Leading the future of biologics

We are the CDMO to bring your biologics assets to life.

Experienced, reliable, and with a strong track record of impeccable regulatory compliance, we offer end-to-end capabilities for development and manufacturing of biologics.

From cutting-edge high yielding cell lines to innovative high concentration low viscosity formulation technology, we deliver the full spectrum of development services across multiple therapeutic modalities. Our state-of-the-art drug substance and drug product cGMP facilities offer manufacturing of biologics products for clinical and commercial use.

cGMP manufacturing 

Our unwavering commitment to cGMP practices means you can rely on us to deliver quality products every time, on time. Our integrated drug substance and drug product cGMP manufacturing facilities, designed with US FDA’s FMD-135 guidance program, offers a unique value proposition for our client needs for clinical and commercial supplies all under one roof. With a dedicated technical lead and project management team that walks with you through the entire product life cycle, we target seamless right-first-time technology transfers to avoid any delays in clinical and commercial manufacturing, aseptic fill/finish as well as analytical method transfers and validations.  

Drug substance manufacturing

Drug substance manufacturing

Our drug substance cGMP manufacturing expertise spans across a wide array of biologics products, including plasmid DNA, peptides, proteins, monoclonal antibodies, conjugated proteins and VLPs from microbial and mammalian platforms. Our facilities are set up for flexible manufacturing for both clinical and commercial supplies, with a robust data package for regulatory submissions. We have a proven track record of significant facility expansion with industry-leading speed to meet our customer’s manufacturing forecasts. We also offer disruptive alternate and resilient supply chain solutions to our customers and support them to meet their clinical and commercial timelines. 

Microbial

Microbial

When it comes to streamlined manufacturing of clinical and commercial biopharmaceuticals derived from microbial hosts, we make it happen. Our state-of-the-art facility incorporates industry standard large-scale stainless-steel (SS) fermenters for upstream and single-use (SU) and conventional systems for downstream processing. The facility is designed to manufacture products that may be expressed as intracellular (soluble or as inclusion bodies) or as secreted products. This hybrid design of having both SS and SU systems in the same facility enables enhanced flexibility and quick turnaround time between batches, thus improving operational efficiencies. 

Key highlights: 

  • Deep experience in manufacturing various types of products, such as recombinant peptides and proteins, conjugated proteins, fragment antibodies, plasmid DNA, etc. expressed in microbial hosts 
  • Upstream fermentation manufacturing scales: 50L, 300L and 1000L SS fermenters 
  • Continuous centrifugation, high pressure homogenization and hollow fiber filtration capabilities for biomass, product, inclusion body (IB) isolation 
  • IB solubilization and refolding capabilities  
  • Aqueous and reverse phase chromatography, ultrafiltration, diafiltration and lyophilization capabilities  
  • Reaction capabilities for enzymatic digestion, conjugation and/ or pegylation steps 

Mammalian

Mammalian

Our mammalian cell culture facility has been designed with enough flexibility to adapt to the most varied requirements, starting from cell banking in dedicated pre-culture suites to manufacturing of products (monoclonal antibodies, bispecifics, glycoproteins, etc.) using mammalian cell lines for clinical or commercial supplies. The pre-culture suites are well equipped to handle cell banking (MCB and WCB) and seed expansion activities. Our cell culture manufacturing suites are housed with industry-standard single use bioreactors (SUBs) that can handle both fed batch and N-1 perfusion processes. Our downstream areas have designated rooms for single use harvest clarification, capture chromatography, polishing and virus negative operations allowing minimum turnaround times between batches.  

 

Key highlights: 

  • Dedicated pre-culture suites with cell banking capabilities and seed train scale-up up to 25L (wave bioreactors) 
  • Upstream cell culture manufacturing suites (2 nos), each of which can support fed batch and perfusion cell culture processes at 50L, 500L and 2000L scales using single use bioreactors  
  • Dedicated suites for harvest clarification, capture chromatography and virus inactivation, intermediate and polishing chromatography, post-virus filtration final UFDF and bulk drug substance filtration steps  

 

Drug product manufacturing

Drug product manufacturing

Our capabilities in drug-device combination products range from device conceptualization and selection to modular automated device assembly and packaging for clinical and commercial supplies. We specialise across multiple device formats including pen devices, autoinjectors and safety syringes. This complements our strong fill finish capabilities across all format types, including multidose cartridges and single use pre-filled syringes. Our goal is to accelerate device development programs – how? With our strong technical expertise and close collaboration with device manufacturers for smooth technology transfer.  

