corporate overview - nitto avecia pharma · anderbilt corporate overview partner with nitto avecia...

WWW.AVECIAPHARMA.COM 10 VANDERBILT, IRVINE CA 92618 TEL: 949.951.4425 TOLL: 877.445.6554

corporate OVERVIEW

OUR DEDICATED PROJECT MANAGEMENT TEAM MAKES OUTSOURCING CONVENIENTNitto Avecia Pharma Services’ client-oriented approach to project management begins with a single, knowledgeable point of contact who guarantees you all the benefits of valued partnership from planning comprehensive meetings to providing detailed weekly reports. Your designated project manager issues quotes, oversees requests, and is able to ensure confidentiality, quality, and ease in communications. Close collaboration with our scientific and quality teams ensures timeliness and outcomes that surpass expectations.

Nitto Avecia Pharma Services is a premier contract development and manufacturing organization offering a comprehensive range of cGMP services including formulation development, parenteral manufacturing, and a complete package of CMC analytical services for small to large molecules and nearly all dosage forms. Avecia Pharma’s experienced staff and robust quality infrastructure has guided clients and expedited time to market since 1988.

PROJECTMANAGEMENT

TEAM

FORMULATION DEVELOPMENT

PARENTERALMANUFACTURING

STRUCTURAL CHEMISTRY

STABILITY

MICROBIOLOGY

DRUG DELIVERY

TECHNOLOGIES

BIOPHARMA DEVELOPMENT

ANALYTICAL DEVELOPMENT

API OLIGO MANUFACTURING

ANALYTICAL CHEMISTRY


corporate OVERVIEW

PARTNER WITH NITTO AVECIA PHARMA SERVICESWhen you need reliable contract development and manufacturing support, look no further than Nitto Avecia Pharma Services — a global leader with a proven track record of providing innovative solutions and seamless support for CGMP manufacturing and analytical CMC support. What’s more, our experienced leadership, state-of-the-art instrumentation and robust quality infrastructure all combine to deliver the high quality results your projects demand.

At Nitto Avecia Pharma Services, our mission is to provide our clients with seamless outsourcing solutions for CGMP contract development and manufacturing. We remain dedicated to the ongoing, versatile expansion of our capabilities and strengthening of our scientific expertise to make your priorities possible.

AVECIA PHARMA’S COMPLETE PACKAGE OF SERVICES

We invite you to visit us, audit our facilities, discover our insight, and learn more about our commitment to excellence. Visit www.aveciapharma.com or call 877-445-6554.

PARENTERAL MANUFACTURING• CGMP Fill/Finish• Aseptic Filling/Lyo• Pre-Clinical through

Commercial

FORMULATION/PROCESS DEVELOPMENT• Formulation

Characterization• Container/Closure

Compatibility Studies

ANALYTICAL CHEMISTRY• USP/NF, EP, BP, JP, ACS,

AOAC, and Client Methods

ANALYTICAL DEVELOPMENT• Phase Appropriate

Validation• Process Validation Support• Cleaning Validation and

Verification• Comparator Studies

and Reference Standard Qualification

BIOPHARMACEUTICALS• Cell-Based Bioassays• Phase Appropriate

Validation• Product Characterization

and QC Testing

DRUG DELIVERY TECHNOLOGIES• Inhalation/Nasal

Product Testing• Transdermal Product

Testing• Device Evaluation

MICROBIOLOGY • Quality Control Testing• Research and Development

STABILITY STORAGE • Standard ICH and Custom

Storage Conditions

STRUCTURAL CHEMISTRY• Extractables/Leachables• Reference Standard

Characterization• Structural Elucidation

of Unknowns• Investigational Studies

OLIGO MANUFACTURING (API) VIA NITTO DENKO AVECIA • Pre-Clinical, Clinical and

Commercial Supply• Small Scale [mg] to Large

Scale [multi kg]


