INSIGHTS ON MANUFACTURING LOGISTICS

• Achieving Cell And Gene Manufacturing Scalability: A Conversation With AVROBIO’s Geoff MacKay

  Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

• Secure The Cell Therapy Supply Chain From Bench To Bedside

  While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks. Here, we consider the challenges and risks associated with the cell therapy cryogenic supply chain and provide considerations for mitigation strategies.

• Evaluating The Constraints Of Long-Term Ultracold Storage

  The number of freezers for the biopharmaceutical market is countless. Some don’t fulfill requirements of Big Pharma or even small biotechs. If you seek for a comparison in the myriad of options and promises with regards to cold storage, the following will be interesting for you.

• Scheduling Aseptic Filling For Preclinical And Clinical Batches

  Flexible production scheduling from a CDMO helps sponsors control costs and timelines even when unexpected development delays occur.

• Designing Agile Manufacturing With An Integrated Drug Substance/Drug Product Ecosystem

  9/3/2021

  Companies that want to accelerate their biomanufacturing operations and use their resources efficiently need access to technologies and solutions that can safely and efficiently complete their workflow from idea to injection.

• Cold Chain Logistics For Cell Therapy Production – A Conversation With Celyad’s Thomas Lequertier

  8/23/2021

  Because cell therapies must be stored and shipped at very low temperatures, maintaining a therapeutic’s integrity through cryopreservation has far-reaching implications for both its efficacy and long-term commercial success. Thomas Lequertier, head of the Cell Therapy Manufacturing Unit at Celyad Oncology, recently sat down with the Business of Biotech podcast to discuss how his company has approached cold chain technology for its CAR-T therapies.

• How To Achieve Scalable Freezing & Thawing Of Biopharmaceuticals

  8/17/2021

  Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios. Read how by standardizing the IFGS – icefront growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale, MidScale or LargeScale, you can fulil this requirement.

• Vendor Partnering In A Bioprocess Manufacturing And Supply Chain Ecosystem

  8/16/2021

  As novel therapies produced and stored under extreme conditions become more common, containers that were adopted decades ago are increasingly unable to meet project needs and regulatory standards. New single-layer assemblies, made with more robust materials and without the curing agents, antioxidants, plasticizers, or adhesives that represent potential contamination sources, may offer companies a safer, more efficient choice.

• How To Build A Robust Packaging Strategy For Rapid Commercialization

  8/3/2021

  Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.