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Corporate Overview
Commercial 7/9/2020 rev 5.6
US Manufactured Premium Pharmaceutical Ingredients
Premium Pharmaceutical Ingredients, Manufactured by People who Care for People who Care
Corporate
BioSpectra rigorously upholds uncompromised standards because… “people matter”
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People Matter
ValuesQuality / Integrity / Respect
VisionA world with safe & effective drugs that deliver consistent, reliable therapeutic effect with every dose
MissionTo manufacture the highest quality Pharmaceutical ingredients under the supervision of the
most rigorous quality system while upholding the most stringent compliance standards
Premium Pharmaceutical Ingredients
GMP Custom Services:• GMP Product Development• Small Molecule Synthesis• Purification of Excipients• Scale-Up, Bench to Bulk• Regulatory Services
GMP Product Categories:• GMP Process Chemicals• Bulk Custom Solutions• Bulk Biological Buffers• Functional Excipients• Active Ingredients
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Exclusively Manufactured in the USA
Commitment to True GMP Products
TRUE GMPBSI does not simply test and package under a “GMP system”; rather, we always increase the quality and compliance levels through multiple steps of synthetic manufacturing and/or purification for all BioSpectra labeled products.
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Exclusively Manufactured in the USA
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Comprehensive Quality & Regulatory Program5
Global GMP Standards Meeting US-FDA, ICH Q7 & IPEC Guidelines Comprehensive Internal Auditing of all Manufacturing Processes Regulatory Services including Drug Master File Submissions FDA Process Validation for all GMP Manufacturing Systems Complete Testing of all Finished Manufactured Lots On-site Quality Control Labs Operating 24/7 Robust Preventive Maintenance Program State-of-the-art Instrumentation FDA Registered & Inspected Raw Materials:
– Qualified and Inspected Sources– 100% Authentic Traceability– Complete Testing
Comprehensive Quality & Regulatory Program6
Quality Assurance
GMP Facilities – Bangor and Stroudsburg PA, USA
Key Features• 175,000 square feet of Modern, GMP manufacturing
& storage
• FDA Registered & Inspected
• True US GMP Manufacturing
• Total Quality Program
• Rigorous Quality Assurance and Process Controls
• Manufacturing Systems designed according to FDA Guidance on Process Validation
• Exemplary Preventive Maintenance Program
• Dedicated USP Water Systems
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US Manufactured Premium, Bulk, GMP Fine Chemicals
• More than 20 GMP Manufacturing Suites with compliance levels ranging from IPEC to ICH Q7
• More than 30 Glass, 316-Stainless Steel and Composite Reactors
• Environmentally controlled Packaging Rooms
• Quality Control Labs with industry leading instrumentation
• Manufacturing Capabilities: Synthesis / Purification / Compounding
• Drying Systems: Spray / Fluid Bed / Rotary / Tray
• Particle Manipulation: Jet Milling / Air Sieve / Rotary & Ribbon Blender
8Key Equipment & Manufacturing Scale
US Manufactured Premium, Bulk, GMP Fine Chemicals
Scale & Capacity
Our Focus 9
1. Solving Key Ingredient IssuesSynthesis, Purity, Compliance & more…
2. Upgrading Your Supply ChainFacilitating the move to higher compliance
3. Full GMP Product DevelopmentAPIs, Excipients & Key Ingredients
US Manufactured Premium, Bulk, GMP Fine Chemicals
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Critical Manufacturing & Ingredient Issues: Inconsistencies from lot to lot / Insufficient purity levels / Contamination / Need for “real” GMP mfg. / Non-dedicated facilities / Incomplete testing & Documentation deficiencies / Absence of true traceability / High Microbial & Endotoxin levels / Recalled or scrap product / Need for custom specifications / Need for higher levels of quality and compliance
Supply Chain Security Issues: Availability / Reliability & trustworthiness / Distance / Safety stock / Manufacturing interruptions / Authentic chain of custody
Regulatory Issues: IPEC, ICH, GMP, FDA, EMA Compliance issues / Need for global specifications / Need for true validated manufacturing processes / Requirement for a higher compliant raw material
Mitigation Experts11
SOLUTION• True GMP Process• Actual Purification• Dedicated Facilities• Base Synthesis of raw materials• US Manufactured GMP Products• True Quality-Based Manufacturing• Total Quality Program: QC / QA / Regulatory • 100% Reliable Traceability of all raw materials• Proven record of adherence to GMP, IPEC, ICH
Guidelines
BioSpectra represents consistent high quality, uniformly manufactured pharmaceutical ingredients.
Exclusively made in the USA and always synthesized, purified or compounded under true GMP standards.
Always manufactured at the appropriate specifications and compliance levels for the intended use in the final drug product.
