Industry Insights

  1. Data Integrity & Your Contract Manufacturer — Common Pitfalls To Avoid 11/3/2017

    This two-part article will address how sponsors can effectively ensure confidence in data integrity at their contract development and manufacturing organizations (CDMOs) and have confidence in the information upon which they base lot release decisions.

  2. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

     

  3. Emerging Biopharma: Your Next 2 Geographic Markets To Tackle After The US 7/7/2021

    While the majority of the world’s drug development and innovation are underwritten by the United States, emerging drug developers should not overlook these two major regions of the world that represent volume, profit, ingenuity, and growth. 

  4. Fluid Management Equipment Market Poised For Growth In Europe 12/7/2020

    In the gynecology market, as the use of hysteroscopes and other less invasive methods increases, more procedures will require the use of fluid management equipment. Notably, there has been significant growth in the sales of both capital equipment and tubing for fluid management during hysteroscopic procedures. This article discusses the current and future fluid management market in Europe.

  5. Can The Cloud Prevent Collaboration Failure In Biopharma? 5/20/2016

    Working in a cloud-based information management and collaboration workspace provides a level of business agility and security that is not available with server-based, on-premises infrastructure.

  6. Handling & Processing Of Potent Compounds: A Holistic Approach 5/5/2017

    The topic of potent compounds may seem obscure; however, it touches virtually every aspect of the biopharmaceutical business, from selection pressure in media to antibody-drug conjugates (ADCs). Every chemical and biological compound we work with has an MSDS (material safety data sheet) and an OEL (occupational exposure limit), which dictate how we must handle the compound and bring to the forefront issues of personnel safety and environmental impact that we must address in our manufacturing plants. When designing a process involving any potent compound, there are three aspects we must address directly: facilities, processing equipment, and people.

  7. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

    Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.

  8. Supporting AAV And Lentiviral Vector Development And Commercialization 1/12/2021

    Plasmids are essential for the development of viral vectors used to manufacture novel gene therapies and viral vaccines. We are supporting the innovation of drug developers in this space by providing standardized royalty-free, bulk AAV helper and lentiviral packaging plasmids for research and GMP production.

  9. Emerging Technologies In The Delivery Of Proteins & Peptides 6/28/2021

    The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.

  10. ISO 10993-23: The “Step-Wise” Approach To Evaluate Potential Irritants In Medical Devices Becomes Effective 5/12/2021

    The new ISO 10993-21:2021 specifies the procedure for the assessment of the biological irritating potential of medical devices, materials, or their extracts. It is relevant to all directly or indirectly contacting medical devices regardless of the nature and duration of body contact.