Pharmaceutical Technology

DECEMBER 8, 2022

Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market. Free Whitepaper.

Communication 122

Communication Immunization Hospitals 122

ISPE

APRIL 13, 2023

A flexible simulator also allows users to append and customize the kinetic rate expressions as needed. This process simulation approach is especially advantageous during late-stage process development and manufacturing. Topics in Chemical Engineering, 2003. These calculations are then shared with the environmental agencies.

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Compounding FDA 98

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. The continued use of paper validation in a Pharma 4.0

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Documentation FDA 98

European Pharmaceutical Review

DECEMBER 22, 2022

Advances in mRNA technologies and cellular delivery systems coupled with their cost effectiveness, manufacturing simplicity and ability to target previously-undruggable pathways has limitless potential that could revolutionise medicine. Manufacturing time for mRNA therapeutics is also fast compared to antibodies or protein-based drugs.

Vaccines 105

Vaccines Immunization Hospitals 105

ISPE

SEPTEMBER 8, 2023

Please note that views expressed by the panelists are not necessarily representative of the position of the FDA, and that questions and responses are lightly edited for clarity. Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER I don’t think many of us would want to subscribe to the concept of second air as appropriate.

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FDA Vaccines Documentation 52

Roots Analysis

AUGUST 29, 2023

As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. Overview of Biopharmaceuticals Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources.

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Roots Analysis

AUGUST 29, 2023

As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. Overview of Biopharmaceuticals Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources.

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Hospital Pharmacy Europe

AUGUST 17, 2023

In the last decade, immunotherapies that treat cancers using the patient’s immune system to recognise, attack and kill malignant cells have reached the market. 10 Once the CAR T-cells are manufactured, they are delivered to hospital pharmacies, making pharmacists central in ensuring appropriate governance and management.

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Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

ISPE

NOVEMBER 23, 2022

The Regulatory Challenges in ATMPs session provided a diverse set of perspectives on regulatory/quality topics as it pertains to late stage/commercial ATMPs, primarily autologous cell therapy.?The Melanie Eacho, Cell Therapies Branch Chief within the Office of Tissues and Advanced Therapies (OTAT) , US FDA/CBER.

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FDA Documentation 52

The FDA Law Blog

JUNE 22, 2023

However, even if an IVD sponsor is willing and able to provide robust data addressing all of these topics, in our experience, CDRH is nevertheless concerned about whether the test, by the nature of its intended use, is appropriate for consumers. See Steven R. This makes seeking clearance of an OTC home test a risky business endeavor.

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FDA Labelling Hospitals 59

Omnicell

SEPTEMBER 5, 2022

Unarguably, the safest-to-use IV medications are those arriving at bedsides in ready-to-administer (RTA) formulations that have not been manipulated between drug manufacturer production lines and drug lines dripping into patients. Fortunately, this is where THRIV comes to play.

Compounding 52

Compounding Sterile Compounds Compounding Pharmacies Documentation 52

ISPE

APRIL 19, 2023

Who oversees the different activities such as construction, commissioning, qualification and validation, equipment manufacturing, IT systems, and other technical aspects of the project? Perform an Impact Systems Analysis. The systems and equipment are classified according to their risk for product quality and patient safety.

Documentation 52

Documentation Communication 52

European Pharmaceutical Review

JULY 20, 2023

However, Batty observed that challenges and ‘unknowns’ include long term efficacy and the duration of expression. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing. Batty also mentioned considerations for improving access to gene therapies.

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FDA 58

Omnicell

SEPTEMBER 5, 2022

It required pharmaceutical manufacturers to enter into an agreement, called a pharmaceutical pricing agreement (PPA), with the HHS Secretary in exchange for having their drugs covered by Medicaid and Medicare Part B. Please visit Omnicell's Webinars to learn more about 340B and other healthcare topics. Add link to Omnicell's Webinars.

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Omnicell Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. Effect of Cannabidiol on Cyclooxygenase Type 1 and 2 Expression and Function in Human Neutrophils. The Journal of Headache and Pain. 2023 Dec;24(1):1-5.

