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    Academic Journals

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• Safeguarding Biologics-Blending Engineering Ingenuity and Managerial Excellence: Efforts to optimize the delivery of sensitive biotherapeutics continue to evolve.

  Author:Suzanne ShelleyFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20232,108 words Article 1650LThe coordinated steps required to safeguard biologic medications, vaccines, and personalized cell and gene therapies (CGTs) from the moment they begin the journey from origin to destination are notoriously complex. Many...

• Considerations for Method Validation: Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

  From:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 2023573 words Article 1400LQ How can an analytical method be validated? A.When using an analytical method published in a pharmacopoeia, the method is considered validated and it just needs to be verified under actual conditions of use (1)....

• Harmonizing Rules Governing SPCs for Medicinal Products: A new unified initiative for patent protection in the EU to boost the competitiveness of the pharma industry is nearing completion.

  Author:Bianca Piachaud-MoustakisFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20231,458 words Article 1680LIn June 2019, it was announced that a targeted recalibration of certain aspects of patent and supplementary protection certificate (SPC) protection aimed at boosting the competitiveness of regulated industries such as...

• Supplementary Handwashing Techniques to Improve Hand Hygiene.

  Authors:Paul L. Pluta, Bradley D. Bartels, and Varanya ChaiyapermFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20232,941 words Article 1080LA fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address...

• Proportion, Balance, and Restraint.

  Author:Mike Hennessy, Jr.From:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 2023442 words Article 1570LThe US Food and Drug Administration (FDA) approved 37 drugs in 2022, within the normal range for the past decade or so. This is quite impressive for the industry given continuing headwinds thrown off by COVID-19 working...

• Advantageous Positioning for Europe in Pharmaceutical Cannabis: The European bio/pharma industry's high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical-grade manufacturing of cannabis-based medicines.

  Author:Felicity ThomasFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20231,953 words Article 1430LA cross Europe, a variety of cannabis or cannabinoid-based products i used in pharmacotherapy are mainly indicated for the treatment of chronic pain, nausea, and vomiting as a result of chemotherapy (1). However, up...

• Improving Gender Diversity.

  Author:Felicity ThomasFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 2023490 words Article 1540LGender equality and diversity is an issue that has been more prevalent in discussions and considerations across the professional landscape over recent years. For women, striving to reach the top positions in company...

• Current Trends in Host Cell Protein Detection for Biologics Manufacturing: In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

  Authors:Zhiping Yao, Wesley Wang, and Weichang ZhouFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20231,318 words Article 1550LBiologics, especially protein drugs, are often produced in cultured cells. Those cultured cells, called host cells, synthesize the target proteins along with the proteins coded by the cell genome for the cells' own...

• Technology for In Vivo CAR T-cell Therapy Advances: In vivo CAR-T gene therapies could overcome the challenges faced by autologous and allogeneic treatments.

  Author:Cynthia A. ChallenerFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20232,661 words Article 1630LThere is no doubt that chimeric antigen receptor (CAR) T-cell therapies have had a tremendous positive impact on patients that have received them; however, autologous cell therapies produced in centralized manufacturing...

• Aiming for Improved Efficacy and Patient Compliance for Topical Ophthalmics: Topical eye treatments can be beneficial for patients with a growing array of eye diseases, but only if taken appropriately.

  Author:Cynthia A. ChallenerFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20231,876 words Article 1580LDrug delivery to the human eye is a rapidly growing area in the pharmaceutical industry, but it is also one of the most challenging. The inherent structure and physiology of the eye make it difficult for drugs to reach...

• Combatting Future Viral Threats With Vaccine Advances: The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

  Author:Jill MurphyFrom:Pharmaceutical Technology Europe (Vol. 35, Issue 2) Peer-Reviewed

  Feb. 20231,204 words Article 1650LSince the beginning of the COVID-19 pandemic, pharmaceutical organizations have experienced major changes, a prime example of which has been the rising requirement for collaborations on multiple different fronts across...