Syner-G

AUGUST 24, 2023

Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to prevent product contamination and to provide a safe product to the patient.

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European Pharmaceutical Review

FEBRUARY 22, 2023

A new report has reviewed the present state of sterile oligonucleotide drug product processing. It includes recommendations to aid in the evaluation and development of terminal sterilisation processes, additionally exploring current regulatory expectations for oligonucleotide drugs. DeCollibus et al. DeCollibus et al.

Communication 83

Communication Drug Development 83

pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Delve into case studies of competence in global aseptic manufacturing.

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PharmaTech

JULY 2, 2023

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

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European Pharmaceutical Review

NOVEMBER 24, 2023

billion (16 billion Danish kroner) to expand its production site in Chartres, France, supporting manufacture of its products for serious chronic diseases. Aseptic production and finished production processes will be added to the site, as well as an extension of the current Quality Control Laboratory.

Pharmaceutical Manufacturing 95

Pharmaceutical Manufacturing Packaging 95

Pharmaceutical Business Review

MAY 9, 2024

Currently, IMA Life has 157 employees in Tonawanda and plans to add another 70 following the expansion. The post IMA Life to build new pharma freeze-drying equipment production site appeared first on Pharmaceutical Business review.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Pharma Pathway

SEPTEMBER 20, 2022

Area: Aseptic, Controlled area Operation (Sealing, Filling, filtration, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc). To observe & follow all rules and regulations of the production department. Sound technical knowledge of Aseptic area & Controlled area related activities.

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Documentation Communication 87

Pharma Mirror

MARCH 29, 2022

Karlsruhe/Germany, Romaco Macofar’s Oftalmica was specially developed for aseptic filling of sterile eye drops, nasal sprays and injectables. Meeting all GMP requirements for safe processing of highly viscous, oily and foaming liquids, the machine additionally offers fast format changes and short cleaning times.

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GMPSOP

AUGUST 14, 2023

How to perform periodic review of systems and processes in pharmaceuticals? Pharmaceuticals quality assurance & validation procedures GMPSOP How to perform periodic review of systems and processes in pharmaceuticals? Aseptic facilities are free from any microbial particulates. No issue with product sterilization.

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Pharma Mirror

JUNE 6, 2021

Terrassa (Barcelona): Telstar will be exhibiting the latest developments in aseptic technology for pharmaceutical production and integrated turnkey engineering & construction services for process facilities at Achema Pulse 2021.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

European Pharmaceutical Review

JUNE 13, 2023

A new therapeutic radionuclide facility, the world’s largest production site of lutetium-177, has opened in Germany. ITM’s additional production site is an important contribution to medical research and drug supply for patients in Germany and worldwide,” shared Udo J. Industry 4.0 technical level. Industry 4.0

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Pharma Pathway

MARCH 14, 2023

Walk-In Interview for Manufacturing Department (Injectable/ Parenteral ) On 19th March 2023 @ Amneal Pharma Sterile Manufacturing (Injectable Unit / Parenteral Unit) Department: Production (Sterile Manufacturing) Designation: Executive/ Officer/ Operator/ Sr. Officer/ Sr. Ltd, Plot No.

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Documentation Communication 80

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. Complex manufacturing processes and development of appropriately qualified or validated test methods present unique challenges which teams must overcome.

Drug Development 80

Drug Development Communication Dosage Chemotherapy 80

GMPSOP

DECEMBER 28, 2022

Environmental monitoring is a documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas. Through environmental monitoring you can receive an insight of presence of contaminants in the environment where pharmaceutical products are processed.

Documentation 52

Documentation Vaccines 52

Express Pharma

APRIL 4, 2024

In this article, we look at some significant differences between liposomes and LNPs that extend beyond their intended applications, encompassing variations in morphology, composition and manufacturing processes. For instance, the classic liposomal product DOXIL follows a ratio of HSPC:CHOL:DSPE-PEG2000=3:1:1. per cent and 38.5

Vaccines 77

Vaccines Compounding Immunity Immunization 77

Pharma Pathway

JANUARY 6, 2023

Zydus Lifesciences Limited-Walk-In Interviews for Production/ QC/ QA/ Engineering On 7th Jan’ 2023. Production: Autoclave compounding Washing / Tunnel / Capping & Lyophilizer – Operator : D. Compounding & Aseptic Filling – Sr. Process Maintenance & QMS – Sr. Job Description.

Compounding 40

Compounding 40

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Cleaning validation concerns – FDA warning letter Edge Biologicals Inc.

Pharmaceutical Manufacturing 84

Pharmaceutical Manufacturing Packaging 84

Pharma Pathway

SEPTEMBER 14, 2022

Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

Biosimilars 77

Biosimilars Compounding Pharmaceutical Companies Pharmaceutical Companies 77

Pharma Leaders

APRIL 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product. Ajinomoto Bio-Pharma stated that the high-speed process is rated to move up to 22,000 syringes an hour through the line, with more than 200 thousand syringes per batch capacity. “As

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Pharma Pathway

SEPTEMBER 19, 2022

Area: Aseptic, Controlled area Operation (Sealing, Filling, filtration, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc). To observe & follow all rules and regulations of the production department. Sound technical knowledge of Aseptic area & Controlled area related activities.

