Industry Insights

  1. 2025 Forecast For Advanced Therapies 1/8/2025

    As we reflect on the lessons from 2024, it’s time to consider what 2025 may hold for the industry. Special attention is given to oligos, mRNA, cell therapies, and AAV.

  2. Market Assessment: Neurovascular Thrombectomy In The U.S. And EU 4/16/2018

    Advancements in technology drive continuous improvements in thrombectomy techniques. But, the competitive landscape is subject to change very rapidly, given the release of Medtronic’s aspiration system. 

  3. A Blueprint For Breakthroughs: Accelerating Rare Disease Therapies 6/11/2024

    To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

  4. Discovery Studies: An Agile Approach To Early Data For Quicker Decisions 8/6/2025

    Discover the power of discovery research, key trends shaping early-phase drug development, and two exclusive case studies from our Sacramento facility.

  5. How Pharmaceutical Shipping Influences Logistics Trends 1/9/2018

    Considering the changes over the last few years and looking ahead to 2018, there are four predictions for pharmaceutical shipping trends that will also likely influence logistics overall.

  6. Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients 10/9/2024

    In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

  7. 4K Operating Room Technology Advancing, Despite Initial Doubts 8/8/2018

    As the minimally invasive approach continues to become standard procedure, demand for surgical visualization equipment will continue to rise. Continued adoption of 4k technology is bolstering growth in the total U.S. video and integrated operating room equipment market, which currently is valued at almost $2.3 billion.

  8. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.

     

  9. Top 10 Inspection Findings From FDA, MHRA, Russia's Ministry Of Health 10/7/2020

    Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.

  10. Tackling 3 Challenges In Developing An Inhaled Gene Therapy 1/5/2024

    Inhalers hold great potential for delivery of high concentrations of gene therapy directly into the lung. This article shares the experiences of a team who have worked on the development of a gene therapy to treat cystic fibrosis.