DPT & Confab - DPT Laboratories
DPT & ConfabDiscover the DifferenceSM
Who we are DPT and Confab are Contract Development andManufacturing Organizations (CDMO) We provide comprehensive pharmaceuticaldevelopment and manufacturing services We specialize in:– Semi-solids (Sterile & Non-sterile)– Liquids (Sterile & Non-sterile)– Solid dose We have operations in the USA and Canada.12/17/2014DPT Laboratories, Ltd. proprietary and confidential2
Our History1938Founded as Texas Pharmacal Company1966Acquired by Warner-Lambert1979Acquired by AlconContract manufacturing begins at San Antonio siteAlcon changes the name to Dermatological Products of Texas1990Acquired by DFB Pharmaceuticals2001Lakewood, NJ site acquired from West Pharmaceutical Services2006New, state-of-the-art 40,000 ft2 Center of Excellence for Research &Development opens2008 50 million facility expansion and enhancement plan begins2010DPT launches expanded sterile development and manufacturingcapabilities2012Acquired by Renaissance Acquisition Holdings2013DPT/Confab alignment
Customers Emerging companies with diverse funding & business models Global pharma Specialty pharma Consumer healthcare Animal health Biotechnology
Combined Dosage Form CapabilitiesCapabilitiesDPTDPTConfabSan Antonio Lakewood MontrealDevelopment ServicesSterile Manufacturing ServicesInjectablesOphthalmicsNasal SpraysOintmentsAdvantages Non-Sterile Manufacturing ServicesAerosol foams & SpraysRectal/Vaginal sions Broader range of servicesComplimentary manufacturing capabilitiesExpertise in product development, techtransfer & scale upAbility to manufacture a wide range ofproducts across multiple dosage formsWorld-wide distribution
OperationsDPT & Confab operate four locations in the USand CanadaSan Antonio, TXLakewood, NJSan Antonio, TX12/17/2014DPT Laboratories, Ltd. proprietary and confidentialMontreal, QC6
San Antonio, TXResearch & Development End to end pharmaceuticaldevelopment services The expertise of over 50 world-classscientists Coordinated activities with engineersand technicians throughout DPT 40,000 ft2 of lab space
Development ExpertiseFormulationsRoute of ginal
Development Services Small molecules, proteins & peptides Large molecule Pre-formulation & Formulation Analytical development and validation Process development and validation Stability studies: ICH and custom Clinical trial material manufacturing Testing services for nasal products Regulatory submission support In vitro release testing (IVRT) QbD Services– Formulation– Process Development– Scale-up
Packaging Services Identification & sourcing services Specification development Dose volume evaluation Drug/package compatibility Container/closure compatibility Commercial scale fill and finish assessment Equipment sourcing, design, engineering, qualification and validation
San Antonio, TXSemi-solids & Liquids Manufacturing Manufacturing solutions for semi-solid& liquid dosage forms Clinical & Commercial scale 650 employees On-site QC and Micro labs 450,000 ft2 of infrastructure
cGMP Compounding Capabilities Pilot, clinical, and commercial scale Batching flexibility from 0.3 kg - 25,000 kg Controlled substances Schedule II – V XP rated compounding suites Lighting options for light-sensitive materials Advanced air filtration and handling Nitrogen/inert gas blanketing Direct to line packaging
Filling & Finishing Capabilities Advanced barrier systems Airless pumps Aluminum canisters Applicators Bottles Jars Laminate tubes Metal tubes Metered dose pumps Large format syringe
Quality and Regulatory HistoryOur commitment to quality – ensuring your products meet the highestquality standards Over 42* audits completed in 2013 Weekly audits by: FDA, DEA, & EMA EHS inspections Customers*Semi-solids & Liquids facility, San Antonio, TX.
