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WHITE PAPERS AND CASE STUDIES

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• Sustainability In Small Molecule API Manufacturing

  Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.

• Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

  Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

• Sickle Cell Cure Within Reach, But At A Steep Cost

  Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.

• 2024 Global Biopharma Sustainability Review

  What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Meet Regulation Requirements With RTU Vials And Cartridges

  Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.

• The Smart Industry Readiness Index: A Path To Achieving Digital Maturity

  In a time defined by the Fourth Industrial Revolution (Industry 4.0), a period transforming industries through advanced technologies, the manufacturing landscape is evolving beyond something we recognize as familiar. With the potential to automate processes, enhance data visibility, optimize operations, and redefine value chains, technology is revolutionizing industries across the globe. However, many organizations grapple with a critical question: How can they assess their digital transformation (DX) readiness for this most important paradigm shift?

• Getting Started With Product Development Strategies

  Simplify and streamline new product development for success. Explore the importance of new product innovation, different process methods, and best practices for optimizing your company’s strengths.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Streamlining ADC Development: Advantage Of An All-In-One Solution

  Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.