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WHITE PAPERS AND CASE STUDIES

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Leveraging The Bolar Exemption To Accelerate Market Access

  Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

• How Advanced Biological Technologies Overcome Complex Wastewater Treatment Challenges In The Oil And Gas Sector

  This white paper explores how advanced biological technologies — including MBBR, IFAS, SBR, and MBR systems — are transforming wastewater management in this sector.

• The Heroes Of Vaccine Development: Lipid Nanoparticles

  Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.

• Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility

  Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.

• Moving CGTx Clinical Development Forward In 2023

  Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.

• Revolutionizing Particle Characterization With Image Analysis And ML

  The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.

• 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.

• Implementation of the New European Health Technology Assessment Regulation (HTAR)

  The European Health Technology Assessment Regulation (HTAR) requires joint clinical assessments for certain therapies starting 2025, impacting market access preparation for companies in the EU.

• Top Biopharma Enhances Regulatory Efficiency

  Learn how this biopharma company was able to assemble project teams focused on implementing real-time document transfer for central IRB documentation and communications, significantly reducing errors and improving data management.

• Democratizes Batch Data Management For AAV Gene Therapies And Accelerates CMO Collaboration

  Read the story of a leading clinical-stage biotechnology company developing gene therapy product candidates in the retinal, metabolic, and neurodegenerative therapeutic areas.

• Current Strategies For Enhancing Bioavailability

  Explore key strategies for enhancing bioavailability of poorly soluble drug compounds, including spray drying, particle size reduction, and lipid-based formulations supported by solid-state analysis.