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eBook: Working Together Is Key to Bioprocess Sustainability

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Sustainability initiatives are launching across the biopharmaceutical industry as companies begin to scrutinize their environmental impacts as part of the growing environmental, social, and governance (ESG) movement in business. Achieving ambitious sustainability goals will require organizations to evaluate their raw materials, production processes, product packaging, operations, and supply and distribution chains — and such work will entail monumental effort. As this special eBook presentation from the editors of BioProcess International and BioProcess Insider demonstrates, bioprocess sustainability necessitates collaboration across the…

Development of an IEX Purification Process for Lentiviral Vectors

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This webcast features: Sushmita Koley, PhD, Senior Scientist, Process Chromatography, Bio-Rad Laboratories. In recent years, gene therapy treatments have increased significantly requiring more efficient processes to purify and deliver these therapeutics. Lentiviral vectors (LVV) are a type of retrovirus and are an effective tool for gene delivery. In this webinar, data will be presented on a high-throughput screening strategy that was employed for LVV purification which provided high yield as well as acceptable HCP clearance. An initial high-throughput screening experiment…

Addressing Gaps in US Biomanufacturing Capacity

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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…

Hybrid Design Considerations in Biomanufacturing: Leveraging Both Stainless-Steel and Single-Use Systems

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Demand for biopharmaceuticals is growing rapidly as new products and manufacturing technologies arise. For example, such approaches as immunooncotherapy and oncolytic viral therapy are now entering one of the fastest growing markets in medicine — cancer treatment. This market “should grow from [US]$177.4 billion in 2021 to $313.7 billion by 2026, at a compound annual growth rate (CAGR) of 12.1%” (1). Both preclinical and final biomanufacturing increasingly incorporate single-use (SU) components, including hardware and systems for containment and connectivity. Solutions…

Digital Transformation in Biopharmaceutical Operations

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With digital innovations revolutionizing consumer-facing products such as medical devices, questions are arising about whether the biopharmaceutical and broader pharmaceutical industries are embracing digital transformation to drive process improvements and meet changing product demands. Below, Fausto Artico (global head and product director of innovation and data science at GSK) shares his insights about digitalization among pharmaceutical companies that are developing protein-based biologics, vaccines, and advanced therapies. Artico has driven several of GSK’s digitalization initiatives, including work with artificial intelligence (AI)…

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidance on the testing and evaluation of viral safety of biotechnological products derived from characterized cell lines of human or animal origin through its harmonized guideline ICH Q5A (1). The latest revision, released for consultation in October 2022, maintains the key principles of previous versions while introducing key changes in response to important advances in the field. Those advances are covered in new sections that…

May 17, 2023

Voices of Biotech: Bristol Myers talks diverse leadership

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When it comes to hiring, there is not enough diversity at upper leadership levels says Vibha Jawa, executive director at Bristol Myers Squibb. In the latest episode of Voices of Biotech, brought to you by BioProcess Insider Expression Platform, Bristol Myers Squibb’s Jawa discusses the limited diversity of the hiring pool, building a network of female professionals, and the importance of career mentorship. Jawa shares her career journey and the challenges in transitioning from academia to industry. “There is always…

May 10, 2023

High Precision: Automated Aseptic Filling of Small Volumes

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Market experts recommend automated filling systems for drug developers seeking to reach the next level in drug-substance management. Many companies are starting automation initiatives, which suggests an overall trend towards automated filling. The stakes are high. Increased process deviation in fluid management can lead to increased loss of valuable biopharmaceutical products. Automated and standardized aliquoting of biopharmaceutical drug substances into single-use bioprocess containers simplifies the manufacturing process while improving throughput, speed, and filling accuracy. Fill out the form below to…

May 3, 2023

Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture

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The rapid advancement and competitiveenvironment of the modern biopharmaceutical industry, accompanied by the need for continuous quality improvement, demand robust analytical instruments. Analytical technology is one key factor contributing to the quality and safety of finished products. Ongoing improvements in analytical instruments are needed to address new challenges, including specificity of target substances, high complexity of matrices, and multiple production stages with a number of input and output parameters and peculiarities. Those factors point to the demand for a versatile…

March 2, 2023