What are parenteral solutions, and why are they important in contract manufacturing?

Parenteral solutions are sterile preparations intended for injection directly into the bloodstream or tissues, bypassing the digestive system. In contract manufacturing, these solutions are critical for delivering active pharmaceutical ingredients (APIs) safely and efficiently. Manufacturers must meet stringent regulatory standards, ensuring the sterility and quality of these products to prevent contamination and ensure patient safety.

What factors should be considered when selecting a parenteral manufacturing partner?

Key factors include compliance with Good Manufacturing Practice (GMP) guidelines, advanced aseptic processing capabilities, and a proven track record in sterile product handling. The ability to scale production and offer comprehensive services—from formulation development to packaging and distribution—is also essential for meeting pharmaceutical clients' needs.

What technologies are used in parenteral contract manufacturing?

Technologies include aseptic filling lines, lyophilisation (freeze-drying) capabilities, advanced HEPA filtration, automated inspection systems, and cold chain distribution for temperature-sensitive products. These innovations ensure the safety, stability, and sterility of parenteral solutions throughout the production process.

How do regulatory requirements impact parenteral manufacturing?

Manufacturers must comply with regulatory authorities like the FDA and MHRA, ensuring their processes meet rigorous standards for sterility, product safety, and efficacy. Regular audits and quality checks ensure adherence to these standards, helping manufacturers avoid delays in production and ensuring successful product launches.

What advancements are shaping the future of parenteral manufacturing?

Key advancements include automation through robotics, the use of isolator and Restricted Access Barrier Systems (RABS) for enhanced sterility, and smart containers with embedded sensors for real-time monitoring. These innovations improve manufacturing efficiency, product safety, and traceability, leading to better outcomes for pharmaceutical companies and patients alike.

Injectables

Buyer's Guides

Parenteral solutions in contract manufacturing for the pharmaceutical industry

Free Buyers Guide Parenteral solutions in contract manufacturing for the pharmaceutical industry The document includes detailed information on the manufacturers…

Buyer's Guides

Pharmaceutical injectables companies (commercial dose) in contract manufacturing for the pharmaceutical industry

News

Sandoz launches ustekinumab biosimilar in Europe

Analyst Comment

Birmingham researchers develop nanobodies for platelet disorders

Analyst Comment

EASD 2023: efficacy of initial TCT in drug-naïve patients with T2D

Sign up to the newsletter: In Brief

I would also like to subscribe to:

Pharma Technology Focus : Focus (monthly)

Thematic Take (monthly)

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close

Sections

Sections

Sections

Sections

Sections

Sections

Parenteral solutions in contract manufacturing for the pharmaceutical industry

Pharmaceutical injectables companies (commercial dose) in contract manufacturing for the pharmaceutical industry

Sandoz launches ustekinumab biosimilar in Europe

Birmingham researchers develop nanobodies for platelet disorders

EASD 2023: efficacy of initial TCT in drug-naïve patients with T2D

Digital health and digital therapeutics (DTx) services and providers for the pharmaceutical industry

Leading artificial intelligence (AI) companies in pharma

Sign up for our daily news round-up!

Sign up to the newsletter: In Brief