Product Grades & Compliance Levels
• Bio Active & LBLE* Active • Bio Excipient & LBLE* Excipient• Bio Pharma (Intended use: GMP Process)
*Note: LBLE = Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.
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US Manufactured Premium, Bulk, GMP Fine Chemicals
• cGMP (US-GMP)• IPEC (International GMP)• FDA Registration / Inspection• Internal Controls and Systems• ICH Q7 & other applicable USP & ICH standards
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US Manufactured Premium, Bulk, GMP Fine Chemicals
Galactose, GMP, Excipient Grade– Low Bioburden, Low Endotoxin (LBLE), Low Elemental Impurities (LEI), MulticompendialGuanidine HCl, GMP, Pharma Process & Excipient GradesGuanidine HCl, 6M Solution, Pharma Process & Excipient Grades Guanidine Thiocyanate, GMP, Pharma Process Grade, Bio Ultra Diagnostic Grade HEPES Free Acid, GMP, Pharma Process, Bio Ultra Reagent and Excipient GradesHEPES Sodium- GMP, Pharma Process, Bio Ultra Reagent GradeHCl in IPA (6N) – GMP, Pharma Process GradeL-Cystine Dihydrochloride – GMP, Pharma Process GradeMES Monohydrate - GMP, Pharma Process, Bio Ultra Reagent and Excipient GradesMES Sodium – Bio Ultra Reagent, Low Water Bio Ultra Reagent Grade.MOPS Free Acid, GMP, Pharma Process and Excipient GradesPotassium Bromide (KBr) – GMP, API GradeSodium Chloride 5N, GMP, Sterile Filtered, made with WFI, BPC, Excipient Grade Sodium Decanoate, GMP, Functional Excipient for Parenteral ApplicationsSodium Hydroxide 10N, GMP, <5 ppm Cl, made with WFI, BET TestedSodium Hydroxide, 25%, 5N, 2N, 1N, 0.5N, 0.1N: GMP, made with WFI, Low ChlorideSucrose – GMP, Excipient Grade– Low Bioburden, Low Endotoxin (LBLE), Low Elemental Impurities (LEI), MulticompendialTrehalose – GMP, Excipient Grade– Low Bioburden, Low Endotoxin, (LBLE), Low Elemental Impurities (LEI) -MulticompendialTRIS HCl, GMP, Pharma Process, Excipient, LBLE GradesTRIS/Tromethamine, GMP, Pharma Process, Excipient, LBLE and API Grades -MulticompendialUracil, GMP, Pharma Process GradeUrea, GMP, Pharma Process, Excipient, LBLE and API Grade - Multicompendial
Summary List of Products
GMP Bulk Solutions for Bio Production14
GMP Sodium Hydroxide Solutions (NaOH)15
Custom GMP Manufacturing16
Custom GMP Manufacturing (In-House) 17
API Contract Development & Manufacturing 18
GMP Support Package 19
Parenteral Drug Ingredients20
Final Word
Are struggling to solve their critical ingredient issues that falls within our scope of chemistry & capabilities
Realize the need for higher-purity, higher-compliance Pharmaceutical Ingredients
Understand the value of US manufactured, true-GMP APIs, Excipients and Key Ingredients
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We Seek To Service Customers Who
BioSpectra: Your Partner for Purity, Regulatory Compliance and GMP Product Development
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Jamie StormSales Support SupervisorOffice: +1.610.599.3486Email: [email protected] Focus Areas: Sales & Marketing Support Supervisor, Customer Technical Requests, Order Fulfillment Backup.
Alissa LedergerberSales/Marketing SpecialistOffice: +1.610.599.3402Email: [email protected] Focus Areas: Sales & Marketing Support Specialist.
Connie AugustineDirector, Business DevelopmentOffice:+1.610.599.3428Email: [email protected] Focus Areas: Internal Business Development, Internal Project Liaison (Oversight and Fulfillment), Customer Service.
Kimberlee AceCustomer Service SupervisorOffice: +1.610.599.3426Email: [email protected] Focus Areas: Customer Service Supervisor, Order Entry & Fulfillment, Logistics.
Veronica ForshawCustomer Service SpecialistOffice: +1.610.599.3425Email: [email protected] Focus Areas: Order Entry & Fulfillment, Customer Service Support.
Carly GabaSales Support SpecialistOffice: +1.610.599.3429Email: [email protected] Focus Areas: Sales Support.
The BioSpectra Commercial TeamPaul DiMarcoVice President, Sales & MarketingOffice: +1.610.599.3477Mobile: +1.610.442.0341Email: [email protected] Focus Areas: External Business Development, External Technical Liaison, Global Commercial Program Management, Internal Project Integration
