Contract Development and Manufacturing

Overview

With over seven decades of experience, Mission has mastered the equilibrium of expertise and efficiency. Our mid-sized advantage allows flexibility, responsiveness, and unmatched support in executing your vision while providing a wide range of services for products at any stage of their life cycle.

Using the latest equipment, Mission manufactures high-quality prescription, over-the-counter products and medical devices in our FDA-registered, GMP facility. Our 275,000+ sq. ft. facility has the capacity for both small and large scale production and is located on our expansive Boerne, Texas campus. No matter the size and scope of your project, our experienced team will create a custom package to meet your individual needs and exceed expectations.

For partnership inquiries, please contact us at [email protected]

Analytical Services

Mission Pharmacal offers a wide range of analytical services to accommodate the diverse portfolio of testing required by the multitude of products we manufacture. In addition, our laboratory abides by current Good Manufacturing Practices (cGMP). Mission’s dedicated analysts work diligently to provide in-process manufacturing testing support, close quality investigations, and aid development operations in technical transfer activities. With the assistance of our analytical services group, Mission has the ability to not only maintain and excel in current quality and product partnerships, but also embrace new development and commercial growth.

Analytical Services offered:

  • Method transfer
  • Cleaning validation/verification
  • ICH stability testing and storage
  • USP/NF testing
  • Release testing

Analytical Instrumentation/Capabilities:

  • GC (FID and headspace)
  • HPLC (PDA/dual wavelength detectors)
  • UPLC
  • Ion chromatograph
  • Atomic absorption spectrophotometer
  • UV/VIS spectrophotometer
  • Franz cell (IVRT)
  • Dissolution (USP type 1 and 2)
  • FTIR
  • ICP mass spec
  • Laser particle size analyzer
  • TOC
  • Osmometer

Development

Mission’s vigorous development activities coupled with strategic partnerships enable us to deliver novel healthcare solutions. Our formulators and analytical chemists can develop solid oral dosage forms, topical semi-solids, and topical and oral liquids. Our pharmaceutical technical transfer specialists work to scale up and commercialize pharmaceutical products that help treat or prevent life-diminishing medical conditions. Their work has yielded a strong, benefits-focused, diverse product portfolio. We are supporting multiple Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDA) currently in development to meet growing consumer demand for high-quality, American-made generic drugs.

Development Services offered:

  • Analytical method development and validation
  • Pre-formulation studies
  • Product formulation
  • Clinical supply manufacturing

Regulatory Support

Mission Pharmacal not only provides manufacturing, analytical, and development support, but also regulatory support. Mission offers an array of regulatory services and prides themselves on their years’ worth of experience in nurturing multiple Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDA). From the development phase to commercialization phase, Mission is capable of delivering regulatory assistance to partners in all areas of the pharmaceutical industry.

Regulatory Services offered:

  • Regulatory strategy support
  • Regulatory agency meetings
  • Document quality review
  • Regulatory electronic submission preparation and publishing services
  • Electronic (eCTD) submissions via ESG
  • Labeling strategy and target product profiles
  • Licensing services
  • CMC strategy and authoring
  • Advertising and promotional material review/OPDP submissions
  • Pharmacovigilance services

Manufacturing

Mission Pharmacal’s advanced pharmaceutical facility features 275,000+ square feet of space. Using the latest high-capacity equipment, we manufacture gels, liquids, creams, and tablets. We meticulously maintain this environmentally controlled, highly secured facility on our expansive Boerne, Texas campus. We also strictly adhere to current Good Manufacturing Practice (cGMP) regulations enforced by the U.S. Food and Drug Administration (FDA). We manufacture a variety of products and offer our leading-edge capabilities and technologies to other companies through select partnership agreements. Offering a full range of contract services and over seven decades of manufacturing experience, Mission is the ideal partner for both U.S. and international pharmaceutical companies.

Technical Services offered:

  • Process development and optimization
  • Technology transfer
  • Scale-up

Semi-Solid (Topical) and Liquid (Topical and Oral) Capabilities:

  • High-shear mixing
  • Heating and cooling-capable jacketed vessels

Tablet Capabilities:

  • High-shear and fluid-bed granulation
  • Direct compression
  • Aqueous and organic coating
  • Immediate and controlled release
  • Blending
  • Milling
  • Particle sizing
  • Co-melts

Packaging

Mission offers a full spectrum of packaging capabilities to our partners. Separate environmentally-controlled suites house each packaging line to prevent cross-contamination and protect process integrity and quality.

Mission’s warehousing facilities provide secure, temperature and humidity-controlled environments for storage of raw materials, packaging components, and finished goods. We provide total turnkey component and product inventory sourcing and management with electronic data interchange (EDI) capabilities.

DSCSA compliant (serialization) and Unique Device Identification (UDI) Capabilities:

  • Bottle filling (tablets, semi-solids, and liquids)
  • Tube filling
  • Jar filling
  • Blister packaging
  • Sachets (tablets and semi-solids)
  • Cartoning
  • Tray packing

We are a Verified-Accredited Wholesale Distributor (VAWD), which is an accreditation for pharmaceutical wholesale distribution facilities. Those wholesale distributors that achieve accreditation are in compliance with state and federal laws and NABP's VAWD criteria and proudly display the VAWD Seal.

VAWD accreditation plays a pivotal role in preventing counterfeit drugs from entering the United States drug supply – it helps protect the public from drugs that have been contaminated, diverted, or counterfeited. The U.S. supply of prescription drugs is produced and delivered to patients via a complex distribution path, and VAWD accreditation helps ensure that the wholesale distribution facility operates legitimately, is licensed in good standing, and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions.

Wholesale distributors that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo a site survey every three years.