SanKav Pharmaceuticals

We provide the global community with small molecule, biologics, organic treatments and medicines. Through innovative state-of-the-art personalized medicines, we seek to cure and prevent common and rare diseases for diverse individuals in rural and urban communities. SanKav is a CMO, CDMO, Contract Laboratory Services provider for Testing of In-vitro and In-vivo samples that includes CRO services of bioavailability, pharmacokinetic, bio-equivalence and clinical programs testing. Our services include R&D, manufacturing, validation and testing of API/ drug substances, intermediates and finished dosage forms of small molecules and biologics, and associated materials such as excipients, bioprocessing aid materials and packaging components. SanKav provides services for FDA and other regulatory submissions and FDA correspondences. Our biologics technology platforms include the following: ? Antibody therapies and processes [mAb, bi-specific mAb, and mAb fragments] ? Vaccine delivery [DNA vaccine, viral vector vaccines, inactivated viral vaccines, recombinant protein vaccines, virus-like particles (VLP), nanoparticle vaccines and mRNA vaccines] ? Supporting processes [plasmid and viral vectors such as adeno, adeno-associated, and lentiviral] ? Cell and gene therapies [autoimmune, cardiovascular, neurological, adeno-associated virus (AAV) based therapy, CAR-T cell therapy, CRISPR] ? Adapt to new product modalities [flexible workflows for mAb, AV, pDNA, and mRNA] ? Aseptic fill finish-vial, PFS Our additional complex laboratory testing/ test certificates (CoA) include: ? Comprehensive laboratory testing for Plant-Based Products, package containers, bags, etc. including Pesticides ? Full testing for the Petroleum and Hydrocarbon based materials, products, package containers and bags, tubing, etc. ? Extractables & Leachables ? Tests to support the Environmental Protection Agency (EPA) samples including water testing (well water, city water) for companies, town, county and state.

网站

www.sankavpharma.com

SanKav Pharmaceuticals的外部链接

所属行业

制药业

规模

2-10 人

总部

Washington Township，New Jersey

类型

私人持股

创立

2016

领域

Manufacturing、Research & Development、Regulatory Support、FDA Compliance & Quality、GMP Due Diligence and Audits、Technology Transfer、Facility Design / Validation、Quality Systems Management、Scientific Advisor、Large Molecules (Biologics)、Microbiological Testing、Small Molecules、Aseptic Manufacturing、Contract Services、CMO、CDMO、Contract Custom Packaging、Contract Laboratory、Cleaning Validation、Pesticides testing、Plant-based Biologics、Antibodies、Cell Therapy、Gene Therapy、Viral Vectors、mRNA Technology、pDNA Technology、Vaccine Delivery、EPA Samples Testing、Herbals、Contract Testing of Petroleum Products、Extractables、Leachables和Cosmetic Products Testing