Theertha is pleased to offer cutting edge and competitive development services to collaborators from cell line development to fill and finish support
Clone Development & Characterization
Existing process Optimization
Cell Based Bioassay
Scale-up design and Support
Process Validation support
mAbs and Therapeutic Protein
Vaccine candidate evaluation
Plasmid Supply (Industrial Grade)
Reagents (Plasmids & Vector) release & Characterization assay
utilize Theertha team extensive expertise in biopharmaceutical development.
Improve, optimize the product’s titre and/or scale-up an existing process to reduce the overall cost of manufacturing.
Transfer existing processes From Theertha to Collaborator site of manufacturing.
Theertha scientists have extensive experience in mammalian (CHO) and bacterial (E. coli) cell line development. Team has developed various cel banks for a number for monoclonal antibodies (biosimilars), recombinant proteins, hormones and recombinant vaccines.
Theertha team specializes in handling microbial and mammalian-based products across different host and expression systems. By utilizing various media, feeds, and supplements to optimize protein titer and enhance protein quality.
The well-equipped facility and specialized expertise of Theertha Downstream team allow for efficient optimization of protein purification strategies. With a focus on chromatography techniques (affinity, ion- exchange, hydrophobic interaction), UF/DF, and virus inactivation and removal, by ensuring the safety and purity of the purified protein.
‘The Analytical Team supports upstream and downstream development by developing and validating various in-house analytical methods such as HPLC, UPLC, capillary electrophoresis, and more. ‘Team ensures method transfer, validation, and delivers a panel of analytical test methods for characterizing and releasing the drug substance, along with comprehensive reports and protocols.
Formulation development for therapeutic proteins focuses on maintaining stability during storage, transport, and delivery. This includes excipient selection, buffer studies, and optimization of parameters for stability. Other considerations involve storage container selection, mixing studies, lyophilization cycle development, and filter selection for quality assurance.
Theertha provides comprehensive analytical and biophysical characterization services. Team is expertise in interpreting data and delivering accurate information supports product development at all stages. Services including reference material characterization, manufacturing site changes, and biosimilar-to-innovator comparabilty.
Technology transfers a critical aspect of biosimilar development, ensuring the successful transfer of knowledge, processes, and methodologies from one location or organization to another. It involves thorough testing to confi that the transferred technology can consistently produce the desired product while meeting quality standards and ensuring safety for human use.
Theertha strives to develop a lean and agile Quality Management System (QMS) that aligns with giobal regulatory requirements and business demands. This entails capturing customer feedback and regulatory changes, integrating them nto operations, and maintaining a streamlined structure that balances. compliance and operational efficiency.
Theertha offers extensive scale-up and manufacturing support for biopharmaceutical companies, facilitating seamless transitions from small-scale to large-scale production. We support to optimize process parameters, ensure scalability, and maintain product quality throughout the scale-up process.
Theertha scientists have extensive experience in mammalian (CHO) and bacterial (E. coli) cell line development. The team has developed various cell banks for a number for monoclonal antibodies (biosimilars), recombinant proteins.
Theertha Biopharma offers comprehensive process development services for clients aiming to develop biosimilars, novel products, conduct discovery research, and manufacture enzymes and other recombinant proteins. Our expert team provides tailored solutions, ranging from early-stage development to late-stage optimization, to meet the specific needs of our clients. We ensure adherence to rigorous quality standards, regulatory compliance, and customer-specific requirements throughout the process. With our expertise in process characterization, optimization, scale-up, and advanced technologies, we help clients successfully navigate the complexities of biopharmaceutical development and bring innovative products to market.
Whether it's biosimilar development, novel product formulation, discovery research support, or the manufacturing of enzymes and recombinant proteins, Theertha Biopharma is committed to delivering efficient and cost-effective process development solutions. Our collaborative approach, technical expertise, and timely communication ensure project success and enable clients to achieve their goals in the rapidly evolving biopharmaceutical industry.
Tailoring solutions to meet the unique needs of each client, whether it's biosimilar development, novel product formulation, discovery research, or enzyme/recombinant protein manufacturing.
Ensuring adherence to rigorous quality standards, regulatory compliance, and customer-specific requirements throughout the process to guarantee the safety and efficacy of the products.
Utilizing state-of-the-art technologies and techniques for process characterization, optimization, scale-up, and analysis to enhance efficiency, productivity, and overall success.
Engaging in close collaboration with clients, involving timely and effective communication, to foster a partnership that promotes shared understanding, project success, and the achievement of goals.
