Articles, App Notes, Case Studies, & White Papers

1. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

   21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

2. Designing Agile Manufacturing With An Integrated Drug Product Ecosystem

   Companies aiming to accelerate biomanufacturing operations and use resources efficiently need access to technologies that can safely and efficiently complete their workflow from discovery to delivery.

3. Regulatory Guidance On GMP Software 2/23/2022

   Explore the regulatory requirements for software in a biopharmaceutical GxP environment and why software is invaluable for creating an audit trail, reporting, and automating regulatory-related tasks.

4. New Hope For Neuronal Diseases With Polymer Nanoparticle-Based Gene Therapy 1/28/2025

   A new polymer nanoparticle (PNP) system enables targeted delivery of large genetic payloads to neuronal cells, advancing gene therapies for NF1 and other nervous system disorders.

5. Single Nucleus Dispensing 10/11/2022

   Learn how a single cell dispenser was used to isolate single DNA-labeled nuclei to demonstrate compatibility with snRNA-seq workflows.

6. Introduction To mRNA Manufacturing 2/15/2023

   The SARS-CoV-2 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more.

7. Unlocking The Benefits Of FTZ Subzones For Pharmaceutical Manufacturing

   Explore how a contract manufacturer that is approved as a certified FTZ subzone can help sponsor companies unlock significant benefits and gain a competitive edge in the global pharmaceutical industry.

8. A Proven Platform For Solid-Phase Oligonucleotide Synthesis 5/25/2022

   Facilitating oligonucleotide synthesis with state-of-the-art equipment and process support is critical to maximizing oligo production and achieving consistency at scale.

9. Contract Design And Development Vs. In-House: Finding The Best Fit 11/18/2024

   Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.

10. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales is difficult. In this study, we leveraged existing physical characterization data and scaled a process from microbioreactor to production scale.