Business

Ensuring Data Integrity in GxP

Our world provides us with abundant data at every moment of every day that we constantly analyze to make decisions. What is most important in a business/laboratory context is that the data we receive be attributable, accurate, legible, permanent, contemporaneous, and original. A company’s pharmaceutical quality system (PQS) plays a vital role in analyzing data integrity. As explained in ISO/IEC 2382:2015, data describe formalized representations of information suitable for communication, interpretation, or processing (1). According to the same ISO standard,…

Accelerating Rare-Disease Drug Development: The Key Role of Patient Registries

In the United States, a rare disease is defined as a condition that affects fewer than 200,000 people nationwide. The World Health Organization defines a rare disease as a disorder that affects fewer than 65 per 100,000 people (1). In the European Union, the definition narrows to five in 10,000 people. Ten percent of the global population is affected by at least one of the >10,000 identified rare diseases — which accounts for about 30 million people in the United…

Achieving Success with a Life-Sciences Start-Up Company

If you are an ambitious life-science professional seeking to create the next big innovation, starting your own company can enable you to share your ideas with the rest of the world. Opportunities abound within the industry, as shown by the frequent innovative breakthroughs that drive our professional lives. However, although you may be an expert within your industry, it takes careful planning and specialized knowledge of the business world to channel your expertise into a successful new company. Here, you’ll…

Professional Attire Guidelines for Bioprocessing

The global biotechnology industry has undergone a significant period of growth over the past three to four years. The COVID-19 pandemic accelerated the size and importance of an already growing sector, compounding the responsibility that falls on developers and manufacturers to deliver products that are uncontaminated and safe. Ensuring compliance with industry regulations is essential to safety, and professional attire for laboratories and cleanrooms is an integral part of adhering to standards. Biomanufacturing businesses often handle living cells, cell components,…

Post-COVID Supply-Chain Challenges Are Easing, Part 1: New Competition Is Changing Industry’s Buying Behavior

The SARS-CoV-2 pandemic created unprecedented stresses on bioprocessing and healthcare supply chains as suppliers struggled to find materials to meet demand for COVID-19 vaccines and therapeutics. BioPlan Associates, with BioPhorum and its members, recently researched the biomanufacturing industry’s response to the pandemic and prepared a white paper, Impact of COVID-19 on the Bioprocessing Supply Chain (1). Before COVID-19, the bioprocess supply industry had been growing consistently at 12–14% (nearly doubling revenue every five years) since 1990. During COVID, growth in…

eBook: Working Together Is Key to Bioprocess Sustainability

Sustainability initiatives are launching across the biopharmaceutical industry as companies begin to scrutinize their environmental impacts as part of the growing environmental, social, and governance (ESG) movement in business. Achieving ambitious sustainability goals will require organizations to evaluate their raw materials, production processes, product packaging, operations, and supply and distribution chains — and such work will entail monumental effort. Herein, BPI managing editor Brian Gazaille speaks with Brian Fahie, head of analytical development at Biogen, about that company’s efforts to…

The Future of Virtual Audits and Audit Success

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,…

Biopharma 4.0 — the Talent Evolution

Biopharma 4.0 refers to applications of data and digital technologies to biotherapeutic manufacturing. Technological advances now enable the internet and its embedded systems to serve as a nucleus through which biomanufacturers can integrate production lines and processes across organizational boundaries, thereby forming a networked and agile value chain. Solutions under the industry 4.0 umbrella include • platforms for “smart” manufacturing made possible by the internet of things (IoT) • artificial intelligence (AI) • systems for process automation • technologies for…

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

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…

The Talent Enigma in Digital Biomanufacturing

Demand for talent in the biopharmaceutical industry already had been climbing before the COVID-19 pandemic, showing an increase of 26% from 2018 to 2020. By the end of 2021, a further 32% surge was observed in the United States and Europe, against a 10% rise in the supply of expertise. Bolstered at first by the need to manufacture SARS-CoV-2 vaccines and therapeutics and now by the threat of new pandemics, current market drivers include increases in investment, initial public offerings…