• Drug substance solubility stability profiles

• Drug substance – excipient compatibility studies

• R&D stability studies• Thermotropic characteriza-

tion of formulations • Lyo cycle development

• GLP supplies manufacturing • Identification of critical

process parameters (CPP)• Solution of contact –

material compatibility

and hold time studies • DoE studies and process

scale up• Mixing studies

• VirTis 25L Genesis EL freeze dryer with sample thief and Maestro software

• LYOSTAT2 freeze drying microscope system

• TA Instruments Q2000 Differential Scanning Calorimeter with modulated DSC

• UPLC• TA Instruments TGA

Q500 high resolution thermogravimetric analyzer

• Microfluidics Microfluidizer Model M-110P high shear homogenizer

• Malvern Zetasizer Nano Series ZS-90

• Dissolution apparatuses• Malvern Mastersizer

2000 (wet/dry modules)• Mettler Toledo DL39 Karl

Fischer Coulometer• Brookfield HBDV-II+Pro

cone/plate rheometer• Agilent 1200 Series

HPLCs with a range of detectors

• Brookfield CT3 texture analyzer

• HunterLab ColorQuest XE• Ross Dual planetary mixer• Advanced Instrumenta-

tion: Micro-osmometer, specialized pH meters, and micro/analytical top loading balances

FORMULATION / PROCESS DEVELOPMENT

STATE-OF-THE-ART INSTRUMENTATION

• Arrhenius kinetics • Effect of pH• Excipient compatibility• LogD/LogP

• Polymorph screening by DSC

• Solubility/solubilization• Stability evaluation

• Batch record development• Critical process parameters

evaluation

• Method transfer, develop-ment and validation

• Scale-Up from lab to manufacturing

PRE-FORMULATION DISCIPLINED TECHNOLOGY TRANSFER

Avecia Pharma’s experienced and knowledgeable formulation team can reduce product risk and accelerate the drug development process by providing you with the optimum dosage form selection.

formulation/ PROCESS DEVELOPMENT

AVECIA PHARMA’S COMPLETE PACKAGE OF SERVICESPARENTERAL MANUFACTURING• CGMP Fill/Finish• Aseptic Filling/Lyo• Pre-Clinical through

Commercial












and QC Testing






Storage Conditions






Scale [multi kg]



PARTNER WITH NITTO AVECIA PHARMA SERVICES’ FORMULATION DEVELOPMENT TEAMNitto Avecia Pharma Services’ in-depth knowledge covers a diverse range of products, from generics to opthalmics, as well as a wide variety of dosage forms and routes of delivery. Avecia Pharma’s preformulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Our formulation experts unite a thorough understanding of your needs along with the data on the physicochemical properties of the compounds to ensure the delivery of a stable, high quality product.

In addition to our formulation capabilities and complete CMC support, we also conduct the necessary analyses, container/closure compatibility studies and pilot batch studies required to move your product through the regulatory process.

OUR PROJECT MANAGEMENT TEAM SERVES YOU BETTEROur signature service assigns you a single, dependable point of contact who guarantees all of the benefits of valued partnership such as strategic planning meetings, weekly reports, high quality data, and detailed post-project follow-up.

formulation/ PROCESS DEVELOPMENT


• Three manufacturing suites• Single use components

• Passive RABS filling line• Dedicated air-handling

in each suite

• No seasonal uncertainties• Formulation lab

and pilot suite

• Flexible and scalable

• Filling Machine with 100% vial weight check capability

• Water for Injection (WFI) generation and storage

• Steam sterilizer

• Pure Steam generation and distribution

• Vial washer

• Lyophilizer/Freeze dryer• Depyrogenation oven

• Liquid • Lyophilized • Emulsions/Suspensions • Liposome

LEADING-EDGE FACILITY

STATE-OF-THE-ART EQUIPMENT

EXPERTISE IN MULTIPLE DOSAGE FORMS

• Toxicology, clinical trial and commercial manufacturing

• CGMP fill/finish• Aseptic filling/lyo

(0.3-100mL vials)

• Custom hand fills• Process assessment

and validation• Lyophilization• Terminal sterilization• Tangential flow filtration

• Microfluidization• Inert gas purge/overlay• Documentation

preparation (including CMC submission)

• Formulation/product development

• Analytical and Biophar-maceutical development

• CMC analytical testing• Stability• Visual inspection, labeling

and packaging

COMPLETE PACKAGE OF SERVICES

Avecia Pharma is a CGMP contract development and manufacturing organization offering parenteral manufacturing services from pre-clinical to commercial. With a state-of-the-art facility, experienced staff, and robust quality infrastructure, Avecia Pharma delivers client-centric solutions in a timely manner.

parenteral MANUFACTURING


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and QC Testing






Storage Conditions






Scale [multi kg]



PARTNER WITH NITTO AVECIA PHARMA SERVICES’ PARENTERAL MANUFACTURING TEAMNitto Avecia Pharma Services has a state-of-the-art facility capable of handling an array of unique products. The facility is complemented by a well-trained and knowledgeable staff with a proven track record of developing processes for some of the most sensitive and complex products. Nitto Avecia Pharma Services’ manufacturing department produces batches at the highest quality as the team works hand-in-hand with the Formulation and Quality teams as well as other resources to develop the documentation, process flow, material list and equipment recipes needed in the successful transfer from a lab environment into manufacturing.

