March 2023

March 2023: From the Editor

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The first event that we editors attend each year usually is the annual WCBP (Well-Characterized Biopharmaceutical Products) conference hosted by CASSS, formerly the California Separations Science Society. Held in Washington, DC, each January, the meeting is prefaced by a day-long offering of two CMC Strategy Forums. The combined event brings together scientists and regulators from around the world to explore current issues in biopharmaceutical development from a chemistry, manufacturing, and controls (CMC) perspective. Presentations often include updates and progress reports…

March 21, 2023

Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System

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Pharmaceutical companies and regulatory agencies strive to foster scientific excellence in drug development and evaluation so that members of the public can access the high-quality medicines that they need. Recent European Medicines Agency (EMA) approvals for COVID-19 vaccines highlight those organizational accomplishments and showcase the application of risk-based chemistry, manufacturing, and controls (CMC) flexibilities that are embedded within the European Union (EU) regulatory system. Many of the CMC flexibilities outlined herein were established for PRIME (priority medicine), a scheme that…

March 21, 2023

Patent Before Publish: Maximizing the Benefits of Your Research

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For many life-science researchers at universities and other institutions, documenting and disseminating discoveries through publication is the natural culmination of their work. It is the process by which researchers, a group that includes principal investigators (PIs), postdoctoral researchers, and graduate students, advance their careers. It is a core piece of their continual efforts to secure funding for future work. Most researchers are rewarded for the number and quality of their publications, which are judged, in part, by their impact factor…

March 21, 2023

Learning Management: Evaluation of Retraining Risk at Indian Pharmaceutical Companies

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Human medicinal product manufacturers face complexity and uncertainties regarding operational performance. Effective training management plays a major role in support and implementation of a pharmaceutical quality system. The minimum regulatory requirement is to employ adequately trained personnel with sufficient knowledge, skills, and experience. Software-based e-learning training methods are used widely across pharmaceutical companies. Achieving quality compliance depends significantly on several factors, from training preparation to assessments. To comply with the current regulatory requirements, pharmaceutical companies need to implement learning management…

March 21, 2023

Predictive Algorithm Modeling for Early Assessments in Downstream Processing: Using Direct Transition and Moment Analysis To Assess Chromatography Column Integrity at Production Scale

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Failure to detect breaches in chromatography column performance can be disastrous during large-scale commercial manufacturing. Our company uses algorithm modeling for near–real-time monitoring of column packing quality and sensitive detection of column-integrity breaches. The approach enables us to mitigate risks early on, save cost and time, and thereby deliver consistent product quality and purity during manufacturing. Here we discuss three case studies in which predictive algorithm modeling using moment analysis and direct transition analysis (DTA) helped us monitor column integrity…

March 21, 2023

Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity Chromatography

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According to the World Health Organization (WHO), more than 350 million people worldwide are chronic carriers of hepatitis B virus (HBV) (1). Around 25% of carriers develop liver cirrhosis and/or carcinoma, making HBV responsible for the deaths of one million people annually (1). The virus has a spherical shape with a lipoprotein coating mostly of HBV surface antigen (HBsAg) (2). Knowing that, drug developers have created recombinant HBV vaccines based on HBsAg synthesized in yeast or mammalian cells (3, 4).…

March 21, 2023

A Case Study in Environmental Monitoring: Reviewing Incubation Times Upon Recovery of Microorganisms

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Environmental monitoring (EM) remains an essential detection tool for cleanrooms within healthcare and pharmaceutical-manufacturing facilities. During monitoring, an agar growth medium is incubated at a specific temperature for a set time. There is no single approach to incubation. Researchers have performed several EM incubation studies, with results reflecting a diversity of practice. Typically, biomanufacturing sites either run selective monitoring sessions using single-incubation regimes with two different culture media, or they leverage a dual-incubation system using two temperature ranges with a…

March 21, 2023

Meeting the Unique Needs of Rare-Disease Patients

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The growth of gene and cell therapies (CGTs) and specialty pharmaceuticals represents a radical shift in the treatment of rare diseases. By changing the parameters for care coordination, such innovations are improving patient outcomes and leading to a better quality of life. Treatments for rare diseases have been shown to provide more significant health benefits on average than can drugs that are formulated for more common conditions. Regrettably, over 95% of rare-disease patients in the United States lack a US…

March 21, 2023