Shilpa Biologicals Private Limited

Shilpa Biologicals Private Limited

Shilpa Biologicals is a CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging

About the plant

Shilpa Biologicals is a company based out of India, providing Protein production to Gene to Cell Line Development to GMP to Fill - finish and Packaging, which also includes Formulation Development, Analytical development, Drug Substance, Drug Product and Regulatory support for our global clients.

Our strong scientific team with many years of combined experience working on multiple products for the global market, with state-of-the-art facility to support Gene to GMP (including but not limited to Clone development (Mammalian and Microbial (both MAbs and Non-MAbs) - using multiple platforms like CHO DG44, CHO GS, CHOZN, HEK 293, SP2/0 cell lines and Pichia), RCB, MCB, WCB, Characterization, Analytics, Formulation Development, Optimization, Lot release, Bioassays, validation, Upstream and Downstream process Development, Drug Substance and Drug Product manufacturing), Fill and Finish, Packaging, Stability and Regulatory support has put us ahead of competition.

Our Fermentation facility also has huge capabilities to accommodate commercial scale manufacturing of products. We also supply Albumin on a large scale for any of your requirements.

Glimpse of our Mammalian and Microbial DS & DP Manufacturing and Fill Finish capability:

• Mammalian DS Manufacturing: 50L X 3, 200L X 6,1000L X 3, 2000L X 2
• Microbial DS Manufacturing: 200L X 2, 1000L X 2, 3000L X 2, 30,000L X 2, 55,000L X 3
• DP manufacturing: 3 FF lines, vial, PFS, cartridge. We support Human health, Animal health, ADCs and Vaccines for our global clients.

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Certifications

• ISO

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Activity

• Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, Human / animal extracted products, BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1, 2, 3
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities

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Batch Size / Reactor

• Small, Medium, Large, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L, > 5000 L, 1 - 10 sqm, 10 - 50 sqm, 50 - 100 sqm, 100 - 200 sqm, > 200 sqm

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Genetic analysis & Pharmacogenetics, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support

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