Agere Pharmaceuticals, Inc.

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.

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier

FORMEX - The Formulation Experts

Formex is a pharmaceutical contract development and manufacturing organization focusing on oral and topical dosage forms. Located in San Diego, CA, Formex specializes in bioavailability enhancement of small-molecule APIs, offering innovative formulation technologies such as spray-dry dispersion and hot-melt extrusion. Formex’s array of formulation and analytical services include pre-formulation, API characterization, formulation development, analytical method development, stand-alone analytical testing, ICH stability and storage testing, and cGMP manufacturing. With Formex as your CDMO partner, you can trust that our team of established formulators and analytical scientists have the expertise and cutting-edge technology to create customized solutions for your project’s most difficult challenges.

Integrated Drug Discovery and Development Services
Our integrated offering allows clients to access multiple outsourcing choices across the research and development value chain. We offer the following services

Analytical Services
Method Development & Validation
Extractables & Leachables
Syringability, Injectability, & Inhalation Study
Manufacturer Validation
Raw Material Qualification
ICH Stability & Release Testing
Impurity Analysis & Contaminant Identification
Pre-Clinical, Clinical, & Post-Approval


Pre-Formulation & Formulation

Formulation Optimization
Solid Stage Characterization
IND & NDA Submission Support
Counterfeit Analysis
Degradation Analysis
API Analysis
USP Monograph Testing
Dissolution Studies
Overcoming Solubility Issues
Toxicology Analysis
Clinical Trial Material Manufacturing
Excipient Base Identification
Bioequivalence Analysis
Disintegration Studies

Custom Synthesis
Process R&D

Chemistry R&D and Custom Synthesis
The HDH Pharma scientific team has earned its reputation through its problem solving skills and out of the box thinking when coping with challenging chemistry.
Reaction Optimization
Synthetic route development
Feasibility analysis of synthetic pathways
Methodology studies for process development
Exploratory studies for original compound synthesis

Custom Synthesis Services:
Impurities
Building Blocks
Reference Compounds
Reaction Intermediates
Pharmaceutical Reference Standards

Building blocks and screening compounds Including:
4, 5, 6, and 7– membered heterocycles, fused heterocycles
Lipids, Carbohydrates, and Nucleosides
Pyridines, Pyrimidines, Purines, Substituted Benzenes, Pyrazoles, Osoxazoles, Oxadiazoles, Indoles and Benzimidazoles
Aza-benzimidazoles, and Azitidine, Pyrrolidine, Piperidine

RMC Pharmaceutical Solutions Incorporated (RMC) is an expert technical services organization with a focus on solving CMC (Chemistry, Manufacturing and Control) issues in the bio/pharmaceutical industry. We support areas such as process, analytical and formulation development; quality control and quality assurance; GLP/GMP manufacturing of API and drug product; and packaging/distribution. Our team has the experience and talent to handle any product development project for a new therapeutic, diagnostic or device.