The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward.
Analyses of the biopharmaceutical industry predict that the market for vaccines could grow at a compound annual growth rate of as much as 10.3% between 2013 and 2024. The vaccine industry requires new tools to help bring its pipeline of new products to the market quickly, safely, and economically. Read how Sartorius Stedim Biotech (SSB) is exploring the best ways of implementing single-use platforms for next-generation vaccines that avoid reinventing the wheel for each candidate, thereby reducing time to market, lowering production costs, lowering risks, and increasing flexibility.
To meet global demand, it is predicted that next generation vaccines will be based on recombinant approaches and be produced in intensified single-use systems (SUS) to increase capacity at reduced costs. However, despite their benefits, SUS for vaccine manufacturing face a number of key regulatory challenges, which require greater reliance by the biopharmaceutical industry on SUS suppliers. This article details how Sartorius Stedim Biotech (SSB) is leveraging its quality strategy to address these issues by partnering with polymer and film suppliers to combine material science, film extrusion and bag making expertise, allowing in-depth characterization and process control of extractables/leachables substances and particles profiles of its SUS.
The biopharmaceutical industry is beginning to take the necessary measures to improve the efficiency of monoclonal antibodies. Learn more about how the adoption of single-use technologies is a key strategy for delivering higher productivity and enabling more flexible manufacturing processes.
Global supply chains are often underutilized assets. By embracing the concept of variabilization- transforming fixed costs to variable costs, biotech companies can significantly leverage their supply chain, thereby freeing up valuable resources for new product launches or other priority initiatives. Key to this strategy is finding and engaging a knowledgeable and dependable contract manufacturer. Continue reading to learn more about the advantages of a contract manufacturer and guidance on selecting the best one for your needs.
Contract drug manufacturing organizations (CDMOs) and pharmaceutical developers could realize tangible benefits by implementing a variant of blockchain termed “Distributed Ledger Technology” (DLT). DLT promises to provide better transparency within the pharmaceutical supply chain. Major challenges in executing a DLT include platform integrations, cost, governance, and accountability. To explore theoretical DLT applications, we illustrate using the drug product manufacturing fill and finish CDMO ecosystem of Argonaut Manufacturing Services.
The future of lyophilization continues to balance higher upfront costs versus long-term benefits as improvements in conventional lyophilization technology efficiency are sought. If your product uses cold chain logistics, requires user pipetting, or has a short expiration window, there are significant benefits to introducing a lyophilized version.
Outsourcing pharmaceutical manufacturing is becoming essential to remain competitive in the industry. With various competing Contract Development and Manufacturing Organizations (CDMOs) available, selecting the right CDMO partner for your business can be difficult. Here are the three key areas to consider when selecting your drug product manufacturing partner.
The BioContinuum™ Platform features Next Generation Processing technologies to obtain incremental process benefits now, with a mind to the continuous process of the future. Our unique holistic approach to Next Generation Bioprocessing allows us to realize benefits of process intensification over the entire process, not gained by focusing on one area at a time.
This brochure identifies the technologies available based on the biomanufacturer need. See solutions for upstream productivity enhancements, high concentration formulations, harvest and buffer management solutions, and technologies to enable robust impurity and virus clearance.
Pellicon® single-pass tangential flow filtration (single-pass TFF) is a versatile technology for more productive, high capacity and cost effective downstream processes that allows facilities to meet the demands of higher titer and connected or continuous processes.
When it comes to outsourcing focused on commercial success, you need a CMO that has been there many times through deep scientific expertise and world-class manufacturing capabilities.
Since manufacturing processes can vary widely, it takes an experienced, technologically exceptional partner to anticipate potential needs of manufacturers and to offer flexible options, especially for companies who are looking to outsource. To address these requirements, Thermo Fisher Scientific has developed a broad portfolio of bioprocessing liquids and containers, both standard and customized, to provide a high level of quality for your workflows.