Chemistry, Manufacturing and Controls (CMC)

Product Elacestrant Dihydro chloride

Elacestrant Dihydrochloride is a high-purity Active Pharmaceutical Ingredient (API) and oral Selective Estrogen Receptor Degrader (SERD). It selectively targets and degrades estrogen receptor-alpha ($\text{ER}\alpha$), offering a targeted oncological treatment for postmenopausal women and adult men with&nb...

Product DeepC Biologics Agents: Biologic Formulation and CMC

Specialist AI agents that do biologics formulation and CMC work across antibodies, ADCs, bispecifics, mRNA-LNP, AAV and cell therapy. Give DeepC a molecule, sequence or program and get decision-ready deliverables in minutes: biologic formulation strategies with excipient and buffer selection justified by a...

DeepC Biologics Agents: Biologic Formulation and CMC

Product Biologic drug substance CDMO services

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

Product Lyophilized-Vial Filling and Cycle Development

BE BioSol provides integrated formulation, lyophilization-cycle development and aseptic vial-filling services for biologics, vaccines and complex injectable products requiring enhanced stability or extended shelf life. Our teams support programs from early development and clinical manufacturing through pro...

Lyophilized-Vial Filling and Cycle Development

Product Flow Chemistry Process Development & Scale-Up Services

Amar Flow Laboratory combines flow-reactor technology with process-development expertise to help customers convert batch chemistry into safe, practical and scalable continuous processes.

Services can include feasibility studies, batch-to-flow conversion, reactor selection, mixing and heat-tr...

Flow Chemistry Process Development & Scale-Up Services

Product Integrated CMC Solutions for Advanced Therapies

Customised CMC development and manufacturing for a broad range of advanced biologic modalities. Services include process development, analytical characterisation, scale‑up, and GMP manufacturing, tailored to the characteristics and development stage of each modality.

Integrated CMC Solutions for Advanced Therapies

Product Regulatory Affairs

Our team of Regulatory affairs experts make our service offerings stronger.
Following are our Regulatory offerings:

• Regulatory Operations, Affairs

• Regulatory Intelligence, Information Management COTS

• Regulatory Strategy & Business Consulting

• Health Autho...

Product Small-molecule API Manufacturing

From clinical manufacturing to reliable commercial supply
ESTEVE CDMO provides flexible, reliable and fully integrated API and HPAPI manufacturing services, supporting complex small-molecule programs from clinical supply through validation and commercial production.

Across our...

Product Process Development

BioDuro-Sundia’s process development services support drug substance production, providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq...

Product Cell Culture Media

JSBio, a prominent brand in Asia, is a leading provider of serum-free cell culture media. Our comprehensive product portfolio covers a wide spectrum of cell lines, with a strong focus on mainstream ones like CHO, 293, insect cells, and BHK .These media are extensively applied across core biopharmaceutical ...

Product Sodium Metaperiodate

Vinyl Kft is the sole producer of Sodium metaperiodate in the EU. The manufacturing and logistic facility is located in Budapest, Hungary. • Organic chemical applications: determining the structure of carbohydrates; oxidation at benzylic position to aldehydes; oxidation of benzyl alcohols to benzoic acids...

Product TIDES CDMO Services

Porton TIDES CDMO Services Platform has established multiple R&D centers and GMP production bases in Shanghai and Chongqing, China, providing end-to-end integrated API and Drug Product CDMO solutions for peptide and oligonucleotide products to global pharmaceutical companies and new drug R&D organi...

Product GMP-Ready Genesynthesis Manufacturing

DNA Productsnagene provides fully sequence-verified DNA products manufactured under GMP-compliant processes. Our portfolio includes circular plasmid DNA, linearized plasmid DNA and gene fragments for gene therapy, cell therapy, mRNA and synthetic biology applications.
Products are manufactured in Vien...

Product Process Chemistry

During API chemical development, there are three words that every partner is focused on: quality, speed, and cost. Although chemical reactions may work perfectly on lab scale, moving from milligrams to kilograms or tons is not a simple, linear process. Working as an extension of your team, Pharmaron’s proc...

Product Kemwell Biopharma

SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...

Product GMP and CMC Laboratory Services

GMP & CMC Laboratory Services: We deliver regulatory-driven, phase-appropriate laboratory support for CMC programs - from preformulation through formulation to product release - ensuring compliance and quality at every stage. Among our capabilities are centres of excellence for method development and ...

