Articles

41. Aptuit Blister Packaging Case Study 4/28/2011
    A client, in need of global blister packaging, had received an exorbitant estimate from a Clinical Packaging and Logistics provider other than Aptuit.
42. Mastering The Extended Clinical Supply Chain Whitepaper: Strategic Advantages For Clinical Trials 4/28/2011

    The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies.

43. Maximizing The Success Of Your CRO Partnerships Whitepaper 4/28/2011

    It’s certainly true that pharmaceutical companies are under intense pressure to replenish pipelines and reverse a trend in which R&D returns are falling below the costs of capital.

44. How Can I Avoid Mycoplasma Contamination And Other Serious Cell Culture Problems? 5/26/2010

    Cell culture research and engineering have greatly impacted human health, ranging from vaccine manufacturing to stem cell therapies, cell-based assays and cancer immunotherapeutic products. Critical to the success of these applications is the quality of the cultures used. The following article offers suggestions on management and protection of your cultures. By Bionique

45. Case Study: Product Development Of An Inhaled Protein 4/9/2010

    A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.

46. Product Development Of An Inhaled Protein 4/9/2010
    A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.
47. Poster: CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
48. Case Study: Pharmacokinetics - Client Wins With Unique Camargo Methodology 6/27/2006
    Demonstrate equivalency of clinical and commercial batches of the same drug