Custom API Manufacturing
Curia provides scientific expertise and state-of-the-art technologies to support the chemical development and cGMP manufacture of complex APIs, including generics, potent and cytotoxic compounds, sterile APIs, steroids and controlled substances. Our world-class facilities offer global-scale commercial production at a cost-effective price. Access our extensive portfolio of more than 240 commercial APIs, including generics, along with our products and services from more than 12 GMP manufacturing facilities in the US, Spain, Italy, France, Germany and India.
We provide custom synthesis and contract manufacturing services at small- and large-scale for all phases of discovery, development and manufacturing. Our teams bring extensive chemical and technical expertise to develop flexible, scalable solutions and cost-effective processes tailored to your needs, regardless of complexity.
Our multipurpose facilities, approved by regulatory authorities such as the FDA, PMDA, KFDA, ANVISA, MHRA and AIFA, leverage established quality management systems and environmental sustainability programs.
Our complete suite of capabilities includes:
- Cryogenic reactions
- Chiral synthesis
- Fermentation
- Steroids
- High potency compounds
- Sterile APIs
- Controlled substances
- Hazardous reactions
Partner with us for the most advanced technology for the production and safe containment of your compound.
Our teams are experts in the cGMP production of highly potent compounds, from grams to hundreds of kilograms per year. We have 30 years of experience in the production, handling and containment of cytotoxic and other highly potent compounds.
Curia’s SafeBridge®-certified facilities include jacketed glass reactors, portable Hastelloy or glass-lined kettles, portable and fixed pressure filters/dryers, HPAPI isolators, as well as particle size reduction technology.
Curia was awarded ‘Industry Leader’ status in Potent Compound Safety Certification. Learn more!
Capabilities
- Equipment including cGMP-compliant glove box isolators and reactors capable of handling materials with OELs under 1 ug/m3
- Manufacturing capabilities up to 1200 L reaction scale with batch sizes of 50–100 kilograms
- Large-scale cryogenic capabilities
Collaborate with us for the safe, secure development and manufacture of DEA-controlled substances and regulated chemicals.
We offer a full range of DEA registrant capabilities, including the manufacture, development, Import, export and chemical analysis of Schedule I-V controlled substances including phenidates, amphetamine derivatives and precursors, and opioid precursors.
Our team is uniquely positioned to deliver advanced cGMP manufacturing services for DEA-controlled substances. Our capabilities ensure that we apply revolutionized industry best practice to manufacture the highest quality products with robust technologies and appropriate analytics to release your materials.
Capabilities
- DEA registrations for manufacturing, research and export of Schedule I-V controlled substances
- DEA-licensed to import Schedule II narcotic raw materials
- Dedicated aseptic fill and finish facility licensed to handle Schedule II, IIN, III, IIIN, IV and V controlled substances
- High capacity and flexibility with 3 US API manufacturing plants
- Controlled substance vault and DEA manufacturing areas
- Drug classes such as cannabinoids, stimulants, including phenidates, amphetamine derivatives, Opioids and their precursors
- Proven track record of regulatory compliance for scheduled drugs
- Expert production and containment capabilities
- Access to validated processes and established raw material sources
- Piloting collaborative partnerships in Controlled Substance drug development, including Schedule I & II-V
Our experts provide a complete range of synthesis capabilities for your sterile API projects, from raw materials through regulated early- and late-stage intermediates to bulk APIs.
We offer advanced building blocks based on proprietary, leading technologies that we use in these synthesis situations.
Our sterilization capabilities are available to you as an independent service if you need additional capacity or do not have bulk sterile facilities. Or work with us to integrate API production for a simpler, more seamless process.
Our dedicated facilities contain a range of flexible chemistry capabilities that permit the handling of hazardous reagents in chemical syntheses. This enables us to make your overall synthesis and process chain integrated and more efficient.
Microfiltration
Our scientists apply high-performance microfiltration to accomplish sterilization. We often use this technology with powder, which is dissolved, filtered and crystallized. Microfiltration is nondestructive, which means it differs fundamentally from traditional sterilization methods. We offer many techniques to precisely control the physical properties of the final product.
Quality Assurance
We bring more than a decade of experience creating the appropriate conditions for the media fill and process validation for sensitive and difficult-to-handle products.
Our QA follows the strictest FDA, ICHQ7A and ICHQ1A guidelines, and our quality control team determines all relevant parameters. Our plant, particularly in the aseptic processing area, employs a system of airlocks and cleanroom zones from class D through class A in the product zone.
