Download A Complete Guide to Aseptic Manufacturing
Pii has released the first in a series of e-books about Aseptic Manufacturing. You will learn how to:
- Overcome the challenges of a fill/finish tech transfer
- Integrate robotics into your fill/finish
- Select alternative primary packing options
- Choose the right CDMO partner for your aseptic manufacturing needs
AND get the answers to your FAQs about parenteral production, lyophilization, sterilization processes, and cGMP practices.
Aseptic manufacturing of parenteral drugs presents many challenges and sterile fill/finish requires skilled project managers and specialized state-of-the-art equipment and facilities. This is why bio/pharma companies are partnering with contract development and manufacturing organizations, like Pii.
Parenteral Drug Development
Surging demand for self-administered drugs, a rise in the adoption of monoclonal antibodies, and increased research to fund parenteral drug development are some of the reasons why the parenteral drug market is poised to reach a staggering value of $802 billion by the end of 2029, according to FACT. MR.
Parenteral drugs are pharmaceutical preparations given by any other route besides by mouth or anally. Any enteral preparation has to pass through the stomach and liver before being absorbed into the body and a sizeable part is destroyed or modified by these organs. Hence, parenteral preparations are made for drugs that should reach target organs in almost unchanged form. Also, the time to achieve therapeutic blood level reduces with these preparations.
For these reasons, parenteral drug development requires skilled and experienced scientists who specialize in aseptic filling, terminal sterilization, and lyophilization, and cytotoxic drugs into vials, syringes, and cartridges.
Aseptic Manufacturing Resource Center
The global aseptic pharma processing market was valued to be $10 billion in 2020 and is expected to reach $24 billion by 2031, according to ResearchAndMarkets.com. This growth is attributed to the reduced risk of high-cost product loss, high growth in the generics and biopharmaceuticals markets, and growing demand for contract manufacturing organizations for aseptic manufacturing of pharmaceutical products.
There were close to 500 parenteral drugs in the pipeline as of 2018 and the proportion of which requiring parenteral administration rose by ~2% from 2018 to 2019, according to a report from Fact.MR. This growth is driving CDMOs to make significant investments in advanced manufacturing capabilities as aseptic processing requires careful planning, thoroughly trained personnel, and specialized facilities/equipment and automation to properly execute. Highly specialized CDMOs have adopted specific aseptic processing technologies and have the cleanroom facilities to minimize contamination risk from personnel, materials, and equipment.
Vaccine - Fill & Finish Tech Transfer
From the outset of the pandemic, companies demonstrated how beneficial tech transfer can be. Groundbreaking collaborations resulted in around 358 voluntary partnerships for vaccine production – of which over 89 percent included technology transfer – helping to make possible the unprecedented production of over 11 billion doses of COVID-19 vaccines by the end of 2021. Pharmaceutical companies were able to find trusted partners that met several rigorous criteria for tech transfer and had the ability to scale up. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) says this is a testament to both their technical capacity, but also to the value partner countries placed on technology transfer as a key economic and development growth opportunity.
IFPMA warns that an effective tech transfer demands the right infrastructure is in place. “The transfer process is not as simple as sharing a vaccine recipe,” says Thomas B. Cueni of IFPMA. While all tech transfers present their unique set of challenges, vaccines are especially complex and often require regulatory experts as part of the tech transfer process. Vaccines require special temperature control and handling procedures.