European Pharmaceutical Review

JULY 7, 2022

However, she notes that useful information for assessing risks in your facility and preparing for upcoming inspections can be gleaned from other’s warning letters and regulatory inspection observation reports, such as FDA 483. The other observations related to facility design and cleanliness.

Documentation 96

Documentation Vaccines 96

Express Pharma

APRIL 21, 2023

The Dholka manufacturing facility passed the USFDA audit with nil 483 observations The Dholka manufacturing facility of Cadila Pharmaceuticals has successfully cleared the US Food and Drug Administration (USFDA) audit yet again. USFDA Inspector Vivin George conducted the facility’s audit from April 3 to 7. Dr Rajiv I.

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Express Pharma

MARCH 20, 2024

This formulation, designed to manage SCD, eliminates the need for cold storage, thereby enhancing accessibility and affordability for SCD patients nationwide. Under the leadership of Health Minister Mansukh Mandviya and with guidance from a member of NITI Aayog, Dr V K Paul , Akums has achieved this milestone.

Dosage 91

Dosage 91

European Pharmaceutical Review

MARCH 28, 2023

Eli Lilly and Company will double its investment to nearly $1 billion at its new biologics drug manufacturing facility, in Raheen, Limerick, stated Ireland’s Industrial Development Agency (IDA). Eli Lilly claimed that based on current design estimates, Limerick is estimated to produce 3.17

Pharmaceutical Companies 71

Pharmaceutical Companies Pharmaceutical Companies 71

European Pharmaceutical Review

MARCH 6, 2023

The Oxfordshire campus comprises of Europe’s largest collection of open access, publicly funded scientific facilities. ” Post-construction, the facility “will harness mRNA science that aims to develop and deliver innovative vaccines to the UK public that address emerging threats from respiratory viruses.”

Vaccines 82

Vaccines 82

FADIC

OCTOBER 20, 2023

Project management services for healthcare South London and Maudsley NHS Foundation Trust requires assistance in managing various projects across their portfolio of healthcare facilities in South London, including both community facilities and secure hospital environments with strict security.

Hospitals 52

Hospitals Documentation 52

Express Pharma

DECEMBER 7, 2023

He explained about the role of performance management, leadership, people, culture, risk and quality management etc. Thus, a major take away from this session was that pharma facilities have to adapt to a rapidly evolving healthcare landscape and meet the need for innovative therapies.

Generic Medicine 102

Generic Medicine Documentation 102

Pharma Manufacturing

MAY 26, 2022

With utility costs on the rise, many pharma manufacturers are taking a closer look at their facilities and finding that better facility design, resource management and maintenance strategies can offer sources of overlooked savings, as well as opportunities for sustainability.

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Pharmaceutical Business Review

NOVEMBER 1, 2023

All three laboratories in North America are said to be designed and managed uniformly. The full-service solutions offered by Altasciences include preclinical safety testing, clinical pharmacology and proof of concept, programme management, bioanalysis, medical writing, clinical monitoring, biostatistics, and data management.

Clinical Pharmacology 59

Clinical Pharmacology 59

pharmaphorum

SEPTEMBER 23, 2020

Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

Drug Development 141

Drug Development 141

European Pharmaceutical Review

NOVEMBER 16, 2022

For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working. Achieving commercial scale as a biotech: embracing quality by design. Embracing the spirit rather than the letter of regulations.

Documentation 111

Documentation Vaccines Drug Development 111

Pharma Pathway

FEBRUARY 28, 2023

Manager Qualification: M.Sc, B.Sc, B.Pharm, M.Pharm, Diploma, ITI, B.Tech, BE Experience: 01 to 15 years Location: Indore Date : 4th & 5th March 2023 Time: 09:00 AM to 05:00 PM Venue: Papaya Tree Hotel, A.B. Executive/ Operator/ TA/ Asst.

