Transactional Content Management

WHITE PAPERS AND CASE STUDIES

• Navigating Regulatory And Development Milestones

  This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

• Denver Water Protects Customers With Data-Driven Lead Reduction Program

  Denver Water is committed to delivering a safe, reliable water supply to its customers. The water provided to homes and businesses is lead-free, but lead can get into the water as it moves through customer-owned, lead-containing household fixtures, plumbing, and water service lines—the pipe that brings water into the home from the main in the street.

• Meta Biomed Accelerates Digital Transformation

  Meta Biomed's scientists ran hundreds of experiments, but they lacked a clearly defined way of sharing information and knowledge between individuals and teams. They also wanted to centralize their product development data and achieve a more structured way of working to boost innovation, embed quality throughout the supply chain and accelerate product certifications—especially as they sought to become a leading supplier of surgical sutures in the global market. A single, centralized database solution now allows them to hold all of their product development data.

• Quality Assurance In Additive Production

  Whether in research or in production, the laser parameters must be checked regularly. For this purpose, Fraunhofer Research Institution for Additive Manufacturing Technologies IAPT generally turns to the Ophir BeamWatch AM, which measures the laser beam without contact, is compact enough to be used inside the production chamber, and delivers measurement results quickly. This case study covers the full story.

• A Successful Approach For Managing Unexpected Increases In Potency For HPAPIs

  CDMOs face the challenge of managing new APIs in development projects with incomplete toxicity and pharmacology data. When a development project initially classified as an occupational exposure band (OEB)-4 highly potent API (HPAPI) had been later reclassified as an OEB-6 compound, the company upgraded a state-of-the-art containment production line to ensure operator safety and keep the project on track in less than one year.

• Robinson Tech Ditches StorageCraft, Takes Backup to New Level With Unitrends MSP

  In 2006, Robinson Tech was just Dan alone in a garage. Now, there are seven full-time staffers that interact with roughly 70 clients each month, with about 20 of them on full remote monitoring and management (RMM) contracts and the rest on break/fix support.

• Hospital Researchers Turn To Corning To Help Scale Up Ex Vivo Expansion Of Adipose Stem Cells

  Autologous fat grafting is the least invasive method for breast reconstruction, but also has major drawbacks, including high tissue resorption rates of up to 80%. Researchers in Denmark had a hypothesis: what if you could enrich the human fat graft with autologous adipose stem cells (ASCs) to increase graft survival? But they faced a major obstacle: how do you culture a sufficient volume of stem cells to increase grafting success? They turned to Corning, who designed a scale-up solution that’s enabling them to grow the billions of stem cells required to move forward with this clinical study.

• Maximizing Yield And Minimizing Risk In Aseptic Filling

  Explore the process of how a new fill line was planned for and implemented, while also considering how best to mitigate contamination risks.

• Container Closure Integrity Testing Of Sterile Injectable Product

  This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.

• Texas Cardiology Research Department Transforms Document Access, Fuels Productivity

  What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.

• When Clinical Trials Meet The Real World: Bridging The Experimental And Post-launch Divide With Data Integration

  Real world evidence and pooled clinical trial data are becoming increasingly available, linkable and minable to find valuable insights quickly. As we evolve into a new era of data integration, biopharma companies stand to benefit enormously from bridging the experimental and post launch worlds of clinical data to support the entire product lifecycle. 

• Metal Detection System Helps Nuts ‘N More Deliver Contaminant-Free High Protein Spreads

  Nuts ‘N More has taken the initiative to install high level operational procedures and technologically innovative equipment specifically to comply with rigid food safety guidelines. An important part of the company’s quality push is the use of an Eriez Xtreme® Metal Detector Conveyor System, which inspects every jar produced at Nuts ‘N More for metal contamination.