Custom, Made-to-Order Biologic Products

Complex Technologies

Bio-organic Custom APIs, Excipients and Adjuvants
Complex Technologies
Novel Excipients and Adjuvants

SAFC® has the capability to produce a number of high value, custom biologic products that are used as raw materials, excipients, or adjuvants for the biopharmaceutical industry. Whether it is to provide non-animal GMP reagents like our recombinant trypsin (TrypZean), using polyaminoacids and polynucleotides for uses such as adjuvants for vaccines, or excipients such as our non-animal cholesterol product, SyntheChol.

SAFC Pharma® can often provide the solution for custom biologic needs that our clients have, either through our own network of facilities, or through our extensive supply chain.

Adjuvants
	Keyhole Limpet Hemocyanin (KLH): SAFC has developed a high molecular weight KLH as well as the lower molecular wight subunit. This adjuvant has been investigated for use in a number of cancer vaccines. KLH is typically conjugated to an antigen and SAFC provides conjugation services for both clinical and commercial applications
	Polyarginine: SAFC is the leader in the supply of poly-l-amino acids under GMP for a myriad of drug delivery applications. Poly-l-Arginine has been used as an adjuvant in a number of infectious disease applications.
	Polyinosinic acid / Polycytidilic acid (Poly I/C): Is finding it way into a growing number of vaccines for cancer, autoimmune and infectious disease. SAFC also manufactures Poly A/U for similar applications.
	Lipid A: SAFC has been manufacturing Lipid A for more than 20 years for use in non-GMP research applications. This adjuvant has been investigated in a number of cancer and infectious disease vaccine applications. SAFC will be able to supply Lipid A under GMP for use in clinical and commercial applications by the end of 2009.
	Contract Manufacturing: SAFC also produces a number of proprietary adjuvants on a contract basis. Please inquire

SAFC is also developing novel products for use in stabilizing biologic drugs and for use in targeted drug delivery applications:
	recombinant HSA: is being developed as a lower cost alternative to the current recombinant HSA options being offered today. HSA is an important stabilizer for recombinant protein drugs.
	Poly-l-glutamic acid and Poly-l-lysine: have found their way into a growing number of targeted drug delivery applications whereby the API is conjugated to the polyaminoacid of choic
	Conjugation Services: SAFC is a leader in the conjugation of both potent and non-potent API's to a wide variety of drug delivery molecules. With separate facilities for HPAPI conjugation, SAFC is developing a leading position in the antibody drug conjugate (ADC) market.

Bio-organic APIs Synthesis and Purification
SAFC Pharma also offers cGMP bio-organic synthesis and purification of bio-organic intermediates, excipients and bulk actives. With over 30 years of experience and expertise in custom APIs scale up and manufacturing to both Pharmaceutical and Bio-pharmaceutical customers SAFC has a wide range of expertise to support customers including:
	Lipids
	Detergents
	Buffers
	Polyamino acids
	Carbohydrates
	Custom solvent sanitization blends
	Other custom processes derived from a variety of natural and synthetic sources

Capabilities:
	Skilled API manufacturing workforce operating 7 days per week.
	cGMP compliant, multifaceted facility with fully validated equipment and Part 11 compliant distributive control system.
	Design compliant with Process Safety Management guidelines to handle large quantities of flammable solvents.
	Complete segregation, enclosed processing, USP Purified water, process control and HEPA-filtered air that is temperature controlled (~ 70 °F)
	Manufacturing of 100 kg product quantities batches.
	100, 200, and 750 gallon glass-lined reactors that can be heated to 120 °C or cooled to –20 °C
	3,000 gallon crystallizer.
	Vacuum filtration capacity up to 0.6 M2.
	Product separation via a Peeler Centrifuge and/or large Vacuum Filter dryers up to 2.0 m2 in size.
	Two large walk in hoods including 50L reactor for small scale manufacturing.
	Fully validated Distributed Control System (DCS) controling and monitoring reactor's parameters, facility's utilities and USP water system.

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