Documentation 40

Documentation Communication 40

pharmaphorum

SEPTEMBER 28, 2022

This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and increased regulatory stringency, to the latest technologies in rapid microbiological testing methods and data integrity. Event Hashtag: #MicrobiologyEurope. Who Should Attend? Download the brochure at: [link].

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pharmaphorum

SEPTEMBER 23, 2020

The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation. Workshop A – 08.30 – 12.30 London, UK.

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Pharmaceutical Technology

MAY 22, 2023

The facility includes a high-speed automated aseptic fill-finish line for small and large molecules. The customer experience centre offers more than 250 products in fields including chromatography and mass spectrometry, genetic analysis and sequencing, cell therapy and molecular biology.

Vaccines 59

Vaccines 59

pharmaphorum

MARCH 22, 2022

for manufacturing, with the aim of streamlining and enabling greater automation through adoption of digital tools, is leading to greater interest in the potential for VR and AR to improve efficiency and reduce costs in production. The pharma industry’s overall push into industry 4.0 The importance of manufacturing.

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European Pharmaceutical Review

AUGUST 12, 2022

Since ophthalmic preparations are typically manufactured aseptically, with sterility ensured by sterile filtration rather than terminal sterilisation, literature about the effects of terminal sterilisation on these products is limited. The sterility of the products was not assessed in the study. An assay prescribed by Ph.

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pharmaphorum

DECEMBER 28, 2022

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. But what steps can the smaller companies at the cutting edge take to make them acquisition-ready and maximise their value during this process?

Pharmaceutical Manufacturing 113

Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies 113

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. This greatly affects the analytical results, given that the acceptable limits are so low in the case of sterile products.

Pharmaceutical Companies 88

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 88

Express Pharma

MARCH 23, 2023

Obviously, human performance variability and its impact on product quality have clearly grabbed the attention of regulators worldwide. The current facility and process design doesn’t support the implementation of new learnings. New learnings are lost very fast due to the unavailability of opportunities to practice on the ground.

Communication 94

Communication 94

Express Pharma

MAY 10, 2023

It extends all the way down to the healthcare sector’s expectations for every component, instrument, and process orbiting the development and manufacture of medicine—especially parenteral drugs. For example, in a 5mL vial, there are typically 3 mLs of liquid drug product and 2 mLs of gas that sits above it. micron filter.

Packaging 83

Packaging Dosage Labelling Immunity 83

Pharmaceutical Technology

MAY 5, 2023

Switzerland-based Siegfried has purchased a 95% stake in DiNAMIQS, a biotechnology firm that focuses on the development and production of viral vectors for cell and gene therapies. Siegfried will leverage DiNAMIQS’ capabilities to commercial scale by constructing a facility that complies with good manufacturing practice standards.

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GMPSOP

FEBRUARY 10, 2024

There should be a clear process to establish training needs, provide training, and evaluate, record, and reward archives as required by the local regulatory authorities. Gowning qualification training applies to all staff working in cleanroom processing areas on top of the training regime mentioned above.

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Health and Personal Care Stores Documentation Packaging Compounding 52

pharmaphorum

JULY 28, 2022

These supply chain issues raise significant risks for the industry due to shortcuts being taken that are not based on product safety and quality. Until the company is found to be in compliance, there will not be a normal distribution of drug products. Tackling shortages. The stakes are high. Logistical challenges.

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Diabetes Dosage Pharmaceutical Manufacturing Documentation 102

pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Compounding Immunity Immunization 52

GMPSOP

MARCH 20, 2024

The same principle can be applied to pharmaceutical instruments, especially those directly impacting product quality and safety. This article will discuss the general requirements for instrument calibration in production and laboratory testing, which may affect pharmaceutical products’ identity, strength, quality, or purity.

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

Pharmaceutical Technology

FEBRUARY 3, 2023

When you consider the existing challenges limiting the upstream production of viral vectors, this figure becomes even more alarming. The established method for this process is a triple transfection using three different DNA plasmids. Naturally, scientists are investigating ways the transient transfection process could be improved.

Communication 97

Communication Dosage Packaging Vaccines 97

European Pharmaceutical Review

AUGUST 31, 2023

Even with extremely rapid vaccine development, limitations in production capabilities can have real-life implications. To cope with the growing demand for production flexibility and agility, IMA Group is structured according to highly specialised pharmaceutical divisions that concentrate on specific processing and packaging areas.

Vaccines 83

Vaccines Packaging Pharmaceutical Companies Pharmaceutical Companies 83

Express Pharma

MAY 7, 2024

Steriline, the European manufacturer of standard and robotic lines for the aseptic processing of injectable drugs, will exhibit at Achema 2024, from June 10 to 14.It “methodology first developed five years ago and now improved to further save time and speed up production’ – according to the company’s statement.

Packaging 101

Packaging Pharmaceutical Manufacturing Labelling 101