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WHITE PAPERS AND CASE STUDIES

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

• Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

  This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

• Innovative FSP Solutions For Biopharma Growth And Transition

  To optimize clinical development, the pharmaceutical industry is increasingly adopting innovative outsourcing strategies with CROs.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• 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.

• Transforming Environmental Monitoring And Sample Management

  Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• Exploring Open Collaboration In The Water Industry

  This white paper will explore the necessity of open data, open software, and open collaboration in the water sector. 

• Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

  The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

• A Toolbox For An Effective Tech Transfer

  As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.