Figure 1: ()   Selection of a CMO is critical to biologic drug development; and the primary selection criterion is experience. How do biotech companies measure experience? CMO experience can be measured in many ways — primary metrics include (1) total number of GMP processes developed by a CMO; (2) number of projects involving your strain; (3) number of projects involving your product type; (4) GMP production success rate; (5) total number of GMP lots produced; and (6)…

          Water is a key raw material used in manufacturing products within the healthcare, pharmaceutical, and biopharmaceutical industries. Microorganisms found in these water systems are mainly stressed, slow-growing strains characterized by long incubation times (five to seven days) before growth can be detected using traditional microbiology methods such as membrane filtration or pour plates. That time required before contamination can be detected in water can cause delays in product release and extend the storage time of…

In response to the biopharmaceutical market needs, the focus of Irvine Scientific today is to provide chemically defined and animal-derived component-free cell culture media for use in the production of recombinant proteins. Drug development companies that do not invest in the costly and complex work of media development can rely on the services of Irvine Scientific to obtain and optimize formulas for their production cell lines. As the leader in rapid turn-around time for providing specially formulated products to clients,…

          The complete characterization and analysis of biopharmaceuticals includes the application of size- exclusion chromatography (SEC) to measure protein aggregates and other size variants. Soluble protein aggregates in particular can contribute to immunogenicity. Accurate analysis and quantitation of biotherapeutic protein aggregates is therefore often required. Current HPLC/silica-based SEC methods can be time- consuming and unreliable. Their uncertain results may be due to changes in retention time, peak shape, or spacing between peaks as well as irreproducibility…

          The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to…

As the adoption of single-use products continues to grow at a very fast pace in the biopharmaceutical industry, customers and suppliers are becoming increasingly aware of the potential impact of these products on the net environmental footprint of operations. At Millipore, a key goal is to design and manufacture products with the lowest carbon and water footprints possible and to ensure that these products are managed in the most environmentally friendly way. Millipore’s sustainability vision calls for the company’s operations…

Life Technologies is at the forefront of a quest to improve the human condition. Growing numbers of biotherapeutics, revolutionary blood products, emerging biosimilars, and a vaccine industry moving toward cell culture–based production systems all promise to transform traditional disease treatment. Leveraging core expertise in cell culture, downstream purification, and rapid molecular-based contaminant testing, life technologies offers biotherapeutic and vaccine production solutions under trusted GIBCO® and Applied Biosystems® Brands. GIBCO® Media and Feeds for Upstream Cell Culture New in 2010, GIBCO®…

          With over 45 years’ experience in microbial protein expression, we deliver animal-free, recombinant biological products and technologies to forward-thinking medical device, drug formulation, and drug delivery manufacturers. Working closely together with our customers, we can provide customized biological solutions to make their products safer and more effective while getting them to market faster and hassle free.   Recombinant Human Albumin (rHA)   A range of rHAs (Recombumin®, albucult®, CellPrime™ rAlbumin AF-S) developed for industrial cell…

The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices, and components used in product manufacturing. Packaging includes components such as vials, caps, and stoppers. Drug delivery devices include nebulizers and inhalers. Components used during product manufacturing include filters, tubing, fittings, connectors, bioprocess bags, and bioreactors. Lancaster laboratories provides support by performing extractables and leachables testing. Extractables are compounds that can be extracted from a…

  A Comprehensive Solution         Innovative Viresolve Pro Family: Robust, productive, next generation Quality and Manufacturing Expertise: Over 15 years of virus filter manufacturing experience; state-of-the-art membrane plant; comprehensive validation; raising the standard of performance and integrity tests Industry-Leading Service and Support: Process development, optimization, and scale-up; leading the industry with spiking strategy and validation; services covering every stage of adoption   Building Assurance Test By Test (Figure 1)   No one does more than Millipore to…