Contract Manufacturing
Partner with ADMA Biologics for clinical-stage or commercial aseptic filling and final packaging requirements
Our in-house aseptic fill-finish capabilities offer clinical stage and commercial clients the speed and flexibility demanded to meet the needs of caregivers and patients.
Leading the way with innovative immune globulin products
ADMA Biologics is an end-to-end commercial biopharmaceutical company leading a new age of manufacturing, marketing, and commercializing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
With three FDA-licensed approved products, including ASCENIV™ (Immune Globulin Intravenous, Human – slra), BIVIGAM® (Immune Globulin Intravenous, Human), and NABI-HB® (Hepatitis B Immune Globulin, Human), ADMA’s mission is to continue to successfully develop and commercialize plasma-derived, human immune globulins targeted to specific patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations.
- In-house aseptic filling capabilities with our FDA-approved Cytiva SA25 filling machine
- In-house finishing inclusive of packaging and serialization capabilities
- End-to-end fully commercial biopharmaceutical company
- Capable of full product transfers and initial phase product concept development
- Experts, with hands-on approach to production and development
- Excess capacity providing for potential public and private sector CDMO opportunities
Vertically integrated end-to-end capabilities from raw material collection to fill-finish
Plasma collection
Manufacturing
Plasma-derived biologics production facility
Testing & Validation
QC/Scientific lab
Commercial & Medical Affairs
Distribution
In-house aseptic filling with FDA-approved Cytiva SA25 filling machine
Our in-house aseptic fill-finish capabilities offer clinical stage and commercial clients the speed and flexibility demanded to meet the needs of caregivers and patients.
- Robotic filling technology
- No gloveports
- Validated vaporized hydrogen peroxide (VHP) cycle
- Single-use, disposable flowpath
Leading the way with innovative immune globulin products
ADMA Biologics is an end-to-end commercial biopharmaceutical company leading a new age of manufacturing, marketing, and commercializing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
With three FDA-licensed approved products, including ASCENIV™ (Immune Globulin Intravenous, Human – slra), BIVIGAM® (Immune Globulin Intravenous, Human), and NABI-HB® (Hepatitis B Immune Globulin, Human), ADMA’s mission is to continue to successfully develop and commercialize plasma-derived, human immune globulins targeted to specific patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations.
In-house finishing including labeling, packaging, and serialization
- Automated machine labeling with camera inspection
- Serialization with camera inspection and weight checks
- Integrated team for filling inspection and finishing
Leading the way with innovative immune globulin products
ADMA Biologics is an end-to-end commercial biopharmaceutical company leading a new age of manufacturing, marketing, and commercializing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
With three FDA-licensed approved products, including ASCENIV™ (Immune Globulin Intravenous, Human – slra), BIVIGAM® (Immune Globulin Intravenous, Human), and NABI-HB® (Hepatitis B Immune Globulin, Human), ADMA’s mission is to continue to successfully develop and commercialize plasma-derived, human immune globulins targeted to specific patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations.
Commercial scale QA systems and QC lab capabilities
Quality assurance
- Electronic documentation management and control
- Incoming raw materials quality assurance
- Quality on-the-floor operations inspection
- Product release reviews
Quality control/scientific laboratory
- Product testing and release
- Small scale process development
- Assay development and validation
Our customer service model:
rooted in compliance, collaboration, and quality
Leading the way with innovative immune globulin products
ADMA Biologics is an end-to-end commercial biopharmaceutical company leading a new age of manufacturing, marketing, and commercializing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
With three FDA-licensed approved products, including ASCENIV™ (Immune Globulin Intravenous, Human – slra), BIVIGAM® (Immune Globulin Intravenous, Human), and NABI-HB® (Hepatitis B Immune Globulin, Human), ADMA’s mission is to continue to successfully develop and commercialize plasma-derived, human immune globulins targeted to specific patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations.
On time
Products will be delivered according to agreed timelines.
High quality
At ADMA Biologics we are dedicated to quality across all functions and ensure customers’ quality standards for finish & filling are met.
Error-free
At ADMA Biologics we have a world-class project management staff who will ensure no detail is overlooked.
On budget
All projects will be proactively managed within the approved budget. Changes in scope will be clearly communicated and documented.
Within compliance
Services are to be delivered within company policy and in compliance.
In partnership
We are dedicated to our customers and are committed to being a true partner in your success. We will collaborate with your team to meet your goals.
Recent publication on aseptic filling
Environmental monitoring for closed robotic workcells used in aseptic processing: data to support advanced environmental monitoring strategies
Authors: McCall J, Barnard N, Gadient K, et al.
Published: AAPS PharmSciTech. 2022;23, 215: 1-12