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GMP and cGMP with Ascendia Pharmaceutical Solutions

When developing new drugs, it’s important to understand and follow GMP/cGMP guidelines to ensure their product meets necessary safety and quality regulations. Ascendia Pharmaceutical Solutions adheres to GMP/cGMP standards, for sterile and non-sterile manufacturing. All our services are tailored to pharma companies to consistently deliver safe, effective drugs that improve lives.

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Ascendia Pharmaceutical Solutions has invested in talent, technology, and manufacturing space to now offer pharmaceutical and biological drug development teams services that extend from discovery to cGMP manufacturing. With the capabilities, clients can transition a development program quickly to cGMP manufacture of first-in-man clinical materials. with specialized equipment to manufacture aseptic sterile suspensions - and more efficient next-generation RNA-LNP development.

A Few Key Distinctions

GMP and cGMP

While GMP and cGMP are quite similar, they have a few key distinctions. GMP, or Good Manufacturing Practices, are the core regulatory standards established by the United States Food and Drug Administration (FDA). The FDA enforces these standards across all aspects of the drug manufacturing process to ensure that drug products are safe and effective.

cGMP, or Current Good Manufacturing Practices, are a more rigorous set of guidelines that build upon GMP. The aim is to ensure products are being manufactured, according to the most current and improved standards. So, as new information and standards become available, cGMP regulations evolve with them.

Key Differences between GMP and cGMP

There are two main areas where cGMP and GMP differ:

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Importance of Adhering to cGMP

There can be serious consequences if cGMP protocols aren’t followed. The FDA can demand a product recall, or they can withhold approval for a new product if cGMP regulations aren’t followed throughout the development and manufacturing process.

CDMOs, including Ascendia, that offer cGMP services receive frequent check-ins, virtually and in-person, to ensure they are compliant with current regulations. Additionally, they’re subjected to announced and unannounced visits to their facilities.

cGMP Offerings by Ascendia

Ascendia Pharmaceutical Solutions offers a comprehensive suite of cGMP-compliant formulation development and manufacturing services. They are tailored to both sterile and non-sterile product development.

cGMP Sterile Manufacturing

For injectables, ocular formulations, nasal preparations, certain topical dosage forms, and other sterile projects, Ascendia offers:

Four clean room with a freeze dryer for vials, and/or pre-filled syringes, with 100/10,000 classification and output capabilities of up to 5,000 units per batch

Four S1 clean rooms for vials, cartridge and/or pre-filled syringes, with 100/10,000 classification and output capabilities of up to 30,000 units per batch

Five S2 clean rooms (planned) for vials, with 100/10,000 classification and output capabilities of up to 150,000 units per batch

cGMP Non-sterile Manufacturing

For non-sterile oral formulations, including tablets, capsules, solutions and suspensions, and topical dosage forms:

Five S1 clean rooms with 100,000 classification and pilot batch-sized output capabilities of up to 100,000 units per batch

Eight S2 clean rooms (planned) with 100,000 classification and output capabilities of over 100,000 units per batch

Reach Out Today

Ascendia’s expertise extends beyond simply complying with cGMP. Our experienced team ensures that clients, and their products, meet regulatory requirements seamlessly to facilitate smooth audits and approvals, and can tailor solutions for diverse client needs.

If you’re looking for a CDMO who understands the complexities of cGMP for the development of successful pharmaceutical products, reach out today to see how we can become your Partner of Choice.