In December 2022, the President’s Council of Advisors on Science and Technology (PCAST) submitted a report to Joe Biden about biomanufacturing in the United States. In a letter prefacing the report, the council cochairs noted that the bioeconomy is “poised for enormous growth over the coming decades” (1). On 22 March 2023, the White House Office of Science and Technology Policy responded with a set of five initiatives to help realize the potential of the nation’s bioeconomy. The broad goal…
Today’s drug manufacturers are faced with the need to find efficiencies across a wider range of modalities than ever before, even as gaps in technology still exist. The economics of the process includes cost and time and must also consider quality and reproducibility. Working with suppliers that understand the full scope of drug development and commercialization challenges, and provide reliable, scalable solutions tailored to each unique process is critical to success. In this special report, the team from Polyplus reintroduces…
Bioprocessing materials such as cell-culture media, sera, and reagents are used in the development of different drug products such as recombinant proteins, immunotherapies, and regenerative medicine. Biopharmaceutical research materials include DNA/RNA isolation reagents, chemicals, buffers, stains, and washing solutions. Media provide nutrients essential for cell growth in culture. Advancements in culture media (both serum-based and serum-free) have enabled researchers to culture different types of cells and microorganisms, including mammalian and bacterial host cells for protein expression (e.g., Chinese hamster ovary…
Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Emmanuel Ligner, Chief Executive Officer, Cytiva. In 2021, Cytiva collaborated with London’s Financial Times survey group to establish an annual biopharmaceutical industry resilience index. Ligner explained that his company spearheaded the project to quantify life-science leaders’ confidence in the industry and to identify areas for improvement. The inaugural survey collected impressions from more than 1,000 executives about supply-chain resilience, talent recruitment, research and development activity, manufacturing agility, and regulation. The industry…
The past 20 years have been a period of rapid change and development in the world and in the biopharmaceutical industry. One of the biggest changes has been the introduction of a pathway for biosimilars in the decade after 2010. Before that, no provision for “generic” versions of biologics existed. The European Medicines Agency (EMA) approved the first monoclonal antibody biosimilar in 2013, and the US Food and Drug Administration (FDA) followed with its first approval in 2015. Those approvals…
The commercial successes of the biopharmaceutical industry over the past 20 years are a reflection of a maturing industry whose increasing focus on efficiency and cost effectiveness will expand the adoption of digital technologies into knowledge management, process/cost optimization, and manufacturing. The ultimate goal continues to be reducing costs to manufacture effective medicines efficiently and broaden patient access to life-saving drugs. Here, we review the journey of bioprocess cost models and how they have helped the industry build process knowledge…
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…
Significant growth of the cell and gene therapy (CGT) pipeline in recent years demonstrates the enormous potential of these modalities to treat or even cure otherwise intractable diseases. Several CGT products have been approved for clinical use over the past five years. More than 75 such products have come to the market around the world so far. They include chimeric antigen receptor (CAR) T-cell therapies that involve genetic engineering of patient cells ex vivo as well as in vivo gene therapies…
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…
The number of collaboration arrangements for emerging technologies is increasing significantly, especially among companies developing COVID-19 diagnostics, vaccines, and therapeutics. Consequently, a massive amount of capital was invested in the biopharmaceutical industry in 2020. These deals range in value from the low millions to several billion dollars, representing significant risks and value for investors. Some recipients of that capital are seeking partners with whom to collaborate, sharing both the costs and risks associated with their activities and bringing innovative technologies…