Industry Insights

  1. Anticipating The Formulation Challenges Of Complex Molecules
    6/7/2016

    If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drug products, developers may have to go back and change their API production processes. In the worst cases, Phase 1 and Phase 2 trials may have to be redone. And due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.

  2. How Global Pharma Orgs Can Achieve Process Validation Success
    2/10/2017

    The pharmaceutical market has transformed into a global industry within the span of just a few decades. Many companies have sites across the globe, presenting challenges when it comes to harmonizing process validation approaches among sites. There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary to achieve success.

  3. Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    5/30/2015

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  4. 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets
    5/4/2016

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

  5. Top Five Tips For Chromatography Sample Preparation
    1/21/2017

    Chromatography comprises a group of molecular separation techniques commonly used in proteomics to isolate proteins of interest from heterogeneous samples. Despite the fact that these methods are purification strategies in their own right, it would be ill advised to introduce crude sample to your chromatography setup from the outset. The vast majority of samples encountered require some form of processing before they can be placed on the analytical instrument.

  6. The Multivariate World Is Expanding For Research And Industrial Data Analysis
    12/9/2016

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  7. How Big Data Is Transforming Pharmaceutical Manufacturing
    8/12/2016

    Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

  8. Integrating Quality Control Tools Into Print Workflow Automation Solutions
    6/6/2016

    For print professionals, the complexities of labeling and packaging can present numerous challenges. Ask any member of a prepress department and they will tell you that artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

  9. Useful Tips For Fab Protein Purification
    1/21/2017

    While protein purification is a well-established, conventional and highly trusted discipline, the approaches it employs can be as diverse as its targets. This makes a lot of sense as proteins come in many different sizes, structures and possess unique binding affinities and biological activities. As such, it’s not surprising that specific proteins require purification strategies tailored to their own unique physico-chemical properties.

  10. Evolution Of Biologic Pipelines Calls For Next-Generation Expression Systems
    9/14/2016

    Today’s mAb competition focuses on unmet therapeutic needs and biological mechanisms that have not yet been explored. As a result of this evolution, the purification of biologics is becoming increasingly challenging. This article discusses Lonza’s XS™ expression platform, which addresses the need for next-generation expression systems.