Featured Content

Podcast: Opening the gates for women in biotech

There is no lack of talented women in the biotech space but the gates blocking their progression must be open for them to fully realize their potential, says consultant Nadine Ritter. Companies’ Diversity, Equality, and Inclusion (DEI) policies are too often just an exercise in box-checking, said Nadine Ritter, president and analytical advisor at Global Biotech Experts and long-time member of BioProcess International’s editorial board. “If it’s just virtual signaling on a website then I don’t care… show me the…

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…

Reducing Downstream Scale-Up Needs: Advances Toward Continuous Downstream Processing

The biopharmaceutical industry generally acknowledges that upstream and downstream aspects of drug-substance manufacturing are experiencing a capacity mismatch. Today, many recombinant proteins can be produced at expression titers of 3 g/L, with some yields exceeding 10 g/L. Such titers represent 100-fold increases in production capability compared with values from twenty years ago (1, 2). Increases in cell-culture density and improvements to perfusion-mode bioreactor systems hold promise for increasing yields further still. Such developments, combined with the broad availability of concentrated…

Mycotoxin Risk Determination: Measuring the Potential for Patient Exposure with Antithrombin Alfa Sourced from Transgenic Goat Milk

Antithrombin alfa is a recombinant human antithrombin developed as an anticoagulant treatment for people with hereditary antithrombin deficiency who are undergoing surgical or childbirth procedures (1). Marketed under the ATryn brand name by LFB SA (Les Ulis, France), antithrombin alfa was approved for use in adults by the US Food and Drug Administration (FDA) in February 2009 (2). Antithrombin alfa is expressed in the milk of transgenic goats and purified through a multistep downstream process encompassing both filtration and chromatography.…

Mind the Gap: Managing Relationships Between Upstream and Downstream Intensification

Process intensification (PI) describes an integrated framework of strategies to maximize the output of a unit operation, a process, or an entire facility. By implementing PI strategies, biomanufacturers can accomplish their productivity goals by increasing production speeds and titers, reducing facility footprints, and cutting costs. Overall, such changes improve production efficiency and flexibility. Collectively, the biotherapeutic industry has made multiple advancements in intensifying upstream processing. PI strategies include using high-density cell banks, implementing seed-train intensification (n – 1 perfusion), and…

Bench to Bedside: Why Successful Drug Development Requires a Team Approach

The process from drug development to market approval takes many years and requires both integration and orchestration of several activities based on deep scientific and commercial expertise. We tend to think of drug development as a sequential, phase-driven process during which a product is taken methodically from discovery through preclinical studies, clinical development, and ultimately commercial launch. In reality, development of new drugs is not linear; rather, it requires integrated coordination between collaborators from different functions and stakeholders — from…

Bioprocessing Facilities in Asia Consider Domestic Alternatives to Western Suppliers

The global biopharmaceutical industry had been growing robustly even before the COVID-19 pandemic. According to the BioPlan Associates Top 1000 Biofacility Index and Biomanufacturers Database (1), bioprocessing capacity worldwide increased an average of 12% over the past decade. China has seen nearly double that rate. India’s bioprocessing segment also is showing strong growth. Because those regions represent 37% of the world’s population — and with rapidly growing middle-class economies, — demand for biologics there is outstripping that elsewhere. Historically, Western…

High-Yield Production of rAd26-S for Sputnik V Vaccine Component I: An Optimized Process in a Scalable Shaken Bioreactor

The recent outbreak of the severe acute respiratory syndrome coronavirus (SARS-CoV-2) led to the development of different vaccine approaches worldwide to prevent the coronavirus disease 2019. The first registered vaccine on the market was the Sputnik V product based on two recombinant adenoviral vectors (Ad5 and Ad26). The product has received approval in 70 countries by several national and regional regulatory authorities, meanwhile. Though the availability of SARS-CoV-2 vaccines in most developed countries is not an issue any longer, other…