Facility Design/Engineering

A Plug-and-Produce GMP Plant for Cell and Gene Therapy — Part 1: Case Study in Modular Facility Design and Deployment

The use of approved advanced therapy medicinal products (ATMPs) remains limited despite their potential to address unmet medical needs. One example uses chimeric antigen receptor (CAR) T cells for treatment of refractory lymphoma (1). Typically, such medicinal products begin with cells that are harvested from a patient and genetically programmed to recognize and eliminate tumor cells upon reinfusion. Several cell therapies based on this and other technologies are approved for use in the United States, Europe, and China (2). Given…

BioProcess Insider Interview: Dr. Ger Brophy, Avantor

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Dr. Ger Brophy, Executive Vice President, Biopharma Production, Avantor. Avantor has expanded its biopharmaceutical capabilities significantly over the past year. In addition to opening facilities in The Netherlands and Massachusetts for manufacturing and distribution of single-use systems, respectively, the company has broken ground on sites in Ireland and Singapore. Avantor also acquired Masterflex, a manufacturer of peristaltic pumps and fluid-handling solutions. Brophy explained that such activity exemplifies Avantor’s efforts to increase…

BioProcess Insider Interview: James Park, Samsung Biologics

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: James Park, Executive Vice President, Samsung Biologics. Samsung Biologics has established itself among the world’s largest CDMOs. It currently provides 364,000 L of bioreactor capacity, primarily in stainless-steel format, across three sites in Songdo, South Korea. Park reported that construction continues on a fourth facility. In October 2022, the plant will bring six 10,000-L bioreactors online for GMP production of recombinant proteins. A second construction phase is scheduled to add 12…

Reflections on the Evolution of Biopharmaceutical Manufacturing: A Virtual Roundtable with Scientists from Sartorius

As a trusted partner in the life-sciences industry, Sartorius has contributed significantly to the evolution of biopharmaceutical manufacturing. To reflect on the rich history of the industry, we arranged a virtual roundtable. Based on shared questions, we corresponded about what we considered to be the most important scientific, technological, and operational developments in the past 20 years of bioprocessing. We also reflected on the emergence of new modalities and how such products are likely to shape the future of the…

Challenging the Norms of Facility Design and Innovation

The past 20 years have spurred new technologies that enable flexible solutions to changing market demands. Small-scale tools, improved analytical methods, and innovative facility designs are among the notable breakthroughs. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies. Below, Elyse Vlahos (director of process engineering at Genesis AEC) provides her perspective on innovation and future industry developments. Innovation and Regulations What have been the most important technical innovations over the past…

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…

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…

Multimodal Facility Design for Cell and Gene Therapies

Cell and gene therapies (CGTs) are progressing rapidly through development pipelines and advancing through clinical trial phases. Manufacturing capacity will need to be sufficient when such products are approved for commercialization. Thus, biomanufacturers are seeking ways to leverage multimodal facilities. I spoke with Stephen Judd, who is principal process engineer for biologics and cell and gene therapy at DPS Group, an engineering and construction management consultancy. We talked about design considerations for multimodal facilities, how such facilities contribute to overall…

Elevating Your Pharmaceutical Facility to the Next Digital Plant Maturity Level

Pharma 4.0 technologies, offshoots from the Industry 4.0 model, focus on introducing new technologies for increased levels of digitalization within the pharmaceutical manufacturing industry. Many companies hesitate to embrace the Pharma 4.0 concept fully even though digitalization efforts are leading the way toward new levels of efficiency and productivity. The biopharmaceutical industry currently lags behind other industries in implementing digital technologies because of its rigorous and strict regulatory requirements. Adopting Pharma 4.0 tools and concepts benefits manufacturers by harmonizing the…