Services
Conceptual Facility Design
At Invigorate Biotechnologies LLP, we are convinced that defining your manufacturing strategy early on in your development phases is critical to ensure a successful commercial launch. We are also aware that designing a production facility is a complex process that requires adequate expertise and anticipation of underlying challenges. Therefore, our conceptual design team is here to support you in the modelization of your facility concept responding to capacity and cost estimations.
Upfront view on expected production capacity and facility requirements & costs.
Get advised on how technology selection affects facility design.
Implement your facility strategy while optimizing your space, time, costs, and personnel needs.
Manufacturing costs appreciated early on in development for informed development and facility deployment strategy.
Optimal production scenario to meet your commercial manufacture perspectives.
Process layout modelization for identification of space and time bottlenecks toward optimized facility design.
Accelerate initial stage of facility set-up with optimal facility models.
Capabilities
As biomanufacturing experts, we understand at Invigorate Biotechnologies the challenges encountered by developers from technology adoption to product commercialization. Having the right support at an early stage is key to success. We aim to unlock the market reach for our customers by giving them the opportunity to concentrate on their core therapy development business, while we support manufacturing success.
GMP Audits
The ideal approach for sustaining consistently high-quality processes and outputs is inspection readiness, which is a continuous, continuing program. Organizations must always be prepared for inspection from the perspective of a regulatory body. The inspection's main objectives are to confirm that the data is accurate and that processes and systems are in line with legal requirements supporting trial participants' safety and wellbeing. An innovative, risk-based strategy ensures that quality procedures are consistently integrated into clinical trial programs for complete compliance and inspection readiness.
An external or internal person or team will conduct a GMP audit to confirm that a factory is adhering to its documented Good Manufacturing Practices.
Capabilities
Invigorate has extensive expertise team of highly skilled GMP auditors for providing GMP audit services all around the world. Our GMP auditors have experience of audits of API, Intermediates, Raw Materials, Warehouse Facilities, Packaging Material Facilities, R & D/F & D Laboratories, and Finished Dosage Facilities.
Technology Transfer for vaccines
Technology transfer in the biopharmaceutical sector refers to the transfer of any method, including with its documentation and technical knowledge, between development and manufacture or between manufacturing facilities.
Invigorate Biotechnologies provide end to end and solutions pertaing to any stage (i.e. Drug product, drug substance) for different Recombinant & Polysaccharide conjugate vaccines.
Expertise on following:-
- Polysaccharide conjugate vaccine
The polysaccharide conjugate vaccine covalently joins the polysaccharide and protein antigens, imparts the beneficial properties of the protein antigen to the polysaccharide antigen, improves the immunogenicity of the polysaccharide antigen, and offers an epitope for CD4+ T cells that encourages the memory response.
Polysaccharide conjugate vaccines ready for technology transfer
- Recombinant vaccine
A vaccination created using recombinant DNA technology is known as a recombinant vaccine. In order to do this, DNA encoding an antigen—such as a bacterial surface protein—that triggers an immune response is inserted into bacterial or mammalian cells, where it is expressed before being extracted.
Recombinant vaccine ready for technology transfer
- Hepatitis B vaccine
- Carrier proteins
The protein carrier's main function in glycoconjugate vaccines is to provide T cell epitopes that give an otherwise T-independent antigen, such capsular PS, a T-dependent characteristic, simulating the immune response to proteins.
Carrier proteins ready for technology transfers
- CRM 197 (Genetically modified Cross Reactive Material of diphtheria toxin)
- TT (Tetanus Toxoid)
- Td (Diphtheria Toxoid)
Capabilities
With platform technologies, Invigorate Bio has deep knowledge and competence in research, process development, and commercial scale production of several vaccines, such as the 20-valent pneumococcal conjugate vaccine, the Hib-TT conjugate vaccine, the meningococcal conjugate vaccine, and the hepatitis B vaccine.
Training for Industry Professionals
Invigorate has excellence in technical, regulatory consultation, and guidance services for biologics viz. human vaccines, human cell/tissue products, monoclonal antibodies and pharmaceuticals including sterile and non-sterile products. We consider that inadequately trained personnel is one of the most serious problems being faced inthe industry.We are committed to ensure clients’ lasting success and effectiveness with respect to the compliance and regulatory issues. We offer a full supplement of training programs for personnel at different levels in an organization right from manufacturing operators, mid-level managers to the senior management decision makers. The training programs are tailored to meet the Organization’s needs and requirements.
The trainings delivered are classroom training, on-the-job training and “train the trainer” trainings, which include but are not limited to the following:
- Overview of GMPs
- GMP training for manufacturing module
- GMP Training Product Testing Module
- GMP Trainings Facility & Equipment Maintenance Module
- QMS Module
- Trainings on Integration of Process based Risk Assessment into QMS
- Risk-Management Training
- Gap Assessment Trainings
- Preparedness for an Inspection and Interaction with Auditors
- Data Integrity Training
- Quality Culture Training
- Patent Certification, Exclusivity, and Forfeiture
Training for Pharmaceutical/Biopharmaceutical Graduates
We offer trainings to the individuals who are interested in entering the world of the pharmaceutical industry after graduation. We have devised an online interactivetraining course for the graduates passing out, to familiarize them with the concept ofGMP (Good Manufacturing Practices) standards, which is a vital aspect for the manufacturing of high quality pharmaceutical/biopharmaceutical products.These are the mandatory standards and health authorities perform inspection and audits in order to check the organization’s compliance to these standards.
Our training program inducts the students about these standards and gives them an edge to crack their entry into pharmaceutical industry despite of a massive competitive environment.The students will understand:
- Fundamental of the pharmaceutical industry.
- Overview of the Manufacturing Facility
- Pharmaceutical regulation and its importance.
- Basic overview of the GMP requirements in pharmaceutical industry
- Awareness & Understanding of Technical jargon of the GMPs