Outsourced Pharma White Papers

  1. Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up 2/11/2020

    In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

  2. Bioavailability Enhancement: The Key To Unlocking The Potential Of Drug Development Pipelines 5/5/2020

    In this paper we look at the process CoreRx goes through when given an active ingredient with low bioavailability and four approaches that may be applied to increase the amount of the therapeutic that enters systemic circulation.

  3. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes 4/2/2019

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  4. Tumor-Infiltrating Lymphocytes: What, Why, And How 7/1/2020

    As we’ve begun to understand the complexities of immune mechanisms through technology, we’ve found better ways to fight disease. Here, we focus on an important player in such targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes (TILs).

  5. 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.

  6. What Clinical Teams Should Know About The Benefits Of Auto-Injectors 8/20/2019

    For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.

  7. Guidelines To Bring Your Biologic To Market: Are You Prepared? 4/16/2019

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  8. Microtableting: Going Small To Create More Targeted, Effective Therapeutics 5/5/2020

    The desire to create more targeted, effective therapeutics with fewer side effects has driven drug formulators to expand into more technically demanding areas over the past decade. Microtablets are one result of this burst of creativity and engineering expertise. Going small opens up numerous new delivery options, but also creates additional challenges for drug formulators and manufacturers.

  9. Viral Clearance: The Basics On How To Conduct Effective Studies 5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  10. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process 5/30/2019

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.