Production Featured Articles

41. Quantifying Latency In Batch Processing Using Seeq 5/27/2021

    In batch processing operations, the combination of numerous concurrent and independent steps can lead to bottlenecks, causing the process to pause and wait for a downstream operation to finish before the preceding steps can move forward. This introduces latent time to the cycle and lengthens the time required to complete each batch.

42. Pandemic Demand Forces Rapidly Increased Production And Expertise 5/19/2021

    Solis BioDyne, one of the leading reagent suppliers in Europe, manufactures a ribonuclease inhibitor used in COVID-19 diagnostic tests. Previously manufactured at bench scale, the company now needed to quickly increase production 50-fold to meet demand.

43. Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing 5/19/2021

    As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. 

44. Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs 5/14/2021

    Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop. 

45. Quality-by-Design Approach To Enable High-Dose Drug Delivery With Autoinjectors 5/12/2021

    Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.

46. Implementing Small-Scale Models For Biopharmaceutical Development 5/12/2021

    Small-scale models (SSMs) are widely used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article from a BioPhorum Development Group discusses the applications of the models, including viral clearance, quality oversight, and design considerations for justification of SSMs.

47. What You Need To Know About Manufacturing OTC Products 5/4/2021

    As more medications move to OTC status, people are interested in playing a more active role in managing their health and controlling their healthcare choices. However, self-medication comes with risks.

48. Scale-Up: The Next Mountain To Climb In Technology Transfers 5/4/2021

    Turning a promising drug candidate into a successful pharmaceutical product involves scaling-up the processes so a commercial supply can be achieved, which involves technical hurdles.

49. What Is The Best Way To Scale-up The Manufacturing Process For My Pharmaceutical Product? 5/4/2021

    With the bright promise of ramping sales and distribution comes the immediate challenge of identifying the most optimal manufacturing strategy to maximize your product’s market acceptance. Take a closer look at the most important parameters to consider for a successful scale-up.

50. How A CDMO Can Increase The Competitiveness Of Your Product 5/4/2021

    Simple manufacturing outsourcing services no longer meet financial and environmental protection requirements. High-tech, value-added process development and industrial application represent the future development trend of the pharmaceutical outsourcing industry.