Analytical Services

Product Description

Analytical Services: QC Chem/Microbio, stability, etc.

INCOG BIOPHARMA SERVICES

US
2022

On CPHI since
1

Certificates
50 - 99

Employees

Company types

CMO/CDMO

Primary activities

Analytical Services

Contract Manufacturer

Supply Chain

Compare Add to favorites Added to favorites

INCOG BIOPHARMA SERVICES

US
2022

On CPHI since
1

Certificates
50 - 99

Employees

Company types

CMO/CDMO

Primary activities

Analytical Services

Contract Manufacturer

Supply Chain

Compare Add to favorites Added to favorites

More Products from INCOG BIOPHARMA SERVICES (1)

Product Drug Product Fill-Finish Services

Fill-Finish Capabilities (product type) and Capacity:
Sterile liquid products
Biosafety level (BSL) 1, BSL 2 (OEL >= 10 µg/m³)
Vaccines (inactivated)
Current capacity: ~40M units/year

Compare

INCOG BIOPHARMA SERVICES resources (2)

Sponsored Content Building resiliency into single-use systems

Jo Anne Jacobs, Director of Technical Services at INCOG BioPharma Services, discusses building a functional equivalence model for single-use manufacturing equipment and assemblies for use in drug product manufacturing.

20 May 2022
News INCOG BioPharma Services completes analytical and quality control testing laboratory and technology transfer suite

In February, INCOG BioPharma Services completed its 6,000 sq. foot laboratory space at its Fishers, Indiana headquarters

10 May 2022

Frequently Viewed Together

Product Biologic drug substance CDMO services

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
Product FPFs

• Genexol®PM Inj.(Paclitaxel) • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
Product Tramadol HCl

Grünenthal GmbH offers a selected range of products which includes Tramadol HCl, as API, bulk and/ or finished dosage form. Please contact us for more information.
Product Formulation Development

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
Product Analytical Services & EU Batch Certification

Method Development and validation
Stability Studies
European testing & batch certification
Product GALENIC DEVELOPMENT

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...
Product Complex drug formulation

We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...
Product Analytical Services

ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership:...
Product Quality control: Pharmaceuticals

Conscio offers GMP-certified and ICH-compliant chemistry, manufacturing and controls assays (CMC) as well as analytical support during validation of manufacturing processes. Samples are analyzed by approved and validated methods for routine batch testing, stability studies, analyses of high potency product...
Product GMP and CMC Laboratory Services

Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability s...
Product Batch release and import from no-EU countries

We possess a manufacturing authorization for batch release

We provide the following services:

1. Batch release by a Qualified Person.
2. Adoption of responsibility as external Qualified Person.
We serve our partners with:

• Method transfer ...
Product Stability Studies

QACS Labs offer drug development services. Pharmaceutical testing includes pharmaceutical stability testing, storage stability services and custom solutions based on international standards. We test API’s, raw materials and final products in recommended environmental storage conditions such as Temperature,...
Product Quality Control Testing

Analytical chemistry services from SGS provide you with the bio/pharmaceutical expertise and regulatory qualifications to perform the necessary raw material testing, and testing on APIs, finished products, packaging material and medical devices.
Product Consulting: Quality Management System

Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
Product Custom Protein Synthesis

We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
Product Contract Development Services

Famar R&D is offering a complete set of Contract Development services.

• Formulation and process development for Rx, Gx, OTC, Cosmetics (Solids, Semi-solids /liquids dosage forms, Sterile liquids & Lyophilized powders) and Medical Devices • Analytical methods development and validation&nbs...
Product Laboratory Services

Laboratory Services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-...
Product Analytical Techniques

Comprehensive analysis during formulation development and GMP manufacture is vital to ensure that your drug has optimal delivery properties and stability profile as well as supporting your regulatory submissions.
Product Mikromol custom reference standards

Creating pharmaceutical reference standards to customer specification has always been at the heart of the Mikromol business. We understand that you are constantly discovering new actives and impurities of interest - each year, our dedicated, highly-qualified customs team produces several hundred new materi...
Product Aseptic fill and finish

We offer solutions for companies that need CMO capacity concerning the aseptic filling of syringes and assembly and packaging of pre-filled syringes and auto-injectors. We will enhance your product by adding value through manufacturing if you require additional capacity or a complete technology transfer. q...
Product Recombinant Protein Expression in Mammalian Cells & E. coli

Expression systems utilizing mammalian cells for recombinant protein manufacture introduces proper protein folding, post-translational modifications, and protein assembly, which are important for producing proteins of complete biological activity, and thus is in high demand in the therapeutic development a...
Product Sterility Assurance Testing

Nelson Labs is a leading provider of sterility assurance test services for medical device, pharmaceutical and tissue manufacturers for both sterile and nonsterile products. Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. Medical device standards are...
Product Wasdell Laboratory Services

By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...
Product Analytical Development:

•Development and validation of analytical methods to ensure accurate quantification, purity assessment, and impurity profiling.

•Characterization of raw materials, intermediates, and final APIs using techniques such as HPLC, GC, MS, NMR, and XRPD.

