Nicheoutsourcing
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The document discusses niche outsourcing, specifically outsourcing cell banking and characterization. It notes that niche outsourcing allows companies to avoid resource constraints and focus on core competencies. It then provides details on the regulatory requirements and testing involved in cell banking, characterization, and establishing master and working cell banks for different cell types including mammalian, bacterial, human, primate, insect, and E. coli cells.
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LinkedIn: https://www.linkedin.com/company/quality-assistance
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This document discusses biosafety testing for cell and gene therapies performed by BioReliance, a testing services division of Merck KGaA. It outlines the comprehensive testing performed at various stages of development, including testing of cell banks, viral vectors, and final drug products. Testing evaluates important product attributes like identity, purity, potency and residuals to ensure safety and quality. A wide range of assays are used to characterize products and identify potential contaminants.
TestGene catalogue
Main file> http://www.slideshare.net/rustradeESP/testgene
TestGene develops and manufactures kits for molecular genetics. Products are intended for use in research, practical medicine, and in the fields of molecular biology. The focus area – non-invasive genetic testing in obstetrics and oncology. The company has its own production laboratory with the necessary equipment for manufacturing and quality assurance of kits based on "real time PCR".
Cell Line Development: Reducing timelines and increasing titres
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Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
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The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Development of Monoclonal Antibodies -Creative Biolabs
This document discusses several methods for developing monoclonal antibodies: hybridoma technology which fuses B cells and myeloma cells to produce hybridomas; surface display technology which uses genetic engineering to display antibody fragments on surfaces like phage, bacteria or yeast for screening; and transgenic technology which uses transgenic mice to produce monoclonal antibodies. It also describes Creative Biolabs' services for monoclonal antibody development including hybridoma generation and screening as well as in vitro surface display technologies.
Improved Platforms for CHO Cell Line Development
Review of the integration of CHOZN and UCOE cell line development platforms, and the performance of the combined systems.
Yeast Display Technology - Creative Biolabs
Yeast display is a novel technique widely used to express the proteins at the yeast surface after translation and maturation in a eukaryotic system. The slide named yeast display technology is created by Creative Biolabs who has established unique Ultraff™ yeast display platform to meet customers'requirement. In the slide, we will give you a comprehensive introduction to yeast display, including yeast display system, the process of yeast display system construction and application of yeast display. It is believed that you can fully understand yeast display technology after studying the slide.
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Development of quality control assays for cell-based medicinal products (ISCT...
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Development of Monoclonal Antibodies -Creative Biolabs
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Viral clearance studies are important for evaluating the safety of biopharmaceutical products during development and should become more stringent as the product progresses through clinical trials. Early phase studies emphasize safety and use model viruses to evaluate individual purification steps, while later phase studies treat viral clearance as part of overall process validation and use multiple viruses to model unknown contaminants. Key considerations for viral clearance studies include risk analysis, selection of critical manufacturing steps to evaluate, choice of model viruses, validation of scaled-down process and assays, and interpretation of virus reduction factors at each step. Regulations and guidelines provide recommendations on the appropriate scope and design of viral clearance studies during different phases of product development.
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This document discusses biosimilar medicines. It defines biosimilars as medicines similar to existing approved biopharmaceutical medicines. Biosimilars have similar quality, safety and efficacy profiles but are not identical. Their development and approval process is more complex than for generics due to the biological nature of biopharmaceuticals which are sensitive to manufacturing changes. Guidelines from the European Medicines Agency provide recommendations on demonstrating biosimilarity in terms of quality, non-clinical and clinical testing. Ensuring biosimilars are highly similar seeks to guarantee their safe substitution for biopharmaceuticals while increasing treatment access and lowering costs.
Usp 36 Chapter 1116 environment monitoring
Merupakan penggalan USP 36 chapter 1116 mengenai Microbiological Control And Monitoring Of Aseptic Processing Environments
Untuk mendapat softcopy atau informasi lebih lanjut silahkan hubungi delli.intralab@gmail.com
Microbial bioprocessing
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Upstream process
The document discusses the upstream oil sector, which involves searching for and extracting crude oil and natural gas. It describes the process of using 3D seismic investigations to identify oil reserves underground, then drilling oil rigs to access the oil. There are different types of rigs used for onshore versus offshore drilling. The drilling process involves installing casing pipes and other equipment to prepare the well for production.