Curia offers several sterilization techniques:
| Moist heat | Dry heat | Irradiation | Aseptic filtration | |
|---|---|---|---|---|
| Principle | Autoclave 121 °C 15 min |
Autoclave 160 °C 120 min |
yRay/electron beam > 25 kGy |
Dissolution/filtration Crystallization |
| Forms | Aqueous product | Dry powder Non-aqueous liquid |
Dry powder Non-aqueous liquid |
Dry powder Non-aqueous liquid |
| Advantages | Closed vessel Cost-efficient |
Closed vessel Cost-efficient |
Closed vessel | 2 in 1 step Stability of API Impurities control |
| Disadvantages | New impurities | New impurities Time consuming |
New impurities Apparatus cost Dark packaging |
Manipulation Packaging step |
| Sterilization | Destructive sterilization | Chemical purification and sterilization |
||
Partner with us to improve the cost of goods, develop new IP, enhance and simplify your process safety, deliver more efficient and “green” chemistry, and create routes to novel molecules.
Our multidisciplinary approach tightly integrates fermentation and biocatalysis tools with our extensive chemistry capabilities to design and optimize the best overall process for your project.
We offer extensive expertise, facilities, experience and execution for assessing, developing and implementing syntheses that benefit from fermentation, biocatalysis, synthetic biology and related approaches.
Our team has nearly 30 years of experience delivering comprehensive program support, from innovative strain/enzyme selection and route scouting to rapid pilot-scale to efficient commercial manufacturing.
Services
- Fermentation development and commercial manufacturing
- Biocatalysis and biotransformation
- Natural product production, semi-synthetics and natural product chemistry
- Bioprocess separations and development
- Drug metabolite synthesis
Propane-phosphonic Acid Anhydride – T3P
From development to commercial scale requirements, we can help you develop a superior reagent with our T3P application program.
We have over nearly 30 experience in coupling reactions for a variety of chemical reactants from amides, heterocycles and esters and to carbon-carbon bonds. This allows us to provide a free application program for T3P process development carried out under a strict confidentiality, giving you complete control of your intellectual property.
With proper optimization and process development support from us, T3P is proven to be the optimal reagent in many cases. Our expertise allows integration of the coupling and extraction steps required and provides an optimum solution for commercial scale-up.
We have large capacity and small-scale ISO 9001:2008 certified facilities dedicated to the manufacture of your custom T3P solutions.
Available solvents
T3P is currently supplied as a 50% (w/w) solution in a variety of solvents allowing a greater adaptation and optimization to your process needs.
Solvents include:
- Ethyl Acetate
- Butyl Acetate
- THF
- 2-MeTHF
- Toluene
- N,N-Dimethylformamide
- Chlorobenzene
- Methylene Chloride
- Acetonitrile
- Any other compatible solvent
T3P
T3P, propanephosphonic acid anhydride, is an exceptional reagent for amide/peptide bond formation. T3P is very easy to use and combines excellent reaction selectivity, almost no epimerization, high product purities and excellent yields. Because of its properties, hazardous additives, such as explosive HOBt, are not required.
Additionally, the T3P reagent is non-toxic, non-allergenic/non-sensitizing and the salt by-products are nonhazardous and completely water soluble.
It works well in other condensation reactions, such as esterifications and may be used as a mild reagent for alcohol oxidations and the Lossen rearrangement.
T3P provides excellent selectivity and high yields with simple product isolation by liquid/liquid extraction. Its advantages translate into high-quality products and improved economics, particularly for large-scale, complex coupling reactions.
Benefits include:
- Safe handling: No CMR properties, nontoxic, no allergenic or sensitizing properties
- Wide range of other condensation reactions possible
- Several pharma applications up to 100-ton scale
- Reduced overall process costs
- Easy purification and workup
- Low epimerization during coupling
- No additives required
- Standard peptide couplings can be done in many different solvents and with common protecting groups
- Broad functional group tolerance, mild reaction conditions and high yields
Boronic Acids, Biaryls, Grignards and Organolithiums
We can meet your Oxa acid supply needs – from lab-scale to multiton quantities, we’re your perfect partner.
Oxa acids can be supplied in commercial multiton quantities from our DIN ISO 9001:2008 certified production facilities or in laboratory scale to support your in-house testing
Our expertise, capabilities and equipment enable us to provide all kinds of customized developments to meet your needs.
Catalog Oxa Acids
We offer a number of Oxa Acids available through our fine chemicals catalog including:
- 3,6,9-Trioxadecanoic Acid (TODS)
- 3,6,9-Trioxaundecanedioic Acid (TUDS)
- 3,6-Dioxaoctanedioic Acid (DOODS)
High-tech applications
Oxa acids are uniquely structured high-tech materials. Their unique combination of lipophilic and hydrophilic functions makes them “multi combatants” with applications in pharmaceuticals, nanotechnology, cosmetics and chemistry.
