Biopharmaceuticals Downloads
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Environmental Monitoring Handbook for Pharmaceutical Manufacturers - Application Notes
Covering everything from the technology of particle counting, to the regulatory standards that apply to the pharmaceutical manufacturing industry, to the instrumentation and techniques needed to meet them. This premier handbook helps readers understand the topic of environmental monitoring more holistically and more extensively. With the release of the much-anticipated EU GMP Annex 1 2022 ...
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The New EU GMP Annex 1 Revision 2017 Comments from Industry Experts - Applications Note
The updated EU GMP Annex 1 Draft was released for public comment in December 2017, and the industry experts at Particle Measuring Systems have shared their response on the ...
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Classification, Qualification and Monitoring According to EU GMP Annex 1 Rev 12 - Applications Note
The latest Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and ...
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Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements - Application Notes
Introduction Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. The importance of record-keeping in ...
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PVC Liner Panel for Indoor Cannabis Grow - Brochure
Octaform is a manufacturer of a PVC liner panel that will ensure the facility will perform well and meet all compliance requirements / GMP considerations. PVC is essential as it has been proven in cannabis production, pharmaceutical and even surgical facilities because it has the lowest propensity to accumulate molds and other pathogens. In cannabis, it has the added benefit of offering high ...
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IVDR: our next Challenge? - Brochure
With the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) becoming applicable in May 2022, the European Bioanalysis Forum, as many others, is looking at the impact of this regulation on (bio)pharmaceutical drug research and development. Already, we observe a growing concern of the industry on potential scope creep of the IVDR into early clinical studies for assets where it is believed the ...
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Vaccine Assays 2024 - Brochure
Immunogenicity assays play a vital role in evaluating the safety and efficacy of vaccines by measuring the immune response induced in vaccinated individuals, and serve as crucial tools in vaccine development, clinical trials, licensure, and post-marketing surveillance. Various methods are employed in vaccine immunogenicity assays, ranging from traditional techniques like LBAs to advanced ...
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Bio Reme - Bioculture for Pharma - Brochure
Bio Reme Pharma is very much effective for partial degradation and sustaining of biodegradable solvents, microbicides, antimicrobial substances and drugs intermediated in low concentrations. Bio Reme Pharma is capable to withstand high shock load which is happens due to change in production and R & D of new products in pharmaceutical, Nutraceuticals, Formulations, Antibiotics & Drugs, and ...
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CPC AseptiQuik C Spec Sheet
AseptiQuik® C Connectors provide quick and easy sterile connections, even in non-sterile environments. AseptiQuik® C connectors’ “CLICK-PULL-TWIST” design enables users to transfer media easily with less risk of operator error. The connectors’ robust design provides reliable performance without the need for clamps, fixtures or tube welders. Biopharmaceutical ...
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Croyez - Model GMP IL - 1 Beta (Interleukin-1 Beta), Human Protein - Brochure
Interleukin-1 beta (IL-1β) also known as leukocytic pyrogen, leukocytic endogenous mediator, mononuclear cell factor, lymphocyte activating factor and other names, is a cytokine protein that in humans is encoded by the IL1B gene. There are two genes for interleukin-1 (IL-1): IL-1 alpha and IL-1 beta (this gene). IL-1β precursor is cleaved by cytosolic caspase 1 (interleukin-1 beta ...
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Croyez - Model GMP IL - 2 (Interleukin-2), Human Protein - Brochure
Interleukin-2 (IL-2) is an interleukin, a type of cytokine signaling molecule in the immune system. It is a 15.5-16 kDa protein that regulates the activities of white blood cells (leukocytes, often lymphocytes) that are responsible for immunity. IL-2 is part of the body's natural response to microbial infection, and in discriminating between foreign ("non-self") and "self". IL-2 mediates its ...
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SIM-Teq - Model GMP-25TD - Contamination Probe Training Device - Brochure
Simulates features and functions of the Mirion GMP-25 External Pancake Probe when connected to SIM-Teq RDS-31TD. Realistic response based on source/detector geometry. Detects simulated α, β, or α+β Contamination Sources. Demonstrates saturation when detector response is > 50,000 cps. Use with any SIM-Teq RFID contamination source(s) OR respond to TWR source or control ...
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DPTE?? System Brochure
Manufacturing technologies are pushing productivity further with ever higher demands on throughput. GMP requirements are also getting stricter. Pharmaceutical companies must find methods to minimize microbial and particle contamination while keeping up the pace in production. As a result, isolators are now the gold standard for the production of aseptic or toxic products in pharmaceutical ...
By Getinge AB
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LeKrius 3D Storage Bag - Brochure
The multi-layer co-extrusion film used for the 3D storage bags ensures extremely low gas transmission, good physical strength, excellent chemical compatibility and biocompatibility of the aseptic storage bags. The bags can be safely used for storage and transport of various biopharmaceutical liquids. The standard 3D storage bags are available in various types and specifications from 50 L to 3000 ...
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Nuclear Magnetic Resonance (NMR) in Biopharmaceutical Analysis
Nuclear magnetic resonance (NMR) plays an irreplaceable role in drug research, development, and manufacturing. lt gives information on the three-dimensional structure, interaction, and molecular dynamics of the organic molecules in a liquid, solid, gaseous state, and even in-situ biological environment. ...
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Tema Safeflow - Class II Biohazard Safety Cabinet - Brochure
SAFEFLOW is a Class II biohazard safety cabinets with a GMP grade A laminar flow, with different shielding configurations; it is designed for the manual preparation of Nuclear Medicine radiopharmaceuticals injectable doses. ...
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Tema - Model SYNT - Synthesis Modules Hot Cell Systems - Brochure
SYNT cell has been designed to host automatic radiopharmaceutical synthesis modules, offering a controlled and safe environment in compliance with the latest GMP guidelines. Its inflatable seals are granting an ISO 10648:2 air tightness while the ventilation system provides a GMP class B clean air environment. ...
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Tema - Model NMC DSI - PET/Nuclear Medicine Manipulation Cell System- Brochure
The laminar flow shielded isolator Mod. NMC DSI has been specifically designed for both manual and automatic pharmaceutical preparation of FDG doses for PET diagnostics and conventional Nuclear Medicine isotope doses, according to the GMP standard procedures. ...
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Tema - Model DHC - Dispensing Hot Cell System - Brochure
DHC is a GMP grade A shielded isolator, with vertical laminar flow all over the working area, dedicated to radiopharmaceuticals dispensing processes in a controlled and safe environment. DHC was first conceived to provide the most relevant radiopharmaceutical companies a total laminar flow dispensing shielded isolator compliant with the latest GMP, USP and FDA regulations. ...
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Tema - Model NEXT - Fully Automatic Dispensing Unit for Vials and Syringes - Brochure
From pharma to nuclear medicine: the Radio-protection reborn; NEXT is the groundbreaking combo of a non-shielded isolator with a shielded automatic dispenser: from Pharma to Nuclear Medicine, a fully GMP-compliant aseptic process with a smart shielding solution for a cutting-edge approach to radio-protection. ...
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