Biomanufacturing Featured Articles
-
New DSCSA Compliance Blueprint Includes FDA & Industry Input
4/12/2023
Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.
-
Final Guidance Locks In FDA’s Definitions For Suspect And Illegitimate Drug Product
4/7/2023
With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.
-
Controlled Substances In Clinical Trials
3/30/2023
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
-
Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility
3/24/2023
As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.
-
Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
-
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
3/7/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
-
Improve Biopharma Quality With Manufacturing Execution Systems (MES)
3/6/2023
Start moving toward more efficient record keeping protocols with manufacturing execution systems (MES) software that reduces quality issues, accelerates resolution, and improves operations.
-
Strategic Procurement For Emerging Pharmas & Biotechs
2/27/2023
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.
-
Design A Digital Transformation Architecture
2/24/2023
Learn how to accelerate the pace of business and responsiveness to the market for your organization with digital transformation technology.
-
Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug Development
2/23/2023
One main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.