Laboratory Services Alcami s comprehensive development and testing services are well established and ready to assist your pharmaceutical product

Transcription

1 Laboratory Services Alcami s comprehensive development and testing services are well established and ready to assist your pharmaceutical product needs.

2 The Alcami Advantage Alcami specializes in all phases of pharmaceutical development from critical preformulation studies to commercial product lifecycle management. Over the past 30 years, Alcami has supported more than 500 Investigational New Drug (IND) filings and over 50 New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA) and New Animal Drug Applications (NADA). Our fully integrated laboratory services are well established and ready to help our clients get the most out of their portfolios. The advantage of using Alcami is our consistent and reliable on-time delivery flexibility, and our wealth of technical expertise / experience. The majority of compendial raw materials are released in 10 business days or less with an available option for expedited services as short as one day. Alcami has the technology and experience to help you at any stage of your drug development from formulation creation, unique and specialized method development, and to stability planning and start up. Alcami holds an exemplary compliance record. When you partner with us, you receive access to our analytical centers of excellence ensuring fast and responsive support. Alcami offers a full array of pharmaceutical development and commercialization laboratory services including: Early-phase, clinical and commercial formulation development Analytical method development and validation Biopharmaceutical analytical development and validation Stability storage and testing Principal offerings: Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS Compendial method verification and validation studies Compendial microbiological testing to support drug product development, release and stability Drug substance reference standard characterization studies Active pharmaceutical ingredient release and stability testing Drug product release and stability testing Stability storage and testing Elemental impurities per USP <232>, <233> Container and closure system integrity testing Disinfectant qualification and disinfectant efficacy Abuse Deterrence and Food Study capabilities Microbial Identification by MicroSEQ Filter Validation Expertise Comprehensive Large Molecule capabilities

3 Connected At Every Level Alcami offers individualized development and manufacturing services that can be integrated for a less fragmented and faster pathway for products. Formulation Development Guide your development program every step of the way from Compound to Clinic Alcami s Formulation Development team proactively guides your development program every step of the way from Compound to Clinic. Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dosage forms. We offer early-phase accelerated programs for new chemical entities (NCEs) and generic drug development for human and veterinary applications (ANDA and ANADA). Alcami s formulation development scientists provide full chemistry, manufacturing and controls (CMC) supporting drug candidates that encompass all biopharmaceutical classification system schemes (BCS class I through class IV). We specialize in more challenging compounds with limited solubility, stability, or bioavailability. Our formulation and analytical experts can provide creative solutions for your toughest pharmaceutical challenges. Our formulation development services include: Drug substance pre-formulation studies (API & excipients) API salt form selection API polymorph screening API structural chemistry Formulation development preclinical to commercial for brands and generics (Drug product) Bio-availability enhancement Matching placebo development Drug-excipient compatibility studies Prototype development (delivery system) Pediatric formulations Pharmaceutical process development and optimization QbD Technology transfer and process scale-up Our operations and quality systems are designed to effectively and efficiently develop small and large molecules for topical, parenteral, and solid oral dosage forms. Alcami s team of formulation development experts has successfully supported these product types across clinical and commercial phases.

4 Method Development A full complement of advanced analytical and information technologies Alcami offers seamless analytical method development, method validation and testing solutions with a full complement of advanced analytical and information technologies. Alcami s electronic laboratory notebook (ELN) data collection systems are fully integrated to maximize efficiency and flexibility and deliver results. Alcami has the flexibility to provide stand-alone solutions or comprehensive support for pharmaceutical development programs. Alcami s analytical development and validation services include: Drug substance and drug product methods Assays, related substances, chiral purity, elemental impurity and residual solvent analysis Dissolution testing with UV and HPLC backend (Apparatus I-IV, VII) Phospholipid and fatty acid analysis Physical & structural chemistry Remedial method validation / method life-cycle evaluation studies Drug substance and reference standard material characterization and qualification Drug product comparator studies Abuse deterrence and food compatibility studies Extractables and Leachables studies Heavy metals, trace metal impurities and elemental impurity testing Analytical Testing Alcami provides comprehensive analytical testing for new drug entities, generic drugs, animal health products, OTC medications, chemicals, and biopharmaceuticals. Alcami has a network of cgmp centers of excellence in Missouri, North Carolina, and New Jersey to provide a quality, fast and responsive service. Our innovative analytical capabilities support drug product development and manufacturing for clinical trial supply and commercial programs, including analytical development and validation for small molecule; biotech, large molecule, analytical development and validation; physical chemistry and material characterization; stability storage and analysis and compendial raw materials testing. With 30 years of experience in analytical, biopharmaceutical and microbiological testing, Alcami can serve pharmaceutical ingredient, excipient or drug product challenges. Biopharmaceutical Development and Testing Supporting the growing number of biotechnology- derived therapeutic agents Alcami offers a broad range of biopharmaceutical analytical services to support the growing number of biotechnologyderived therapeutic agents. Our scientists are equipped with the technology and experience to support a wide variety of biopharmaceutical and biologic products, including proteins, antibodies, antibody drug conjugates (ADC) and nucleic acids (DNA, RNA or oligonucleotides). Capabilities: Extensive Range of Chromatographic Techniques (HPLC and UPLC with UV, PDA, RI, FL, ELSD, CAD, IC, Conductivity, Electrochemical Detection, GC and Headspace GC with FID, TCD, GC / MS and LC / MS / MS, MALDI, QTOF) ICP-MS, AA, Graphite Furnace, ELISA, KF, ckf, Oven ckf, UV, AAA, N-terminal Sequencing, X-Ray Diffraction, TGA, DSC, Particle Size Analysis (Malvern, Sympatec) Electrophoresis including CE-LIF, Sterility Isolators and a wide range of Dissolution capabilities. Bioassay, structure and sequencing, identity, carbohydrate analysis, and surface charge analysis.

