Assured Testing Services

Agere is a global leader in bioavailability enhancement and cGMP services. Our comprehensive formulation design and development capabilities leverage Agere's Quadrant 2 solubilization formulation platform. Quadrant 2 empowers formulation development to efficiently explore a broader design space. Adhering to quality by design (QbD) guidelines de-risks results to achieve your target product profile.

All client services -- from formulation through clinical trials materials manufacturing -- are customized per API and done on a fee-for-service basis.

Formulation Development
• Formulation design and development
• Solubilization formulation expertise
• Innovative analytical technologies
• Materials science and characterization
• Computational modeling

cGMP Manufacturing
• Spray drying
• Tablets
• Capsules
• Inhalation powders
• Topical dosage forms

cGMP Analytical
• Full support for manufacturing and release testing
• Method development and transfer
• Method qualification/validation
• Full stability suite of services

EMAIL: info@agerepharma.com or careers@agerepharma.com

Eurofins CDMO (Alphora Research Inc.) is an FDA-approved contract development and manufacturing organization (CDMO) focused on process chemistry, cGMP scale-up, and analytical method development for niche and complex, small molecule active pharmaceutical ingredients (APIs). We are currently staffed by 140+ experienced scientific chemists, engineers, chemical operators, business development and support staff. Our 74,000+ ft² facilities include:
- Synthetic organic laboratories
- cGMP analytical laboratories
- cGMP kilo laboratories
- cGMP manufacturing plants
- cGMP warehouse
- cGMP stability chambers
- non-GMP and cGMP high potency laboratories

Ambio Pharmaceuticals is the parent company of AmbioPharm, Inc. and Ambio, Inc.

AmbioPharm was founded in 2005 and is headquartered in North Augusta, South Carolina, USA specializing in developing highly efficient manufacturing processes for peptide-based Active Pharmaceutical Ingredients (APIs) at very small to very large scales. In our manufacturing facilities in South Carolina, USA and Shanghai, China, we manufacture New Chemical Entities (NCEs) and generic peptide APIs under cGMP for clients worldwide. Both facilities have been inspected multiple times by the FDA with excellent outcomes.

Ambio is a drug development company with a rich and growing pipeline of proprietary drug development programs for bioequivalent and biosimilar versions of the world’s best-selling peptide drugs.

API MANUFACTURING:
Apertus manufactures active pharmaceutical ingredients (APIs) for companies that make finished dosage products and/or develop novel dose delivery systems and formulations. Our focus is providing bulk (Schedule II–V) controlled actives, however non-controlled APIs are also within our project portfolio.

ANALYTICAL SERVICES:
Apertus performs analytical methods development and services on a variety of instrument platforms. Our primary focus is LC (UV), LCMS and GCMS. We can use existing methods or develop novel methods on a per-project basis. In addition, we can provide methods validation, impurity identification and tech transfer packages.

PHARMACEUTICAL SERVICES:
Apertus provides services for drug discovery and preclinical development on a kilo-lab scale. We can supply intermediates, specialty chemical synthesis, process optimization and scale-up services. In addition we can aid in characterizing RLDs via dissolution profiles, chemical analysis and microscopy. All services can be provided under cGMP if desired.

Bio-synthesis is a biology contract manufacturer of high quality nucleic acids, peptides and other molecular biology products for the research, diagnostic and therapeutic industries. Bio-Synthesis operates an ISO 9001 certified facility and is compliant with 21 CFR 210/211 and 21 CFR 820. Our solutions help advance drug discovery and bio-medical research. Founded in 1984, Bio-Synthesis is a privately held firm based in Lewisville, Texas.

Custom Peptide Specialists
Bio-Synthesis has been a provider of Peptide Synthesis services to the life science research community since 1984. We offer a complete range of premium quality peptide products ranging from bulk API polypeptides to high throughput library peptides and peptide array preparation. We also provide a large number of peptide modifications as well as peptide synthesis for diagnostic and therapeutic applications. Bio-Synthesis specializes in both, liquid phase and solid phase fmoc peptide synthesis chemistry. We have a long standing record in preparing biologically active polypeptides including long, complex and hydrophobic peptides synthesized to your specifications.

Custom Oligonucleotide Specialists
As a pioneer in oligonucleotide synthesis, Bio-Synthesis has been pursuing the development of new oligonucleotide-based techniques that can produce compounds with superior binding affinity and chemical/biological stability. As such, Bio-Synthesis has introduced a third generation of nucleic acid analogs, Bridged Nucleic Acid (BNA). These are RNA analogues which can be synthesized and spiked with DNA or RNA in order to modify the formation of nucleic acid helices.