With five state-of-the-art cGMP facilities and a global customer base, OneSource has an impeccable quality compliance record with successful inspections by major health agencies, including the USFDA and EU authorities. 

 

Key highlights:  

  • Deep expertise across the entire life cycle of drug-device-combination products, from conceptualization, device evaluation, process definition, assembly equipment to cGMP clinical and commercial manufacturing 
  • Capability to assemble and test more than nine pens / autoinjector devices across different device manufacturers 
  • Demonstrated manufacturing excellence, utilizing state-of-the-art isolator-based barrier systems and single use manifold systems 

Technology Transfer capabilities

Technology Transfer capabilities

OneSource has a dedicated technology transfer team for both drug substance and drug products, with deep experience in phase-appropriate technology transfers during various stages of the product life-cycle. Our core expertise in technology transfers begins with comprehensive and robust gap assessment followed by developing a strategy that enables right-first-time outcomes for our clients. The tech transfer team not only focuses on successful batch execution, but also provides innovative and robust solutions for achieving reproducible results batch after batch. We collaborate to act as the bridge between the client, process development team and manufacturing team and walk with our customers towards their regulatory, clinical and commercial success.  

Key highlights:

  • Thorough gap assessments and facility fit assessments followed by development of robust scale-up approach and batch definition strategies for right-first-time technology transfers 
  • Comprehensive process risk assessment, using tools like FMEA, initiating from as early as development stage through the PPQ stage to identify and define critical process parameters (CPPs) and non-CPPs 
  • Collaboration with the development team for late-stage process development studies involving scale down model development and qualification, process characterization experimental design and statistical data review, identifying NORs and PARs for CPPs, developing PPQ strategy and performing additional lab-scale and at-scale support studies  
  • Development of control strategy at various stages of the product life cycle using data from the stage-wise process risk assessments 
  • Developing appropriate product life-cycle management strategies and continued process verification approach to ensure robust and reproducible commercial manufacturing 

Development capabilities

We have access to some disruptive expression systems for microbial and mammalian based biologics products to develop high yielding stable cell lines. Our team of experienced scientists are capable of leveraging these cell lines and platform processes for driving highly accelerated timelines to make our client’s FIH and other assets clinic-ready. The team is also highly skilled in performing late-stage development activities and generating robust data and process control packages for clinical and commercial manufacturing. Our comprehensive analytical assessments support data packages that always meet global regulatory standards and encompass development, qualification, validation and characterization for both product and impurities.  

Cell line platforms

  • Cutting-edge cell lines for microbial and mammalian hosts  
  • Microbial platforms with titer expressions up to 10-30 g/L of soluble recombinant protein or peptide with the capability of being secreted to significantly simplify downstream processing 
  • Mammalian cell lines with capability to express up to 8-10 g/L of product in up to 5-7 days of cell culture production cycle 

Drug Substance Process development

Our skilled process development team collaborates with our customers and provides robust and reproducible processes for their success. This includes early stage process development of biologics from microbial and mammalian hosts using platform processes and QbD based approach that enables accelerated timelines for FIH material generation. We also have deep expertise in late-stage process development and collaborate with the tech transfer team for developing robust PC data package enabling appropriate PPQ strategies and robust process control strategies. 

The OneSource advantage: 

  • Deep technical expertise – To offer development solutions for a wide range of therapeutic modalities 
  • Accelerated timelines – High throughput systems for fast process development and optimization at industry-leading speeds 
  • Offer disruptive solutions – By developing efficient processes using high yielding cell lines and robust platform processes 
  • Design of experiment (DoE) approaches – For process optimization that provides an early understanding of potential CPPs, NORs and PARs. 
  • Early scalability fit assessment – To enable right-first-time technology transfers and scale-ups 
  • Comprehensive Late-stage Development – To develop robust data package and control strategies for critical and non-critical parameters 
  • Regulatory submissions support – By generating relevant data packages for IND and BLA submissions 
  • Cost benefit – By carefully selecting raw materials and consumables without compromising on quality 

Analytical development and method transfer

Our wide range of technologies and high throughput methodologies support all stages of process and product development, from method development, qualification and validation to impurity profiling and product comparability at various stages of product life-cycle. We also design analytical testing panels for lot release, stability and product characterization, across various types of biologics products. Our highly streamlined method transfer approaches aid in successful implementation and validation in quality control laboratories. Our state-of-the-art analytical laboratories offer a high level of automation for analytical and bioassay development and physicochemical and functional characterization of biologics. 

