Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.
- Legal And IP Protection For New Biotechs
- Understanding The Importance Of Real-time Monitoring For Protein Aggregation
- Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
- The 6 Types of Bio/Pharmaceutical Consultants
- FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
- FDA Warning Letters Dipped, But Don’t Get Cozy
- Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses
Understanding The Importance Of Real-time Monitoring For Protein Aggregation
BioSolution’s Danny Chou, Ph.D., Pharm.D., breaks down the advantages of real-time monitoring for protein therapeutics, including how these approaches can accelerate timelines, produce better data, and smooth regulatory compliance.
Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.
The 6 Types of Bio/Pharmaceutical Consultants
In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants,” but, in fact, there are different types of consulting services. Determining which will serve you best is an important decision before you seek support.
FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
FDA Warning Letters Dipped, But Don’t Get Cozy
Between October last year and March this year, FDA inspectors showed a heightened level of discretion for OAI inspections, choosing to withhold enforcement action. This isn't an invitation to breathe easy; there's a reasonable explanation for less enforcement action.
Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses
Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.
Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations
Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.
BIOSIMILAR WHITE PAPERS
A Risk-Based Approach To The Development Of An Injectable Combination Product
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
Inspection Of Injectable Products For Visible Particulates8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
Outstanding Sensitivity For Confident SPR Interaction Analysis7/20/2022
Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.
Regulatory Considerations For Alternative Microbial Methods2/28/2022
We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.
Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster3/24/2023
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
COGs Process Economics For Autologous Cell Therapy8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.