Bioprocessing White Papers

  1. When Powders Fail To Flow

    There are many traditional measurement methods for characterizing the “flowability” of powders: angle of repose, flow cup, tap test. Practitioners know that the information may not be useful some of the time, but experience helps to separate the meaningful test results from those that may be suspect.

  2. Superior Ointments: What's The Strategy?

    Customer perception of what constitutes a good medical ointment is based on the results produced. First impression, however, comes when the product is applied to the skin by the customer.

  3. Expediting Companion Diagnostic Development Through Collaboration

    August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.

  4. Be In Control Of Product Quality – Do Not Just Rely, But Understand

    Maik W. Jornitz, President, G-CON Manufacturing LLC

    Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC

  5. Solid Dosage: Stacking Sacks Of Powder For Processing

    By Robert G. McGregor, General Manager, Brookfield Engineering

    Many powders and granular materials spend time in static storage prior to processing. They may be kept in bags, sacks, or special containers in a warehouse near the plant. Unfortunately, some powders will gain significant strength over time due to the pressure caused by the stacked sacks of material, leading to a product that will not discharge from the sacks when required.

  6. Applications For Circulating Tumor Cells To Support Clinical Trials In Asia

    Advances in our understanding of cancer have accelerated the development of new diagnostics over the past decade. Now, when assessing the efficacy of an experimental drug, clinical trial teams can supplement traditional markers from tissue biopsies with assessments on circulating tumor cells (CTC). The rollout of such tests has, to date, largely been limited to Western markets, but this is changing. By Ken Pennline, Ph.D., Vice President and, Global Head, Cytometry Services, LabCorp Clinical Trials

  7. On Target With Antibody Drug Conjugates

    Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises

  8. The Benefits Of A Cloud-Based, Real-Time, M2M-Enabled Cold Chain

    This white paper describes cold chain logistics and examines the challenges encountered by globalization and a highly complex regulatory environment. It surveys existing solutions in the pharmaceuticals industry as well as innovative, scalable solutions enabled by a cloud-based service enablement platform.

  9. Four Things To Know About Generic Pharmaceuticals & Freeze Drying

    Lyophilization is a useful tool in the manufacturing of prescription drugs, both generic and name brand. The article "Freeze Drying Generics: Cost Advantages and Considerations" covers the pros and cons of lyophilization in the pharmaceutical sector, but doesn’t offer advice on how to optimize the lyophilization process. The additional information below this excerpt gives context to the author's comments. By Jenny Sprung, Labconco Product Manager

  10. Are You Planning To Fail?

    The problem with managing demand and supply variability in the supply chain stems from the inability of traditional planning systems to solve the bullwhip effect, a problem demonstrated by Prof. By Narayan Laksham and Richard Sherman