Downstream Processing White Papers and Case Studies

1. Avoiding Drug Shortages With Microbial Detection 3/6/2013

   Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant

2. Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers 5/25/2012

   Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager

3. Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 7/11/2011
   Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
4. Agilent Microarray Grant Application Support White Paper 1/25/2012
   This guide offers an overview of Agilent’s microarray and SureSelect product offerings with ordering details to assist researchers with the details of grant submission.
5. Biomanufacturing Supply Chains 12/22/2011

   This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.

6. Accelerating Biopharmaceutical Development From DNA To Drug 7/8/2016

   In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.

7. Quality By Design In Biomanufacturing 12/22/2011

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

8. Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes

   Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.

9. Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks 8/16/2012

   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.
    

10. Metal Removal From Fine Chemical Products

    Metal contamination in various injectable or even oral medicines is a serious concern.