European Pharmaceutical Review

MARCH 19, 2024

The research explained that companies are looking to reduce manufacturing costs and increase productivity, which is driving implementation of this type of bioprocessing. These advancements “aim to optimise productivity, increase yield, and enhance product quality while reducing overall production costs.”

Documentation 69

Documentation 69

Fierce Pharma

JULY 18, 2023

In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. In tandem with Taiwan’s Food and Drug Administration, GSK this week initiated a recall of two batches of its severe asthma injection Nucala after glass fragments were found in a vial of the drug.

Packaging 80

Packaging 80

pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. Early commercial batches of Pfizer/BioNTech’s COVID-19 vaccine had lower than expected levels of intact mRNA.

Vaccines 138

Vaccines Documentation 138

BioPharm

DECEMBER 1, 2023

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Documentation 52

Documentation 52

European Pharmaceutical Review

FEBRUARY 6, 2024

These are discussed in EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products. Update January 2019: This Q&A has been superseded by the Guideline on The Sterilisation of the medicinal product, active substance, excipient and primary container. What is the maximum bioburden level?

Packaging 52

Packaging Dosage 52

European Pharmaceutical Review

JULY 4, 2023

The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.

Documentation 94

Documentation Labelling 94

BioPharm

NOVEMBER 1, 2023

Sara Fathollahi, PhD, product application specialist at DFE Pharma, makes the case of how excipient suppliers can support the transition from batch to continuous manufacturing.

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STAT

JANUARY 6, 2023

Continuous manufacturing produces a drug product from start to finish through a nonstop, integrated assembly. In contrast, most of the pharmaceutical industry currently uses batch manufacturing, which involves producing a finished drug product through multiple distinct steps in series.

FDA 99

FDA 99

European Pharmaceutical Review

MARCH 13, 2024

The company’s response indicated that it would perform a retrospective evaluation of “indicators of sterility assurance… with applicable product impact assessment.” Based on its inspection findings, the FDA concluded that for instance, production staff could alter master batch records. References Warning Letters. cited2024Mar].

FDA 90

FDA Documentation 90

European Pharmaceutical Review

JULY 17, 2023

The resulting pilot-scale system is intended to improve society’s ability to respond to future pandemics as well as accelerate the development and production of mRNA technologies. However, continuous manufacturing enables a product to be made non-stop and avoids delays caused by pauses and transfers between batches.

FDA 92

FDA Vaccines 92

The FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Labelling 59

Labelling Communication FDA 59

European Pharmaceutical Review

AUGUST 25, 2022

DURING THE development of new types of active pharmaceutical ingredients (APIs) or medicinal products, scale-up at a pilot plant is an important proof of concept. Offering the opportunity to assess the efficacy of a synthesis and refine it prior to production stages, these facilities are both critical and integral to development processes.

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European Pharmaceutical Review

MAY 3, 2023

For instance, digital biomanufacturing, also known as digital bioprocessing, has become promising in helping to improve process robustness and drug product quality. This is expected to help in the creation of a uniform process, which can decrease the deviation in quality of each batch. services.

Compounding 91

Compounding 91

European Pharmaceutical Review

JANUARY 23, 2024

Key benefits of aptamers reported in the paper include their high stability and rapid production (synthesis or modification). For instance, monoclonal antibody production is costly, time-intensive and is subject to batch-to-batch variations.

Immunization 93

Immunization 93

pharmaphorum

NOVEMBER 27, 2022

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Reducing capacity issues. Cutting down on safety stock.

Communication 105

Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

STAT

SEPTEMBER 21, 2022

Following a recent month-long inspection, the agency scolded Catalent for various problems, such as failing to investigate unexplained discrepancies in batches of products and to ensure that product sampling and testing met quality control criteria.

Vaccines 91

Vaccines FDA 91

Outsourcing Pharma

JANUARY 16, 2023

The FDA found traces of a nitrosamine in batches of vonoprazan, delaying the commercialization of the product and its application for an additional indication.

FDA 52

FDA 52

European Pharmaceutical Review

AUGUST 7, 2023

While usually produced via batch manufacturing , this latter process is time-consuming, requires specialised equipment results in a large amount of waste. So a big benefit of continuous-flow manufacturing is that it is easy to adjust the production volume as needed.”

Compounding 75

Compounding Hospitals 75

European Pharmaceutical Review

FEBRUARY 12, 2024

The method was validated across numerous batches and a fed-batch bioreactor. However, the complexity of these bio-processes “are very complicated” and sometimes in practice they are “inconsistent…and any variation in the process may affect the quality and stability of the product, resulting in inestimable economic losses.”

