Frequently asked questions

PAN-Biotech is a German life science company specializing in products and solutions for cell culture and bioprocessing, from upstream cell cultivation to downstream purification and formulation. Its portfolio includes cell culture media, sera, supplements, reagents, buffers, stock solutions and water products for research, biotechnology and biopharmaceutical manufacturing.

PAN-Biotech supports applications including Cell & Gene Therapy, Vaccine Production, mRNA Technology and Antibody Production with research-use-only (RUO), GMP-grade and customized solutions.

PAN-Biotech was founded in 1988 in Aidenbach, Germany, and has more than 38 years of experience in the life sciences and cell culture industry. The company develops and manufactures products for research, biotechnology and biopharmaceutical applications, including solutions for upstream and downstream bioprocessing.

PAN-Biotech is based in Aidenbach, Bavaria, Germany, where its products are developed and manufactured. The company produces cell culture, bioprocessing and GMP-grade products in Germany, supporting both upstream and downstream applications under its “Made in Germany” quality commitment.

PAN-Biotech is led by Jens Hartmann, President and CEO of PAN-Biotech GmbH. Under his leadership, the company focuses on cell culture, bioprocessing and solutions for research, biotechnology and biopharmaceutical manufacturing.

PAN-Biotech is guided by four core values: innovation, integrity, customer focus and quality. These values shape the company’s approach to product development, manufacturing, customer relationships and long-term partnerships across the life sciences and biotechnology industries.

PAN-Biotech serves customers across the life sciences, biotechnology, pharmaceutical and healthcare sectors. Its customers include universities, research institutes, biotechnology and pharmaceutical companies, diagnostic and clinical laboratories, hospitals, contract development and manufacturing organizations (CDMOs), and distributors of laboratory and life science products.

PAN-Biotech supports customers throughout the bioprocessing workflow, from upstream applications such as cell cultivation, cell expansion and media preparation to downstream processes including purification, buffer preparation and formulation. The company therefore serves both research laboratories and organizations involved in regulated biopharmaceutical manufacturing.

PAN-Biotech operates a certified quality management system in accordance with ISO 9001 and ISO 13485 and is also FDA registered. For regulated biopharmaceutical manufacturing, PAN-Biotech and its GMP manufacturing arm, PAN-Celltech, manufacture GMP-grade products in facilities designed and operated in accordance with EU GMP Annex 1 requirements.

PAN-Biotech is primarily a manufacturer, developing and producing its own cell culture media, sera, reagents, buffers and water products in Germany. Its portfolio supports the complete bioprocess, from upstream cell cultivation and media preparation to downstream purification, buffer exchange and final formulation.

Products are available for applications including Cell & Gene Therapy, Vaccine Production, mRNA Technology and Antibody Production.

PAN-Biotech combines in-house manufacturing in Germany with an integrated portfolio for both upstream and downstream bioprocessing. Upstream solutions support cell expansion and bioreactor processes, while the downstream portfolio includes GMP buffers, stock solutions, process reagents and WFI-quality water for purification, viral safety, UF/DF and final formulation.

Customers can scale from research-use-only (RUO) products to GMP-grade and customized manufacturing while working with one supplier across the bioprocess.

PAN-Biotech offers customized manufacturing, CMO, CDMO and OEM services in addition to its standard product portfolio. Manufacturing capabilities cover upstream products such as cell culture media and supplements as well as downstream buffers, stock solutions, reagents and water solutions.

Services include customer-specific formulations, process development, scalable production, customized packaging and GMP-grade manufacturing for regulated biopharmaceutical applications.

PAN-Biotech follows a sustainability approach based on the principles “Recycle, Reduce, Replace.” Initiatives include the free return and recycling of PET cell culture bottles, reducing plastic use through larger-volume bag formats, and promoting serum-free cell culture solutions where appropriate.

PAN-Biotech also works to reduce its environmental impact through measures such as solar-powered electricity, sustainable resource use and waste reduction.

PAN-Biotech both develops and manufactures its own portfolio of cell culture media, sera, reagents, buffers, water products and other life science solutions. In addition, the company offers customized manufacturing based on customer-specific formulations, packaging and process requirements.

These capabilities support both upstream and downstream bioprocessing, from research-use-only (RUO) products to customized and GMP-grade solutions for biotechnology and biopharmaceutical applications.

Citrate Buffer 100 mM, pH 3.0 (CT-62500) is the standard low-pH elution buffer, and it doubles as the low-pH viral-inactivation hold. Glycine 100 mM, pH 3.0 (CT-69500) is the alternative.

