INSIGHTS ON MANUFACTURING LOGISTICS

• How To Avoid Bag Breakages With Product Loss

  A global Contract Manufacturing Organization (CMO) produces different drug substances (BDS) of highly valuables mABs in batch sizes from 10l to 700l for clinical phases up to commercialized products. They were facing a challenge with single use bags with a high loss rate of 0,5% to 5% due to their sensitivity at sub-zero temperatures. Read how they set up a cold chain process and implemented robust technologies around the brittle single use bag and to consequentially reduce product loss.

• High-Density Cell Banking

  How high-density cell banking accelerates upstream processes by providing a larger volume of concentrated cells at the start of a production run, shortening seed training from weeks to days. 

• Drug Substance Management With Single Use vs. Stainless Steel

  Fast freeze rates, safe storage and proper shipping of bulk drug substances are imperative. This case study compares the advantages and disadvantages of single-use systems and cryovessels.

• Laboratory Freezer For Single Use Technology

  Biopharma manufacturers are increasingly using single use tech for storage, shipping, and transfer of substances. Aabandoning cost-intensive and bulky platforms can save considerable amounts of money.

• Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply

  Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.

• Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply Chain

  To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route for drug substance, drug product, and clinical trial packaging needs.

• Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies

  The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

• Managing Clinical Ancillary Supplies At Global Scale

  Clinical ancillary management expertise helps biopharma company oversee a large, global trial from start through finish.

• Low-Temperature Solutions For Bioprocess Applications

  Janelle Rupkalvis, Life Sciences applications explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.