Quality Focused Parenteral Manufacturing
PYRAMID Laboratories located in Costa Mesa, California offers a wide range of parenteral manufacturing services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both clinical and commercial products.
The company’s facilities are housed in three buildings encompassing 90,000 square feet which houses their state-of-the-art commercial parenteral manufacturing facility, quality control laboratory, corporate offices, a clinical manufacturing facility and warehousing, storage and distribution, shipping and receiving areas.
The company takes pride in its comprehensive QA/QC program. This program, which will soon be fortified with the addition of a new, in-house microbiology lab assures clients that they are receiving the highest quality possible.
Background and Capabilities
PYRAMID Labs was founded by its President and CEO Medhat Gorgy in 1988. The company’s original focus was on analytical testing, however, in 2000 the company transitioned to manufacturing injectables as a contract manufacturing organization (CMO). Starting from a 600 square foot lab, PYRAMID has grown to its present size in the span of 30 years.
Konstantin Kazarian, PhD, Project Manager, Business Development explains the company’s wide range of parenteral capabilities, “We are a CMO focused on parenteral drug products, offering a comprehensive pipeline of services to pharmaceutical and biotech companies, including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products. The analytical and development laboratory offers product development and analytical capabilities performing dozens of methods in a cGMP setting.”
He continues, “Our strategy is based on a ‘one-stop-shop’ concept which is focused on offering our clients a wide array of services for all phases of parenteral drug development, from early stages to commercial manufacturing.”
Industry Issues and Expertise
The pharmaceutical industry in general is a very technology and experience-based market. To be successful companies need to be aware of market trends and challenges. Operating in the highly specialized parenteral manufacturing segment of the market, as PYRAMID Labs does, only amplifies the need to keep abreast of industry issues, trends and challenges.
Dr. Kazarian explains the trends shaping the parenteral market, “We see two major trends that have been dominating the parenteral market for quite some time: the increasing number of biologics, combined with the trend towards improved usability of injectables for patients, which leads to increased presence of PFS (pre-filled syringe) solutions on the market. Tight regulatory requirements are also a hallmark for injectables, leading to the use of sophisticated equipment in a highly controlled cGMP environment. These key factors may become a serious challenge for a pharmaceutical company sponsoring development of a new parenteral drug.”
Konstantin continues. “These challenges include investment in advanced technology and skilled staff, together with monitoring of the market and industry environment and keeping up with new standards and regulations. Outsourcing of development and manufacturing of injectables is a cost-effective and efficient way to obtain technical expertise, operational efficiency, and regulatory support needed to produce such products.”
“At Pyramid we offer our clients decades of experience with injectable biologics in various formats: liquid and lyophilized vials, together with PFS.”
In addition to the technical experience PYRAMID labs brings to parenteral manufacturing, the company also has extensive experience working with all sizes and types of companies. “Due to versatility of our services, spanning from formulation development through all stages of clinical development to commercial manufacturing, our clients are very variable in size and organizational structure: from Big Pharma to small virtual biotech startups,” says Dr. Kazarian. “We have Big Pharma clients who have been working with us on regular basis for many years. We also work with a variety of mid and small-sized companies from all around the world including Canada, EU, Japan, China and Australia.”
Medhat Gorgy, President and CEO of PYRAMID Laboratories, adds detail to the company’s technical experience, “Most of our clients are either virtual companies or large pharma. Let’s start with the virtual companies. They come to us and they have a concept of a formulation. Sometimes when they come to us they do not have the final formulation or the delivery and so on. So we help a lot in this area. Big pharma, again, sometimes they have unique processes. They come to us and we are able to accommodate them and help them to develop the process.”
Mr. Gorgy continues, “We receive a lot of compliments in this area; that we were able to solve an issue that they were struggling with. We have a lot of expertise between the staff we have here and the number of years they have been in the industry. PYRAMID has built a reputation for creatively solving problems. We do not just follow the industry history or practices. We follow whatever it takes to deliver a safe drug to the patient.”
A Focus on Quality
PYRAMID Labs is a quality-based company with their Quality Assurance System at its core, around which all operations are structured. Patrick Biggins, the Executive Vice President of Operations at PYRAMID, describes the company’s quality-focused culture, “Medhat and the group here at Pyramid strive for quality. Quality is the cornerstone of the entire organization. We have the ability to work with clients from the beginning of product development all the way through the lifecycle of the product, and across that entire range is the quality system that we use here at Pyramid. It’s compliant with the European regulations, it’s compliant with the FDA regulations and it’s also compliant with other foreign or international companies.”
The addition of the company’s new microbiology lab will also reinforce the company’s commitment to quality, and its clients. “The new microbiology lab is going to be key,” says Mr. Biggins. “It’s going to help us continue our growth. We have a good foundation here and this is a service that we have looked at in the past and now we are starting to make the investment to provide that service. Microbiological testing can be a hindrance or an obstacle for a company going to market because you have to send the testing outside and now you are not only worrying about your clients’ schedule and your schedule, but now you have the schedule from the outside service. Bringing it inside will allow us to become more of a one-stop shop by providing that testing capability to our clients.”
Mr. Gorgy reinforces the company’s quality-based structure, “Our clients always tell us the Pyramid Laboratories Inc. name is associated with quality. We invest a lot in the quality system and training of our staff. This actually shows in our FDA inspection history. In April 2018, we had an unannounced FDA inspection that lasted nine days with three inspectors. It was very comprehensive and we received zero observations.”
A Focus on Clients
PYRAMID Labs offers a business model that accommodates both a wide range of services for every stage of parenteral product development, and a flexible and dedicated approach to every client’s needs.
Dr. Kazarian explains the details of the company’s client-focused program, “Every client has an assigned project manager, who is responsible for leading all project-related communications between the client and different departments of the company, in most cases acting as a single point of contact for the client. We provide openness and transparency encouraging clients to be present on site during manufacturing of their products. All new clients are welcome to come to our facilities for a tour to better understand our capabilities.”
President and CEO, Medhat Gorgy explains how the company works with new clients and how PYRAMID can accommodate the need for specialized equipment or services, “This is handled on a case by case basis. And the scale may vary dramatically, you can have a client come in and you have to purchase a dedicated piece of equipment. Typically, the client understands this is going to be very specific to their product. We do not share equipment or devices. It is always client specific. On the other hand, we might have a unique project that will require a very large investment of time, money and resources.
Mr. Gorgy continues, “Recently, we had a company that interviewed 21 CMOs, and they chose Pyramid to perform their special project. In this project, they invested a lot of money to customize their processes. The fortunate thing in this case with this company, is that we had the space and the expertise. Most of the time, of course, we have what the client is looking for, but once in a while, we have special requests and we will work to accommodate them.”
Looking Ahead
With a comprehensive quality assurance system in place and the experience and expertise to handle all sizes and types of client projects, PYRAMID Labs is looking toward the future. “Right now the company is growing,” says Mr. Gorgy, “and our immediate vision is to staff the company to meet the needs of this growth.” “Within the next year or so,” he continues, “we’re going to add two packaging lines for commercial vials and syringes. In addition, we’ll be adding another fill-finish facility at a higher speed to accommodate the volumes we’re receiving. I would say within the next two to three years, Pyramid should be at least double the size of what we have right now.”
“We will continue to focus on parenteral dosing, as this is our expertise.”