Yes. PAN-Biotech provides batch-specific Certificates of Analysis (CoAs) for its products. Customers can request the relevant CoA by contacting PAN-Biotech and providing the product and batch or lot number.

No. PAN-Biotech products are intended for in-vitro laboratory use, research or further manufacturing, depending on the specific product. They are not approved for diagnostic or therapeutic use in humans or animals.

Customers are responsible for ensuring that a product is suitable and compliant for their specific intended application.

Standard PAN-Biotech products can be ordered directly through the online shop. For some destination countries, direct online ordering is not available, and orders over 70 kg also require an individual quotation.

In these cases, customers can use the “Request an offer” function in the shopping cart. PAN-Biotech will provide a customized quotation, and the order becomes valid once the customer confirms the offer in writing, for example by email.

There is no minimum order quantity for PAN-Biotech standard catalog products. For custom formulations, contract manufacturing or customer-specific batch production, minimum quantities depend on the product, formulation and manufacturing process.

PAN-Biotech reviews each custom project individually and confirms feasible batch sizes as part of the quotation process.

PAN-Biotech confirms receipt of your order promptly. The order becomes binding once PAN-Biotech accepts it by email or dispatches the goods; acceptance may take place within 10 days after receipt of the order.

If you need to change or cancel an order, please contact PAN-Biotech as soon as possible. Changes or cancellations are generally easiest to process before the order has been formally accepted or shipped.

Yes. Customers can request a formal written quotation through the PAN-Biotech online shop using the “Request an offer” function, or by contacting the PAN-Biotech sales team directly.

The quotation includes the applicable product and shipping costs and becomes binding once it is accepted in writing.

Yes. PAN-Biotech offers product samples to support testing, development and research activities, depending on product availability and intended use. Customers can request a sample through the PAN-Biotech service center and provide details about the product and planned application.

For Fetal Bovine Serum (FBS), smaller FBS SHOTS are also available for product evaluation, with selected products available directly through the online shop or upon request.

PAN-Biotech offers several payment methods, including payment by invoice and selected online payment options available through the PAN-Biotech online shop.

For orders with payment after delivery, invoices are due upon receipt of the goods and invoice without deduction, unless different payment or cash-discount terms are explicitly stated on the invoice. In the event of late payment, the applicable terms are governed by PAN-Biotech’s General Terms and Conditions.

PAN-Biotech prices are quoted in Euros (EUR) and exclude statutory value-added tax (VAT). Unless otherwise agreed, additional costs such as packaging, shipping and, for international orders, applicable customs duties or other official charges may be added separately.

The applicable prices and additional costs are shown in the individual quotation or during the ordering process.

PAN-Biotech ships its products from Aidenbach, Germany. Expected delivery times depend on the product, destination and shipping conditions and are provided on the relevant product page or in the order confirmation.

Unless a specific delivery date has been agreed, delivery periods are approximate. According to PAN-Biotech’s General Terms and Conditions, a dispatch period of approximately three weeks applies where no other delivery period has been stated or agreed.

Yes. PAN-Biotech ships products to customers worldwide. For many destinations, orders can be placed directly through the PAN-Biotech online shop.

If direct online checkout is not available for your country, you can use the “Request an offer” function in the shopping cart. PAN-Biotech will then provide an individual quotation including the applicable shipping conditions and costs.

Orders over 70 kg cannot be completed through standard online checkout. Instead, customers can use the “Request an offer” function in the shopping cart to receive an individual quotation based on the most suitable shipping option.

The order is confirmed once the quotation has been accepted in writing.

The warranty period for PAN-Biotech products is one year from the date of delivery, unless otherwise agreed or specified for the individual product.

If a PAN-Biotech product arrives damaged or defective, please notify PAN-Biotech in writing as soon as the issue is discovered. If requested, the affected product should be returned for inspection.

If the complaint is confirmed as valid, PAN-Biotech will repair or replace the product as appropriate and reimburse standard return shipping costs.

For orders, product questions or general enquiries, you can contact PAN-Biotech by email at info@pan-biotech.de or by phone at +49 8543 6016 30.

You can also use the PAN-Biotech online contact form and service center for product samples, Certificate of Analysis (CoA) requests, recycling enquiries and other support requests.

PAN-Biotech GMP-grade products are manufactured by PAN-Celltech in a dedicated EU Annex 1 facility under validated and controlled conditions. They are supplied ready-to-use, with full batch traceability, a Certificate of Analysis and Certificate of Conformity for each batch, and Drug Master File (DMF) support where available.

