CHARLESTON, SC OVERVIEW

Alcami Company Overview Connected at every level.2 Over 800 employees across seven sites in North America and Europe ~740,000 square feet of laboratory and production space State-of-the-art technology and infrastructure Outstanding compliance record with the FDA, HPB, MHRA, and EMA QP audited for drug product distribution outside the United States DEA compliant for controlled substance development, testing and finished dosage form manufacturing Electronic Laboratory Notebooks (ELN) operational in NC, NJ & MO

Balanced strength across three business units Connected at every level.3 Germantown, WI Weert, Netherlands Edison, NJ St. Louis, MO Wilmington, NC Durham, NC Germantown, WI Weert, Netherlands Wilmington, NC Charleston, SC

Our Businesses Connected at every level. 4 API Small Molecule Development & Production Drug Product Sterile & Oral Production Analytical Testing & Development Services Abuse Deterrent Studies Disinfectant Studies Biotech Services Filter Validation MicroSeq™ Solid State Chemistry Extractable/ Leachable Controlled Substances Potent Compounds Environmental Monitoring Antibiotics Packaging Serialization

API Development and Manufacturing Connected at every level. 5 Route SelectionSolid State ChemistryProcess Chemistry Advanced Chemical Intermediates Active Pharmaceutical Ingredients Pre-Clinical Through Commercial Germantown, WI & Weert, the Netherlands

Drug Product Manufacturing – Solid Oral Dose Connected at every level. 6 Wilmington, NC Over-Encapsulation Film Coating 2kg – 120kg Roller Compaction 5kg-100kg Wet Granulation 6kg-100kg Pediatric Tablets Xcelodose R600S Autodose TM Comparator Blinding Blends 1kg-650kg Capsules- Powder Blend & Granulation, Size 00-4 Tablets- Immediate, Modified Release, Coated

Drug Product Manufacturing - Parenteral Connected at every level. 7 Liquid Fills of Solvent-Based Formulations 2mL-50mL vials Batch Size ,000 vials Solutions, Emulsions, Suspensions and Homogenization (including Micro fluidization Capacity L) Lyophilized Formulations Pre-Filled Syringes (Coming Soon) Charleston, SC

Connected at every level.8 Alcami is a leading contract development and manufacturing organization (CDMO) with expanded capabilities and capacity providing an integrated offering for both drug substance and drug product at every development stage beginning with solid state chemistry and formulation development. Company Overview

Type of Products Connected at every level.9 The Charleston facility manufactures: Contract Manufacturer of sterile injectable products Development, clinical and small scale commercial batches. Includes small molecules, biologics, proteins, and controlled substances. Processes employed include aseptic processing, terminal sterilization and lyophilization.

Charleston, SC Facility Connected at every level.10 The manufacturing areas consist of a series of specialized and general-purpose rooms divided into controlled areas: – Grade A and Grade B areas (ISO Class 4.8/5) Line 1 Filling (M128), Line 1 Capping (M126), Line 1 Sterilized Component Staging (M124) Line 2 Filling (M107) & Component Cool Down (M110) – provided with 100% HEPA coverage and separate, dedicated air handlers – Grade C (ISO Class 7) Compounding (M120, M107), Component Preparation (M115,M121, M133), Microfluidization (M107/M120), Sampling / Dispensing (M143) – Grade D (ISO Class 8) Equipment Washing (M116) and Change Rooms – Controlled Room Temperature Warehouse area

Equipment – Vial Washers Connected at every level.11 Vial washers: each vial that is filled is individually washed with hot WFI (internally and externally). This process is validated to ensure that the glass vials are chemically clean 2 options – Cozzoli (pictured) and Penn Tech Rotary.

Equipment – Depyrogenation Ovens Connected at every level.12 After vials are washed, they are treated in a forced hot air oven at 250 o C to ensure the destruction of endotoxins. The process is validated with thermocouples and endotoxin carriers and ensures the reduction of at least 3 logs of endotoxin. (Annual requalification schedule). The hot recirculating air is filtered through HEPA filters to maintain low particulate levels during the depyrogenation process. These filters are also recertified every 6 months. Double door pass through design

Equipment – Sterilizers Connected at every level.13 The Finn Aqua and BMT sterilizers have been qualified for standard loading patterns via thermocouple mapping and use of Biological Indicators to ensure a Sterility Assurance Level of The sterilizers are re-qualified annually The sterilizer employs a “double door pass through” style design, such that sterilized items can be unloaded directly into the Grade B area.

Processes Connected at every level.14 Aseptic manufacture and filling: For this and all of the above processes, the bulk product is sterilized by bulk filtration using 0.22µ filters (2 in series is standard). All units are handled by operations personnel in an aseptic manner to prevent contamination of the sterile-filtered product. After filling and stoppering, the vials are transferred and capped/over sealed, also in a Grade B (Grade A at rest) environment.

Processes Connected at every level.15 Terminal Sterilization: After the product is filled, stoppered and sealed with an aluminum overseal, the trayed vials are loaded into an autoclave. Terminal sterilization uses WFI that is recirculated in the sterilization chamber at a setpoint of 122.2C +/- 1.0C in general. The actual cycle used is product specific and validated for that product. Each product formulation must be validated separately. Alcami employs thermocouples for monitoring and Biological Indicators for engineering or clinical products where validation is not yet performed or not required.

Process Connected at every level.16 Visual Inspection All filled vials are 100% inspected in Inspection Booths for visual defects in the container/closure system and visible particulates in the product. The booths employ the use of 2000 – 3750 lux lighting, reflecting off an alternating background of white and black. Lighting is verified daily per USP. All employees that perform inspection (including QA) must undergo an annual physical eye examination. Operators are challenged annually with NIST traceable particulates.

Other Processes – Gowning and Traffic Patterns Connected at every level.17 Gowning and Traffic Patterns: All personnel adhere to gowning requirements prior to entering the manufacturing areas and follow specified traffic patterns. Transition zones are employed between areas of increasing cleanliness and require additional garments as necessary Persons qualified for aseptic gowning must re-qualify annually and must participate in at least one successful Aseptic Process Simulation annually.

Alcami Positions Scientists Chemists Biologists Microbiologists Engineers Chemical R&D Engineers Process Engineers Validation Engineers Facility Engineers Instrument Engineers Project Managers Connected at every level.18 Quality Specialists Quality Control Quality Assurance Regulatory Compliance Technicians Laboratory Technicians Manufacturing Technicians Material Control Technicians Visual Inspectors Safety Specialists

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