Your CMO for recombinant peptide and protein products using microbial expression systems

Experienced & Proven

Enteris BioPharma is a proven strategic partner in the contract manufacturing of recombinant peptide and protein products using microbial expression systems. With nearly 20 years of API manufacturing expertise, Enteris BioPharma has an extensive history of documented clinical and partner success.

Utilizing our state of the art proprietary manufacturing technologies, we provide leading companies with a full array of services to meet their manufacturing needs from pre-clinical to commercial scale.

Convenient & Scalable

Our inspected and fully cGMP compliant 32,000 sq. ft. facility is conveniently located in the heart of the Northeast United States Life Science Corridor. Fully scalable to meet your needs, we are dedicated to producing API in a safe and secure environment with an unwavering commitment to exceptional end to end support throughout the process.

• 32,000 square feet

• Inspected & cGMP compliant

• State of the art equipment

• 20 years of API manufacturing

• Multi-kilogram production capacity

• Clinical to commercial

• Conveniently located

Documented Success

Enteris BioPharma has an extensive history of documented clinical and partner success from small scale Phase 1 API programs to commercial scale manufacturing of FDA approved product. For nearly 20 years we have been manufacturing high-yield recombinant peptide and protein products using microbial expression systems in partnership with multiple leading pharmaceutical companies.

Exceptional Support

State of the art equipment to meet all your manufacturing needs

• 1,000 liter working volume B. Braun microbial fermenter

• 300 sq. ft. Millipore TFF membranes

• Alfa Laval disc stack centrifuge

• Rainee homogenizer

• Complete downstream puri�cation suite

• Multiple chromatography columns up to 1m diameter

• Explosion-proof area for safe solvent handling and RP-HPLC

• Bulk tray lyophilizer

Customizable Services

Enteris BioPharma Contract Manufacturing

provides proven and reliable end to end

service in delivering production volumes

from pre-clinical to multi-kilogram

commercial quantities. Our 32,000 sq. ft.

FDA inspected and cGMP compliant facility

is equipped with state of the art technologies

to ensure cost-e�ective, high yield,

production of quality API using microbial

expression systems. From fermentation to

harvesting and downstream puri�cation

through to stability testing, process validation,

QA and regulatory support, Enteris BioPharma

has the technological capability and

expertise to meet the needs of the most

discerning partner.

Conveniently located in the heart of the

Northeast Life Science Corridor.

• Fortical, a nasal calcitonin product (FDA approval 2005)

• Calcitonin API

• Teriparatide API

• GSK - Clinical trial material

• Novartis - Clinical trial material

• Complete QA/QC

• Microbiology services

• Raw material management

• Stability testing

• Regulatory support

• Impurity testing

• In-process assays

• Specialized analytical testing

• Scale-down modeling of your process

• Transfer-in of existing analytical methods

State of the art facility delivers proven results in a safe, secure and fully cGMP compliant and inspected environment.

For more information about working with Enteris, please contact Paul Shieldstoday at pshields@enterisbiopharma.comor by calling 973-453-3520

Your trusted partner for delivering high-quality clinical and commercial API

www.enterisbiopharma.com

83 Fulton StreetBoonton, NJ 07005 USAP: 973-453-3520E: pshields@enterisbiopharma.com

For more information about working with Enteris, please contact Paul Shields, Ph.D.V.P. Operations today