Compounding 79

Compounding 79

Roots Analysis

MARCH 26, 2024

The drug manufacturers adopted this technology either as a full replacement of batch process or as a part of hybrid. The process allows the manufacturing of pharmaceutical products 24×7 without any hold time. This technology provides a product with improved quality assurance and high product consistency.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

European Pharmaceutical Review

OCTOBER 16, 2023

Further details of the ADC filling line agreement Under an extended customer agreement, construction of the new line will enable commercial supply of these products. When the news was announced, Lonza stated the first batches were planned to be fulfilled in April 2023. The new filling line is projected to be operational in 2027.

Compounding 94

Compounding 94

ISPE

APRIL 13, 2023

Another important component is unstructured macroscopic kinetic models that capture cell culture performance including biomass growth, substrate consumption, and both growth and non-growth associated product formation, enabling the rate of change of different biomass states to be tracked. Sustainability by design for pharmaceutical products.”

Compounding 98

Compounding FDA 98

BioPharm

MAY 16, 2023

Transferring from a conventional batch mode to a multi-column chromatography (MCC) process significantly increases the productivity of the Fab fragment capture.

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40

European Pharmaceutical Review

APRIL 30, 2024

The World Health Organization (WHO) has published a new draft guidance on mitigating nitrosamine contamination in pharmaceutical products. Risk and impact assessment should be done with root cause determination”, alongside investigation to determine whether shared facilities, equipment or other batches have been contaminated.

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57

Omnicell

JANUARY 10, 2023

Bethany Donato Director, Product Marketing On November 1, the U.S. The latest revisions, which take effect November 1, 2023, exempt some robotic devices from surface sampling after every batch of Category 3 compounded sterile products (CSPs) and instead allow users of self-enclosed robotic devices to surface sample once per day.

Sterile Compounds 98

Sterile Compounds Compounding Omnicell Patient Care 98

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

based virtual biopharmaceutical company, who develops drug candidates for neurological diseases, to oversee the Quality and Compliance aspects for the Drug Substances and Drug Products in various phases of Product Development. The development batches were outsourced from multiple vendors in India.

Documentation 40

Documentation Communication 40

European Pharmaceutical Review

JULY 7, 2023

Turpentine is also a waste product from the paper industry. Pharma within planetary boundaries Benefits of sustainable turpentine-based pharmaceuticals The researchers hope that this more sustainable , ‘biorefinery’ approach could replace the need for crude oil products in the chemical industry.

Compounding 94

Compounding 94

The FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. Last week, 11 such letters were posted in the Tuesday batch of posted Warning Letters. If FDA wanted to create that impression, it likely succeeded.

FDA 59

FDA Documentation Labelling 59

Roots Analysis

AUGUST 8, 2023

Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins, cell and gene therapy. Fed-batch mode of operations also known as semicontinuous process. What is Single-use Bioreactors?

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The FDA Law Blog

OCTOBER 27, 2022

This final guidance provides recommendations to original applicants and holders of approved applications for human drugs and certain biological products on implementing chemistry, manufacturing, and controls (CMC) postapproval changes(s) through the use of a Comparability Protocol (CP).

FDA 105

FDA Documentation 105

Pharmaceutical Technology

AUGUST 24, 2022

To reduce batch-to-batch variations, the preferred control parameter is ribbon strength. Based on the idea that ‘consistent density means consistent product quality’, the at-gap density can also be used for development and scale-up. Figure 1: Compressibility and Bondability plot of tablets with MCC and 0.5% Conclusion.

FDA 52

FDA 52

Pharmaceutical Technology

AUGUST 10, 2022

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. They are also likely to have already worked with a similar molecule and can even anticipate the hurdles a company may face in production. Proven results??. Process Flow diagram?

Packaging 52

Packaging Communication 52

ISPE

NOVEMBER 17, 2022

The techniques used demonstrate how continuous process optimization can be enabled and the process control strategy is permanently updated while keeping product quality under strong assurance and also increasing energy savings and productivity. Drying the product is when the water evaporation takes place. Background.

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98

European Pharmaceutical Review

OCTOBER 19, 2023

EMA stated that the pens have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs. According to the Medicines and Healthcare products Regulatory Agency (MHRA) all counterfeit pens identified at (two) UK wholesalers have been recalled; none of the pens have been supplied to UK patients.

Labelling 95

Labelling 95

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient.

FDA 92

FDA 92

Pharmafile

AUGUST 23, 2022

million contract with an unnamed major global pharmaceutical client, to manufacturing a new batch of H1N1 flu challenge virus, and to conduct a human challenge trial to test the client’s antiviral product. Open Orphan has announced that its subsidiary hVIVO has signed a £10.4 read more.

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52

ISPE

JUNE 15, 2023

Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™ ™ & Your Organisation’s Digitlization Journey Trudy Patterson Thu, 06/15/2023 - 09:27 iSpeak Blog iSpeak Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™

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