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Biologics and biosimilars Understand how to bring biologics to market, from research to regulatory compliance.


How to bring biologics and biosimilars to market

The increasing prevalence of chronic diseases and the aging population have created a growing demand for effective and innovative treatments. For chronic diseases such as autoimmune disorders or cancer, and those associated with old age, such as rheumatoid arthritis, biological drugs offer effective long-term solutions for patients, improving their quality of life.

As our understanding of the mechanisms of diseases improves, researchers can identify specific paths and molecular targets for intervention. Due to their suitability for targeted disease management, biological drugs are often preferred over traditional medications, as they frequently exhibit higher effectiveness and fewer side effects. Advances in biotechnology, including genetic engineering and recombinant DNA technology, have expanded the range of diseases that biologics can treat.

The individualization of biological drugs tailored to individual patient profiles allows for personalized treatment plans, particularly relevant in oncology and other areas where genetic variability plays a significant role. The continuous development of new biological drugs broadens the treatment options available to patients and physicians.

Regulatory agencies have established frameworks for the development and commercialization of both original ‘innovator’ biological drugs, and Biosimilars (an officially approved version of an ‘innovator’ product which is manufactured after expiry of the original product patent).

Nevertheless, for drug development professionals, there are two major regulatory hurdles on the road to commercial success: the clinical trial application, which defines the scope of the clinical testing phase; and the marketing authorization application, which proves compliance.  (In the USA, these are known as the investigational new drug Application and the new drug application respectively.) Approval by the regulatory authorities for both is obligatory. The challenge is that the regulations and standards for entry differ for each regional or international market. 


Containment and delivery for biologics

Despite their advantages for treating disease, biological drugs also bring new challenges for primary packaging. An experienced guide will help you reduce the time to market and maximise the value of patent protection.

Biologics Molecule


Biological drugs often contain sensitive proteins that can denature or degrade when exposed to environmental factors such as light, heat, or oxygen. Therefore, primary packaging must provide a barrier against these elements.


Contamination risks are higher with biologics because they are derived from living organisms, so primary packaging must prevent microbial contamination and maintain sterility throughout the product's shelf life.

Storage temperature

Some biologics require storage at specific temperatures, including freezing, so packaging materials must withstand freeze-thaw cycles without compromising the drug's integrity.

Container interaction

Biological drugs can interact with the packaging, leading to leachables and extractables that could impact product safety, so packaging materials must be carefully selected to obviate these interactions.


Compatibility between the drug and the packaging material is crucial, since some biologics may interact with specific container materials, affecting drug stability and efficacy.


Precise and consistent dosage delivery is essential for biologics, as small variations can have significant clinical implications, so primary packaging must enable accurate dosing.


Since Biologics are not only administered by professional healthcare providers, but increasingly by patients themselves, primary packaging must facilitate easy and safe administration, via features such as prefilled syringes or auto-injectors.



Storage temperature

Container interaction





Partnership based on knowledge and experience

We promote human health by collaborating with drug developers to create complete containment and delivery solutions for biologic and biosimilar drugs. Thanks to our detailed knowledge of materials, markets and regulations we can show you an effective path to achieving compliance for your primary packaging. We are experts in every stage of development for drug containment and delivery solutions: from design & selection; through clinical testing; to commercialisation and production.


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Pre-Clinical Research

The objective of the pre-clinical phase is not simply to identify viable formulations. Based on their research, the R&D team also submits a clinical trial application which accurately describes the drug and the scope of testing on humans. In this context, the drug must work in tandem with primary packaging to provide safe & effective container for storage, delivery and administration, too.

Container design

We can turn your concept into a reliable containment solution, by evaluating the feasibility of ideas, testing prototypes & documenting development with Design History Files.

Learn more about drug containment and delivery services

Container selection

Analytical services from our independent laboratories will validate the compatibility of your containment solution for the requirements of your specific drug product.

Learn more about analytical testing services

Clinical phases I, II, III

These test phases ensure that only safe and effective medications reach the market. A series of carefully designed trials on human subjects, determines whether the drug, its primary packaging and its administration mechanisms treats the targeted medical condition safely and effectively; and identifies risks or adverse reactions.

Clinical testing

Analytical testing validates the compatibility of your containment solution with the requirements of your specific drug product. This generates objective data to support the selection of the ideal containment solution, solve root-cause challenges, and prepare regulatory-compliant evidence about containers and combination devices for new drugs.