5 Microbiology Committed to your product s safety, efficacy and timely project completion. At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective methodologies for developing our customers biologic and biopharmaceutical products. Alcami offers a full range of compendial, compliant microbiological testing per the USP, EP / PhEur, JP, BP: Water Activity Testing Microbial Identification by MicroSEQ (Genetic Sequencing) Disinfectant Qualification Studies including Direct Inoculation and Surface Methods Determining Suitability of Compendial Microbiological Methods (USP / Ph.Eur / JP Microbiology Testing, Full Monograph Testing of Pharmaceutical Water) Protocol Generation and Microbiological Method Development and Validation for Non-Compendial / Custom Methods Water System Testing and Environmental Validation Sterility Testing using Barrier Isolation Technology Microbial Enumeration Testing and Tests for Specified Microorganisms (Harmonized) Microbial Cleaning Validation Recovery Studies Antimicrobial Preservative Effectiveness Testing Turbidimetric and Cylinder Plate Assays for Antibiotic Potency and Residual Antibiotic Particulate Matter Testing by Light Obscuration and Microscopy Endotoxin testing by Gel-Clot, Chromogenic and Turbidimetric Techniques Microbial Identification by VITEK Strain typing by DiversiLab rep-pcr system Total Viable Spore Count, Purity, and Post-exposure Testing of Biological Indicators Container Closure Integrity Testing by Dye Immersion and Microbial Ingress Environmental Monitoring Support Equipment Qualification and Validation Support Cleaning Validation using Total Organic Carbon Analysis Stability Ready to fulfill stability storage and testing requirements. Whether a drug substance or final product is in development or already on the market, Alcami is ready to fulfill stability storage and testing requirements. We offer ICH, VICH and customized storage conditions so that all potential environmental and similar ambient conditions are evaluated accurately. With Multiple locations, Alcami can offer you the insurance that you need to ensure the safety and compliance for your stability study. Operational Environmental Stability Chambers Operating Setpoint Capacity (ft 3 ) 5 C C / 60%RH C / 40%RH C 5.94 klux & W/m 2 or 7.20 klux (ICH, Option 1 or 2) C / 15%RH C / 35%RH C C / 65%RH 2000 Open C / 75%RH C C C C C C / 75%RH 1100 Total 18,200 ft 3 Alcami conducts more than 600 successful stability studies a year in our stability facilities, operations that occupy 8,000 square feet and a chamber capacity of 18,200 cubic feet. We offer testing of controlled substances and potent compounds as well. Alcami s facilities and chambers are fully secured with 24/7 monitoring, process and system redundancies, backup power and comprehensive disaster recovery plans. Microbial Retention Filter Validation.

6 To meet client needs around the world, Alcami has state-of-the-art facilities at strategic locations in the United States and Europe. Alcami offers all phases of pharmaceutical development for small and large molecules through two laboratories located in Durham and Wilmington, North Carolina. These facilities have supported more than 500 investigational New Drug (IND) filings and over 50 NDAs, ANDAs and NADAs since Two cgmp API facilities in Germantown, Wisconsin and Weert, Netherlands support Alcami s process development / scale-up and clinical and commercial supply for customers worldwide. The Weert facility also serves as the company s Center of Excellence for Solid State Chemistry. Regional cgmp analytical laboratories in St. Louis, Missouri, Wilmington, North Carolina and Edison, New Jersey provide comprehensive analytical testing solutions for Alcami customer s new drug entities and biopharmaceuticals, as well as generic drugs, chemicals and animal health, and medicated consumer health products. Alcami s cgmp drug product manufacturing facilities support preclinical, clinical and commercial supply. Our Charleston, South Carolina facility is focused on processing parenteral products while the Wilmington, North Carolina facility is dedicated to solid oral dose manufacture. Both are fully integrated with Alcami s packaging and distribution center. GLOBAL HEADQUARTERS DEVELOPMENT SERVICES & ANALYTICAL TESTING 2320 Scientific Park Drive Wilmington, NC Tel: wilmington@alcaminow.com DEVELOPMENT SERVICES 4620 Creekstone Drive, Suite 200 Durham, NC Tel: , durham@alcaminow.com ANALYTICAL TESTING 165 Fieldcrest Avenue Edison, NJ Tel: , edison@alcaminow.com 6200 S. Lindbergh Boulevard St. Louis, MO Tel: , stlouis@alcaminow.com 08/2016