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Genome Editing for Cell-Line Development

At BPI Europe in April 2019, Dirk Gewert (business unit leader of bioproduction at Horizon Discovery) told BioProcess Insider that Chinese hamster ovary (CHO) cell lines haven’t changed much in the 30 years since they were first used in biomanufacturing (1). Only a few companies offered commercially available, production-ready CHO cell lines for large-scale manufacturing of biotherapeutics. “In all cases,” he said, “cell lines were selected by identifying high-expressing clones and focusing on process optimization to improve expression and other…

Cell-Line Development for Expressing IgM Antibodies

Immunoglobulin G (IgG) antibodies have been studied and applied as biopharmaceuticals for decades, and they remain dominant in the monoclonal antibody (MAb) pipeline. By contrast, immunoglobulin M (IgM) molecules are much larger and consequently more challenging for biomanufacturing and therapeutic application. Essentially, they appear as clusters of the familiar Y-shaped IgG molecules, joined at their bases in pentameric (Figure 1) or hexameric forms. That structure gives them 10 and 12 binding moieties, respectively, which translate to superior binding power (avidity)…

Pseudomonas fluorescens: Cell-Line Development of a Commercially Proven Platform for Biopharmaceutical Manufacturing

A number of factors contribute to delivering a robust, highly productive, and reliable process for manufacturing a therapeutic protein. They begin with a cell-host system and a gene-expression strategy that determine a developer’s ability to optimize growth and expression titers. But for many therapeutic proteins, initial attempts to develop a production process are based on evaluation of limited factors and tend to yield only small quantities or poor product quality. Automation can enable parallel building and expression screening of diverse…

Ask the Expert: Analytical Tools to Accelerate Cell-Line Development Workflows

Cell-line development (CLD) involves screening thousands of clones to identify the most stable and productive candidate for an upstream manufacturing process (Figure 1). Such assessment requires considerable time and resources for preparation and execution of multiple cultivations and analytical assays. In March 2022, Lukas Klein and Dirk Müller (scientist and manager of media and process development, respectively, at Sartorius) delivered a BPI Ask the Expert webinar about integrating their company’s Ambr 15 Cell Culture bioreactor and Octet label-free biolayer interferometry…

eBook: Biopharmaceutical Outsourcing — Capacities, Companies, and Current Trends

Although many biopharmaceutical companies leverage in-house capabilities to produce their therapies, contract manufacturing partners represent a significant part of the biologics industry. Recent capacity investments, facility expansions, and mergers and acquisitions (M&A) activity even suggest that third-party biologics production is gaining traction. In this eBook, BioProcess Insider’s founding editor, Dan Stanton, takes the pulse of today’s outsourcing sector. First, he speaks with Dawn Ecker (director of bioTRAK database services at BDO) to establish what kinds of companies are amassing mammalian…

Keeping supply chains resilient in times of crisis

Robust risk management can offset supply chain problems that have been further aggravated by COVID-19, says Samsung Bioepis’ Thomas Newcomer. Since the start of the COVID-19 pandemic, the pharmaceutical industry has experienced many unprecedented situations. Disruptions to drug supply chains has become a primary concern across various markets. As much of the industry’s resources has been invested in pandemic response, the pharmaceutical industry has experienced an increase in supply chain or regulatory bottlenecks and in some cases drug shortages. This…

AGC doubles viral vector capacity at Longmont plant

AGC Biologics is adding viral vector suspension technology and capacity to advance manufacturing of gene therapies at its Longmont, Colorado facility. The expansion will come online in the third quarter of 2022 to help meet market demands and, according to the contract development manufacturing organization (CDMO), the investment will more than double the site’s viral vector capacity. “Viral vector manufacturing is a complex process and developers are turning to AGC Biologics because we have the expertise and programs to help…

MilliporeSigma pumps $470m into Ireland filtration plants

Merck Life Science – aka MilliporeSigma – will build facilities to increase filtration equipment and membrane capacity at sites in Cork, Ireland. The total investment is split between two facilities in Cork, with a new filtration manufacturing facility being built at Blarney Business Park for €150 million ($160 million) and €290 million being invested in nearby Carrigtwohill for a manufacturing plant supporting the immersion casting of membranes. From Carrigtwohill, the first commercial products will be produced in 2026. “At full…

May 2022: From the Editor

When we founded BPI 20 years ago, already there were murmurs about the “death of print” in the publishing industry. And it’s true that in the ensuing decades, many publications (especially newspapers) have gone fully digital to save money and stay in business. But in every survey we’ve run over the years, the majority of our readers always have preferred the print version of BPI. Our digital edition has increased in popularity steadily — probably as older generations slowly give…

Good Biotechnology Governance to Combat Bad Blood: Using Cautionary Tales and Storytelling to Catalyze Start-Up Success

In January 2022, after months of proceedings and years of speculation, a jury found Theranos founder Elizabeth Holmes guilty of conspiracy to commit fraud and multiple charges of wire fraud (1). The trial of her former business partner Ramesh (also known as Sunny) Balwani began in March 2022. Theranos, a private medical device company in the healthcare sector, aimed to change the face of blood testing through benchtop in vitro diagnostics (IVDs) that were rapid, highly sensitive and specific, and…