Reinventing How Drugs Are Invented: Making a Case for Simplicity in Drug...
The biopharmaceutical industry has entered into a creativity crisis. Despite billions in revenue, it has become a stagnant behemoth, struggling to deliver new therapies near the pace or price that the...
View ArticleEnsuring 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...
View ArticleAccelerating 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...
View ArticleAchieving 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...
View ArticleProfessional 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,...
View ArticleeBook: Outsourcing — Triumphs and Turmoil in Establishing Biologics CDMOs
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...
View ArticleUnlocking the Power of Wizardry for Regulatory Compliance
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...
View ArticleBioProcess Insider Interview: Min Park, Chief Business Officer, Aton Biotech
Moderator: Millie Nelson, Editor, BioProcess Insider. Featuring: Min Park, Chief Business Officer, Aton Biotech. In an industry with no shortage of contract development and manufacturing organizations...
View ArticleBioProcess Insider Interview: Andrew Mears, Chief Executive Officer, Lead...
Despite the overall growth of the biopharmaceutical industry, talent shortages remain a problem across organizations from product manufacturing to research and development. According to Mears,...
View ArticleBioProcess Insider Interview: Emmanuel Ligner, Chief Executive Officer, Cytiva
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...
View ArticleInnovating Biologics Regulation: Insights from the Founding Director of the...
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...
View ArticleBiopharmaceutical Mergers and Acquisitions: Their Impact on the Services...
The biopharmaceutical industry is, and always has been, rife with mergers and acquisitions (M&A) activity, with small biotechnology companies combining technology and platforms, mid-size...
View ArticleFrom Digitalization to Early Planning: Key Trends Revolutionizing...
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...
View ArticleBuilding a Biotechnology Business While Helping Women Shine
Women make up a significant percentage of the people who have established careers in the biopharmaceutical industry. However, the industry still needs to work toward creating equal representation in...
View ArticleeBook: 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...
View ArticleStandard Operating Procedures in a Good Practice Environment: Benefit or Burden?
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...
View ArticleMeeting Biopharmaceutical Market Needs: What Digital Solutions Need To Succeed
Although advanced digital solutions have become essential to the success of biopharmaceutical companies in recent years, a December 2022 survey from healthcare and life-sciences consultancy Sage Growth...
View ArticleLearning Management: Evaluation of Retraining Risk at Indian Pharmaceutical...
Human medicinal product manufacturers face complexity and uncertainties regarding operational performance. Effective training management plays a major role in support and implementation of a...
View ArticleeBook: 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...
View ArticleAddressing Gaps in US Biomanufacturing Capacity
In December 2022, the President’s Council of Advisors on Science and Technology (PCAST) submitted a report to Joe Biden about biomanufacturing in the United States. In a letter prefacing the report,...
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