Insights On Drug Development

31. Quality Matters – SEC Analysis For Antibody Aggregates 10/25/2019

    Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

32. Kaleido Biosciences Successfully Meets Aggressive IND Filing Thanks To Strategic Partnership 10/8/2019

    Designed specifically for new and emerging companies such as Kaleido Biosciences, The Quick to Care™ program is an integrated solution that combines drug substance and drug product development, clinical manufacturing, forecasting, demand planning and clinical trial supply execution managed by a single program manager.

33. Managing The Challenges Of Small Batch Formulations 10/3/2019

    A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.

34. Is Your Complex Formulation Process Set Up For Success? 10/1/2019

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

35. Preparing For Your CDMO Selection Process 10/1/2019

    Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Don't be unprepared from the outset of your search. 

36. Corynex Protein Expression: Simplifying Recombinant Protein Production 10/1/2019

    Adding biologics to your pipeline requires innovative approaches to drug development and cost mitigation. Simplifying the recombinant protein production and purification processes is a good place to start.

37. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

38. An End-To-End, Semi-Continuous Process For mAb Production 9/22/2019

    See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

39. Overcoming Bioavailability Challenges In Oral Formulation Development 8/27/2019

    With nearly 90% of developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must address this obstacle by applying approaches to improve an API’s pharmacokinetics. 

40. How To Adapt Your Biomanufacturing Process To Maximize Production 7/26/2019

    Today’s novel solutions and technologies can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.