Inprocess quality control tests for biological products
The document discusses quality control tests for various biological products like vaccines, blood products, toxins, antitoxins, allergens and in-vivo diagnostics. It provides details of tests like sterility testing, purity testing, detoxification testing, and assays to test for properties like immunoglobulin content, hemoglobin level, platelet count, and allergenic activity.
Lecture 1 introduction
Industrial microbiology involves using microorganisms to produce valuable products through fermentation. The lecture discusses fermentation processes and products. Key points:
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2. The fermentation process involves selecting microorganisms, culture media, growth conditions, and downstream processing to harvest and purify products.
3. Major fermentation products include antibiotics, vitamins, organic acids, alcohols and recombinant proteins. High value biopharmaceuticals produced in mammalian cell culture are a growing market.
Pharmaceutical Documentation
This document discusses the importance of good documentation practices in the pharmaceutical industry. It defines documentation and outlines the types used, including documents, records, guidelines and policies. Good documentation ensures traceability and compliance. Key aspects include legible, accurate writing and signatures with dates. Changes must be clearly indicated without obscuring original records. Good documentation benefits include quality assurance, compliance and training.
upstream & downstream process of antibiotics
The document discusses upstream and downstream processing of antibiotics, hormones, and vaccines. Upstream processing involves fermentation and includes inoculum preparation, culture media development, and fermentation. Downstream processing refers to product recovery, purification, and formulation stages after fermentation. These include steps like separation, concentration, purification. The document provides details of these processes for antibiotics like penicillin, hormones, and vaccines.
Quality control tests for tablets
The document discusses various quality control tests that are performed on tablets during manufacturing, including tests for general appearance, hardness, friability, weight variation, content uniformity, disintegration and dissolution. It provides details on procedures and limits for these tests according to pharmacopoeial standards like the British Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia. The tests are important to ensure tablets meet requirements for reproducibility, stability and accurate dosing of the active drug.
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This document discusses biopharmaceuticals, which are medical drugs produced using biotechnology. It classifies biopharmaceuticals into several categories, including monoclonal antibodies, vaccines, thrombotic agents, interferons, blood factors, and hormones. Interferons are proteins produced by immune cells in response to challenges from viruses and tumors. They help the immune response by inhibiting viral replication and activating immune cells. Interferons are commercially produced from lymphocytes isolated from blood and induced to produce interferons. Biopharmaceuticals have advantages like being highly effective, specific, and safer than other drugs, with fewer side effects. They have many commercial applications in treating conditions like anemia, cancers, hepatitis B, and more. Biopharmaceuticals
Quality Control Tests For Tablets and Capsules(QC)
This document discusses quality control tests for tablets and capsules. It describes tests for general appearance, size, shape, thickness, color, and odor. It then compares quality control tests from the British, Indian, and United States Pharmacopoeias, including tests for content of active ingredients, disintegration, uniformity of content and weight, and labeling. Specific tests are described for different types of tablets, including uncoated, enteric coated, dispersible, and modified release tablets. Common non-official tests like hardness and friability are also summarized.
Good documentation practice
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
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Vaccines provide immunity to diseases and contain agents that stimulate the immune system. There are several types including whole organism vaccines using killed or attenuated microbes, purified components like toxoids and polysaccharides, recombinant and DNA vaccines. Vaccines work by inducing both antibody and cellular immune responses. While effective, they also carry small risks like adverse reactions that researchers continue working to understand and improve safety.
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This document discusses quality control tests that are performed on parenteral products. It describes 7 key tests: uniformity of content, volume of liquid, pyrogen, sterility, clarity of solution, uniformity of weight, and bacterial endotoxin. These tests ensure parenteral products meet standards for dosage uniformity, volume accuracy, freedom from fever-causing substances, freedom from microbes, visibility of solutions, weight consistency, and limits on bacterial contaminants. The tests are important for ensuring parenteral products are safe and effective for patients.
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This SlideShare explores the full results of this study, including detailed market-by-market breakdowns of intention levels for each technology – and how attitudes change with age, location and seniority level. If you’re marketing a tech brand – or planning to use VR and wearables to reach a professional audience – then these are insights you won’t want to miss.
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Artificial intelligence (AI) is everywhere, promising self-driving cars, medical breakthroughs, and new ways of working. But how do you separate hype from reality? How can your company apply AI to solve real business problems?
