European Pharmaceutical Review

SEPTEMBER 11, 2023

CGT Catapult will partner with contract development and manufacturing organisation (CDMO) Rentschler Biopharma and Refeyn Ltd to improve the process of manufacturing adeno-associated viruses (AAV) through automated and digital process analytical technologies (PAT). This is partly because current analytical methods usually use manual sampling.

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European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Figure 1 : adapted from Saha, G. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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FDA 122

ISPE

APRIL 17, 2023

Using Robotics in the ATMP Space Trudy Patterson Mon, 04/17/2023 - 09:38 iSpeak Blog iSpeak Using Robotics in the ATMP Space Josh Russell 17 April 2023 The use of robotics to manufacture Advanced Therapy and Medicinal Products (ATMP) solves many challenges, including significantly limiting exposure to human generated contamination.

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European Pharmaceutical Review

DECEMBER 4, 2023

The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. One of the most significant perceived challenges is the ability to implement new innovations and increase productivity while adhering to stringent regulatory demands.

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European Pharmaceutical Review

JULY 17, 2023

The resulting pilot-scale system is intended to improve society’s ability to respond to future pandemics as well as accelerate the development and production of mRNA technologies. However, continuous manufacturing enables a product to be made non-stop and avoids delays caused by pauses and transfers between batches.

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FDA Vaccines 92

European Pharmaceutical Review

DECEMBER 1, 2023

2 Over time, CE has advanced to become a superb complement to high-performance liquid chromatography (HPLC), and in many cases has also evolved as an automated and quantitative replacement for conventional slab gel electrophoresis methods such as SDS-PAGE and isoelectric focusing (IEF).

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Compounding 89

pharmaphorum

NOVEMBER 27, 2022

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Automation can be such a solution. Automation can be such a solution.

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Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 104

European Pharmaceutical Review

AUGUST 2, 2023

Research published in Biotechnology and Bioengineering has demonstrated two innovative, automatic, online, real-time sample acquisition and preparation systems for in-process monitoring, control, and release of biopharmaceuticals. The autonomous PAT platform includes fluidic conduits and strategically placed material handling mechanisms.

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European Pharmaceutical Review

MAY 29, 2023

One of these key technologies is automation, a recent paper explained. As these products are parenteral and according to the GMP are sterile, the costs associated with their manufacturing are high. In an aseptic environment, a medium to high level of automation allows 24/7 production continuity according to the market needs.

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Process Improvement Packaging Vaccines FDA 72

European Pharmaceutical Review

NOVEMBER 16, 2023

Yet the single-use bioprocessing market face several challenges, such as concerns about the quality and consistency of single-use products, the lack of standardisation in the industry, supply chain security and the high cost of single-use equipment.

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European Pharmaceutical Review

FEBRUARY 22, 2023

1 While the process was developed in the 1970s and 1980s, there have been several advances over the past few years, with drives to improve sustainability, increase testing speed and leverage automation to minimise deviations. The post Endotoxin trends: sustainability, automation and beyond appeared first on European Pharmaceutical Review.

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ISPE

JUNE 2, 2023

It involves a wide variety of analytical technologies, requires well trained analysts, and is a major component of the critical path to regulatory submissions and product release. Quality Quality Control (QC) For more information, please contact: communities@ispe.org.

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Method Validation 98

European Pharmaceutical Review

MARCH 28, 2024

Pharmaceutical and biotechnology environmental monitoring market Influencing factors The report also covered that due to the biotechnology industry requiring sterile conditions and products, expansion of this sector creates demand for extensive environmental monitoring.

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ISPE

JANUARY 10, 2023

The Aseptic Evolution from Manual Operations to Fully Automated Robotics Solutions. The Aseptic Evolution from Manual Operations to Fully Automated Robotics Solutions. It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention.

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Packaging Documentation 96

European Pharmaceutical Review

AUGUST 30, 2023

According to a report by Transparency Market Research Inc, the global cell and gene therapy (CGT) manufacturing quality control (QC) market is anticipated to value $2.8 Data showed that potency testing as an analytical method dominated the global cell and gene therapy manufacturing quality control industry in the forecast period.

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European Pharmaceutical Review

MARCH 1, 2023

Scaling up the production of mRNA therapeutics to meet today’s growing demand requires improved optimisation of the associated analytics. An automated liquid chromatography‑mass spectrometry (LC-MS) workflow used in conjunction with RNase mass mapping is proving successful in simplifying and accelerating mRNA analysis.

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Vaccines Packaging 105

European Pharmaceutical Review

DECEMBER 6, 2023

In the interview, conducted at CPHI Barcelona, Krishna Venkatesh, Global Head, Sterile Manufacturing Operations at Dr Reddy’s Laboratories explores industry’s growing focus on achieving end-to-end connectivity, as well as the potential of automation and track and trace solutions. What trends are you seeing in the pharma space?

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Packaging Vaccines 80

Roots Analysis

APRIL 15, 2024

The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish , adequate storage with controlled temperatures and analytical testing to offer quality products.