Documentation 87

Documentation 87

Express Pharma

APRIL 3, 2024

The designation of a 25-km radius as “Pollution Free Zone” makes Genome Valley is well-suited for a healthy and fulfilling lifestyle. The approved project encompasses two major corridors, each strategically designed to alleviate congestion and streamline traffic flow along key routes. Corridor 1 spans 18.30

Hospitals 78

Hospitals 78

European Pharmaceutical Review

FEBRUARY 22, 2023

This means practices are designed to work together to achieve proactive contamination control and are evaluated for their collective effectiveness. Dr Madina Karimova, Quality Assurance Manager at Sanofi shared her opinion on PDA’s TR 90 report, highlighting parts she found valuable.

Documentation 87

Documentation Pharmaceutical Manufacturing 87

pharmaphorum

SEPTEMBER 2, 2020

The 3rd Lab Asset & Facility Management in Pharma will return this Winter as your ONLY industry led meeting focusing on R&D asset and FM, enabling you to regain control of your assets , optimize your space and benchmark best practices to stay ahead of the curve. What’s New in 2020? Streamed Content.

Drug Development 52

Drug Development 52

European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Immunity Immunization 52

STAT

MARCH 26, 2024

There were nearly 28,000 additional doses of pills for “self-managed” abortions in the six months after the fall of Roe, more than four times the number of pills per month that were reported before the decision. Meanwhile, the Biosecure Act, designed to reduce U.S.

Drug Pricing 229

Drug Pricing Insurance Coverage and Processing Diabetes Pharmaceutical Companies 229

Express Pharma

MAY 18, 2024

This is particularly concerning in regions with inadequate monitoring and wastewater management capacity. Wastewater discharge measurement is essential for designing production facility-specific interventions and assessing the success of reduction and wastewater treatment efforts.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

GMPSOP

AUGUST 15, 2023

Effective use of those actives requires a clear recognition and understanding of the hazards, how to manage the associated risks and adequately control employee and patient exposure. Uncertainty and lack of clarity regarding requirements can result in inconsistent application of design and operation standards.

Dosage 40

Dosage 40

Pharmaceutical Technology

APRIL 25, 2023

The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US. The audit was focused on the quality management systems and platform AAV manufacturing process of the facility. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharma Pathway

DECEMBER 1, 2022

At Endo our investment in state-of-the-art equipment and facilities, commitment to ethical standards, and growing portfolio of products makes us a company where you can enjoy a productive career with long-term potential. Designation : Analyst/ Sr. Department: Quality Control/ Manufacturing. Analyst/ Associate/ Sr.

Dosage 87

Dosage Pharmaceutical Companies Pharmaceutical Companies 87

pharmaphorum

AUGUST 1, 2022

This article follows part one of our two-part series, where we discussed how Philips designs innovation and digital health solutions for areas of India’s healthcare system where options are sparse. . In contrast to India, there’s not only a lack of healthcare facilities, but the facilities are not offering the services needed.

Packaging 78

Packaging Communication Hospitals 78

Express Pharma

DECEMBER 15, 2023

The Waters India GCC is in a newly built facility in Bengaluru’s RMZ Ecoworld technology park, a WELL and LEED Platinum-certified campus that exemplifies a commitment to a healthy and eco-conscious workspace. T Anilkumar, General Manager, Waters India mentioned, “Opening the Waters GCC is a significant milestone for our team in India.

Vaccines 99

Vaccines 99

European Pharmaceutical Review

MARCH 5, 2024

He asserted that the biotech plans to handle this by “operating our own manufacturing facilities for both small molecule medicines and large molecule biologics to support ongoing clinical research and global commercialisation of our internally developed medicines.”

Medical Schools 91

Medical Schools 91

Integra X Files

APRIL 17, 2023

In the context of long-term care pharmacy, COT refers to the various types of facilities or settings where medications are provided and billed. There are also wholesalers, retail pharmacy, specialty pharmacy; various divisions within each of these may fall into their own COT, such as for-profit, not-for-profit, and government facilities.

