Lyophilization & Sterile Injectable Formulation Facilities

The Experts in Lyophilization (Cake Form Parenteral)

Advantages of Lyophilization

Lyophilization, freeze drying, is a crucial enabling process technology for many important parenteral drugs. Close to 60 percent of biopharmaceuticals including enzymes, proteins, hormones and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready to use solution dosage forms.

In solution, many drug substances are susceptible to even modest changes in temperature and chemical environment. These complex molecules undergo hydrolytic, oxidative and aggregation reactions, compromising both potency and safety. Consequently, parenterals must often be distributed cold chained refrigerated or maintained frozen from manufacturing line to patient. Even then, freezing and/or thawing may cause some proteins to aggregate. Lyophilization overcomes poor stability by rending labile drugs and proteins in a solid form more tolerant of long term product storage.

Lyophilisation extends the shelf life of drugs and biological, preserving their chemical and biological properties. It involves less cumbersome storage and handling. Lyophilization reduces the temperature requirement for shipping and protects the biological vitality. Compared with other methods, lyophilisation dries biological at a lower temperature, reducing the damage to the product and retaining the molecular integrity.

Finished Formulations & Categories;

Advantages of Lyophilization

Inthera PharmaMed has extensive experience in sterile contract manufacturing with a wealth of lyophilization expertise. In particular, the optimization of the freeze drying process as it relates to cycle times represents a critical attribute for complex parenteral product development.

Inthera PharmaMed experts support customers’ product development to achieve product stability and improved shelf-life of products destined for clinical or commercial applications. Our fill-finish service for Sterile Powder Lyophilized Vials offers individual filling, suites with lyophilization capacity, along with an intrinsically safe process that enables the use of non-aqueous solvents.

Inthera PharmaMed partnering facilities for Sterile Lyophilization Filling where separate and dedicated filling lines exist to handle non-potent compounds.


>> Aseptic Filling using Nest & Tub technology & Materials

>> Batch Sizes range from 1 – 50 L

>> Vials from 2 R – 10 R

>> Lyophilizer (1 sqm) with Capacity Range of up to 4,000 vials (2 R) – 1,000 vials (10 R) per cycle.

>> Aseptic Fill & Finish plant hosting 2 different lines for Pre-Filled Syringes and Vials respectively. The Vial line can manage Liquid Formulation or Lyophilized Formulation, where the filling line is connected to a 5 sqm Lyophilizer able to handle up to 20,000 vials (2R) or 8,000 vials (10R) per freeze-drying cycle respectively.

Sterile Liquids

Inthera PharmaMed has a long track record of experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampoules, vials and pre-filled syringes. Our facility and equipment design, combined with experienced and trained personnel, is pivotal for success in sterile manufacturing.

Inthera PharmaMed has two main areas of production with a focus on Non-Potent traditional Small Molecules, through its long-standing expertise in Terminal Sterilization, and Aseptic Fill & Finish, through special expertise in the handling of large molecules such as Peptides, Oligonucleotides, Carbohydrates and Biologics.

Terminal Sterilization & Filling

>> 3 Separate Process Rooms Equipped with APV High-pressure Homogenizers & Solution Vessels, with batch sizes ranging from 200 L to 1250 L

>> 5 Filling Lines (3 for Vials, 1 for Ampoules, 1 for Pre-filled Syringes (PFS) /Cartridge – custom)

>> 5 Autoclaves (rotating)

>> Container Range 10 – 100 ml (option 5 ml and 150 ml )

>> Inspection

>> Automatic Inspection Machines for 20 ml & Pre-filled Syringes (PFS)

>> Semi-Automatic Inspection Machines for any other vials (50 ml & 100 ml)

Aseptic Fill & Finish

Inthera PharmaMed Commercial Aseptic Fill & Finish plant hosting 2 different lines (segregated one from the other) for Pre-Filled Syringes and Vials respectively. Our manufacturing process is highly sophisticated and includes automatic inspection, packaging and serialization.

>> Aseptic Filling using Nest & Tub Technology & Materials

>> Batch Size range from 1 to 50 L

>> Vials from 2 to 10 R and PFS from 1 ml (Std or LONG) to 10 ml