•Stability studies and fo...
Product Qualification & Engineering

The act of Validation, originally addressed only to sterilized equipment, now involves all product, process and facility matters.Choose PQE's solutions to ensure that your plant site meets your business objectives while being fully compliant with the latest Good Manufacturing Practice regulations and stand...
Product Customized AI inspection (individual approach)

Image analysis based on Machine Learning is a very flexible tool. Whatever could be seen on the image AI is able to analyze and label as required. That’s why we are happy to work on various containers, substances, and clients specific issues.

Infinite possibilities of using AI:
• Unique co...
Product cGMP Protein and Antibody Purification

KBI Biopharma has extensive experience developing purification processes for a wide variety of biotherapeutics, including: -Monoclonal antibodies-Bispecific antibodies -Enzymes -Fc fusion proteins -PEGylated proteins -Complex glycoproteins KBI supports 40+ annual programs ranging from FIH (First-in-Huma...
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 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 Animal-free Solutions for Endotoxin and Pyrogen Testing

Fujifilm Wako offers following sustainable, animal-free and ELISA-free reagents for endotoxin and pyrogen testing:

1. PYROSTAR™ Neo+: Instead of using traditional LAL reagents, Fujifilm Wako also offers a new alternative of endotoxin detection reagents developed by ...
Product Extractables and Leachables Testing

Our experts have over 30 years of experience in specialized analytical and toxicology assessment for extractable leachable testing. Intertek offers extractables and leachables testing services through GMP-compliant laboratories located in Whitehouse, NJ (USA) and Basel (Switzerland) wit...
Product Automated Headspace Analysis

The verification of quality relevant attributes of the headspace conditions e.g. in lyophilized and liquid filled vials, requires non-destructive and robust inspection technologies. The SPECTRA HSX platform is designed to meet the highest requirements in terms of sensitivity and throughput for automated He...
Product Analytical Chemistry & Microbiology Services

Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.

Our services include:

Analytical
• Raw material and drug product...
Product Quality Services

At Tjoapack, we use our expertise and experience to ensure the highest level of quality across all of our operations. Our in-house qualified persons (QPs) test and check the entire production process before releasing a finished product to the market for sale. Fully approved by the EMA and the FDA, among o...
Product ENANTIOS ROA

ROA spectrometer for measurement of absolute configuration of small molecules and structural motifs of biologics.
Product Specialty Cell Culture Media, Cell Lines and Contract Services for Bacul...

Expression Systems, now an Advancion company, is dedicated to supplying and servicing the cell culture and bio-industrial markets with innovative cell culture media formulations, as well as cell lines, molecular tools, reagents, and contract services. The company specializes in the baculovirus expression v...
Product Development Service

Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...
Product Stability/Ageing Studies

Stability/Ageing Studies: 500 m3 to 2000 m3 ICH-Climates
The Quasaar Stability Centre offers flexible and large-volume storage facilities, which also allow the storage of voluminous packaging units (pallets) up to bulk goods.

In addition to conducting ICH studies, it is also pos...
Product VitalDose® Drug Delivery Platform

VitalDose® EVA is a copolymer drug-delivery platform providing controlled, sustained release through implant and insert dosage forms. The VitalDose® EVA platform is flexible and customizable with high drug loading capacity (≤75%).
Product Pentapharm® BlisterPro® XCEL Services

Imagine design and prototyping Services that enable accelerated market introduction with increased accuracy in stability testing using the most cost-effective blister film to meet your requirements. Contact us for more information.
Product UTPVision Pharma

UTPVision Pharma is a complete series of visual inspection systems for pharma and medical applications: aluminium caps, spray valves, plungers, stoppers and needle shields.

Discover more on: https://www.utpvision.com/en/products/pharma
Product Nitrosamine and Drug Impurities | Testing and Analytical Services

Clearsynth is a globally trusted partner for reference standards and research chemicals. We offer over 3,000 nitrosamine impurities, 5,000+ stable isotopes, and 10,000+ drug impurities, encompassing a vast portfolio of more than 325,000 products serving various industries, including pharmaceuticals, clinic...
Product Analytical services

Our expertise spans across several critical areas:

Microbiology analysis • Microbial Identification (Micro ID) • Bioburden Testing • Endotoxin Testing Utilities Testing (Microbiology and Chemistry) • Water System Testing • Clean Steam Testing • Air Quality Monitoring Raw Ma...
Product Stability Testing

From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...
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 Foreign Particles

Merieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentation combined with a pool of experts in different fields.Download our brochure: https://bit.ly/48HKnVs
Product Stability tests according to ICH

Neotron Pharma provides Stability tests according to ICH standards (zones I, II, IV). We can carry out stability studies in their entirety (storage + analysis) or provide only storage service. The conditions we can offer are listed below:

- 40°C ± 2°C , 75% ± 5% U.R.
- 30°C ± 2°C&n...
Product Functional Polymers

The CDMO Division of KD Pharma offer well-established experience in the chemical functionalization of custom and designer polymers. We are specialized in polymer production used in sensitive applications, where a high level of confidence in production consistency, regulatory compliance and technical perfor...
Product Analytical Services

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
Product Drug Release Studies/In Vitro Release Testing (IVRT)

MedPharm leverages its 20 years of experience to help develop and validate IVRT methods for its clients. We successfully perform IVRT based on FDA and EMA guidelines and continue to influence how these methods are utilized in regulatory submissions.

IVRT is the established method recogniz...