BIO From The Editor and Guest Columns

  1. Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards 5/13/2020

    To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

  2. The Real Threat To Biopharma Supply Chains: Bioprocessing Materials 5/12/2020

    The COVID-19 induced risk to biopharma is not a shortage of pharmaceutical ingredients. It’s the constricting supply of consumable materials and equipment necessary to produce therapies from them. Mike Piccarreta, Partner at Kearney, offers an outlook and practical advice on supply stabilization in this BioProcess Online exclusive. 

  3. Data Integrity In A Cloud-Based World: Regulations & Best Practices 5/11/2020

    There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.

  4. 2 Things Every Emerging Biopharma Needs To Know About Supply Chain 5/8/2020

    For clinicians on the front lines with potential effective therapies who are exploring how to develop new drug products, as well as development-stage companies looking to manage clinical supply chains and transform their organization for product launch, a basic framework is needed in order to integrate supply chain operation into a business strategy.

  5. How Military Thinking Can Improve Pharma Decision Making Under Stressful Conditions 5/8/2020

    As a result of the COVID-19 pandemic, many companies are struggling to make both the decisions they would on any other day as well as those that are required in the current environment. This article explores what military decision-making practices can teach us about how to reach appropriate conclusions during the pandemic or other stressful conditions.

  6. Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219 5/6/2020

    This article discusses some of the history that began the movement from compliance-based approaches to cleaning validation to the science- and risk-based approaches introduced in the American Society for Testing and Materials (ASTM) E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation and the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs).

  7. ILC Therapeutics’ Interferon Alpha 14 Joins The COVID-19 Fight 5/5/2020

    The Glasgow-based emerging biopharma recently tapped veteran biotech leader Alan Walker as CEO as it moves ahead with two therapeutic candidates, an rIFN alpha14 focused on early-stage COVID-19 infection and a tick-derived Evasin targeting late-stage COVID-19 ARDS patients.

  8. How Will COVID-19 Impact Biosimilar Trends In The Top 5 European Markets? 5/5/2020

    It is undeniable that COVID-19 will have a significant impact on biosimilar uptake, particularly in European markets in which governments cover citizens' pharmaceutical needs and where the crisis will lead to an important reduction of available resources. However, it is difficult to assess the extent to which this will occur.

  9. The Missing Links For A Strong Quality Culture: Skill Definition & Assessment 5/4/2020

    To build and sustain a strong quality culture, the organization must understand the critical skills needed to assure all employees can act in the patient’s best interest when making decisions on product quality and usability. 

  10. Should You List All Manufacturing Facilities In Your Drug Substance Application? Understanding The Supply Chain 5/1/2020

    In Part 1 of this two-part article, we will review the significance of listing facilities in a drug application — namely, how it connects the dots in the supply chain from a raw material manufacturer to the distributor, manufacturer, packager, wholesaler, pharmacy, and finally, the patient, helping to effectively manage supply chain integrity.