ARTICLES BY BARBARA BERGLUND

  • What To Do When Your CDMO Receives A Warning Letter
    What To Do When Your CDMO Receives A Warning Letter

    You have just completed a full technical transfer to a CDMO for your commercial drug product. This has been a two-year program and you are gearing up to launch the opening campaign. Then, the regulatory team from the CDMO alerts you that it has been issued a warning letter by the FDA.

  • Critical Considerations In Outsourcing Nanotechnology Drugs
    Critical Considerations In Outsourcing Nanotechnology Drugs

    If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”

  • How To Choose The Right Contract Laboratory For Your Drug Product
    How To Choose The Right Contract Laboratory For Your Drug Product

    Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.

  • Tips For Choosing The Right CMO For Your New Nanotech Drug Delivery System
    Tips For Choosing The Right CMO For Your New Nanotech Drug Delivery System

    It is difficult to be the pioneer seeking a partner who wants the opportunity to be on the cutting edge of new technology — and to participate in the future of medicinal chemistry.

  • What To Do When Your CMO Overpromises And Under-Delivers
    What To Do When Your CMO Overpromises And Under-Delivers

    At some point, you may face the looming reality that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO to report back to your own organization.

  • What To Do When Your CMO Has To Transfer Your Product To A New Facility
    What To Do When Your CMO Has To Transfer Your Product To A New Facility

    You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change.

Barbara  Berglund

Barbara Berglund

Barbara Berglund is COO of CMC Turnkey Solutions, where she applies over 20 years of experience in finished pharmaceutical, API, and medical device manufacturing. In particular, she has direct experience with quality assurance and manufacturing of commercial and clinical trial sterile liquid and lyophilized parenterals, microencapsulated products, intravitreal products, suspensions, and solid dosage forms. She has held strategic leadership positions in quality assurance, quality control, sterile manufacturing, and project management and has a particular interest in technical transfers both of processes and analytical procedures. Berglund has an undergraduate degree in chemistry and postgraduate degrees in chemistry and pharmacological and physiological science. She received her PMI PMP (Project Management Institute Project Management Professional) certification in 2007 and her ASQ CQA (American Society for Quality Certified Quality Auditor) and ASQ CMQ/OE (Certified Manager of Quality/Organizational Excellence) certifications in 2015.