API Manufacturing

Analytical development and quality support

Process and cleaning validation activities must start early in development, addressing your control strategy with a goal of 100% success in manufacturing. We can develop specifications, perform risk assessments, implement process controls, and perform validated cleaning procedures. Other services include:

• Analytical development using MS, HPLC, iCE/IEF, CGE, ELISA, UV, NMR, IR
• Process development
• In-process and release QC testing
• Stability studies

High potent API manufacturing

High potent active pharmaceutical ingredients (HPAPI) are effective at much smaller dosage levels than traditional APIs, but their potent characteristics present specific handling challenges. As a leader in this area, we offer:

• 25 years of experience in HPAPI development and manufacturing
• Purpose-built SafeBridge^®-certified facilities with specialized containment engineering
• Extensive quality and regulatory experience, with active drug master files (DMFs) filed in over 30 countries

Our SafeBridge^®-certified facilities in Madison and Verona, Wisconsin maintain a complete range of kilo labs, pilot plants, and commercial capabilities for the manufacture of HPAPIs down to single-digit nanogram containment levels, featuring appropriate room pressurization, airlocks, ventilation, and isolators to properly handle these materials. We combine industry-leading expertise in HPAPI and biologics to commercialize high-potent conjugates.

In addition, our ADC manufacturing facility in St. Louis, Missouri is specifically designed for conjugation of HPAPIs to antibodies or other therapeutic proteins used as targeted therapies. The first commercial ADC facility in North America, it offers dedicated high-containment suites that meet all standards for current good manufacturing practices (cGMP) and has been SafeBridge^®-certified since 2009.

Complex APIs

We offer cGMP synthesis and purification of bio-organic intermediates, excipients, and bulk actives. With more than 30 years of experience in custom API scale-up and manufacturing for both pharmaceutical and biologics, we can effectively support your needs for:

• Polyamino acids, including Poly-L-Lysine and others
• Carbohydrates
• Lipids
• Detergents
• Buffers

ADCs and bioconjugation

For more than 35 years we have been a leader in the conjugation of highly active molecules to monoclonal antibodies (mAbs), helping to develop and manufacture antibody drug conjugates (ADCs) that deliver highly active or potent pharmaceutical ingredients (HPAPIs) to targeted cells. You’ll find everything you need to simplify your pathway to patients:

• Development experience with more than 65 different ADC constructs and more than 600 batches
• GMP experience with more than 20 commercial-scale ADC constructs and more than 160 batches
• Proven expertise enabling more than 30 IND programs
• Random cysteine or lysine conjugation technology
• Site directed conjugation via engineered mAbs or enzyme catalyzed
• Non-natural amino acids (NAA)
• Various payloads – auristatins, PBD, tubulysines, maytansiods, and custom toxins
• Extensive analytical capabilities for characterization, including mass spectrometry
• Release testing and stability for both bulk drug substance (BDS) and drug product (DP)
• Personnel and suites dedicated to ADC development, manufacturing, and testing
• Dedicated cGMP manufacturing facility for HPAPIs, antibodies, linkers, and complex conjugation processes
• 10,000-square-foot commercial-scale manufacturing facility supporting clinical Phase I/II/III and commercial ADCs

If you need support with candidate selection, our ADC Express™ pre-clinical conjugation services can also help accelerate production of development-grade ADC constructs with essential analytical characterization of key quality attributes. This combination of extensive bioconjugation expertise and proven platform technology will efficiently turn your antibody and/or linker and payload into an ADC, while enabling scaling and shortening your path to the clinic.

Activated PEGs

As a global partner, we can supply commercial quantities of high-quality functionalized polyethylene glycol (PEG) for use with therapeutic proteins, as linker substances for ADCs, or as part of medical devices such as biodegradable hydrogels or therapeutic proteins. Our offerings include a broad range of functionalized, high-purity PEGs of different molecular weights and activation chemistry, as well as reagents and process materials for use in every phase of clinical development and in commercialized products.

Our comprehensive services can also help ensure your success with:

• PEGylation feasibility studies
• Process development of PEG-drug conjugate manufacturing
• Development of analytical methods
• Pilot production of PEG-drug conjugate
• Development of PEGylated biosimilars

Offering You a World of Capabilities

The global footprint of our contract manufacturing services assures you of wide-ranging regulatory and supply expertise, easily accessed through a single trusted partner.

Our locations:

• Arklow, Ireland (cGMP)
• Bangalore, India (non-GMP)
• Buchs, Switzerland (cGMP)
• Madison, Wisconsin (cGMP)
• St. Louis, Missouri (cGMP)
• Schaffhausen, Switzerland (cGMP)
• Sheboygan Falls, Wisconsin (non-GMP)