Impact Pharmaceutical Services

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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FDA 52

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 84

Communication 84

ISPE

JULY 28, 2023

™ & Aseptic Conference Trudy Patterson Fri, 07/28/2023 - 10:40 iSpeak Blog iSpeak Message from the Chair: Why Attend the 2023 ISPE Pharma 4.0™ ™ & Aseptic Conference Jörg Zimmermann 28 July 2023 I have been active in ISPE for many, many years, but when I attended my first ISPE Pharma 4.0™

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STAT

MARCH 31, 2023

Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a Food and Drug Administration inspection report obtained by STAT. Continue to STAT+ to read the full story…

FDA 88

FDA 88

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.

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Packaging 96

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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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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ISPE

JULY 28, 2023

I realized that my network within ISPE was very much focussed on Aseptic, Manufacturing, and Quality, and not so much on Digitalization and Pharma 4.0™. ™ and digitalization are more and more used in all aspects of our industry, while operations and aseptic processing do need the tools to bring them to the next level.

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ISPE

DECEMBER 13, 2022

Building off of the success of the 2022 ISPE Aseptic Conference , the program committee has developed a robust program covering key areas in aseptic manufacturing, processing, and filling for students, emerging leaders, and seasoned industry professionals. What impacts to cGMP facility design are expected?

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Dosage FDA 52

BioPharm

OCTOBER 19, 2022

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. SUS enables innovative process solutions around aseptic fluid management and improves aseptic liquid transfer in various manufacturing facilities. And so is the importance of single-use systems.

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BioPharm

OCTOBER 19, 2022

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. SUS enables innovative process solutions around aseptic fluid management and improves aseptic liquid transfer in various manufacturing facilities. And so is the importance of single-use systems.

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ISPE

SEPTEMBER 15, 2022

Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. Barrier systems as RABS and isolators are recommended to be used for the manufacturing process and these two technics have been put in different clauses for each requirement, as these systems are different. Thu, 09/15/2022 - 13:50.

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Documentation FDA 97

Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

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Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

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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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 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.

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STAT

APRIL 3, 2023

We hope your journey today is meaningful and productive. Your tips and insights help the world go around… Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated , according to a U.S.

FDA 74

FDA 74

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.

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Communication Dosage Chemotherapy Documentation 81

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.

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FDA Packaging 85

ISPE

SEPTEMBER 8, 2023

2023 ISPE Aseptic Conference Regulatory Panel Logan Thomas Fri, 09/08/2023 - 11:35 InTouch September / October 2023 2023 ISPE Aseptic Conference Regulatory Panel Jörg Zimmermann 1 September 2023 On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session.

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FDA Vaccines Documentation 52

ISPE

SEPTEMBER 7, 2023

Numerous pharmaceutical companies are diversifying their portfolios, while some are taking a leap into the ATMP (Advanced Therapy Medicinal Product) era. The commercialisation of an ATMP product has always been under the spotlight. The emergence of new therapies leads to the need for multi-modal manufacturing facilities.

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Hospitals Pharmaceutical Companies Pharmaceutical Companies 98

Hospital Pharmacy Europe

DECEMBER 11, 2023

One option considered by the DHSC was to set out in legislation which members of the pharmacy team could carry out certain parts of the dispensing process. This option was discounted due to the difference in training levels between the two professions – national level seven for pharmacists and national level three for pharmacy technicians.

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Hospitals Documentation 52

ISPE

FEBRUARY 8, 2023

In Europe, it felt like every day brought a new rule to set you back to the drawing board, when an approval of a mere clinical trial application was a never-ending process, with people sometimes looking at you and secretly thinking, “Why bother? The bar is raised, and the opportunity for safer products is to be grabbed.

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Immunization FDA 90

Roots Analysis

AUGUST 29, 2023

Cell therapy consumables are materials which are used in the manufacturing of cell therapies, however, do not form a part of the final product. Raw materials used for the production of cell therapies include culture media, growth factors, extracellular matrices and reagents.

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ISPE

FEBRUARY 16, 2023

Penfold, MBA, CEng, MIET 16 February 2023 The updated EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products released in August 2022 introduced changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination.

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Documentation FDA 52

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

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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Pharmaceutical Companies Pharmaceutical Companies 136

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.

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Vaccines 59

Hospital Pharmacy Europe

AUGUST 17, 2023

In CAR T-cell therapy, which is classified as an advanced therapy medicinal product, autologous T-cells are genetically engineered ex vivo to express CARs that direct the patient’s lymphocytes to kill the tumour cells. The engineered cells are expanded in a dedicated production facility and then administered via infusion to the patient.

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Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

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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Roots Analysis

JANUARY 14, 2024

Overview of Biologics Biologics refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources. Expression Systems for Biologics The processes associated with the manufacturing of biopharmaceuticals are complex and require highly sterile and aseptic conditions.

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Immunization Vaccines FDA 40

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?

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 116

ISPE

AUGUST 15, 2023

™ Digital Transformation and 2) Annex 1 implementation from EU GMPs dedicated to sterile products. This approach not only enhances product quality by avoiding disruptive turbulence from high air velocity at 0.45 How can hardware, software, and process understanding be combined to create good GMP validation documents?

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Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 26, 2022

2022 brought back in-person international conferences, starting with Facilities of the Future in February, followed by the 2022 ISPE Aseptic Conference in March, which I have been deeply involved with for almost 15 years. Most Board members were able to attend in person, and we had very productive Board and Executive Committee sessions.

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Packaging Compounding Communication Vaccines 52

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 89

Pharmaceutical Companies Pharmaceutical Companies FDA 89

Roots Analysis

FEBRUARY 26, 2023

Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery (LADD) of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases.

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Dosage 52