Bioprocessing White Papers

41. Why Biopharma Lifecycle Management? 12/4/2020

    The biopharma industry has ambitions to accelerate industry 4.0.This white paper explores the major bottlenecks in the development lifecycle and the current barriers to effective digital transformation.

42. Using Single-Use Connectors To Increase The Integrity Of Closed Systems 12/3/2020

    It is critical the single-use sterile connectors you select meet the sterility and reliability needs of your application, as minimizing the threat of contamination using a closed system is essential.

43. Getting Your Investigational Drug Regulatory Ready 12/1/2020

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

44. Strengthening Our Supply Chain During Extraordinary Times 11/19/2020

    This white paper provides an overview of the short-, mid- and long-term strategies we have developed, implemented, and continue to advance in response to the pandemic. Learn more!

45. Have Confidence In Your Bio/Pharma Data 11/17/2020

    The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.

46. How Can Outsourcing Buffer Preparation Help Meet The Urgent Need For A SARS-CoV-2 Vaccine? 11/16/2020

    As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale. In this planning, the preparation of process liquids and buffers should be considered.

47. Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors 11/10/2020

    Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.

48. Biopharma Tech Transfer: Facility Fit And Process Gap Assessments 11/3/2020

    Biopharma tech transfer, critical to successful development, manufacturing, and commercialization, requires careful planning and evaluation to meet scale up and GMP timelines.

49. Enabling Fast, Appropriate Drug Product Supply For Phase 1 Clinical Trials 10/30/2020

    Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

50. Product Development For An Oral Solid Dosage Using Continuous Manufacturing 10/30/2020

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.