Specialty Pharmacies 87

Specialty Pharmacies Hospitals 87

European Pharmaceutical Review

AUGUST 29, 2022

During the design process, spent media samples can be analysed for amino acids and nutrients to fine-tune the media based on the cells’ needs” However, some groups want to use their own current media as a starting point for further optimisation. Discussions with the client enables the right service to be selected for their needs.

Process Improvement 87

Process Improvement 87

European Pharmaceutical Review

AUGUST 2, 2023

The authors explained that an innovative analytical strategy is essential for building resilience and managing risks in manufacturing quality as well as for gaining competitiveness in the industry. Therefore, designing an instrument that reduces sample and reagent consumption to a few microliters is more advantageous, Wu et al.

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Fuld & Company Blog

SEPTEMBER 5, 2023

Years off its R&D time and win new business A leading industrial polymer manufacturer sought to reduce costs and minimize its environmental impact by improving its waste management processes. Delivering sustainable innovation How we helped a leading industrial polymer manufacturer cut 1.5

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pharmaphorum

JULY 25, 2022

Approximately 75% of the population resides in rural tier two and tier three cities and villages in India, and less than 20% of the country’s medical facilities are in those regions, creating an enormous imbalance and leading to immense inaccessibility for millions of rural residents. Not so much in tier two and tier three.”.

Communication 116

Communication Hospitals 116

GMPSOP

OCTOBER 16, 2022

Table of Contents Contamination control is taken extremely seriously by the GMP facilities as it can adversely affect the quality and safety of food and drugs they produce. How to prevent cross-contamination in GMP facility? You must take numerous preventive measures to reduce or eliminate cross-contamination risks in GMP facility.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

European Pharmaceutical Review

NOVEMBER 9, 2023

Through process optimisation and investment in such technologies, MSD’s Dublin Biotech site has managed to “triple output annually,” site head Liam Dunne explains. When it comes to biologics, scaling up production to ensure global supply is a remarkable process that embodies Industry 4.0

Biosimilars 80

Biosimilars Drug Development 80

Pharmaceutical Business Review

JULY 19, 2023

Funding for this deal was provided via the expansion of Harrow’s secured credit facility with funds managed by Oaktree Capital Management. Funding for this deal was provided via the expansion of Harrow’s secured credit facility with funds managed by Oaktree Capital Management.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Express Pharma

NOVEMBER 7, 2023

Corporate Capital Ventures has been designated as the Book Running Lead Manager to the issue while KFIN Technologies is the Registrar. The new facility is expected to be commercialised by April 2025.” The offering consists of a fresh issuance of 56,00,000 equity shares with a face value of Rs 10 for each share. crores in FY22.

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Pharma Pathway

DECEMBER 5, 2022

Facility Management (Production). Designation: Executive/ Sr. Manager/ Assistant Manager. We are Conducting Walk-In Interview On 11th Dec’ 2022 for multiple openings in Biologics Operations (Upstream/ Down stream- Production). Details are Below; Upstream (Production). Downstream (Production). Executive/ Jr.

Vaccines 80

Vaccines 80

Pharmaceutical Technology

JUNE 19, 2023

A few aspects that are oftentimes overlooked include the importance of mapping all of the lanes from your depot or storage facility to the clinic, but also who will be met at the site and where. Designing a world-class gene therapy suite Cryostorage is an important feature of any advanced therapy facility.

Packaging 52

Packaging Compounding Communication Pharmaceutical Companies 52

pharmaphorum

JANUARY 6, 2021

In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer. In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years.

Hospitals 119

Hospitals Communication 119

Express Pharma

APRIL 11, 2023

DCTs leverage digital technologies to enable patients to participate in clinical trials from the comfort of their own homes or nearby medical facilities, instead of having to travel to a centralised trial site. However, as the adoption of DCTs increases, so do the challenges associated with implementing and managing them.

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