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This document describes the services provided by a cell culture laboratory, including maintaining various mammalian and invertebrate cell lines, characterizing new cell lines, freezing and thawing cell lines, and evaluating contamination. The laboratory isolates and identifies various viruses, parasites, and other pathogens in cell cultures and animals. It also develops vaccines against pathogens like Coxiella burnetii, Chlamydia, and Cryptosporidium using infected cell cultures. The laboratory produces medium and large scale infected cell cultures for vaccine production.
Releasing Your AAV Therapy with Confidence: Regulatory Considerations and Key...
Watch the presentation of this webinar here: https://bit.ly/3icKkbZ
Ensuring the safety and quality of your AAV vector is of the utmost importance. Join this webinar for a high-level overview of the regulatory requirements for AAV testing throughout the manufacturing process, as well as a more detailed look at rcAAV and infectious titer assays.
Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy including: high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors.
This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication competent AAV testing and infectious titer determination by TCID50.
In this webinar, you will learn:
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Presented by:
Steven McDade, Senior Technical Specialist, Field Technology Management
Alfonso Lavorgna, Ph.D., Operations Manager, Virology Services
Vaccine Cell Bank and Virus Seed Characterization
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
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Setting up for successful lot release testing by Edmund Ang
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
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CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
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Exprssion vector
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microbial genetics
This document provides an overview of microbial genetics. It begins by defining key terms like genetics, gene, genome, and phenotype. It then discusses DNA structure and replication, explaining how DNA is copied semiconservatively. The processes of transcription and translation are described, showing how DNA is transcribed into mRNA and then translated into proteins. The document outlines gene regulation in bacteria through operons and repression and induction. It also covers mutations, mutagens, horizontal gene transfer through transformation, conjugation and transduction, and mobile genetic elements like plasmids and transposons.
SteilLinkedInResume2015
Benjamin P. Steil has over 15 years of experience in virology research. He received his Ph.D. in Microbiology and Immunology from the University of Colorado Denver in 2008, and has since worked as a postdoctoral fellow and staff scientist developing viral vaccine adjuvants. His skills include viral particle production, nucleic acid techniques, mouse models, and immunological assays. Currently he is seeking a position where he can apply his expertise in vaccine design and development.
Does your cell line have a secret avoid surprises with characterization
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
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The cell line integrity
1) Cell lines used for manufacturing biopharmaceuticals must meet strict quality criteria to ensure high quality, stable production. This includes being capable of high productivity, producing molecules with the appropriate structure and quality, and accepting and stably expressing foreign DNA.
2) Master cell banks are critical starting materials that are extensively tested for sterility, mycoplasma, and adventitious agents to ensure safety.
3) Routine monitoring of cell line integrity and performance during biomanufacturing helps evaluate the process and cell line stability over time.
Use of rapid quality control test methods as alternatives to traditional meth...
Abstract:
As the market for advanced therapy medicinal products (ATMP) matures the complexities of these molecules are evident and challenging when routine standard quality control (QC) testing is applied. Short shelf life from the point of manufacture to administration to the patient results in relatively low volumes for small scale clinical trials or small patient populations. Within a limited time period and with this low product volume, it is necessary to complete required regulatory QC testing, be that for early or late phase clinical trials, or for licensed drug product in a reduced timescale. So, the challenges with QC testing of cell and gene therapies using traditional test methods is time to results, due to short shelf-life, and availability of sufficient sample, due to low production volumes. Over the past years the application of rapid testing of short-life cell and gene therapies that may also help conserve limited product availability have been utilised. Regulatory expectations for using rapid test methods in place of classical or compendial test methods have been defined and this presentation will provide examples and data from our own experience of a range of alternate methods for application to ATMP products.
Presentation Sirion Web V7 Spoken
Sirion offers genetically modified cell services including cell line optimization, immortalization, and gene overexpression or silencing using viral vectors like adenovirus and lentivirus. They guarantee delivery of any gene to any mammalian cell type and greater than 90% knockdown maintained over experimental timeframes. Sirion claims to provide customized genetically modified cells, viruses, and services in weeks rather than the months needed for in-house solutions.
