Comprehensive Development Services
accelerating your biologics journey
At Bora Biologics, we understand that the path from concept to commercialization is complex. Our development services are designed to streamline every stage of your biologics project, ensuring high-quality outcomes and timely delivery. With our expert team and state-of-the-art facilities, we are your trusted partner in biologics development.
Our Capabilities
We offer a wide range of development services tailored to meet your specific needs:
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Contract
Development - Tech Transfer
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Cell Line
Development -
Mammalian Process
Development -
Microbial Process
Development -
Analytical
Development -
Formulation & Drug
Product Development
Contract Development
Our flexible contract development services adapt to your project requirements, providing you with tailored solutions that fit your timeline and budget. We collaborate closely with you to ensure that your goals are met with precision and efficiency.
Tech Transfer
We facilitate seamless tech transfer processes, ensuring that your project transitions smoothly from development to manufacturing. Our experienced team implements best practices to maintain product integrity and compliance throughout the transfer. explore
Cell Line Development
Our robust cell line development services utilize advanced techniques to create high-yield, stable cell lines tailored to your biologics. From CHO to HEK293 systems, we ensure optimal expression levels to support your product needs. explore
Mammalian Process Development
With a focus on quality and efficiency, our mammalian process development services optimize manufacturing processes to enhance product quality and reduce costs. We employ advanced technologies to streamline workflows and ensure consistent results. explore
Microbial Process Development
Our expertise in microbial process development ensures rapid and cost-effective production of microbial-derived biologics. We utilize optimized strain selection and fermentation strategies to maximize yield and quality. explore
Analytical Development
We provide comprehensive analytical development services, including method development and validation, to ensure your product meets regulatory standards. Our analytical team is dedicated to delivering accurate and timely results to support your project.explore
Formulation & Drug Product Development
Our formulation specialists work closely with you to develop effective drug products that meet your specific requirements. We focus on stability, compatibility, and delivery methods to ensure your product’s success in the market.explore
Commitment to Quality
Quality is at the forefront of our development process. Our Quality Management System (QMS) adheres to stringent regulatory requirements, ensuring that every development stage meets the highest standards for safety, efficacy, and compliance. We conduct thorough testing and validation at each phase to guarantee product integrity.
Quality Control & Assurance
Our mature QMS employs rigorous testing protocols, ensuring the safety, identity, strength, and purity of every product.
Explore our Quality Control & Assurance processesSupply Chain Management
A robust supply chain is the backbone of a successful biopharmaceutical program, from GMP warehousing to inventory and vendor management.
Explore our Supply Chain AdvantagesProgram Management
Our timeline-driven collaborative approach ensures your vision is realized, expectations are met, and projects progress seamlessly.
Explore our Program Management philosophyProven Expertise in Biologics Development
With a track record of successful development projects, Bora Biologics has established itself as a reliable partner in the biopharmaceutical industry. Our collaborations with leading companies highlight our commitment to and excellence in biologics development.
State-of-the-Art Facilities
Our combined manufacturing footprint spans over 130,000sf featuring modular cleanrooms and advanced bioreactor systems to support large-scale production. Explore Facilities
Proven Track Record
With over 45 biologics and biosimilars developed, over 100 successful cGMP batches delivered, 2 commercially approved biosimilars in U.S. and Canada, and partnerships with leading pharmaceutical and biotech companies, we have established ourselves as a trusted partner in the biologics industry.
Expert Team
Our diverse team of scientists, engineers, and regulatory experts possesses a wealth of knowledge and experience, ensuring you benefit from the best practices in biologics manufacturing.
Let's Collaborate
If you’re ready to advance your biologics development 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 UsTech Transfer
seamless transition for optimal results
At Bora Biologics, we understand that successful biopharmaceutical development relies on effective technology transfer. Our Tech Transfer process is designed to ensure a smooth and efficient transition from development to manufacturing, minimizing risks and maximizing product quality.
