Fierce Healthcare

AUGUST 17, 2023

However, they're often underequipped and treating patients that would benefit from earlier intervention or services from a more dedicated facility, provider groups say.

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European Pharmaceutical Review

APRIL 15, 2024

external factors such as equipment, seasonality, and the transit of people and supplies between environments can potentially influence the transfer of microorganisms found in cleanrooms” Soares et al. The authors emphasised that regular maintenance was key in maintaining control of bioburden levels. 13 percent).

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STAT

AUGUST 10, 2023

Following an extensive inspection, the Environmental Protection Agency fined Genentech more than $158,000 for hazardous waste violations at a facility in California, the latest instance in which a pharmaceutical company has been cited for failing to adhere to environment regulations.

Pharmaceutical Companies 97

Pharmaceutical Companies Pharmaceutical Companies 97

ISPE

SEPTEMBER 5, 2023

This includes implementation of commercially available and custom developed equipment yielding superior results, improved competitive position, and/or demonstrated imaginative collaboration with vendors/suppliers/manufacturers, all while maintaining and meeting stringent safety standards. Chugai Pharmaceutical Co. was founded in 1925.

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ISPE

SEPTEMBER 27, 2023

We are thrilled to announce our partnership with the European Aseptic and Sterile Environment (EASE) to host our in-person instructor led training at their state-of-the-art facility in Strasbourg, France, providing participants with an exceptional hands-on learning environment. What is EASE?

Documentation 98

Documentation 98

European Pharmaceutical Review

APRIL 11, 2024

A current good manufacturing practice (cGMP) oligonucleotide manufacturing facility is set to be built Berlin. It will utilise AKB’s oligo manufacturing equipment, covering all upstream and downstream manufacturing unit operations from synthesis to concentration, the parties confirmed.

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Pharmafile

JANUARY 24, 2023

Published date: 24/01/2023 Summary: London, 24th January - finnCap Cavendish, part of finnCap Group plc, is pleased to announce it has advised on the sale of Therapy Equipment Limited to ESAB Corporation. Founded in 1983, Therapy Equipment Ltd. Founded in 1983, Therapy Equipment Ltd. Founded in 1983, Therapy Equipment Ltd.

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STAT

MAY 23, 2023

So Devens seemed a better candidate than most prisons for an early vaccine rollout: It’s one of just seven facilities in the country equipped to handle federal prisoners with complex medical conditions like end-stage renal disease — people who were also especially vulnerable to dying from the coronavirus.

Nursing Homes 103

Nursing Homes Vaccines 103

ISPE

OCTOBER 10, 2022

While traditional facilities work with the aim of producing consistent, repeatable products, the Iovance Cell Therapy Center (iCTC) is designed to produce individual TIL cell therapies for thousands of patients a year. To plan for future growth, Iovance used a “butterfly” design so that the facility could eventually double its capacity.

Hospitals 98

Hospitals Immunization 98

BioPharm

SEPTEMBER 26, 2023

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

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European Pharmaceutical Review

JUNE 12, 2023

billion) to expand an existing active pharmaceutical ingredient (API) production facility in Hillerød, Denmark. The new 65,000-square-metre facility in Hillerød will be designed as a multi-product facility, with flexibility to accommodate new processes. The facility is expected to start producing API by early 2029.

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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. Could centrifugal bioreactor accelerate cell-therapy manufacturing?

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European Pharmaceutical Review

JULY 26, 2023

A Finnish contract development and manufacturing organisation (CDMO) specialising in biopharmaceuticals, has announced it is investing over €50 million to expand its manufacturing facility in Turku, Finland. The size of the new facility will be 6,400m 2 (69,000ft 2 ). The size of the new facility will be 6,400m 2 (69,000ft 2 ).

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STAT

JANUARY 22, 2024

These included problems in tracking manufacturing processes and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, according to an inspection report. The FDA inspection in July at a Lilly plant in Branchburg, N.J., detected eight separate deficiencies.

FDA 99

FDA 99

The FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. Raising the question: how does FDA define “all parties?”

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FDA Documentation Medical Records 105

STAT

DECEMBER 18, 2023

The Food and Drug Administration found quality control lapses at Moderna’s main factory, including with equipment used to manufacture drug substance for its Covid-19 vaccine , Reuters reports. The September 2021 inspection took place at Moderna’s facility in Norwood, Mass.,

FDA 96

FDA Vaccines 96

OctariusRx

MARCH 3, 2024

Is your facility ready? Not all facilities face the risk of MH, but for facilities who use MH-triggering agents such as inhaled general anesthetics or succinylcholine , the danger is real and must be taken seriously. Is your facility using MH-triggering agents? Keep an appropriate supply of medications and equipment.

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Outsourcing Pharma

JANUARY 11, 2023

Digital twins could overcome common data management issues at equipment-intense research facilities, according to a paper published in the journal Sensors.

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European Pharmaceutical Review

FEBRUARY 15, 2024

New laboratory features at the Pharmaceutical Center of Excellence The laboratory is now equipped with a new SKAN isolator suite, enabling Nelson Labs to perform testing for sterility assurance with the highest level of sterility control. The new isolator suite will complement the existing sterility assurance capabilities at the lab.