Nitto Avecia Pharma Services has received licenses for Pharmaceutical Drug and Device Manufacturing by the California Food and Drug Branch in addition to receiving an ISO 13485 certificate for contract manufacturing and formulation of pharmaceutical, biopharmaceutical, and medical device products.


parenteral MANUFACTURING

analytical CHEMISTRY

EXPANSIVE SERVICES


STATE-OF-THE-ART INSTRUMENTATION• HPLC (UV-Vis, PDA, RI,

FI, CAD, ELSD, EC, and conductivity)

• ICP-MS• ICP-OES• LC/MS: Quadrupole,

triple quadrupole and quadrupole-time-of-flight of mass spectrometers with APCI and ESI

• GC: direct injection and head space capability (FID, TCD and NPD)

• GC/MS MSD with El and Cl ionization source

• Malvern Zetasizer Z690• Malvern Mastersizer

2000• Brookfield HBDV-II+Pro

cone/plate rheometer

• HunterLab ColorQuest XE colorimeter

• AccuSizer• GFAA• Flame AA• FTIR• Polarimeter• UV-Vis spectrophotometer

• Fluorescent spectrophotometer

• TGA• DSC/TGA • IC• CE• UPLC• Total organic carbon

(TOC) analyzer

• Dissolution • Disintegration • Total organic carbon • Thermal analysis

(DSC/TGA)• Mercury analysis • Moisture determination

(Karl Fischer, TGA, direct/coulometric titration)

• Water activity • Inorganic impurity profile• Container/Closure testing• Atomic absorption (flame

AA, GFAA) • Friability, disintegration• Analytical Method

Remediation• Particle size distribution

• Osmolality • Melting point

determination • Residual solvents • Organic volatile impurities• Viscosity determination• Nitrogen analysis • Gas analysis (oxygen,

carbon dioxide, etc.

• Specific gravity • Limit test • Identification test • Amino acid profile • Impurities profile • Particulate Matter

(Methods I/II)• Specific Rotation• Glass grain test

Providing analytical chemistry services since 1988, Nitto Avecia Pharma Services has established streamlined processes supported by experienced staff to provide reliable, expedited testing for nearly all drug substances, products, and components.


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and QC Testing






Storage Conditions






Scale [multi kg]



analytical CHEMISTRY

PARTNER WITH NITTO AVECIA PHARMA SERVICES’ ANALYTICAL CHEMISTRY TEAMNitto Avecia Pharma Services’ long-standing team is committed to providing expert and timely analytical chemistry support. We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing including controlled substances (Schedules I-V)

We specialize in handling drug substances, drug products, and nearly all dosage forms including tablets, capsules, semi-solids, parenterals, sterile, transdermal, and inhalation products. Our device specialists oversee routine chemical and functional testing of packaging (elastomers, glass, plastics) and component testing. We also assist with vendor and contract manufacturer qualification. These essential services are why Nitto Avecia Pharma Services has earned a solid reputation in the industry since 1988.

At Nitto Avecia Pharma Services, our mission is to provide our clients with outsourcing solutions that make their drug development priorities possible.