Our Approach to Tech Transfer
We employ a structured and collaborative approach to technology transfer that encompasses:
Comprehensive Assessment
Our team conducts an in-depth evaluation of your existing processes and technologies to identify key requirements and potential challenges. This assessment allows us to develop a tailored tech transfer plan that meets your specific needs.
Cross-Functional Collaboration
We facilitate close collaboration between development, manufacturing, and quality teams to ensure alignment and clear communication throughout the transfer process. This teamwork is essential for addressing any technical hurdles and ensuring successful implementation.
Robust Documentation
Our thorough documentation practices capture all critical information related to your processes, including protocols, specifications, and quality standards. This documentation serves as a reference throughout the tech transfer, ensuring compliance and consistency.
Training and Support
We provide comprehensive training and support to your teams, equipping them with the knowledge and skills needed to operate and maintain the transferred technology effectively. Our experts are available to address any questions or concerns during the transition.
Commitment to Quality
During a recent tech transfer project at Bora Biologics, our MSAT team worked closely with a client to ensure a seamless transition from development to manufacturing. By identifying potential bottlenecks early, we reduced the tech transfer timeline by 25%. This collaboration not only mitigated risks but also empowered our client to advance their projects with confidence and speed.
Miguel Carrion, Vice President, Process Development & MS&T at Bora Biologics
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.
Proven Tech Transfer Track Record
With a robust history of successful tech transfers across a diverse range of biologics, Bora Biologics has firmly established itself as a trusted partner in the biopharmaceutical industry. Our commitment to excellence is reflected in several key areas:
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Diverse
Experience -
Impressive
Production Metrics - Timely Delivery
- Client Success
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Continuous
Improvement -
Regulatory
Expertise
Diverse Experience
Our extensive portfolio includes successful tech transfers for monoclonal antibodies, recombinant proteins, and complex biologics. This breadth of experience equips us with the insights needed to navigate various challenges unique to each product type.
Impressive Production Metrics
We have produced over 70 batches using our cGMP facility in Taiwan, achieving a remarkable 100% success rate continuously since 2014. This track record underscores our reliability and capability in executing successful tech transfers that culminate in high-quality product manufacturing.
Timely Delivery
We pride ourselves on our ability to deliver high-quality products on time, every time. Our streamlined processes and proactive project management ensure that your timelines are met, allowing you to advance your product through the development pipeline without delay.
Client Success
Numerous biopharmaceutical companies have partnered with us for their tech transfer needs, achieving successful commercialization of their products. Our successful projects highlight our ability to drive results and foster long-term relationships.
Continuous Improvement
We employ a culture of continuous improvement, regularly reviewing and refining our tech transfer processes to enhance efficiency and effectiveness. This commitment ensures that we stay ahead of industry trends and best practices.
Regulatory Expertise
Our team comprises seasoned professionals with deep knowledge of regulatory requirements across global markets. This expertise enables us to effectively navigate the complexities of compliance, ensuring a smooth transition and reducing the risk of regulatory hurdles.
Partner with Confidence
At Bora Biologics, we are dedicated to your success. Our proven track record in tech transfer, combined with our commitment to quality and client satisfaction, positions us as the ideal partner for your biopharmaceutical projects. Together, we can bring your innovations to market efficiently and effectively.
Connect With UsCell Line Development
tailored solutions for optimal biologics production
At Bora Biologics, our Cell Line Development services are designed to provide you with robust, high-yield cell lines tailored to meet the specific needs of your biopharmaceutical products. Our expertise in this critical phase of biologics development ensures that you have a solid foundation for successful manufacturing and commercialization.
Our Comprehensive Approach to CLD
We employ a systematic and scientifically rigorous approach to cell line development, encompassing the following key components:
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Initial Design
and Selection - Gene Optimization
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Clone Screening
and Selection -
Characterization
and Validation
Initial Design and Selection
Our process begins with a thorough assessment of your project requirements, including target product characteristics and production goals. We leverage advanced technologies to select the most suitable cell line platform, whether it be CHO, HEK293, or another proprietary system.
