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TPP CDMO

TPP CDMO: Key Points & Capabilities

TPP CDMO San Diego LLC: Re-shoring of drug manufacturing back to the United States.

US-Based CDMO Highlights:

- Inspected 4 times since 2012

- Passed FDA general GMP inspection (01/2023)

- VAI Status

Key Manufacturing Equipment:

- Sterile formulation mixer

- Automated vial filler

- Freeze-dryer for lyophilization of products

- Milling & blending

- Compression & encapsulation

- Spray & rotary granulation

- Particle & bead coating

Formulation & Product Development: 

- Physical characterization & excipient compatibility

- Dosage form design & solubility assessment

- Process design, optimization, and scale-up

- Technology transfer & manufacturing readiness

Capabilities

TPP Tech's facility is located in San Diego, CA.
The facility's potency capabilities: Up to Category 3A CDMO Footprint, 24,400 square feet.
DEA Controlled Substance Registrations:

  • Manufacturer: Schedule IIN, IV, V, List I

  • Analytical Lab: Schedules II, IV, V, List I

Specializations: Sterile product manufacturer, solutions in vials, lyophilization, implants (compressed and molded), liposomes, micro and nano particulate suspension, liquid filled hard gelatin capsules, modified release technology, phase-appropriate formulation and analytical development, complex formulations, and controlled substances

U.S. Based Manufacturing

TPP’s subsidiary, Contract Development and Manufacturing Organization— Societal CDMO San Diego. It specializes in the production of seven dosage forms, including Sterile Injectables, Sterile Ophthalmic Drops, Tablets, Capsules, Oral Liquids, Non-Sterile Liquid Syringes, and non-sterile Liquid Powder Syringes.

Comprehensive Capabilities

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The Societal CDMO San Diego

Pharmaceutical Development Capabilities

Societal San Diego CDMO is a US-based pharmaceutical contract development and manufacturing organization (CDMO) that can support your product from the early stages of chemistry, manufacturing, and controls (CMC) development to its first commercial launch and beyond. Our friendly and professional teams enable you to connect directly with project managers and actual pharmaceutical scientists working on your. We are dedicated to helping you navigate the intricate landscape of science, development, logistics, and regulations to ensure your pharmaceuticals are successfully approved and delivered to your patients.

Formulation & Product Development

Our expertise spans a wide range of complex dosage forms, supported by full laboratory capabilities that often lead to intellectual property (IP) generation.

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Key services include:

  • Physical Characterization & Excipient Compatibility

  • Dosage Form Design & Solubility Assessment

  • Process Design, Optimization, and Scale-Up

  • Technology Transfer & Manufacturing Readiness

Manufacturing Excellence

We provide end-to-end manufacturing solutions, from early-phase clinical batches to full-scale commercial production. Our structured technology transfer, quality control, and assurance teams ensure seamless oversight of drug manufacturing.

 

Key Capabilities include:

  • Milling & Blending

  • Compression & Encapsulation

  • Spray & Rotary Granulation

  • Particle & Bead Coating

Clinical cGMP Manufacturing & Packaging

Partnered with numerous pharmaceutical and biotech companies across the globe to provide supplies for clinical programs at all stages of drug development

The program's success is essential to timely delivery and high-quality clinical supplies. Societal CDMO collaborates with various pharmaceutical and biotech companies, small and large, worldwide to provide supplies for clinical programs at every stage of drug development.

 

We have implemented adaptable, phase-appropriate systems to deliver finished drug products that meet the demands of fast-paced clinical programs. This includes manufacturing matching placebos for your active drug product.

 

If your product is in a specialty area, such as ophthalmic inhalation powders, we may also be able to assist you. Don't hesitate to contact our experts to discuss your specific requirements. Our extensive clinical manufacturing and packaging capabilities are designed to handle small and large volumes, ensuring a customized solution for drug products' manufacturing and packaging needs.

 

Our cGMP clinical manufacturing and packaging facilities in the United States support global trials. 

Commercial cGMP Drug Manufacturing & Packaging

Engages in large-scale specialty production of solid and liquid pharmaceutical finished drug products and controlled substances within our cGMP facilities.

Commercial Manufacturing:

When your pharmaceutical finished drug product is prepared for scale-up to commercial manufacturing, or if you need to transfer or qualify a secondary manufacturing source, Societal CDMO San Diego is ready to assist you. With over 30 years of experience in US-based commercial pharmaceutical manufacturing and development, we produce and supply bulk finished drug products and packaged drug products for markets worldwide.