• HPLC (UV-Vis, PDA, RI, FI, CAD, and ELSD)

• UPLC/UHPLC• GC/MS MSD (El and Cl

ionization source)

• GC: direct injection and head space capability (range of detectors)

• LC/MS: MSD with APCI and ESI

• IC (conductivity and ECD

• DSC/TGA • Dissolution (apparatuses

I, II, VI) • MALS• Karl Fischer

• LC/MS/MS: Quadrupole, triple quadrupole and time-of-flight of mass spectrometers with APCI and ESI

• HIAC

• Assay and related substances

• Chromatographic purity • Stability indicating assays • Forced degradation

studies • Dissolution

• Gap analysis and remedial validation

• Residual solvents • Extractables/Leachables • Chiral drugs • Cleaning procedures

• Characterization of reference standard and drug substances

• Process validation support • Comparative studies • Reference standard

qualification

• Counterfeit product evaluation

• Vendor qualification• Method development

and phase-appropriate validation

EXTENSIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION SERVICES

With over thousands of methods developed, validated, and/or transferred supporting IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.

analytical DEVELOPMENT


Commercial












and QC Testing






Storage Conditions






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PARTNER WITH NITTO AVECIA PHARMA SERVICES’ ANALYTICAL DEVELOPMENT TEAMNitto Avecia Pharma Services’ analytical development group has experience in support of various dosage forms within the generic and branded pharmaceutical industries. The team’s diverse background has enabled Avecia Pharma to develop an in-depth understanding of all facets of the drug development process. In addition, Avecia Pharma offers extensive experience in gap analysis and remedial validation of existing methodologies to comply with current CDER/ICH guidelines for validation.

As development partners, we design detailed protocols for method development, validation, and technology transfer based on the products phase in the drug development process.



analytical DEVELOPMENT


• Identity by Amino Acid Analysis

• Protein content• Peptide mapping

• Immunoassays• Residual DNA analysis• Purity/Potency

• Glycosylation analysis• Functional analysis • Process and product

related impurity analysis

• Disulfide bonds: Thannhauser method

• Determination of extinction coefficients

• Stability studies

• Fast Real-Time PCR: Applied Biosystems 7500 (QPCR)

• iCE3 Capillary: Protein Simple

• Fast Resolution Chromatography

• UPLC• UHPLC

• LC/MS/MS• LC/QTOF• Agarose and cellulose

acetate (flatbed chambers)• HPLC (UV/Vis, PDA, RI,

FL, CAD, ELSD, ES, DAD, MALS)

• IC• CE

• SDS-Page (multiple formats)• Immunoblot (multiple

formats)• Solo VPE• Tecan M1000 Pro

Plate Reader• MD SpectraMax M5

and L Plate readers• Biotek ELx405 Microplate

Washers

• Ultra-centrifuge• UV transilluminator• Gel DOC (UV/VIS):

BIO-RAD• Post column amino acid

derivatization system: Pickering

• UV/VIS Spectrophometer

PRODUCT CHARACTERIZATION EXPERTISE


• Cell-based bioassays• Western blot analysis• Residual host cell protein• Residual chemical analyses• Residual DNA analysis

• Binding assay (ELISA, HTRF, AlphaLISA)

• Ninhydrin-positive substances

• Gel electrophoresis (SDS-Page)

• Capillary electrophoresis: CGE, CZE, cIEF, iCE

• Isoelectric focusing (IEF)• Peptide mapping • Protein content (strength)• Amino acid analysis

• HPLC (RP, SEC, HIC, IEX and mixed mode)

• Surfactant analysis• Sugar analysis• Glycan analysis

COMPREHENSIVE BIOPHARMACEUTICAL SUPPORT

Supporting start-ups to globally recognized biotech companies, Nitto Avecia Pharma Services has the track record and knowledge to provide comprehensive support for biomolecules at all phases.

biopharmaceuticals


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and QC Testing






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Scale [multi kg]



PARTNER WITH NITTO AVECIA PHARMA SERVICES’ BIOPHARMACEUTICAL TEAMFrom proof-of-concept to commercialization, depend on the scientific strength of Nitto Avecia Pharma Services. We offer reliable technical expertise, rigorous quality systems, state-of-the-art instrumentation, and thorough experience working with a range of biomolecules including nucleic acids, natural and recombinant proteins, monoclonal antibodies, peptides, carbohydrates, vaccines, as well as oligonucleotides. What’s more, we maintain focus on the leading edge of science, service, and seamless collaboration.

Nitto Avecia Pharma Services provides a broad range of services including but not limited to method transfer, method development and validation, drug substance/drug product release, stability, process and product related impurity analysis, leachable and contaminants, and investigational support for large molecules programs. Our customer service oriented project management team can help leverage your supply chain capabilities and improve project efficiencies to reduce time to market.

