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    BioPharma B.V.

    CDMO
    United States
    https://biopharmabv.com
    Drug Product
    Qualification/Validation Services
    Company Overview

    About

    BioPharma B.V. is a leading contract development and manufacturing organization headquartered in United States. We specialize in Clinical Trial Materials, Commercial Manufacturing with state-of-the-art facilities serving clients globally.

    Key Expertise

    Aseptic Processing, Cell & Gene Therapy, Lyophilization, Liquid/Semi-Solid, Antibody-Drug Conjugates (ADC)

    Therapeutic Areas

    Cardiovascular
    Endocrinology
    Quick Facts
    HQ:United States
    Founded:1985
    Employees:27
    Capabilities & Services

    Core Capabilities

    • Sterile Injectable
    • Sterile Fill/Finish
    • Fill/Finish (Vials)

    Types of Organization

    Drug Product Manufacturer (finished dosage, fill-finish, packaging)
    Drug Substance / API Manufacturer

    Dosage Forms

    Cartridge / Pen

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Batch Sizes

    10L-100L
    1L-10L
    5000L+
    1000L-5000L

    Annual Capacity

    Commercial (10,000-100,000 units/year)

    Markets Served

    North America
    Manufacturing Facilities

    3 sites worldwide

    BioPharma B.V. - Headquarters

    265 Industrial Park, San Diego, San Diego, 13456
    View on Map
    225,029 sq ft
    Established 1994

    Site Capabilities

    5 capabilities
    Oral Solid Dose
    Sterile Injectable
    Liquid/Semi-Solid
    Cell & Gene Therapy
    Biologics Drug Product

    BioPharma B.V. - North Carolina Facility

    687 Technology Drive, North Carolina, North Carolina, 90407
    View on Map
    496,628 sq ft
    Established 1998

    Site Capabilities

    3 capabilities
    Viral Vectors
    Regulatory Support
    Method Development & Validation

    BioPharma B.V. - Chicago Facility

    66 Pharma Drive, Chicago, Chicago, 79983
    View on Map
    186,922 sq ft
    Established 2011

    Site Capabilities

    5 capabilities
    Antibody-Drug Conjugates (ADC)
    Method Development & Validation
    mRNA Production
    Stability Studies
    Liquid/Semi-Solid
    Regulatory Approvals
    Drug Approval 6VG5IT
    EMA · #APR-9XZ2AD5P · 2019-02-01
    Product Portfolio

    Precision Formulation Service

    Brochure

    Our specialized service offering for CNS (Central Nervous System) applications.

    Suspension
    Solution
    Lyophilized Powder
    Delivery: Topical, Subcutaneous

    Standard API Service

    Brochure

    Our flagship service offering for Cardiovascular applications.

    Lyophilized Powder
    Injectable
    Suspension
    Delivery: Transdermal, Inhalation

    Precision Fill-Finish Service

    Brochure

    Our specialized service offering for Respiratory applications.

    Solution
    Suspension
    Lyophilized Powder
    Ointment
    Delivery: Intramuscular, Topical, Inhalation

    Precision Formulation Service

    Brochure

    Our flagship service offering for Metabolic Disease and Dermatology applications.

    Injectable
    Solution
    Tablet
    Cream
    Delivery: Inhalation, Topical

    BioReactor Systems

    High-quality pharmaceutical manufacturing solution designed to meet stringent regulatory requirements and deliver consistent results.

    Tablet
    Capsule
    Injectable
    Delivery: Oral

    Purification Platforms

    High-quality pharmaceutical manufacturing solution designed to meet stringent regulatory requirements and deliver consistent results.

    Tablet
    Capsule
    Delivery: Oral

    Sterile Fill-Finish Services

    High-quality pharmaceutical manufacturing solution designed to meet stringent regulatory requirements and deliver consistent results.

    Tablet
    Capsule
    Delivery: Oral
    Clinical Trial Experience

    Involvement in 10 clinical trials

    Trial Phases
    Phase 1
    Phase 2
    Preclinical
    Roles
    Manufacturing Partner
    Collaborator
    Sponsor
    Contract Research Organization
    Site
    Therapeutic Areas
    Ophthalmology
    Rare Disease
    Oncology
    Metabolic Disease
    Infectious Disease
    Dermatology
    Immunology
    Respiratory
    Other
    Cardiovascular
    CNS (Central Nervous System)

    Case Studies

    2 published case studies showcasing past projects, challenges and outcomes.

    Other Cell Therapy Development Partnership

    Phase III
    Biologics
    Small Molecule
    Apr 2020 – Mar 2023
    359 views

    Successful Phase III manufacturing program for a virtual pharma client.

    Challenge

    The client required rapid scale-up of their Other therapeutic with aggressive timelines and complex analytical requirements.

    Solution

    We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.

    Outcome

    The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.

    Other
    Respiratory
    Download PDF

    Successful Scale-Up of Monoclonal Antibody Production

    Phase II
    Small Molecule
    Sep 2020 – Mar 2022
    385 views

    A comprehensive overview of how BioPharma B.V. successfully delivered this complex pharmaceutical manufacturing project.

    Challenge

    The client required rapid scale-up while maintaining strict quality standards and regulatory compliance. Time-to-market was critical.

    Solution

    Our team implemented innovative process optimization techniques, leveraged advanced manufacturing technologies, and established robust quality control systems.

    Outcome

    Project completed 30% faster than industry average with zero quality deviations. Client achieved regulatory approval on first submission.

    Rare Diseases
    Certifications

    FDA Registration

    U.S. Food and Drug Administration

    ISO 9001:2015

    International Organization for Standardization

    FDA (U.S. Food & Drug Administration)

    Various

    EMA (European Medicines Agency)

    Various

    ISO 9001 (Quality Management)

    Various

    ISO 14001 (Environmental Management)

    Various

    Pmda Registration

    Various
    Customer Reviews
    4.1

    Overall Rating(Based on 17 reviews)

    Project Management3.6
    Technology Transfer4.2
    On-Time Delivery3.7
    Communication Responsiveness4.5
    Innovation4.7
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    Key facts about BioPharma B.V.

    • BioPharma B.V. is headquartered in the United States.
    • BioPharma B.V. was founded in 1985.
    • BioPharma B.V. has 27 employees.
    • BioPharma B.V. has 3 manufacturing sites listed on CDMO Hub, in San Diego, United States, North Carolina, United States and Chicago, United States.
    • BioPharma B.V.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

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    CDMOs in United StatesCDMOs in North AmericaSterile Injectable CDMOsFill-Finish CDMOsFill/Finish (Vials) CDMOsCartridge / Pen CDMOsCytotoxic / ADC Handling CDMOs
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