Regulatory Affairs

eBook: Outsourcing — Triumphs and Turmoil in Establishing Biologics CDMOs

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Outsourced development and manufacturing once were all but out of the question in the biopharmaceutical industry. Regulatory changes, technical and scientific advances, and an increasingly global market have transformed a once-risky option into a common business strategy. This eBook brings a historical perspective and valuable advice from lessons learned through decades of experience. Well-known industry advocate and executive consultant Roger Lias highlights the challenges and keys to success on the service-provider side as the economic environment invites budding entrepreneurs to…

Unlocking the Power of Wizardry for Regulatory Compliance

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Regulatory compliance is not just a legal requirement, but it is also a critical aspect of ensuring patient safety and trust. The consequences of noncompliance can be severe, incur costly fines, and damage a company’s reputation. Understanding Wizard Tools for Compliance Adobe Acrobat plug-ins from third parties offer users an array of “wizards” that help to streamline the creation of important regulatory documents by addressing different requirements and obstacles. Regulatory compliance can be a challenging and time-consuming process for businesses…

September 19, 2023

BioProcess Insider Interview: Emmanuel Ligner, Chief Executive Officer, Cytiva

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Cytiva created its Biopharma Resilience Index about three years ago during the COVID-19 pandemic to better understand industry needs and trends. According to Ligner, the most recent survey asked about 1,250 executives at biopharmaceutical companies about how they rate the resilience of the industry in five important categories: supply chain, research and development (R&D), manufacturing agility, regulation, and talent. The feedback that Cytiva has received enables it to assess industry needs on a global scale. The data also inform the…

August 21, 2023

Innovating Biologics Regulation: Insights from the Founding Director of the US FDA’s Division of Monoclonal Antibodies

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Biopharmaceutical researchers, manufacturers, and regulators converged on Washington, DC, in January 2023 to attend CASSS’s 26th annual Well-Characterized Biological Products (WCBP) meeting. Among the opening festivities at each such event is conferral of the prestigious William S. Hancock Award for Outstanding Achievements in Chemistry, Manufacturing, and Controls (CMC) Regulatory Science. The prize honors people who have spurred on significant advances in scientific principles, applied technologies, and science-based regulations for biomanufacturing process development, characterization, analysis, and quality assessment. The 2023 recipient…

August 17, 2023

From Digitalization to Early Planning: Key Trends Revolutionizing Life-Science Operations and Regulations

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Life-science companies must stay on top of new requirements, innovations, process improvements, and potential roadblocks to navigate complexities across the development, manufacturing, and regulatory life cycles of their products. Amid the increasing availability of cutting-edge technologies such as artificial intelligence (AI) and blockchain ledgers, organizations must establish best practices to support strategic decision-making, improve information collection and sharing with key stakeholders, and prioritize supply-chain management. Below, I share some insights from our team about emerging digital technologies and their implications…

August 17, 2023

Standard Operating Procedures in a Good Practice Environment: Benefit or Burden?

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I was both excited and curious the day I started a new job in the quality affairs department of a pharmaceutical company. As usual, I attended onboarding meetings and received a training plan that contained a list of standard operating procedures (SOPs). So far, so good. But once I looked into the company’s training documents, my excitement turned to surprise. The SOP training included more than 150 good practice (GxP) SOPs, several of them longer than 50 pages and full…

June 26, 2023

The Future of Virtual Audits and Audit Success

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Audits are a vital quality-management tool in the biopharmaceutical industry. Whether the activity is verifying supplier or partner qualifications, contributing to corrective and preventative actions (CAPAs), or fulfilling regulatory requirements, proactive auditing is key to successful operations. Over the past couple of years, virtual audits — also known as remote or distance audits — have enabled biopharmaceutical companies to maintain compliance and quality-assurance (QA) demands despite COVID-19–related travel restrictions and social-distancing protocols. Now that the world is opening up again,…

May 23, 2023

Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic

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On average it can take or even exceed US$1 billion to get a pharmaceutical product to market, and nine out of 10 products developed never make it to commercialization (1). As technology advances, more potential therapies and preventatives are being developed and optimized by virtual companies. They are typically small, newly formed organizations that build their momentum on programs for novel products. Because many of the program activities are outsourced, virtual start-up companies developing pharmaceutical products raise concerns about ensuring…

May 23, 2023

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidance on the testing and evaluation of viral safety of biotechnological products derived from characterized cell lines of human or animal origin through its harmonized guideline ICH Q5A (1). The latest revision, released for consultation in October 2022, maintains the key principles of previous versions while introducing key changes in response to important advances in the field. Those advances are covered in new sections that…

May 17, 2023

Streamlining and Accelerating Biosimilar Adoption in the United States

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Biologic medicines have brought extraordinary clinical benefits to patients living with difficult conditions such as cancer and autoimmune and ophthalmic diseases. But such therapies are expensive, accounting for about 43% of pharmaceutical spending in the United States (1). The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a regulatory pathway for a class of biologics called biosimilars, which replicate branded biologic drugs at lower cost (2, 3). The BPCIA was designed to provide greater access to biologics by…

May 17, 2023