Gene Optimization
We utilize cutting-edge gene editing technologies, such as CRISPR/Cas9, to optimize the expression of your target protein. This optimization enhances yield, stability, and overall quality, ensuring that your cell line performs effectively throughout the production cycle.
Clone Screening and Selection
Our team conducts extensive screening of individual clones to identify those with the highest productivity and desired characteristics. This rigorous selection process guarantees that only the best-performing clones advance to the next stages of development.
Characterization and Validation
We perform comprehensive characterization of the selected cell lines, including stability assessments, growth kinetics, and protein expression profiling. This validation ensures that your cell line is well-defined and capable of consistently producing high-quality biologics.
Experts in Cell Line Development
Therapeutic Protein Production
Host cell bank qualification
CHO-K-derived cell line with clear history
Cell line development & monitoring
Accurate predictions using early data
Compliance with ICH
Monoclonality and documented traceability
Freedom-to-Operate
Host cell line and vectors developed In-House
Performance
4-6 g/L titer (pre-process development & optimization) with proven track record
Hear from Our Experts
Addressing the Complex Demands of Cell Line Development eBook
Committed to Your Success in CLD
Working with Bora Biologics to develop our recombinant protein has been an excellent experience. Bora’s team has been fully engaged during the cell line and scale-up process and responsive to Technical and Quality requests. We hope to continue working with them to manufacture.
CEO of Q-Sera
Get Started Today
If you’re ready to develop a robust cell line for your biopharmaceutical project, contact us today. At Bora Biologics, we are committed to providing you with tailored solutions that enhance your product development journey from the very beginning.
Connect With UsMammalian Process Development
streamlined processes for reliable and cost-effective manufacturing
At Bora Biologics, our Mammalian Process Development services are designed to support the entire lifecycle of biopharmaceutical production, from early development through to commercial manufacturing. We specialize in optimizing both upstream and downstream processes to ensure high-quality, scalable production of biologics.
Our Expertise in Mammalian Process Development
Upstream Production
We focus on developing high titer, scalable production processes for a variety of molecules, including monoclonal antibodies (mAbs).
Mammalian Cell Culture Development
Our expertise ensures optimal cultivation conditions, maximizing yield and quality throughout the production process.
Downstream Processing
Our downstream process development is customized to each unique protein, allowing us to create efficient purification schemes that maximize yield and quality. We employ high throughput resin screening and chromatography development to quickly identify the most effective purification methods. Additionally, our process includes comprehensive filtration development, encompassing depth filtration, sterile filtration, viral clearance, and tangential flow filtration (TFF). These innovative techniques streamline purification processes, ensuring that even the most complex molecules are handled effectively and safely.
Tailored Solutions
We understand that each mammalian process development project is unique. Our approach includes:
In our partnership with a leading biopharmaceutical company, Bora Biologics applied cutting-edge technology to their mammalian process development. Our efforts led to a 40% increase in yield while overcoming scale-up challenges. With our focus on compliance and efficiency, we enabled our client to concentrate on their innovative therapies, knowing they had a reliable partner in us.
Dr. Toby Hong, Director of Analytical & Upstream Process Development at
Bora Biologics
Proven Track Record
With years of experience in mammalian process development, our team has successfully advanced numerous projects from IND to BLA submission with seamless technology transfer and scale-up. Our commitment to excellence is reflected in our ability to deliver consistent, reliable, and cost-effective manufacturing solutions.
Why Choose Bora Biologics for Mammalian Process Development?
Expert Team
Our highly technical staff possesses extensive mammalian process development experience, enabling efficient parallel development activities and comprehensive process characterization.
Advanced Technologies
We leverage cutting-edge techniques and high-throughput technologies, including extensive use of DOE statistical software, to maximize product knowledge while minimizing experimentation requirements.
Quality Assurance
Our commitment to quality includes viral clearance study design and support, ensuring compliance with regulatory requirements. Our processes are aligned with manufacturing and quality control standards, facilitating seamless technology transfer.
