May/ June 2021

Volume 24, Issue 4




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Articles in this Issue

  • Message from the Editor: What's Next?

    In 1971 the Who released the album Who’s Next. The album was an immediate success and has been mentioned by many music critics as their best album and one of the greatest albums of all time. Songs from the album include such classic hits as Baba O’Riley, Bargain, Going Mobile, Behind Blue Eyes, and Won’t Get Fooled Again.
  • Drug Development in Oncology in the Era of Precision Medicine

    Cancer research is complex: trials require specific design expertise and often include biomarker and companion diagnostics, and failure rates tend to be higher than for drugs tested in other therapeutic areas. To mitigate risks associated with these complex studies, the right choice of endpoints, adequate definition of selection criteria, sensible use of safety and efficacy assessments, and state-of-the-art statistical planning, analysis and modelling tailored to oncology is vital.
  • Vaccines and Therapeutics for COVID-19 – How Can Understanding SARS-CoV-2 Glycosylation Lead...

    The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 160 million people worldwide. Researchers have targeted the SARS-CoV-2 structural proteins to better combat the pandemic. Of the four structural proteins, spike (S), membrane (M), envelope (E) and nucleocapsid (N), the S, M and E proteins are glycosylated whereas the N protein is phosphorylated.
  • Process Analytical Technology as a Tool to Optimize and Accelerate Pharmaceutical Process Development

    Over the last decades Process Analytical Technology (PAT) has been widely used in pharmaceutical development to support process understanding and optimization. Among the different technologies, Near Infrared Spectroscopy (NIRS) has maintained its status as a most versatile and valuable PAT tool for probing the manufacturing of solid dosage forms.
  • The Use of In-House Microbial Isolates in Media Growth Promotion Testing: Challenges and Solutions

    For nearly four decades, the U.S. Food and Drug Administration’s (FDA) expectation has been that pharmaceutical Quality Control (QC) microbiology laboratories include in their media growth promotion testing (GPT) not only type culture (compendial) microorganisms, but also those microorganisms isolated from the firm’s manufacturing facility.
  • An Interview with Marcus Curl - Director of Product Applications - InVitria

    InVitria provides an alternative to serum and serum-proteins in the production and formulation of therapeutics. We specialize in creating completely blood-free raw materials for research and manufacturing for gene therapy, cell therapy, diagnostics, medical devices, and vaccine production.
  • QC Corner: How the 2020 draft EU GMP Annex 1 changes will affect sterile pharmaceuticals manufacturing...

    EU GMP Annex 1, which regulates the manufacturing, control and release of sterile pharmaceutical products, is undergoing some substantial changes, as the current 2020 draft suggests. These will directly affect manufacturers in North America insofar as their exports to Europe are concerned, and probably leave a mark at home as well.
  • Considerations Regarding Specifications for Allo Therapies

    One of the many challenges for startup biotech companies is generating Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available (ALCOA+) supporting DATA in establishing drug substance and drug product specifications.
  • Significance of Innate Immunity in Mitigating SARS-CoV-2 Infection

    Continuously surging numbers of global COVID-19 cases caused by rapidly emerging SARS-CoV-2 mutants forming more contagious and deadly viral strains force our scientific capacity to find creative ways to control the pandemic. While current SARS-CoV-2 vaccines are quite effective in reducing the severity of the disease, hospitalization and deaths, none is yet known to provide complete protection from acquiring SARS-CoV-2 infections and to prevent reinfections of the recovered adults or possibly even the vaccinated population.
  • Pioneering a Data Strategy to Support Pharmaceutical Operations and Technology

    Regardless of industry, maximizing the value of data has become an important objective in the digital age. As more pharmaceutical operations find themselves tasked with building long-term digital strategies, the most fundamental goal is to maximize the value of data for patients. Developing a comprehensive strategy for how a business manages its data is not easy, especially when it involves changes to the workforce, existing business processes, and technology choices.
  • How to Investigate Temperature and Humidity Excursions of Stability Chambers

    The purpose of a Stability Program is to support the expiration dating of pharmaceutical products, medical devices, and biologics and recommend storage conditions. These products are manufactured and placed in special environmental chambers (stability chambers) with specific temperature and humidity conditions according to the ICH Q1A (R2) guideline.
  • A Model for Aseptic Operations Governance (Structure, Competencies, Governance and Attitude)

    Manufacturing sterile parenteral products with aseptic technique has become more complex because of multiple technical, scientific and compliance challenges. This article recommends an overall approach based on structure, competencies, governance and attitude to ensure the best possible outcome.
  • An Interview With Jim Huang, PhD - CEO - Ascendia Pharmaceuticals

    Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile- and non-sterile-enabling formulations, along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product development, as well as OTCs and nutraceuticals. Our projects range from discovery-stage molecules (NCEs) to life-cycle management projects.
  • Key Considerations for Stabilizing Oxidation-Prone Lipid-Based Drug Delivery Systems

    Lipid-based excipients are present in a wide range of drug delivery systems for different routes of administration, including oral, topical, transdermal, and parenteral. By their nature, lipid-based excipients confer unique advantages on the delivery of poorly soluble drug actives as solubilizers and bioavailability enhancers.
  • Caffeine: Past, Present, and Future

    When thinking about caffeine, the first thought that often comes to mind is the drink “coffee”, despite the fact that caffeine can be obtained from a variety of other sources. Coffee dominates modern drink consumption, but tea was the original popular caffeinated drink.
  • USP <643> Total Organic Carbon Recent Changes – FAQs

    The United States Pharmacopeia (USP) specifies regulations for pharmaceutical manufacturing and testing to ensure safe and effective drug products. USP Total Organic Carbon (TOC) pertains to requirements for testing pharmaceutical grade water.
  • Pharmaceutical P.I.N. Points Patent Innovation News

    The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in March 2021.
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