Product Sterile Fill Finish

Eramol specialises in early-phase sterile fill-finish, including aseptic processing, terminal sterilisation, sterile vial manufacturing, clinical packaging, UK & EU QP release and clinical trial supply.

Aseptic and Terminal sterilisation small molecule large molecule/biologics ADCs ATMPS...

Product CDMO service

CDMO for SVPs (including oncology drugs), GLP-1 drugs, anaesthetic drugs, small nucleic acid drugs, freeze-dried ODTs, tablets, and hard capsules, with 9 GMP workshops, 19 production lines in total.

Product CGMP Contract laboratory services

Our mission is to deliver outstanding pharmaceutical services at affordable prices, with an emphasis on speed, accuracy, and clear communication, ensuring every client receives dependable results and a seamless experience.

We invite attendees to visit Booth 915 to discuss how CRC Labs can...

Product Photochemical Reactors

Photochemical reactor is mainly applied to research gas / liquid phases, fixed / simulated visible light, Photochemical reaction under conditions of photocatalyst,etc.It is widely used in fields of Chemosynthesis, environment protection, life science, etc. The photochemical reactors can improve t...

Product A CDMO PARTNER FOR LIFE

FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies. Our focus is to combine technical leadership in process d...

Product Roller Compactor (PP 150 C)

Our smallest roller compactor for use in the chemical industries. Suitable for research, development, pilot plants and production. The robust design with double-sided roll mounting ensures stable processes and versatile applications.

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 (launc...

Product in-vivo PK Studies

Our drug product pre-formulation and formulation development services can also includes in vivo PK studies, conducted with multiple animal species and a rapid turnaround time. This additional service further extends our full suite offering to our clients while eliminating the need for additional vendor sou...

Product Gamma Irradiated Cleanroom Facemasks With Tyvek Side Extensions

Gamma Irradiated, Extra Large Cleanroom Facemask with Tyvek® Side Extensions, Green or Blue, with Double Elastic Headbands and with or without Fog-Prevention Adhesive are made from an inner facing of soft cellulose material, an outer facing of spunbonded polypropylene and a 100% meltblown polypropylene med...

Gamma Irradiated Cleanroom Facemasks With Tyvek Side Extensions

Product Custom synthesis and drug discovery services

We specialize in the custom synthesis of complex organic molecules, with deep expertise in developing high-purity reference standards, Impurities, Metabolites, Stable isotopes essential for pharmaceutical research, development, and regulatory submissions.

Custom synthesis and drug discovery services

Product Technology Transfer and Contract Manufacturing Partnership, Barbados

BPI is building pharmaceutical formulation capacity in Barbados and is looking for technology transfer partners: established manufacturers with proven products and processes seeking a production base for CARICOM and the Global South.

BPI's transfer framework covers 5 components: f...

Technology Transfer and Contract Manufacturing Partnership, Barbados

Product Accelerated Pharmaceutical Solutions

ICON’s Accelerated Pharmaceutical Solutions provide a seamless, end-to-end approach to formulation development and optimisation for small molecules and biologics. Our comprehensive services cover everything from formulation screening and optimisation to analytical method development, validation, and custom...

Product Analytical Services

Wilmington PharmaTech provides a comprehensive suite of analytical testing capabilities supporting in-process, release, and stability testing.

Analytical method development and validation
Full GMP release testing (clinical and commercial API)
Non-GXP and GLP testing
Reference S...

Product Large Molecule Characterization

We deliver comprehensive large-molecule characterization for peptides, oligonucleotides, proteins, antibodies, vaccines, and biologic/chemical conjugates. Our integrated analytical packages support CMC development, comparability assessments, and submission-ready documentation—helping you make confident, da...

Product Phosphor-amidites

amidites are the building blocks for Oligonucleotides. Primopus produces high volume, high quality, large scale batch-sizes for higher volume Oligo applications.Supply chain backward integrated with our parent company Deccan Fine Chemicals in India.

Product Biologics Contract Manufacturing

Chime Biologics is a leading global CDMO, focused on ensuring our customers' success in delivering innovative biologic medicines to patients across the world. Chime Biologics can support customers end to end, from pre-clinical support and cell line development through to clinical and commercial manufacturi...

Product Biosafety Testing

Maximize patient safety with rigorous biosafety testing: Solvias offers an extensive portfolio of CMC biosafety testing services. As your trusted partner in biosafety, we offer state-of-the-art facilities, a highly skilled team, and rigorous testing protocols to uphold the highest safety standards.

