Biomay AG

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated contract research, development and manufacturing organization providing scientific services – from early discovery to commercial supply. Our innovative capabilities for novel molecular entities (NMEs) cater to a wide range of industrial sectors, including pharmaceutical, biotechnology, nutrition, animal health, consumer goods and speciality chemical companies.

Our Discovery services include conducting early-stage research from target identification to delivery of drug candidates for further development. Development services encompass activities from pre-clinical to clinical trials including Drug Substance Development (DSP), Drug Product Development (DPD) and associated services to demonstrate safety, tolerability and efficacy of the selected drug candidate.

Our Manufacturing services for small and large molecules include cGMP-compliant facilities for clinical supplies, registration batches as well as commercial volumes through our API manufacturing plant & disposable Biologics manufacturing facility.

Driving our innovative culture is our highly qualified team of 4200 scientists supported by state-of-the-art infrastructure and market-leading technology. Our scientists have both the skills and the capability to deliver great science, ensure robust data management, IP security & quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.

With 2 Mn sq ft of specialist discovery, development & manufacturing facilities, Syngene offers dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife. We also work with biotech companies pursuing leading-edge science as well as multinationals including GSK and Merck KGaA. Smaller and virtual companies, non-profit institutions, academic centers and start-ups also collaborate with us for their research-related requirements.

Write to us at bdc@syngeneintl.com

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

Cerbios is a swiss privately held company specialized in the development and manufacturing of chemical and biological APIs for its world-wide partners.

The exclusive R&D and manufacturing expertise is available to our Pharma partners needing to develop and scale-up NCE or NBE for clinical trials, registration and commercial purpose.

cGMP APIs made by Cerbios in its FDA inspected site in Switzerland are sold worldwide mainly to pharma companies including EU, USA and Japan.

Cerbios is specialized in Reduced Folates (world leader position) but also in the manufacturing of High Potency Active Ingredients (HPAPIs) with a series of Vitamin D derivatives requiring sophisticated production units with high containment levels.

Another core business is the research, development and production of Probiotics of Pharma quality.
On top of that, in the last 17 years, CERBIOS has acquired a vast experience with Recombinant Proteins from mammalian cells (CHO) based on a state-of-the-art platform.

Service for third parties in exclusive manufacturing is concentrated in the area of HPAPI and Recombinant Proteins.

Full CMC support is given to our customers in order to provide them with the supply of cGMP clinical batches, registration/validation material and commercial manufacturing. Paramount to that is the supply of all documentation required for a successful registration.

GMP XRPD and SAXS Studies of Pharmaceuticals
DANNALAB is an independent contract research company that specializes in physico-chemical studies of pharmaceuticals, biopharmaceuticals and drug delivery systems. To date we have successfully completed more than 450 projects, with 60+ active pharmaceutical substances.

Our core expertise relates to X-Ray Powder Diffraction (XRPD or XRD) and Small Angle X-Ray Scattering (SAXS), combined with a range of complementary techniques.

At DANNALAB we use XRPD (XRD) to identify the polymorphic type and crystallinity of an active pharmaceutical ingredient (API) in its pure form, as well as in formulation or dosage forms. We support our customers during research, pre-formulation and formulation stages. XRPD methods for API characterisation are also applied during stability studies and used for quality control during batch release.

Small Angle X-Ray Scattering (SAXS) to Study Drug Delivery Vehicles and Biologics:
We use SAXS to study the structure of drug delivery systems - micelles, liposomes and nanoparticulates. We also use SAXS to study the higher-order structure of biologics, their aggregation pathways and their stability patterns. You can find more information on our drug delivery and biopharmaceuticals pages.

Pharmaceutical Patents
To ensure effective and safe intellectual property management, we offer a range of services related to pharmaceutical patents.

Good manufacturing Paractice (GMP) Quality System
Among our services we offer method development and validation. Our facility and procedures are compliant with the cGMP quality system. The methods we offer are developed according to USP <941>, Ph.Eur. <2.9.33> and ICH guidelines.

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