Compounding 84

Compounding Documentation Insurance Immunization 84

ISPE

MARCH 28, 2023

The five experts discussed this topic from different angles, expressed their opinions freely, and actively offered suggestions while also providing suggestions. Mr. Gao Xiaowei moderated the discussion session, Ms. Lynn Wang, Head of Project and Alliance Management of Wuxi Bio；Ms. Shi Yun, QA Manager of Restone Biomedicine Co.,

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

The five experts discussed this topic from different angles, expressed their opinions freely, and actively offered suggestions while also providing suggestions. Mr. Gao Xiaowei moderated the discussion session, Ms. Lynn Wang, Head of Project and Alliance Management of Wuxi Bio；Ms. Shi Yun, QA Manager of Restone Biomedicine Co.,

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

The Thyroid Pharmacist

AUGUST 4, 2023

In fact, it’s present in up to 55 percent of the European population, is naturally occurring, and often has no negative health consequences – unless expressed. [1] While we can’t change our genes, I can tell you that we can absolutely change their expression! When I first saw my test results, I thought to myself, I have bad genes.

Insurance 105

Insurance Immunization Insurance Coverage Dosage 105

The People's Pharmacy

MAY 1, 2023

The opinions he expresses are his own. Our medical system is based on a fast-food-like model of herding patients/customers. The Profit Motive Prioritizes Treatment Rather than Prevention: We need to remove the profit motive from our medical system by adopting national health care like most other advanced nations.

Health and Personal Care Stores 64

Health and Personal Care Stores Insurance Refill Authorization Insurance Coverage 64

European Pharmaceutical Review

FEBRUARY 23, 2023

Given the widely reported challenges of validation and qualification of microbiological methods, as well as lab compliance and keeping up with compendial amendments, I have steered away from these topics here. Currently entering the market are ‘robotic’ systems that perform environmental monitoring, cleaning and disinfection processes.

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Dosage Vaccines 94

Roots Analysis

AUGUST 31, 2023

Gene switches are sites on genes where regulatory molecules can bind to trigger transcription process, leading to expression of a particular gene. Further, the expression of any gene is dependent on the rate at which it is transcribed into mRNA and translated into proteins.

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Compounding Immunization 40

The Checkup by Singlecare

AUGUST 5, 2023

Potential risks of genetic damage, immune system activation, and misuse are very real. You have every right to be interested in this topic, and as with any polarizing issue, it is best to be well-informed. Our immune system is capable of killing cancer cells; in fact, it is our natural surveillance system to prevent cancer.

Immunization 52

Immunization FDA 52

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

PharmaShots

FEBRUARY 27, 2023

Mekala Rao (Chairman – Technology Global PHT Expo & Summit – 2023 and President – Atachi Systems, USA) – “motivation to attend Global PHT is to understand the cultural gap in the production of innovative medicine, healthcare systems between eastern and western world.

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Packaging Hospitals FDA Pharmaceutical Companies 40

The FDA Law Blog

JANUARY 5, 2023

It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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FDA Hospitals 59

ISPE

OCTOBER 27, 2022

Regardless of whether you are a part of the Manufacturing, Sales, Quality, HR, IT (not intended to align with stereotypes above) or any organization we all ultimately have the same goal - fulfill a patient’s unmet need in a safe and efficacious way. Now try to imagine it completely differently. What would it look like? The Culture Club 1.

Documentation 52

Documentation 52

ISPE

NOVEMBER 30, 2022

Making Maintenance a True Asset in Pharma Manufacturing Through Digitalization. Making Maintenance a True Asset in Pharma Manufacturing Through Digitalization. Figure 1 shows where PPM fits relative to system performance and quality assessment in an APM strategy. Trudy Patterson. Wed, 11/30/2022 - 14:39. iSpeak Blog.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

AUGUST 26, 2022

28,29-33) Gut infections can impact nutrient absorption, metabolism, mitochondrial health, and the immune system. (28) These types of infections impact the immune system and can become triggers for autoimmunity; they can also disrupt ongoing metabolic processes. Gut bacteria balance can also be affected by gut infections such as H.

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Immunization Chemotherapy Insurance Dosage 86