Regulatory Affairs

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

by

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…

Learning Management: Evaluation of Retraining Risk at Indian Pharmaceutical Companies

by , and

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…

Focus on Aseptic Processing: A Report from the September 2022 PDA Annex 1 Event in Amsterdam

by

The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include. The Parenteral Drug Association (PDA) has organized a series of four workshops, the third of which took place in…

Triton X-100 Elimination: The Road Ahead for Viral Inactivation

by and

The nonionic surfactant Triton X-100 (C14H22O(C2H4O)n) is a key chemical used in ensuring the viral safety of biological medicinal products. Two pharmaceutical sectors share an extensive historical background with it: biopharmaceuticals and plasma-derived products, for which it is used to inactivate lipid-enveloped viruses. Recently, environmental regulations in the European Union have encouraged or mandated a phase-out of this surfactant (1). The goal of the ruling is to protect aquatic ecosystems from potential Triton X-100 degradation products that can function as…

December 12, 2022

The BARDA Industry Day Breakdown

by

This panel discussion features: Gary Disbrow, PhD, Director, Biomedical Advanced Research and Development Authority; Kristen Herring, PhD, Vice President, The Conafay Group; Ivan Silva, PhD, Principal Consultant, Latham BioPharm Group; Joshua Speidel, PhD, Managing Partner, Latham BioPharm Group; Brian Tse, PhD, Vice President, The Conafay Group. The BARDA Industry Day (BID) Breakdown was a webinar intended to better inform potential BARDA collaborators on the agency’s practices, intentions, and interests. Leveraging the information learned from BID 2022, The Conafay Group (TCG)…

December 1, 2022

Transforming the Biopharmaceutical Development Roadmap

by

Biopharmaceutical analytical methods have improved significantly since the early 1990s. Techniques and fundamental mechanisms largely have remained the same, but modern analytical tools are delivering better insights into drug-product characteristics thanks to improved reagent quality, method intensification, and automation. Harmonized regulations and the revolutionized role of contract development and manufacturing organizations (CDMOs) also continue to support bioprocess transformations. Improved Analytics and Standardized Single-Use Equipment Today’s analytical methods provide high resolutions and deliver reliable results quickly. For example, sodium dodecyl sulfate–polyacrylamide…

August 22, 2022

20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series

by , and

Formerly known as the California Separation Science Society, the CASSS organization has maintained a close relationship with BioProcess International since its inaugural year. In particular, the CMC Strategy Forum series began the same year that BPI’s original staff joined Informa to develop a new international trade publication covering biopharmaceutical development and manufacturing. Beginning with our February 2004 issue, BPI has been proud to publish dozens of reports from this influential series of meetings over the years. Their success around the…

August 19, 2022

Surveying the Biosimilars Regulatory Landscape

by and

BPI’s history coincides with that of biosimilars development. Although nonpeptide biosimilar products did not begin receiving commercial authorization until the 2010s, health authorities and drug makers already had been exploring the complex concept of biosimilarity. In the May issue of BPI’s first volume, Theresa L. Gerrard (then an independent consultant who also had been director of the Division of Cytokine Biology at the US Food and Drug Administration Center for Biologics Evaluation and Research, FDA CBER) wrote: The potential for…

August 19, 2022

From PDFs to Digital Submissions The Rapid Pace of Regulatory Change

by

The pace of regulatory change in the pharmaceutical industry over the past 20 years has been rapid. Although heightened emphasis on patient safety, data transparency, and harmonization has prompted new guidance’s and requirements, perhaps what is most notable is the rate at which technology has changed how processes are documented and regulated. Today, digitization is entrenched in day-to-day life and is steadily becoming the norm among health authorities and at pharmaceutical companies. But just two decades ago, incorporating technology-led regulatory…

August 19, 2022

eBook: Biopharmaceutical Training — Designing Effective Adult-Learning–Based Programs

by and

Biopharmaceutical industry training is imperative not only to ensure patient safety, but also to develop a skilled workforce that can support successful businesses. Current good manufacturing practice (CGMP) skills and behaviors are needed so that products being developed, manufactured, and delivered are compliant and within specifications. Individuals who fulfill roles within development, manufacturing, and delivery processes need some level of education to develop all the necessary skills and behaviors. Adult earners have unique needs and requirements that must be incorporated…

June 28, 2022