Outsourced Pharma White Papers

51. Pediatric Dosage Forms: Reformulation And Development Expertise 1/20/2022

    Infrastructure and expertise cover the sweet spot for producing the small-to-midsize batches needed to meet industry demands for PDFs and orphan drugs, and also extend to large-scale manufacturing.

52. Demystifying Performance Testing: Strategies To Qualify Combination Products 11/30/2020

    Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article starts with applicable regulations and guidances, and then performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed.

53. End Of End Point Assays: SPR Analytics In Vaccine Design, Development 2/18/2021

    Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.

54. The Development, Scale-Up, And Manufacturing Of Semi-Solid Dosage Forms 1/20/2022

    Topical products, whether prescription dermatological drugs or over-the-counter lotions, creams, or gels, present unique challenges in terms of development and manufacturing.

55. Oral Controlled Delivery Of Poorly Water-Soluble Drugs 1/27/2022

    Various drug delivery nanotechnologies, such as nano-suspensions, lipid microemulsions, nano-emulsions, and amorphous solid dispersions, have been critical in overcoming bioavailability challenges.

56. Balancing Cost Efficiencies In The Drug Development Process 1/24/2022

    Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.

57. Perspectives On Trends In Outsourcing The Development And Manufacturing Of Biologics 3/18/2022

    Read more on trends related to outsourcing and share what attributes of an outsourcing partner that are sought by developers and manufacturers of biopharmaceuticals.

58. Facilitating 21 CFR Part 11 Compliance With Bioprocessing Automation Software 8/16/2021

    How Bio4C Orchestrator™ Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.

59. Enabling Fast, Appropriate Drug Product Supply For Phase 1 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.

60. Maximizing Batch Yields In Aseptic Manufacturing: High Value Actives 7/10/2020

    Advances in drug and biologics discovery have allowed the development of more sophisticated and highly targeted therapeutics, with active ingredients becoming increasingly costly to manufacture. Handling high-value, complex active ingredients requires a mindset that rigorously protects against unnecessary loss of active ingredient.