Enabling safe, cost-effective Animal Health products – molecule to market
While the time from bench to market is shorter for veterinary products as compared to humans, veterinary formulations are more complex and diverse since you need to consider variability across multiple species. Further, for companion animals, you need to consider ease of use for the pet owner, dosing flexibility, etc.
Syngene understands these challenges, having worked with several global clients in the veterinary space. We offer services across veterinary hygiene, care, and nutrition products spanning small and large molecules for companion animals. We have supported numerous clients for NCEs and API development, including successfully undertaking several process scale-up programs. We have unique capabilities in developing anti-parasitic products and offer various dosage forms to treat acute and chronic diseases – pain, dermatology, and infections.
Our Discovery services span every critical program milestone, including analytical, bioanalytical, and safety assessments required for Regulatory Dossier preparation across small and large molecules. We design studies that satisfy stringent global regulatory requirements covering regulatory authorities in Europe, the US, and Japan.
Our Development services include drug substance development, formulation development, analytical testing, phase appropriate analytical method validations, GMP manufacturing, and packaging services. For large molecule development, Syngene has an OECD GLP-certified Regulated Large Molecule Laboratory. Here, a dedicated team of scientists actively works with animal health manufacturers to support animal safety and efficacy trials across a host of animal health programs.
We also have integrated capabilities to support NCEs, APIs and formulation development, process scale-up, DMPK, Toxicology, and PK studies. This capability offers you the benefits of faster time-to-market and lower costs.
Discovery services: Target to IND
We support research programs from target identification to investigational new drug (IND) application. Our services include chemistry, biology, DMPK, analytical and toxicology.
Syngene provides test items formulated in solution/suspension prior to dosing. Our Analytical methods supporting toxicology programs include high performance liquid chromatography (HPLC) or gas chromatograph (GC). We also have experience in physicochemical testing to meet the regulatory requirement.
Our Bioanalytical team provides services spanning early discovery until the preclinical phase. Our scientists have the expertise to develop and validate quantitative bioanalytical assays or transfer them to LC-MS/MS method.
We offer a comprehensive portfolio of in vitro and in vivo short and long-term toxicology studies to evaluate oral, dermal, and inhalation toxicity, dermal and ocular irritation, and skin sensitization. We also perform neurotoxicology (detailed functional observations and assessments), development, reproductive toxicity, and a wide range of genetic toxicology assays.
Formulation Development capability across dosage forms
Our capability in formulation development extends across dosage forms and clinical supplies for oral solids and injectable fill-finish. We ensure the palatability of our formulations early in the development stage for chewable oral formulations. We follow quality by design (QbD), risk analysis (FMEA), and design of an experiment (DoE) processes during formulation development to ensure the success of our programs.
Our capabilities in formulations are as follows:
- Multi-drug combination chewable tablets
- Hard chew and soft chew tablets
- Spot-on, topical, ready-to-use injections; multi-dose injections; lyophilized powder for injections; complex injection dosage forms
- Can handle compounds up to OEL class 4 (1 mcg/m3)
- Solubility enhancement techniques including amorphous conversion by spray-drying and hot-melt extrusion; nano-milling in wet dispersion form
- Evaluating stability in super stress conditions and open exposure studies
- Simultaneous analytical estimation methods for multi-drug combination products
- Differentiated / 505b2 formulations from ideation to GMP batch manufacturing for clinical studies
- Formulations for APIs susceptible to degradation
- Formulations having a very low drug dose (microgram levels)
- Polymorph screening and other pre-formulation activities for new chemical entities (NCE).
GMP Manufacturing of oral solids
We have a dedicated Oral Solids GMP manufacturing facility for Animal Health products that can handle Clinical and VICH batches of up to 50 kg. The facility can handle animal origin materials (meat flavor granules) and APIs like ectoparasiticides (other than pesticides). We follow phase-appropriate quality requirements to expedite early-phase activities as per client requirements.
Our capabilities are as follows:
- Manufacturing of hard chew and soft chew tablets
- Manufacturing of large size tablets ( ~7 g) using a special tablet press
- Blister packing of tablets up to 12 mm thickness using blister packing machine
- Pouch-packing of individual blisters to cater to clinical study requirements
- Manufacturing of registration stability batches
- Stability center to conduct VICH stability studies
Protein therapeutics in Animal Health
The discovery, development, and manufacturing of protein therapeutics is a fast-growing area of research in animal health. Academic laboratories and biopharma companies are continuously focussing on developing critical medicines and vaccines for livestock/farm animals and companion animals. As with any biotherapeutics, the determination of purity, safety, and efficacy is an essential part of the regulatory approval process in animal health drugs. Hence, it is mandatory to provide PK, immunogenicity, and PD data to regulators for market authorization of animal health biologics.
An advantage in animal health is that the methods used to determine PK, PD, and immunogenicity in animals are based on the same immunoassay platforms and guidelines used for human health biotherapeutic development. Additionally, animal health diseases have the disease targets already studied in humans in some instances. Hence, translating a therapy from humans to animals makes for speed and commercial sense. In contrast to human health drugs, animal health drugs also involve smaller clinical studies from pilot to pivotal trials, making them faster to bring to the market.
Syngene’s Regulated Large Molecule Laboratory
Syngene’s regulated Large Molecule laboratory is an OECD GLP-certified laboratory with more than 15 years of experience in developing and validating immunoassays for various drug classes for human health. This comprises early-stage preclinical (animal matrix) and late-stage clinical (human matrix) studies that involve the development and validation of PK, ADA, Nab, and PD assays.
A natural evolution for the lab (since the group had adequate experience working with biological matrices from animals) was supporting animal health manufacturers with large molecule immunoassays and ligand-binding assays. In the last few years, Syngene has been actively working with animal health manufacturers to support their safety and efficacy trials through a dedicated team focused on animal health programs.
Recently, our laboratory completed the development and validation of immunogenicity methods (Cell-based and MSD) for three large molecule drugs for diseases in canines and felines. For all animal health studies, the laboratory follows EMA and USFDA guidelines for bioanalytical (prescribed by CDER and CVM) immunogenicity assays. This is because immunoassays platforms for PK, immunogenicity, and PD are the same across animal and human studies. We also refer to recommendation papers and topic-specific white papers during the study method design, validation, and sample analysis phases.
Comprising a well-qualified and multi-skilled staff, the laboratory uses global immunoassay platforms like ELISA, MSD, Alphalisa, RIPA, and SPR to generate meaningful PK immunogenicity, PD, and biomarker data for developing animal health drugs for global clients.