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Biopharmaceutical Analysis

Biopharmaceutical Analysis
Product Description

Solvias has a solid reputation with market-leading biopharmaceutical companies for the characterization and QC analysis of monoclonal antibodies (mAbs), glycoproteins, PEGylated proteins and peptides and biosimilars (follow-on biologics).. This means that businesses of all sizes, even smaller biotechs, can benefit from our knowledge of working with top level companies. Our biopharmaceutical expertise can help you understand the composition of your drug product or substance. Characterization studies, method development, method validation, stability studies, quality control and batch release analysis under FDA Current Good Manufacturing Practice (CGMP) are at the heart of what Solvias offers. Our services are in accordance with the International Conference on Harmonisation (ICH) guidelines of technical requirements for registration of pharmaceuticals for human use. We collaborate with you to plan milestone-based projects that fit your drug development program.

Solvias AG

  • CH
  • 2015
    On CPHI since
  • 500 - 999
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Analytical Services

Solvias AG

  • CH
  • 2015
    On CPHI since
  • 500 - 999
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Analytical Services

More Products from Solvias AG (10)

  • Analytical Services

    Product Analytical Services

    Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...
  • Custom Synthesis

    Product Custom Synthesis

    Solvias has all the experience, resources and expertise required to meet your custom synthesis and manufacturing needs.
    Custom synthesis:  lead synthesis up to 20 kg or more / synthesis of scaffolds and building blocks / synthesis/isolation of reference compounds
    Process R&D for: chiral inte...
  • Biological Analysis

    Product Biological Analysis

    Solvias provides high calibre microbiology, chemistry, toxicology and cell biology services according to GMP, CGMP (FDA), GLP and ISO 17025 standards.Testing for sterile and non-sterile products / Environmental testing / Specialised studies (antibiotics, integrity testing, alternative methods) / Endoxin an...
  • Catalysis Technology

    Product Catalysis Technology

    Solvias has a proven track record for the efficient and successful development of catalytic processes. This world-wide recognized expertise spans from discovery (catalyst evaluation) to the production of multi kg batches under optimized reaction conditions.

    Solvias’ areas of technical expert...
  • Cell and Gene Therapy

    Product Cell and Gene Therapy

    Solvias offers a comprehensive range of orthogonal analytical methods for ATMPs. Our cell and gene therapy building blocks include raw materials testing, cell culture media specific analysis and oligonucleotide analytics. For gene therapies, vector analytics covers the full range of AAV or LV release a...
  • Extractables and Leachables Testing

    Product Extractables and Leachables Testing

    Solvias provides expert testing and consulting services for Extractables & Leachables in single-use process materials and container closure systems. With our proprietary EXLEA database, we provide unique automated high throughput screening of more than 6000 Extractablesusing Accurate Mass LC/MS/MS Tech...
  • Ligands

    Product Ligands

    Solvias provides wide range of catalysis and ligands which includes ligands. It offers over 700 own ligands and catalysts in its portfolio, all having well-known industrial applications for asymmetric hydrogenation and CX-coupling. Every ligand in portfolio is synthesized through key common intermediates. ...
  • Quality Control and Release Analysis

    Product Quality Control and Release Analysis

    Solvias provides wide range of analytical services which includes quality control and release analysis. The analyses are routinely performed at Solvias according to GMP quality standards for drug substances & products, intermediates, starting materials and excipients. Contact us for more information.
  • Solid-State Development

    Product Solid-State Development

    Solvias provides an integrated and comprehensive approach to solid-state development – from systematic salt, co-crystal, and polymorph screening to controlled scale-up of the crystallization process, all complemented with the full range of physico-chemical studies performed in our laboratories.
  • Stability Studies

    Product Stability Studies

    Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...