At Nitto Avecia Pharma Services our mission is to provide our clients with outsourcing solutions that make their drug development and commercialization priorities possible.


biopharmaceuticals


• LC/MS/MS: Quadrupole, triple quadrupole of mass spectrometers with APCI and ESI

• LC/MS-QTOF

• GC/MS (EI and CI ionization)

• UPLC-MS/MS• GC (multiple detectors)• HPLC (multiple detectors)

• ICP-MS• ICP-OES• Flame AA• GFAA

• IC• FTIR • DSC/TGA • TOC

LEADING-EDGE INSTRUMENTATION

• Extractables/leachables studies

• Reference standard/drug substance characterization

• Structural elucidation of target/lead compounds

• Elemental analysis• Structural elucidation

of unknowns• Purification of impurities

and degradation products• Amino acid analysis

• Peptide mapping• Glycan analysis• Enantiomeric studies• Residual analysis in

support of biotechnology- derived products

• Residual Solvent Screening by GC/MS

• Melamine analysis by GC/MS and LC/MS

• Structural characterization of protein variants and isoforms

INDUSTRY-LEADING STRUCTURAL CHEMISTRY SERVICES

With over 10 years industry experience per structural scientist, Nitto Avecia Pharma Services’ strategic, systematic approach provides high quality solutions for identification, characterization, and development of highly sensitive methodologies.

structural CHEMISTRY


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and QC Testing






Storage Conditions






Scale [multi kg]



PARTNER WITH NITTO AVECIA PHARMA SERVICES’ STRUCTURAL CHEMISTRY TEAMWith a multidisciplinary team including biochemists, synthetic organic chemists, and analytical chemists, Avecia Pharma offers an array of approaches and techniques to characterize drug structures and analyze their purity at every step of the development process. In addition, Avecia Pharma’s integrated team approach unites our structural chemists with scientists from other departments to provide a comprehensive set of capabilities and expertise that will efficiently accelerate and strengthen the process of characterizing and identifying complex chemical and protein compounds.

Nitto Avecia Pharma Services’ structural chemistry team has expertise that goes beyond chemical characterizations to include a deep understanding of all facets of drug development that can impact the successful development and launch of a product. This includes experience analyzing different routes of administration, meeting regulatory requirements, solving packaging issues, and identifying potential problems in manufacturing. With in-depth academic history, diverse industry experience, and influential industry involvement, Avecia Pharma’s structural chemists are unsurpassed.


structural CHEMISTRY


• 25°C/60% RH• 30°C/65% RH• 30°C/75% RH

• 40°C/75% RH• 25°C• 50º C

• 5°C, Refrigerator• -20°C, Freezer• -70°C, Ultimate freezer

• Photostability chambers – ICH options I and II

• Customized conditions

RANGE OF STORAGE CONDITIONS INCLUDING ALL ICH CONDITIONS

• Stability protocol generation

• Stability testing• Stability storage• Stability summary report

generation

• Freeze/thaw studies• Stability time points and

conditions specific report generation

• Preclinical stability• Clinical stability

• Stability indicating method development and validation

• Release testing• Method transfer and

analyses qualification

• Assay, impurities, dissolution, water content, etc. of various formulations

COMPREHENSIVE STABILITY STUDIES AND SERVICES

With over 14,000 ft2 storage capacity and over 14 ICH and custom conditions, Nitto Avecia Pharma Services has the capability to help design stability studies tailored to product needs.

stability


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and QC Testing






Storage Conditions






Scale [multi kg]



PARTNER WITH ANITTO AVECIA PHARMA SERVICES’ STABILITY TESTING TEAMFor the quality control and security your projects demand, all cGMP validated environmental and photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Our walk-in, reach-in, UV/visible and fluorescent photostability chambers are supported by back-up chambers, a reserve generator and an electronic notification system.

