DOWNSTREAM PROCESSING FEATURED ARTICLES

Dr Reddy Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize Biosimilars

Dr. Reddy’s Laboratories Ltd. [NYSE:RDY] and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Mammalian Virus Purification Using Ceramic Hydroxyapatite

    Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We  propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.

  • Removal Of Host Cell Proteins During Monoclonal Antibody Purification

    Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc

  • Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks

    Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time  for column loading.
     

  • Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media

    Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

  • Quality By Design In Biomanufacturing

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  • Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers

    Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.

DOWNSTREAM PROCESSING PRODUCTS

SoftGrip pipettes routinely receive the highest user satisfaction score of 10 on 11 different aspects of a pipette, including plunger and eject forces, weight, diameter, and texture.

Cellulosic, polypropylene or glass fiber depth filter media clarify or retain agglomerates and macromolecules. Protect downstream membrane filters and columns. Multiple inlet / outlet connections including sanitary tri-clamp, hose barbs, quick connectors, elbows or NPT. Disc for small volume, up to full sized Cartridges and capsules for process scale operations.

ZenPure designs, mold-manufactures and injects its own filter components. Engineering, product development and filter production under ISO standards facilitate full quality audit and traceability to meet the highest industry standards. Validation support documentation is available for appropriate products.

AseptiQuik® STC Connectors integrate the AseptiQuik® sterile connector and the Steam-Thru® II SIP connector, giving manufacturers even greater flexibility for hybrid stainless steel and single-use processing. 

Polyethylene (PE) and PTFE hydrophobic membranes for economical air / gas and vent filtration. Virus, bacteria and spore retentive. PE is gamma stable and will substitute PVDF. Retention ratings from 0.01um in gas applications or 0.1um in liquid applications, to 10um.

PES, Nylon or Cellulose Acetate hydrophilic membranes provide performance improvements over other membrane types like PVDF. Microbially retentive micron ratings from 0.04um, 0.1um and 0.2um to prefilter ratings 0.45um, 0.65um and up to 1.2um.

ZenPure designs, mold-manufactures and injects its own filter components. Engineering, product development and filter production under ISO standards facilitate full quality audit and traceability to meet the highest industry standards. Validation support documentation is available for appropriate products.

Our integrated single-use bioreactors are designed as complete out-of-the-box jacketed systems, each paired with an integrated controller and temperature control unit (TCU).

Macro-Prep hydrophobic interaction chromatography (HIC) media are methacrylate-based, 50 µm beads used for protein, polypeptide, enzyme, and nucleic acid purification.

Natrix HD Membranes offer a breakthrough in membrane architecture that will forever change downstream purification. Available in two chemistries: Q (strong anion exchange) and Sb (strong cation exchange and hydrophobic group).

The Pyros Kinetix® Flex is an optical tube reader that runs both chromogenic and turbidimetric assays in compliance with the USP, EP, and JP bacterial endotoxin test chapters.

DOWNSTREAM PROCESSING MULTIMEDIA

Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.

Beckman Coulter's Randall Lockner, marketing manager for centrifugation, explains the highlights of the floor model ultracentrifuge, the Optima X Series.

Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.

DOWNSTREAM PROCESSING INDUSTRY NEWS