Product pentafluoro(phenyl)-l6-sulfane

Phenyl sulfur pentafluoride

Product Acetone-d6

Acetone-d₆ is a versatile deuterated reagent and solvent designed for stable isotope labeling applications. It is extensively used in the synthesis of deuterated APIs, intermediates, metabolites, and analytical reference standards. Its high isotopic purity ensures reliable deuterium incorporation, making i...

Product Deuterated Products

Specialised in Deuterium Chemistry, Clearsynth Manufactures Deuterated Reagents, Deuterated Intermediates and Deuterated APIs (such as Deutetrabenazine, Deuruxolitinib, Deutivacaftor, Deucravacitinib, Donafenib)

Production capacity from mg to tons scale.

Our key reagents are Benzene D...

Product Slurry & Multiphase Flow Reactors – SlurryFLO® , MACFLO™ & CSTR (Flow Chemistry)

SlurryFLO® is engineered specifically for solids-containing streams. Multiple agitated cells maintain solids suspension and strong local mixing, while controlled cell-to-cell transfer provides staged residence-time behaviour. Independent jackets and process ports support thermal control, sampling and monit...

Slurry & Multiphase Flow Reactors – SlurryFLO® , MACFLO™ & CSTR (Flow Chemistry)

Product Tubular Flow Reactors: PinchFLO™ and CorFLO® (Flow Chemistry)

PinchFLO™ uses engineered variations in tube geometry to repeatedly generate radial mixing through passive hydrodynamics. This enhances fluid contacting and heat transfer while providing predictable residence-time behaviour and straightforward scale-up without mechanical agitation.

CorFLO® combi...

Tubular Flow Reactors: PinchFLO™ and CorFLO® (Flow Chemistry)

Product Microreactors: MicroFLO™ & PhotoFLO® (Flow Chemistry)

MicroFLO™ is Amar Flow Laboratory’s microchannel flow-reactor platform engineered for rapid mixing, efficient heat transfer and precise residence-time control. Its high surface-area process and utility channels enable fast heating and cooling, making it suited to highly exothermic, temperature-sensitive an...

Microreactors: MicroFLO™ & PhotoFLO® (Flow Chemistry)

Product Recombinant Antigen and Vaccine Solutions for Livestock & Poultry

Combines advanced expression technologies with optimised vectors, cell culture processes, and downstream purification for high‑productivity and cost‑efficient manufacturing. Multimerisation and nanoparticle platforms enable the design of defined antigen structures in various multimeric forms, supporting ne...

Recombinant Antigen and Vaccine Solutions for Livestock & Poultry

Product Biomedical and Healthcare Recombinant Protein Solutions

Combines molecular engineering, host cell optimisation, expression system development, and process optimisation to address complex protein structures. The IgMax® platform enables production of pentameric IgM at high expression levels, with near‑complete pentamer assembly and excellent purity after downstre...

Biomedical and Healthcare Recombinant Protein Solutions

Product Formulation Development

BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage form...

Product Analytical Development

BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

Product Periodic Acid

Periodic Acid is available in different grades, in puriss, in technical and in 50 % solution form. Vinyl Kft. is the sole producer of Periodic acid in the European Union. The manufacturing and logistic facility is located in Budapest. Periodic Acid application: • Organic chemical applications: determ...

Product Flow Chemistry

The use of continuous flow chemistry for large-scale processing of pharmaceutical materials is accelerating. Continuous flow manufacture, often referred to as ‘flow chemistry’ or ‘continuous flow’, is a means of undertaking a chemical reaction using a continuous stream of different reagents confined in a p...

Product Drug Product Manufacturing

Pharmaron’s drug product development team provides complete development expertise to accommodate product and batch size needs for standalone and integrated projects. By leveraging our unique Pharmaron network in China and the UK, we support the custom manufacturing of high-quality drug products across all ...

Product Biologics and Conjugates CDMO Services

Porton Biologics and Conjugates CDMO Service Platform specializes in customized development services for Biologics and various novel conjugate drugs, including ADC, AOC, DAC, PDC, RDC, and others. With strategically co-located R&D centers and manufacturing facilities enabling efficient logistics and op...

