Aseptic Fill & Finish – The Critical Step in Sterile Manufacturing

Peptides are short chains of amino acids that act as highly specific biological messengers in the body. Because of their precision, potency, and favorable safety profiles, they have become one of the fastest‑growing classes of therapeutic molecules used in metabolic diseases, oncology, infectious diseases, and cosmetic applications.

CordenPharma is a global leader in peptide drug substance development and manufacturing. With 130 years of cumulative peptide expertise, the company provides end‑to‑end capabilities including SPPS & LPPS synthesis, Tag-Assisted Peptide Synthesis (TAPS), oral peptide manufacturing, complex peptide conjugations, HPLC purification, precipitation, analytical development, scale‑up expertise, and peptide-injectable fill & finish. Discover our Peptides platform.

Oligonucleotides are short chains of nucleotides, the basic building blocks of DNA and RNA. They typically range from about 15–30 nucleotides, though they can be shorter or longer depending on their application. Their defining feature is their ability to bind sequence, specifically to complementary DNA or RNA, which makes them powerful tools in both research and therapeutics.

CordenPharma delivers comprehensive oligonucleotide capabilities, combining GMP oligonucleotide manufacturing with state-of-the-art aseptic fill & finish, to provide true end-to-end support from API development through final drug product.

Proteins are large, complex molecules made up of long chains of amino acids. They play essential roles in all living organisms, from building tissues and enzymes to driving immune responses and cellular communication. Their structure determines their function, and because they are biologically active, they often require careful handling, controlled environments, and specialized formulation when developed as injectable therapies.

CordenPharma formulates and fills proteins, including antibodies and fragments (ABs, fABs), as part of our injectable development capabilities.

Monoclonal antibodies (mAbs) are lab‑made proteins designed to mimic the way the immune system naturally identifies and neutralizes harmful targets. They are created by producing many identical copies (“clones”) of one specific antibody that binds to a single, precisely defined antigen. This makes mAbs highly targeted tools used widely in medicine, including treatments for cancer, autoimmune diseases, infections, inflammatory conditions, and more.

CordenPharma offers the filling of injectables containing monoclonal antibodies.

High potency typically describes active ingredients or drug products that are biologically active at extremely low doses and therefore require special containment and handling measures for operator safety. Highly potent compounds are routinely used in oncology because many cancer treatments act at very small therapeutic doses with targeted, powerful effects.

CordenPharma provides fully integrated, end-to-end Highly Potent & Oncology services spanning the development & manufacturing of APIs and Drug Products, including aseptic filling and packaging. Learn more about our Highly Potent APIs & Oral Solid Drug Product Manufacturing.

Advanced Therapy Medicinal Products (ATMPs) are a class of innovative medicines for human use that are based on genes, tissues, or cells. They represent some of the most advanced biomedical technologies and often offer treatment options for diseases that previously had no cure.

CordenPharma’s injectables filling services and LNP (Lipid Nanoparticle) capabilities directly support key ATMP-related therapeutic classes, such as mRNA, oligonucleotides, plasmid DNA (via partnerships), and other genetic payloads. Discover our Lipid Nanoparticle (LNP) formulation development & GMP manufacturing services.

Small molecules are low molecular weight drug substances, typically below ~900 Da, that can enter cells easily and interact with biological targets such as enzymes or receptors. They are usually chemically synthesized, stable, and most often administered orally, but they can also be formulated as sterile injectables, nasal sprays, liquids, and other dosage forms.

CordenPharma offers extensive capabilities across the full value chain, from small molecule API development & manufacturing through final drug product, including aseptic fill & finish when the small molecule requires a sterile presentation.

Discover our Oral Solid Dose (OSD) small molecule manufacturing capabilities.

• 3 Aseptic Filling Lines: Including Robotized Open RABS (Restricted Access Barrier Systems) for maximum sterility assurance.
• Future-Ready Expansion: Installation of 2 new isolator lines (1 high-speed PFS filling line for late stage & commercial and 1 flexible combo line for phase 1-3, small-scale commercial (operational mid-2027 & 2028))
• Ready-to-Fill (RTF): Fully compatible with Nest & Tub formats for efficient aseptic processing.

• Pre-Filled Syringes (PFS): 1 ml to 10 ml (fill volumes starting from 0.5 ml).
• Vials: Standard sizes from 2R to 20R.
• Cartridges: Dedicated filling for 3 ml formats.
• Inspection: Manual & fully automatic inspection lines for both PFS and vials.

• Batch Sizes: Flexible range from 10 L to 300 L .
• Compounding: Choice of Stainless Steel vessels or Single-Use Systems (Disposable) to eliminate contamination.
• Pumps: Rotational or Peristaltic pumps (gentle handling for shear-sensitive biologics).
• Lyophilization: Integrated freeze-dryer for stable lyophilized vials.