July 2010

Formulation and Fill for a Vaccine with Alum Adjuvant

          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…

Sustainability and Corporate Responsibility

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…

New Bioprocessing Standards from Molecule to Market

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®…

Novozymes Biopharma

          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…

Lancaster Labs Develops Extractables Database for LC/MS Analysis

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 Major Leap Forward in Viral Clearance Technology

  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…

Mobius® CellReady Single-Use 3-L Bioreactor

The Mobius Cellready 3-L bioreactor is a single-use, stirred-tank bioreactor ideal for bench-scale cell culture of mammalian cells. The Mobius Cellready bioreactor is preassembled and gamma-irradiated to reduce set-up and cleaning times compared with glass stirred- tank reactors. It can be used right out of the box, and after a simple set-up, turn-around can be achieved in as little as a few hours. The Mobius Cellready bioreactor has the benefit of single- use technology coupled with the familiarity of bench-top…

Your Partner for High-Quality Protein Hydrolysates

FrieslandCampina Domo, a division of the Ingredients Business Group of Royal FrieslandCampina BV, is one of the operating companies formed as a result of the merger between Friesland Foods and Campina in January 2009 to form Royal FrieslandCampina. Royal FrieslandCampina is a leading global multinational company, with 22,000 employees and revenues of over 9 billion Euros. Formerly Known As DMV International The operating company FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods…

Biological Manufacturing

RecipharmCobra Biologics is the specialist biologics division of the Recipharm AB group, one of the leading contract development and manufacturing organisations in Europe. We provide a comprehensive range of services, from early-stage development to the supply of GMP material for Phase I, II, and III clinical trials. We are with you every step of the way. The Market Is Growing — So Are We We have provided contract development and manufacturing services to customers worldwide for more than a decade,…

Demonstrating Millipore Express® SHR Filters Mycoplasma Clearance Capability

          Mycoplasma is known to be a common source of bioprocessing contamination and one of the most difficult contaminants to detect. The effect of a mycoplasma contamination can be catastrophic, resulting in loss of a batch, loss of future production, down-time for investigation and corrective actions, and the potential risk of therapeutic supply shortages to immunocompromised patients. To demonstrate Millipore Express SHR filters’ mycoplasma clearance capability over extended filtration times, two separate Acholeplasma laidlawii retention studies…