Insights On Facility Design

41. A Molecule’s Journey – Break Down Roadblocks To Commercial Success 1/4/2018

    A guide for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility.

42. Fast-Tracking A QbD Approach 12/28/2017

    QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed. 

43. G-CON Gene Therapy Facility 2017 10/25/2017

    PODs provide the environments for the entire upstream and downstream process for a state of the art gene therapy facility.

44. Turnkey Facility And Cleanroom Solutions Transform Biopharma Manufacturing 10/6/2017

    Flexible and modular facility designs that can be built in a factory, shipped to the site and then rapidly assembled have been recognized and are being addressed by innovative suppliers.

45. Expanding Single-Use Biomanufacturing Into New Locations 6/8/2017

    If you have decided to add capacity in-house, you need to consider which location enables you to meet demand. Having knowledge of the local operating environment and regulatory considerations is vital. 

46. Determining The Right Type Of Biomanufacturing Capacity 6/8/2017

    In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.

47. Designing A Biomanufacturing Facility Incorporating Single-Use Technologies 12/5/2016

    When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?

48. Biologic Manufacturing Capacity Expansion With Single-Use Technologies — Key Variables To Consider 12/5/2016

    The following presentation is based on a simulation of a 2 × 2000 L mAb process. The simulation compares a single-use process train (SU) with a comparable stainless steel-based process train (SS), both modelled in a traditional, stick-built facility. Are you interested in a simulation of your biomanufacturing process? With our range of simulation tools, we can assist in this, whether it is for scale up/down, “de-bottlenecking”, process intensification, transition from stainless to single use, or general optimization.

49. Don't Be A Daredevil When Retrofitting Your Facility 5/18/2016

    With mergers/acquisitions and cost-cutting initiatives, facilities are being shut down and product lines consolidated into existing facilities—risking sub-optimal layout and design.

50. Modular, Flexible, Or Both? Keys To Biomanufacturing Facility Design 3/10/2016

    In addition to traditional brick-and-mortar facilities, there are a range of alternative facility designs, including modular container, modular stick-built, isolator, and autonomous cleanroom POD designs