Manufacturing

The Changing CDMO Landscape

Contract development and manufacturing organizations (CDMOs) have evolved from simple service providers to full partners. Such companies now offer development and end-to-end services for highly complex biologics in a transition from contract manufacturing organizations (CMOs) and contract research organizations (CROs) to CDMOs. Before 2000, some drug companies (e.g., Merck, Novarits, Boehringer Ingelheim, and others) offered their excess manufacturing capacity to other drug makers. Chemical companies provided fill–finish and related services. Between 2000 and 2008, a number of dedicated CMOs emerged:…

Small Samples, Big Discoveries: Characterizing AAV Aggregates at Low Volumes and Identifying Their Root Causes

Gene therapies that use AAVs have shown great promise, but can be unstable due to their fragile composite DNA/protein nature, which presents an analytical challenge when determining root cause of subvisible particle (SVP) formation and product instability. Understanding how these proteins interact with leaked payloads will allow better insight into avoiding aggregate buildup. Yet, this has been difficult, hampered by legacy systems that cannot conduct low volume SVP analysis or interrogate for DNA content. That’s about to change. In one…

eBook: Factors Affecting Scalability of Cell Therapies

The number of cell and gene therapies in different phases of development is increasing. The industry currently needs to increase commercial good manufacturing practice (GMP) capacity to keep up with current and future demands. Cell and gene therapy scale-up from clinical to commercial capacity levels can reduce cost of goods and thus price per dose.  An optimized bioprocess facilitates scale-up from hundreds (clinical scale) to thousands of doses (commercial scale). Different approaches for increasing scale can be taken. For example,…

IVT Journal Archive

IVT Network Archive The Journal of Validation Technology, The Journal of GXP Compliance, and the IVT Network have served proudly for nearly 30 years as a global knowledge base for validation and compliance professionals in FDA-regulated industries. To make peer-reviewed validation resources available to the broader biomanufacturing community, the IVT Network is joining sister publication BioProcess International. Starting in July 2022, articles from the past two years of JVT and GXP can be accessed here on the BioProcess International website.…

China’s First Digital mRNA Vaccine Facility: Leveraging Automation and Digitalization Solutions

Vaccines against sudden acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are designed to elicit immune responses that prevent recipients from getting — or becoming seriously ill or dying from — novel coronavirus disease (COVID-19). Two available COVID-19 vaccines are based on genetically engineered messenger RNA (mRNA). After administration, such molecules give muscle cells “instructions” for how to make target proteins — e.g., the SARS-CoV-2 spike (S) protein. Immune-system detection of those proteins prompts creation of neutralizing antibodies. Immediately upon delivery of…

Flexible Vaccine Manufacturing: Collaborations Bringing Localized Solutions

The COVID-19 pandemic has become the most recent reminder of how accessibility to drugs and vaccines depends heavily on geographical location and a country’s economic health. Some countries continue to lack the infrastructure, regulatory support, and trained workforce necessary for establishing a viable bioindustry. Unizima, part of the Univercells Group, is a team of experts, scientists, and engineers that partners with public and private companies and other organizations to help build biomanufacturing capabilities in low- and middle-income countries (LMICs). We…

Advancing In Silico Tools for Vaccine Development and Process Modeling

The COVID-19 pandemic has demonstrated the importance of — and significant demand for — vaccines. However, vaccine development for large-scale manufacturing can be difficult and resource intensive because of the diversity and complexity of vaccine types that are needed. Developing a new vaccine typically takes more than a decade, with costs ranging from US$200 million to $500 million per successful program. That figure rises to $8 billion for epidemic vaccines (1). Vaccine programs also face a 90% risk of failure…

Developing Subunit Vaccines Based on an Amphiphile Platform

Subunit vaccines stimulate immune cells by delivering selected components of a pathogen of interest rather than the entire pathogen. Elicio Therapeutics is developing subunit vaccines that target a recipient’s lymph node to elicit a robust immune response. The vaccines are based on the company’s amphiphile (AMP) platform (Figure 1). The platform-based drug candidates are targeting cancer and COVID-19. Their development would allow the vaccine to be stored without the need for ultracold and cold storage. Below, we discuss the development…

Development of Allergen Immunotherapies

Desentum, a biopharmaceutical company that specializes in developing allergen immunotherapy (AIT) products, has partnered with contract development and manufacturing organization (CDMO) Biovian to advance hypoallergens based on targeted modifications to recombinant proteins. I spoke with Kati Sallinen (director of strategy and communications at Desentum) and Jonne Vaarno (project manager at Biovian) about their companies’ development of AITs and a potential platform to treat different types of allergies. Our Discussion We all know someone with an allergy, and many people have…

Facing a Unique Challenge: Building an In-House Cell and Gene Therapy Manufacturing Facility During the Pandemic

In 2019, Expression Therapeutics (ET) obtained investigational new drug (IND) approval for its lead clinical product. The third-generation lentiviral vector (LV) expresses a bioengineered coagulation factor VIII to be used in an autologous hematopoietic stem- and progenitor-cell gene therapy for patients with severe hemophilia A. Like many other emerging biotechnology companies, ET’s initial strategy used reputable contract development and manufacturing organizations (CDMOs) for vector and cell manufacturing needs and a prominent clinical contract research organization (CRO) with extensive experience in…