Lakewood, NJSterile & Specialty Product Manufacturing Aseptic manufacturing solutions forsterile dosage forms 250 employees On-site QC and Micro Labs 180,000 ft2 of infrastructure
Lakewood, NJSterile & Specialty 180,000 ft2 of manufacturing, laboratory, and support infrastructure 5 Grade A aseptic filling suites SVP MAC Ophthalmic solution Multi-Dose nasal Ointment / Gel Ointment suite 4 Grade C filling suites 7 classified processing and support suites including XP rated compounding suite DEA, Class I-V
Filling Capabilities Micro-dose Vials Multi-dose pumps Tubes Ophthalmic Solutions Otic Solutions Vials (MAC)
Laboratory ServicesMicro – Analytical – Biotech Environmental Monitoring for Classified areas Sterility testing using an isolator system In-house microbial identification Media prep lab with autoclave In-house test method validation Microbial limit testing (MLT) Antimicrobial effectiveness testing (AET) Biotech Assays
SVP Capabilities 5,000 ft2 of newly constructedmanufacturing area–12/17/2014DPT Laboratories, Ltd. proprietary and confidential19Consists of Grade D, C & Bclassified zone Modular construction – veryflexible and cleanable Designed with future expansionin mind
IMA Washer and Depyrogenation Tunnel Vial washer & depyrogenation tunnelin Grade D zone
IMA Filler Grade B- In room Grade A- Insidefiller enclosure(RABS)
Quality and Regulatory HistoryOur commitment to quality – ensuring your products meet the highestquality standards Over 21* audits completed in 2013 Weekly audits by: FDA, DEA, & EMA EHS inspections Customers*Sterile & Specialty Products facility, Lakewood, NJ
140,000 square feet facility 400 highly trained and experiencedemployeesMontreal12/17/201423 36 manufacturing suites 18 packaging suites Narcotic license (vault level 10)
Product Categories OTCDrug identification productsNDAANDANutraceuticalsVeterinary products12/17/2014DPT Laboratories, Ltd. proprietary and confidential24
Solid Dose Manufacturing & Packaging Powder MixingStandard GranulationHigh Shear GranulationPowder CompactionTableting – (regular, double core, double layer)Tablet CoatingEncapsulation –(capsule-into-capsule)Tablet PrintingBlistering
Liquid Manufacturing & Packaging nsSuppositories –aluminum & plastic shellPlastic unit-doseMetal & plastic tube fillingJarsBottles
Development Services Formulation Re-engineering of manufacturing & packaging Technical transfers- manufacturing & packaging
Compliance Health Canada FDA EMAMutual Recognition Agreement - between Canada &17 countries in Europe. No need for inspection.No need for product retesting
Contact Uswww.dptlabs.com1-866-225-537812/17/2014DPT Laboratories, Ltd. proprietary and confidential29
DPT/Confab alignment 1938 1966 1979 1990 2001 2006 2008 2010 2012 2013 . . 40,000 ft2 of lab space . Development Expertise Formulations Route of Administration Aerosols Nasal Creams Ophthalmic Emulsions Oral Extrusions Paren
Slippery Rock University of Pennsylvania DPT 216038 51.2308 Temple University DPT 216339 51.2308 Thomas Jefferson University DPT 216366 51.2308 University of Pittsburgh DPT 215293 51.2308 . Proposed Stevenson University DPT Program . DPTE 511 Basic Sciences I provides a study of the morphology of the human body including the macroanatomy (gross
Expectations associated with the WKU DPT Program. The information contained within this manual is intended to provide information and guidelines for decisionmaking by all pa- rties associated with the WKU DPT clinical education program. This manual is intended to supplement the following: WKU University Handbook, WKU DPT Student Manual, and .
in the DPT program. Students are referred to the DPT Clinical Education Handbook for policies and procedures related to the Clinical Education program. The policies are not intended to be unduly restrictive; rather, they are intended to protect and make explicit student rights and responsibilities, and to insure that DPT program
of the WKU Student Handbook. Additionally, the DPT Program Student Manual provides information regarding policies, procedures, and requirements specific to the WKU DPT Program. Student enrolled int eh DPT Program are expected to be familiar with the information in this Manual, the Clinical Education Manual, and acknowledge such by signing the
Kaizen Events in Your Lab and Hospital Leslie Sprick Managing Partner Sprick, Stegall & Associates, LLC www.sprickstegall.com Lab Quality Confab 2011: 2 Email from Lean Client: Post Kaizen Event Dear Leslie, Our LEAN project has significantly improved our TAT, work flow and physician satisfaction. After a year and major cross training,
Lab Quality Confab Meeting– Educational speaker Product/brand awareness advertising White Paper – ROI focus Webinar – Ongoing customer education Webcast Showcase – New features/extensions Executive War College – Educational speaker Lab Quality Confab
2015 Network Learning Confab and Member Meeting Inspire, Mobilize, Transform Thursday, June 25th . and the new “Quality of Life” framework . Learning Lab Lunch Tap into
using Scrum for agile software project management in a university environment. The paper is divided into three parts. In the first part an overview of the Scrum method is given. In the second part .
