Biosimilar Development solution center

1. 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.

2. Biotech’s Market Outlook In 2023 & Beyond 2/23/2023

   This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.

3. Streamlining The Integrity Testing Process – From Test To Report 2/22/2023

   Discover a digital transformation solution that provides first of its kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.

4. After Decades Of Biomanufacturing Workforce Development, What’s Next? 2/1/2023

   We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

5. Establishing A Robust Workflow To Identify High-Performing Clones 1/13/2023

   Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.

6. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

   The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

7. Taking Charge Of Your Stability Program 10/5/2022

   Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

8. Optimizing Lipid Formulations For Targeted RNA-LNP Applications 9/13/2022

   Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.

9. Process Development Considerations For RNA-LNP Therapeutics 9/13/2022

   Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).

10. Key Stages In mRNA-Based Therapeutic Development 9/13/2022

    Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.