Quality and Experience Crucial for Sterility Assurance

The increasing complexity of drug substance and formulated drug products is affecting the entire supply chain. At the same time, expectations for quality assurance are climbing, and patients are demanding innovative drug delivery systems that provide convenience. CDMOs like Dalton Pharma Services with extensive experience in sterile manufacturing combined with a long track record of compliance and the use of closed process systems have a competitive edge.

Sterile Liquid and Powder Filling

Dalton Pharma Services is a cGMP contract service provider of integrated chemistry, drug development and manufacturing services, including expertise in cGMP API and solid and sterile finished dose manufacturing. With all services located in our single facility in Ontario, Canada, we have full control over all sterile processing — including aseptic manufacturing/sterile filtration and low bioburden filling followed by terminal sterilization with wet or dry heat or gamma irradiation — from start to finish.

Extensive Qualification and Validation

Extensive qualification and validation combined with strong microbiologic analysis capabilities and experienced and highly trained operators are essential for achieving successful sterile fill/finish operations. In addition to these capabilities, Dalton has a solid environmental monitoring program for both viable and nonviable particles. Operators are subjected to comprehensive gowning and aseptic process-operation qualification procedures. All cleanrooms are qualified and validated before use, as are all equipment and components that support sterile processing, cleaning agents (used for a minimal time at a minimal concentration) and microbiological methods.

Sterile Chemical Reactions

In addition to traditional sterile processing capabilities, Dalton has the unique ability to perform aseptic organic chemistry processes. This capability is made possible through the installation of a restricted-access barrier system (RABS) designed specifically to handle organic solvents. As a result, we can perform aseptic crystallizations and other transformations, including nanoparticle synthesis. We are able to convert non-sterile APIs into sterile APIs and then package them in bulk or into dosage units.

Sterile Liposomal Formulations

Liposomal formulations are increasingly common, because they can be used to enhance the solubility of poorly soluble APIs. Liposomes are also used in some formulations to protect sensitive APIs from other ingredients in the formulation and to enable delayed or targeted delivery of APIs. The size of liposomal particles varies significantly. Some are sufficiently small to pass through aseptic filters, while others are larger and cannot be filtered. Formulations containing these liposomes must be terminally sterilized, but sterilization in an autoclave often changes the percent liposomal encapsulation and/or the liposomal size distribution. These products must be produced via aseptic formulation, which is more complicated and requires specialized equipment and expertise.

Quality and Experience

Dalton places an emphasis on quality, reliability, speed and flexibility — all at one centralized location. We move projects seamlessly from inception to cGMP manufacturing, simplifying client supply chains and reducing timelines and cost.

Our commitment to quality and our comprehensive quality systems ensure that our facility is under excellent control at all times. An inspection conducted by the U.S. Food and Drug Administration in January 2019 resulted in zero 483 citations, confirming our high performance. These results were achieved despite the complex sterile processing projects that Dalton tackles on a regular basis, from sterile liposomal and nanoparticle formulations to sterile crystallizations. 

With more than 30 years of experience in sterile liquid manufacturing and 17 years in sterile powder manufacturing, including aseptic filling and terminal sterilization of a wide variety of APIs and formulation types using many different types of equipment, Dalton has amassed significant knowledge that is applied to each new project.

Our dedicated and committed workforce brings together highly trained engineers and scientists from all over the world with international experience and different perspectives and viewpoints. This diversity ensures an open-minded approach to innovation and problem solving that adds real value for our clients.

This expertise is supported by our ongoing continuous improvement efforts and investments in our facility and equipment. A recent $10 million facility and capital expansion project included addition of a new automated sterile liquid filling system and analytical capabilities for elemental impurities. We will also soon expand our powder filling capacity with the addition of a high-throughput robotically controlled sterile powder filling line. 

Peter Pekos

Mr. Pekos is CEO of Dalton Pharma Services, which he co-founded in 1986. He has managed all phases of its growth into a leading supplier of contract drug development and manufacturing services to the global pharmaceutical and biopharmaceutical industries. Mr. Pekos has founded several other companies. He served as the founding Chairman of ventureLAB, a not-for-profit, Regional Innovation Center. He obtained his MSc. in synthetic chemistry at York University and his BSc. degree in chemistry/biochemistry at the University of Toronto.