cell-free synthesis (CFS) has been used to produce biomolecules such as RNA, DNA, peptides, and proteins (1). However, most of these applications have been in early stage research and small-scale proof-of-concept studies, with rare examples of large-scale production. The slow industrial uptake of CFS has been attributed to low productivity, which suggests an uneconomical path to large-scale manufacture. Typically, a CFS platform includes a genetic template (encoding the product of interest), chemical additives (nucleotides…