Outsourced Pharma White Papers

31. Precision Microdosing Accelerates Drug Development 8/16/2021

    Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

32. Sophisticated Formulation Approaches For Insoluble Drug Candidates 1/24/2022

    A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

33. Address Biopharma's Evolving Information, Automation Needs 10/26/2020

    A dramatic increase in the information available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharma manufacturers operate. 

34. Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development 1/26/2022

    The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.

35. A Multifaceted Strategy For Viral Safety In AAV Processes 3/10/2022

    Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.

36. Digital Transformation In Regulatory: Achieving Excellence Virtually 1/24/2022

    As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

37. 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.

38. FDA Designations for Rare Disease Products: A Complete Guide 8/27/2021

    This paper highlights the designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Explore the criteria, timeline and maintenance, and benefits of each designation.

39. It Hasn’t Been Easy For Pharma To Be Green 10/2/2020

    Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.

40. Quality By Design And Design Control Roadmap For Combination Products 11/30/2020

    Quality by design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability.