PYRAMID Laboratories, Inc.

Pyramid Laboratories, established in 1988, is located in Southern California, USA. Our facilities are housed in three (3) buildings covering approximately 70,000 sq. ft.

The main building contains our newly built, state-of-the-art commercial parenteral manufacturing facility, our quality control laboratory, and corporate offices.

The second building houses our clinical manufacturing facility. Our third building contains our warehousing, storage and distribution, shipping and receiving areas.

Our leading-edge manufacturing facilities allow PYRAMID to offer the pharmaceutical and biotech industries a wide range of services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products.

Each of our buildings is equipped with an emergency back-up power generator to provide 100% power to each building in the case of electrical power loss. Each of our laboratory instruments, computers, and manufacturing PLC’s are equipped with UPS units to cover the eight seconds required for the generator to provide power. This feature assures that critical operations such as lyophilization cycles and proper storage conditions for API, finished product, stability samples, and IT servers are maintained during any power loss.

A comprehensive in house QA/QC program is maintained to assure our clients that the services they receive are highest quality possible. PYRAMID’s QA/QC program adheres to the applicable regulatory requirements with attention to the specifics as outlined in the Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) guidelines, as well as European standards.

Over the years, PYRAMID has established a reputation for performance, professional integrity and quality services.

Formulation & Process Development

The scientific staff at PYRAMID Laboratories, Inc. has more than 30 years of experience across all areas of parenteral formulation and manufacturing. From pre-clinical through clinical and on to commercial manufacturing, PYRAMID focuses on optimizing your product’s stability and performance. With our in-depth expertise, we can assist your development efforts in the following areas:

• Liquid formulations
• Lyophilized formulations
• Suspension and dispersed-system dosage forms
• Manufacturing process design and optimization of existing processes
• Manufacturing scale-up and technology transfer

Whether your product is a small molecule or a biotech pharmaceutical (protein, peptide or oligonucleotide), PYRAMID can assist you in the design and execution of pre-formulation and formulation development studies that will help define your final drug product formulation. Of course, the results of the formulation development work must be integrated with primary packaging selection and process design phases to yield a parenteral product that meets or exceeds your performance expectations for clinical drug product, and ultimately, for a marketable product.

If you choose to lyophilize your drug product, PYRAMID has the experience and tools necessary to help design a stable dosage form along with an effective and efficient lyophilization cycle. PYRAMID scientists have an extensive knowledge of successful formulation strategies for stabilizing sensitive protein and peptide pharmaceuticals. Our differential scanning calorimeter and lab scale lyophilizers allow us to establish optimum lyophilization cycle parameters for your drug product.

PYRAMID’s well known and highly respected analytical testing laboratory will be an indispensable part of the development effort. Existing methods can be tech-transferred into the laboratory or the experienced PYRAMID analytical scientists can assist in the development of stability-indicating analytical methods for use in development studies as well as finished drug product release and stability studies. The laboratory has stability incubators covering the full array of ICH temperature and humidity conditions to support these activities. These incubators are connected to a back-up power supply and are continuously monitored by a SCADA system that will contact maintenance personnel if operational problems arise.

LYOPHILIZATION

Product & Cycle Development

PYRAMID’s goal in the development of a lyophilized drug product is to produce a pharmaceutically elegant and physico-chemically stable product that can be easily reconstituted and administered to the patient. Scientists at PYRAMID have the background and knowledge in lyophilization technology to assist you in reaching that goal for your drug product.

PYRAMID has the laboratory equipment, differential scanning calorimeter and laboratory-scale lyophilizers, to aid in the development of optimal formulations and lyophilization cycles for your drug product. Experience has shown that the cycles developed on our laboratory-scale units scale-up well to our clinical manufacturing lyophilizer, a 30 sq. ft. shelf area unit.

Clinical Manufacturing

Depending on the vial size, the clinical freeze dryer can lyophilize batches up to 7,000 vials. Of course, filling, loading and unloading of the clinical lyophilizer is done under Class 100 conditions in PYRAMID’s aseptic, clinical manufacturing facility.

Commercial Manufacturing

PYRAMID’s commercial, aseptic manufacturing facility has a much larger 213 sq. ft., Telstar lyophilizer that can accommodate up to 37,500 vials that are 5 mL or 10 mL in size. This lyophilizer has both CIP and SIP capabilities, is connected to a back-up power supply and is equipped with redundant critical operational components (coolant compressors, circulation pumps and vacuum pumps) to minimize the risk of breakdown during a freeze drying cycle. Vials to be lyophilized are washed, depyrogenated/sterilized, filled and stoppered on our IMA high speed, vial line located in our commercial, aseptic manufacturing facility.

CLINICAL SUPPLY MANUFACTURING

PYRAMID’s Aseptic Sterile Clinical Manufacturing services include formulation, processing, and filling capabilities for Pre-clinical, stability studies, and Clinical for both vial and syringe applications for the Biotech and Pharmaceutical industries, for all regulatory phases.

Clinical API’s for many clients are expensive. PYRAMID’s system and practices are designed to minimize losses, ensuring clients the highest maximum yield of finished product possible.

PYRAMID’s new state-of-the-art, commercial scale manufacturing facility can accommodate the transfer and scale-up from Phase III Clinical to Commercial manufacturing.

Development

• PYRAMID specializes in assisting with the development of processes and formulations for difficult products. Our capabilities include filling of various products with equipment designed for low volume aseptic fills. Product types range from simple solutions to more complicated delivery systems containing proteins, oligonucleotides, peptides, liposomes, etc.
• PYRAMID is highly specialized in developing and filling compounds that have low solubility

Vial Filling

• Currently PYRAMID fills a wide range of vial sizes: 2 mL, 3 mL, 5 mL, 10 mL and 20 mL. The filling machine is capable of up to 250 mL bottles.

Syringe Filling

• Our syringe filling and stoppering system utilizes the Becton Dickinson Hypak™ system and our liquid processing capabilities range from volumes less than one liter to over one hundred liters at a variety of fill volumes.
• PYRAMID fills 0.5 mL, 1.0mL, 2.25 mL, and 3 mL syringes routinely. The filling system can accommodate 5 mL and 10 mL syringe configurations as well.

Lyophilization

• The clinical freeze dryer can lyophilize batches up to 7,000 vials, depending on the vial size. Filling, loading and unloading of the clinical lyophilizer is done under Class 100 conditions in PYRAMID’s aseptic, clinical manufacturing facility.

Commercial Manufacturing

PYRAMID’s new state-of-the-art, Aseptic Commercial Manufacturing facility provides fill/finish services for both vial and syringe applications for the Bio-Pharmaceutical industries.

Vial Filling

PYRAMID’s new Commercial IMA vial-filling line is equipped with:

• Inline Washer – HYDRA 1300
• Sterilization (Depyrogenation) Tunnel – Blue Galaxy 870
• F200 Filling machine with a 100% Weight Check
• Capping Machine – ALU200
• Ink Jet Station – Libra /Videojet 1310
• Labeler – Labeler Sensitive 350
• Telstar Freeze Dryer – Lyomega 180 (213 sq. ft.)
• Currently PYRAMID fills a wide range of vial sizes: 2 mL, 3 mL, 5 mL, 10 mL and 20 mL.

Syringe Filling

• Our syringe filling and stoppering system utilizes the Becton Dickinson Hypak™ system and our liquid processing capabilities range from volumes less than one liter to over one hundred liters at a variety of fill volumes.
• PYRAMID fills 0.5 mL, 1.0mL, 2.25 mL, and 3 mL syringes routinely. The filling system can accommodate 5 mL and 10 mL syringe configurations as well.