Business Process Outsourcing

WHITE PAPERS AND CASE STUDIES

• CRO Implements A Successful, Patient-Centric Decentralized Solution For An On-going Clinical Trial During COVID-19

  A mid-sized biotech company was in the middle of conducting an open-label long-term safety study with 137 active patients across 25 sites in the US and Canada. Then the COVID-19 pandemic hit. Rho developed a customized and decentralized solution for their study that would ensure patient safety and data quality while allowing their study to progress according to FDA guidelines for conducting research during this pandemic.

• Spiralift® SLX: First Line Of Defense For Prison Effluent

  For years, Graterford Prison, a maximum security facility in Pennsylvania, experienced continuous problems with their wastewater system. Their antiquated equipment consisted of bar screens, grinders and comminutors which were frequently overwhelmed by the sewage generated daily by 3,600 inmates. To make matters worse, the trash and debris often included full sheets, blankets, clothing, shoes, and plastics which the prisoners stuffed into the toilets in their cells and flushed. The ensuing sewage clogs, backups and flooding created headaches for the maintenance staff and interfered with the institution’s functioning.

• Drug Repurposing Trends, Strategic Approaches To Shorter Timelines

  As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.

• Resolutum Global Leverages Medrio To Succeed In A Complex Phase 1 Oncology Study

  In a recent rescue study, Resolutum Global, a contract research organization, faced the challenge of building a hybrid paper/EDC solution for an ongoing study that the previous provider had conducted on paper over 4 years. By leveraging Medrio, they were able to succeed in this task and deliver satisfaction to the study sponsor.

• Taskmaster® Titan® Grinders To The Rescue At ECUA

  The Emerald Coast Utilities Authority (ECUA) was having a difficulty with their sewage grinders. They were running four grinders supplied by a well known manufacturer at two of their pump stations, with each station processing approximately 10 mgd. Unfortunately, their first set of grinders turned out to be problematic. They created a lot of down time and generated excessive maintenance costs. ECUA needed a new solution to solve their problems and get their pump stations functioning properly.

• QbD For Process Development, Scale-Up Of A Novel ALS Drug Product

  A stepwise approach to Quality by Design (QbD), which drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

• CRO Leverages Partnership With Integrated Central IBC To Initiate Sites In COVID-19 Vaccine Research

  The COVID-19 pandemic forced a CRO to reimagine what was possible as it became clear traditional timelines would not be sufficient to move the new COVID vaccines through clinical trials and to the public at warp speed. Working with Advarra, they were able accelerate review times so the COVID vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

• Rapid Deployment Of Manufacturing Options: An Analysis Of Risks And Benefits

  Biomanufacturers seeking the best approach to rapid implementation of flexible manufacturing capacity take into account the benefits presented by different modular construction options. Here we analyze different approaches to building manufacturing capacity and assess the economic benefits of each approach.

• Process Engineering And Industrial Modeling Collaboration Delivers Improved Efficiency And Facility Throughput

  Utilizing a wide range of expertise, IPS team members interfaced with MilliporeSigma’s operational group to design new layouts and processes that would optimize the facility’s flow and throughput.

• Impact Of The Freeze-Drying Process And Lyoprotectants On Nanoparticle Stability

  Read highlights from a recent webinar describing the challenges of freeze-drying nanoparticles and how a group has designed and evaluated solutions to lyophilizing LNPs.

• Pioneer In CAR T Programming Technologies Centers Batch Data Management And Approvals Around Skyland PIMS®

  A cell therapy developer has an extensive pipeline of CAR T treatments with its lead program recently entering pivotal trials. It wanted to move off of Excel-based batch data management to a centralized database to accelerate process verification with workflows and a single version of the truth. By implementing Skyland PIMS® allowed them to tightly control batch data review and build a clear audit trail.

• Alternative Buffer Management Strategies To Achieve Downstream Process Improvements

  Understanding the alternative buffer management strategies available and the resources needed to execute them can help ensure you have the tools necessary to remain competitive in today’s growing bioprocessing industry.