Yes. PAN-Biotech GMP-grade products are manufactured by PAN-Celltech in a dedicated facility designed and operated in accordance with EU GMP Annex 1 requirements for sterile manufacturing. Production is carried out under controlled and validated conditions to support regulated biopharmaceutical applications.

Yes. Every PAN-Biotech product can be supplied in GMP quality on request. A growing range of GMP-grade products is available as standard, while other catalogue formulations can be manufactured as customized GMP products by PAN-Celltech.

This approach supports both upstream and downstream bioprocessing and enables customers to scale from research-use-only (RUO) development to regulated clinical and commercial manufacturing.

Yes. PAN-Biotech offers matched research-use-only (RUO) and GMP-grade formulations across its upstream and downstream portfolio. This includes cell culture media as well as buffers, reagents, water products and other bioprocessing materials.

Matched grades allow customers to develop and qualify their processes in research and transition to GMP manufacturing while keeping the formulation and supplier consistent where corresponding grades are available.

Yes. PAN-Biotech GMP DPBS (CT-36500) is backed by a filed FDA Type IV Drug Master File (DMF). Customers can reference PAN-Celltech’s confidential manufacturing and quality data in their own regulatory submission through a Letter of Authorisation.

Yes. PAN-Biotech offers customized GMP manufacturing for media, buffers, reagents and other sterile solutions according to customer-specific formulations and process requirements.

GMP production is carried out by PAN-Celltech, the GMP manufacturing arm of the PAN-Biotech Group, in a facility designed and operated in accordance with EU GMP Annex 1. Batch sizes can be scaled up to 1,000 L and are supported by the required quality and batch documentation.

PAN-Biotech offers a range of ready-to-order GMP-grade products through its GMP portfolio. For larger volumes, customer-specific formulations or custom GMP manufacturing, customers can contact the PAN-Biotech sales team directly to discuss requirements and receive an individual quotation.

PAN-Biotech operates a certified quality management system in accordance with ISO 9001 and ISO 13485. The company is also FDA registered, listed with EDQM, and licensed under EU Regulation 1069/2009 (Vet. No. DE 09 275 0001 14).

Sterile products are filled under clean-room conditions according to EU GMP criteria, while GMP-grade manufacturing is carried out in facilities operating in accordance with EU GMP Annex 1 requirements.

Yes. PAN-Biotech performs in-house quality testing for endotoxins, mycoplasma, sterility, pH, osmolality, conductivity, RNase/DNase activity and other relevant quality parameters.

Performance testing can also include cell growth, plating efficiency and cloning efficiency, supporting comprehensive quality control for research-use-only (RUO) and GMP-grade products.

PAN-Biotech research-use-only (RUO) products are designed for research and process development, while GMP-grade products are intended for regulated clinical and commercial manufacturing.

GMP-grade products are manufactured under controlled conditions with qualified raw materials, enhanced documentation and full batch traceability. PAN-Biotech provides RUO and GMP solutions across both upstream and downstream processing, supporting the transition from cell culture and process development through purification and final formulation.

Customers should consider transitioning from research-use-only (RUO) to GMP-grade materials as early as practical when a process is intended for regulated clinical or commercial manufacturing.

PAN-Biotech supports this transition with matched RUO and GMP-grade products across upstream and downstream processing. This helps customers move from cell culture and process development through purification and formulation while keeping formulations and the material supplier consistent where matched grades are available.

Yes. PAN-Biotech develops and manufactures customized media, reagents, buffers and other bioprocessing solutions based on customer-specific requirements.

Customers can define parameters such as components to include or exclude, buffering requirements and liquid or powder format. PAN-Biotech evaluates the technical feasibility and provides an individual quotation for the custom formulation.

Yes. PAN-Biotech offers CMO, CDMO and OEM services for biotechnology and pharmaceutical companies across both upstream and downstream bioprocessing.

Services include the manufacture of cell culture media, reagents, buffers, stock solutions and other bioprocessing materials, as well as formulation development, process optimization, scalable manufacturing, customized packaging and private-label production.

Turnaround times for custom manufacturing depend on the product, batch size, documentation and qualification requirements. PAN-Biotech is set up for flexible, time-critical production and can assess urgent requests individually based on current manufacturing capacity.

In previous GMP projects, PAN-Biotech has provided quotations within days and completed large-volume custom production within a matter of weeks.

PAN-Biotech offers different contract manufacturing models depending on the customer’s needs. As a Contract Manufacturing Organization (CMO), PAN-Biotech manufactures existing customer formulations. As a Contract Development and Manufacturing Organization (CDMO), the company also supports formulation development and optimization.

