Small Molecule Services
SK pharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated small molecule facilities located in the USA (California, Texas, Virginia), Ireland, and Korea specialize in process development, scale-up, and CGMP compliant production from kilograms to multi-ton quantities.
With 80 years of experience in mastering challenging chemistries, we have developed capabilities that support a wide range of processes and technologies. SK pharmteco is capable of handling all scales of production. Our products are manufactured in full compliance with the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (CGMP) and other regulatory agencies.
Energetic Chemistries
We have extensive expertise in commercial scale production using highly energetic chemistries. Our toolbox offers a rich palette of clean, reliable, and scalable reactions. Energetic chemistries often offer a clean and efficient synthetic route and can be scaled safely at SK pharmteco using specialized process development expertise and processing technologies. Development and production of energetic chemistries at SK pharmteco can be performed from laboratory to commercial scale under CGMP compliant conditions in the United States.
High Potency Manufacturing
SK pharmteco has a long history of successful production of highly potent compounds, including cytotoxic compounds. We maintain the required knowledge, experience, and facilities necessary to safely handle the commercial scale production of these compounds. Specialized process development and analytical capabilities for highly potent compounds are also maintained at SK pharmteco. We ensure that all potent compounds are handled safely by optimized process design, use of appropriate engineering controls, and adherence to strict administrative controls and procedures.
Chromatographic Separations / SMB
SK pharmteco has decades of experience conducting chromatographic separations at commercial scale in a highly regulated environment. Our Simulated Moving Bed (SMB) processes can be developed in a few weeks and are easily scalable. In many cases, scale-up from gram to multi-ton quantities can be achieved in less than six months.
Our services include SMB screening, method development, proof-of-concept demonstration, and production of gram to multi-ton quantities of intermediates and APIs. SK pharmteco operates the largest CGMP SMB unit in the US (5 x 1,000 mm), which supports commercial scale API production of hundreds of metric tons per year. Our facilities include kilo-scale and pilot scale units to support smaller quantities also under CGMP conditions.
Controlled
Substances
Security System:
- Fully fenced perimeter
- Guarded gate to enter facility
- Armed security guards 24/7
- CCTV across campus with continuous monitoring and recording
- High security CS facility with secure vault and alarmed fencing
- Biometric access to labs and key processing areas
- Controlled Substances processing and storage areas
- High potency processing areas and isolators
Fully Vetted Security:
- Inspected annually by DEA for registration renewal
- Inspected biannually by DEA for CS compliance
- Inspected annually by US Department of Homeland Security
- Prior inspections by DHS CA and BARDA (US HHS)
SK pharmteco is registered with the U.S. DEA to manufacture Controlled Substances (Schedule II-V). Our controlled substance manufacturing is conducted in California within a highly secure area and in Virginia in an access-controlled production building. Both are registered with and audited by the DEA.
Our controlled substance facilities can be remotely operated to safely run hazardous chemical processes and hydrogenations, while containing reactants, intermediates, and products with an Occupational Exposure Limit as low as 1.0 µg/m3. SK pharmteco’s DEA facilities support laboratory development, pilot production, and full-scale production with reactor capacity up to 2,000 gallons (7.57 m³).
SK pharmteco-CA is Registered for Multiple APIs Including:
- Thebaine Intermediate
- Tapentadol
- Levorphanol
- Methylphenidate
- Dexmethylphenidate
SK pharmteco also has Schedule I researcher’s license experience for research and development on Cannabinoid derivatives and other drug products.
Specialized
Chemical
Capabilities
In addition to our core specialties, SK pharmteco also has the ability to handle challenging chemistries and regulated compounds, such as:
- Nucleosides and Nucleotides
- Phosphorus Oxychloride
- Anhydrous HBr and HCl
- Metal Hydrides
- Mercaptans
- Anhydrous Ammonia
- Hazardous Solvents (diethyl ether, methylene chloride, chloroform, and benzene)
- Organometallics
- Chlorosulfonic Acid
- Epoxides and Oxetanes
- Polymerizations
- Sodium Cyanide
- Hydrazine
- Pyrophoric Reagents
Continuous
Processing
Examples of Large-Scale Semi-Continuous and Continuous Processing at SK pharmteco:
- Chromatography (SMB)
- Liquid/Liquid Extractions (Continuous Centrifuges)
- Distillation (Falling Film Evaporation)
- Elutriation (Continuous Solid Decanting)
- Diazomethane
- Nitrations
- Grignards
- Azide Chemistry
- Aziridine Formations
- Phosphorylation Reactions
- Hydrogenations
- Ozonolysis
- Diels –Alder
- Aldol Reactions
- Cryogenics
- Pyrophoric Reagents
- Cyclopropanations
SK pharmteco has a continuous diazomethane generator that produces CGMP diazomethane in a large-scale multi-product facility. Additionally, we design and build our own reactor skids at lab and production scales to handle various types of chemistry.
Our services include process development, engineering, and production of kilogram to multi-ton quantities of fine chemicals under continuous processing conditions. Our continuous processing expertise can be applied to help customers in reducing costs and improving control of chemical processes.
