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Drug Product

precision packaging for tomorrow's therapies

At Bora Biologics, we understand that the final steps in biopharmaceutical production are just as critical as the initial stages. We specialize in high-quality biologic drug substances (DS) and seamlessly transfer them to Bora Pharmaceuticals for comprehensive drug product (DP) services. This powerful partnership ensures excellence in every vial – and efficiently streamlines your path from lab to market.

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The Power of One

expediting project success

With a commitment to quality and compliance we provide a seamless end-to-end CDMO experience that simplifies client partnerships through The Power of One – a customer-centric approach that sets us apart from other biologics CDMOs by providing one agreement that drives project success from start to finish.

  • One Team
  • One Timeline
  • One Target
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Collaboration Defines Us

Collaboration is not just a buzzword; it’s the cornerstone of our program management ethos. We understand the intricacies of outsourcing and prioritize close partnerships with our clients. Our commitment to transparency and communication ensures that your biologics program is executed efficiently and with meticulous attention to detail.

  • Dedicated Program Manager From the moment you partner with us, you’ll be assigned a dedicated program manager who serves as your primary point of contact. This experienced professional orchestrates all project-related activities, ensuring open lines of communication and facilitating collaboration.
  • Subject Matter Experts (SMEs) Our interdisciplinary team of SMEs brings a wealth of knowledge and firsthand experience across all stages of development—from research and development to GMP manufacturing. This diverse expertise guarantees that every facet of your project is managed with the highest level of proficiency.
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Timeline-Driven Approach

We recognize that time is of the essence in biopharmaceutical development. Our timeline-driven approach ensures that your projects progress seamlessly from inception to completion, allowing us to bring vital treatments to patients faster.

  • Tailored Project Plans We design customized project plans that align with your goals and timelines, adapting to any changes that may arise during the process.
  • Integrated Planning and Analytics We streamline and shorten go-to-market timelines through collaborative efficiencies
  • Regular Progress Updates Stay informed with consistent updates on project milestones and timelines, fostering trust and accountability.

State-of-the-Art Fill & Finish Facility

With highly experienced teams and next-gen technology, we meet the highest regulatory standards while prioritizing your needs, offering flexibility and scalability to accommodate varying batch sizes and timelines. Visit Bora Pharmaceuticals for more.

Overview
  • Baltimore, MD, USA
  • 87,000 square foot cGMP facility
  • Clinical and commercial
  • Vials & pre-filled syringes
  • Liquid & lyophilization
  • Inspection, packaging, and serialization
  • Analytical services and on-site testing
  • Ambient storage (2-8C, -20C, -70C)
By the Numbers
  • 40+ different customers
  • 120+ presentations manufactured
  • 65+ unique product
  • 70% biologics
  • 3 formulation suites
Technology
  • Groninger® FlexPro 50 Isolator Line
  • Chase-Logeman 2-Headed High Speed Filling Line
  • Chase-Logeman Single Headed Filling Line
  • AST GENISYS® Automated Line
  • AST GENISYS® C Isolator Filling Line Online 2026
  • Terminal sterilization
Compliance
  • US FDA
  • PDMA
  • Turkish MOH
  • Korean FDA
  • TGA Australia
  • Russian Ministry of I&T
Capabilities
  • Testing of API/DS
  • Method Transfer and Validation
  • Analytical Support for Development Studies
  • Component Testing
  • In-process, Final Product, and Stability Testing
  • Bioburden, Endotoxin, and Sterility
  • Environmental Monitoring
  • CCIT by FMS-Carbon Dioxide Headspace Analysis
  • Foreign Particle Identification by Microscopy
Visual Inspection
  • Phoenix Imaging MIB-80 inspection booths (100% manual visual inspection)
  • Semi-automatic visual inspection (SAVI) technology
Packaging
  • Labeler – Weller (high speed)
    • Laser ablation printing (~400 vpm)
    • Thermal transfer printing (~300 vpm)
  • Cartoner – Jones
Serialization
  • Ability to generate serial numbers or receive them from clients
  • TraceLink for Track & Trace Services
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Bora Biologics

the logical choice

Join the ranks of biopharma pioneers who trust us.
Explore how we minimize risks and accelerate your success.

Partner with us

Client-Centric

100% commitment to supporting your success

We have been the client, bringing multiple biologics from IND to BLA. Your needs and goals are at the forefront of our approach. By involving you in every step of the process, we ensure transparency and alignment, reducing the likelihood of misunderstandings and ensuring the outcome meets your expectations.

Experience

14 years developing & manufacturing biologics

We have honed our ability to navigate complexities. Our track record from concept to commercialization means we can apply best practices and lessons learned, ensuring smoother project execution.

Expertise

125 seasoned scientists & regulatory professionals

Our team exudes deep knowledge and specialized skills, with over 50% holding advanced degrees. This expertise allows us to foresee potential challenges and implement proactive solutions, reducing the likelihood of setbacks.

Commercial-Ready

US FDA registered GMP manufacturing facility

We focus on delivering solutions that are ready for market. With clinical to commercial scale facilities consistently meeting compliance standards, we ensure your project is primed for success, minimizing the risk of costly revisions or delays.

Allied

access to global CDMO resources

Our partnership with Bora Pharmaceuticals provides additional resources and insights. This network enables us to leverage shared knowledge and expertise, further mitigating risks and accelerating the overall success of your project.