As an Original Equipment Manufacturer (OEM), PAN-Biotech produces customer-specific or private-label products according to defined formulations, packaging and labeling requirements. These services are available for media, reagents, buffers and other upstream and downstream bioprocessing solutions.

Yes. Through its “Gateway to Europe” program, PAN-Biotech supports non-EU companies with local manufacturing, GDP-compliant logistics and distribution within Europe.

As an OEM and CMO partner, PAN-Biotech can also support technology transfer, quality control and product release according to customer-specific requirements.

Yes. PAN-Biotech provides a batch-specific Certificate of Analysis (CoA) for its GMP water products, including WFI Quality Water and WFI Beyond.

For WFI Beyond, the CoA documents parameters including appearance, conductivity, total organic carbon (TOC), endotoxin, RNase/DNase activity, sterility and all 24 ICH Q3D elemental impurities.

Yes. PAN-Biotech provides lot-specific Certificates of Analysis that document the relevant specifications and test results for its GMP water products.

For WFI Beyond, the CoA includes measured results for parameters such as conductivity, total organic carbon (TOC), endotoxin, sterility, RNase/DNase activity and all 24 ICH Q3D elemental impurities. The corresponding analytical methods and pharmacopoeial references are defined in the product specification and quality documentation.

Yes. PAN-Biotech can establish customer-specific Quality Assurance Agreements (QAAs) and formal change-notification agreements for its GMP water products.

The scope is defined individually based on the customer’s quality, regulatory and supplier-qualification requirements. Where a change-notification agreement is in place, customers are informed of quality-relevant changes that may affect the product.

PAN-Biotech WFI Quality Water and WFI Beyond are produced using a membrane-based process rather than distillation. The validated purification process includes reverse osmosis, ultrafiltration, electrodeionization and final sterile filtration.

WFI Quality Water meets the applicable Ph. Eur. and USP Water for Injection requirements. WFI Beyond goes beyond these compendial requirements by meeting additional and more stringent specifications for selected quality parameters, including endotoxin, RNase/DNase activity and elemental impurities.

PAN-Biotech’s Open Downstream is a complete GMP downstream processing (DSP) system, offering qualified buffers, stock solutions, reagents and WFI-quality water for every major step of biologic purification.

The portfolio supports downstream processes including harvest and clarification, capture, viral inactivation, chromatographic polishing, ultrafiltration/diafiltration and final formulation. WFI Beyond is available as an optional beyond-compendial water standard for applications with particularly demanding purity requirements.

Yes. PAN-Biotech offers GMP-grade buffers, stock solutions, reagents and water products for every major downstream processing step, from harvest and clarification through capture, viral inactivation, chromatographic polishing, ultrafiltration/diafiltration and final formulation.

A core set of frequently used stock solutions, including sodium chloride, Tris, citrate, acetate, phosphate and histidine, can be used across multiple downstream stages. Standard GMP products are available for common requirements, while custom GMP formulations can be manufactured for process-specific applications.

PAN-Biotech’s downstream products are grouped in the Downstream / DSP section of the product portfolio. Individual product pages provide information such as composition, available pack sizes and article numbers.

Customers can use these product pages to identify suitable buffers, stock solutions, reagents and water products for specific downstream processing steps.

PAN-Biotech’s standard downstream products are stocked in defined pack sizes: 500 mL for high-volume buffers, salts, CIP reagents and water products, and 100 mL for concentrated excipients and additives.

For larger-scale downstream processing, 1,000 mL bottles and single-use bags from 1 L up to 1,000 L are available on request, allowing customers to scale from development to GMP manufacturing.

Yes. Every PAN-Biotech downstream buffer is available on request in a beyond-compendial version manufactured with WFI Beyond — Water for Injection engineered beyond the Ph. Eur./USP monograph.

This option is intended for downstream applications with particularly demanding endotoxin and purity requirements and can be selected specifically for the process steps where enhanced water quality is required.

Yes. PAN-Biotech can manufacture customized downstream formulations for specific process requirements, including buffers, stock solutions and reagents.

Custom GMP formulations are produced by PAN-Celltech according to customer-specific recipes and specifications, allowing customers to adapt individual downstream process steps while remaining within the PAN-Biotech manufacturing platform.

Yes. The core PAN-Biotech Open Downstream range consists of catalogue GMP-grade products manufactured by PAN-Celltech in a facility operated in accordance with EU GMP Annex 1 requirements and within an ISO 9001-certified quality management system.