Product Small Molecules CDMO Services

Porton Small Molecule CDMO Service Platform operates R&D centers and GMP manufacturing sites across the United States, Europe, and China. We provide global pharmaceutical companies and new drug R&D organizations with end-to-end CDMO services that span all stages of drug development and commercializ...

Product Methyl Iodide

Vinyl Kft is the sole Methyl Iodide and Ethyl Iodide producer in Europe. The manufacturing and logistic facility is located in Budapest, Hungary where production was started in 1876. Applications: • Used as a catalyst in acetic acid production (Monsanto process). • Common intermediate in the manufacturi...

Product Oligonucleotide Analytical Development Services

Analytical Development for Oligonucleotides: For oligo-based drugs, our services span from GLP bioanalysis to GLP/cGMP characterization, supporting development with robust analytical expertise. We support product development, from quality control testing of amidite starting materials and early stage produc...

Oligonucleotide Analytical Development Services

Product Nasal Drug Development

Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laborato...

Product Non Sterile Manufacturing

Oral dosage forms (tablets, capsules, oral liquids)Actives and placebos

Product Discovery Process Chemistry

Scaling your drug program from discovery to development is challenging. By bridging our discovery and process R&D capabilities, our dedicated discovery process chemistry team enables the rapid development of candidate compounds to accelerate programs to key preclinical milestones.

Pharmaron’...

Product Kilo-scale Glass Microflow reactor

The CM-D series continuous flow reactors is a high-throughput glass microreactor processed from high borosilicate float glass. The four-layer structure design includes the heat exchanger in the reactor to reduce the space occupancy rate. The design of the structure ensures the maximization of mixing effici...

Product Ethyl Iodide

Content (GC): min. 98 %

Humidity (KF): max. 0,20 %

Ethanol (GC): max. 0,20 %

Free acid (as HI): max. 0.10

We can also meet individual custom...

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 Oral Dose Drug Product Development & Manufacturing

WuXI STA's comprehensive drug product development platform for oral dosage forms offers our clients a complete line of solutions from pre-formulation development through to final product manufacture at commercial scale. Our capabilities include;

• Solid oral tablet/capsule (including liquid...

Oral Dose Drug Product Development & Manufacturing

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 Nitrosamine & NDSRI Services

Milestone Pharma's Nitrosamine and NDSRI Research Platform delivers a comprehensive and compliant one-stop solution, covering risk assessment, method development and validation, confirmatory testing, and submission-ready report generation.

The platform strictly adheres to ICH, FDA, and EMA guide...

Product In-Vitro-Bioequivalence

Integrated in vitro bioequivalence support across oral, topical, transdermal, nasal, inhalation, injectable, and nanomedicine products.

Capabilities include dissolution and release testing, IDR, IVRT, IVPT, permeability studies, spray and particle characterization, binding assays, cyclodextrin i...

Product Nano Particle _banner_pc_2x.webp Particle Characterization for Biologics & ATMPs

Milestone Pharma provides particle characterization for biologics and advanced therapy medicinal products (ATMPs), delivering fit-for-purpose data to support formulation development, stability and comparability, and CMC submissions.

We design orthogonal analytical strategies across size, morphol...

Nano Particle _banner_pc_2x.webp Particle Characterization for Biologics & ATMPs

Product Analytical Method Development & Validation

Our phase-appropriate solutions cover method design, qualification, validation, and transfer, ensuring robust performance from preclinical to commercialization. Leveraging advanced chromatographic, spectroscopic, and physicochemical techniques, we support small molecules, biologics, and complex formulation...

Analytical Method Development & Validation

Product Reference Standards & Impurity Synthesis

Nitrosamine impurity is a key component of Milestone Pharma‘s custom impurity services. The nitrosamine-related compounds and reference standards listed on this page support drug development and quality control applications. Our strengths include an integrated multi-platform strategy, deep methodological e...

Reference Standards & Impurity Synthesis

Product Pharmaceutical & Medical Device Testing (E&L, Sterility, Biocompatibility)

Our capabilities cover pharmaceutical packaging testing, extractables and leachables (E&L) studies, container closure integrity testing (CCIT), sterility assurance, biocompatibility testing, chemical characterization, and global regulatory support. Backed by ISO 17025-accredited laboratories and experi...

