VxP Commercial Services COM-A 2017 · VxP Pharma Purdue Research Park 5225 Exploration Drive...
Transcript of VxP Commercial Services COM-A 2017 · VxP Pharma Purdue Research Park 5225 Exploration Drive...
VxP Pharma
Purdue Research Park
5225 Exploration Drive
Indianapolis, IN 46241
Tel: 317.759.2299
Fax: 317.713.2950
Commercial Services: Manufacturing, Packaging and
Dedicated Storage Facilities
VxP Pharma Services provides product
development, scale–up and manufacturing services
as well as sterile fill finish capabilities to the global
pharmaceutical and biopharmaceutical markets.
• Commercial Packaging and Labellingo Primary Packaging - Blisters, Bottles, Sachets/Pouches
o Secondary Packaging – Wallets, Cartons, Dosepacks
o Biopharmaceutical Labelling and Packaging – Vials, Ampules, Syringes
• Commercial Manufacturingo Technology Transfer
o Commercial API
o Solid Dose Manufacturing
� Tablets, Capsules, Powders
o Sterile Fill Manufacturing
� Parenterals, Adjuvants, Biologics
o Topical Manufacturing
� Creams, Lotions, Ointments
o Dedicated Facilities
� Oral Solid & Topical
� Aseptic Products
Commercial Services Overview
Commercial Packaging & Labelling
• Overview
– Over 30 years commercial manufacturing and packaging
experience from our US-FDA approved facilities
– State of the art high speed equipment
• Blisters
• Bottles
• Vials
• Sachets
• Wallets
• Biopharmaceutical labelling/packaging
Commercial Packaging & Labelling
• Primary Packaging
– Bottles, Jars & Tubs
– Bottling lines for solid dose products:
• Tablets
• Capsules
• Soft gels
Commercial Packaging & Labelling
• Primary Packaging (continued)
– Blisters:
• Thermoform: Aclar, PVC, PVdC
• Coldform: Alu/Alu
• Lidding Foils: Alu/Paper
– Sterile Products:
• Vials: Traditional, Lyophilized
• Ampules: Glass (5mL/15mL)
• Syringes: Luer lock, Slip tip
• Bottles: BTC (Ophthalmic)
Commercial Packaging & Labelling
• Secondary Labelling & Packaging
– Cartons
– Wallets/Dose packs
– Complex Kit Assembly
• Medication kits
• Diagnostic kits
• Sample kits
• Patient Information & marketing packs
– Biopharmaceutical Labelling & Packaging
• Vial Cartons
• Ampule Cartons
• Syringe Trays & Tubs
Commercial Manufacturing Services
• Overview
– Experience with manufacturing and packaging solid oral
dosage forms (tablets, capsules & powders) for over 30
years.
– Wide range of processing equipment
• State of the art equipment list
• Provides flexibility to match batch size needed
• Blend sizes up to 2.5 tons
– Through comprehensive SOP’s, rigorous training and a range of
process controls we ensure that all products meet your
specifications.
* We are licensed to process/store all schedules of Controlled Drugs.
• Technology Transfer
– We work with our client partners to carefully plan and
ensure a successful technology transfer.
– We establish high-level timelines for deliverables and define
team roles and responsibilities to ensure that the
technology transfer process is simple, clear and as defined
as possible.
– Our technology transfer approach ensures delivery of a
consistent process that is:
• Consistent & repeatable
• Robust packaging
• Delivering the highest quality product
Commercial Manufacturing Services
• Commercial API
– From raw material sourcing to distributed drug product we
provide a total supply chain for your drug product.
• Small molecules
• Peptides and proteins
• Quantities: from Gram to Multi-ton scale
– Our experienced process chemists rigorously develop and
challenge the processes, evaluate process controls, identify
impurities, and determine their purge and fate
characteristics.
Commercial Manufacturing Services
• Facilities
– We have a range of facilities delivering Grams to Multi-ton scale
intermediates and API for clinical and commercial requirements.
• Large Scale API Manufacturing Facilities
• Kilo Labs for Rapid Delivery of First-In-Human Supplies
• Contained Facilities for the Manufacture of Potent and Cytotoxic Compounds
• Class 10,000 Facilities for the Manufacture and Purification of Peptides
• Chromatographic Equipment for Rapid Purification
• Micronization Equipment
– Commercial-scale Aseptic and Ophthalmic manufacturing areas
for ointments and sterile liquids
Commercial Manufacturing Services
• Oral Dose Manufacturing
– Tablets
• Immediate and Modified Release
• Uncoated and Coated (including Enteric coating)
• Tab-in-Tab
• Bi-Layer
– Capsules
• Hard Gelatin Capsules
• Soft gels
– Powders
• Granules
• Oral powders for reconstitution
• Operating equipment at
various scales allows us to
match our capabilities to your
processing requirements.
• Coupled to our development
capabilities we have a rich
understanding of scalability
and process parameters.
Commercial Manufacturing Services
• Topicals
– Gels, Creams, Ointments, Lotions
• Dispersed Systems
– Emulsions & Suspensions
• Liquids/Solutions
– Oral & Sterile/Ophthalmic
• Transdermal
Commercial Manufacturing Services
• Specialized Dosage Forms
– Our team can effectively manufacturing a number of
specialized pharmaceutical dosage forms at commercial-
scale volume including:
• Mini Tabs
• Controlled Release Sprinkles
• Hot Melt used in High Shear Granulation
• Wax Matrix
• Chewable Controlled Release
Commercial Manufacturing Services
Commercial Manufacturing Services
• Sterile Fill
– Equipment for Aseptic Products:
• 5mL – 15mL Aseptic Filling (Solutions and Suspensions)
• 1g – 5g Ointment Filling
• Liquid Processing Equipment (50L – 500L)
• Unipac Silver 80 Ointment Filler (90 units/minute)
• Chase Logemann Monobloc (60 units/minute)
• Unit Dose Filler (1mL – 5mL)
* Contact us today for a current Equipment List
• Sterile Fill
– With significant experience in processing high value,
temperature sensitive sterile products, we can perform
secondary labelling and packaging for a range of
biopharmaceutical presentations including:
• Vials – Traditional & Lyophilized
• Ampules – Glass (5/15mL)
• Syringes – Luer lock & Slip tip
• Bottles – Bottle/Tip/Cap (BTC)
Commercial Manufacturing Services
• Ophthalmic/Otic Capabilities
– Sterilization:
• Steam/Terminal
• Aseptic Filtration
– Dosage Forms:
• Ointment
• Solutions
• Suspensions
Commercial Manufacturing Services
Dedicated Facilities: Storage & Distribution
• We have extensive separate storage facilities for:
– API
– Raw Materials
– Finished Goods
• Once your order has been received and processed, we can
efficiently and cost-effectively distribute your drug product:
– In a suitable shipping container
– Utilizing temperature controlled vehicles/shipping systems
– With data recording/tracking systems
– We can ensure that your drug product is delivered on time
Product Launch & Distribution
• From labelling and packaging to end-user distribution, we
ensure supply of your drug product to the global market, from
launch into commercial supply.
• Providing end-to-end management of drug product supply, we
can tailor the following Commercial Support Services to your
needs:
– Product Launch Consulting Services
– Global Import Testing & QP Market Release
– Order Processing & Financial Services
– Distribution Services
THANK YOU
For additional information:
VxP Pharmawww.vxppharma.com
Phone: 317.759.2299
Email: [email protected]