Learn more about analytical testing services

Independent laboratories

Rigorous testing at our accredited facilities examines key aspects such as the compatibility between drug and materials, packaging performance, or container closure integrity testing (CCIT) and includes document management prior to submission.

Learn more about SCHOTT Pharma's PartnerLab



Turning a promising drug candidate into a viable product that generates revenue and profit requires more than just successful compliance. You will need to plan the scale-up and scale-out of production facilities carefully to ensure effective manufacture and distribution.

From early samples to commercial production 

For customers without the capability to fill samples for testing, we offer flexible fill-and-finish operations for syringes, cartridges and vials. Scalable production enables you to match the growing volumes required for early-stage testing, or clinical testing through phases I, II and III.

Learn more about fill-and-finish services

Scale-up and scale-out

After approval, we can quickly scale-up as production transitions to full commercialisation while maintaining the highest standards of container quality, safety, and efficacy. Our manufacturing and support network permits scale-out of primary packaging production across 16 global locations, to avoid disruptions and ensure stable and consistent supply. Once a new drug is brought to market, production filling in RTU format can also be scaled out effectively. Sourcing via multiple CMOs - with fill-and-finish taking place in parallel across a number of facilities to supply local markets – is fast path to scale-out, and reduces the risk of international supply-chain interruptions.

Learn more about RTU and time-to-market



Containment solution choices

When you want to explore the choices that are open to you, SCHOTT Pharma is ready to assist. We have hands-on experience of a wide range of drug containment and delivery materials, formats, shapes and sizes. 

SCHOTT FIOLAX® is a Type I Borosilicate that continues to be the de facto quality standard for glass in the pharmaceutical industry. And our advanced Cyclic Olefin Copolymer (COC) solutions lead the way in break-resistant, lightweight, transparent syringes that come with full regulatory support and decades of expertise.

A polymer prefillable syringe is a solution for deep cold drug storage and transport

Polymer syringes

SCHOTT TOPPAC®  prefillable COC syringes are designed to reduce contamination risks and keep biologics stable for increased shelf life. These syringes feature a cross-linked silicone layer for minimal silicone interactions and superior stability of sensitive biologic drugs. COC syringes do not release ions, have minimal protein adsorption, and maintain a stable pH over time for optimal long-term storage stability. They are highly adaptable and easily integrated into existing fill-and-finish processes, making them ideal for a wide range of therapeutic applications.

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Glass syringes

syriQ BioPure® and syriQ BioPure® silicone-free prefillable glass syringes are ideal for storing and administering sensitive biologics, as the FIOLAX® Borosilicate Glass minimizes the risk of drug-container interaction. Prefillable syringes are suitable for both autoinjector and homecare use. Their low silicone levels and tight dimensional specifications support consistent gliding forces and injection times. In addition, pre-sterilised syringes, delivered in ready-to-use format, ensure flexible and cost-effective filling for short production runs, plus scalability for high volume production.

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A vial being a possible containment solution for low temperature mRNA vaccines


Vials made from FIOLAX® Type I Borosilicate Glass are the ideal platform for the development of high-value drugs as they ensure drug stability during research while reducing the risk of time-consuming reformulations should you choose to transition your drug to other containment and delivery formats during clinical trials. EVERIC® pure vials provide increased stability and delamination control for biologic drugs and their buffers. SCHOTT Type I plus® vials include silicone dioxide coating that reduces adsorption and ensures low leachable levels for biologics in the neutral and acidic pH range.

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Designed for reliable integration into self-injection devices such as pens, autoinjectors and wearable devices, cartriQ® high-precision RTU cartridges facilitate the transfer of administration from hospital to home care, by allowing patients to inject drugs easily and safely in the comfort of their own home. cartriQ® solutions are available in a range of small and large volume single chamber formats. Double-chamber cartridges provide an elegant solution for single-dose delivery of lyophilized drugs. SCHOTT Pharma's cartridges are available in both flexible and bulk filling options.

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Experts for vials, cartridges, glass & polymer syringes will help you design & select the containment and delivery solution that is most appropriate for your drug.


Clinical testing and analysis by our independent and FDA-accredited laboratories in Germany, Switzerland and the USA, will help you demonstrate compliance.


Our knowledge of international regulations and standards, as well as country-specific laws and guidelines, will help you to prove drug safety and efficacy.


Our global network of in-house experts will help you reduce time-to-market and maximise the value of patent protection.

Get in touch

Diana Löber

Diana Löber

Product Manager Bulk & Sterile Solutions

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