We have the latest Stability Laboratory Information Management System (LIMS) to ensure compliance. The system accommodates sophisticated sample management, as well as allows the stability department to generate cumulative reports.



stability


• Sterility test validation (bacteriostasis/fungistasis)

• LAL validation (inhibition/enhancement)

• Disinfectant efficacy testing

• Method development and validation

• Closure integrity testing (microbial ingression and dye immersion)

• Sterilization validations (steam, EO, gamma radiation, chemical)

• Bioburden recovery• Environmental monitoring

PRODUCT VALIDATION/ RELEASE TESTING EXPERTISE

• Microbial limits testing based on USP, EP, JP

• Antimicrobial effectiveness testing

• Bioburden testing

• LAL endotoxin quantifi-cation (gel-clot, kinetic chromogenic, and turbidimetric methods)

• Container/Closure Integrity testing (micro-bial ingression and dye immersion)

• Water quality testing• Sterility testing

• Environmental monitoring (including on site EM support, sampling and testing services)

• Specialized microbiology testing

EXPERIENCED MICROBIOLOGICAL SUPPORT

With nearly 30 years’ experience in supporting all compendial microbiological testing, Avecia Services has the in-depth experience, established quality systems, and expertise to best support your product life cycle at any stage.

microbiological TESTING


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PARTNER WITH NITTO AVECIA PHARMA SERVICES’ MICROBIOLOGY TEAMAs the demand for precision and timeliness of microbiological data increases, trust Nitto Avecia Pharma Services to deliver. We offer a comprehensive range of microbiological testing services supported by our highly experienced microbiology team, including testing according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards and client specific methodologies. Our depth of expertise, combined with our novel approach to dedicated project management, and high-quality reporting, ensures well timed execution of your project deliverables.

At Nitto Avecia Pharma Services, our mission is to provide clients with outsourcing solutions that make drug development priorities possible.


microbiological TESTING


• Digital flow meters• Copley Andersen

Cascade Impactors™ (28, 60 LPM) MSP Next Gen-eration Impactor (NGI)™

• Multi-stage liquid impinger• Dose uniformity sampling

apparatus (MDI/DPI) • Copley Scientific model

TPK critical flow controller

• InnovaSystem Mighty-Runt Actuator Station

• Malvern Mastersizer 2000• Malvern Zetasizer ZS90

• Copley Breath Simulator (BRS100)

• Copley Scientific Inhaler Testing Data Analysis Software (CITDAS)

• Assay• Chromatographic purity• Drug release profile

(dissolution)• Residual solvents• Stability studies

• HPLC: Waters, Agilent, Dionex (UV/VIS, PDA, FI, RI, CAD, ELSD, EC, and conductivity,

• HIAC • High resolution

chromatography

• LC/MS: MSD with APCI and ESI

• LC/MS/MS: Sciex 3000 and 4000 with ESI and APCI

• GC/MS: Agilent MSD with El and Cl ionization source ionization source

• IC (detectors: conductivity and ECD)

• GC: direct injection and head space capability (range of detectors)

• Dissolution (apparatus VI)

INHALATION/NASAL ADVANCED INSTRUMENTATION

TRANSDERMAL TESTING EXPERTISE

TRANSDERMAL INSTRUMENTATION

• Drug product characterization

• Drug content assay • Aerodynamic particle size

distribution by NGI/ACI• Deliverable-dose uniformity

• Pressure testing• Retention of prime• Valve delivery• Shot weight• Leak rate• Device counters

• Emitted/delivered dose• Cyr test (storage

orientation)• Primary particle

size determination• Bulk density

• Water content• Microscopic evaluation• Spacer evaluations• Particulate matter• Rate of delivery/total

delivery

INHALATION/NASAL COMPREHENSIVE TESTING STUDIES

Nitto Avecia Pharma Services has in-depth experience with a wide range of drug delivery device technologies to offer your programs comprehensive technical support.

drug delivery TECHNOLOGIES


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PARTNER WITH NITTO AVECIA PHARMA SERVICES’ DRUG DELIVERY TECHNOLOGIES’ TEAMNitto Avecia Pharma Services is known as a dependable resource throughout the pharmaceutical, biopharmaceutical, and medical device industries for its experience in transdermal and inhalation/nasal product development support, including formulation as well as device evaluation.

We combine our core competencies in drug delivery technologies’ development with an ongoing commitment to state-of-the-art instrumentation and technology. Additionally, we provide an innovative approach to cross-functional scientific expertise and experience, high quality systems, and above-and-beyond project management. This culmination makes Avecia Pharma the source to trust for the exceptional quality and reporting your projects demand.



drug delivery TECHNOLOGIES


Contact us at 877-445-6554 or visit www.aveciapharma.com. Learn more by downloading our Elemental Impurities Tool Kit.

