American Custom Chemicals Corporation

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

LAMPIRE Biological Laboratories specializes in polyclonal and monoclonal antibody development, cell culture devices and services and a wide variety of biological products. Founded in 1977, this Pennsylvania-based company offers an extensive line of secondary antibodies, purified IgGs, human and animal blood products, plus a comprehensive line of animal tissues and organs. Other products and services include large animal models for polyclonal antibody development, the OMNI C3® cell culture bag, and high-quality BSA. Support services include peptide synthesis, antigen design, antibody purification, custom conjugation and immunoassay development. In addition, LAMPIRE has earned primary vendor status with biopharmaceutical, diagnostic and medical device manufacturers worldwide. LAMPIRE Biological Laboratories was founded on the principle that each and every customer is entitled to our best effort at all times and that each employee consciously and constantly strives to improve that effort. We believe our customers are the life-blood of our business and deserve the most courteous and attentive treatment we can give them. If you have any questions regarding what Lampire can do for you, please visit our website at www.lampire.com or contact us via email at lampire@lampire.com or call 215-795-2838.

Founded in California in 2001, Acme's core mission is to support global customers as a true chemistry CRO alliance partner. We seek to make intellectual contributions in medicinal chemistry while providing exceptional synthetic chemistry service. We are committed to provide reliable services and deliver good quality products in a timely fashion.

Acme has about 130 chemists (15 PhD bench chemists in Palo Alto and 115 chemists at Shanghai). We also co-own a non-GMP manufacturing facility outside of Shanghai (from hundreds kilo grams to tons scale). We currently have a total of five scale up labs at Acme Shanghai site. We have reactors ranging from 10, 20, 50, and 100 L, and can handle temperatures from 150 oC to -78 oC. We can perform manufacturing projects and produce raw material for GMP.

Our US and China sites both have access to in house: NMR, LC-MS, Analytical and Prep HPLC, CombiFlash, Biotage Flash System, High-Pressure Reactor, Microwave Synthesizer, Photo Reactor, Polarimeter, Freeze-Dryer and more. We operate on a custom synthesis (FFS) or FTE equivalent model.

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Applied Biological Materials (abm) provides quality research reagents and custom services at incredible prices. We have an extensive product range to make abm your one-stop supplier for all your research needs: PCR, RT-PCR, qPCR, antibodies, siRNA, miRNA, CRISPR, stable cell lines, immortalized cell lines, growth factors, and various viral expression systems (adenovirus, lentivirus, AAV). If you can’t find what you need, please let us know; our R&D team will tailor to your needs. We also provide custom services for the more challenging or time-consuming parts of your research projects. Custom recombinant adenovirus, custom lentivirus, custom cloning, gene synthesis, protein production and sequencing services are a few examples of abm’s assortment of services available to you. Conducting research shouldn’t cost you a fortune! abm is here to help!

Please contact us for more information on any of our products and available services.

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All of our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources.

Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.

GMP Product Categories:
• Bulk, GMP Biological Buffers
• Active & functional Excipients
• GMP Process Chemicals and Bulk GMP Solution Solutions

Custom GMP Services Include:
• Purification of Key Ingredients
• Full GMP Product Development
• Small Molecule Custom Synthesis
• API Development & Manufacturing
• Custom GMP Compounded Solvents & Solutions

Comprehensive Quality and Regulatory Program
• FDA Registered and Inspected
• Document Support - DMF Submissions
• Global GMP Requirements – US, IPEC, ICH Q7