Business Process Management

WHITE PAPERS AND CASE STUDIES

• How A Leading CDMO Reduced Yield Variability With Automation

  Explore the transformative journey of a leading CDMO company and how they adopted an innovative platform that enhances data analytics and drives pharmaceutical manufacturing advancements.

• Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes

  The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

• Atlantic Research Group Builds Competitive Advantage With Medrio EDC

  By using Medrio’s EDC platform, learn how Atlantic Research Group was able to achieve the flexibility needed to span multiple therapeutic areas and eliminate redundancy in documentation.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• 7 Critical Factors For Predictable Quality In Medical Device Manufacturing

  Quality medical device production requires diverse engineering expertise, electronic integration, and a proven track record across seven key elements.

• How Can The Industry Drive Down The Cost Of Viral Gene Therapies?

  This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.

• Material Selection For Medical Device Manufacturability

  Choosing the right material in the earliest stages of research & development can make all the difference in beating your competitors to market and avoid increased project costs, development delays and manufacturing setbacks.

• Mobile App And Wearable Integration Collects Longitudinal Data

  Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.

• Calculating Your Business Case For Continuous Manufacturing

  Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Digital Transformation And Quality By Design For Enhanced Development

  Discover how digital transformation and Quality by Design are revolutionizing pharmaceutical development to boost efficiency, enhance compliance, and accelerate innovation across the drug lifecycle.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.