Solvias AG resources (5)

Frequently Viewed Together

  • Product cGMP Cell-based Bioassays

    Cell-based bioassays that comply with cGMP: Using a variety of techniques, including cell-based assays, ligand and receptor binding assays, and flexible multiple assay approaches – our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1)...
  • Product Biotherapeutics

    To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

    Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
  • Product Development Sciences

    Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale...
  • Product MilliStak+® Depth Filters

    Innovative, High-Performance Pod Filters are Ideal for Primary and Secondary Clarification in Lab, Pilot and Process-scale Applications. Millistak+® depth filter media is offered in a scalable, disposable format: the Pod Filter System. 
  • Product Cortellis CMC Intelligence™

    Cortellis CMC Intelligence™ product is a comprehensive database of guidelines / granular collection of CMC data requirements for initial registration of small-molecule and biologics drugs around the world that can be used to avoid delays in product approval and successfully bring a drug to the market (laun...
  • Product Aprotinin

    DADELI is a GMP-certified pharmaceutical manufacturer for intermediates,APIs and finished formulations.Our main APIs include HCG,Aprotinin(Currently in China we are the only one to produce Aprotinin complying with the latest EP 11.0), Oxymatrine,Isoniazidum,Egg Lecithin,Daidzein,etc.Warmly welcome all cust...
  • Product Reference Materials Management Services

    To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we’re fully equipped to provide ...
  • Product Supply Chain Management

    • GMP Compliant Storage of a wide range of client products from API and excipients to consumables as well as both Stability and Retention sample programs. • Facility and Staff certified for storage, handling, and shipment of hazardous materials. Including Flammable, Toxic, Potent, etc. products. • Envir...
  • Product UV Light Blocking Tyvek Equipment Covers

    UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.
  • Product ADAPTEK® TECHNOLOGY

    ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....
  • Product Biosimilars Portfolio

    • Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
  • Product BioHale® Trehalose Dihydrate

    BioHale® Trehalose Dihydrate is a non-reducing disaccharide consisting of two glucose molecules which are linked by an α, α-1,1 bond. It is used in the pharmaceutical industry as a stabilizer of biologics.

    Trehalose Dihydrate has proven to be highly effective in protecting cell membranes...
  • Product Pre-assemble processing skids

    Briggs design and manufacture pre-assembled processing skid units. We have examples where Briggs have supported lab scale trails to pilot trails which have then enabled the design and manufacture of manufacturing scale units.Our skids are usually bespoke design and Briggs offer a turnkey package which can ...
  • Product SEFAR PHARMA GMP BAGS

    SEFAR PHARMA GMP BAGS are the certified filter bag solution for the pharmaceutical industry.

    The design has been developed to avoid contamination from the needle felt.

    The high filtration efficiency is granted by an ePTFE microporose membrane laminated on polyester or PTFE needle felt...
  • Product Sterile Products Contract Manufacturing

    Our main CDMO activity is the large scale manufacturing of injectable products in our internationally reputed site in Pau (France). The site is organized around 9 independent workshops, specialized in the aseptic filling under isolators of potent molecules such as anticancer cytotoxics, monoclonal ant...
  • Product Protein Analysis and Charactersation

    Our protein analysis scientists provide characterization services in accordance with the ICH Q6B Guidance to ensure the quality and consistency of your product. With strengths in protein structure analysis including higher order structure, physiochemical property determination, bio...
  • Product Walk in Cooling Cabinet.

    The Walk-In Cooling Cabinets / cold rooms are designed according to ICH guidelines, WHO, MCA and USFDA requirements to maintain uniform conditions. They are superior in airflow distribution, temperature control technology, cabinet construction and are manufactured as per cGMP regulations.
    Biggest Walk...
  • Product Lioflor drops

    Lioflor® drops is a dietary supplement based lactic species Bifidobacterium animalis ssp lactis BLC1, probiotic belonging to the family of Bifidus, present in the intestinal flora of man. The Bifidobacterium animalis ssp lactis BLC1 is able to colonize the intestine and promote the balance of intestin...
  • Product Analytical services - OEL: 50 ng/m3

    • Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...
  • Product Bioprocessing solutions and excipients for protein therapeutic formulations

    From excipients for protein therapeutic formulations, to innovating solutions for bioprocessing, we have decades of experience in protein delivery. TALK TO US about our latest launches: Virodex™ detergent range, a sustainable alternative to Triton™ X-100 for viral inactivation and cell lysis. Plus, Tween...
  • Product Extractables and Leachables Testing

    Solvias provides expert testing and consulting services for Extractables & Leachables in single-use process materials and container closure systems. With our proprietary EXLEA database, we provide unique automated high throughput screening of more than 6000 Extractablesusing Accurate Mass LC/MS/MS Tech...
  • Product Analytical Services

    Physico-Chemical testing
    - General identification (TLC, HPLC)
    - Assay (UV/VIS, HPLC-UV, GC-FID, LC-MS/MS) and dosage uniformity
    - Related substances identification and quantification (HPLC-UV, GC-FID, LC-MS/MS)
    - Physical determinations (pH, viscosity, density)
    - Moisture...
  • Product Candesartan Cilexetil EP Impurity A

    Impurity in commercial preparations of Candesartan.
  • Product R&D Research and Development

    The Pharmaceutical Analyses Department of Spark-Lab conducts research and development work in cooperation with pharmaceutical and cosmetics manufacturing plants. The Laboratory provides services through its highly skilled personnel and state-of-the-art equipment at the initial phase of works on a g...
  • Product Protein Aggregation Analysis and Characterization

    Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel...
  • Product Methanol Gradient HPLC Grade

    Largest synthetic acetonitrile and high purity solvents manufacturer. • 35,000 t/a synthetic acetonitrile ; • 25,000 t/a high purity acetonitrile ; • 10,000 t/a HPLC solvents ; • 10,000 t/a solvent blending and packaging capacity.
  • Product Anthrone 

    Anthrone    formula: C14H10O    formula  weight:194.23    purity:98%
  • Product Oligonucleotide Analytical Development Services

    Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch r...
  • Product Idrofolic drops

    Hematological disorders. Prevention of the defects of the neural tube.

    DOSAGE5-10 drops per day unless otherwise medical advice.1 drop contains: 40 mcg of Folic Acid.

    INGREDIENTSFolic Acid (Vitamin B9).

    CHARACTERISTICSIdrofolic drops is a dietary supplement of Folic Acid in...
  • Product AUTOCOATER

    Design is cGMP – Current Good Manufacturing Practices compliance. Fully automatic film & sugar coating process by PLC Controls with HMI Touch screen.Extremely user friendly software and operation through PLC The machine structure comprising of  Perforated Pan, water collection tank...
  • Product Analytical Services

    Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...
  • Product Proton DK 50 Drops

    Rickets prophylaxis and Vitamin K deficiency bleeding (VKDB).

    DOSAGE6 drops per day until the bottle is empty.6 drops contains 400 I.U. of Vitamin D3 + 50 mcg of Vitamin K1.

    INGREDIENTSVitamin D3 (Cholecalciferol) + Vitamin K1 (Phylloquinone).

    CHARACTERISTICSMicellar soluti...
  • Product (S)-Lercanidipine D3 Hydrochloride

    A dihydropyridine calcium channel blocker.;Labeled Lercanidipine, intended for use as an internal standard for the quantification of Lercanidipine by GC- or LC-mass spectrometry.
  • Product Diazepam Impurity F (BP)

    Impurity in commercial preparations of Diazepam
  • Product Sterile Grade at ISO Class 5 facility

    Kikkoman can offer "sterile grade” products, purified through a super purification process at our ISO Class 5 facility, approved by the Japanese Authority. 
  • Product ilon Classic Ointment - No.1 in German pharmacies

    Herbal medical product effectively helps with symptoms of skin inflammation such as redness, tightness, swelling and pain with pus. Top-selling blistering ointment in Germany.