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European Pharmaceutical Review

JULY 8, 2022

As established facilities age, various risk considerations emerge. While some risks related to the processes and facilities becoming obsolete or incremental modifications over time making production less efficient, he also included microbial contamination concerns, which will be the focus of this summary.

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ISPE

JUNE 23, 2023

Presentations will discuss harmonized approaches to advancements in drug development, design and equipment solutions, and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient and sustainable manner to improve patient health. and Chugai Pharma Manufacturing Co.

Pharmaceutical Companies 94

Pharmaceutical Companies Pharmaceutical Companies 94

ISPE

SEPTEMBER 13, 2023

Marcy Sanford 13 September 2023 Facility of the Year Award (FOYA) Winners in the Supply Chain category exemplify novel application of principles, systems, and management tools aimed at improving operational speed, robustness, and response. NOMINATE YOUR FACILITY FOR THE 2024 FOYA PROGRAM! WANT TO LEARN MORE? Register Now!

Vaccines 98

Vaccines 98

European Pharmaceutical Review

APRIL 26, 2024

Use of disposable and pre-filled syringes means this equipment can be prepared and filled as per good manufacturing practice (GMP) requirements in pharmaceutical production facilities, the authors wrote. This is notable, because according to Rodríguez-Pombo et al., treatment adherence can be an issue for certain patients.

Compounding 71

Compounding Hospitals 71

BioPharm

DECEMBER 1, 2022

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

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ISPE

OCTOBER 27, 2022

Supporting Cell & Gene Therapy through Multimodal & Flexible Facilities. Supporting Cell & Gene Therapy through Multimodal & Flexible Facilities. Facilities must be created with flexibility in mind, able to run multiple products and production types to remain viable. Flexible Facilities. Multimodal Facilities.

Packaging 52

Packaging Communication Immunization Vaccines 52

ISPE

AUGUST 30, 2023

Additionally, these principles, systems, and tools ensure business continuity through a stable supply environment, health and safety, and customer satisfaction from existing or new facilities, processes, and manufacturing operations. It represents Ireland’s only biological contract manufacturing facility.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies 98

European Pharmaceutical Review

OCTOBER 26, 2022

Gallogly College of Engineering at The University of Oklahoma (OU) has announced it will open the OU Bioprocessing Core Facility, a shared research centre for biopharmaceutical manufacturing and bioprocess engineering in 2023. A total of $7 million will support those involved to equip the facility with state-of-the-art technology.

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The FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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FDA 72

European Pharmaceutical Review

SEPTEMBER 12, 2023

First is that the CCS extends to every aspect of sterile manufacturing operations (processes, equipment, facilities and manufacturing activities). Opening the session, moderator Tim Sandle highlighted six fundamental aspects of contamination control.

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Documentation 127

ISPE

SEPTEMBER 7, 2022

Winners in this category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies and unique solutions that exemplify the next generation of agile, flexible, efficient and effective new and existing pharmaceutical and biotechnology facilities. FOYA Judges.

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ISPE

SEPTEMBER 21, 2023

The recent Annex 1 and discussions leading to this update in regulation have brought about a significant change that punctuates the landscape of pharmaceutical engineering, and it plays out in equipment and how drug product manufacturers are taking steps to achieve product quality. ™ and Annex 1 Conference couldn’t be better.

Documentation 98

Documentation FDA 98

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

BioPharm

DECEMBER 5, 2022

In addition, personnel, equipment, and facilities from the acquired companies will expand Reaction Biology’s presence in Germany while enabling its global customers to leverage Bioassay’s expansive portfolio of regulated clinical and commercial services.

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45

ISPE

SEPTEMBER 8, 2022

The agenda of this content area is designed to discuss the innovation and use of emerging technologies at different stages of facility designs and drug development. The accelerated construction of the facilities for new therapies and expectations to meet sustainability goals are the leading trends in the pharmaceutical industry.

Packaging 93

Packaging FDA 93

Pharmafile

FEBRUARY 6, 2023

The new facility is expected to have a capacity of 20 million doses per year by the fiscal year of 2024. Production equipment has already been installed at a plant currently run by a subsidiary, Daiichi Sankyo Biotech, which is based in Kitamoto near Tokyo.

Vaccines 52

Vaccines 52

ISPE

APRIL 27, 2023

Each of these approaches has its own costs and benefits which life sciences leaders must evaluate when planning their green facilities. Four steps explained A decarbonized facility is built with low-carbon, reused, or recycled materials. Here are just a few examples: By 2030, Eli Lilly and Co.

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ISPE

NOVEMBER 29, 2022

Advanced Therapy Medicinal Products (ATMPs) / Cell / Gene Therapies present some unique challenges that manufacturers and equipment builders must overcome. Attendees will hear how filling equipment is customized to suit cell/gene therapy projects. Accessibility goes beyond financial affordability. Learn More & Register.

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Vaccines Hospitals Packaging 98