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Syringe Filters in Drug Development: Purity for Pharmaceutical Success

Good Manufacturing Practices: Aseptic and Sterile Processing May 2, 2020 · Taking the proper steps to comply with current good manufacturing practices (cGMPs) for aseptic and sterile processing i...
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Good Manufacturing Practices: Aseptic and Sterile Processing

May 2, 2020 · Taking the proper steps to comply with current good manufacturing practices (cGMPs) for aseptic and sterile processing in an efficient and effective manner is necessary for pharmaceutical manufacturing facilities and labs. Pharmaceutical Technology Europe spoke with Ulrich Herber, senior global product specialist manager for Microbial Solutions

All about Pre-filled Syringe Systems - PDA

drug’s development and launch is delayed1 Drug development takes a long time Bringing a New Drug to Market is Complex and Costly Drug development is increasingly risky Increasing costs › It can cost $2.6 billion to bring a new drug to market1 › It takes an average of ten years from discovery to market2

Progress in biopharmaceutical development - PMC

Nov 2, 2017 · The purity of the active ingredient in a pharmaceutical drug and the composition of the final product can be verified relatively easily. Highly pure chemical substances from various sources, including those composed of a mixture of isomers, can be generally considered similar or even identical for practical purposes 1 .

Sterile Injectables Device and Packaging Trends

Mar 14, 2022 · The global injectable drug-delivery device market, which includes conventional syringes, needle-free injectors, autoinjectors, pen injectors, and dual-chamber devices (powder and liquid), is expected to grow from $15.38 billion in 2020 to $17.13 billion in 2021 at a CAGR of 11.4% and $25.79 billion in 2025 (CAGR of 10.8% from 2021 to 2025). 2.

Acrodisc MS Syringe Filters Used in a Clinical Test - Pall

Oct 7, 2021 · The drug flutamide is an orally active anti-androgen used for the management of metastatic carcinoma, in particular the treatment of advanced prostate cancer. Unfortunately, like many oncology drugs, it has serious side effects that need to be managed. Chief amongst these is severe hepatotoxicity mediated by the drug’s toxic metabolites.

Sample filtration for superior HPLC performance. - MilliporeSigma

a large dead volume of the filter unit. Therefore, small filter units are the right choice. Spartan 13 decreases the dead volume to less than 10 µl. The Mini-UniPrep offers an innovative product for small volume sample preparation. This syringe-less filter unit is made for volumes up to 400 µl.

Insights and Resources - Patheon pharma services

Small molecule drug development has changed substantially in recent years. With the heightened focus on molecularly targeted therapies, small molecule active pharmaceutical ingredients (APIs) and drug products are more complex and potent than ever, requiring increasingly specialized manufacturing processes and drug delivery solutions.

Filter selection for dissolution testing | Cytiva

Filtration is central to drug dissolution testing in pharmaceutical quality control (QC) and drug development. Dissolution testing determines how fast a drug is released from the dosage format by measuring the amount of active pharmaceutical ingredient (API) dissolved at specific time points as samples are withdrawn from the dissolution vessel.

13 Millimetre Syringe Filter Improves Testing Accuracy for

Feb 28, 2013 · The new 13 mm size, which is designed specifically for small sample analysis using LCMS, complements Pall’s current Acrodisc MS syringe filter offering of a 25 mm filter. The 13 mm Acrodisc MS syringe filter improves the accuracy of testing, enhances LCMS performance and extends the longevity of testing instrumentation. The low extractable

Considerations for Sterile Filtration of Biologic Drugs

Jul 2, 2019 · Pharmaceutical Technology, Pharmaceutical Technology-07-02-2019, Volume 43, Issue 7. Sterile filtration is often required for biologics but presents degradation and compatibility challenges. Selection of a sterilization strategy for a drug product that requires aseptic manufacturing is generally determined by the stability of the drug substance.

Filter Validation Studies for Pharmaceutical QC – Factors

The objective of this study was to provide guidance on filter selection during method development and validation with a special emphasis on analyte binding to syringe filters. The following membrane and analyte characteristics were evaluated as part of this study: Choice of membranes Effect of physico-chemical properties of analyte

Pharmaceutical Membrane Filtration Systems | American

The membrane filtration systems used in the pharmaceutical industry must meet stringent regulatory requirements to ensure the safety, efficacy, and purity of the final drug product. Thus, choosing the right pharmaceutical membrane filtration system is essential for achieving high-quality drug production. Showing 8 of 8 products.

Synthesis and Anti-Inflammatory Activity Evaluation of Some

Nov 10, 2022 · Hyper-inflammation aggravates the symptoms of both communicable and non-communicable diseases. Therefore, anti-inflammatory compounds may have wide therapeutic application. Benzimidazole is a privileged scaffold and its success in drug development is evident from the long list of benzimidazole-based drugs with wide range of applications. This study was undertaken to develop new small molecules

Millex® Syringe Filters - MilliporeSigma

Millex. Syringe Filters. Setting the standard in small-volume filtration (1-200 mL), the unsurpassed consistency of Millex ® syringe filters in sample preparation has led to the development of many methods specifying their use. Featuring reduced sample loss due to minimal hold-up volumes, Millex ® syringe filters are ideal for use in a

Why analyte binding to syringe filters must be studied during

Oct 13, 2020 · The easiest method for determining analyte binding to a syringe filter is to filter the sample through it and subsequently collect and analyze various filtrate fractions. Comparing these samples with a centrifuged sample that represents 100% recovery will provide information on analyte binding as well as the volume required for filter saturation.

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