Q: Are single-use biopharma processes the “silver bullet” to overcome cost, capacity, and investment issues?
Probably not, but they create a tremendous opportunity. The flexibility and containment options of single-use equipment or unit operations offer production capacity advantages due to process volume variability and multiple product processing opportunities. Setup times, which can take up to 8 hours for conventional stainless steel systems, are reduced to minutes. Single-use process equipment does not require high initial investment capital, and running costs are greatly reduced as single-use systems come presterilized and do not need cleaning, (i.e. copious amounts of WFI [water for injection]). So, single-use processes sound like the “silver bullet,” but one has to be aware there are limitations, such as higher volume ranges and mechanical stability. The balance of a future bioprocess will probably be a hybrid of single-use and reusable process steps, all in accordance with the needs of the development stage, application, and/or individual process steps. To summarize, opportunity yes, but “silver bullet” would be overenthusiastic.
Jornitz is the founder of BioProcess Resources LLC. He has nearly 25 years of experience in the biopharm industry, focusing on validation, optimization, and training in aseptic processing, including process surveys.
Q: What are the most vulnerable areas of the pharma supply chain, and how can I fix them?
The weak link in the pharmaceutical supply chain is education. For as much progress that has been made in recent years to educate the front end of the downstream pharmaceutical supply chain, there is still a considerable gap and lack of knowledge at the pharmacy level and “last mile” of distribution, particularly when it comes to the proper storage and distribution of time- and temperature-sensitive drugs. While everyone in the supply chain has a responsibility to the drug, it is the drug applicant or license holder (generally the manufacturer) who bears ultimate responsibility for delegating these requirements. It is therefore incumbent upon and necessary for the manufacturer to assure it has clear understanding and documented control over the entire supply chain process through the implementation of a robust quality management system (QMS). A QMS is defined by the United States Pharmacopeia as “an outline of policies, processes, and procedures that enable the identification, measurement, control, and improvement of the distribution and storage of drug products.” A critical element of a QMS is the implementation of, and adherence to, contractual agreements or service level agreements between stakeholders in the supply chain.
O’Donnell is technical director for Tegrant Corporation, ThermoSafe Brands. He retired in 2005 from Abbott Laboratories as Principle Packaging Engineer with 26 years of packaging experience.
Q: What one change could I make to my bioprocess to get the best return on investment?
One change to maximize ROI is minimizing use of WFI. Money is spent not only for infrastructure and raw water but also for the energy to heat, purify, store, and distribute WFI throughout a facility. WFI costs between $1 and $5 per liter and is likely to be the most expensive raw material. Minimization techniques include:
l Using purified or noncompendial water for prerinse and chemical cleaning cycles, saving WFI for the final rinse only
l Recirculating hot WFI at 65° C instead of 80° C; the lower temperature saves energy and will control bacterial growth
l Determining the minimum number of volumes actually required for column steps (such as equilibration, cleaning, etc.) instead of an arbitrary number
l Determining the minimum volume of fluid needed to actually clean equipment to validated levels of cleanliness
Careful water management can lead to significant cost reduction as well as positive environmental benefits.
Prior to his current position at Bio-Rad Laboratories, Dr. Mark Snyder spent 13 years at Bayer HealthCare as associate director of process sciences in charge of the Purification Process Development Group.
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