AGC Biologics

We deliver CDMO / CRO services, from 8 sites, working alongside Pharma & Biopharma innovators to advance new therapies to market. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody drug conjugates) and gene therapies (such as RNA and DNA oligos).
Our drug development services advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our GMP clinical supplies manufacturing capabilities include sterile injectables, ophthalmics, capsules, tablets, solutions/suspensions, and topicals.
Our commercialization and manufacturing support comes from our FDA-registered laboratories that provide submission-ready methods validation reports, finished product release testing, ICH Stability programs, raw materials clearance programs, extractable-leachable studies, and full microbiology laboratory support.

AutekBio, Inc. (www.autekbio.com) is a biopharmaceutical contract development and manufacturing company (CDMO) specializing in the production of therapeutic proteins and antibodies from mammalian cell culture. AutekBio has developed proprietary, integrated technology platforms to provide one-stop total solution “from DNA to NDA” for biopharmaceutical companies. Headquartered in the US, with manufacturing facility conveniently located in the Free Trade Zone of Beijing, AutekBio is uniquely positioned to be your trusted partner to open new frontier in the world of quality therapeutic biologics.

Our Mission: A Premier China Based Biologic CMO for the World

• No internal product development – Service Only
• No drug discovery program – CMO Only
• Serve our partners’ manufacturing needs - “from DNA to NDA”

Company Vision:

• Open new frontiers in manufacturing quality therapeutic biologics
• Deliver affordable biologics to the needed
• Gateway to Chinese market

BIONEEDS INDIA PRIVATE LIMITED is a Bangalore based Contract Research Organization providing Integrated Discovery, Development and Regulatory Services to Pharmaceutical,
Biopharmaceutical, Agrochemical, Industrial chemical, Herbal/Nutraceutical and Medical device companies.

Accreditation/Certifications
• National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forests and Climate Change, GOI.
• State Drug Controller as a Government approved Drug Testing Laboratory for carrying out tests on Drugs / Cosmetics and
• Raw Materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
• Review Committee on Genetic Manipulation (RCGM), department of biotechnology, GOI to conduct experiments on animals for DNA or Genetically modied resources
• Bioneeds is AAALAC certified for laboratory animal care
• Bioneeds’ in-house R & D unit is recognised by Department of Scientic and Industrial Research (DSIR)
• ISO 17025 certified for Biological evaluation of Medical Devices
• Bioneeds has best-in-class infrastructure equipped with state-of-the-art facilities with 2,50,000 sqft built-up area.
• Vivarium with 85 exclusive animal rooms built as per international standards
• Cutting edge Drug Discovery and Development Labs to support Medicinal chemistry, Biology, In vivo Pharmacology,
• Toxicology, Custom synthesis, Process R&D, cGMP manufacturing, Formulation and Analytical development services

Since its founding in 1992, bioWORLD has established, maintained, and succeeded in its core mission to manufacture and supply high-quality molecular tools, biological reagents, and laboratory supplies to analytical laboratories, academia institutions, and research corporations globally. bioWORLD specializes in numerous product lines for the Life Sciences and Biotechnology industries. With product focuses including bioAffinity reagents for protein purification and proteomics research, recombinant proteins and synthetic peptides, plant, microbiological, animal, and yeast media, and many other fields. In addition, bioWORLD offers services including custom peptide synthesis and antibody production.

The company's headquarters are in Dublin, Ohio, with sales offices located across the globe. Through both in-house manufacturing and supply chain acquisitions, bioWORLD supplies products to biomedical and life sciences industries. In addition, we provide custom laboratory services and formulations for R&D in the biotechnology industry. bioWORLD is a growing company, with both domestic channel partners (i.e. Fisher Scientific, Spectrum Chemical, Thomas Scientific, etc.) as well as established international distribution partners in 45 countries.

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