Biologics manufacturers are challenged today with reducing variability and costs, as well as speeding time to market by collaborating across growing manufacturing networks with external and internal partners spread across the globe. As they strive to develop and improve process performance and quality to meet business, regulatory and patient needs, effective utilization of their process and quality data is critical to success. The Biologics Made Right First Time Industry Process Exerience enables understanding of critical bioprocess drivers, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability and maximize profitability and shorten time to market.
BIOVIA Laboratory Information Management System is purpose-built to manage 21st-century product and process informatics requirements with a specific focus on scale-up, manufacturing and compliance that eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy BIOVIA LIMS. The result is streamlined deployment, substantially lower total cost of ownership and rapid time to value.
As your premier service provider, Althea’s ADC service offerings will simplify your supply chain by consolidating high containment conjugation, formulation, fill finish and release and stability testing at the same facility.
Althea delivers high quality sterile contract manufacturing and thorough inspection systems that are customized to your manufacturing needs. We offer a broad range of sterile dosage forms, including prefilled syringes, liquid vials, and lyophilized vials.
Althea’s focused expertise and capabilities in current Good Manufacturing Practices (cGMP) production of microbial-based biotherapeutics make us one of the industry’s leaders in microbial fermentation. We offer a broad range of microbial-based cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Althea is a recognized leader in plasmid DNA manufacturing for vaccines and gene therapy products. Althea has demonstrated experience in developing and manufacturing nearly 300 cGMP lots of bulk drug substance and has an impeccable regulatory track record. Our comprehensive, validated equipment has been utilized to fulfill numerous drug substance projects for preclinical and clinical supply. For additional information about Althea’s drug substance manufacturing services including contract cGMP microbial fermentation and biologics manufacturing, please contact us.
Althea’s complete range of drug Process Development capabilities offers the tools to address your needs. We develop processes for producing small quantities of proteins for early testing or establish robust, reliable and scalable processes that enable a strong commercial advantage. Althea also provides access to a proprietary drug delivery platform, called Crystalomics® technology, for the development of alternative drug delivery formulations of second generation drug substances.
Thermo Scientific CX5-14 film is engineered to meet the most demanding requirements of your bioproduction processes.
The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency.
In March 2014, GE Healthcare Life Sciences announced the completion of the acquisition of the HyClone cell culture media business from Thermo Fisher Scientific. The addition of the HyClone portfolio significantly broadens our existing capabilities in life sciences research and bioprocessing. The result is a comprehensive portfolio of products and services across the whole biomanufacturing workflow, from upstream to downstream, from discovery to commercialization.
Nice Insight offers products and services focused on a variety of marketing intelligence needs. Whether you need a macro understanding of the contract manufacturing industry, or a micro understanding of particular providers and capabilities, Nice Insight can help with your market research needs.
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