Delivering efficient and cost-effective solutions that optimize resources and maximize value for clients, while maintaining the highest quality standards.
Process Development (Expression and Growth) Upstream process optimization
Formulation composition finalization with excipients as per reference product.
At Theertha Biopharma, we provide comprehensive formulation development services for biopharmaceutical products. Our experienced team specializes in the design and optimization of formulations to ensure product stability, efficacy, and patient acceptability. Here's an overview of our formulation development capabilities:
We work closely with our clients to understand their specific product requirements and develop tailored formulations. Our team considers factors such as drug substance characteristics, target indication, route of administration, and patient preferences. Through systematic formulation design, we optimize the compatibility of ingredients, select appropriate excipients, and establish formulation strategies that maximize product performance.
Stability is a critical aspect of formulation development. We conduct comprehensive stability studies to assess the physical, chemical, and biological stability of the formulated product over time. By subjecting the formulation to various stress conditions, including temperature, humidity, light, and pH, we evaluate its robustness and identify potential degradation pathways. This information helps us refine the formulation to ensure long-term stability and shelf life.
Pre-formulation studies are conducted to understand the physicochemical properties of the drug substance and guide the formulation development process. We investigate parameters such as solubility, particle size, polymorphism, and compatibility with excipients. These studies enable us to select the most appropriate formulation approach and optimize the formulation composition and manufacturing process.
Once a formulation is developed, we further optimize it to enhance attributes such as bioavailability, drug release profile, and patient compliance. Our team utilizes advanced techniques, including Quality by Design (QbD) and Design of Experiments (DOE), to systematically explore and optimize formulation variables. We also ensure that the formulation can be scaled up to commercial manufacturing without compromising its quality and performance.
The drug development process is typically divided into three major steps: early-stage development, preclinical development, and clinical trial. The transition from early-stage development to preclinical development is a continuum, and results of preliminary pharmacology and toxicology testing often contribute to the drug development. The preclinical campaign includes a demonstration of the consistency of and product characterization, biosimilarity establishment and including stability and specification setting.
The objective of this stage is to establish consistency of the developed process.
Product characterization includes side by side comparability studies of inhouse product with reference product.
The purpose of stability testing is to provide evidence on how the quality of a drug substance.
The objective of this stage is to qualify methods necessary for Drug Substance and Drug Product release testing.
Two phases of dossier preparation involved in this stage, prior to approval to conduct preclinical studies and post completion of preclinical studies.
The objective of this stage is to establish consistency of the developed process.
Theertha Biopharma is a trusted partner in quality management, providing end-to-end support to clients. They assist in the establishment of a robust QMS, tailored to the client's specific needs and regulatory requirements. Theertha enables clients to achieve regulatory compliance, maintain operational efficiency, and continuously improve their quality systems.
We assist in the validation of the transferred manufacturing process at the receiving site. Our team works closely with clients to develop validation protocols and provide guidance on the execution of process validation studies. We ensure compliance with regulatory guidelines and industry best practices to establish the robustness, reliability, and reproducibility of the manufacturing process.
We develop a detailed technology transfer plan tailored to the specific needs of the client. The plan outlines the transfer milestones, timelines, responsibilities, and deliverables. Our team collaborates closely with the client to address any technical challenges, mitigate risks, and ensure a seamless transfer of technology.
As part of the technology transfer process, we assist clients in optimizing and scaling up the manufacturing process to ensure successful commercial-scale production. We apply our expertise in process characterization, optimization, and scale-up to refine the process parameters, optimize yields, and enhance productivity while maintaining product quality and consistency.
We provide ongoing support and monitoring during the technology transfer process and subsequent commercial manufacturing. Our team remains available to address any questions, concerns, or challenges that may arise, ensuring a smooth transition and successful implementation of the transferred technology.
Theertha Biopharma, a leading provider of comprehensive regulatory support services, specializes in assisting clients in the biopharmaceutical industry. Their expert team excels in preparing and submitting regulatory dossiers, such as IND applications, BLAs, and MAAs, ensuring the submissions are complete, accurate, and compliant. Theertha Biopharma maintains close collaboration with regulatory authorities, addressing queries and requests for additional information for a seamless review process. Furthermore, they offer ongoing regulatory compliance support, conducting regular audits, quality assessments, and compliance reviews to uphold adherence to GMP, GCP, and other pertinent regulatory guidelines. Theertha Biopharma's knowledge and meticulous approach aid clients in effectively navigating the intricate regulatory landscape and sustaining compliance throughout the product lifecycle.