Each batch is supplied with a Certificate of Analysis. Selected products, including GMP DPBS (CT-36500) and WFI Beyond, are additionally supported by filed FDA Type IV Drug Master Files.

PAN-Biotech aims to dispatch standard in-stock downstream catalogue products within 24 hours of order. Actual delivery times depend on the destination, shipping method and product requirements and are shown on the relevant product page or order confirmation.

Larger formats, customized GMP formulations and beyond-compendial versions are produced to order, with lead times depending on the specific product and project requirements.

PAN-Biotech supports the major stages of downstream processing (DSP), including harvest and clarification, capture, viral inactivation, chromatographic polishing, ultrafiltration/diafiltration (UF/DF), final formulation and quality control.

The Open Downstream portfolio provides GMP-grade buffers, stock solutions, process reagents and water products for use across these purification and formulation steps.

PAN-Biotech offers GMP-grade buffers, concentrated stock solutions, process reagents, excipients and Water for Injection (WFI) quality water for downstream processing.

The portfolio includes materials used for equilibration, washing, elution, viral inactivation, chromatography, ultrafiltration/diafiltration and final formulation, with standard, scalable, customized and beyond-compendial options available.

PAN-Biotech provides concentrated stock solutions such as sodium chloride, Tris, citrate, acetate, phosphate and histidine that can be used across multiple downstream processing steps.

Using a core set of qualified stock solutions allows customers to prepare process-specific working buffers while reducing the number of individual raw materials that need to be sourced and qualified.

PAN-Biotech supports downstream processes from research and process development through to GMP manufacturing with matched research-use-only (RUO) and GMP-grade products, scalable packaging and customized formulations.

Customers can start with smaller formats during development and scale to larger bottles or single-use bags of up to 1,000 L while keeping the supplier and, where matched grades are available, the formulation consistent.

Water is a fundamental raw material in downstream processing because it is used to prepare buffers, stock solutions and process reagents and can also be present in final formulation steps. Its quality can therefore influence multiple stages of purification and the quality of the materials used throughout the process.

PAN-Biotech offers WFI Quality Water that meets Ph. Eur./USP requirements as well as WFI Beyond for applications requiring additional control of parameters such as endotoxins, nucleases and elemental impurities.

Compendial downstream materials are manufactured to meet applicable pharmacopoeial requirements such as Ph. Eur. and USP specifications. PAN-Biotech’s beyond-compendial approach adds additional control and documentation for impurity risks that may be relevant to modern biopharmaceutical manufacturing.

Depending on the product, these controls can include endotoxins, RNase/DNase activity, elemental impurities, residual solvents, nitrosamines, extractables and leachables, and animal-origin risks. Beyond-compendial downstream buffers can be manufactured with WFI Beyond on request.

PAN-Biotech’s downstream portfolio supports biopharmaceutical processes for Monoclonal Antibody Production, mRNA Technology, Cell & Gene Therapy and Vaccine Production.

Although the purification processes differ between these applications, they all rely on qualified buffers, process reagents and water products for steps such as clarification, chromatography, concentration, buffer exchange and final formulation.

PAN-Biotech provides buffers, stock solutions, process reagents and water products for major downstream steps in monoclonal antibody manufacturing, including Protein A capture, low-pH viral inactivation, chromatographic polishing, ultrafiltration/diafiltration and final formulation.

The portfolio includes standard GMP-grade products as well as scalable, customized and beyond-compendial options for process-specific requirements.

Upstream processing (USP) covers cell growth and product expression, including cell expansion, seed train development and cultivation in bioreactors. Downstream processing (DSP) begins after harvest and covers recovery, purification, concentration and formulation of the target biologic.

PAN-Biotech supplies materials for both stages, including cell culture media and supplements for upstream processing and GMP-grade buffers, stock solutions, reagents and water products for downstream processing.

Buffers are essential in downstream processing because they control pH, ionic strength and other process conditions during purification, washing, elution, viral inactivation, ultrafiltration/diafiltration and final formulation.

PAN-Biotech offers GMP-grade buffers and concentrated stock solutions for multiple downstream processing steps, including standard, scalable, customized and beyond-compendial options.

Downstream processing is critical because it determines how effectively a biologically produced therapeutic product is recovered, purified, concentrated and formulated after production in the upstream process. Each downstream step must remove impurities while maintaining product quality, stability and consistency.

PAN-Biotech supports these processes with qualified GMP-grade buffers, stock solutions, reagents and water products for purification and formulation workflows.