Upstream Contract Services

Contractor Perspectives: Best Practices for Transfer, Handling, Testing, and Storage of Cell Banks

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For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory Board Scott M. Wheelwright, PhD, for his perspectives. Wheelwright brings many years of experience to this discussion, with insights into the evolution of technologies and practices extending back to the early launch of the biopharmaceutical industry. Currently, he provides consulting support for companies with manufacturing and sourcing in China and other Asian countries. He also…

June 23, 2021

Ask the Expert: Leveraging Cloud Capabilities to Execute CHO Cell Culture Experiments

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Process development teams have relied for decades on benchtop bioreactors to perform mammalian-cell–culture experiments; however, doing so requires significant resources and staffing. During a 24 February 2021 presentation, Deborah Pascoe, PhD, vice president of operations at Culture Biosciences (Culture), explained how to leverage her company’s high-throughput, cloud-connected bioreactors to execute Chinese hamster ovary (CHO) cell cultures with high reproducibility and scalability. Pascoe’s Presentation Pascoe described her company as an extension of a customer’s laboratory. After technology transfer, Culture and a…

April 16, 2021

Application of Targeted Locus Amplification for Enhanced Apollo X CHO Clone Screening

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Speed to market is an important consideration for the development of lifesaving therapies, including recombinant monoclonal antibodies. However, increased speed must be balanced with quality to enable quick and efficient delivery of biopharmaceuticals to patients. Important determinants of quality include the genomic location and integrity of the transgene sequence within a recombinant cell line. Traditional methods of genetic characterization can provide incomplete information and results can be difficult to interpret. However, next-generation sequencing (NGS) approaches such as Targeted Locus Amplification…

June 17, 2020

Ask the Expert: A Robust, Stable Platform for Biologics Development

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Sean Liour (vice president for project management at GenScript ProBio) delivered an Ask the Expert presentation on 18 March 2020 to explore the advantages of his company’s platform for cell-line development. Liour explained that successful biologic development hinges on robust host cell lines, capable expression vectors, and discriminating clone-screening systems. Overviewing relevant technologies and capabilities, Liour illustrated how his company’s ProCLD platform helps sponsors navigate cell-line development. Liour’s Presentation Researchers must weigh their options carefully when selecting a host cell…

May 24, 2020

Ask the Expert: Accelerating Timelines By Integrating Cell-Line Development and Manufacturing

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In a 31 October 2019 “Ask the Expert†presentation, Nicole Wakes (group leader of Abzena’s cell-line development team) observed that drug sponsors often outsource their early upstream activities to a few different contract research organizations (CROs). But that strategy can thwart short timelines and introduce regulatory and financial risks. Wakes described Abzena’s upstream approach, illustrating how partnering with a single, multicompetent CRO from cell line construction through manufacture can streamline workflows. Integrating cell line development and manufacturing in this way…

February 6, 2020

Emerging Technology Trends in Biologics Development: A Contract Development and Manufacturing Perspective

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For a contract development and manufacturing organization (CDMO), process development and manufacturing of recombinant proteins must be linked because of tight timelines driven by client expectations. Those are in turn driven by a need for rapid progression to clinical testing. Early in process development, the choice of raw materials needs to reflect existing supply chain and manufacturing infrastructure, but remain suitable for scaling up to meet future needs. One approach is to establish platform processes for a class of molecules…

October 14, 2016

The Rise of Biopharmaceutical Outsourcing to Indian CDMOs

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India is becoming an increasingly attractive destination for outsourcing biotechnology services by global biopharmaceutical companies. As “Big Pharma†continues on its path of finding ways to lower costs for development and manufacturing of biopharmaceuticals, Indian contract development and manufacturing organizations (CDMOs) are being viewed as capable and beneficial service providers that possess the necessary technical expertise and regulatory-compliant facilities. According to its 11th annual report on biopharmaceutical manufacturing capacity and production, BioPlan Associates ranked India fourth in the world as…

June 1, 2014

Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

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Over the past decade, monoclonal antibodies have become mainstream therapeutics for treating a broad range of conditions from autoimmune disorders to cancer. Part of this evolution is increasing time and cost pressure on biopharmaceutical companies to bring new drugs to market 1, 2. Additionally, companies now routinely engineer and screen molecules for developability and manufacturability during discovery before selecting a final candidate molecule. The biosimilar development paradigm also demands significantly more bioanalytical analysis during initial cell-line and process development. Thus,…

June 1, 2014

Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence

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The cell therapy industry is undergoing a natural evolution from scientific curiosity into a commercially and clinically attractive opportunity (1). This evolution is by no means complete, and growing evidence suggests that its progression is driving significant developments in cell therapy bioprocessing — notably, convergence. Table 1:&#8 194; () Progressively, bioprocessing technologies primarily used in production of noncell-based products are being evaluated for cell therapy bioprocessing applications (2). Consequently, this process of convergence is leading to an increasing proportion of…

March 1, 2014

Cost-Effectiveness and Robustness Evaluation for Biomanufacturing

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As the biotech sector has matured, it has come under increasing economic and regulatory pressures for continuous improvement in both drug development and manufacturing. As a result, assessing the value potential of alternative strategies has become critical to decision-making in areas such as bioprocess and facility design, capacity sourcing, and portfolio selection. Related decisions typically involve large cash expenditures and thus have a direct bearing on the feasibility of business units and whole companies. Figure 1:  () Making such decisions…

December 1, 2013