In general, what are some current challenges facing pharmaceutical companies developing new parenteral products?
The nature of injectable product’s route of administration dictates application of highest quality and sterility standards to all such products. Tight regulatory requirements are necessary to comply with those standards, leading to the use of sophisticated equipment in a highly controlled cGMP environment. These key factors are vital to deliver on product quality and safety. On the other hand, they may become a serious challenge for a pharmaceutical company sponsoring development of a new parenteral drug.
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. Currently, business models involving a CMO partner for parenteral drugs are widely used in the industry by all types of players, spanning from Big Pharma to biotech startups.
Please tell me about PYRAMID Laboratories and the services it offers to companies wishing to develop and manufacture parenteral products.
PYRAMID Laboratories, Inc. is a CMO focused on parenteral drug products, offering a comprehensive pipeline of services to pharmaceutical and biotech companies.
Established in 1988, we are based in Southern California, USA. Our three-building campus, conveniently located between Los Angeles and San Diego, covers over 90,000 square feet of state of the art facilities, allowing PYRAMID to offer a wide range of services 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/GLP setting.
For 30 years, we have provided clients with Top Quality reliable services assuring that their critically important parenteral products reach patients in need.
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: Analytical Method Development and Validation; Formulation, Lyophilization and Process Development; Clinical and Commercial Vial and Syringe Fill / Finish; Clinical and Commercial Product Lyophilization; Labeling and Packaging; Parenteral Storage and Distribution; API and Drug Product Stability Studies, and Clinical Trial Material Management.
When a company is looking for a provider of parenteral drug development and manufacturing services what are some of the questions a company should ask a potential contract development and manufacturing services provider? How does PYRAMID Laboratories answer these questions, and, how does PYRAMID Laboratories set itself apart from other companies offering similar services?
There are several key aspects that a company should focus on while evaluating CMO candidates:
- Industry reputation
- Expertise and training of personnel and management
- Regulatory and audit history
- Capabilities – from development to commercial
- Accessibility / Site Visits and Tours
- Personal commitment to client goals and objectives
- Management involvement in client projects and, most importantly,
- The company track record with clients and regulatory agencies.
At PYRAMID, we consider our reputation as the key asset of our business. This is why we only take projects in which we are confident of being able to deliver top-quality results within the agreed timeline. Our management and personnel have decades of experience in all aspects of parenteral product development and manufacturing, supported by advanced degrees in chemistry and life sciences. Our business model accommodates both a broad range of services for every stage of parenteral product development, and a flexible and dedicated approach to every client’s needs, making us an ideal partner for injectable development and manufacturing. All of the above allows us to successfully collaborate with multiple clients of different sizes and organizational structures, and many of these partnerships are still strong and successful after ten or more years.
PYRAMID Laboratories offers a wide range of drug development and manufacturing services. How does the company integrate all of its services into one cohesive package and how does this benefit your clients?
A one-stop-shop business model to which PYRAMID adheres is a win-win strategy for both the client and the CMO. It is more time and cost-effective for our clients to have a single CMO partner for the whole project, than to collaborate with multiple companies on different stages of product development, undergoing several tech transfers and increasing uncertainty. It is also beneficial for us to have a stable relationship with the client all the way through the product’s development and manufacturing cycle.
Throughout our 30-year history, we have continuously expanded our capabilities to offer our clients a greater range of services: from analytical services to manufacturing of vials and later pre-filled syringes on clinical and commercial scale to stability studies and cGMP storage and distribution services. Currently, PYRAMID is capable of covering every aspect of parenteral drug development and manufacturing from pre-formulation development studies and clinical Phase I batches to commercial manufacturing and distribution. Recently, one of the products that was developed at PYRAMID was licensed by a Big Pharma player. We are also very proud of successfully passing three PAI’s in 2016 with no Form 483s issued.
Looking forward, are there any new technologies or services that PYRAMID Laboratories is evaluating to better serve the parenteral drug development and manufacturing needs of its current and future clients?
PYRAMID is growing rapidly. We recently increased our facility footprint which will allow us to continue developing our services portfolio. We are also setting up a new microbiological laboratory to bring all microbial testing in-house. Several other projects are in earlier stages of development. These activities will expand the technologies and services that we offer to existing and new clients. To learn more about our services, we invite you to meet us at our booths at CPhI North America 2018, TIDES 2018 and Bio 2018.