Biosimilar Development insights

  1. Staying Flexible In Biomanufacturing

    The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.  

  2. Keys To Consistent Bioprocessing

    The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.

  3. Evolution of Single-Use Bioprocessing Into BioPharm 4.0

    Using data analytics to drive continuous improvements in efficiency.

  4. Raw Materials Management: Technology Advancements Improving Transparency And Global Collaboration

    The ultimate goal of the biopharmaceutical industry is to ensure a consistent supply of safe and effective drugs to patients who need them. One key factor in doing so is to address the challenges of raw material sourcing and management.

  5. Utilizing External Collaboration To Accelerate Vaccine Development

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

  6. Thermo Fisher Scientific Suzhou, China Manufacturing Site Capabilities

    Watch this video to learn more about this manufacturing site capabilities, quality management systems, PPI implementation, product expansion, assurance of supply and lead times.

  7. Industry 4.0 Connects Machines And Data

    By applying remote monitoring solutions, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers improved process reliability and product quality through unlimited possibilities of connecting machines and data.

  8. Raw Material Variability Control: Where Do We Go From Here?

    Cory Card, Principal Scientist at GE, discusses not just ideas shared at a recent industry symposium on raw material variability control, but, most importantly, where to go from here.

  9. Amgen’s Digital Transformation: Linking Raw Material Data From Suppliers To Patients

    Using its Supplier Relationship Excellence (SRE) program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to better understand operational performance. 

  10. How Biopharma Is Capitalizing On The Antibody Boom

    Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.