Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll…

          In order to reduce scale-up costs and facility capital expenses, biotechnology companies are adopting single-use systems. To fully enable the single-use paradigm, automation software, hardware, and single-use sensors must be optimized; moreover, both validation documents and materials certifications must be readily available for cGMP implementations. Finesse provides turn-key, configure-to-order measurement and automation solutions for many single-use bioreactor types: “stirred-tank,” “paddle,” or “rocker” systems. The Finesse turn-key system is optimized for each bioreactor type to maximize…

          In an effort to mitigate potential risks associated with the introduction of adventitious agents from animal-derived media components, the biopharmaceutical industry has largely shifted to serum-free and/or chemically defined media in cell culture production systems. Successful serum-free media formulations have been developed using plant-derived protein hydrolysates in combination with recombinant supplements such as insulin, transferrin, and human serum albumin, produced in nonanimal systems. The performance benefit provided by any medium supplement is subject to its…

          The FDA requires a minimum of two viral clearance steps operating by different mechanisms to provide assurance of viral clearance. To be considered robust, a viral clearance step must be validated to consistently remove model viruses with at least 2 logs of clearance. When filtration is used, the objective is to obtain effective viral clearance without causing protein (product) loss. 3M Purification Inc. Zeta Plus™ VR Series filters can be used upstream in cell culture…

          Single-use systems have become all the rage in the biotechnology industry, driven largely by the need to reduce cleaning requirements and associated time, validation, and cost factors with stainless vessels. A well-developed single-use system will ensure lower risk of contamination in manufacturing while eliminating the cleaning process and cleaning validation.   Providing Solutions   Advanced Scientifics provides specific solutions to process needs in fluid transfer and handling, offering flexibility in the design and componentry of…

Biopharmaceutical companies are increasingly interested in single-use innovations to improve performance and alleviate up- and downstream bottleneck constrictions. High-priority considerations for improvement include decreasing the number of process steps, reducing the risk of cross-contamination, and achieving a higher sterility assurance level. One bottleneck today is a need to collect QC samples at various steps during biopharmaceutical commercial-scale cGMP manufacturing, which typically is a labour-intensive manual activity that holds a potential risk of contaminating product or personnel. Alfa Wassermann Separation Technologies…

Following a strong showing at this springs interphex in New York there is little wonder why ALLpaQ® has become established as an industry leader when it comes to the containment and handling of Biopharmaceutical fluids. The ALLpaQ® Cleanroom range of biotech containers was launched at interphex New York 2011. As predicted, it has since created a strong demand in Europe and is now available in the United States. Rationale Realizing that a significant proportion of the landed cost of products…

Research and early process development generally rely heavily on screening and examination of cultures grown in microtiter and shake-flasks. Unfortunately, the growth environment in these formats is extremely different from the bioreactor conditions used in larger-scale production. This application note describes two tools for improving growth conditions at these scales. Theµ-Flask: Cultures grown in traditional microplates are usually sealed using simple plastic lids or adhesive tape seals. Such systems suffer from well-to-well variability, poor gas transfer, excessive evaporation, and cross-contamination.…

Technology Innovation ATMI® is an acknowledged technology leader in the development and manufacture of single-use bioprocess systems and consumables. Its innovative disposable technologies, best-of-breed polymer films, ultraclean ISO Class 5 manufacturing conditions and whole-bag integrity testing set a high bar for the single-use industry. Today, ATMI is raising the bar even higher with the introduction of Helium integrity Testing (HIT™). Helium Integrity Testing ATMI’s patent-pending HIT technology allows each ATMI 2-D Bioprocess vessel (BPV) to be tested for defects that…

As a CMO partner, Avid Bioservices provides fully integrated services across the process chain to develop and commercialize a biologic including cell line and process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory submissions. We provide first-hand expertise and knowledge to navigate a biologic from concept to commercialization because we are a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage, publicly traded biotech company with a management team experienced in the development and commercialization of therapeutic proteins.…