Method Development (Physicochemical)

• Clone analysis through gel electrophoresis, western blot, biolayer interferometry, RTPCR
• Product concentration estimation for all modalities
• Product-related impurity profiling (both for size, charge and other post-translational modifications)
• Process -related impurity profiling (host cell protein, host cell DNA, residual process-related impurities)
• Quantitative and qualitative batch release methods
• Support process development with highly efficient and high throughput in-process analytics using:
• HPLC/UPLC based methods
• Chip based methods

Method Development (Bioassay)

• Cell-based bioassays
• Quantitative binding ELISA potency and titer determination
• Impurity clearance testing – HCP ELISA, HCD by QPCR
• Binding affinity by SPR (Biacore) or BLI
• Enzyme and viral vector assay

Characterization packages

• Comparability and similarity studies
• Primary structure
• Secondary & higher-order structure
• Product characterization package comprising, structural, physicochemical, functional attributes

Stability

• Product optimization studies
• R&D stage studies
• Product in-use studies
• GMP regulatory submission studies
• ICH compliant, covering zone-based specifications

Drug product development

Our access to novel high concentration–low viscosity formulations can provide disruptive drug product solutions for manufacturers looking to move away from the conventional intravenous and intramuscular administration routes to more patient-friendly subcutaneous routes of administration. Combining this with our expertise in drug-device development, we can add immense value to our customers. Our formulation development offering includes both early stage and late stage formulation and drug product process development, including:

  • Early formulation assessment: Fast product evaluation during clone selection stage to demonstrate product stability and development ability 
  • Novel formulation development: High concentration-low viscosity formulations for concentrated biologics products (monoclonal antibodies, fragment antibodies, ophthalmic products, etc.)  
  • Streamlined formulation development to support IND submissions 
  • Early stage formulation development and parameter optimization studies with respect to: 
  • Buffer and excipient selection, optimization and order of addition 
  • Physical parameter (pH, storage temperature, mixing studies, etc.) screening and optimization 
  • Filter screening and sizing studies 
  • Tubing compatibility studies 
  • PPM studies: Selection of the right type of PPM and its compatibility with product and excipients 
  • Device development and selection: Selecting the right type of device for administration 
  • Late-stage formulation development studies: 
  • Drug product process risk assessment and characterization studies for defining NORs and PARs 
  • E&L studies
  • Shipping validation studies 
  • PPQ: Enabling development of robust and well-defined PPQ strategy 
  • Regulatory submissions: Supporting regulatory submissions by generating robust data packages  
  • Life-cycle management: Support LCM programs and provide solutions to our clients for improving COGs by increasing batch sizes, using alternate equivalent RMs and consumables, etc. 

Quality Management Systems

Quality is central to our culture. That’s why we have designed robust quality management systems that our Quality Control and Analytical Development teams live by. They’re built to make our teams proactive and responsive in ensuring all-time compliance with global standards from developing and deploying robust quality systems, continuous governance through effective metrics and risk mitigation strategies. 

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Regulatory

We don’t just meet regulatory standards – we uphold them. With two decades of compliance excellence and 138 successful audits under our belt, we’re the CDMO that regulators trust. Our track record speaks for itself – did you know that 100% of our regulatory inspections passed without any critical observations? Our flagship site, providing integrated drug substance and drug product manufacturing, including drug-device-combination expertise, has FDA approval from the CDER and CDRH. And our highly experienced teams can anticipate regulatory shifts and provide comprehensive regulatory support at every stage of drug product development.  

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State-of-the-art facilities

Our operations are supported by two cutting-edge facilities that offer flexibility to support bespoke development and manufacturing needs for your biologics assets. Approved by multiple regulatory bodies and equipped with the latest technology, our sites uphold rigorous quality standards, ensuring reliable and compliant operations.

550,000ft²

of dedicated space for process development and drug substance manufacturing.

Resources

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