July/August 2021

Volume 24, Issue 5




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Articles in this Issue

  • Advancing to Recombinant Heparin

    Heparin is a potent anticoagulant that has been used clinically to manage blood clotting since 1935. Hundreds of thousands of doses are administered daily in the U.S. during surgery and for patients at risk of venous thromboembolism. Medical devices that come in contact with blood, such as dialysis tubing, are also coated with heparin. The importance of heparin is underscored by its inclusion on the World Health Organization’s list of essential medicines and a worldwide market of over $7B annually.
  • New Expectations for Training – Tied to Implementation of Contamination Control Strategies

    With the upcoming implementation of the revised Annex 1 of the European Union GMPs, many companies are developing contamination control strategies. For some, this is a newer experience, as the requirements apply to both sterile and non-sterile manufacturing operations. A key consideration in the development of a contamination control strategy is what happens if a contamination risk is detected. One would assume, that if a risk is identified, appropriate corrective actions should be taken to mitigate or eliminate the contamination risk.
  • The Use of In-House Microbial Isolates in Disinfectant Efficacy Testing: Challenges and Solutions

    “Routinely used disinfectants should be effective against the normal microbial vegetative flora recovered from the facility... If indicated, microorganisms associated with adverse trends can be investigated as to their sensitivity to the disinfectants employed in the cleanroom in which the microorganisms were isolated.”
  • QC Corner: Recent Updates to Guidances Help Standardize Extractables and Leachables Testing

    Risk assessment for extractables and leachables (E&L) contained in polymeric manufacturing components is an important step to evaluate patient safety. In medium to high risk applications, testing for extractables by using solvents that simulate the worst case is the first step to determine what the potential leachables are. If patient safety cannot be demonstrated under these conditions, then evaluating leachables, substances that migrate under typical conditions, may be required. Leachables studies are critical for the pharmaceutical and medical device industries where packaging safety and toxicology studies are required for product registration. Risk assessment is becoming more standardized, and this trend is being driven by the evolving industry guidances on E&L for single-use manufacturing, an approach that has become quite common in the pharmaceutical industry.
  • Countering Misinformation Spread About the COVID-19 Pandemic

    Today it’s a free-for-all on social media, which has become the main source of information for people on the COVID-19 pandemic, and sometimes a major source of information for even conventional media, so there is a huge opening for misinformation. Whereas the goal of scientific journals is to disseminate science in an unbiased manner with checks and balances built in through the peer-review process and post-publication responses from readers, the goal of information about science on social media may or may not be about science, but could be about casting science from a political, ideological, and/or financial perspective. The author believes he can play a modest role in helping to correct some of this misinformation. An earlier review article, that I co-authored addressing controls to minimize disruption of the pharmaceutical supply chain during the COVID-19 pandemic was published in 2020.
  • Quantifying AAV Viral Titer and Integrity with ddPCR

    As the COVID-19 pandemic and subsequent vaccine development showed us, viruses and their components can both cause disease and help prevent it. While genetic illnesses are not born from a viral infection, scientists have found in recent years that viruses like adeno-associated virus (AAV) and lentivirus might be the key to solving these stubborn diseases. Specifically, they serve as the primary delivery vehicle for treatment. After gutting them of their native genetic material, scientists exploit their infectious nature to plant therapeutic genetic sequences in patients’ cells to either augment or silence problem genes and restore normal function.
  • Microbiology of COVID-19: The Rise of the Mutants, Emergence of SARS-CoV-2 Variants as a Response...

    The COVID-19 pandemic has presented major challenges to national public health systems and created serious socio-economics disruptions around the world. A zoonotic event that triggered the spillover of SARS-CoV-2 to human populations has not been decisively described. However, genomic surveillance of SARS-CoV-2 infections provided rapid viral characterization, rapid diagnostic tests, effective vaccines, and epidemiological analysis of COVID-19.
  • Laser-Induced Breakdown Spectroscopy of Pharmaceutical Products

    Analytical methods that can determine the quality of pharmaceutical products fast and without the need for sample preparation are highly desirable. Laser-induced breakdown spectroscopy (LIBS) is such a tool. Within fractions of a second it can provide the elemental composition, e.g. at a specific location on a tablet. Scanning the measurement position across the specimen even allows mapping virtually all chemical elements. This article provides an overview of the working principle of LIBS and features its applications to pharmaceutical products.
  • Microbiology Roundtable

    Charles River Laboratories, Senior Product Manager, Accugenix: Besides the obvious answer of COVID-19 vaccine production, availability, and safety, we continue to see pharmaceutical companies respond to new and stricter regulatory requirements like Annex 1 and USP <60>. We’re seeing an increase in the frequency of cleanroom validations, environmental monitoring, microbial testing and identifications, and trending of data.
  • Application of Advanced Proteomic and Mass Spectrometry Technologies to Enhance the Efficacy...

    The Chinese Hamster Ovary (CHO) cell line is the dominant mammalian expression system for biopharmaceutical production. Improving the efficiency of production of these biologics will be critical in controlling costs to healthcare systems as more of these drugs come to market. Proteomic and mass spectrometry analysis has been used to profile recombinant CHO cells to get a greater understanding of the molecular and cellular mechanisms that result in a high producing cellular phenotype.
  • Quantification of Residual Host Cell DNA in Protamine Sulfate Drug Product Using Droplet Digital...

    Protamine Sulfate (ProS) is the only FDA approved anticoagulation reversal agent for unfractionated heparin. ProS is biologically derived from chum salmon sperm and therefore may be contaminated with residual salmon sperm DNA. Because residual host cell DNA (resDNA) may pose a safety concern to patients, the amount should be closely monitored during manufacturing and strictly regulated in final drug products. The regulatorily defined acceptance level (10 ng per dose) of resDNA in drug products poses great challenges for accurate quantification of resDNA, particularly for the products used in high doses or formulated in complex matrixes. resDNA quantification in the presence of the cationic arginine-rich ProS structure can be challenging due to the polyanionic resDNA binding to ProS which may render isolation and analysis of resDNA problematic.
  • Pharmaceutical P.I.N. Points Patent Innovation News July/August 2021

    Ayurvedic medicines attain/maintain harmony in the system and work on improving the health of the body rather than treating symptoms. The patent covers compositions to treat renal disorders and mainly nephrons. The patent describes processes to prepare bhasmas, gugglu and shilajit. The compositions contain various herbs and several minerals (iron, iron rust, copper pyrite, gold) as actives and the disclosed formulation may act as at least one of anti-lipid, free radical scavenging, hypolipidemic and nephro-protective agent. The inventor conducted animal tox studies followed by a clinical trial.
  • Message from the Editor: A Crisis In Pain Management

    Let’s start off with some facts from the National Institute of Drug Abuse - Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them. Between 8 and 12 percent of people using an opioid for chronic pain develop an opioid use disorder.
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