    Active ingredients: Larch turpentine, turpentine oil of the maritime pine type, eucalyptus oil


    ...
  • Product Ready-to Use CHO cell lines

    UGA Biopharma GmbH offers to their clients so called Ready-to-use Biosimilar Cell Lines. This are in-house developed CHO cell lines stably expressing different biosimilar molecules, that are instantly available for in-licensing. The client profits, because the cell lines are directly available, and develop...
  • Product Automated Total Nitrosamine Analyser

    • Reaching low detection limits is essential for accurate nitrosamine analysis. The Automated Total Nitrosamine Analyser is sensitive enough to detect down to 1 ppb of NDMA. • The Automated Total Nitrosamine Analyser can analyse up to 10 samples per hour.  Using this as a tool to screen samples for ...
  • Product Fundraising

    Operating across all key life science sectors, PharmaVentures offers deep sector expertise to help you derive optimal value from your funding transactions.

    We support our clients with strategic advice and full end-to-end process management capabilities to achieve the best outcome from their stra...
  • Product Drug safety, in vitro and In vivo studies

    In support of human clinical trials and marketing authorization approval, Galileo Research offers a full battery of toxicity studies for the regulatory development of small drugs, as well as biologics and advanced therapies, in compliance with Good Laboratory Practice (GLP), ICH and OECD guidelines.

  • Product cUSP- Ready to use Standard Solutions

    cUSP - Ready to use standard solutions for Analytical / QC chemist, Analyst , Scientist.  cUSP products are known for their Reliability, Reproducibility, Repetitive results, Consistence results in each analysis.  cUSP series of products are manufactured under strict ISO standards. cUSP products a...
  • Product VV Earth Sil Oxygen (Silicon Tube) platinium cured silicon tube

    • (Platinum Cured silicon with only Bi product as water) • Temp : -40°C +200°C approx • Food grade EU Regulation n.10/2011 • FDA Regulation and European Pharmacopoeia produced in class 10000 clean room conditions tensile strength 8 MPa (approx), Suitable for Peristaltic Pump.
  • Product Lioflor caps

    Lioflor caps is a dietary supplement of probiotics, useful to help the balance of intestinal flora, also indicated as an adjunct in the prevention of relapsing forms of vaginosis, vaginitis and infections of the lower urinary tract.

    DOSAGE
    1 caps a day between meals, unless medically indica...
  • Product Medical Device Grade Chondroitin Sulfate Sodium

    Medical Device Grade Chondroitin Sulfate Sodium extracted from shark bone as raw material,  fish source is more similar to human DNA and easily absorbed by the human body. And Enzymolysis by special enzymes, is harmless to the human body, and will enzymatic hydrolysis of excess proteins. It can be pur...
  • Product (S)-N-(1-Amino-1-oxobutan-2-yl)-4-chlorobutanamide-d3

    Labelled (S)-N-(1-Amino-1-oxobutan-2-yl)-4-chlorobutanamide. (S)-N-(1-Amino-1-oxobutan-2-yl)-4-chlorobutanamide is a related compound of Levetiracetam.
  • Product 2-Amino-3-chloro-N-hydroxy-propanamide-15N,d3

    Intermediate in the preparation of labelled Cycloserine.
  • Product Solid state screenings & investigations

    • These studies bring together knowledge on the nature of the solid states of a given compound (intermediates or APIs) and its associated properties (stability, solubility, dissolution) in order to select the right solid phase. • Screening operated: salts, cocrystals, polymorphs and amorphous solid dispe...
  • Product Adefovir-d4 Diethyl Ester

    A labelled phosphonate ester of Adefovir, as an antiviral agent.
  • Product Quality Control

    We offer a highly professional quality management throughout the organization. In more than 500 m² of laboratory facilities, we annually test approx. 1,500 product Batches . The area of responsibility for quality control already starts with choosing the appropriate suppliers. Hence, in...