Special Thanks to our Loyal Clients from our President |
“As Founder and CEO of Quality Chemical Laboratories I appreciate your confidence in our science and collaborative efforts in the important work of developing treatments and therapies for the many health care challenges in the world. QCL’s strength in science allows us to offer solutions. Thanks to your company for allowing QCL to provide services as an approved outsourcing partner.
It is an exciting year as QCL is constructing a new facility doubling our footprint with more laboratories, new manufacturing capabilities, *sterile fill/finish, and lyophilization services. *New facility planned to be online in 2024/2025….” – Yousry Sayed, PhD |
“We do what is scientifically right and treat our clients as partners or extensions of QCL. If a client has a problem, QCL has a problem to solve.”
As this is the inaugural edition of QCL’s Newsletter, we’d like to start off with an explanation of the purpose of the newsletter. We are aiming to add some insights into the breadth of QCL’s capabilities and its future. QCL was founded in 1998 and started as an analytical contract laboratory for the pharmaceutical industry. Over the past 25 years QCL has grown into so much more than just a contract lab, we have become a brand that “Delivers Science, Compliance & Quality into Medicines” and are now a full-service Contract Development & Manufacturing Organization (CDMO).
General updates
- QCL has added NMR to their testing services. This was previously sub-contracted, but we now have the instrument qualified and ready for GMP use.
- QCL has added a new CCIT* (non-destructive) equipment, Sepha – multi-Q-HD that utilizes either pressure or vacuum decay. The old method can still be performed but is done by dye-ingress and is time-consuming. The new method can be performed much quicker, and this obviously makes our clients happier.
- Additional laboratory space for Biotech, HPLC (FP), LC/MS & GC/MS are soon to be opening in 2024 in the new construction 3220-C.
*Container Closure Integrity Test
Sponsor organizations
- Parenteral Drug Association (PDA)
- PDA-SE Chapter (Official Sponsor) https://www.pda.org/chapters/north-america/southeast#sponsorship
- Triangle Biotech Tuesday (TBT) https://www.trianglebiotechtuesday.com/
- International Society for Pharmaceutical Engineering (ISPE) https://ispe-casa.org/event/2023-ispe-port-city-connects/#registration-form#registration-form
new construction - 3220-C
QCL is expanding our manufacturing capability. QCL’s current manufacturing department is limited to oral solid dose and non-sterile formulations. This includes capsules, tablets, mini-tablets, solutions, films, creams, and gels. We can do formulation development of sterile products, but only non-GMP work at this time.
QCL’s main initiative with the expansion is to move into sterile fill/finish manufacturing of early phase clinical trial materials and small-scale commercial products. Most of the 110,000 ft2 space is dedicated to two (2) sterile fill-finish lines from AST (Pictured left). These machines were custom built for QCL and house some of the most advanced automated fill/finish technology available. The isolator-barrier technology utilizes highly reliable robotics for hands-free processing and rapid change over of equipment.
The larger of the 2 lines (AST GENiSYS R20i) will have liquid and lyophilization capabilities and is still awaiting delivery to QCL. This line will be qualified with 2R vials and 20R vials with an operating speed up to 20 vials per minute.
The smaller line (AST GENiSYS C20i) is an advanced and compact filling and closing system for automated processing of nested, custom, and ready-to-use vials, syringes, and cartridges. Qualification and validation activities have begun, and the line will be qualified with 10R vials with operating speeds up to 10 vials per minute. See these systems in action at the following link: https://www.youtube.com/watch?v=dTvNU0Lkk74
QCL plans to have the new facility ready for GMP manufacturing by 2025.