Automation

WHITE PAPERS AND CASE STUDIES

• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• Adapting To The Medical Monitor: Driving Tech Adoption In Clinical Analytics

  Reasoning for physician monitors’ reluctance, and what technology needs to offer to convince monitors their work can be more efficient: quickly detecting safety signals and speeding time to submission.

• How An MSP Enhances Compliance For Healthcare And Finance Clients

  Eric Gaffin is the Director of Cybersecurity and Compliance Services for Advanced Technology Group, a managed security and IT services company with a 20-year track record of delivering cutting edge solutions to clients in heavily-regulated industries. See how he’s using ActivTrak to address his clients’ compliance needs.

• Connected Data Flow And Standards: A Data Management Approach

  Data management experts work with a four-step innovation process to create connected data flow and standards: digitization, centralization, standardization, and automation. Together, these steps address data challenges, while increasing efficiency and optimizing quality. Explore each step in the available white paper.

• The Insource Vs. Outsource Dilemma

  Prior to making critical capacity decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best strategy for its manufacturing. Discover the critical elements of this analysis that may help to balance your assessment.

• Industry Best Practices For Novel Biotherapeutic Entities

  As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules. However, informatics technologies have not kept pace with these scientific innovations. It’s unlikely that any single life science company, technology vendor or academic group will be able to solve these issues unaided. But together we can establish systems and processes that make working with these new entities more efficient.

• How Can We Predict Immunogenicity Earlier?

  With many biotherapeutics a strong immunogenic response can limit the effectiveness of the treatment or cause a more serious illness. This remains a challenge for scientists as the underlying mechanisms of unwanted immunogenicity still aren’t completely understood. Detecting and preventing unwanted sources of immunogenicity as early in the discovery process as possible has become a top priority for research organizations since biotherapeutic development becomes increasingly costly as it moves downstream.

• Can mRNA Disrupt The Biopharma Industry?

  mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.

• How SARS-CoV-2 Shifted Biologics Production

  The novel coronavirus SARS-CoV-2 caused a period of rapid biopharma adaptation, from which trends are emerging. What can we learn from the crisis, and which changes are here to stay?

• Vision And Paperless Ops Make Northeast Scientific A MedTech Industry Leader

  Managing all the documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. A modern manufacturing execution system allowed them to manage documentation by eliminating paper.

• Extrusion- Spheronization, Engineered For Today’s Controlled Release Forms

  Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex OSD therapeutics.

• Illustrating A Successful Small Biotech-CDMO Relationship

  Explore the experience of selecting and working with a global CDMO partner and the value for one virtual company established to develop the molecular design and process development for a complex protein.