SAFC Biologic APIs and Conjugation Experts

The St. Louis, Missouri (USA) campus is a key center of manufacturing excellence in cGMP biologics, with over 25 years experience in plant- and animal-based therapeutic protein extraction and purification, bio-conjugation, excipients and adjuvants manufacturing. In addition, SAFC St. Louis works in close alignment with SAFC Madison (Wisconsin) Highly Potent APIs (HPAPI) manufacturing operations to lead the industry in its ability to handle high potency conjugation projects.

Completely segregated manufacturing operations support customer requirements for large-scale programs, with capabilities to extract biomass at up to 6,500 kg/week, then purify material in chromatography columns up to 1.5 meters in diameter in a clean room environment. Extensive analytical capabilities and dedicated compliance resources, along with extensive manufacturing capabilities help SAFC customers around the globe to accelerate their biologic drug development programs.

ADC and Bioconjugation

SAFC’s clinical ADC manufacturing facility was purpose-built for the handling of HAPIs, antibodies, linkers and for performing complex conjugation processes in a cGMP suite featuring isolators and specialized handling equipment.

• SafeBridge^® Cat. IV certified since May 2009
• 800 sq-ft footprint including airlocks
• ISO 8 classified clean room environment
• Unidirectional personnel flow with entry, de-gown, and exit airlocks
• Personnel airlocks separate from equipment/material airlocks

For commercial scale-up, a new 10,000 sq-ft manufacturing suite is opening mid-2015:

• Ability to manufacture batches up to 600 L/3 kg under Grade C classification
• Segregated areas for HAPI solids handling, conjugation, with aseptic bulk filling under Grade A classification

Animal-Sourced APIs Manufacturing

Purpose-built, completely segregated facilities have been specifically designed to support animal protein extraction and purification at commercial scale to meet growing customer demand for animal-sourced therapeutic proteins.

Manufacturing for sample projects includes:

• Thrombin (wound care)
• Hyaluronidase (eye care)
  
• Porcine/bovine-sourced Trypsin
• Wide variety of excipients (such as Keyhole Limpet Hemocyanin)

Plant-Sourced APIs

The St. Louis cGMP facility was specifically designed to handle the increasing demand for key intermediates, excipients, adjuvants and APIs made from plant-derived materials. SAFC’s dedicated upstream plant biomass extraction and clarification facility is equipped to process up to 6,500 kg of plant biomass/week. Facility features:

• Separate cGMP plant extraction and downstream purification
• Purification ISO 7 and ISO 8 classified suites
• Unidirectional process flows
• Equipment wash room
• Fixed, stainless steel jacketed biopharm grade tanks to 3,200 L
• Disposable technology availability
• Delta V control system, central Clean In Place (CIP) skid chromatography and TFF skids

Analytical Services

Complete analytical support, from development of specifications, risk assessment, implementation of process controls and validated cleaning procedures. In addition, our analytical capabilities offer:

• Solid state chemistry and analytical services for every API developed and manufactured at SAFC (services available in Europe and the U.S.)
• Phase-specific analytical development
• Characterization, certification and control of all incoming raw materials
• QC testing of in-process materials
• Release testing upon request
• Analytical instrumentation, including:
  – CMS
  – NMR
  – HPLC
  – UV
  – IR

Quality Management

• Dedicated Quality Assurance (QA) team
• Highly experienced personnel
• ISO 9000 cGMP and ICH Q7A compliant operations
• Numerous successful client audits
• Rigorous compliance program in place

Project Management

SAFC’s project managers lead multi-functional teams and serve as the single point of contact for customers to help facilitate the timely communication of important technical information and production timelines.