Leading the future of biologics

Expert drug substance and drug product development and manufacturing

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, across microbial and mammalian technology platforms, for our clients.

From cutting-edge high yielding cell line technology to innovative novel formulation technology, we deliver the full spectrum of development services across multiple therapeutic modalities. Our world class cGMP facilities offer a unique value proposition of integrated drug substance and drug product manufacturing to produce final finished product in all possible product formats (including Autoinjectors and Pen devices), for clinic or commercial use.

cGMP manufacturing

Our commitment to cGMP practices across both drug substance and drug product manufacturing means you can rely on us to deliver quality product every time, on time. Our integrated drug substance and drug product cGMP manufacturing facilities, designed with USFDA’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, like plasmid DNA, peptides, proteins, monoclonal antibodies, conjugated proteins, VLPs, etc. from microbial and mammalian platforms. Our facilities with flexible manufacturing scales, cater to our customer needs for both clinical and commercial supplies with 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 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. 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:

  • Upstream fermentation manufacturing scales: 50L, 300L and 1000L SS fermenters
  • Midstream processing by continuous centrifugation, high pressure homogenization and hollow fiber filtration
  • Inclusion body solubilization and protein refolding capabilities
  • Multiple chromatography systems for aqueous and reverse phase chromatography
  • Ultrafiltration-diafiltration systems for concentration and buffer exchange
  • Reaction capabilities for enzymatic digestion, conjugation and pegylation steps
  • Lyophilization capabilities for Drug Substances

 

Mammalian

Mammalian

Our mammalian cell culture facility has been designed to execute various types of customer 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) that can each support fed batch and perfusion cell culture processes at 50L, 500L and 2000L scales using single use bioreactors
  • Dedicated harvest clarification rooms for each upstream suite
  • Capture chromatography systems and virus inactivation systems
  • Intermediate and polishing chromatography skids
  • Virus filtration skid
  • Ultrafiltration-diafiltration skids for concentration and buffer exchange steps
  • Drug Substance bulk filling in container of choice (FTTp bags, bottles etc.)

 

Drug product manufacturing

Drug product manufacturing

OneSource is a one-stop CDMO, with end-to-end development and manufacturing capabilities for formulation, fill-finish and drug delivery devices. Our capabilities in drug device combination products range from device conceptualization and selection to modular automated device assembly & packaging for clinical and commercial supplies, across multiple device formats including pen devices, autoinjectors & safety syringes. This capability complements our strong fill finish capabilities across all format types, including multidose cartridges and single use PFS. OneSource enables its clients to accelerate their device development programs using strong technical expertise & deep relationship 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 technical expertise to provide solutions spanning the entire life cycle of the DDC products: from conceptualization, device evaluation, process definition, assembly equipment to cGMP clinical and commercial manufacturing
  • Capability to assemble & test more than 9 pens / autoinjector devices across different device manufacturers, offering great flexibility of device format and assembly
  • Demonstrated manufacturing excellence, utilizing state-of-the-art isolator-based barrier systems and single use manifold systems, and network offering a capacity of 40 million cartridge & pen assembly (100 million by Dec’ 2025) and 28 million PFS formats from USFDA and EMA approved facilities

Technology Transfer capabilities

Technology Transfer capabilities

OneSource has a dedicated technology transfer team for both drug substance and drug product, 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 assessment and facility fit assessment 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 and non-critical process parameters
  • Collaborate with the development team for late-stage process development studies involving:
    • Development and qualification of appropriate scale-down models
    • Development of precise experimental design for process characterization studies
    • Statistical analysis of the data from PC studies and develop appropriate normal operating ranges (NOR) and proven acceptable ranges (PAR) for critical and key process parameters
    • Development of study designs for resin life-time, virus validation and such other studies using scale down models
    • Development of COGs optimization strategies
  • Development of PPQ strategy using the information from PC 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. Our blend of highly experienced scientists with young innovative minds use efficient, reproducible and robust platform processes for early-stage process development drivinghighly accelerated timelines to make our client’s FIH and other assets clinic-ready. These processes are designed to enable right-first-time scale-up and technology transfers from the development laboratories to manufacturing scales. The team is also highly skilled in performing late-stage development activities using qualified scale-down models and generating robust data and process control packages for clinical and commercial manufacturing. Platform-based methods to support process development and method development for product characterization is one of our core skills. 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

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. The team also specializes in selecting raw material and consumable vendors that provide a significant cost benefit to our customers. 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:

  • Fast to IND – High throughput systems for accelerated process development and optimization at industry-leading timelines
  • Use design of experiment (DoE) approaches for process optimization that provides an early understanding of potential CPPs and NORs and PARs.
  • Selecting raw materials and consumables that offers a high level of cost benefit to our customers without compromising on quality
  • Streamlined development and qualification of scale-down models for each unit operation
  • Designing process characterization and ranging studies with statistical data analysis to develop best-fit NORs and PARs

Analytical development and method transfer

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, product comparability at various stages of product life-cycle, lot release, stability and stage-appropriate product characterization , across therapeutics ranging from peptides, conjugated proteins, plasmid DNA, monoclonal and bispecific antibodies and other complex modalities.. Our highly streamlined method transfer approaches aid in successful implementation and validation in quality control laboratories. Our state-of-the-art analytical laboratories offers high level of automation not only for analytical and bioassay development but also for end-to-end physicochemical and functional characterization of biologics.

Drug product development

Drug product development

We offer development of novel high concentration, low viscosity formulations for various products that can be injected through sub-cutaneous route of administration rather than conventional intravenous or intramuscular routes. Our formulation development offering includes both early stage and late-stage formulation development as well as drug product process development.

  • Formulation development Buffer and excipient screening studies
  • Primary Container and closure selection studies
  • Device (pens and autoinjector) selection and development
  • Formulation process development (order of addition, flow rates, mixing studies, etc.)
  • Tubing compatibility studies
  • Filter screening and sizing studies
  • Freeze-thaw studies
  • Late-stage development studies (E&L studies, characterization and ranging studies, 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.

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, providingng 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.

550000ft²

of dedicated space for process development and drug substance manufacturing.

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