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    Academic Journals

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• Select Continued Process Verification for Cleaning Validation-Challenges and Pitfalls: Continued process verification (CPV) for a cleaning validation (CV) programme begins once the validation study is complete. Planning for the CPV needs to be considered, however, as the cleaning validation is planned. Otherwise, the necessary parameters for the CPV might not be captured in a way to allow the smooth transition from the CV study to the CPV programme to maintain the validated state of cleaning.

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  Continued Process Verification for Cleaning Validation-Challenges and Pitfalls: Continued process verification (CPV) for a cleaning validation (CV) programme begins once the validation study is complete. Planning for the CPV needs to be considered, however, as the cleaning validation is planned. Otherwise, the necessary parameters for the CPV might not be captured in a way to allow the smooth transition from the CV study to the CPV programme to maintain the validated state of cleaning.

  Authors:Richard J. Forsyth and Sabine ImamogluFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20223,107 words Article 1290LValidating cleaning in a pharmaceutical manufacturing facility is a regulatory requirement (1-4). Inregulatory guidance documents, programme basics, regulatory expectations including prerequisites, and acceptance...
• Select Digital Integration Platform.

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  Digital Integration Platform.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 202295 words Brief article 1420LScitara's Scientific Integration Platform (SIP) is a cloud-native infrastructure designed to realize the full benefits of digital transformation. SIP establishes a flexible, adaptable framework that facilitates a fully...
• Select The Need for Speed: How Operation Warp Speed Shifted the Pharma Industry: A new focus on speed to market creates challenges for facility design and construction.

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  The Need for Speed: How Operation Warp Speed Shifted the Pharma Industry: A new focus on speed to market creates challenges for facility design and construction.

  Author:Christa MyersFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20221,523 words Article 1310LDuring the COVID-19 pandemic, speed-to-market in drug manufacturing went from important to "mission critical"--and that is not changing anytime soon. CRB conducted a survey of 500 life and biopharma leaders, and when...
• Select Outsourcing's Race Toward Novelty: Recent developments in the outsourcing industry include a focus on early development services, biosimilar production, and RNA technology.

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  Outsourcing's Race Toward Novelty: Recent developments in the outsourcing industry include a focus on early development services, biosimilar production, and RNA technology.

  Author:Grant PlayterFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022787 words Article 1440LBio/pharma is a fast-paced industry that is continuously innovating via new technologies and techniques. The determination of what, if anything, should be outsourced throughout the development, manufacturing, and...
• Select Quality Still a Priority: As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

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  Quality Still a Priority: As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

  Author:Susan HaigneyFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022823 words Article 1560LThe pandemic created many challenges in 2021 for both pharmaceutical manufacturers and regulatory organizations. The quality of pharmaceutical products continued to be a focus, but many facility inspections were...
• Select Tackling the Big Issue of Solubility: Poor solubility remains a big issue for drug development and, as such, is driving innovation in approaches and use of novel technologies to help overcome the associated challenges.

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  Tackling the Big Issue of Solubility: Poor solubility remains a big issue for drug development and, as such, is driving innovation in approaches and use of novel technologies to help overcome the associated challenges.

  Author:Felicity ThomasFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20221,155 words Article 1490LIncreasingly, poorly soluble compounds are forming part of the development pipeline, driving greater innovation in ways to overcome the associated challenges these compounds give rise to. To learn more about solubility...
• Select Dual-Shaft Mixer with High Shear Rotor/Stator.

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  Dual-Shaft Mixer with High Shear Rotor/Stator.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022107 words Brief article 1410LROSS has incorporated a high shear rotor/stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements. Rather than including a typical high-speed disperser blade, the mixer comes...
• Select Regulating Digital Therapeutics: DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

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  Regulating Digital Therapeutics: DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

  Author:Cheryl BartonFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20221,176 words Article 1570LThe Digital Therapeutics Alliance (DTA) defines digital therapeutics (DTx) as products that deliver: "evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or...
• Select Changes Afoot: 2022 Outlook for Pharma and its People: An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.

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  Changes Afoot: 2022 Outlook for Pharma and its People: An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.

  Author:Felicity ThomasFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20222,962 words Article 1490LThe year 2021 has been transitional for the most part, with many stakeholders of the bio/pharma industry getting used to the 'new normal' or post-pandemic working life. Industry continues to drive innovation across the...
• Select Biologics Testing Highlights Need for Analytical Skills: There is need for training personnel in various analytical skill sets for biologic drug substance testing.

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  Biologics Testing Highlights Need for Analytical Skills: There is need for training personnel in various analytical skill sets for biologic drug substance testing.

  Author:Feliza MirasolFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20221,329 words Article 1390LThe complexity of biologic drug substances requires specialized analytics and the training to do the analyses. It is not enough to know how to run the assays, but also how to interpret the data to give meaningful...
• Select Addressing the Training Gap for Single-Use Technologies: Workforce training is crucial for biopharmaceutical manufacturing.

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  Addressing the Training Gap for Single-Use Technologies: Workforce training is crucial for biopharmaceutical manufacturing.

  Authors:Michael Moedler and Helene PoraFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20221,820 words Article 1500LDeployment of single-use technologies (SUT) has accelerated over the past few years as manufacturers adopt SUT at the commercial scale. The spike in demand has exacerbated an existing shortage of employees trained in the...
• Select IN MEMORIAM.

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  IN MEMORIAM.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022470 words Article 1540LMichael J. Hennessy, Sr., was the beloved chairman and founder of MJH Life Sciences, parent company of Pharmaceutical Technology. Hennessy spent his career turning his passion for building businesses and creating jobs...
• Select Taste and Appearance: Selecting the Right Excipients: Dosage form and patient needs drive excipient choice.

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  Taste and Appearance: Selecting the Right Excipients: Dosage form and patient needs drive excipient choice.

  Author:Cynthia A. ChallenerFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 20222,987 words Article 1520LMedication adherence is a crucial issue today, and drug manufacturers are seeking to develop drug products that meet the needs of patients with respect to ease of use and palatability. For oral formulations, taste,...
• Select Sustainable Biowaste Treatment System.

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  Sustainable Biowaste Treatment System.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022160 words Brief article 1560LSuncombe's MicroEDS BioWaste Treatment System is a biologically hazardous waste decontamination unit that can process between 150 to 500 L of waste per day. The low-volume system is certified to ASME and ISO/EN standards...
• Select Next-Generation Cas9 Proteins.

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  Next-Generation Cas9 Proteins.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022115 words Brief article 1720LThermo Fisher Scientific's Invitrogen TrueCut Hifi Cas9 Protein is designed for research applications that require highly precise genome editing, such as the engineering of chimeric antigen receptor (CAR)-T cells and the...
• Select Good Manufacturing Practice on Demand? Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

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  Good Manufacturing Practice on Demand? Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022561 words Article 1170LQ. We have been manufacturing speciality chemicals for many years. Some clients have asked us to manufacture intermediates and drug substances for them in compliance with good manufacturing practices (GMPs). We are very...
• Select Hot Picks for 2022.

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  Hot Picks for 2022.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 1) Peer-Reviewed

  Jan. 2022375 words Brief article 1610LDespite the continued turbulence from COVID-19, the bio/pharma industry experienced another good year for drug approvals in 2021. The latest available figures from the European Medicines Agency (EMA) showed that 2021...