Nitto Avecia Pharma Services has nearly 30 years of analytical experience with Heavy Metals analysis. Additionally, Avecia Pharma has actively participated in the industry since the early 2000s on this subject matter via technical posters, papers, presentations, and through collaborating with clients.

Avecia Pharma’s experienced staff can help you:

• Develop/transfer, validate and test elements listed in <232> and beyond

• Perform a general screening for elements listed in <232> and beyond (for informational purposes only)

HOW CAN AVECIA PHARMA HELP YOU PREPARE?

WHO WILL BE REQUIRED TO COMPLY?

UTILIZING MODERN, PRECISE INSTRUMENTATION

• Pharmaceutical• Biopharmaceutical• Excipient

• Medical Device• Nutraceutical

• ICP-MS • ICP-OES

THE 2018 DEADLINE IS QUICKLY APPROACHING. Contact an Avecia Pharma Subject Matter Expert today.

In an effort to improve and modernize the USP General Chapter <231>, Heavy Metals, USP has proposed the addition of two new General Chapters and one Supplemental General Chapter.

• <233> Elemental Impurities – Procedures• <232> Elemental Impurities – Limits• <2232> Elemental Contaminants in Dietary Supplements

The updated USP methodologies (harmonized with ICH Q3D) utilize modern technologies to provide better precision, sensitivity, and accuracy. To comply with these changes, drug products will be required to fall within the proposed limits. The implementation date is proposed for January 1st, 2018.

USP has announced the new required methodology proposed to replace General Chapter <231>, Heavy Metals.

elemental IMPURITIES


Contact us at 877-445-6554 or visit www.aveciapharma.com.

OUR COMPREHENSIVE SERVICES

• pMDI• Nasal products

• LDPE ampoules• PVC blister packs

• Injectables• Medical devices

• IV bags• Ophthalmics

• GC/MS and/or GC-FID (including headspace analysis)

• LC/MS/MS or LC/UV• ICP/MS

• UPLC/MS/MS• QTOF

Regulations make Extractables and Leachables studies an essential part of your development process. Our team of skilled scientists is highly experienced in developing and validating new methodologies in support of various container/ closure systems.

• Three-phase systematic approach - Profile extraction studies - Control extraction

studies - Leachables studies

• Routine container/closure testing

• Formulation compatibility and stability

• Identification, isolation and quantification of Extractables and Leachables

EXPERTISE SUPPORTING A RANGE OF PRODUCTS AND DELIVERY SYSTEMS


Investigate the potentially harmful effects of your container/closure system on your drug product by partnering with Nitto Avecia Pharma Services. Our team of structural scientists have over 10 years of experience with polymers, elemental impurities, and an array of pharmaceutical products to assist in identifying the threat of contamination to your drug products. Let Avecia Pharma leverage this expertise in a thorough examination of impurities in your drug formulation.

Avoid introduction of foreign materials in the drug development process.

extractables/LEACHABLES


Contact us at 877-445-6554 or visit www.aveciapharma.com.

OUR EXPERTISE ENCOMPASSES

OUR MULTIPLE POINTS OF INTERACTION

Assure compliance now with Nitto Avecia Pharma Services’ cost effective identification and quantification of impurities.

• Joint review of DMF/physico-chemical properties of the API and excipients

• Meetings to ensure appropriate:

- Technology – GC-FID/TCD/ECD or GC/MS via direct injection or head-space sample introduction

- Limits, e.g., TDI - Procedure for method transfer/validation - Process – prescreening, routine testing, API qualification

Nitto Avecia Pharma Services provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory, and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

residual SOLVENTS TESTING

• Detection, profiling and control support of residual solvents in drug substances, excipients, and drug products - Water-Soluble/Water-Insoluble raw materials

and APIs - Screening for potential interference - Screening for identification of unknown peaks - Feasibility studies

FASTER ANALYSIS, ENHANCED SENSITIVITYNitto Avecia Pharma Services remains committed to ongoing, effective upgrades in software and instrumentation so you can benefit from faster, more selective and sensitive testing. Currently, you benefit from Avecia Pharma’s state-of-the-art equipment that reduces the number of separation phases.

• Strict compliance of ICH guidelines

• Development and validation of analytical methods

• Assistance in regulatory reporting

• Comprehensive and accurate reports

• Remediation of existing materials and products

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