Business

Virtual Audits: A New Reality in the World of COVID-19

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The novel coronavirus disease 2019 (COVID-19) pandemic has every industry seeking out ways to accomplish time-sensitive activities using a number of virtual approaches. This is certainly true in the biopharmaceutical sector, in which good manufacturing practice (GMP) audits are required to manufacture medicinal drug products for human use. Examples include supplier/vendor audits, mock inspections, and preapproval and prelicense inspections (PAIs and PLIs) conducted by sponsors and regulatory authorities. Auditors usually perform such activities on site and only sometimes remotely. In…

June 10, 2020

Patient Access Tops the List of Advanced Therapy Milestones at Phacilitate 2020

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In a highly anticipated presentation at the 2020 Phacilitate Leaders World event — part of Advanced Therapies Week, along with the World Stem Cell Summit in Miami, FL — Susan Nichols (chief executive officer for Falcon Therapeutics), highlighted 10 events from 2019 that drove conversation, investment, and innovation in regenerative medicine. Although clustered regularly interspaced short palindromic repeats (CRISPR), business consolidations, and production capacity powered the cell and gene therapy (CGT) space in 2019, a new proactive focus on patient…

April 14, 2020

A Framework for a Competency-Based Curriculum

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Training departments in biopharmaceutical manufacturing facilities are at the forefront of ensuring that their employees are trained in accordance with regulatory compliance standards that govern the industry. More important, the purpose of training is to equip employees with relevant knowledge, skills, and abilities to perform their job functions competently. A competency-based curriculum has the potential to facilitate a training approach that addresses both the practical training needs and desired performance outcomes in a workplace. Competency-Based Curriculum Recently, I was involved…

April 13, 2020

Developing a Biopharmaceutical Workforce for Today and Tomorrow

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Biomanufacturing is constantly evolving, developing new treatments and therapies through cutting-edge methodologies and facing increasing integration of big data and analytics. But keeping up with innovation in this segment requires a workforce with advanced skill sets. The US State of Rhode Island (RI), with a rich manufacturing history and a thriving biotechnology sector, has taken on that challenge. We are preparing a robust talent pool — the greater Providence area contains over 1.6 million people — to become the highly…

April 13, 2020

The Next Global Life-Science Leader

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Canada’s life-science industry is exceptional at producing innovative research. With less than 0.5% of the world’s population, our country produces 5% of the globe’s total research publications. Canada’s citation rate ranks among the top six nations and is 43% higher than the global average (1). At the same time, our life-science industry is competing with other global jurisdictions into which investment is flowing. The US state of Massachusetts, already the number one biotechnology cluster in the world, has committed US$1.5…

March 3, 2020

A Response Plan for Viral Contamination in Bioproduction Facilities

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The biopharmaceutical industry uses living biological systems as a platform for manufacturing of protein-based drugs, vaccines, and other therapies derived from or consisting of different cell types. On one hand, living systems are inherently susceptible to viral infection and may harbor endogenous viruses, so the potential for such contamination cannot be eliminated. On the other hand, the industry has an excellent patient-safety record. Viral safety is achieved through three fundamental measures: prevention (e.g., by selection), removal (by clearance and/or reduction),…

March 3, 2020

Supply and Demand Trends: Mammalian Biomanufacturing Industry Overview

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Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five selling recombinant proteins — Humira (adalimumab, AbbVie), Keytruda (pembrolizumab, Merck), Herceptin (trastuzumab, Genentech), Enbrel (etanercept, Amgen), and Avastin (bevacizumab, Genentech), all antibodies — totaled over US$48 billion. The compound annual growth rate (CAGR) for antibodies revenue was about 20% from 2004 to 2014. Those products include naked monoclonal antibodies (MAbs), Fc-fusion…

February 7, 2020

Cell Banking for Cell and Gene Therapy: Regulatory, Ethical, and Scientific Considerations

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Regenerative medicine holds great potential for human disease management, with hundreds of cell and gene therapy (CGT) products for tissue/organ reconstitution or replacement in different stages of development and clinical testing for toxicity, safety, and efficacy. For example, currently more than 60 CGTs have marketing authorization (although many with only conditional approval) from central regulatory agencies worldwide (1). Those products are treating conditions such as hematopoietic malignancies, immunological disorders, and cartilage disorders. Most of those treatments use culture-expanded autologous or…

January 31, 2020

eBook: Joining Forces — Industry Collaborations Toward BioProcess Success

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Companies in the biopharmaceutical industry increasingly are working together to solve the many challenges of product/process development and biomanufacturing. Suppliers seek end-user help in refining technologies; academics and small innovators attract the financing and business acumen of large companies; equal partners share in technological problem-solving; and sponsors engage the development expertise of contract research and manufacturing organizations. Other examples of biopharma industry collaborations abound, too. Citing critical examples from the September 2019 BioProcess International East Conference in Boston, MA, this…

January 28, 2020

eBook: Speed to IND — Balancing Risk and Reward

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With so many biopharmaceuticals obtaining breakthrough or fast-track designations, companies that use accelerated strategies to be first in human studies can be left with significant quality and manufacturing challenges that must be solved later on. Despite regulatory encouragement to create solid design spaces and define parameters according to quality by design (QbD), those may go by the wayside given the pressures of speed. The reward is the investigational new drug (IND) application itself — but if companies lock in subpar…

December 11, 2019