Manufacturing

The Era of Digital Biomanufacturing

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The digital revolution in manufacturing began with an explosion in monitoring, analytics, and new computing capabilities. Combined with such advances as artificial intelligence (AI), automation, and robotics, they are changing our concepts of manufacturing in general — from product development and factory operations to materials supply. This evolution also connects product and process designers and leaders in manufacturing engineering. Digital manufacturing (DM) isn’t a dream or a concept on some advanced developer’s design table; it’s occurring now and will change…

March 20, 2017

CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations

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On 26 January 2015, CASSS hosted a program in its ongoing series of semiannual Chemistry, Manufacturing, and Controls (CMC) Strategy Forums at the Mayflower Hotel in Washington, DC. Since this series’s inception in 2002, each installment has focused on one of a wide array of topics spanning the fields of biopharmaceutical product development, manufacturing, analysis, quality, and regulation. For this forum, the program committee chose to devote a full program to a topic that was previously the focus of an…

March 20, 2017

Drivers, Opportunities, and Limits of Continuous Processing

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Biologics represent a significant group of approved drugs, and they are expected to continue their exceptional growth in the foreseeable future. At first glance, innovative monoclonal antibodies (MAbs) and their derivatives seem to dominate the field; however, biobetters, biosimilars, and other therapeutic proteins have gained in relevance lately. This diverse portfolio also is reflected in the range of different biomanufacturing processes used. Most blockbuster antibodies are produced by mammalian cells cultured in large bioreactors (10–20 m³) in fed-batch mode. But…

March 20, 2017

Conditional/Inducible Gene-Expression Mouse Models Using Advanced Gene Editing

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Transgenic mouse models have been an essential part of biomedical research for many decades. They have provided valuable insights in developmental biology, gene regulation, and our understanding of the genetic basis of human disease. And they play a critical role in drug discovery and development. Traditional methods to generate these mouse models entailed a milieu of disadvantages: e.g., low efficiency, high incidence of undesirable recombination outcomes, randomly and multiply inserted genes of interest, ectopic expression, gene silencing, and insertional mutations…

March 20, 2017

The Cell and Gene Therapy Industry: Looking at 2016 and Beyond

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Politically 2016 was surprising and dramatic here in the United Kingdom and elsewhere. Although it was not surprising for cell and gene therapies per se, the growth that we have seen in this industry has been pretty dramatic around the world as well. The industry has seen investors of all types maintaining their interest in cell and gene therapy, with a number of new deals made: e.g., Bluebird bio and Medigene signed a strategic R&D collaboration and licensing agreement, and…

March 20, 2017

Accelerated Development Through Strategic Analytical Partnerships

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The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing…

March 14, 2017

Outsourcing Biosimilar Development

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As the debate continues over the high cost of pharmaceutical treatment options, the development of biosimilars continues to play a dominant role in that discussion and will be an important part of the solution. Biosimilar companies are working at a feverish pace to develop the next generation of follow-on products. Outsourcing to a growing group of contract development and manufacturing organizations (CDMOs) is a key strategy for savvy developers to accelerate their products’ launch. Finding the right CDMO isn’t an…

March 14, 2017

Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry

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Expanding biopharmaceutical pipelines and therapeutic modalities are feeding a boom in outsourcing key elements of development and manufacturing projects. The rapid growth of the industry as well as of emerging therapeutic areas (e.g., antibody–drug conjugates, biosimilars) challenge sponsors and contractors alike to meet industry needs. The authors in this featured report explore increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on…

March 9, 2017

Critical Aspects of Technology Transfer to CMOs

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Technology transfer in pharmaceutical manufacturing most often is mentioned as occurring between two organizations and involving discrete product lifecycle stages: e.g., a sponsor and a contract manufacturer and from development to manufacturing. According to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use: “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for…

March 9, 2017

Specialized Outsourcing Services: Antibody–Drug Conjugates

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Managing just the conjugation part of an antibody–drug conjugate (ADC) project can be a challenge. So when you consider all the component parts of an ADC, it is understandable why so many related activities are outsourced. At Piramal Grangemouth, we provide conjugation development and manufacturing services. Together with our sister sites in the United States and United Kingdom, we offer payload manufacture and fill–finish capability. The Grangemouth (UK) site has been involved in ADC conjugation services now for over 13…

March 8, 2017