  • Oral Solid Tablets

    • DEA License for Schedule II, IIIN, IV, V, List I

    • Capable of handling solvents

  • Oral Solutions and Suspensions

    • 2,000 L jacketed tanks

    • Manufacturing batch sizes up to 4,000 L

Commercial Packaging:

  • Automated bottle packaging line for capsules and tablets

    • HDPE bottles 40cc – 500cc

    • Serialization, aggregation, tracking, and trace

  • Automated packaging line for oral solution and suspensions

    • HDPE bottles 20mL to 500mL

    • Serialization, aggregation, tracking, and trace

  • Controlled temperature warehouse

    • Vaults for Controlled Substances

  • Global distribution

Formulation Development

We assist you in creating high-quality finished dosage forms, including control-released oral solids, oral liquids, long-acting injectables, topicals, and other innovative drug delivery systems.

We have the expertise and a proven track record to formulate a wide range of finished pharmaceutical products, such as:

  • Oral solids (immediate or modified-release), tablets, capsules, and multi-particulates

  • Oral liquids

  • Injectables (liquid or lyophilized)

  • Novel drug delivery technologies (from liposomes to long-acting microspheres and beyond)

Your pharmaceutical molecule plays a crucial role. A vital initial step is creating a robust and effective drug product formulation tailored to your specific dose, administration route, and patient demographic. When you collaborate with our team, we begin by understanding objectives and addressing any concerns you may have. We prioritize long-term relationships and value teamwork. Unlike larger conglomerates, we offer speed, flexibility, attention, and responsiveness.

More Details:

Quality Assurance

Our quality management system enhances design, development, production, and distribution, providing a competitive edge through innovation and continuous quality improvement

At Societal CDMO San Diego, we are dedicated to being the leading contract development and manufacturing organization (CDMO) for both small and medium-sized pharmaceutical clients and their patients. Quality management and assurance are fundamental to operations. We aim for exceptional leadership, compliance, and service throughout every drug development project life cycle phase.

Our commitment to quality for our customers is straightforward — we strive to uphold industry standards while providing high-quality pharmaceutical products, processes, and services to ensure the satisfaction of both customers and patients.

 

We are focused on maintaining a quality system that aligns with cGMP set by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and international health authorities. Our dedication to customer satisfaction drives us to continuously enhance the quality of our products, processes, and services We make certain that the appropriate environment, training, and tools are in place to support this commitment.

Technology Transfer

We specialize in technology transfer and supports early phase development through to commercial manufacturing. Discover our unique approach to technology transfers.

Societal CDMO San Diego possesses the capability and knowledge to seamlessly transfer your technology while assisting you from early-stage development to commercial manufacturing. Discover more about our distinctive approach to technology transfers.

Technology transfers play a crucial role in the development life cycle, paving the way for successful pharmaceutical manufacturing. The objective is to leverage existing products and process knowledge, including critical product attributes and process parameters, alongside a robust quality systems infrastructure to establish a manufacturing control strategy and process qualification. Once it is confirmed that the parameters set during development align with the design space or are adjusted during scale-up, product realization is achieved.

At Societal CDMO San Diego, our experienced team employs proven procedures to guarantee a successful product transfer. We tailor our process to address each product’s specific technical challenges, goals, and objectives. Our commitment is facilitating the quickest and most efficient technical transfers, maximizing technical, commercial, and regulatory success.

Facilities & Equipment

Our top-tier drug product development and manufacturing includes R&D, analytical development, quality control labs, manufacturing, and packaging, perfectly  to meet your project needs

Our state-of-the-art drug product development and GMP manufacturing facility spans 245,000 square feet, featuring analytical development, quality control labs, manufacturing, packaging, and more, ideally positioning us to meet your project requirements. Our knowledgeable team possesses extensive experience, including DEA-controlled substances, to support you in bringing your product from concept to market.

cGMP QC & Analytical Development Equipment:

Our labs are equipped to create and validate testing methods and conduct testing on raw materials, in-process items, and finished products

  • Chromatography

  • Spectroscopy

  • Dissolution

  • Moisture analysis

  • Particle size analysis

  • Total Organic Carbon (TOC)

  • Polarimetry

  • Friability

  • Differential Scanning Calorimetry (DSC)

  • Thermal Gravimetric Analysis (TGA)

Development and Commercial-Scale Manufacturing Equipment:

We offer equipment for various needs, from initial feasibility and formulation development to commercial manufacturing.

  • Blending

  • Bead manufacturing and coating

  • Granulation

  • Tablet coating

  • Milling

  • Compression

  • Fluid-bed and spray-drying

  • Encapsulation

  • Lyophilization

  • Microfluidization

  • Thin Film Freezing

  • Liquid and semi-solid Filling 

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