Biosynth Carbosynth

CSBio is a leading peptide and peptide synthesizer manufacturing company located on the edge of Silicon Valley in Menlo Park, California. Since 1993, CSBio has been providing high quality custom peptides, cGMP peptides and automated peptide synthesizers to the global biotech community. Our peptide products and peptide synthesis equipment can be found in peptide production laboratories and pharmaceutical companies worldwide.

CSBio now also offers solid phase peptide synthesis resins as well as high quality Fmoc and Boc protected amino acids for use in both R&D and cGMP peptide manufacturing. Our state of the art cGMP manufacturing facility provides cGMP peptides for preclinical and clinical programs and our commercialization and regulatory teams can take you from toxicology studies through market commercialization. Our product line also includes a complete list of generic peptide APIs including the most widely used peptide APIs in the industry. Whatever your peptide requirements, CSBio can assist you in reaching your ultimate goals by offering high quality products and world class support.

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

Mayuka Labs, a start-up, is an integrated custom manufacturing company. It specializes in custom research, custom synthesis & custom manufacturing for Innovator and Generic companies across the world who seek to leverage high quality, competitively priced Indian chemistry skills to their advantage.
Mayuka Labs is supported by world-class analytical services. Our high energy team has extensive experience in the USFDA approved API manufacturing space. Our capabilities include bench, kilo lab, pilot and commercial scale production from gm to tons, including high value low volume molecules and tough chemistry.
Headquartered in New Delhi, Mayuka’s DSIR (Department of Science and Industrial Research) recognised R&D and pilot plant is located in Nacharam Hyderabad and it's large scale intermediates facility is located in Kopargaon, Maharashtra.

MINAKEM is a fully integrated development partner and commercial manufacturer for pharmaceutical companies.

- API manufacturing (Innovators/Generics and Highly Potent)
- Custom development (process development and optimization)
- Custom manufacturing
- Production of Key intermediates and building blocks

All development and manufacturing activities are supported by highly skilled R&D technical centres, strong and state of the art analytical services including solid form and QBD laboratories.

MINAKEM’s talented team also ensures high-quality services in Quality Assurance, Regulatory Affairs, Safety, Health and Environment (SHE).

Minakem is a technology-driven company with expertise in complex multi-step synthesis, pressure chemistry, chiral synthesis, halogenation chemistry, steroid chemistry and “prazole” chemistry…

Minakem has operations in 3 different sites, which are all US FDA and local health agencies approved and is :

- Dunkirk, France – former AstraZeneca “prazoles” and budesonide production site
- Beuvry-la-Forêt, France
- Louvain-la-Neuve, Belgium – former Ajimonoto-Omnichem site, specialized in vinca alkaloids synthesis

Strong synergies within MINAKEM facilities sites offer customers the flexibility, responsiveness and cost-effectiveness paired with the strong technical know-how to create significant added value within our customers’ supply chains.

Minakem is part of the Minafin Group (link to Minafin site), and as such has access to all technologies, resources, and capabilities to respond to its client’s needs, especially with Leuna, Germany, and Pennakem (USA).

 
PharmaBlock Sciences (Nanjing), Inc. (SZSE:300725) is a leading provider of innovative chemistry products & services throughout the pharmaceutical R&D process and commercial production. Its core businesses include: a rationally designed building blocks (BBs) collection, supplying from discovery, to development & commercial; development & manufacturing of RSMs, intermediates & APIs for drug development & commercial.

Officially operated in 2008, PharmaBlock has rapidly gained recognition for its outstanding capabilities in the design, synthesis, & supply of novel BBs. It has generated a large and unique collection of high-quality and diverse BBs, which are increasingly adopted by drug hunters to enrich the structure options, improve compound quality, expand patent space and eventually accelerate drug discovery projects. Inspired by the BBs, it has established a powerful drug discovery platform for medicinal chemists to quickly identify hit/lead. The platform includes a set of efficient tools, including but not limited to FBDD, DELT, & Virtual Screening.

Following the new molecules advancing from discovery to development, and into the market, the company is committed to a more comprehensive & long-term service to valued customers. In addition to strengthening process R&D capabilities & mfg. capacity to secure the sustainable supply of BBs, the company is providing CDMO solutions of RSMs, key intermediates & APIs. To further realize safe, efficient and green process & mfg., it has developed an advanced chemistry & engineering technology platform, featuring flow chemistry, micropacked bed hydrogenation, catalysis, crystallization, solid state chemistry etc.

Over the past years, PharmaBlock has partnered with almost all the top pharmaceutical companies, and hundreds of small to medium-sized biotechs around the world. Our ever changing mission is to support clients to accelerate drug discovery & development, and move the new molecule to commercial in full speed.