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Oversight

ensuring excellence at every step

At Bora Biologics, we believe that exceptional oversight is the foundation of successful biopharmaceutical development. Our commitment to quality, transparency, and collaboration ensures that we deliver innovative solutions to market faster and more cost-effectively. Trust us to safeguard the integrity of your projects from start to finish.

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Quality Control & Assurance

supporting regulatory compliance

Our mature Quality Management System (QMS) employs rigorous testing protocols to guarantee the safety, identity, strength, and purity of every product. With a focus on precision and compliance, our expert team conducts comprehensive testing throughout the production lifecycle.

Incoming Raw Material Testing

We meticulously assess raw materials to ensure they meet our stringent quality standards.

In-Process Control Testing

Real-time monitoring safeguards product consistency during production.

Product Release Testing

Each final product undergoes thorough testing to ensure readiness for distribution.

Generation & Qualification of Assay Cell Banks

We establish and validate assay cell banks to support accurate and reliable analytical testing.

Qualification of GMP Reference Standard

Our rigorous qualification of reference standards enhances the accuracy of testing methodologies.

ICH Compliant
Stability Studies

We design, execute, and analyze stability studies in accordance with ICH guidelines, ensuring product shelf-life determination.

Phase-Appropriate Method Qualification/Validation

Analytical methods are tailored and validated for each phase of development to ensure reliability.

Hear from Our Experts

Designing Quality into Biomanufacturing: A Proactive Approach to Efficiency and Compliance

More Discoveries
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Quality Control Equipment

Our advanced quality control equipment ensures that your program remains compliant at every phase of its lifecycle. Our facilities are equipped with state-of-the-art technology, including:

  • HPLC & UPLC SystemsHigh-Performance Liquid Chromatography and Ultra-Performance Liquid Chromatography systems enable precise and accurate substance analysis.
  • CE-SDS (Laser Induced Fluorescence)Capillary Electrophoresis with Laser-Induced Fluorescence detection ensures accurate characterization of proteins.
  • Plate ReadersAdvanced plate readers facilitate Enzyme-Linked Immunosorbent Assay (ELISA) and endotoxin testing.
  • Vi-CELL Automatic Cell CounterPrecision cell counting for cell-based assays.
  • qPCRPrecise nucleic acid analysis.
  • UV/Vis SpectrophotometerAccurate UV/Visible light analysis supports substance quantification.
  • HIAC Particle CounterPrecise measurement of particle size distribution in liquid samples.
  • Sievers Total Organic Carbon AnalyzerAccurate determination of total organic carbon supports purity assessment.
  • ICH Compliant Stability StorageControlled conditions for stability studies are maintained according to ICH guidelines.
  • Cryo FreezersAssay Cell Banks are stored in cryo freezers to maintain cell viability and integrity.
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Let's Collaborate

If you’re ready to advance your biologics project, contact us today. At Bora Biologics, we are dedicated to supporting your journey from concept to commercialization, ensuring that your development needs are met with expertise and precision.

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Supply Chain Management

robust solutions accelerate your success

A well-managed supply chain is the backbone of any successful biopharmaceutical program. At Bora Biologics, we prioritize efficiency, communication, and collaboration throughout the supply chain process to ensure seamless operations and high-quality product delivery.

Vendor Management

Our comprehensive vendor management strategy is designed to uphold the highest standards of quality and compliance:

Vendor Qualification and Monitoring

We conduct thorough assessments and continuous monitoring of our vendors to ensure they meet our stringent quality criteria.

Change Notification System

Our efficient system provides timely updates regarding any changes in vendor operations or materials, ensuring transparency and responsiveness.

Audit Program

Regular audits uphold accountability and adherence to our quality standards, fostering trust and reliability.

Scheduled Meetings with Key Vendors

We maintain open communication through regular meetings with key vendors to enhance collaboration and alignment.

Quality Event Trending Analysis

In-depth analysis of quality events allows us to identify trends and implement preventive measures, ensuring continuous improvement.

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Inventory Management

Our advanced inventory management practices guarantee accuracy, efficiency, and traceability every step of the way:

Validated ERP
System – QAD

Our QMS is meticulously designed to monitor and validate every aspect of the tech transfer. It encompasses comprehensive risk management strategies, real-time monitoring, and rigorous documentation practices, ensuring transparency and traceability throughout the process.

14,000 sq. ft. Multilevel
GMP Storage

Our expansive, GMP-compliant storage facilities are designed to accommodate diverse product needs while maintaining strict compliance.

Temperature-Controlled
Storage Conditions

We offer controlled storage environments tailored to various requirements, ensuring product integrity.

Status, Lot, and
Expiration Tracking

Detailed tracking of status, lot numbers, and expiration dates ensures that every product remains compliant and traceable throughout its lifecycle.

Material Segregation
by Client

Our inventory system allows for the segregation of materials by client, enhancing organization and facilitating tailored solutions.

We developed a great partnership over the past 3 years with Bora Biologics and their dedication to our needs is evident in the lifespan of the project. Their attention to detail and timely responses had been very helpful and appreciated. We will be glad to engage them again for our future projects.

CEO of Arbele

With these competitive advantages, Bora Biologics not only ensures compliance but also enhances the reliability and success of your tech transfer, providing you with peace of mind as you move forward in your biopharmaceutical journey.

Let's Collaborate

If you’re ready to advance your biologics project, contact us today. At Bora Biologics, we are dedicated to supporting your journey from concept to commercialization, ensuring that your development needs are met with expertise and precision.

Connect With Us

Program Management

seamless collaboration for exceptional outcomes

At Bora Biologics, we believe that effective program management is the key to transforming your vision into reality. Our collaborative approach ensures that we function as a seamless extension of your organization, delivering results that exceed expectations.

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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 Managers 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.
  • Regular Progress Updates Stay informed with consistent updates on project milestones and timelines, fostering trust and accountability.

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.