Talking with several biopharma companies over the last few weeks, I found that many are looking to invest significant dollars into their facilities, adding staff to address their expanding projects and accelerate their pipeline production to full commercialization. But some are finding ways to do much more with their current resources.
Real Dollars + Real Problems = Barriers to Market Success.
Increasing the demand for raw materials to meet new production requirements translates to additional project load to; adding inspections, controls, raw material analysis, storage and quarantine of raw materials to keep up with ever increasing chemical demands volumes. Making sure the expiration dates, lot volumes, refrigerated storage needs are properly addressed can really stretch current resources and budgets, causing manufacturing teams to miss production schedules and output goals. Hiring additional head-count in QA/QC, logistics and the build-out of storage capacity, is costly, time consuming and challenging. Additional burdens to move forward are increased by limitations from local fire codes and hazard restrictions.
The Wild West and the Production Possibility Frontier
What some West Coast pharma manufactures are turning to, are new technologies and creative supply chain solutions. If you are pushing the limits of your facility and approaching the edge of your current capacity, the next expansion could increase your risk or even end in failure to meet production goals. Some manufacturers have recognized the limits of their current resources and have applied the concept of the Production Possibility Frontier. Moving outside this boundary, to add new projects, is risky without the addition of new technologies or adding expensive new resources.
California pharma manufactures are faced with the additional problem from the distance of East Coast raw material suppliers, CA state restrictions and local regulations on hazardous materials storage, all increasing the risk of missing production goals when adding new projects. So, how are successful pharma manufacturers able to expand current capacity, without significant capital cost outlay, without the long process of adding infrastructure and the difficulty in bringing on new head-count?
The question becomes; how can we expand, do more, without adding enormous costs, delays and reduce the risks? How can I ensure that what I need, to reach my production targets, is in my facility; the right product, at the right time, right quantity, right expiration date, with the right documentation…? Rapid low cost expansion has been achieved through the deployment of technology based solutions and by leveraging their supply-chain partner’s capacity.
The Two Pronged Approach
Thermo Scientific’s TruScan™ RM Analyzer Analyzer for raw material identification and finished product inspection delivers reliable analysis in seconds, right at the point-of-need, to decrease sampling costs and increase inventory turns. The TruScan RM analyzer performs through sealed packaging to minimize contamination and exposure with enhanced compliance features for regulated environments.
Doe&Ingalls, California service center provides 43,000 square feet, ISO 9001:2008 registered and cGMP-compliant chemical storage capacity. 2 to 8ºC cold storage and frozen storage, solid wall cleanroom space, H4/H3 rated to store hazardous materials, including flammables, corrosives, poisons and oxidizers. Permitted to offer Specialty Denatured Alcohols in addition to DEA List 1 & 2 Materials, such as Iodine, γ-Butyrolactone, Monoethylamine and Piperidine. Additional special services are available to provide rapid acceptance of incoming chemical raw materials into the manufacturing site.
Together we can help you expand your capabilities and improve your economic efficiency in reaching your pharma and biopharma production goals.
Source: Michael Shelly’s LinkedIn
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