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SOP Guide for Pharma

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Tag: protein purification SOP

Biosimilars: SOP for Selection of Stably Transfected Clones – V 2.0

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Biosimilars: SOP for Selection of Stably Transfected Clones – V 2.0 Standard Operating Procedure for Selection of Stably Transfected Clones in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/010/2025 Supersedes SOP/BS/010/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the process for selecting, isolating, and…

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Biosimilars V 2.0

Biosimilars: SOP for Transient Transfection Methods – V 2.0

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Biosimilars: SOP for Transient Transfection Methods – V 2.0 Standard Operating Procedure for Transient Transfection Methods in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/009/2025 Supersedes SOP/BS/009/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for transient transfection of mammalian cells using lipid-mediated…

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Biosimilars V 2.0

Biosimilars: SOP for Agarose Gel Electrophoresis – V 2.0

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Biosimilars: SOP for Agarose Gel Electrophoresis – V 2.0 Standard Operating Procedure for Agarose Gel Electrophoresis in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/008/2025 Supersedes SOP/BS/008/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for performing agarose gel electrophoresis to separate,…

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Biosimilars V 2.0

Biosimilars: SOP for Restriction Enzyme Digestion and Mapping – V 2.0

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Biosimilars: SOP for Restriction Enzyme Digestion and Mapping – V 2.0 Standard Operating Procedure for Restriction Enzyme Digestion and Mapping in Biosimilar Research Department Biosimilars SOP No. SOP/BS/007/2025 Supersedes SOP/BS/007/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standard method for performing restriction…

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Biosimilars V 2.0

Biosimilars: SOP for Plasmid Amplification and Purification – V 2.0

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Biosimilars: SOP for Plasmid Amplification and Purification – V 2.0 Standard Operating Procedure for Plasmid Amplification and Purification in Biosimilar Development Department Biosimilars SOP No. SOP/BS/006/2025 Supersedes SOP/BS/006/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the process for amplifying and purifying plasmid DNA…

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Biosimilars V 2.0

Biosimilars: SOP for Transformation and Electroporation – V 2.0

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Biosimilars: SOP for Transformation and Electroporation – V 2.0 Standard Operating Procedure for Transformation and Electroporation in Biosimilar Development Department Biosimilars SOP No. SOP/BS/005/2025 Supersedes SOP/BS/005/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the standardized procedure for introducing recombinant plasmids into host cells…

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Biosimilars V 2.0

Biosimilars: SOP for Preparation of Competent Cells – V 2.0

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Biosimilars: SOP for Preparation of Competent Cells – V 2.0 Standard Operating Procedure for Preparation of Competent Cells in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/004/2025 Supersedes SOP/BS/004/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the process for preparing chemically and electrocompetent E….

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Biosimilars V 2.0

Biosimilars: SOP for Vector Design and Cloning – V 2.0

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Biosimilars: SOP for Vector Design and Cloning – V 2.0 Standard Operating Procedure for Vector Design and Cloning in Biosimilar Research Department Biosimilars SOP No. SOP/BS/003/2025 Supersedes SOP/BS/003/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure for designing plasmid expression vectors and…

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Biosimilars V 2.0

Biosimilars: SOP for Gene Synthesis and Sequence Verification – V 2.0

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Biosimilars: SOP for Gene Synthesis and Sequence Verification – V 2.0 Standard Operating Procedure for Gene Synthesis and Sequence Verification in Biosimilar Development Department Biosimilars SOP No. SOP/BS/002/2025 Supersedes SOP/BS/002/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the standardized procedure for gene synthesis…

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Biosimilars V 2.0

Biosimilars: SOP for Selection of Host Cell Lines – V 2.0

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Biosimilars: SOP for Selection of Host Cell Lines – V 2.0 Standard Operating Procedure for Selecting Host Cell Lines in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/001/2025 Supersedes SOP/BS/001/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for selecting host cell…

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Biosimilars V 2.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Gels V 2.0
  • Injectables V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

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