Outsourced Pharma App Notes & Case Studies

51. Has The Age Of Antisense Oligonucleotides Finally Arrived? 7/16/2021

    The case for antisense oligonucleotides is stronger than ever before because of recent advances in understanding the genetic basis of human diseases and predictable potential to correct faulty protein expression by non-conventional means.

52. A Simple, Three-Step Approach To Optimize The Fed-Batch Process For mAb Production 6/2/2021

    We describe a straightforward way to achieve high-performing fed-batch process for a knockout cell line. This workflow improved titers 500% compared with CHO cell culture in basal medium.

53. Outsourcing Success Requires Constant Evolution 4/14/2020

    Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and market research data can help biopharma companies make more informed CMO selection decisions.

54. How To Achieve Precise And Flexible Dosing With Multiparticulates 6/22/2021

    For orally delivered medicines, developers often must balance a drug’s “curb appeal” — its specific delivery mechanism, taste, ease of administration, and convenience — with safety and efficacy.

55. Upstream Platform For Continuous Lentiviral Vector Production 12/1/2020

    Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

56. Shaping The Future Of Biopharma Through Next-Generation Contract Drug Manufacturing 4/14/2021

    With the biopharmaceutical industry undergoing significant transformation, it is essential that CDMOs evolve to meet the intricate, dynamic needs of their clients.

57. 6 Reasons You Don’t Use Pharmaceutical Market Research 2/28/2020

    If you're using one of these six excuses for ignoring pharma market research, you're failing to understand barriers to success, missing the market’s perspective, and leaving assumptions unvalidated.

58. Delivering Clinical Trial Medications Direct-To-Patient 10/15/2020

    In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.

59. Keys To Successful Risk Management In Clinical Trials 1/5/2021

    Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

60. Outsourcing Drivers For Small Molecule Manufacturing 7/6/2021

    ISR’s recent survey of small molecule outsourcers found that the majority of respondents outsource for one of two reasons: for all of their manufacturing needs, or to augment their internal manufacturing capacity.