European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

Dosage 77

Dosage Packaging Compounding Labelling 77

European Pharmaceutical Review

JUNE 23, 2023

A report published by BioPhorum titled ‘ Minimizing the impact of bioburden and sterility testing on gene therapy batch yield ’ offers recommendations for reducing the volumes required for testing. Challenges in bioburden testing Gene therapy manufacturing processes result in low yields, particularly in early product development stages.

Documentation 72

Documentation 72

The Pharmacist

JULY 10, 2023

A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging. But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box.

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Dosage Labelling Packaging 74

European Pharmaceutical Review

APRIL 29, 2024

This work is relevant for microbial testing of short shelf-life products, where reliable microbiological testing is difficult. BET sustainability from your endotoxin experts Associates of Cape Cod International showcases its services and its endotoxin testing capabilities. Interested? Register your details to download a copy.

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European Pharmaceutical Review

FEBRUARY 16, 2024

The traditional batch process was compared with end-to-end continuous bioprocesses with either protein A (ProA) capture or column-free capture, employing aqueous two-phase extraction (ATPE) or precipitation from economic, environmental, and robustness perspectives. Neves et al. An increase in consumables usage in continuous mode was observed.

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European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. The affected batches are: Mexiletine hydrochloride 50mg Hard Capsules, PL 31644/0027.

Documentation 87

Documentation 87

STAT

JANUARY 10, 2023

Continue to STAT+ to read the full story…

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Express Pharma

NOVEMBER 13, 2023

Leaders in medical device assembly are pioneering solutions with unprecedented capabilities to produce multiple product types, facilitating small-batch flexibility without compromising on productivity. Materials glide on independently controlled shuttles, adapting to the new product or packaging seamlessly.

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Packaging Communication 104

Express Pharma

AUGUST 21, 2023

The integration of the current distribution hub with new manufacturing operations features cGMP suites, quality testing, warehousing of certified products, batch-to-batch traceability, and customised palletization capabilities. The post Avantor inaugurates expanded Singapore hub appeared first on Express Pharma.

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Drug Development 86

Express Pharma

SEPTEMBER 5, 2023

Recommending an immediate halt in its use, the advisory states, “Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product.” State drug controllers have also been told to closely monitor the movement, sale, distribution, and stock of these specific drug products in the market.

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PharmaTech

DECEMBER 2, 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.

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Documentation 52

Express Pharma

JANUARY 29, 2024

The company informed that the DSIR approved research laboratory is equipped with the latest molecular and formulation research tools, microbiology testing facilities, sterile batch production capacity, and high-end quality assurance/quality control analytical equipment.

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Research Laboratories 73

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 68

Documentation 68

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.

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Vaccines Documentation 131

PharmaTech

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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Pharmaceutical Business Review

JANUARY 25, 2024

The facility is designed to bolster in-house production of drug substances for Investigational New Drug (IND)-enabling studies and trials. The 20,000ft 2 facility includes a lipid formulation production suite and additional suites for mRNA and plasmid DNA (pDNA) manufacturing. Ballal said: “This marks an exciting era for Entos.

Vaccines 104

Vaccines 104

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.

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Documentation Labelling 93

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?

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Dosage Packaging 52

PharmaTech

NOVEMBER 2, 2023

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.

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PharmaState Academy

FEBRUARY 3, 2024

Interest Form For Next Batch We limit the number of participants in a batch so that high-quality interactive learning can happen. In case you have missed this batch, you can fill out the Interest form for the next batch. We will send you the information, once the registrations open for the next batch.

Communication 59

Communication 59

Pharma Pathway

MARCH 1, 2023

Sai Life Sciences Limited- Walk-In Interview for Production On 5th March 2023 Job Description Sai Life Sciences delivers advanced Discovery, Contract Development and Manufacturing Solutions, through a broad suite of expert capabilities across the molecular lifecycle. Concurrent Completion of batch process records.

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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].

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Documentation Pharmaceutical Manufacturing 89

Pharma Pathway

JANUARY 2, 2023

Aurobindo Pharma-Walk-In Interviews for Freshers in Production/ Packing On 4th Jan’ 2023. Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. Walk-In Interviews for Freshers in Production/ Packing Department @ Aurobindo Pharma. Job Description.

Pharmaceutical Manufacturing 90

Pharmaceutical Manufacturing 90

GMPSOP

AUGUST 16, 2023

Process Validation Guidelines for Formulated Products Pharmaceuticals quality assurance & validation procedures GMPSOP Process Validation Guidelines for Formulated Products The Process Validation must ensure by testing that a process is capable of repeatedly and reliably produce a formulated product of the required quality.

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Dosage Documentation 40

RX Note

MARCH 30, 2024

Introduction In general, a drug recall can be seemed as a way to protect the public from a defective or potentially harmful product. Degree II: Products with minor health risks or are substandard. Degree III: Products with other reasons for recall. Should be under an embargo within 24 hours.

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Adverse Reactions Hospitals 40

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.

Vaccines 91

Vaccines 91

Express Pharma

MARCH 20, 2024

The greatest challenge for PFS is the product nature itself. [+] West Pharmaceutical Services have specific products that cater to small batch size requirements of biologics. . [+] West Pharmaceutical Services have specific products that cater to small batch size requirements of biologics.

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Packaging Vaccines 52

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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Express Pharma

MARCH 23, 2023

GELITA has launched a fast-setting gelatin that enables a breakthrough in fortified gummy production. Branded CONFIXX, the new gelatin allows for the starch-free production of gummies with a sensorial profile that has previously only been attainable with a starch-based manufacturing process.

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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.

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epicur

DECEMBER 19, 2023

Did you know they have one of the largest 503B product portfolios in veterinary medicine? Complete Product List For easy ordering of the products your patients need. Explore our complete product portfolio of 100% manufactured 503B drugs. Printable Product List Reason two? Plus, every batch is tested.

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Pharma Pathway

DECEMBER 19, 2022

-Hiring for Freshers in Production QC/ QA Departments -Apply Now. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 78

Pharmaceutical Business Review

JANUARY 18, 2024

With the integration of advanced technology, the facility is capable of handling various batch sizes, both fed-batch and perfusion. Eurofins CDMO Alphora is engaged in providing active pharmaceutical ingredients (API’s) / drug substance and drug product development for small molecules and biologics.

Packaging 59

Packaging 59

Express Pharma

AUGUST 23, 2023

Large-scale biotechnology production presents distinct and complex process and automation challenges. These processes adhere to strict regulatory guidelines to ensure product quality, and ABB’s System 800xA solution reduces manufacturing errors and ensures high-quality yields.

Vaccines 95

Vaccines 95

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.

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Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

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 90

Compounding 90

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.

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Immunity Immunization 92