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WHITE PAPERS AND CASE STUDIES

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Lean Six Sigma Methodology Drives Cost Savings: 2 Success Stories

  Learn how applying Lean methodologies in two different laboratory settings led to significant cost savings and improved operational efficiency.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Regulatory Publishing Expertise Across The Entire Development Journey

  Learn how with expert support, three separate sponsors were able to issue flawless IND, MAA, and NDA submissions to the FDA and EMA, expediting the process of bringing their product to market.

• Improve Your Molecular Cloning Process With Synthetic Biology Automation

  Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.

• Advancements In Microbial Manufacturing Of Biopharmaceuticals

  Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market

  Discover how an experienced CDMO offering a purpose-built facility with flexible capacity can help biopharmaceutical companies bring their products to market quickly and efficiently.

• Outsourcing Manufacturing Of Acetic Acid And Benzyl Alcohol Solutions

  Custom buffer solutions produced for a multinational biopharmaceutical company, enabled a fast facility expansion while still meeting the customers strict quality and regulatory requirements.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• Exploring Perfusion Technology For Virus Manufacturing Process Intensification

  Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.