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Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

Omnicell

JANUARY 10, 2023

Greg Haas Senior Manager, Product Marketing Staffing is the number one problem facing employers today, especially hospitals and health systems. The importance of automation for pharmacies has never been greater. Health system pharmacy is one of the hardest-hit areas.

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European Pharmaceutical Review

OCTOBER 18, 2023

Features of the new line for syringes include the latest automated systems and quality control measures, ensuring the highest levels of safety, efficiency, and product integrity. The systems offer precise and reliable assembly of auto-injectors, meeting the highest industry standards.

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Omnicell

JANUARY 10, 2023

Director Product Marketing & Development, Omnicell With drug costs skyrocketing and the ever-present challenge of drug shortages, throwing away medications can be agonizing. Central pharmacy automation that incorporates expiration date tracking plays a key role in reducing waste. Joy Somogyi Sr. And costly.

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ISPE

JULY 7, 2023

He has been on planning committees for ISPE conferences, on author teams for the ISPE GAMP ® Guide: Records and Data Integrity and the ISPE GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) , and co-led the ISPE APQ Guide: Process Performance and Product Quality Monitoring System author team.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 1, 2020

The time it takes to get a product to the market is critical for companies. Automation can mean the difference between failure and success! What is meant by automating clinical trials? Automation is used to improve the accuracy of results in the clinical trial process from study setup through to submission.

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FDA 109

Omnicell

SEPTEMBER 5, 2022

IV automation and technology-enabled services are helping health systems to take greater control of their drug supply, resulting in: Increased quality and safety of compounded sterile preparations Decreased reliance on 503B vendors Reduced costs Moses H. 23 at 1 pm ET.

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Sterile Compounds Compounding Omnicell Labelling 52

ISPE

JUNE 15, 2023

Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™ ™ & Your Organisation’s Digitlization Journey Trudy Patterson Thu, 06/15/2023 - 09:27 iSpeak Blog iSpeak Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™

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Omnicell

JANUARY 10, 2023

Bethany Donato Director, Product Marketing Achieving the five rights of medication administration is often a destination without a map, failing to acknowledge human factors and system weaknesses that contribute to errors. And one of the highest areas of opportunity for human error is in the sterile compounding process. savings per year.

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Sterile Compounds Compounding Omnicell Communication 93

Roots Analysis

AUGUST 9, 2023

It is worth mentioning that in recent years, several healthcare stakeholders have actively undertaken initiatives to incorporate a manufacturing execution system (MES) into their production lines, with an aim to connect, monitor and control the complex manufacturing process.

Documentation 52

Documentation Communication 52

Omnicell

JANUARY 10, 2023

Leif Parcell Senior Product Marketing Manager Did you know that surgical patients are three times more likely to experience a harmful medication error than those in other healthcare settings? Given the number of high-alert controlled substances administered under often intense conditions inside the operating room (OR), it's no surprise.

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Controlled Substances Omnicell Medication Dispensing Hospitals 52

pharmaphorum

JANUARY 30, 2023

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field.

Documentation 52

Documentation 52

Omnicell

SEPTEMBER 5, 2022

The recommendation for IV workflow management system technologies that incorporate barcoding to verify ingredients and finished compounded sterile products (CSP) volumes, especially with chemotherapy and pediatric infusions, is very clear. ” There are other reasons why IV compounding automation makes sense.

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Compounding Sterile Compounds Omnicell Hospitals 52

ISPE

JULY 28, 2023

Adapting production to the requirements of Annex 1 does mean hardware modifications for some operations, for example for the provision of steam-sterilization of indirect product contact parts (i.e.: vibrator bowls) in isolators, but also the automation of lyophilizer-loading.

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Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Documentation Packaging Vaccines 59

European Pharmaceutical Review

JUNE 30, 2023

Demand for process analytical technology ( PAT ) is being driven by the growing adoption of automation and digitalisation in sectors such as pharmaceutical industry, a report by Market.us A limitation to implementing PAT in pharmaceutical production is that infrastructure such as hardware and software is expensive.

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Compounding 91

ISPE

JULY 28, 2023

Adapting production to the requirements of Annex 1 does mean hardware modifications for some operations, for example for the provision of steam-sterilization of indirect product contact parts (i.e., vibrator bowls) in isolators, but also the automation of lyophilizer-loading.

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European Pharmaceutical Review

JUNE 30, 2023

Other limitations include that there are only a few access countries for the global LAL and tachypleus amoebocyte lysate (TAL) product. Farming horseshoe crabs in a controlled environment is one approach, according to Francis, author of the paper. It provides a controlled, synthetic reagent for endotoxin testing.

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Communication 86

European Pharmaceutical Review

FEBRUARY 13, 2023

The method is an important innovation for quality control ( QC) in production lines. Methods are now needed to perform quality control of this new technology in a more effective, efficient way. Then, automated analysis helps ascertain structures with the help of a sequence database.

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European Pharmaceutical Review

OCTOBER 10, 2023

Schneider Electric, a leader in digital transformation, energy management and automation, has announced the speaker lineup for its exclusive event, Life Sciences Innovation Day – Accelerating Digital Transformation Ambition.

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