Their properties can be exactly tailored for a given application and they offer leading sustainability characteristics due to their biodegradability.
Oxa acids may be used in the design of prodrugs with tailored bioavailability, as unique reagents, or as speciality products in cosmetics, nanotechnology and other high-tech applications.
You can choose from a portfolio of Oxa acids with one or two acid functions and a wide variety of different chain lengths for exactly tailored properties:
- Very broad liquid range due to low melting and high boiling points
- Unique combination of lipophilic and hydrophilic functions
- Water soluble
- Biologically degradable
- Excellent heat stability
- Outstanding complexing properties
Leverage more than 15 years of experience in the field of organometallic chemistry and a global infrastructure and we’ll deliver a wide range of high-quality compounds at large scale. We tailor organometallic reactions to provide you with a high degree of selectivity and extremely pure end products.
Our flexible program assists you at all stages of a project, from hit-to-lead screening for targets in our proprietary in-house library, initial feasibility studies through to GMP batch production for clinical and commercial production.
We operate manufacturing equipment for cryogenic and organometallic reactions at all potential scales. We grow with your demands, from discovery and structure–activity relationship (SAR)-based drug design to solve your complex challenges.
Integrated with leading solid state chemistry capabilities, our team creates robust, safe, scalable routes and can support your late stage process development. We use Design of Experiment (DoE) and Quality by Design (QbD) principles to define your critical process parameters (CPP) and ensure quality.
Benefits
Many of the compounds we can achieve through organometallic chemistry are not available by other routes. In other cases, organometallics can reduce the number of synthetic steps required to produce a target molecule. This allows the use of less expensive base materials for the synthesis of high-value compounds.
Portfolio
Our portfolio includes the manufacture and use of virtually all types of organohalides as precursors for organometallic synthesis.
Organolithium and magnesium compound production is based on our leading halogen organics expertise, our strengths in catalyst development and our ability to perform subsequent syntheses with these compounds. We also introduce chloro-derivatives into the synthetic strategy to lower your costs.
Our capabilities with bromo compounds enable us to meet all organometallic synthesis requirements including:
- Lithium technology and lithium metals
- Boronic acids
- C-C, C-N, C-O coupling
- Synthesis of heterocycles from organometallic intermediates
Capabilities
- Hit to lead screening for targets in a Proprietary in-house library
- Analytical
- React RAR
- FBRM Focused Beam Reflectance Measurement
- Reaction modelling – Dynochem
- DOE software
- Reactors from mls to gallons
- Stability studies
- Characterization
- Polymorph studies using XRPD
- Polymorph screens
- Salt screens
- Dynamic vapour sorption
- Differential Scanning calorimetry/Reaction calorimetry
Leverage our advanced API production capabilities including halogenations, reactive metals and alkyllithiums, cyanides, HCN and other hazardous chemistries to optimize your project.
Our scientists have mastered the efficient production of APIs and intermediates using a broad range of hazardous chemistries. We utilize integrated technologies including halogenations, use of alkali metals, cyanide chemistry and many others to assist in your decision making process.
Through decades of experience working with hazardous materials up to a very large scale, we maintain the highest levels of safety and environmental control with even the most complex reagents and solvents.
Our experts are equipped to carry out highly exothermic reactions, handle extremely reactive substances and thermally or mechanically unstable compounds.
Halogenations
We skillfully employ various innovative technologies for the introduction of halogens into a broad range of substrates at large scale. These include:
- Chlorination of heterocyclic compounds with phosphorous oxychloride
- Bromination of aromatic and heteroaromatic materials
- Iodination of aliphatic and aromatic intermediates
Reactive Metals and Alkyllithiums
We use lithium and magnesium metal as well as various alkyllithium compounds in our organometallic methods.
Our technical experts bring two decades of experience handling such reactions at large scale. Due to the safety risks posed by the reactions of lithium and lithium compounds, we have invested significant resources into safety studies.
Cyanides and HCN
Our extensive technology portfolio involves many different transformations using alkali cyanides and acetone cyanohydrine. Special palladium-based catalysts allow the substitution of aryl halides to aryl nitriles. Our enzymatic application portfolio involves:
- oxynitrilase handling
- yielding enantiopure cyanohydrins
- mandelic acids
- amino alcohols and other derivatives
In such reactions, we apply HCN that is generated by in situ methods to minimize safety risks.
Other Hazardous Chemistries
Our broad portfolio of hazardous chemistries enables us to offer optimal synthetic solutions and access to products that are not available with classical chemical methods.
We possess the expertise and technology to combine such hazardous reactions within the highly different fields of modern organometallic, enzymatic and heterocyclic chemistry.