Oncogenic viruses
The document discusses viral oncogenesis and viruses associated with human tumors. It provides a brief history and discoveries related to oncogenic viruses over the years. Some key points include that approximately 10-20% of human tumors are caused by viruses. Viruses can cause cancer through direct introduction of viral oncogenes or indirect modulation of cellular genes. Some major viruses associated with human cancers include human papillomavirus, Epstein-Barr virus, hepatitis B and C viruses, and human T-cell leukemia virus.
Primordial Germ Cells- A tool for avian genome manipulation
This presentation deals with the scope and technique of avian genome manipulation by using avian primordial germ cells to obtain the pharmaceuticals using chicken egg as a bioreactor system and also to enhance the overall poultry production, and disease resistance, etc.
SPERMATOGENESIS & Stem cells
Spermatogenesis is the process by which spermatogonial stem cells in the seminiferous tubules of the testes proliferate and differentiate into mature sperm. Spermatogonial stem cells self-renew to maintain spermatogenesis throughout a male's life and can also differentiate into sperm. These stem cells can be identified by markers and cultured in vitro while maintaining their stem cell properties. Transplantation of spermatogonial stem cells into testes has resulted in donor-derived spermatogenesis, offering potential applications such as preservation of fertility.
The cell line integrity
The cell lines used to manufacture biopharmaceuticals must meet strict quality criteria to ensure high-quality, stable products. Master cell banks are critical starting materials, and should be sterile, mycoplasma-free, and tested for identity and purity. Cell lines must stably express the drug with high productivity, appropriate quality and structure, and be robust enough for large-scale production. Comprehensive testing of cell lines and banks is required by guidelines to confirm identity, purity, freedom from contamination, and genetic stability.
CRYOPRESERVATION.pptx
This study investigated the effects of vitrification on morphology and mRNA expression of apoptotic genes in sheep immature cumulus oocyte complexes. Immature oocytes were collected from sheep ovaries and divided into groups for cryopreservation using different cryoprotectants. The oocytes were evaluated for morphology before and after vitrification and thawing. Real-time PCR was used to analyze expression of apoptotic genes BAD, BAK, BAX, BID, BOK, BCL2A1, BCL2, MCL1 in fresh and vitrified oocytes. Results showed varying recovery and damage rates among oocytes cryopreserved with different cryoprotectants. Morphological changes included cracked or split zona pell
CRYOPRESERVATION.pptx
This study investigated the effects of vitrification on morphology and mRNA expression of apoptotic genes in sheep immature cumulus oocyte complexes. Immature oocytes were collected from sheep ovaries and divided into groups for cryopreservation using different cryoprotectants. The oocytes were evaluated for morphology before and after vitrification and thawing. Real-time PCR was used to analyze expression of apoptotic genes BAD, BAK, BAX, BID, BOK, BCL2A1, BCL2, MCL1 in fresh and vitrified oocytes. Results showed varying recovery and damage rates among oocytes cryopreserved with different cryoprotectants. Morphological changes included cracked or split zona pell
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This document describes ProteoCell Biotechnologies Inc., a company that offers an integrated cell line engineering and bioprocess development platform called ProteoCell SSI. The platform includes molecular engineering to design high producing cell lines, preliminary bioprocess development overlapping with clonal selection, and GMP cell banking and process development. ProteoCell's services cover molecular engineering, cell culture, purification, and bioprocess consulting. The ProteoCell SSI platform aims to rapidly generate stable high producing cell lines and test clones in bioreactors to simulate production conditions before cell banking.
Jaeho Lee Specialty
This document summarizes the education and research experience of Jaeho Lee. He earned a B.S. in Environmental Horticulture from the University of Seoul and an M.S. in Entomology from Seoul National University. For his graduate thesis, Lee developed a film-assisted honeybee egg collection system to improve honeybee genome editing techniques. He then used these techniques to successfully knockout the nAChR alpha6 gene in honeybees, proving the concept of creating pesticide-resistant honeybees. Lee has also published research on head louse adhesion proteins and acetylcholine esterase paralogs in bedbugs and honeybees.
iPSC-derived Cardiomyocytes
Acroscell provides ready-to-use beating human induced pluripotent stem cells (iPSC)-derived cardiomyocytes. Generated from mature cells that have been genetically reprogramed to a pluripotent stem cell state, induced pluripotent stem cells (iPSCs) can be readily expanded and induced to specialize or differentiate into cardiomyocytes in vitro.
https://www.creative-bioarray.com/acroscell/ipsc-derived-cardiomyocytes.html
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