Our Commitment to Innovation
At Bora Biologics, we are dedicated to continuous improvement and innovation in our mammalian process development services. We invest in the latest technologies and methodologies to enhance production efficiency, reduce costs, and improve product quality. By staying ahead of industry trends, we ensure that our clients benefit from the most effective and reliable solutions available.
Get Started Today
If you are looking to advance your biopharmaceutical project with a reliable partner in mammalian process development, contact us today to learn how Bora Biologics can support your goals. Our team is ready to collaborate with you to bring your innovative therapies to market efficiently and effectively.
Connect With UsMicrobial Process Development
streamlined processes for reliable and cost-effective manufacturing
At Bora Biologics, our Microbial Process Development services cater to the full lifecycle of biopharmaceutical production, from initial development through to commercial scale. We specialize in optimizing microbial fermentation processes to ensure high-quality, cost-effective production of biologics.
Our Expertise in Microbial Process Development
Fermentation Development
We focus on developing scalable fermentation processes for a variety of microbial systems, including E. coli and yeast, to produce proteins, enzymes, and other biologics.
Microbial Cell Culture Optimization
Our team specializes in optimizing microbial cell culture conditions to maximize yield and product quality. This involves fine-tuning parameters such as pH, temperature, and nutrient levels throughout the cultivation process.
Downstream Processing
We provide tailored downstream processing solutions for microbial-derived products. Our purification strategies are designed to efficiently isolate and purify target proteins while ensuring product integrity. We employ advanced techniques, including chromatography and filtration, to streamline purification and enhance yield.
Tailored Solutions for Microbial Process Development
Recognizing that every microbial process development project is unique, our approach includes:
Bora Biologics recently supported a client in microbial process development, where our expertise in fermentation and strain optimization made a significant impact. We achieved a 35% cost reduction in their production processes, streamlining their development efforts. Our commitment to empowering clients ensures they achieve their project goals faster, enhancing their competitiveness in the biopharmaceutical market.
Pawel Stanczak, PhD, Director, Process & Drug Product Development at Bora Biologics
Proven Track Record in Microbial Process Development
With years of experience in microbial process development, our team has successfully advanced numerous projects from IND to BLA submission with seamless technology transfer and scale-up. Our commitment to excellence is reflected in our ability to deliver consistent, reliable, and cost-effective manufacturing solutions.
Why Choose Bora Biologics for Microbial Process Development?
Expert Team
Our highly skilled staff possesses extensive experience in microbial process development, enabling efficient parallel development activities and comprehensive process characterization.
Advanced Technologies
We leverage cutting-edge fermentation technologies and high-throughput screening methods to maximize product yield while minimizing experimentation.
Quality Assurance
Our commitment to quality includes thorough process validation and compliance with regulatory requirements, ensuring that your products meet the highest standards.
Our Commitment to Innovation
At Bora Biologics, we are dedicated to continuous improvement and innovation in our microbial process development services. We invest in the latest technologies and methodologies to enhance production efficiency, reduce costs, and improve product quality. By staying ahead of industry trends, we ensure that our clients benefit from the most effective and reliable solutions available.
Start Your Microbial Process Development Project with Bora Biologics Today!
If you are looking to advance your biopharmaceutical project with a reliable partner in microbial process development, connect with us to learn how Bora Biologics can support your goals.
Connect With UsAnalytical Development
comprehensive solutions for biopharmaceuticals
At Bora Biologics, our Analytical Development services are designed to support the characterization and quality assessment of biologics throughout their lifecycle. We leverage state-of-the-art equipment and innovative techniques to ensure compliance and enhance product understanding, enabling the successful development of your biopharmaceuticals.
Our Analytical Capabilities
We provide a wide range of analytical services to assess both identity and purity, as well as to identify product-related and process-related impurities.
