VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive...

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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

Transcript of VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive...

Page 1: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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

Page 2: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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.

Page 3: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 4: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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

Page 5: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

Commercial Packaging & Labelling

• Primary Packaging

– Bottles, Jars & Tubs

– Bottling lines for solid dose products:

• Tablets

• Capsules

• Soft gels

Page 6: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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)

Page 7: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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

Page 8: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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.

Page 9: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 10: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 11: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 12: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 13: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• Topicals

– Gels, Creams, Ointments, Lotions

• Dispersed Systems

– Emulsions & Suspensions

• Liquids/Solutions

– Oral & Sterile/Ophthalmic

• Transdermal

Commercial Manufacturing Services

Page 14: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 15: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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

Page 16: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• 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

Page 17: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

• Ophthalmic/Otic Capabilities

– Sterilization:

• Steam/Terminal

• Aseptic Filtration

– Dosage Forms:

• Ointment

• Solutions

• Suspensions

Commercial Manufacturing Services

Page 18: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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

Page 19: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

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

Page 20: VxP Commercial Services COM-A 2017...VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 Commercial Services: Manufacturing,

THANK YOU

For additional information:

VxP Pharmawww.vxppharma.com

Phone: 317.759.2299

Email: [email protected]