Services
LLB is already valued with privileged partnerships from some of the top ranking pharma and biopharma companies and has acquired the status of preferred service partner among all the ranks in pharma, biopharma and life sciences sectors globally. We strive and commit to help our partners succeed in their endeavours.
Integrated Services
Luminol Biopharma being an integrated biopharmaceutical company offers prospective partnerships and services from Lead to Drug to biopharmaceutical and biotechnology companies.
LLB offers full-range R & D, Analytical, Preclinical and Clinical Development services to those who seek comprehensive or selective partnerships or services.
The company has half-a-decade passionate and enriching expertise in gene synthesis; cloning; protein expression; clone development; cell banking and characterization; long-term maintenance of pure, stable and high-yielding clones; developing competitive edge upstream and downstream processes for recombinant proteins and monoclonal antibodies; product development and characterization in comparison with innovator drug; and over a decade special expertise on preclinical and clinical development in accordance with international pharmacopeias, FDA, EMA, OECD, WHO, ICH, ISO, Schedule Y, GLP and others under its parent organization.
Luminol Biopharma provides end-to-end technology development and transfer services in biologics particularly for biosimilar molecules.
R & D Support
R & D services include any ‘proof of concept’ studies, gene synthesis, cloning and clone development for optimal expression of target drug molecule with bacteria, yeasts and mammalian cells, cell banking and characterization, competitive upstream and downstream process development, process scale-up and validations with respect to recombinant proteins, monoclonal antibodies, stem cells, classical fermentation products or new products of any biological category.
Key and critical support and services within process and product development and characterization include high expression of target proteins; host cell characterization and banking; media mapping; metabolic studies and modulations; refolding and recovery optimization; quick, efficient and economical chromatographic purification; PEGylation process and analytical development; immunogenicity prediction, assessment and modulations; functional assessment and modulations; and any other protein engineering aspects.
Formulation development and stability studies in line with regulatory guidelines are the other part of our R & D services.
Analytical Services
LLB offers establishment, standardization, verification and/or validation of Pharmacopoeial analytical methods or analytical research and development services towards product characterization and development.
ELISA, Biological Assays, Immuno-Assays, Receptor Binding Assays and Cell Based Assays are specialized services from Luminol Biopharma.
LLB extends routine analytical services and certifications as well with drug products, drug substances, intermediates and raw materials and chemicals.
Preclinical Development
LLB with over a decade of proven specialization and expertise and being a preferred preclinical and clinical partner in pharma and biopharma sectors offers comprehensive or selective preclinical and clinical services.
We have successfully conducted over 250 in vivo and in vitro studies in compliance with the Schedule Y, OECD, ICH, ISO, Indian Pharmacopoeia, British Pharmacopoeia, NCCLS guidelines and mutually evolved and accepted Protocols. Independent Quality Assurance Unit within the Division ensures the system and quality of the data generated as per GLP compliance.
Our Preclinical Research Unit is registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment & Forests, Govt. of India for the breeding of animals and to conduct research on animals with prior approvals from Institutional Animal Ethics Committee (IAEC) / Institutional Bio Safety Committee (IBSC) as applicable.
LLB produces and supplies polyclonal antibodies of various animal origins including that of goat and sheep. As also, monoclonal antibodies adopting hybridoma technology with the highest purity and quality compliance. The company also offers cascade immunization of host cell proteins (HCP) from bacteria, yeasts and mammalian cells and supply of affinity purified antibodies.
The preclinical services include in vivo and in vitro toxicity and safety studies, biological assays using various test animals and systems, pharmacological investigations, pharmaco- and toxico- kinetic studies etc to pharma and biopharma industries worldwide in accordance with international pharmacopeias, FDA, EMA, OECD, WHO, ICH, ISO, Schedule Y, GLP and others.
The toxicity studies cover acute, sub-acute, chronic and sub-chronic toxicity, genotoxicity, hepatotoxicity and cytotoxicity among others. Skin Sensitization, Eye Irritation and Dermal Irritation are part of standard preclinical services.
PK/PD and BA/BE studies are specialized studies being offered with a decade of accomplished experience. As also bio-analytical method development and validations.
The preclinical unit also offers pathological, haematological, biochemical, immunological and microbiological studies besides supporting on various functional assays covering and including inflammation, pain and metabolic disorders, and non-GLP discovery studies.
Clinical Partnerships
LLB’s parent organization Micro Therapeutic Research Labs is a pioneer and an accomplished clinical partner in India as well as abroad for past 12 years. Visit MTRL at www.microtheraps.com for details.
Business Solutions
LLB extends its further support on technology evaluation and due diligence, process improvements, process economy, overall process and operational cost optimization, quality compliance and upgradation, regulatory documentations and submissions, quality and regulatory training, quality audits, new project conceptualization, product selection and portfolios, new project proposals, US-FDA and WHO-GMP compliant biopharma and pharma plant designing, turn key projects, US-FDA, WHO-GMP, ISO, GLP regulatory guidance, In-licensing and out-licensing, business policies and strategies and the other existing or emerging needs of pharma, biopharma and biotech industries.