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Product Related
Impurities -
Process Related
Impurities -
Structural
Characterization -
Biological / Functional
Characterization - Microbiology
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Miscellaneous
Testing
Product Related Impurities
- Aggregation Size Variants
- Analyzed by SE-HPLC, SEC-MALS, and CE-SDS
- Charge Variants
- Evaluated using Ion Exchange Chromatography (IEX) and Capillary Isoelectric Focusing (cIEF)
- Hydrophobicity Variants
- Assessed for oxidation and Drug-Antibody Ratio (DAR) variants by RP-HPLC and HIC, along with released glycans via HILIC and post-translational modification (PTM) analysis by LC-MS
Process Related Impurities
- Host Cell Proteins(HCP)
- Host Cell DNA (hcDNA)
- Antifoam and Surfactants
- Protein A
Structural Characterization
- Primary Structure
- Intact mass analysis
- Peptide mapping
- Sequence variant analysis by LC-MS
- Higher Order Structure
- Disulfide bond analysis
- Free thiol quantification
- Far- and near-UV Circular Dichroism (CD)
Biological / Functional Characterization
- Cell-based potency assays (e.g., proliferation and inhibition)
- ADCC characterization using DELFIA (TRF) or reporter gene assays
- Signaling pathway characterization
- Ready-to-thaw cell banks
- ELISA and AlphaLISA® assays
- Surface Plasmon Resonance (SPR)
Microbiology
- Bioburden and endotoxin testing
Miscellaneous Testing
- Analysis of excipients, including polysorbate and PEG
- Amino acid analysis, particulates, and titer assessments
Our Analytical Equipment
Our facilities are outfitted with cutting-edge analytical equipment, ensuring high-quality results and compliance at every phase of your program:
- HPLC & UPLC Systems
- High-Resolution Mass Spectrometers
- CE-SDS and icIEF Systems
- MALS and Semi-Preparative HPLC Systems
- Plate Readers and Vi-CELL Automatic Cell Counters
- UV/Vis Spectrophotometers
- HIAC Particle Counters and Sievers Total Organic Carbon Analyzers
- ICH Compliant Stability Storage and Cryo Freezers
- Photostability Chamber and Tecan Liquid Handler
Why Choose Bora Biologics for Analytical Development?
Expert Team
Our analytical scientists possess extensive experience in biologics characterization, ensuring that your products meet regulatory standards and industry best practices.
Advanced Technologies
We utilize cutting-edge analytical techniques and equipment to provide reliable and accurate data, enhancing your product development process.
Commitment to Quality
Our rigorous quality assurance programs ensure that your biopharmaceuticals remain compliant and of the highest quality at every stage of development.
Hear from Our Experts
Strategies and Tactics for Success in Biologics Analytical Testing
Customized Solutions for Biologics Development: Leveraging Adaptive Platforms to Meet Customer Needs
Designing Quality into Biomanufacturing: A Proactive Approach to Efficiency and Compliance
Developing a Toolbox of Functional Bioassays for Optimizing ADCC
Analysis of Therapeutic Monoclonal Antibodies Using a Platform Size Exclusion-HPLC Method
More Discoveries
Start Your Analytical Development with Bora Biologics
If you are looking for reliable analytical development services to support your biopharmaceutical projects, connect with us to learn how Bora Biologics can help you achieve your goals efficiently and effectively.
Connect With UsFormulation & Drug Product Development
innovative solutions for advancing biopharmaceuticals
At Bora Biologics, we specialize in Formulation and Drug Product Development, focusing on creating safe, effective, and stable biopharmaceutical products tailored to meet the unique needs of our clients. Our comprehensive capabilities ensure that your drug products are developed with precision and care, leveraging cutting-edge technologies and methodologies.
Drug Product Development Capabilities
With a commitment to innovation and optimization, our drug product development services include:
- High Throughput Pre-Formulation Screening
- Drug Product and Formulation Development
- Biophysical Characterization
- Spectroscopy-Based Assay Development
- Thermal and Kinetic Stability Assessment
- Excipient Compatibility Studies
- Pooling and Mixing Characterization
- Filtration and Integrity Assessments
- Filling Process Characterization
- Extractable and Leachable Assessment
- Drug Product Package Selection and Testing
- Drug Product Shipping Assessment
- Regulatory Drafting and Audit Support
- DP Administration and IV Bag Compatibility
High Throughput Pre-Formulation Screening
Rapid assessment of formulation conditions to identify optimal parameters for drug stability and efficacy.
