Articles

81. Brochure: Drug Development 8/10/2010

    PharmaZell is your partner for custom synthesis and cGMP manufacturing of small molecule APIs and intermediates.

82. Brochure: Contract Manufacturing 8/6/2010

    Drug Substance and Advanced Intermediate development and manufacture to support clinical through commercial requirements.

83. 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

84. Comprehensive Preclinical Development Program 4/9/2010
    Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. By Aptuit, Inc.
85. 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.

86. 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.
87. Case Study: Controlled Drug Handling 4/9/2010
    A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. Aptuit’s client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator. By Aptuit, Inc.
88. 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
89. Case Study: Pharmacokinetics - Client Wins With Unique Camargo Methodology 6/27/2006
    Demonstrate equivalency of clinical and commercial batches of the same drug
90. Article: The 505(b)(2) Alternative - An NDA that Saves Time and Money 6/27/2006
    Time is money – a fact well understood by those in the pharmaceutical industry, where developing a new product can take almost a decade and cost hundreds of millions of dollars...