Pharmaceutical & Medical Device Testing (E&L, Sterility, Biocompatibility)

Product cGMP Drug Substance & Drug Product Testing & Release

Rapid, high-quality, cGMP-compliant DS and DP release testing: Solvias has decades of experience performing drug substance and drug product testing and release for small molecules, biologics, and cell and gene therapies. We can help establish your critical quality attributes (CQAs) and devise the right com...

cGMP Drug Substance & Drug Product Testing & Release

Product Custom Solutions

Custom-tailored solutions for every stage of drug development: Solvias provides custom solutions tailored to your needs at every stage of drug development. Our team has the expertise, broad capabilities, and advanced technologies to design or optimize phase-appropriate testing solutions for any program, no...

Product Excipient & Raw Materials Testing and Release

Rapid, High-Quality Raw Material and Excipient Testing and Release: Ensuring the quality of excipients and raw materials is critical. Solvias provides comprehensive excipient and raw material testing and release services, helping you navigate the regulatory landscape and ...

Excipient & Raw Materials Testing and Release

Product Extractables & Leachables Testing

Reduce risk and take extractables and leachables off the critical path: Too often, E&L studies follow a one-size-fits all approach that may only provide a superficial understanding of the risks presented by different materials and container closure systems. Solvias goes beyond this ...

Product Impurity Testing & Contamination Control

Minimize risks with effective impurity testing and contamination control: Using advanced methods and an expert team, we offer comprehensive solutions to identify impurities and contaminants that threaten product efficacy and safety.

Impurity Testing & Contamination Control

Product Stability Testing

Comprehensive stability testing from a single, dedicated source: Solvias offers efficient, comprehensive stability studies in accordance with ICH guidelines. With our deep expertise, large storage capacity, and flexible approach, we deliver fast, accurate results.

Product Global Regulatory Affairs & CMC Submission Support

WuXi STA's dedicated Global Regulatory Affairs CMC teams offers comprehensive CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through foreca...

Global Regulatory Affairs & CMC Submission Support

Product IC MIXER

IC Mixer is a mixing device that makes the material quickly dispersed and mixed in the process of circulation by means of internal circulation. It can make the powder and solvent quickly and evenly mixed, and the dispersion period is consistent. It has good dispersibility and efficient mixing wit...

Product ChemieR™ - ACS grade Chemicals

ChemieR is a Trusted name in the chemical industry, renowned for providing high quality reagents that meets the rigorous demands of modern Laboratories. From routine analysis to specialized research , ChemieR providing an exceptional standards of purity, consistency, accuracy, reproducibility and reliabili...

Product CMC and Process Development for novel Biotherapeutics

At bespark*bio, we deliver bespoke bioprocess development services that solve CMC challenges across the lifecycle of novel biotherapeutics.

We combine proven process building blocks with data modeling and machine learning to reduce lab work, increase accuracy, and accelerate development. Our hol...

CMC and Process Development for novel Biotherapeutics

Product GMP Manufacturing Services for mRNA and LNP

ARCALIS provides GMP-compliant manufacturing of mRNA and LNP formulation services, including commercial-scale production. With its facilities in Minamisoma, Japan, ARCALIS supports flexible batch sizes, technology transfer, and regulatory documentation. Notably, ARCALIS was selected as the manufacturin...

GMP Manufacturing Services for mRNA and LNP

Product Non-GMP mRNA Development & CMC Services

ARCALIS provides a fully integrated, end-to-end R&D support service for early-stage mRNA drug discovery. The service includes sequence design with proprietary AI-driven codon optimization algorithms, mRNA manufacturing, LNP formulation, and evaluation using in vitro/in vivo studies.

Product Pillar 1: Product Development

Our services for Quality & Compliance:

- CMC Pre and Postapproval
- Quality Systems Consulting and Operational Quality Assurance
- Audits and Inspection Readiness
- Management of Compliance

Product Hydroxypropyl Methyl Cellulose HPMC

Hydroxypropyl Methylcellulose(HPMC)

CAS NO.:9004-65-3

Hydroxypropyl Methylcellulose (HPMC) are non-ionic cellulose ether & its derivatives that have hyrdroxyl groups on the cellulose chain substituted for a methoxy or hydrox...

Product New Drug & Chemical Services

1.Custom Synthesis 2.R&D of Synthetic Processes and Custom Manufacturing 3.Contract Manufacturing Service 4.CMC Service for New Drugs

Product Submissions Assistance

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filin...

Product CMC Services - Chemistry, Manufacturing and Controls

BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development.

Our experts can advise you on pharmaceutical development strategy and provide oversight for the overall product development process to ensure key development milestones are successfully re...