Kappa Chemistry Custom Synthesis
Kappa Chemistry is a GMP certified API contract laboratory
Kappa Bioscience, maker of K2VITAL® vitamin K2 MK-7, was founded on a platform created by, and relying on expertise from, Synthetica AS of Oslo, Norway. Synthetica was the first company to develop and subsequently patent the process for synthesizing vitamin K2 – approximately 70 years after Edward Doisy shared a Nobel prize for the first synthesis of vitamin K1.
In 2016, Kappa acquired Synthetica, bringing fully in-house Synthetica‘s long and unparalleled experience with the organic chemistry of vitamin K. This allowed Kappa to incorporate the synthesis production capabilities which have become such a crucial part of Kappa’s success in the ingredients marketplace.
Additionally, this afforded Kappa the opportunity to leverage and build upon Synthetica‘s first-in-class analytical capabilities. Kappa Chemistry was introduced to the market in 2017.
Chemical synthesis is one of the pillars in Kappa Chemistry, and by insourcing production and laboratory services, Kappa achieved full control of the value chain for K2VITAL®, its flagship product.
The acquisition also enabled Kappa to strengthen and widen its core offerings with the addition of laboratory services and it has provided new R&D platforms for product development.
Kappa Chemistry specializes in custom synthesis, analytical services for the pharmaceutical industry, and the synthesis and analysis of non-commercial organic chemicals. The scientific team is engaged with preparation of starting materials, intermediates, biologically active drugs and reference compounds on a milligram-to-kilogram scale, enabling Kappa Chemistry to tailor services to customer-specific requirements. Chemical synthesis is well known as an essential part of drug development, and this has become a vital and strategic component in Kappa‘s continual pursuit of innovation and development of the vitamin K2 market.
Kappa Chemistry is a GMP certified API contract laboratory, with a 16-year history of providing high quality synthesis and analytical services, and unmatched experience with the vitamin K2 molecule.
Analytical services include:
- Active Pharmaceutical Ingredients (API)
- Raw materials
- Solid formulations
- Tablets (coated and uncoated)
- Capsules (hard and soft gelatine capsules)
- Liquid formulations (solutions, suspensions, injectables)
- Semi-solid formulations (gels, creams, ointments, suppositories)
Full services include, but are not limited to:
- Analysis according to official monographs (PhEur, USP, AOCS)
- Method development / implementation / optimization & validation
- Stability studies
- Forced degradation studies
- Impurity profiles
- Structural Elucidation of Unknowns
- Reference Standard Characterization
- Solubility studies
- Response factor studies
- Batch control
- Release analysis
- Process support
- Technology transfer to QA with contract manufacturing partners
- QP - Qualified person service
Kappa Chemistry: Superior Standards
While developing synthetic MK-7, Kappa was determined to do so as if it was an API for pharmaceutical use. Purity and general quality would only then be of a standard acceptable to Kappa. Rigorous characterization programs were initiated, thus enabling a thorough description of the molecule and its quality.
- Quality & Safety
- Product development
- Science Papers
- Tutorial: Quality & Safety
Scalable capacity for mass-market production demands: Kappa’s current production capacity already exceeds the total projected yearly global vitamin K2 demand through 2020.
Industry-leading pricing: Kappa continuously reinvests in R&D and manufacturing processes to drive ingredient price points to levels that support commercial adoption. In 2017, Kappa led the market with a 45% price reduction – marking a significant step on the path to mass-market commercialization of K2.
Purity: all-trans vitamin K2 MK-7 (USP).
Quality: GMP, HACCP, ISO 22000:2005 manufacturing and distribution standards.
Stability: Patent-pending microencapsulation technology ensures stability in challenging formulations.
Long shelf life in finished products: 36 months shelf life on all ingredients; supported by extensive stability data on ingredients and finished formulations.
Approvals: Novel Food (EU), TGA (AUS), sGRAS (USA), drug registration in India (2017). Application processes are initiated in countries including China, Thailand and others. Kosher and Halal certifications.
Kappa developed the K2 Formulation LookBook, including more than 120 ready-to-use product formulations and dosage forms targeted towards all K2 health applications and a wide range of consumer groups.
Kappa’s on-going ExperienceCard Program develops innovative vitamin K2 formulations in collaboration with industry leaders. Each ExperienceCard concept represents a novel product formulation that is specifically designed to solve an existing market problem or to address a health segment or consumer group in a new way. K2VITAL® vitamin K2 MK-7 provides the central ingredient in each of the products. Partners provided synergistic co-ingredients, innovative dosage or manufacturing technology, or other elements that make these forward-looking products possible.