Drug Product and Formulation Development
Tailored solutions that encompass all aspects of formulation to enhance product performance.
Biophysical Characterization
Comprehensive analysis of physical properties to ensure product stability and efficacy.
Spectroscopy-Based Assay Development
Utilizing advanced spectroscopy techniques to develop reliable assays for quality control.
Thermal and Kinetic Stability Assessment
Evaluating the stability of drug products under various conditions to ensure long-term efficacy.
Excipient Compatibility Studies
Assessing the compatibility of excipients with active pharmaceutical ingredients (APIs) to ensure formulation integrity.
Pooling and Mixing Characterization
Analyzing the effects of pooling and mixing on formulation stability.
Filtration and Integrity Assessments
Comprehensive evaluations of filtration processes, including compatibility, integrity, and bacterial retention support.
Filling Process Characterization
Detailed assessments of the filling process to ensure product quality and compliance.
Extractable and Leachable Assessment
Evaluating manufacturing components for potential extractables and leachables to guarantee product safety.
Drug Product Shipping Assessment
Rigorous assessment of packaging options, including functional studies for syringes and compatibility testing
Drug Product Shipping Assessment
Ensuring that drug products maintain integrity throughout the shipping process.
Regulatory Drafting and Audit Support
Providing expert guidance and documentation to facilitate regulatory compliance.
DP Administration and IV Bag Compatibility
Assessing compatibility of drug products with intravenous administration systems.
Integrated Allosteric Formulation Development Platform
Our cutting-edge Allosteric Formulation Development Platform enables fast, economical, and precise formulation development for a variety of biologics, including:
- Monoclonal antibodies and their fragments
- Antibody-Drug Conjugates (ADCs)
- Cytokines, enzymes, and growth factors
- Synthetic peptides and recombinant fusion proteins
- Liposomes, lipid nanoparticles (LNPs), micelles, and polymers
Biophysical and Analytical Platforms
We employ advanced biophysical and analytical techniques to ensure comprehensive characterization of drug products:
- Biophysical High Throughput Platform
- Spectroscopy Techniques: Fluorescence, CD, NMR, ESR, FTIR, Raman, and Light Scattering (LS)
- Biophysical Techniques: Differential Scanning Calorimetry (DSC), Analytical Ultracentrifugation (AUC), and Surface Plasmon Resonance (SPR)
- Analytical Platform
- A variety of HPLC-based methods (e.g., SEC, RP, CEX, HIC, HILIC), MALS, cIEF, CE-SDS, and mass spectrometry (MS)
- Comprehensive assessments of osmolality, particle size (HIAC), morphological characterization (MFI), photostability, pH, viscosity, and protein concentration/solubility (A280/350)
- Design of Experiments (DOE) and statistical analysis using JMP and GraphPad
Why Choose Bora Biologics for Formulation & Drug Product Development?
Expertise in Biologics
Our experienced team is well-versed in the complexities of biologics formulation, ensuring that your products meet both efficacy and safety standards.
Innovative Platforms
Our unique formulation platforms enable rapid development and adaptation to various biologic formats, ensuring flexibility in your drug development process.
Commitment to Quality
We prioritize quality assurance at every stage of development, ensuring compliance with regulatory standards and the highest product integrity.
Start Your Formulation & Drug Product Development with Bora Biologics
If you are looking for innovative and reliable formulation and drug product development services, connect with us to learn how Bora Biologics can help you bring your biopharmaceuticals to market efficiently and effectively.
Connect With Us
Bora Biologics
the logical choice
Join the ranks of biopharma pioneers who trust us.
Explore how we minimize risks and accelerate your success.
Client-Centric
100% commitment to supporting your success
Experience
14 years developing & manufacturing biologics
Expertise
125 seasoned scientists & regulatory professionals
Commercial-Ready
US FDA registered GMP manufacturing facility
Allied
access to global CDMO resources