Application Notes & Case Studies

  1. What Cleanroom Build Method Is Best For You?

    Your future cleanroom is a critical asset, it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

  2. Custom Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations

    A GMP manufacturing suite was developed from its inception by AES, which included a custom-designed and constructed Clinical Manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

  3. Purposeful Design And Development Of A Next-Generation Single-Use Bioprocess Film

    Fortem film development is an important investment by GE Healthcare, as it helps meet the industry need for a fully characterized platform film across all bioprocessing applications with supply chain transparency as a focal point. 

  4. Meeting Milestones—And Patient Needs—Through Expedited Delivery Of Phase I Materials

    To quickly deliver their product to patients in need, Reneo Pharma teamed up with Thermo Fisher Scientific to take advantage of its Quick to Clinic for Oral Solid Dose program.

  5. Manufacturer Finds Solution For Transporting HPAPI Product with Containment

    A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving Highly Potent Active Pharmaceutical Ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. read how Flow Sciences used a recently developed containment device and augmented to fit the specific needs of the client.

  6. Precise Control Of Gas Flows Within The BIOSTAT® B-DCU

    To meet the oxygen demand of cells a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT® B-DCU bioreactor system. Several comparative cell cultivations were performed.

  7. Automated Glucose Control

    Within this application is an example method on how to establish glucose feed control is documented and as well as highlighting the key benefits of applying this method to other processes.

  8. UniVessel® Single Use Bioreactor For CHO Fed-Batch Cultures

    The motivation for utilizing single use (SU) bioreactors is the reduced turn-around time and labor required for cleaning and autoclaving traditional glass vessels as well as the associated costs for maintenance and repair.  Sartorius’ 2L UniVessel® SU has an option for an external water jacket system controlled by Sartorius’ BIOSTAT® controllers. In this study, we determined the feasibility of the UniVessel® SU and BIOSTAT® B-DCU II combination by performing detailed comparability studies of cell growth, viability, monoclonal antibody (mAb) productivity and product quality attributes (aggregation, charge variation and glycosylation) using three recombinant CHO cell lines.

  9. Closed And Semi-Automated Processing Of CAR T Cells

    Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

  10. Solid Dose Manufacturer Installs Serialization Efforts For Compliance

    Artesan Pharma demonstrates how an effective program of serialization, i.e. the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.