GMP / cGMP Manufacturing

Botanical drug industry is a new emerging one. To stay competitive, ABDC stays focused on domain expertise of botanical drug and guides already established GMP manufacturing capability to offer cost-effective botanical product GMP manufacturing service of clinical trial materials and commercial pharmaceutical products:

  • Scale up from R&D to cGMP manufacturing

  • Technology transfer

  • Drug development process

  • Formulation optimization

  • Clinical trial materials GMP manufacturing

  • Pharmaceutical products manufacturing

  • Release testing

  • Certificates of Analysis

  • Formal stability studies according to ICH guidelines

  • Commercial product manufacturing

 
 

Aseptic Processing

The aseptic manufacturing of sterile drug products that are subject to a new or abbreviated drug application (NDA or ANDA) takes specific know-how and proficiency. 

During aseptic processing, the drug product, container, and closure are first subjected to sterilization methods separately, and then brought together. Before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes. To ensure product sterility from initial processing through aseptic packaging, the sterilization, aseptic filling, and closing operations are all validated.

  • Aseptic processing

  • Aseptic filling

  • Aseptic packaging

 

Clinical Supply Manufacturing

Packaging and labeling for:

  • Sterile fill syringes

  • Bottles

  • Over encapsulation

  • Blister packaging

  • Bulk packaging

  • Bulk labeling

  • Sachets

  • Powder in bottle

Pharmaceutical product dosage forms:

  • Capsules, hard gelatin or HPMC (hydroxypropyl methyl cellulose), liquid-filled

  • Capsules, hard gelatin or HPMC, powder-filled

  • Capsules, controlled or sustained release

  • Tablets, immediate release

  • Tablets, controlled or sustained release

  • Tablets, enteric-coated

  • Topical gels, creams, ointments

  • Oral liquids

  • Over-encapsulation

  • Injectables, including lyophilization

 

Specialty Commercial Manufacturing

Process of formulation improvement and validation includes:

  • Formulation and process optimization of drug product

  • Scale-up from R&D to commercial cGMP batch manufacturing

  • Process validation

  • Technology transfer

Once the dosage form is decided on, specialized technology is utilized to accomplish manufacturing on site.

  • Oral Solid Tablets, Liquid-Filled Hard Gelatin Capsules

    • Multiple-dose to single daily dose

    • Controlled release of highly water-soluble drugs

    • Immediate release of lipophilic drugs

  • Topicals, Gels

    • Increased bioavailability

    • Enhanced stability

    • Optimized Viscosity

    • Optimized network for high electrolyte content

  • Parenteral Injectables, Intramuscular, Subcutaneous and Intravenous

    • Increased circulating half-life, optimized biodistribution

    • Improved safety and efficacy

    • Pharmacodynamically optimized formulations

    • Long-acting formulations

 

Ophthalmic Clinical and Commercial Manufacturing

Process to complete a fully sterile ophthalmic drug begins with sterile water, an important component in the ophthalmic manufacturing process. Once completely purified, the water is piped through airtight aseptic tubes to assure that no impurities can contaminate the water and jeopardize its sterile nature.

Next, the water is mixed with the pharmaceutical grade raw materials that have been tested for ID potency and bioburden. Although the measuring process is computer controlled, the entire process is being overseen by IRISYS scientists.

Once the solution has passed in-process Quality Control Testing, it passes through redundant sterilizing filters into sterile eye dropper bottles. This step in the process is completed by a fully automatic filling machine without any human contact. The robotic machine then inserts dropper tips, the bottles are capped and labels automatically applied. It is at this point that serialization can take place. Full aggregation from bottle to shipper to pallet is available for small and large batches.

Throughout the ophthalmic manufacturing process testing is performed for:

  • Water Quality

  • Absence of Microbiological Contamination

  • Physical and Chemical Characteristics

  • Adequacy of Environment Conditions (Environmental monitoring)

  • Once the bottles are filled and packaged and quality control tests have been completed to ensure the finished product meets all specifications, Quality Assurance reviews and approves all documentation and the drugs are sent out to the clinical sites for human testing or distribution centers for commercial distribution.

 

Lyophilization

​Lyophilization has been around since 1890 and was originally used in the food industry. Lyophilization is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. Products can be lyophilized directly in vials, or in trays with later packaging of the powdered material.  Lyophilized powders and can be easily stored and shipped. Storage in the solid state at controlled moisture content can provide a significant stability advantage for active pharmaceutical ingredients.

We have a technologically advanced commercial injectable vial filling and lyophilization system, built by SP Industries, capable of GMP filling of 2 mL up to 50 mL vials. Large scale capacity up to about 7,500 X 10R vials per batch.

Philadelphia, USA