CARBOGEN AMCIS

DIATHEVA is an Italian biotech company founded in 2002 with the aim to bring research into industrial products by cooperating with firms, public and private research institutions.

DIATHEVA focuses on development, production and marketing of new and innovative products (antibodies, recombinant proteins, immunoassays and SNPs detection kits) for diagnostics, research and therapeutic applications in the field of: Cancer, Microbial Infection and Pharmacogenetics.
DIATHEVA has a GMP authorized facility designed for the manufacture of APIs for pre-clinical and clinical trial studies with a special emphasis on new immunogens against HIV and other microbial pathogens. DIATHEVA is the first facility in Italy able to provides GMP service on-demand. From 2009 DIATHEVA has been a member of Marche BIOTECH and has been collaborating with the most important biotechnological companies in the Marche region extending its scientific network.
From 2010 DIATHEVA has been providing a wide range of pharmacogenetic tests for personalized and predictive medicine based on High Resolution Melting technologies with priority focused on anti-tumoral treatments.

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

IBI Istituto Biochimico Italiano G. Lorenzini S.p.A. is a biopharmaceutical company with global reach. We stand out for our aseptic filling processes for injectable drug products and we have a consolidated leadership in penicillin market.

We are present in retail and hospital segment, export and for third parties completion.

Formulation, process development and manufacturing of chemical entities, proteins, biological and innovative delivery systems, from early stage to industrial scale up, are areas of intervention as CDMO in partnership with research institutes or private companies.

• GMP production for biological medicinal products (active substance from CHO cell culture, peptides, monoclonal antibodies)
• GMP production of sterile drug products
• GMP production of sterile API and finished products
• CDMO and GMP production for orals, topicals, injectables
• Aseptic filling of injectable medicinal products
• Micro and nanoparticles formulations aimed to delivery of different classes of active molecules
• Pharmaceutical development
• Analytical validations, stability testing
• MA and IMP registration and Batch Release services
• Investigational Medicinal Product production

IBI produces its products in conformity with the regulations of the European Pharmacopoeia and the cGMP norms and is certified by the most demanding Health Authorities: FDA, AIFA, EDQM, TGA.

CIR (Crédit d'Impôt Recherche) accreditation from the French Ministry of Research (Ministère de l'Enseignement Supérieur et de la Recherche) for 2016, 2017, 2018.

More information: www.ibi-lorenzini.com
Licencing in and licencing: bd@ibi-lorenzini.com
Pharmaceutical Development Services: pds@ibi-lorenzini.com

Pepceuticals Limited, established in 1998, is a specialist British manufacturer of synthetic peptides. We remain dedicated to supplying the Life Science industry with high-quality custom peptides and an antibody manufacturing service. Over the years, Pepceuticals has established a reputation for excellence in the field of peptide synthesis, having developed novel technologies that allow us to prepare complex peptide molecules. We are committed to providing solutions to researchers globally by continuing to increase our development program of large and small synthetic peptide libraries, and enhancing the prospects of obtaining new research candidates.

We provide a comprehensive drug development program that allows us to furnish peptides manufactured under cGMP, from milligram to kilogram quantities and to support all aspects of peptide manufacture. Furthermore, we also have an active program to develop generic peptide active substances (API’s) that cover many different disease areas.

At Pepceuticals, we operate a stringent Pharmaceutical Quality System which verifies that the products we supply meet or exceed industry standards. Pepceuticals holds an API manufacturing licence as granted by the MHRA (Medicines and Healthcare Products Regulatory Agency) and BSI ISO 2001-2015 accreditation from the British Standards Industry (BSI) for our manufacturing practices. Our Quality Control (QC) team, ensure that our instrumentation, operating/ testing, and staff training are maintained and continually updated to achieve these high standards. Our aim is to deliver all our products in a reliable time frame with a full certificate of analysis and supporting data.

We ensure effective project management and good communication with all our clients; from sales to product delivery we aspire to offer a complete solution. We trust that you will enjoy the benefits of working with Pepceuticals, as a reliable, flexible and innovative peptide manufacturer.

Apex Molecular is a leading UK based Chemistry Services Contract Research Organisation based at Alderley Park, providing specialist chemistry services to the pharmaceutical, biotechnology and applied chemistry sectors.

Our customers include innovative drug discovery, biotech, agritech and advanced materials companies. We work closely with our clients to integrate our chemistry services into their organisations to expand their capabilities and speed up the development of their project pipelines. We operate our synthetic chemistry expertise across the early discovery & development chemistry scales (milligrams to hundreds of grams).

Our flexible approach to project design, combined with our transparent communication and flawless project execution ensures that our clients'​ project portfolios are managed with minimum risk.

Apex Molecular's chemistry services include:

Custom/Contract synthesis
Medicinal Chemistry
Highly potent API synthesis
Rapid Scale up & Development
Materials Chemistry
Computational Chemistry

In addition to our standard chemistry labs we also have a high potency chemistry facility. With the specialist facility we offer chemical synthesis services to the Antibody Drug Conjugate community for the bespoke synthesis of cytotoxic warheads and payloads. We also offer a range of toxins and linker products all manufactured in the UK

Our high potency facilities include:

Clean room with isolator
Dedicated chemistry laboratory
Independent air handling system with negative pressure cascade
Automated purification
Analysis by LCMS and 1H nmr